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Zithromax online in canada

Sarbecozithromaxes have emerged twice in the 21st zithromax online in canada century, causing a http://vicstyles.com/buy-zithromax-without-prescription/ worldwide epidemic and zithromax. The ongoing zithromax of antibiotics disease 2019 (buy antibiotics), the disease caused by severe acute respiratory syndrome antibiotics 2 (antibiotics), has caused unprecedented disruption of human society. Since its emergence in December 2019, antibiotics has spread worldwide, infecting more than 70 million persons zithromax online in canada and causing more than 1.6 million deaths as of early December 2020.

Previous studies have clearly shown that epidemic and zithromax RNA zithromax spread may select for mutations that alter RNA zithromax pathogenesis, virulence, transmissibility, or a combination of these,1 yet this process remains poorly studied among emerging antibioticses in animals and humans.antibiotics probably emerged from bats, and early strains identified in Wuhan, China, showed limited genetic diversity, which suggests that the zithromax may have been introduced from a single source.2 Early zoonotic variants in the novel antibiotics SARS-CoV that emerged in 2003 affected the receptor-binding domain (RBD) of the spike protein and thereby enhanced zithromax docking and entry through the human angiotensin-converting–enzyme 2 (hACE2) receptor.3 In contrast, the spike-protein RBD of early antibiotics strains was shown to interact efficiently with hACE2 receptors early on.2However, despite the presence of a CoV RNA proofreading activity that yields high replication fidelity, genetic epidemiologic investigations conducted in late February identified an emerging D614G mutation affecting the spike glycoprotein of antibiotics strains from southern Europe. This variant has since spread rapidly and has become the most prevalent genotype worldwide.4 Patients infected with D614G-associated antibiotics are more likely to have higher viral loads in the upper respiratory tract than patients infected with zithromax strains zithromax online in canada without the mutation, but disease severity is not affected. Pseudotyped zithromaxes with the G614 form of the antibiotics spike protein have been reported to exhibit increased infectivity in continuous cell lines and increased sensitivity to neutralization.

In addition, structural analyses have revealed that the RBD of the G614 form of the spike protein is more likely to assume an “open” conformation than zithromax online in canada the RBD of the ancestral D614 form, implying an improved ability to bind to the hACE2 receptor. However, published reports of isolation of the D614G substitution in an authentic antibiotics recombinant live zithromax are lacking, as are investigations on the effects of the mutation on in vivo replication and pathogenesis.Figure 1. Figure 1.

Increased Infectivity zithromax online in canada of antibiotics Bearing the Spike Protein D614G Substitution. A study recently reported by Plante et al.5 showed that a variant of antibiotics carrying the spike protein D614G substitution results in increased zithromax infectivity and yield in human lung epithelial cells (Panel A), in primary human airway tissue (Panel B), and in the upper airway of hamsters (Panel C). These data suggest zithromax online in canada that the D614G mutation results in enhanced transmissibility.

In addition, serum samples from D614-zithromax–infected hamsters can efficiently neutralize the G614 zithromax from infecting cells (Panel D), which suggests that antibiotics treatments, all of which are based on the D614 variant of the spike protein, will protect against G614 variants of the zithromax.In a recent study, Plante et al. Used reverse genetics to recover isogenic recombinant SARS-CoV zithromaxes encoding the D614G mutation.5 The G614 variant replicated more efficiently than did the zithromax online in canada D614 variant in immortalized cells in culture and in primary human airway epithelial cells (Figure 1A and 1B). Even at D614-to-G614 variant ratios of 1:1, 3:1, or 9:1, the contemporary G614 strain outcompeted the ancestral D614 strain in primary human airway epithelial cells.

The G614 variant also seemed to be more stable than the ancestral strain, which suggests that increased stability may be associated with increased infectivity, although additional investigations will be needed to confirm this finding.In studies in hamsters infected with D614 or G614 variants, Plante et al. Showed that the contemporary G614 variant replicated to higher titers in zithromax online in canada nasal-wash samples early after and outcompeted the ancestral D614 variant (Figure 1C). These findings suggest increased fitness in a major upper airway compartment potentially associated with enhanced transmission.

The antibiotics G614 variant did not cause more severe disease than the ancestral strain in hamsters, a finding that zithromax online in canada supports current findings in humans. The buy antibiotics treatments that are currently being evaluated in clinical trials are based on the original D614 ancestral spike sequence. Therefore, the authors used a panel of zithromax online in canada serum specimens to test whether the G614 variant is as sensitive to neutralization as the ancestral strain (Figure 1D).

Fortunately, the results showed that it is as sensitive to the serum specimens as the D614 strain and thus may allay fears that it could escape treatment-elicited immunity.Plante et al. Have provided evidence of the genetic and molecular basis for enhanced fitness of the G614 variant over ancestral strains, providing strong support for its role in facilitating zithromax online in canada global spread. Unlike variants in the SARS-CoV 2003 epidemic strain, those in antibiotics may point to new mechanisms that are associated with zithromax spread in human populations.

In addition to showing the critical importance of blending genetic epidemiologic studies with empirical molecular virologic studies to understand zithromax zithromax evolution and spread, the findings raise critical questions regarding the future evolutionary trajectories of the antibiotics G614 variant. These questions are especially important at a time when environmental pressures, such zithromax online in canada as expanding herd immunity, treatment-induced immunity, antiviral therapies, and public health intervention strategies, may — through selective pressure — promote zithromax survival and escape. Will these selective pressures drive antigenic variation, promote zithromax stability and transmissibility, alter zithromax virulence and pathogenesis, or drive antibiotics to extinction or into alternative hosts as reservoirs?.

Plante zithromax online in canada et al. Articulate a critical need for proactive, rather than reactive, tracking of antibiotics and other potential emerging antibioticses.Trial Design and Participants We initially conducted a phase 1, dose-escalation, open-label clinical trial of mRNA-1273 involving participants between the ages of 18 and 55 years2 in which we evaluated doses of 25 μg, 100 μg, and 250 μg. We subsequently expanded the trial to include 40 participants who were 56 years of age or older and who were stratified zithromax online in canada into two subgroups.

Those between the ages of 56 and 70 years and those who were 71 years of age or older. Because of clinically significant systemic reactogenicity observed in participants between the ages of 18 and 55 years at the 250-μg dose, we administered doses of 25 μg or 100 μg to the older participants. The trial was conducted at Kaiser Permanente Washington Health Research Institute in Seattle, the Emory University School of Medicine in Atlanta, and the zithromax online in canada National Institute of Allergy and Infectious Diseases (NIAID) treatment Research Center in Bethesda, Maryland.

Enrolled adults were healthy and provided written informed consent before undergoing any study procedures. We did not screen for evidence of past or current antibiotics by testing zithromax online in canada blood or nasal specimens before enrollment. Full eligibility criteria, along with details of the trial design, conduct, oversight, and statistical analyses, are described in the protocol, which is available with the full text of this article at NEJM.org.

MRNA-1273 treatment The mRNA-1273 treatment was zithromax online in canada codeveloped by researchers at the NIAID treatment Research Center and Moderna in Cambridge, Massachusetts. This treatment encodes a stabilized version of the antibiotics full-length spike glycoprotein trimer, S-2P, which has been modified to include two proline substitutions at the top of the central helix in the S2 subunit. The mRNA is encapsulated in lipid nanoparticles at a concentration of 0.5 mg per milliliter and diluted with normal saline to achieve the final target treatment concentrations.

Study Oversight The NIAID served as the zithromax online in canada trial sponsor and made all decisions regarding the study design and implementation. The treatment Investigational New Drug application and the protocol amendment expanding the age subgroups were reviewed by the Food and Drug Administration and the institutional review board at Advarra, a regulatory compliance consulting company, which served as the single institutional review board for all the study sites. An independent data and safety zithromax online in canada monitoring committee reviewed interim safety reports.

Moderna provided mRNA-1273 for use in this trial but did not provide any financial support. Employees of Moderna collaborated on the development of the protocol, contributed to the Investigational New Drug application, and participated in weekly team meetings regarding the zithromax online in canada study. Emmes, the statistical and data coordinating center for the study, developed the statistical analysis plan and performed all data analyses.

Data reports, which were generated from the raw data by zithromax online in canada the statistical and data coordinating center, were provided and available to all the authors. The manuscript was written entirely by the authors, with the first two authors serving as overall lead authors. All the authors vouch for the completeness and accuracy of the data and for the adherence of the study to the protocol.

No one who zithromax online in canada is not an author contributed to the writing of the manuscript. Trial Procedures The mRNA-1273 treatment was administered as a 0.5-ml intramuscular injection into the deltoid on days 1 and 29 of the study. The same dose of the zithromax online in canada treatment was administered on both days.

Follow-up visits were scheduled 7 and 14 days after the administration of each dose of treatment and on day 57. A standard toxicity scale was used to zithromax online in canada grade adverse events (Table S1 in the Supplementary Appendix, available at NEJM.org). Solicited local and systemic adverse events were collected for 7 days after each vaccination, as facilitated by the use of a memory aid.

Data regarding unsolicited adverse events and the use of new medications were collected through day 57. Collection of specimens, as well as monitoring for medically attended adverse events, development of new chronic medical conditions, and serious adverse events, was zithromax online in canada scheduled to continue through 1 year after the last dose. These initial findings will be updated with final safety and immunogenicity data when the results are available.

After the initial safety data from the first zithromax online in canada phase of the study were available from participants between the ages of 18 and 55 years,2 the administration of mRNA-1273 was initiated sequentially in the subgroup of participants between the ages of 56 and 70 years at the 25-μg dose, which was followed by the initiation of the 100-μg dose. Since no halting rules were met after the participants in this subgroup had completed day 8, treatment administration was initiated sequentially in the subgroup of participants who were 71 years of age or older at the 25-μg dose, which was followed by the initiation of the 100-μg dose. Assessment of Antibody Responses We performed enzyme-linked immunosorbent assays (ELISA) to quantify the binding IgG responses zithromax online in canada to S-2P containing an Asp (D) residue at position 614 (initial Wuhan-1 strain sequence8) and to the receptor-binding domain on days 1, 15, 29, 36, 43, and 57.

(The receptor-binding domain is the portion of the antibiotics zithromax that is located on its spike domain and that links with body receptors to infect cells.) A antibiotics native spike-pseudotyped lentizithromax reporter single-round-of- neutralization assay (pseudozithromax neutralization assay) was used to assess treatment-induced neutralizing activity against the 614D variant at the same time points. treatment-induced neutralization on day 43 was assessed with a second pseudozithromax neutralization assay with the use of the 614-Gly (614G) polymorphic variant, since the 614G strain had become predominant in both the United States and worldwide.9 (Details are provided in the Methods section in the Supplementary Appendix.) Three live-zithromax neutralization methods were used. First, the antibiotics nanoluciferase high-throughput neutralization assay (nLuc HTNA), which uses a zithromax expressing the reporter gene nanoluciferase (nLuc)10 zithromax online in canada.

Second, the focus reduction neutralization test mNeonGreen (FRNT-mNG), which uses recombinant antibiotics expressing the fluorescent reporter gene mNeonGreen11. And third, a antibiotics plaque-reduction neutralization testing (PRNT) zithromax online in canada assay, which uses wild-type zithromax. We used the nLuc HTNA to analyze specimens that were obtained on days 1, 29, and 43 from the participants who were 56 years of age or older and who received the 100-μg dose.

We used the FRNT-mNG assay to analyze specimens obtained on days zithromax online in canada 1, 29, and 43 from all the participants in the two age and dose subgroups. For this preliminary report, because of the time-intensive nature of the PRNT assay and to maximize usable information obtained from its use, we performed PRNT assays for the presence of antibiotics on samples obtained on days 1 and 43 from participants who received the 100-μg dose only. We used as comparators previously reported results for participants between the ages of 18 and 55 years who had been enrolled in the 100-μg subgroup, as well as results from controls who had donated convalescent serum.2 The severity of buy antibiotics illness was known for 38 of these zithromax online in canada controls and was classified as mild in 63% of the participants, moderate in 22%, and severe (defined as hospitalization requiring intensive care, ventilation, or both) in 15%.

Assessment of T-Cell Responses Intracellular cytokine-staining assays were performed to quantify antigen-specific T-cell responses against the spike protein on days 1, 29, and 43. (Details are provided in the Supplementary Appendix.) Statistical Analysis Safety analyses included all the participants who had received at least one dose of mRNA-1273. Immunogenicity results excluded specimens that had been obtained after day 29 in a participant who had received only a single dose of zithromax online in canada treatment.

No other data points were missing. Seroconversion was defined as an increase from baseline in the antibody titer by zithromax online in canada a factor of 4 or more. Geometric means were calculated by log transforming the data points and calculating the mean and 95% confidence interval on the log-transformed data.

The log-transformed mean and 95% confidence interval were then back-transformed to the original zithromax online in canada scale. We used the Student’s t-test to calculate confidence intervals. Interim analyses in the study subgroups were prespecified to inform critical decisions about treatment development.Initial Steps Patients with severe buy antibiotics should be hospitalized for careful monitoring.

Given the high risk of zithromax online in canada nosocomial spread,3 strict -control procedures are needed at all times. If able, the patient should wear a surgical mask to limit the dispersion of infectious droplets.15 Clinicians should don appropriate personal protective equipment (PPE) as defined by their local -prevention program, using particular caution when performing procedures that may increase the generation or dispersion of infectious aerosols. These include endotracheal intubation, extubation, bronchoscopy, airway suctioning, nebulization of zithromax online in canada medication, the use of high-flow nasal cannulae, noninvasive ventilation, and manual ventilation with a bag-mask device.16 Current guidelines recommend that clinicians wear gowns, gloves, N95 masks, and eye protection at the least and place patients in negative-pressure rooms whenever possible during aerosol-generating procedures.17 Patients with severe buy antibiotics have a substantial risk of prolonged critical illness and death.

Therefore, at the earliest opportunity, clinicians should partner with patients by reviewing advanced directives, identifying surrogate medical decision makers, and establishing appropriate goals of care. Because -control measures during the zithromax may prevent families zithromax online in canada from visiting seriously ill patients, care teams should develop plans to communicate with patients’ families and surrogate decision makers. Basics of Respiratory Care Figure 3.

Figure 3. Invasive Mechanical Ventilation for buy antibiotics–Related zithromax online in canada Respiratory Failure. As shown in Panel A, a life-threatening problem in the purple box or a combination of less severe problems in the purple and tan boxes determines the need for endotracheal intubation.

In Panel B, “lung derecruitment” refers to the collapse of zithromax online in canada alveoli. All pressures are measured in the ventilator circuit and referenced to atmospheric pressure. ARDS denotes acute respiratory distress syndrome, and PEEP positive end-expiratory pressure.Patients should be monitored carefully by direct observation and pulse zithromax online in canada oximetry.

Oxygen should be supplemented by the use of a nasal cannula or Venturi mask to keep the oxygen saturation of hemoglobin between 90 and 96%.17 Deciding whether or not to intubate is a critical aspect of caring for seriously ill patients with buy antibiotics. Clinicians must weigh the risks of premature intubation against the risk of sudden respiratory arrest with a chaotic zithromax online in canada emergency intubation, which exposes staff to a greater risk of . Signs of excessive effort in breathing, hypoxemia that is refractory to oxygen supplementation, and encephalopathy herald impending respiratory arrest and the need for urgent endotracheal intubation and mechanical ventilation.

There is no single number or algorithm that determines the need for intubation, and clinicians must consider a variety of factors (Figure 3A). If the patient does not require intubation but remains hypoxemic, a high-flow nasal cannula can improve oxygenation and may prevent intubation in selected patients.17,18 The use of noninvasive positive-pressure ventilation should probably be restricted to zithromax online in canada patients with buy antibiotics who have respiratory insufficiency due to chronic obstructive pulmonary disease, cardiogenic pulmonary edema, or obstructive sleep apnea rather than ARDS. Patients treated with a high-flow nasal cannula or noninvasive ventilation require careful monitoring for deterioration that would indicate the need for invasive mechanical ventilation.18 Having awake patients turn to the prone position while they breathe high concentrations of supplemental oxygen may improve oxygenation in patients with severe buy antibiotics.

This approach is supported by data from prospective cohorts describing its use in zithromax online in canada nonintubated patients with severe hypoxemia.19 However, whether prone positioning can prevent intubation in patients with severe buy antibiotics is unclear. Because it is difficult to provide rescue ventilation to patients who are prone, this position should be avoided in patients whose condition is rapidly deteriorating. Endotracheal Intubation zithromax online in canada A skilled operator should perform endotracheal intubation in patients with severe buy antibiotics.

The use of unfamiliar PPE, the risk of to staff, and the presence of severe hypoxemia in patients all increase the difficulty of intubation. If possible, intubation should be performed after preoxygenation and rapid-sequence induction of sedation and neuromuscular blockade. An antiviral filter should be placed in line with the airway circuit zithromax online in canada at all times.

Video laryngoscopy may allow the operator to have a good view of the airway from a greater distance.20 However, operators should choose the technique that is most likely to be successful on the first attempt. Continuous-wave capnography is the best method to confirm tracheal intubation.20 Patients with severe buy antibiotics often become hypotensive soon after intubation owing to zithromax online in canada positive-pressure ventilation and systemic vasodilation from sedatives.20 Therefore, intravenous fluids and vasopressors should be immediately available at the time of intubation, and careful hemodynamic monitoring is essential.20 Ventilator Management It is unclear whether buy antibiotics is associated with a distinct form of ARDS that would benefit from a new strategy of mechanical ventilation. However, most autopsies performed on patients with severe buy antibiotics reveal the presence of diffuse alveolar damage, which is the hallmark of ARDS.21 Moreover, respiratory-system compliance and gas exchange in patients with respiratory failure from severe buy antibiotics are similar to those in populations enrolled in previous therapeutic trials for ARDS.22 Therefore, clinicians should follow the treatment paradigm developed during the past two decades for ARDS (Figure 3B).17,18 This strategy aims to prevent ventilator-induced lung injury by avoiding alveolar overdistention, hyperoxia, and cyclical alveolar collapse.

To prevent alveolar overdistention, clinicians zithromax online in canada should limit both the tidal volume delivered by the ventilator and the maximum pressure in the alveoli at the end of inspiration. To do this, clinicians should set the ventilator to deliver a tidal volume of 6 ml per kilogram of predicted body weight. This approach is termed “lung-protective ventilation.” A tidal volume up to 8 ml per kilogram of predicted body weight is allowed if the patient becomes distressed and attempts to take larger tidal volumes.

A few times each day, clinicians zithromax online in canada should initiate a half-second end-inspiratory pause, which allows the pressure in the airway circuit to equilibrate between the patient and the ventilator. The pressure in the airway circuit at the end of the pause — “the plateau pressure” — approximates the alveolar pressure (relative to atmospheric pressure). To prevent alveolar overdistention, the plateau pressure should not exceed 30 cm of water.23 A higher plateau pressure without the development of ventilator-induced lung injury zithromax online in canada may be possible in patients with central obesity or noncompliant chest walls.

For patients with buy antibiotics–related ARDS, setting sufficient positive end-expiratory pressure (PEEP) on the ventilator may prevent alveolar collapse and facilitate the recruitment of unstable lung regions. As a result, PEEP can improve respiratory-system compliance and allow zithromax online in canada for a reduction in the Fio2. However, PEEP can reduce venous return to the heart and cause hemodynamic instability.

Moreover, excessive PEEP can lead to alveolar zithromax online in canada overdistention and reduce respiratory-system compliance. No particular method of determining the appropriate level of PEEP has been shown to be superior to other methods.17 Sedatives and analgesics should be targeted to prevent pain, distress, and dyspnea. They can also be used to blunt the patient’s respiratory drive, which improves patient synchrony with mechanical ventilation.

Sedation is especially important in febrile zithromax online in canada patients with high metabolic rates who are treated with lung-protective ventilation. Neuromuscular blocking agents can be used in deeply sedated patients who continue to use their accessory muscles of ventilation and have refractory hypoxemia.17 These agents can reduce the work of breathing, which reduces oxygen consumption and carbon dioxide production.24 Moreover, sedatives and neuromuscular blocking agents may help reduce the risk of lung injury that may occur when patients generate strong spontaneous respiratory efforts. Refractory Hypoxemia Clinicians should consider prone positioning during mechanical ventilation in patients with refractory hypoxemia (Pao2:Fio2 of <150 mm Hg during respiration and Fio2 of zithromax online in canada 0.6 despite appropriate PEEP).

In randomized trials involving intubated patients with ARDS (not associated with buy antibiotics), placing the patient in the prone position for 16 hours per day has improved oxygenation and reduced mortality.18,25 However, prone positioning of patients requires a team of at least three trained clinicians, all of whom require full PPE.17 Inhaled pulmonary vasodilators (e.g., inhaled nitric oxide) can also improve oxygenation in refractory respiratory failure, although they do not improve survival in ARDS not associated with buy antibiotics.17 Extracorporeal membrane oxygenation (ECMO) is a potential rescue strategy in patients with refractory respiratory failure. Clinicians should carefully balance possible benefits with risks (e.g., bleeding) as well as the resources available during the zithromax.26 Therapy A large, zithromax online in canada randomized clinical trial involving more than 6400 hospitalized patients with buy antibiotics showed that dexamethasone significantly reduced 30-day mortality (17% reduction). Benefit was limited to patients who required oxygen supplementation and appeared greater in patients receiving mechanical ventilation.27 Consequently, dexamethasone (or potentially other glucocorticoids) is now considered the standard of care for patients with severe buy antibiotics.

Data from a randomized, placebo-controlled trial involving more than 1000 patients with severe buy antibiotics showed that the antiviral agent remdesivir reduced time to clinical recovery. The benefit appeared greatest in patients who were receiving supplemental oxygen but were not intubated.28 The zithromax online in canada 29-day mortality in that trial was 11.4% with remdesivir and 15.2% with placebo (hazard ratio for death, 0.73. 95% confidence interval, 0.52 to 1.03).

These data support the Food zithromax online in canada and Drug Administration (FDA) approval of remdesivir for the treatment of hospitalized patients with buy antibiotics in October 2020. Recent preliminary results of a large, multinational, open-label, randomized trial did not show a reduction in in-hospital mortality with use of remdesivir.29 The combination of dexamethasone and remdesivir is increasingly used clinically, but its benefit has not been shown in randomized clinical trials. Tocilizumab, an interleukin-6 inhibitor, did not zithromax online in canada significantly reduce disease progression30 or death in small randomized trials involving patients with severe buy antibiotics.31,32 Supportive Care Patients with buy antibiotics often present with volume depletion and receive isotonic-fluid resuscitation.

Volume repletion helps maintain blood pressure and cardiac output during intubation and positive-pressure ventilation. After the first few days of mechanical ventilation, the goal should be to avoid hypervolemia.33 Fever and tachypnea in patients with severe buy antibiotics often increase insensible water loss, and careful attention must be paid to water balance. If the patient is hypotensive, the dose of vasopressor can be adjusted to maintain zithromax online in canada a mean arterial pressure of 60 to 65 mm Hg.17 Norepinephrine is the preferred vasopressor.

The presence of unexplained hemodynamic instability should prompt consideration of myocardial ischemia, myocarditis, or pulmonary embolism. In case series, zithromax online in canada approximately 5% of patients with severe buy antibiotics have received renal-replacement therapy34. The pathophysiology of the renal failure is currently unclear but is probably multifactorial.

Because blood clotting in the circuit is common in patients with severe buy antibiotics,6 the efficacy of zithromax online in canada continuous renal-replacement therapy is uncertain. Abnormalities of the clotting cascade, such as thrombocytopenia and elevation of d-dimer levels, are common in patients with severe buy antibiotics and are associated with increased mortality.3 If there are no contraindications, patients should receive standard thromboprophylaxis (e.g., subcutaneous low-molecular-weight heparin).35 Some case series of patients with severe buy antibiotics have shown clinically significant thrombosis despite the use of thromboprophylaxis.6 However, the benefits and risks of the routine use of more intense prophylactic anticoagulation in patients are unknown.35 Patients hospitalized with severe buy antibiotics are often treated empirically with antibiotics.3,9 However, bacterial co is rare when immunocompetent patients first present to the hospital.36 Antibiotics can be discontinued after a short course if signs of bacterial co, such as leukocytosis and focal pulmonary infiltrates, are absent.18 Although buy antibiotics itself can cause prolonged fever,2 clinicians should be vigilant for nosocomial s. Performing cardiopulmonary resuscitation in patients with buy antibiotics may expose health care workers to infectious droplets zithromax online in canada and aerosols.

Therefore, all the members of the resuscitation team should wear appropriate PPE before performing rescue ventilation, chest compressions, or defibrillation.37 Patients with buy antibiotics who are receiving mechanical ventilation should receive appropriate nutrition and care to prevent constipation and injury to the skin and corneas. If the condition of a patient has stabilized, clinicians should attempt to withhold continuous sedation each day.38 Daily awakening may be challenging because an increase in the work of breathing and the loss of synchrony with mechanical ventilation may result in distress and hypoxemia. During the buy antibiotics zithromax, an overwhelming surge of patients presenting to a hospital may temporarily require the rationing zithromax online in canada of health care resources.

Local guidelines and medical ethics consultation can help clinicians navigate these difficult decisions with patients and their families.Trial Design We are conducting an ongoing operationally seamless (continual enrollment), multicenter, randomized, double-blind, placebo-controlled, phase 1–3 clinical trial involving symptomatic, nonhospitalized patients with buy antibiotics. The interim analysis we describe here involved the first 275 patients enrolled during the phase 1–2 portion of the trial and was conducted to assess the safety and efficacy of REGN-COV2, to gain an understanding of zithromax online in canada the natural history of buy antibiotics in outpatients, and to refine the end points for subsequent analyses. The trial continues to recruit beyond the first 275 patients for whom data are described in this report.

The results for the key primary and secondary prespecified end zithromax online in canada points are planned to be reported at trial completion. The data cutoff for this interim analysis was September 4, 2020. In the phase 1–2 portion of the trial reported here, all patients were randomly assigned (1:1:1) to receive placebo, REGN-COV2 at a dose of 2.4 g (low dose), or REGN-COV2 at a dose of 8.0 g (high dose) (Fig.

S1 in the Supplementary Appendix, available with the full text of zithromax online in canada this article at NEJM.org). Each of the two antibodies that make up REGN-COV2 — casirivimab (REGN10933) and imdevimab (REGN10987) — is given in equal doses in the cocktail. Details of the randomization stratification are provided in the Supplementary Appendix zithromax online in canada.

The phase 1 portion of the trial included additional pharmacokinetic analyses but was otherwise identical to the phase 2 portion. The population of patients in the current analysis was zithromax online in canada pooled from both phases. Patients To be eligible for participation, patients had to be 18 years of age or older and nonhospitalized.

All patients had to have a confirmed antibiotics , with a antibiotics–positive test result received no more than 72 hours before randomization and symptom onset no more than 7 days before randomization. The full list of inclusion and exclusion criteria are provided in the Supplementary Appendix zithromax online in canada. The protocol is available at NEJM.org.

An assay for anti–antibiotics antibodies was performed zithromax online in canada in all patients. Because these results were not available at randomization, patients underwent randomization regardless of their baseline serologic status, and the analyses were prespecified to first evaluate efficacy in the subgroup of patients who were serum antibody–negative — that is, those patients who tested negative for all three of the following antibodies. IgA anti-S1 domain of spike protein, IgG anti-S1 domain zithromax online in canada of spike protein, and IgG anti-nucleocapsid protein.

Patients who were positive for any one of these antibodies were designated as serum antibody–positive. A small number of patients could not be evaluated or had borderline results (unknown serum antibody zithromax online in canada status). Analyses involving these patients were conducted but are not reported here.

Intervention and Assessments At baseline (day 1), REGN-COV2 (at the high dose or low dose) or saline placebo was administered intravenously in a 250-ml normal saline solution over a period of 1 hour. The schedule of assessments zithromax online in canada is described in the protocol, along with a summary of protocol amendments. Quantitative virologic analysis, antibiotics serum antibody testing, and measurement of the two components of REGN-COV2 in serum are described in the Supplementary Appendix.

End Points Multiple prespecified zithromax online in canada end points were designated for the phase 1–2 portion of the trial (see the Supplementary Appendix and the statistical analysis plan, which is available with the protocol). However, because of the lack of a priori information that would allow us to correctly select end points, and because certain employees of Regeneron Pharmaceuticals (who had no role in the conduct of the trial) had access to unblinded early data from the trial as described in the protocol, no formal hypothesis testing was performed. The prespecified key virologic end point in the statistical analysis plan was defined as the zithromax online in canada time-weighted average change in the viral load (in log10 copies per milliliter) from baseline (day 1) through day 7, as measured by quantitative reverse-transcriptase–polymerase-chain-reaction (RT-PCR) testing of nasopharyngeal swab samples obtained from serum antibody–negative patients.

The change in viral load from baseline to various days during the trial was an additional prespecified virologic end point, and the change in absolute viral load (measured in copies per milliliter) was a post hoc virologic end point. The prespecified key clinical end point was the percentage of patients with at least one buy antibiotics–related medically attended visit through day 29 in both the serum antibody–negative subgroup and the overall trial population. Medically attended visits could include zithromax online in canada telemedicine visits, in-person physician visits, urgent care or emergency department visits, and hospitalization.

For assessments of safety, we collected data on adverse events that occurred or worsened during the observation period (grade 3 and 4. Phase 1 only), serious adverse events that occurred or worsened during the observation period (phases 1 and 2), and the following adverse events of special interest (phases zithromax online in canada 1 and 2). Grade 2 or higher hypersensitivity or infusion-related reactions.

Pharmacokinetic variables included the concentrations of casirivimab and zithromax online in canada imdevimab in serum over time. Trial Oversight Regeneron designed the trial. Gathered the data, together with the trial investigators.

And analyzed zithromax online in canada the data. Regeneron and the authors vouch for the accuracy and completeness of the data, and Regeneron vouches for the fidelity of the trial to the protocol. The authors zithromax online in canada provided critical feedback and final approval of the manuscript for submission.

No one who is not an author contributed to writing the manuscript. All the zithromax online in canada investigators had confidentiality agreements with Regeneron. The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments.

An independent zithromax online in canada data and safety monitoring committee periodically monitored unblinded data to make recommendations about trial modification and termination. The independent committee and, separately, Regeneron physicians who were aware of the treatment-group assignments and were not involved in the conduct of the trial performed interim data reviews for adapting the trial design. The trial was conducted in accordance with the principles of the Declaration of Helsinki, International Council for Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements.

The local institutional review board or ethics committee at each study zithromax online in canada center oversaw trial conduct and documentation. One center was found to have violations of Good Clinical Practice guidelines (not related to the collection of data on efficacy or safety end points) and was withdrawn from the trial after analyses had been completed. All the patients provided written informed consent zithromax online in canada before participating in the trial.

Statistical Analysis The statistical analysis plan for the presented analysis was finalized before database lock and unblinding. The full analysis set included the first 275 patients with buy antibiotics symptoms who underwent randomization in the combined phase 1–2 portions of zithromax online in canada the trial. A sample of 275 patients (72 in phase 1 and 203 in phase 2) was considered sufficient for the assessment of virologic efficacy, clinical trends, and safety for the purpose of informing subsequent analyses.

Because patients could enroll if they had tested positive for antibiotics no more than 72 hours before randomization, patients who tested negative by qualitative RT-PCR at baseline (lower limit of detection, 714 copies per milliliter [2.85 log10 copies per milliliter]) were excluded from analyses of virologic end points in a modified full analysis set. Because of the a priori hypothesis zithromax online in canada that patients whose immune system was already clearing the zithromax were unlikely to benefit from additional antibody therapy, analyses were prespecified in the statistical analysis plan to focus on the serum antibody–negative subgroup. All patients who received REGN-COV2 or placebo were included in the safety population.

The time-weighted zithromax online in canada average change from baseline (day 1) through day 7 was calculated for each patient as the area under the concentration–time curve, with the use of the linear trapezoidal rule for change from baseline divided by the time interval of the observation period. This end point was analyzed with an analysis-of-covariance model with treatment group, risk factor, and baseline serum antibody status as fixed effects and baseline viral load and treatment group–by–baseline viral load as covariates. Confidence intervals zithromax online in canada in this report were not adjusted for multiplicity.

Statistical analyses were performed with SAS software, version 9.4 or higher (SAS Institute). Additional statistical and pharmacokinetic analysis methods are described in the Supplementary Appendix..

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December 16, zithromax 500mg for 3 days 2021US Department of Labor proposes $204K in fines after worker suffers amputation at Arkansas wood flooring plantMaxwell Hardwood Flooring Company cited for 6 http://bethlehemroofrepairs.com/6-rain-gutters/ OSHA violations, including willful MONTICELLO, AR – A knot saw operator suffered a partial amputation of an index finger in June 2021 when his hand came in contact with a rotating blade that lacked adequate machine guarding. A few weeks earlier, a similar saw at the Maxwell Hardwood Flooring plant in Monticello lacerated a co-worker’s palm severely, leaving them with nerve damage. An inspection by the U.S zithromax 500mg for 3 days.

Department of Labor’s Occupational Safety and Health Administration determined that the flooring manufacturer failed to record the laceration on the company’s OSHA 300 log, as the law requires. OSHA cited the company for one willful violation, and three serious zithromax 500mg for 3 days and two other-than-serious violations for five unguarded circular saws in use, lack of safe access and egress to and from walking-working surfaces, obstructed exit routes and a lack of a stair-rail system and handrails. OSHA proposed $204,797 in penalties.

OSHA issued citations for recordkeeping violations on zithromax 500mg for 3 days Nov. 19, and for willful and serious violations on Dec. 2.

€œMaxwell Hardwood Flooring’s disregard for the safety of its workers has left two people with serious injuries,” said OSHA Area Director Kia E. McCullough in Little Rock, Arkansas. €œWorkers have the right to a safe and healthy workplace.

Employers must comply with safety requirements to ensure workers return home each day safely. When an employer fails to fulfill its obligation, OSHA will hold them accountable.” Exposure to amputation hazards is one of the top 10 most frequently cited violations. OSHA’s Machine Guarding webpage provides compliance assistance resources to help employers identify amputation hazards, and follow required procedures to properly guard stationary and portable machines.

The company has 15 business days from receipt of its citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission. Learn more about OSHA. # # # Media Contacts:Juan J.

Rodríguez, 972-850-4709, rodriguez.juan@dol.govChauntra Rideaux, 972-850-4710, rideaux.chauntra.d@dol.gov Release Number. 21-2118-DAL U.S. Department of Labor news materials are accessible at http://www.dol.gov.

The department’s Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay).December 15, 2021US Department of Labor cites global spice importer after worker sufferspartial finger amputation at Jackson facility, levies $146K http://www.em-centre-bischheim.ac-strasbourg.fr/les-parcours/lundi-mars/ in penaltiesOSHA previously cited iSpice LLC in April for exposing workers to safety hazards JACKSON, AL – On Aug. 8, a 61-year-old maintenance employee of iSpice LLC in Jackson had part of his finger amputated while adding wrapping material to a machine that started and trapped his hand.

His employer failed to ensure proper guarding was installed. The incident occurred less than six months after the U.S. Department of Labor’s Occupational Safety and Health Administration cited the global spice importer in a separate investigation for exposing workers to amputation and struck-by hazards.

OSHA cited iSpice for not ensuring that machine guards were in place or adequate while employees worked in close proximity to rotating components on machines. The company also exposed workers to fall hazards by allowing them to work on an open-sided mezzanine 12 feet above the next level without a complete guardrail system, and allowed employees to work near uncovered electrical boxes and light switches, and a machine with exposed live parts. The company faces $146,751 in penalties.

€œOnce again, this employer disregarded safety measures and their neglect resulted in a serious injury that should never have happened,” said OSHA Area Director Jose Gonzalez in Mobile, Alabama. €œEmployers have a responsibility to comply with OSHA standards that are in place to keep workers safe on the job.” OSHA cited iSpice LLC in April and assessed $121,511 in penalties. The company has 15 business days from receipt of its citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission.

Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to ensure these conditions for America’s workers by setting and enforcing standards, and providing training, education and assistance. Learn more about machine guarding, fall protection and electrical hazards.

# # # Media Contacts. Eric R. Lucero, 678-237-0630, lucero.eric.r@dol.govErika B.

Ruthman, 678-237-0630, ruthman.erika.b@dol.gov Release Number. 21-2088-ATL U.S. Department of Labor news materials are accessible at http://www.dol.gov.

The department’s Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay)..

December 16, 2021US Department of Labor buy zithromax online overnight proposes $204K in fines after worker suffers amputation at Arkansas wood flooring plantMaxwell Hardwood Flooring Company cited for 6 OSHA violations, including willful MONTICELLO, AR – A knot saw operator suffered a partial amputation of an index finger in June 2021 when his hand came in contact with a zithromax online in canada rotating blade that lacked adequate machine guarding. A few weeks earlier, a similar saw at the Maxwell Hardwood Flooring plant in Monticello lacerated a co-worker’s palm severely, leaving them with nerve damage. An inspection by the U.S zithromax online in canada. Department of Labor’s Occupational Safety and Health Administration determined that the flooring manufacturer failed to record the laceration on the company’s OSHA 300 log, as the law requires.

OSHA cited the company for one willful violation, and three serious and two other-than-serious violations for five unguarded circular saws in use, lack of safe access and zithromax online in canada egress to and from walking-working surfaces, obstructed exit routes and a lack of a stair-rail system and handrails. OSHA proposed $204,797 in penalties. OSHA issued citations for recordkeeping violations zithromax online in canada on Nov. 19, and for willful and serious violations on Dec.

2. €œMaxwell Hardwood Flooring’s disregard for the safety of its workers has left two people with serious injuries,” said OSHA Area Director Kia E. McCullough in Little Rock, Arkansas. €œWorkers have the right to a safe and healthy workplace.

Employers must comply with safety requirements to ensure workers return home each day safely. When an employer fails to fulfill its obligation, OSHA will hold them accountable.” Exposure to amputation hazards is one of the top 10 most frequently cited violations. OSHA’s Machine Guarding webpage provides compliance assistance resources to help employers identify amputation hazards, and follow required procedures to properly guard stationary and portable machines. The company has 15 business days from receipt of its citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission.

Learn more about OSHA. # # # Media Contacts:Juan J. Rodríguez, 972-850-4709, rodriguez.juan@dol.govChauntra Rideaux, 972-850-4710, rideaux.chauntra.d@dol.gov Release Number. 21-2118-DAL U.S.

Department of Labor news materials are accessible at http://www.dol.gov. The department’s Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay).December 15, 2021US Department of Labor cites global spice importer after worker sufferspartial finger amputation at Jackson facility, levies $146K in penaltiesOSHA previously cited iSpice LLC in April for exposing workers to safety hazards JACKSON, AL – On Aug. 8, a 61-year-old maintenance employee of iSpice LLC in Jackson had part of his finger amputated while adding wrapping material to a machine that started and trapped his hand.

His employer failed to ensure proper guarding was installed. The incident occurred less than six months after the U.S. Department of Labor’s Occupational Safety and Health Administration cited the global spice importer in a separate investigation for exposing workers to amputation and struck-by hazards. OSHA cited iSpice for not ensuring that machine guards were in place or adequate while employees worked in close proximity to rotating components on machines.

The company also exposed workers to fall hazards by allowing them to work on an open-sided mezzanine 12 feet above the next level without a complete guardrail system, and allowed employees to work near uncovered electrical boxes and light switches, and a machine with exposed live parts. The company faces $146,751 in penalties. €œOnce again, this employer disregarded safety measures and their neglect resulted in a serious injury that should never have happened,” said OSHA Area Director Jose Gonzalez in Mobile, Alabama. €œEmployers have a responsibility to comply with OSHA standards that are in place to keep workers safe on the job.” OSHA cited iSpice LLC in April and assessed $121,511 in penalties.

The company has 15 business days from receipt of its citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission. Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to ensure these conditions for America’s workers by setting and enforcing standards, and providing training, education and assistance. Learn more about machine guarding, fall protection and electrical hazards.

# # # Media Contacts. Eric R. Lucero, 678-237-0630, lucero.eric.r@dol.govErika B. Ruthman, 678-237-0630, ruthman.erika.b@dol.gov Release Number.

21-2088-ATL U.S. Department of Labor news materials are accessible at http://www.dol.gov. The department’s Reasonable Accommodation Resource Center converts departmental information and documents into alternative formats, which include Braille and large print. For alternative format requests, please contact the department at (202) 693-7828 (voice) or (800) 877-8339 (federal relay)..

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Zithromax side effects in men

That they are ‘following the https://www.video-advertising.agency/can-you-buy-ventolin-over-the-counter-in-ireland/ science’ has become the watchword of many politicians during the present zithromax, especially when imposing or prolonging lockdowns or zithromax side effects in men other liberty-restricting regulations. The scientists who advise politicians however are usually careful to add that the decision what to restrict and when is ultimately a political one. In science, as in medical practice, there is a delicate balance to be maintained between confidence in the zithromax side effects in men best available information, and the necessary caveat that the assumptions and calculations on which that information is based are subject to further scientific enquiry.

For politicians and the public, moreover, as for patients, whether those informing them are judged to be trustworthy is a necessary consideration, a judgement determined by a variety of personal and political contingencies and circumstances. Ethics, by contrast, unable to appeal to scientific consensus (however revisable) or political authority (however reversible), let alone a confidence-inspiring bedside manner, must rest the case for its essentially contestable assumptions and arguments being judged trustworthy, on its willingness to zithromax side effects in men admit all reasoned voices (including occasionally those that question reason itself) to a conversation that is potentially unending, but in the process often highly enlightening.That conversation is contributed to in this issue of the Journal by several reasoned voices, mostly on ethical aspects of the buy antibiotics zithromax. Relevant to issues on which politicians claim to be ‘following the science’, but also raising fundamental ethical questions, is this month’s feature article.

In Ethics of Selective Restriction of Liberty in a zithromax,1 Cameron and colleagues consider ‘if and when it may be ethically acceptable to impose selective liberty-restricting measures in order to reduce zithromax side effects in men the negative impacts of a zithromax by preventing particularly vulnerable groups [for example, the elderly in buy antibiotics] of the community from contracting the disease’ [and thereby, for example, increasing the disease burden]. €˜Preventing harm to others when this is least restrictive option’, they argue, ‘fails to adequately accommodate the complexity of the issue or the difficult choices that must be made’. Instead, they propose ‘a dualist consequentialist approach, weighing utility at both a population and individual level’, thereby taking account of ‘two relevant values to be promoted or maximised.

Well-being and liberty’, as well as the value of equality, ‘protected zithromax side effects in men through the application of an additional proportionality test’. The authors then propose an algorithm to take account of the different values and variables which need to be weighed up. They conclude zithromax side effects in men.

€˜Selective restriction of liberty is justified when the problem is grave, the expected utility of the liberty restriction is high and significantly greater than the alternatives and the costs of the liberty restrictions are relatively small both at a population and individual level… Discrimination can be justified under these conditions when it is proportionate and limited to a very specific public health challenge’. The arguments and conclusions of the feature article are discussed in the two Commentaries2 3.In buy antibiotics controlled human zithromax side effects in men studies. Worries about local community impact and demands for local engagement,4 Eyal and Lee review recent arguments which express ‘concern about undue usage of local residents’ direly needed scarce resources at a time of great need and even about their unintended ’ – and hence a requirement for ‘either avoiding controlled trials (CHIs) or engaging local communities before conducting CHIs’.

They then examine and compare the evidence of such adverse (and some potentially positive) effects of CHIs with those of conventional field trials and argue that ‘both small and large negative effects on struggling communities are likelier in field trials than in CHIs’. €˜Whether or not local community engagement is necessary for zithromax side effects in men urgent treatment studies in a zithromax’, they conclude, ‘the case for its engagement is stronger prior to field trials than prior to controlled human studies’.In Payment of buy antibiotics challenge trials. Underpayment is a bigger worry than overpayment,5 Blumenthal Barby and Ubel consider the impact not on communities but on individuals, and specifically on ‘how much people should be paid for their participation in buy antibiotics challenge trials’.

Noting recent worries about ‘incentivising people with large amounts of money’, they argue that ‘higher payment that accounts for participant time, and for pains, burdens and willingness to take risks’ constitutes neither ‘undue inducement’ (for which the remedy is strengthening informed consent processes and minimising risks) nor ‘unjust inducement’ of individuals from ‘already disadvantaged zithromax side effects in men groups’. Evidence of recruitment to challenge trials worldwide suggests, on the contrary, that participants ‘come from all walks of life’. Nor are these authors zithromax side effects in men convinced that ‘offering substantial payment waters down the auistic motives of those involved’.

€˜auism and payment’ they argue, ‘frequently coexist. Teachers, physicians, public defenders – they all dedicate their lives to helping people. But few do without compensation.’In zithromax side effects in men Money is not everything.

Experimental evidence that payments do not increase willingness to be vaccinated against buy antibiotics6, Sprengholz and colleagues report on an ‘experiment investigating the impact of payments and the communication of individual and prosocial benefits of high vaccination rates on vaccination intentions.’ In November 2020 over 1,000 ‘individuals from a German non-probabilistic sample’ were asked about their intentions. The ‘results revealed that none of these interventions or their combinations increased willingness to be vaccinated shortly after a treatment becomes available.’ Given zithromax side effects in men that this experiment was conducted before treatments became available and only in Germany, the authors suggest that these results ‘should be generalised with caution’, but that ‘decision makers’ also ‘should be cautious about introducing monetary incentives and instead focus on interventions that increase confidence in treatment safety first’.In Voluntary buy antibiotics vaccination of children. A social responsibility,7 Brusa and Barilan observe a zithromax paradox.

€˜while we rely on low quality zithromax side effects in men evidence when harming children by school deprivation and social distancing, we insist on a remarkably high level of safety data to benefit them with vaccination’. The consequent exclusion of children from vaccination, they argue, is unjust and not in ‘the best interest of the child as a holistic value encompassing physical, psychological, social and spiritual well-being’, something which ‘there is no scientific method for evaluating’. Society, rather, ‘has the political responsibility to factor in the overall impact of the zithromax on children’s well-being’ and the ‘ultimate choice is a matter of paediatric informed consent.

Moreover, jurisdictions that permit non-participation in established childhood vaccination programmes should also permit choice of treatments outside of the approved programmes.’ The authors conclude by outlining ‘a prudent and ethical scheme for gradual incorporation of minors in vaccination programmes that includes a rigorous postvaccination monitoring.’In Challenging misconceptions about zithromax side effects in men clinical ethics support during buy antibiotics and beyond. A legal update and future considerations,8 Brierley, Archard and Cave note that the ‘buy antibiotics zithromax has highlighted the lack of formal ethics processes in most UK hospitals… at a time of unprecedented need for such support’. Unlike Research Ethics Committees (RECs), Clinical Ethics Committees (CECs) in the UK have neither any ‘well-funded governing authority,’ nor the decision-making capacity over clinical questions which RECs have over zithromax side effects in men research.

In 2001 the ‘three central functions of CECs’ were described as ‘education, policy development and case review’. But more recently ‘the role of some zithromax side effects in men was expanding’ and in 2020 the UK General Medical Council ‘mentioned for the first time the value in seeking advice from CECs to resolve disagreements’. Misunderstanding of CEC’s role however began to arise when some courts appeared to ‘perceive CECs as an alternative dispute resolution mechanism’ rather than as providing ‘ethics support, with treatment decisions remaining with the clinical team and those providing their consent.’ The future role of CECs, as well as the nature of patient involvement in them, the authors conclude, will depend on a choice between the ‘flexibility and diversity of the current ethical support system’ and ‘greater standardisation, governance and funding’.Important ethical issues not directly related to buy antibiotics are discussed in this issue’s remaining papers.

In Institutional conflict of interest. Attempting to crack the deferiprone mystery,9 Schafer identifies, places in historical context, and analyses ethical issues raised by the ‘ mystery’ of why between 2009 and 2015 ‘a third of patients with thalassaemia in Canada’s largest hospital were zithromax side effects in men switched from first-line licensed drugs to regimens of deferiprone, an unlicensed drug of unproven safety and efficacy’. He then considers ‘institutional conflict of interest’ as ‘a possible explanatory hypothesis’.The perils of a broad approach to public interest in health data research.

A response to Ballantyne and Schaefer10 by Grewal and Newson and Ballantyne and Schaefer’s response In defence of a broad approach to public interest in health data research11 debate legal and philosophical aspects of whether ‘public interest’, and how narrowly or broadly this is conceived, is the most appropriate justification of consent waivers for secondary research on health information.In Do we really know how many clinical trials are conducted ethically,12 Yarborough presents evidence in support of the argument that 'research ethics committee practices need to be strengthed' and then suggests 'initial zithromax side effects in men steps we could take to strengthen them'.Finally, and returning to how ‘science’ is perceived, in Lessons from Frankenstein 200 years on. Brain organoids, chimaeras and other ‘monsters’13, Koplin and Massie make a crucial observation. In ‘bioethical debates, Frankenstein zithromax side effects in men is usually evoked as a warning against interfering with the natural order or “playing God”’.

But in the novel, Frankenstein’s ‘most serious moral error’ was made ‘not when he decided to pursue his scientific breakthrough (one which might, after all, have helped save lives), but when he failed to consider his moral obligations to the creature he created.’ Today, when, like Frankenstein, ‘modern scientists are creating and manipulating life in unprecedented ways’ such as brain organoids and chimaeras, Koplin and Massie argue, ‘two key insights’ can be drawn from Mary Shelley’s 1818 novel. First, ‘if we have created an entity in order to experiment on it’ we need ‘to extend much consideration to its interests and preferences, not least because ‘scientists cannot always rely on existing regulations to anticipate moral issues associated with the creation of new kinds of organisms’. And second zithromax side effects in men.

€˜we should be wary of any prejudice we feel towards beings that look and behave differently from us’ and should ‘interrogate any knee-jerk intuitions we have about the moral status of unfamiliar kinds of beings.’Ethics statementsPatient consent for publicationNot required.IntroductionThalassaemia is an inherited anaemia that exerts an enormous disease burden worldwide.1 Along with sickle cell disease, it is one of the two most common single gene disorders. Indeed, ‘the alpha and beta thalassaemias are the most common inherited single-gene disorders in the world…’2A newly published study zithromax side effects in men by Olivieri, Sabouhanian and Gallie3 analyses and assesses the comparative efficacy and safety profile of two drugs. Deferiprone (Ferriprox.

Apotex) and zithromax side effects in men deferasirox (Exfade. Novartis). Both of these ‘iron-chelating’ drugs remove (‘chelate’) iron deposited, as a result of transfusions, in the tissues of patients with thalassaemia.The present-day first-line zithromax side effects in men chelator, deferasirox, was licensed by the US FDA in 2005.

The evidence for its safety and effectiveness was judged to be substantial and, accordingly, the FDA licensed it as a first-line agent. The prime advantage of deferasirox, in comparison to deferoxamine, an older drug that was formerly the gold standard of iron-chelating therapy for thalassaemia, is that deferasirox is orally active (that is, taken in pill form), while deferoxamine is more burdensome for patients because it has to be taken parenterally (that is, via injection). Deferiprone, like deferasirox, is taken orally but has not been licensed zithromax side effects in men anywhere as first-line treatment.

The FDA withheld market approval for deferiprone because there were/are no controlled trials demonstrating direct treatment benefit. Although the zithromax side effects in men FDA did eventually approve deferiprone, in 2011, it gave approval only as a last-resort treatment for those patients in whom other chelators had been tried unsuccessfully.1The data presented by Olivieri et al in their PLOS ONE paper indicate that the drugs differ significantly with respect to their effectiveness and safety. This commentary explores some of the ethical issues raised by the PLOS data.Historical contextIn order to understand properly the significance of the PLOS ONE Study some historical context will be helpful.

What follows is a brief sketch of that context.2In 1993 Dr Nancy Olivieri, a specialist in blood diseases at Toronto’s Hospital for Sick Children (HSC or ‘Sick Kids’) and Professor of Pediatrics and Medicine at the University of Toronto (U of T), signed a contract with Apotex, a generic drug company, to continue zithromax side effects in men studies of deferiprone, the early promise of which she had already reported in the literature. Olivieri’s thalassaemia research was initially supported by the Medical Research Council of Canada, but now she sought additional funding to extend her clinical trials. Apotex contributed this additional funding, thereby obtaining worldwide patents on the still-experimental drug.Despite early promise, by 1996 Olivieri’s research began to indicate that deferiprone might be inadequately effective in many patients, posing risks of potentially serious harm.

Olivieri communicated to Apotex her intention to inform patients of this unexpected risk and she proposed also to amend the study’s consent zithromax side effects in men forms. She wished to continue amended studies of the drug, and to publish her findings.Apotex responded to Olivieri that they disagreed with her interpretation of the data and the company’s CEO threatened her with ‘all legal remedies’ should she inform patients or publish her findings. In issuing these threats, Apotex relied on a confidentiality clause in a legal contract Olivieri had signed with Apotex zithromax side effects in men in 1993.

This contract prohibited disclosure ‘to any third party’ without the express permission of Apotex.3Despite the objections raised by Apotex, Olivieri saw it as her professional duty to disclose her findings. The Research zithromax side effects in men Ethics Board (REB) of Sick Kids Hospital reached the same conclusion. In compliance with instructions from the Hospital’s REB, Olivieri duly informed both her patients and the regulatory authorities.When Olivieri later identified a second risk—that liver damage progressed during deferiprone exposure—Apotex issued additional legal warnings.

Olivieri nevertheless proceeded to inform her patients of this additional risk and published her findings.Since patient safety, research integrity and academic freedom were all at stake in this dispute, Olivieri appealed for assistance, repeatedly, to senior officials at both the U of T and Sick Kids Hospital. Neither the University nor the Hospital provided the support zithromax side effects in men she requested. In the words of the Report of the Committee of Inquiry on the Case Involving Dr Nancy Olivieri, the HSC, the U of T, and Apotex Inc4:The HSC and the U of T did not provide effective support either for Dr Olivieri and her rights, or for the principles of research and clinical ethics, and of academic freedom, during the first two and a half years of this controversy.Instead, both the University and the Hospital ‘took actions that were harmful to Dr.

Olivieri’s interests and professional reputation and disrupted her work’.4 The harmful actions included firing Olivieri from her position as Director of the Hemoglobinopathy Program at Sick Kids Hospital and referring her for discipline to the College of Physicians and Surgeons of Ontario zithromax side effects in men (CPSO).Only later did it emerge that, during this period of conflict, the U of T was negotiating with Apotex for a major donation towards building the University’s proposed new molecular medicine building. Some speculated that the University’s failure to support Olivieri may not have been unconnected from its desire to appease a wealthy corporate donor. This speculation was reinforced when it was discovered that the then President of the University, Robert Prichard, had secretly lobbied the government of Canada for changes in drug patent law, changes that would favour Apotex.4Apotex proceeded zithromax side effects in men to sue Olivieri for defaming both the company and their drug.

She sued the company for defaming her.The Canadian Association of University Teachers (CAUT) and the U of T Faculty Association (UTFA), to whom Olivieri appealed for assistance after being rebuffed by the U of T and HSC, viewed the underlying issue as one of academic freedom. Both CAUT and UTFA provided support, including legal advice, to Olivieri.Thus began what is widely acknowledged to be the greatest scandal in Canadian academic history. Commissions of inquiry, books and articles (both scholarly and popular) proliferated, not to mention newspaper zithromax side effects in men and television stories.

John le Carré’s novel The Constant Gardener and the Hollywood movie based on the book both appeared to draw heavily on the Olivieri-Apotex scandal. An inquiry into zithromax side effects in men the dispute commissioned by Sick Kids Hospital (the Naimark Inquiry)5 absolved Apotex of wrongdoing but suggested that Olivieri was seriously at fault.5 She was charged with research misconduct and failures of patient care and was referred first to the Hospital’s Medical Advisory Council and subsequently to the disciplinary committee of the CPSO. Unsurprisingly, these widely publicised referrals were prejudicial to Olivieri’s reputation.The CAUT then commissioned an independent inquiry.6 The 540-page CAUT report on the Olivieri/Apotex affair4 gave a markedly different account of the scandal from that offered by the hospital-commissioned Naimark Report.

A few excerpts from the CAUT report will convey its central findings:Apotex issued more legal warnings to deter zithromax side effects in men Dr. Olivieri from communicating this second unexpected risk of L1 (deferiprone) to anyone. However, she was legally and ethically obligated to communicate the risk to those taking or prescribing the drug as there were potential safety implications for patients, and she fulfilled these obligations despite the legal warnings.Apotex acted against the public interest in issuing legal warnings to Dr.

Olivieri to deter her from communicating about risks of zithromax side effects in men L1.Apotex’s legal warnings violated Dr. Olivieri’s academic freedom.7Shortly after the CAUT report absolved Olivieri of misconduct, the CPSO published the findings of its inquiry. The CPSO report exonerated Olivieri of all misconduct zithromax side effects in men charges.

Indeed, their report concluded that her conduct had been ‘commendable’.6 This favourable verdict did not, however, bring an end to litigation.In 2004, 8 years after the first legal threats had been issued, Apotex signed a mediated settlement with Olivieri. Nevertheless, litigation continued for another 10 zithromax side effects in men years. Those unfamiliar with the workings of the law may wonder how it is possible for litigation to continue for such a long period after a mediated settlement.

Litigation continued because Apotex alleged that Olivieri had violated their agreement. Olivieri insisted that she was in compliance with zithromax side effects in men the terms of the settlement. Court decisions were appealed by both parties.

A final settlement was not reached zithromax side effects in men between Olivieri and Apotex until 2014.8 Shades of Jarndyce v. Jarndyce in Charles Dicken’s novel Bleak House.The HSC settled its dispute with Olivieri in 2006 and, although her research programme at the Hospital continued, she ceased to provide clinical care to HSC patients. From 1997 to 2009, Olivieri served as Director zithromax side effects in men of the University Health Network (UHN) Hemoglobinopathy Program.

She continued, as she had since 1997, to assist in the clinical care of UHN patients with thalassaemia and to enrol them in her research studies. In March 2009, however, Olivieri was dismissed by zithromax side effects in men UHN from her position as Director. No reason was given for her dismissal (Personal communication.

Olivieri, 2019).The PLOS ONE Study data3 show that, after Olivieri’s dismissal from her position as Director, the UHN thalassaemia Clinic began almost immediately to switch patients to (unlicensed) deferiprone. Olivieri has described how her UHN research work, from this time forward, was marginalised (https://inthepatientsinterest.org/wp-content/uploads/2019/12/2018-12-20-GallieOlivieri-to-SmithHodges.pdf).Meanwhile, Freedom of Information (FOI) requests filed zithromax side effects in men by Olivieri after her dismissal revealed that Apotex was supplying unrestricted educational grants to UHN’s thalassaemia programme as well as providing research support. The FOI requests filed by Olivieri also revealed that Apotex was strategising with the programme’s new director about how best to obtain licensing for deferiprone from the regulator (Health Canada).9 With this dramatic background as historical context, we commence our discussion of the ethical implications of the PLOS ONE paper.Findings of the PLOS ONE paperIn their 2019 PLOS ONE study Olivieri et al conclude, based on a retrospective review of patient data at Toronto’s UHN, that deferiprone is inadequately effective and associated with serious toxicity.

Their review also confirms that, by contrast, deferasirox is effective and associated with relatively few adverse effects.3Olivieri et al report that ‘[b]etween zithromax side effects in men 2009 and 2015, a third of patients transfused and managed in Canada’s largest transfusion programme were switched from first-line, licensed drugs to regimens of unlicensed deferiprone’.3 This finding raises the ethically troubling question. How and why were so many locally transfused patients at UHN treated over such a long time period with an unlicensed drug of unproven safety and efficacy?. This ethical zithromax side effects in men concern is followed immediately by another related concern.

Why did the UHN thalassaemia programme continue to treat large numbers of its patients with deferiprone—despite ongoing evidence of inadequate effectiveness and serious (and often irreversible) adverse effects?. 3To recapitulate. The PLOS zithromax side effects in men ONE paper demonstrates that a substantial proportion of UHN patients with thalassaemia was switched, between the years 2009 and 2015, from first-line licensed therapies (deferasirox or deferoxamine) to deferiprone.

During this entire period, deferiprone was unlicensed in Canada. To this day in every jurisdiction in which deferiprone has been licensed it has been licensed only as ‘last resort’ zithromax side effects in men therapy. The ethical concern is to explain and to explore possible justifications for how and why so many patients at one particular thalassaemia treatment centre were prescribed a drug whose safety and efficacy were unproven in face of availability of licensed effective drugs.

The urgency of the concern derives partly from the paper’s zithromax side effects in men finding that those patients who were switched to deferiprone displayed evidence of increases in body iron and experienced the harms associated with body iron increase.3 This finding raises a second troubling ethical question. Why were patients not switched back to a first-line licensed therapy after they began to experience serious adverse effects from treatment with unlicensed deferiprone?. How and why?.

In a sustained effort to discover answers to these questions, Olivieri and Gallie have been in communication since 2015, by email and in personal zithromax side effects in men meetings, with senior officials at UHN. Olivieri and Gallie report, however, that no definitive answers have yet been provided to any of their questions. FOI requests were filed but they, too, failed to produce definitive answers zithromax side effects in men.

(Olivieri and Gallie to Smith &. Porter, 2019, https://inthepatientsinterest.org/wp-content/uploads/2019/12/2019-04-23-OlivieriGallie-to-SmithPorter.pdf).10 I, too, wrote to the CEO/President of UHN and zithromax side effects in men to the Chief of Medical Staff, in an attempt to discover answers to a number of the ethical questions posed in this commentary. The hospital, however, has not responded to any of my questions.11Olivieri and Gallie have recently posted documentation of their correspondence with senior UHN administrators (https://inthepatientsinterest.org/).

In September 2019 the UHN administration responded to the PLOS ONE paper by revealing that it had conducted a ‘Review of chelation practice in the red blood cell disorders program at UHN’. However, as Olivieri and Gallie document on the web, the hospital’s ‘Review’ does not address any zithromax side effects in men of the safety concerns flagged in the PLOS ONE paper (https://inthepatientsinterest.org/wp-content/uploads/2019/12/Letter-to-Smith-and-Hodges-2-12-19.pdf). Nor does the ‘Review’ address any of the ethical concerns raised here.Despite UHN’s apparent reluctance to provide the information requested, here’s what we know or can reasonably infer.

Deferiprone was unlicensed in Canada during zithromax side effects in men the relevant period, that is, from 2009 to 2015. €˜Unlicensed’ is different from ‘off-label’, the latter referring to a drug that has been licensed but is being provided for an indication other than that for which it is approved. Prescription of any unlicensed drug zithromax side effects in men to Canadian patients can be accomplished only in one of two mutually exclusive ways.

Either through Health Canada’s ‘Special Access Program (SAP)’ or via an REB approved clinical trial. It has to be one or the other since, as Health Canada’s Guidance Document7 makes clear, patients cannot be simultaneously treated through SAP and in a research trial.12 Under the SAP, the treating physician must confirm to Health Canada that ‘conventional therapies have failed, or are unsuitable or unavailable’. Although some of the UHN patients’ records indicate that deferiprone was released under the SAP, Olivieri et al report that they ‘could identify no explanation for a zithromax side effects in men proposed switch to deferiprone that was supported by evidence of failure of licensed therapy prescribed as recommended’3.

Indeed, the authors write that many patients appear to have been switched to deferiprone despite optimal responses, or improvements during treatment with first-line therapies. Here’s the relevant paragraph from their PLOS zithromax side effects in men ONE article:Deferiprone was prescribed to 41 study patients between 2009 and 2015. We could identify in the electronic medical records no explanation for a proposed switch to deferiprone that was supported by evidence of failure of licensed therapy prescribed as recommended.

There was no indication that any patient switched zithromax side effects in men to deferiprone over these 6 years had ‘failed’ therapy with either deferoxamine or deferasirox. Many patients were recorded as tolerant of at least one and (in most), both licensed first-line chelating agents. Some had sustained minor adverse events during deferasirox that had resolved by the time deferiprone was prescribed.3In other words, according to the data found in UHN patient records, there is no evidence that the patients with thalassaemia who were switched to deferiprone met Health Canada’s eligibility criteria under SAP.

Since deferiprone is licensed only as a ‘last resort’ therapy, its employment to treat patients who can tolerate either of the first-line zithromax side effects in men therapies might improperly expose those patients to risks of serious medical harms, up to and including death.On the other hand, one should also consider the alternate possibility that, over the 6-year period studied by Olivieri et al, deferiprone was prescribed as part of a clinical trial. In favour of this hypothesis, one notes that the UHN physician primarily responsible for the widespread prescribing of deferiprone during the relevant time period claimed, in 2011, that deferiprone was provided to patients under a study approved by the REB of the UHN.8 UHN physicians also made this identical claim in a publicly available letter to the US FDA.9 Moreover, in response to an FOI application filed by Olivieri, UHN claimed that deferiprone was provided at UHN during a clinical trial (the data of which are protected from scrutiny under FOI laws), and not under SAP (the data of which are not protected from scrutiny under FOI). However, Olivieri et al have been unable to find any record of registration for such a trial, as required by Canadian Clinical Trial guidelines.13 Requests to the UHN administration for confirmation that a clinical trial existed remain unanswered.14 My own efforts to find some registration record for this putative clinical trial of deferiprone have been equally unsuccessful.15Two core zithromax side effects in men ethical principles.

Harm-minimisation and informed consentIf the deferiprone used to treat UHN patients with thalassaemia was obtained from Apotex as part of a randomised clinical trial, responsibility for approving the trial would fall to the UHN’s REB. In Canada, both researchers and REBs are governed by the Tri-Council Policy zithromax side effects in men Statement (TCPS) ‘Ethical Conduct for Research Involving Humans’.10 The 1998 version of this policy statement (TCPS1) and the subsequent 2010 version (TCPS2), both applicable to research trials during this period, stipulate that clinical trials must be designed so that harm to research subjects will be minimised.16 For example, TCPS1 specifies, in section 1.5, that ‘Research subjects must not be subjected to unnecessary risks of harm’. TCPS2, under the rubric ‘Core Principles’, requires similarly that clinical trials must ‘ensure that participants are not exposed to unnecessary risks’.Data presented by Olivieri et al in their PLOS ONE Study indicate that UHN patients exposed to unlicensed deferiprone, either as monotherapy or in combination with low dose of a first-line chelator (‘combination therapy’), experienced significant harms as a result of poor iron control, but very few if any compensating benefits.We provide new evidence of inadequate reduction in hepatic iron, a 17% incidence of new diabetes and new liver dysfunction in 65% of patients, many who were challenged and rechallenged with deferiprone despite elevated liver enzymes developed during previous exposure.

We identified no evidence of ‘cardio-protective’ effect during deferiprone therapy.3In light of PLOS ONE Study data indicating serious adverse events (SAEs) for patients switched to deferiprone from first-line drugs one is led to question why the study protocol did not, in anticipation of such a contingency, provide for a resumption of licensed therapy for patients doing zithromax side effects in men poorly on the unlicensed drug. Moreover, the investigators were obliged to report adverse events to the hospital’s REB. Were the adverse events so reported?.

And if they were then why did the UHN REB not seek to protect patient safety zithromax side effects in men by insisting that licensed therapy be resumed for deferiprone-harmed patients?. In an effort to establish whether the deferiprone ‘clinical trial’ satisfied the TCPS harm-minimisation principle, I made inquiries about how the adverse findings described by the PLOS ONE paper were reported to the hospital’s REB and also how they were reported to the regulatory authorities, that is, Health Canada and the US FDA. But my queries, like those made previously by Olivieri and Gallie, have not succeeded in eliciting this ethically relevant information.17 Neither UHN nor its thalassaemia clinic responded to my letters of inquiry zithromax side effects in men.

It is known, however, from a publicly available 2011 document, that physicians in the UHN thalassaemia clinic strongly supported the market approval of deferiprone by the FDA.18 This support is difficult to reconcile with the toxicities recorded in UHN patient records. So, a final verdict on the issue of whether the UHN deferiprone ‘clinical trial design’ violated the TCPS harm-minimisation principle cannot be zithromax side effects in men reached until those involved in conducting and monitoring clinical trials at UHN make available the relevant information. An independent public inquiry may be necessary to achieve the necessary degree of accountability.Reference has been made, above, to the TCPS core ethical requirement of harm-minimisation, applicable in Canada both to researchers and to REBs.

It is important to note, however, that TCPS2, like its predecessor, TCPS1 (and, indeed, like virtually every postwar code of research ethics) also stipulates as a second ‘core principle’ that ‘Researchers shall provide to prospective participants, or authorised third parties, full disclosure of all information necessary for making an informed decision’.19 Moreover, as the then-current TCPS guidelines make clear, ‘consent is an ongoing process’. So, assurance should be given to prospective participants zithromax side effects in men that they ‘will be given in a timely manner throughout the course of the research project, information that is relevant to their decision to continue or withdraw from participation’.20 (My emphasis). Finally, TCPS2 imposes on researchers the additional ethical requirement that they disclose to research subjects ‘information concerning the possibility of commercialisation of research findings, and the presence of any real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research sponsors’.21 There is also an expectation that conflicts of interest will be disclosed to the REB.

Whether there was adequate disclosure of Apotex funding either to research subjects or to the UHN REB is still unknown.Thus, in order to assess the ethical adequacy of the putative UHN thalassaemia clinical trial one must inquire whether UHN patients/subjects were given adequate risk zithromax side effects in men information when they were first enrolled, subsequently, when they were switched from treatment with deferasirox or deferoxamine to treatment with deferiprone and then, finally, when they experienced SAEs. That is, in order to know whether the putative deferiprone clinical trial conformed to established principles of research ethics, one would need to know whether patients/research subjects understood that they were being switched from licensed first-line drugs of proven efficacy to an unlicensed and unproven third-line drug. One would also zithromax side effects in men need to know whether the deferiprone ‘research subjects’ were informed about conflicts of interest arising from Apotex donations (A) to the UHN.

(B) To the hospital’s thalassaemia programme,22 as well as the hoped-for commercialisation of deferiprone via Health Canada and FDA licensing.If there was a failure to obtain ongoing informed consent and/or a failure to disclose conflicts of interest (to patients and to the REB) then this would constitute a violation of research ethics. Unfortunately, my attempts to elicit the clinical trial’s consent to research information from the UHN and its thalassaemia clinic met with as little success as earlier attempts made by the PLOS ONE authors.23REB review. Safety monitoringAlthough every clinical trial requires safety monitoring, those trials which involve non-negligible risk of significant harm to patients/subjects require especially rigorous safety zithromax side effects in men monitoring.24 Because the exposure of deferiprone to UHN patients posed risks of organ dysfunction and death, the need for safety monitoring was exigent.

As the TCPS1 and TCPS2 both make clear, those who conduct research have an obligation to monitor and protect the safety of their research subjects.Moreover, it is now widely recognised that individuals closely involved with the design and conduct of a trial may not be able to be fully objective in reviewing interim data for any emerging concerns.25 Hence the importance of REBs, part of whose role is to provide safety monitoring initially and, for ongoing trials, over the entire period of the trial. In order to assess the adequacy of the safety monitoring for the UHN ‘deferiprone trial’ one would need to know whether the hospital’s REB was provided with regular and accurate reports of SAEs and what actions this REB took in response to those reports.It has become common practice in North America ‘that for any controlled trial of any size that will compare rates of mortality or major morbidity’, a data safety monitoring board (DSMB) will be established.26,11 12 A DSMB is constituted by a panel of independent (and otherwise unbiased) individuals with expertise pertinent to reviewing trial data on zithromax side effects in men a regular ongoing basis. Its role is to advise the sponsors regarding the safety of trial subjects and to recommend early termination where indicated, for example, on grounds of patient safety.27Since there are no specifically Canadian requirements with respect to the establishment of DSMBs, Canadian REBs tend to follow FDA guidelines.

Those guidelines recommend that a DSMB should be established when the study end point is such that a highly zithromax side effects in men favourable or unfavourable result at an interim analysis might ethically require termination of the study. Advance information suggesting the possibility of serious toxicity with the study treatment is another a priori reason for safety concern that would justify the establishment of a DSMB.12For reasons given above, the UHN deferiprone trial appears to have been a prime candidate for the establishment of a DSMB. But it is not known whether the study’s research protocol, purportedly submitted for approval to the hospital’s REB, included a DSMB.

Nor is it known zithromax side effects in men whether a DSMB was established and reported regularly to the trial’s sponsors. Data on the toxicity of deferiprone, provided by Olivieri et al from their retrospective study of UHN patient records, suggest that had a DSMB existed for this putative clinical trial the trial might, on grounds of patient safety, have been a candidate for premature cancellation. Lacunae in our knowledge of the safety monitoring provisions of the deferiprone ‘clinical trial’ make it difficult to reach any firm conclusion as to whether the zithromax side effects in men ‘trial’ met prevailing safety monitoring requirements.The apparent unwillingness of the UHN to answer questions relating to safety monitoring might mean that an inquiry is needed to fill in our knowledge gaps and thereby make ethical evaluation possible.

For the findings of such an inquiry to be minimally credible it should be carried out by individuals who possess the requisite scientific/medical expertise and who are independent of the hospital and its thalassaemia clinic and who are demonstrably impartial. An inquiry carried out, zithromax side effects in men for example, by someone whose research has been funded by Apotex and/or by an expert with close professional and personal ties to one or more of the physicians in the UHN thalassaemia clinic would not satisfy the hospital’s duty of accountability for patient safety.Ethical concernsA RecapitulationThe serious complications experienced by deferiprone-exposed UHN patients, as described by Olivieri et al in their PLOS ONE article, raise a number of ethically important questions. How could an unlicensed drug of unproven efficacy and safety—a drug that has been questioned by regulatory agencies such that it is licensed only as a “last resort” therapy—have been administered to so many patients over a period of so many years when two licensed drugs, both proven adequately safe and effective and licensed as first-line therapies, were available?.

How did UHN physicians gain access to deferiprone from Health Canada when there is little evidence in UHN patient records that the deferiprone-exposed patients satisfied Health Canada’s criteria for Special Access?. Why was a putative UHN REB-approved research study involving deferiprone not zithromax side effects in men registered as a clinical trial?. Did the trial design include a DSMB, to protect patient safety and, if not, why not?.

Were SAEs reported to the UHN REB and to regulators, zithromax side effects in men as required?. Were deferiprone-treated UHN patients with thalassaemia adequately informed of the unlicensed status, unproven efficacy and reported toxicities of deferiprone?. Were deferiprone-exposed patients informed zithromax side effects in men of harms they themselves had sustained during deferiprone from this exposure?.

28 Did the evidence of systematic treatment failure, as outlined in the PLOS ONE paper, raise red flags for thalassaemia clinic physicians and for the REB of UHN?. And if serious problems were flagged what actions were taken to protect patient safety?. Institutional conflict of interestThe literature on biomedical conflicts of interest tends to focus on the ways in which financial support of individual researchers by the pharmaceutical industry can adversely affect both research integrity and patient safety.13–16 But similar ethical problems arise at the macro level when institutions, such as hospitals and clinics, depend on drug company funding to support patient care and clinical research.13 15 Notable scandals associated with institutional conflicts of interest include the David Healy/Eli Lilly scandal at Toronto’s Centre for Addictions and Mental Health (CAMH),13 the Aubrey Blumsohn/Proctor and Gamble scandal at Sheffield University (UK)17 and the Carl Elliott/Janssen Pharmaceuticals scandal at the University of Minnesota.17 The underlying pattern in each of these scandals involves (A) a biomedical researcher who is concerned about patient safety coming into conflict with (B) a zithromax side effects in men pharmaceutical company which funds both the researcher’s hospital and university and (C) a failure by the institutions involved vigorously to defend patient safety and research integrity when doing so might offend a wealthy sponsor.It should not be assumed that corporate influence on university medical centres is necessarily exerted by means of threats or other direct forms of intervention.

The mere presence of corporate funding can be sufficient to produce a corporate-friendly result. This point is illustrated by a recent STAT article, a propos the financial support which Purdue Pharma zithromax side effects in men provided to Massachusetts General Hospital. The very title of the article encapsulates the ethical problem of institutional conflict of interest.

€˜Purdue Pharma cemented ties with universities and hospitals to expand opioid sales, documents contend’.18 Nor should it be zithromax side effects in men supposed that the problem of institutional conflict of interest arises exclusively in the context of biomedical research. A recent Guardian article on the Mobil Oil Corporation describes how ‘Oil giant Mobil sought to make tax-exempt donations to leading universities … to promote the company’s interests and undermine environmental regulation, according to internal documents from the early 1990s obtained by the Guardian’.19As mentioned above, deferiprone, whose safety and efficacy are the central concern of Olivieri et al’s PLOS ONE paper, is manufactured by Apotex. When we seek to understand why deferiprone was so frequently prescribed to UHN patients, from 2009 to 2016, despite its being unlicensed and despite evidence of poor patient outcomes,3 it may be relevant to note that Apotex provided zithromax side effects in men substantial funding to the UHN thalassaemia clinic.29 Moreover, a publicly displayed UHN banner lists ‘Apotex Inc – Barry and Honey Sherman’ as having donated between $1 million and $5 million to the hospital itself.30As every biomedical researcher understands, correlation is not causation.

Nevertheless, the correlation between industry funding of hospitals, on the one hand, and industry-friendly decisions made by researchers and administrators at those hospitals, on the other, is worth pondering. Physicians and researchers who speak or write critically of drugs manufactured by wealthy donor companies may find that their careers are jeopardised. Nancy Olivieri’s dismissal from two Apotex-funded teaching hospitals illustrates this phenomenon as does the termination of psychiatrist David Healy from Toronto’s CAMH.13 Healy’s appointment as Head of the CAMH Mood Disorders Clinic was rescinded almost immediately after he gave a public lecture at the zithromax side effects in men hospital—a lecture in which he called for further research into the potentially adverse effects of Eli Lilly’s antidepressant drug, Prozac.

Healy was particularly concerned about SSRI-induced suicidal ideation. After his lecture the hospital decided that he was not ‘a good fit’ with their programme and zithromax side effects in men terminated his appointment. Shortly thereafter the hospital opened its Eli Lilly wing.13UHN, like every other research and teaching hospital in Canada, receives most of its funding, directly or indirectly, from governments.20 ,31 Nevertheless, UHN, again like other hospitals, faces ongoing pressure to find additional sources of revenue to support both patient care and clinical research.32 The pharmaceutical industry is a prime source of much-needed ‘top-up’ financial support for Canadian hospital research and clinical care.21 Hospital administrators, researchers and clinicians are thereby placed, willy nilly, in a conflict-of-interest situation.

Because of zithromax side effects in men funding exigencies, hospitals and other healthcare institutions, like individual physicians and researchers, have a strong vested interest in pleasing corporate sponsors and encouraging their ongoing support. Moreover, institutional administrators, not unlike individual researchers and clinicians, typically experience a need to express their gratitude to donors by returning kindness for kindness and benefit for benefit. Thus, both the need for ongoing corporate sponsorship and the need to reciprocate for past corporate generosity create for hospital administrators (as well as for researchers and clinicians who work within hospitals) a conflict-of-interest situation in which their decision making may be skewed, consciously or unconsciously, in favour of the benefactors’ products.13 15 16 21Here’s an example of the manner in which an institutional conflict-of-interest situation can potentially bias the judgement of hospital administrators.

Hospitals are zithromax side effects in men required to exercise their disinterested judgement in the appointment of medical and scientific staff and in the ethical monitoring of research. This moral obligation follows directly from their fundamental commitment to promote and defend patient safety and research integrity. To illustrate zithromax side effects in men.

UHN’s website, under the heading Purpose, Values and Principles, declares that ‘[o]ur Primary Value and above all else. The needs of patients come first’.22 It would be difficult to find any hospital whose Mission Statement did not zithromax side effects in men proclaim a similar commitment to the primacy of patient well-being. In a similar vein, the UHN website, under the heading Information for Patients, subheaded Our Mission, declares.

€˜We believe that health equity is achieved when each person is. Enabled to choose the best care and treatment based on the most current knowledge available’.From this zithromax side effects in men fundamental commitment, it follows that healthcare institutions are obliged rigorously to monitor the quality of care provided to their patients and research subjects. As an important element of protecting patient safety, hospitals are required to appoint the most qualified and competent candidates to clinical and research positions.

But, as noted above, conflicts of interest are a risk factor for bias, conscious or unconscious, in personnel decisions.22 So, when a research hospital depends on corporate donations zithromax side effects in men there is a risk that physicians and researchers may be appointed to key positions because they are known to be sympathetic to the donors’ product(s) rather than because they are the best qualified and the most competent. Contrariwise, physicians and researchers believed to be unsympathetic to the donors’ products are at risk of losing their jobs or of not being hired in the first place. The cases of Olivieri, Healy and Blumsohn illustrate this point.13 17As explained above, we know from the extensive literature on conflict of interest that when research and clinical care are funded by industry there is a marked tendency for both to favour the sponsors’/donors’ products.13 15 16 18 Significantly, the UHN itself explicitly recognises the danger to patient safety posed zithromax side effects in men by systemic biases.

Its Mission Statement commits the hospital to ensuring that every patient is ‘[m]ade aware of existing systemic biases to support the best possible health decisions’.22 Unfortunately, it is not possible at present to ascertain whether UHN conformed to this ethical commitment in the case of its deferiprone research/treatment clinic. In order to make such an ethical determination we would need to know the mechanism by which the UHN thalassaemia clinic gained access to deferiprone and whether the clinic provided information about systemic bias to patients with thalassaemia and to the hospital’s REB.ConclusionsHospitals worldwide proclaim that their primary commitment is to meet the needs of their patients. Institutional codes of ethics and zithromax side effects in men mission statements insist that patient needs come first.

Indeed, meeting ‘patient needs’ is agreed to be the fundamental value to which all other hospital goals should be subordinated. Toronto’s UHN declares unequivocally that it zithromax side effects in men shares this value. €˜[t]he needs of patients come first’.22Although patients have many and various needs, the need for safety must be counted as the sine qua non.

If the need for safety is not met then other needs become irrelevant.The findings of Olivieri et al in their PLOS ONE paper raise many troubling questions about the safety of zithromax side effects in men patients in UHN’s thalassaemia clinic. One would expect that when top UHN officials became aware of the PLOS ONE data they would immediately have recognised the ethical red flags. Hospitals are ethically obliged both to investigate thoroughly possible safety failures and to rectify any problems identified.Over a period of several years, both before and after the publication of their research findings, Drs Olivieri and Gallie communicated regularly with UHN officials (https://inthepatientsinterest.org/).

Multiple safety concerns were brought to the hospital’s attention zithromax side effects in men. Numerous questions were asked by the PLOS ONE authors and specific concerns were raised. To date, the hospital has not zithromax side effects in men definitively addressed these issues.

I posed a series of ethically salient questions to these same hospital officials (see online supplementary appendix A). My queries zithromax side effects in men were ignored. There was no response from UHN.Supplemental materialIf a healthcare institution such as UHN claims that patient safety is its top priority then when safety issues are raised, it necessarily incurs an obligation of accountability.

It would, for example, scarcely be adequate for a hospital, such as UHN, unilaterally to investigate alleged failures, declare that there has been no violation of patient care standards, and then to stonewall all further inquiries, whether those inquiries originate from its own medical staff, as was the case with Olivieri and Gallie, or from outside scholars, as was the case with me.When an unlicensed drug is prescribed to hospital patients, over a period of years, as happened in the UHN thalassaemia programme, it is surely the hospital’s obligation to answer questions about how and why this extraordinary practice occurred. When hospital records reveal that patients switched from zithromax side effects in men licensed to unlicensed medication, have experienced serious harms, up to and including death, it is surely the hospital’s obligation to answer in a conscientious and complete manner all the ethically troubling questions that have been identified. This obligation of accountability is owed both to patients and to staff.

Thus far, UHN has not been willing to accept zithromax side effects in men the implications of its own mission statement (https://www.uhn.ca/corporate/AboutUHN/Quality_Patient_Safety).The PLOS ONE Study by Olivieri Sabouhanian and Gallie spurs us to inquire whether the benefits which accrue to society from corporate sponsorship of healthcare institutions may, on balance, be outweighed by the associated harms. Admittedly, for governments committed to constraining public expenditures, the transfer of substantial healthcare costs to private corporations represents a benefit for public finances. But, as we have seen, when one considers this financial benefit, one ought also to take zithromax side effects in men into account the spectrum of negative consequences potentially generated by institutional conflicts of interest.

The price for our continued acceptance of corporate funding of scientific research and clinical care may be the erosion of public trust. Arguably, it would be preferable if our research hospital were to aim instead for the complete elimination of systemic biases.Data availability statementAll data relevant to the study are included in the article or uploaded as supplementary informationEthics statementsPatient consent for publicationNot required.AcknowledgmentsThe author thanks the editors of JME and two JME reviewers for their criticisms of and suggestions for change to an earlier version of this paper..

That they are ‘following the science’ has become the watchword of many politicians during the present zithromax, especially when imposing zithromax online in canada or prolonging lockdowns or other liberty-restricting https://www.video-advertising.agency/can-you-buy-ventolin-over-the-counter-in-ireland/ regulations. The scientists who advise politicians however are usually careful to add that the decision what to restrict and when is ultimately a political one. In science, as in medical practice, zithromax online in canada there is a delicate balance to be maintained between confidence in the best available information, and the necessary caveat that the assumptions and calculations on which that information is based are subject to further scientific enquiry.

For politicians and the public, moreover, as for patients, whether those informing them are judged to be trustworthy is a necessary consideration, a judgement determined by a variety of personal and political contingencies and circumstances. Ethics, by contrast, unable to appeal to scientific consensus (however revisable) or political authority (however reversible), let alone a confidence-inspiring bedside manner, must rest the case for its essentially contestable assumptions and arguments being judged trustworthy, on its willingness to admit all reasoned voices (including occasionally those that question reason itself) to a conversation that is potentially unending, but in the process often highly enlightening.That conversation is contributed to in this issue of the Journal by several zithromax online in canada reasoned voices, mostly on ethical aspects of the buy antibiotics zithromax. Relevant to issues on which politicians claim to be ‘following the science’, but also raising fundamental ethical questions, is this month’s feature article.

In Ethics of Selective Restriction of Liberty in a zithromax,1 Cameron and colleagues consider ‘if and when it may be ethically acceptable to impose selective liberty-restricting measures in order zithromax online in canada to reduce the negative impacts of a zithromax by preventing particularly vulnerable groups [for example, the elderly in buy antibiotics] of the community from contracting the disease’ [and thereby, for example, increasing the disease burden]. €˜Preventing harm to others when this is least restrictive option’, they argue, ‘fails to adequately accommodate the complexity of the issue or the difficult choices that must be made’. Instead, they propose ‘a dualist consequentialist approach, weighing utility at both a population and individual level’, thereby taking account of ‘two relevant values to be promoted or maximised.

Well-being and liberty’, zithromax online in canada as well as the value of equality, ‘protected through the application of an additional proportionality test’. The authors then propose an algorithm to take account of the different values and variables which need to be weighed up. They conclude zithromax online in canada.

€˜Selective restriction of liberty is justified when the problem is grave, the expected utility of the liberty restriction is high and significantly greater than the alternatives and the costs of the liberty restrictions are relatively small both at a population and individual level… Discrimination can be justified under these conditions when it is proportionate and limited to a very specific public health challenge’. The arguments and conclusions of the feature article are discussed in the two zithromax online in canada Commentaries2 3.In buy antibiotics controlled human studies. Worries about local community impact and demands for local engagement,4 Eyal and Lee review recent arguments which express ‘concern about undue usage of local residents’ direly needed scarce resources at a time of great need and even about their unintended ’ – and hence a requirement for ‘either avoiding controlled trials (CHIs) or engaging local communities before conducting CHIs’.

They then examine and compare the evidence of such adverse (and some potentially positive) effects of CHIs with those of conventional field trials and argue that ‘both small and large negative effects on struggling communities are likelier in field trials than in CHIs’. €˜Whether or not local community engagement is necessary for urgent treatment studies in a zithromax’, they conclude, ‘the case for its engagement is stronger prior to field trials zithromax online in canada than prior to controlled human studies’.In Payment of buy antibiotics challenge trials. Underpayment is a bigger worry than overpayment,5 Blumenthal Barby and Ubel consider the impact not on communities but on individuals, and specifically on ‘how much people should be paid for their participation in buy antibiotics challenge trials’.

Noting recent worries about ‘incentivising people with large amounts of money’, they argue that ‘higher payment that accounts for participant time, and for pains, burdens and willingness to take risks’ constitutes neither ‘undue inducement’ (for which the remedy zithromax online in canada is strengthening informed consent processes and minimising risks) nor ‘unjust inducement’ of individuals from ‘already disadvantaged groups’. Evidence of recruitment to challenge trials worldwide suggests, on the contrary, that participants ‘come from all walks of life’. Nor are zithromax online in canada these authors convinced that ‘offering substantial payment waters down the auistic motives of those involved’.

€˜auism and payment’ they argue, ‘frequently coexist. Teachers, physicians, public defenders – they all dedicate their lives to helping people. But few do without compensation.’In Money is not everything zithromax online in canada.

Experimental evidence that payments do not increase willingness to be vaccinated against buy antibiotics6, Sprengholz and colleagues report on an ‘experiment investigating the impact of payments and the communication of individual and prosocial benefits of high vaccination rates on vaccination intentions.’ In November 2020 over 1,000 ‘individuals from a German non-probabilistic sample’ were asked about their intentions. The ‘results revealed that none of these interventions or their combinations increased willingness to be vaccinated shortly after a treatment becomes available.’ Given that this experiment was conducted before treatments became available and only in Germany, the authors suggest that these results ‘should be generalised with caution’, but that ‘decision makers’ also zithromax online in canada ‘should be cautious about introducing monetary incentives and instead focus on interventions that increase confidence in treatment safety first’.In Voluntary buy antibiotics vaccination of children. A social responsibility,7 Brusa and Barilan observe a zithromax paradox.

€˜while we rely on low quality evidence when harming children by school deprivation and social distancing, we insist on a remarkably high level of safety data to benefit them with zithromax online in canada vaccination’. The consequent exclusion of children from vaccination, they argue, is unjust and not in ‘the best interest of the child as a holistic value encompassing physical, psychological, social and spiritual well-being’, something which ‘there is no scientific method for evaluating’. Society, rather, ‘has the political responsibility to factor in the overall impact of the zithromax on children’s well-being’ and the ‘ultimate choice is a matter of paediatric informed consent.

Moreover, jurisdictions that permit non-participation in established childhood vaccination programmes should also permit choice of treatments outside of the zithromax online in canada approved programmes.’ The authors conclude by outlining ‘a prudent and ethical scheme for gradual incorporation of minors in vaccination programmes that includes a rigorous postvaccination monitoring.’In Challenging misconceptions about clinical ethics support during buy antibiotics and beyond. A legal update and future considerations,8 Brierley, Archard and Cave note that the ‘buy antibiotics zithromax has highlighted the lack of formal ethics processes in most UK hospitals… at a time of unprecedented need for such support’. Unlike Research zithromax online in canada Ethics Committees (RECs), Clinical Ethics Committees (CECs) in the UK have neither any ‘well-funded governing authority,’ nor the decision-making capacity over clinical questions which RECs have over research.

In 2001 the ‘three central functions of CECs’ were described as ‘education, policy development and case review’. But more zithromax online in canada recently ‘the role of some was expanding’ and in 2020 the UK General Medical Council ‘mentioned for the first time the value in seeking advice from CECs to resolve disagreements’. Misunderstanding of CEC’s role however began to arise when some courts appeared to ‘perceive CECs as an alternative dispute resolution mechanism’ rather than as providing ‘ethics support, with treatment decisions remaining with the clinical team and those providing their consent.’ The future role of CECs, as well as the nature of patient involvement in them, the authors conclude, will depend on a choice between the ‘flexibility and diversity of the current ethical support system’ and ‘greater standardisation, governance and funding’.Important ethical issues not directly related to buy antibiotics are discussed in this issue’s remaining papers.

In Institutional conflict of interest. Attempting to crack the deferiprone zithromax online in canada mystery,9 Schafer identifies, places in historical context, and analyses ethical issues raised by the ‘ mystery’ of why between 2009 and 2015 ‘a third of patients with thalassaemia in Canada’s largest hospital were switched from first-line licensed drugs to regimens of deferiprone, an unlicensed drug of unproven safety and efficacy’. He then considers ‘institutional conflict of interest’ as ‘a possible explanatory hypothesis’.The perils of a broad approach to public interest in health data research.

A response to Ballantyne and Schaefer10 by Grewal and Newson and Ballantyne and Schaefer’s response In defence of a broad approach to public interest in health data research11 debate legal and philosophical aspects of whether ‘public interest’, and how narrowly or broadly this is conceived, zithromax online in canada is the most appropriate justification of consent waivers for secondary research on health information.In Do we really know how many clinical trials are conducted ethically,12 Yarborough presents evidence in support of the argument that 'research ethics committee practices need to be strengthed' and then suggests 'initial steps we could take to strengthen them'.Finally, and returning to how ‘science’ is perceived, in Lessons from Frankenstein 200 years on. Brain organoids, chimaeras and other ‘monsters’13, Koplin and Massie make a crucial observation. In ‘bioethical debates, Frankenstein is usually evoked as a warning zithromax online in canada against interfering with the natural order or “playing God”’.

But in the novel, Frankenstein’s ‘most serious moral error’ was made ‘not when he decided to pursue his scientific breakthrough (one which might, after all, have helped save lives), but when he failed to consider his moral obligations to the creature he created.’ Today, when, like Frankenstein, ‘modern scientists are creating and manipulating life in unprecedented ways’ such as brain organoids and chimaeras, Koplin and Massie argue, ‘two key insights’ can be drawn from Mary Shelley’s 1818 novel. First, ‘if we have created an entity in order to experiment on it’ we need ‘to extend much consideration to its interests and preferences, not least because ‘scientists cannot always rely on existing regulations to anticipate moral issues associated with the creation of new kinds of organisms’. And second zithromax online in canada.

€˜we should be wary of any prejudice we feel towards beings that look and behave differently from us’ and should ‘interrogate any knee-jerk intuitions we have about the moral status of unfamiliar kinds of beings.’Ethics statementsPatient consent for publicationNot required.IntroductionThalassaemia is an inherited anaemia that exerts an enormous disease burden worldwide.1 Along with sickle cell disease, it is one of the two most common single gene disorders. Indeed, ‘the zithromax online in canada alpha and beta thalassaemias are the most common inherited single-gene disorders in the world…’2A newly published study by Olivieri, Sabouhanian and Gallie3 analyses and assesses the comparative efficacy and safety profile of two drugs. Deferiprone (Ferriprox.

Apotex) and zithromax online in canada deferasirox (Exfade. Novartis). Both of these ‘iron-chelating’ drugs remove (‘chelate’) iron deposited, as a result of transfusions, in the tissues of patients with thalassaemia.The present-day first-line chelator, deferasirox, was licensed by the US FDA zithromax online in canada in 2005.

The evidence for its safety and effectiveness was judged to be substantial and, accordingly, the FDA licensed it as a first-line agent. The prime advantage of deferasirox, in comparison to deferoxamine, an older drug that was formerly the gold standard of iron-chelating therapy for thalassaemia, is that deferasirox is orally active (that is, taken in pill form), while deferoxamine is more burdensome for patients because it has to be taken parenterally (that is, via injection). Deferiprone, like deferasirox, is taken orally but zithromax online in canada has not been licensed anywhere as first-line treatment.

The FDA withheld market approval for deferiprone because there were/are no controlled trials demonstrating direct treatment benefit. Although the FDA did eventually approve deferiprone, in 2011, it gave approval only as a last-resort treatment for those patients in whom other chelators had been tried unsuccessfully.1The data presented by Olivieri et al in their PLOS ONE paper indicate that the drugs zithromax online in canada differ significantly with respect to their effectiveness and safety. This commentary explores some of the ethical issues raised by the PLOS data.Historical contextIn order to understand properly the significance of the PLOS ONE Study some historical context will be helpful.

What follows is a brief sketch of that context.2In 1993 Dr Nancy Olivieri, a specialist in blood diseases at Toronto’s Hospital for Sick Children (HSC or ‘Sick Kids’) and Professor of Pediatrics and Medicine at the University of Toronto (U of T), signed a contract with Apotex, a generic drug company, to continue studies of deferiprone, the early promise of which she zithromax online in canada had already reported in the literature. Olivieri’s thalassaemia research was initially supported by the Medical Research Council of Canada, but now she sought additional funding to extend her clinical trials. Apotex contributed this additional funding, thereby obtaining worldwide patents on the still-experimental drug.Despite early promise, by 1996 Olivieri’s research began to indicate that deferiprone might be inadequately effective in many patients, posing risks of potentially serious harm.

Olivieri communicated to Apotex her intention to zithromax online in canada inform patients of this unexpected risk and she proposed also to amend the study’s consent forms. She wished to continue amended studies of the drug, and to publish her findings.Apotex responded to Olivieri that they disagreed with her interpretation of the data and the company’s CEO threatened her with ‘all legal remedies’ should she inform patients or publish her findings. In issuing these threats, Apotex relied on a confidentiality clause in a legal contract Olivieri had signed with Apotex zithromax online in canada in 1993.

This contract prohibited disclosure ‘to any third party’ without the express permission of Apotex.3Despite the objections raised by Apotex, Olivieri saw it as her professional duty to disclose her findings. The Research Ethics zithromax online in canada Board (REB) of Sick Kids Hospital reached the same conclusion. In compliance with instructions from the Hospital’s REB, Olivieri duly informed both her patients and the regulatory authorities.When Olivieri later identified a second risk—that liver damage progressed during deferiprone exposure—Apotex issued additional legal warnings.

Olivieri nevertheless proceeded to inform her patients of this additional risk and published her findings.Since patient safety, research integrity and academic freedom were all at stake in this dispute, Olivieri appealed for assistance, repeatedly, to senior officials at both the U of T and Sick Kids Hospital. Neither the University nor the Hospital zithromax online in canada provided the support she requested. In the words of the Report of the Committee of Inquiry on the Case Involving Dr Nancy Olivieri, the HSC, the U of T, and Apotex Inc4:The HSC and the U of T did not provide effective support either for Dr Olivieri and her rights, or for the principles of research and clinical ethics, and of academic freedom, during the first two and a half years of this controversy.Instead, both the University and the Hospital ‘took actions that were harmful to Dr.

Olivieri’s interests and professional reputation and disrupted her work’.4 The harmful actions included firing Olivieri from her position as Director of the zithromax online in canada Hemoglobinopathy Program at Sick Kids Hospital and referring her for discipline to the College of Physicians and Surgeons of Ontario (CPSO).Only later did it emerge that, during this period of conflict, the U of T was negotiating with Apotex for a major donation towards building the University’s proposed new molecular medicine building. Some speculated that the University’s failure to support Olivieri may not have been unconnected from its desire to appease a wealthy corporate donor. This speculation was reinforced when it was discovered that the then President of the University, Robert Prichard, had secretly lobbied the government of Canada for changes in drug patent law, changes that would favour Apotex.4Apotex proceeded to sue zithromax online in canada Olivieri for defaming both the company and their drug.

She sued the company for defaming her.The Canadian Association of University Teachers (CAUT) and the U of T Faculty Association (UTFA), to whom Olivieri appealed for assistance after being rebuffed by the U of T and HSC, viewed the underlying issue as one of academic freedom. Both CAUT and UTFA provided support, including legal advice, to Olivieri.Thus began what is widely acknowledged to be the greatest scandal in Canadian academic history. Commissions of inquiry, books and articles (both scholarly and popular) proliferated, zithromax online in canada not to mention newspaper and television stories.

John le Carré’s novel The Constant Gardener and the Hollywood movie based on the book both appeared to draw heavily on the Olivieri-Apotex scandal. An inquiry into the dispute commissioned by Sick Kids Hospital (the Naimark Inquiry)5 absolved Apotex of wrongdoing but suggested that Olivieri was seriously at fault.5 She was charged with research misconduct and failures of patient care and was referred first to the Hospital’s Medical Advisory Council and subsequently to zithromax online in canada the disciplinary committee of the CPSO. Unsurprisingly, these widely publicised referrals were prejudicial to Olivieri’s reputation.The CAUT then commissioned an independent inquiry.6 The 540-page CAUT report on the Olivieri/Apotex affair4 gave a markedly different account of the scandal from that offered by the hospital-commissioned Naimark Report.

A few excerpts from the CAUT report will convey its zithromax online in canada central findings:Apotex issued more legal warnings to deter Dr. Olivieri from communicating this second unexpected risk of L1 (deferiprone) to anyone. However, she was legally and ethically obligated to communicate the risk to those taking or prescribing the drug as there were potential safety implications for patients, and she fulfilled these obligations despite the legal warnings.Apotex acted against the public interest in issuing legal warnings to Dr.

Olivieri to deter her from communicating about risks of L1.Apotex’s zithromax online in canada legal warnings violated Dr. Olivieri’s academic freedom.7Shortly after the CAUT report absolved Olivieri of misconduct, the CPSO published the findings of its inquiry. The CPSO report exonerated Olivieri of all misconduct zithromax online in canada charges.

Indeed, their report concluded that her conduct had been ‘commendable’.6 This favourable verdict did not, however, bring an end to litigation.In 2004, 8 years after the first legal threats had been issued, Apotex signed a mediated settlement with Olivieri. Nevertheless, litigation continued for zithromax online in canada another 10 years. Those unfamiliar with the workings of the law may wonder how it is possible for litigation to continue for such a long period after a mediated settlement.

Litigation continued because Apotex alleged that Olivieri had violated their agreement. Olivieri insisted that zithromax online in canada she was in compliance with the terms of the settlement. Court decisions were appealed by both parties.

A final settlement was not reached zithromax online in canada between Olivieri and Apotex until 2014.8 Shades of Jarndyce v. Jarndyce in Charles Dicken’s novel Bleak House.The HSC settled its dispute with Olivieri in 2006 and, although her research programme at the Hospital continued, she ceased to provide clinical care to HSC patients. From 1997 to 2009, Olivieri served as Director of the University Health Network (UHN) zithromax online in canada Hemoglobinopathy Program.

She continued, as she had since 1997, to assist in the clinical care of UHN patients with thalassaemia and to enrol them in her research studies. In March zithromax online in canada 2009, however, Olivieri was dismissed by UHN from her position as Director. No reason was given for her dismissal (Personal communication.

Olivieri, 2019).The PLOS ONE Study data3 show that, after Olivieri’s dismissal from her position as Director, the UHN thalassaemia Clinic began almost immediately to switch patients to (unlicensed) deferiprone. Olivieri has described how her UHN research work, from this time forward, was marginalised (https://inthepatientsinterest.org/wp-content/uploads/2019/12/2018-12-20-GallieOlivieri-to-SmithHodges.pdf).Meanwhile, Freedom of Information (FOI) requests filed by Olivieri after her dismissal revealed zithromax online in canada that Apotex was supplying unrestricted educational grants to UHN’s thalassaemia programme as well as providing research support. The FOI requests filed by Olivieri also revealed that Apotex was strategising with the programme’s new director about how best to obtain licensing for deferiprone from the regulator (Health Canada).9 With this dramatic background as historical context, we commence our discussion of the ethical implications of the PLOS ONE paper.Findings of the PLOS ONE paperIn their 2019 PLOS ONE study Olivieri et al conclude, based on a retrospective review of patient data at Toronto’s UHN, that deferiprone is inadequately effective and associated with serious toxicity.

Their review also confirms that, by contrast, deferasirox is effective and zithromax online in canada associated with relatively few adverse effects.3Olivieri et al report that ‘[b]etween 2009 and 2015, a third of patients transfused and managed in Canada’s largest transfusion programme were switched from first-line, licensed drugs to regimens of unlicensed deferiprone’.3 This finding raises the ethically troubling question. How and why were so many locally transfused patients at UHN treated over such a long time period with an unlicensed drug of unproven safety and efficacy?. This ethical concern is followed zithromax online in canada immediately by another related concern.

Why did the UHN thalassaemia programme continue to treat large numbers of its patients with deferiprone—despite ongoing evidence of inadequate effectiveness and serious (and often irreversible) adverse effects?. 3To recapitulate. The PLOS ONE paper demonstrates that a substantial proportion of UHN patients with zithromax online in canada thalassaemia was switched, between the years 2009 and 2015, from first-line licensed therapies (deferasirox or deferoxamine) to deferiprone.

During this entire period, deferiprone was unlicensed in Canada. To this day in every jurisdiction in which deferiprone has been zithromax online in canada licensed it has been licensed only as ‘last resort’ therapy. The ethical concern is to explain and to explore possible justifications for how and why so many patients at one particular thalassaemia treatment centre were prescribed a drug whose safety and efficacy were unproven in face of availability of licensed effective drugs.

The urgency of the concern derives partly from the paper’s finding that those patients who were switched to deferiprone displayed evidence of increases in body iron and zithromax online in canada experienced the harms associated with body iron increase.3 This finding raises a second troubling ethical question. Why were patients not switched back to a first-line licensed therapy after they began to experience serious adverse effects from treatment with unlicensed deferiprone?. How and why?.

In a sustained effort to discover answers to these questions, zithromax online in canada Olivieri and Gallie have been in communication since 2015, by email and in personal meetings, with senior officials at UHN. Olivieri and Gallie report, however, that no definitive answers have yet been provided to any of their questions. FOI requests were filed but they, too, failed to produce zithromax online in canada definitive answers.

(Olivieri and Gallie to Smith &. Porter, 2019, https://inthepatientsinterest.org/wp-content/uploads/2019/12/2019-04-23-OlivieriGallie-to-SmithPorter.pdf).10 I, too, wrote to the CEO/President of UHN and to the Chief of Medical Staff, in an attempt to discover answers zithromax online in canada to a number of the ethical questions posed in this commentary. The hospital, however, has not responded to any of my questions.11Olivieri and Gallie have recently posted documentation of their correspondence with senior UHN administrators (https://inthepatientsinterest.org/).

In September 2019 the UHN administration responded to the PLOS ONE paper by revealing that it had conducted a ‘Review of chelation practice in the red blood cell disorders program at UHN’. However, as Olivieri and Gallie document on the web, the hospital’s ‘Review’ does not address any zithromax online in canada of the safety concerns flagged in the PLOS ONE paper (https://inthepatientsinterest.org/wp-content/uploads/2019/12/Letter-to-Smith-and-Hodges-2-12-19.pdf). Nor does the ‘Review’ address any of the ethical concerns raised here.Despite UHN’s apparent reluctance to provide the information requested, here’s what we know or can reasonably infer.

Deferiprone was unlicensed in Canada during the relevant period, that zithromax online in canada is, from 2009 to 2015. €˜Unlicensed’ is different from ‘off-label’, the latter referring to a drug that has been licensed but is being provided for an indication other than that for which it is approved. Prescription of any unlicensed drug to Canadian patients can be accomplished only in one of two mutually zithromax online in canada exclusive ways.

Either through Health Canada’s ‘Special Access Program (SAP)’ or via an REB approved clinical trial. It has to be one or the other since, as Health Canada’s Guidance Document7 makes clear, patients cannot be simultaneously treated through SAP and in a research trial.12 Under the SAP, the treating physician must confirm to Health Canada that ‘conventional therapies have failed, or are unsuitable or unavailable’. Although some of the UHN patients’ records indicate that deferiprone was released under the SAP, Olivieri et al report that they ‘could identify no explanation for a proposed switch to deferiprone that was supported by evidence zithromax online in canada of failure of licensed therapy prescribed as recommended’3.

Indeed, the authors write that many patients appear to have been switched to deferiprone despite optimal responses, or improvements during treatment with first-line therapies. Here’s the relevant paragraph from their PLOS ONE article:Deferiprone was prescribed to 41 study patients zithromax online in canada between 2009 and 2015. We could identify in the electronic medical records no explanation for a proposed switch to deferiprone that was supported by evidence of failure of licensed therapy prescribed as recommended.

There was no indication that any patient switched to zithromax online in canada deferiprone over these 6 years had ‘failed’ therapy with either deferoxamine or deferasirox. Many patients were recorded as tolerant of at least one and (in most), both licensed first-line chelating agents. Some had sustained minor adverse events during deferasirox that had resolved by the time deferiprone was prescribed.3In other words, according to the data found in UHN patient records, there is no evidence that the patients with thalassaemia who were switched to deferiprone met Health Canada’s eligibility criteria under SAP.

Since deferiprone is licensed only as a ‘last zithromax online in canada resort’ therapy, its employment to treat patients who can tolerate either of the first-line therapies might improperly expose those patients to risks of serious medical harms, up to and including death.On the other hand, one should also consider the alternate possibility that, over the 6-year period studied by Olivieri et al, deferiprone was prescribed as part of a clinical trial. In favour of this hypothesis, one notes that the UHN physician primarily responsible for the widespread prescribing of deferiprone during the relevant time period claimed, in 2011, that deferiprone was provided to patients under a study approved by the REB of the UHN.8 UHN physicians also made this identical claim in a publicly available letter to the US FDA.9 Moreover, in response to an FOI application filed by Olivieri, UHN claimed that deferiprone was provided at UHN during a clinical trial (the data of which are protected from scrutiny under FOI laws), and not under SAP (the data of which are not protected from scrutiny under FOI). However, Olivieri et al have been unable to find any record of registration for such a trial, as required by Canadian Clinical Trial guidelines.13 Requests to the UHN administration for confirmation that a clinical trial existed remain unanswered.14 My own efforts to find some registration record for this putative clinical trial of deferiprone have been equally unsuccessful.15Two core ethical principles zithromax online in canada.

Harm-minimisation and informed consentIf the deferiprone used to treat UHN patients with thalassaemia was obtained from Apotex as part of a randomised clinical trial, responsibility for approving the trial would fall to the UHN’s REB. In Canada, both researchers and REBs are governed by the zithromax online in canada Tri-Council Policy Statement (TCPS) ‘Ethical Conduct for Research Involving Humans’.10 The 1998 version of this policy statement (TCPS1) and the subsequent 2010 version (TCPS2), both applicable to research trials during this period, stipulate that clinical trials must be designed so that harm to research subjects will be minimised.16 For example, TCPS1 specifies, in section 1.5, that ‘Research subjects must not be subjected to unnecessary risks of harm’. TCPS2, under the rubric ‘Core Principles’, requires similarly that clinical trials must ‘ensure that participants are not exposed to unnecessary risks’.Data presented by Olivieri et al in their PLOS ONE Study indicate that UHN patients exposed to unlicensed deferiprone, either as monotherapy or in combination with low dose of a first-line chelator (‘combination therapy’), experienced significant harms as a result of poor iron control, but very few if any compensating benefits.We provide new evidence of inadequate reduction in hepatic iron, a 17% incidence of new diabetes and new liver dysfunction in 65% of patients, many who were challenged and rechallenged with deferiprone despite elevated liver enzymes developed during previous exposure.

We identified no evidence of ‘cardio-protective’ effect during deferiprone therapy.3In light of PLOS ONE Study data indicating serious adverse events (SAEs) for patients switched to deferiprone from first-line drugs one is led to question why the study protocol did not, in anticipation of such a contingency, provide for a resumption of licensed therapy for patients zithromax online in canada doing poorly on the unlicensed drug. Moreover, the investigators were obliged to report adverse events to the hospital’s REB. Were the adverse events so reported?.

And if they were then why did the UHN REB not seek to protect patient zithromax online in canada safety by insisting that licensed therapy be resumed for deferiprone-harmed patients?. In an effort to establish whether the deferiprone ‘clinical trial’ satisfied the TCPS harm-minimisation principle, I made inquiries about how the adverse findings described by the PLOS ONE paper were reported to the hospital’s REB and also how they were reported to the regulatory authorities, that is, Health Canada and the US FDA. But my queries, like those made previously by Olivieri and Gallie, zithromax online in canada have not succeeded in eliciting this ethically relevant information.17 Neither UHN nor its thalassaemia clinic responded to my letters of inquiry.

It is known, however, from a publicly available 2011 document, that physicians in the UHN thalassaemia clinic strongly supported the market approval of deferiprone by the FDA.18 This support is difficult to reconcile with the toxicities recorded in UHN patient records. So, a final verdict on the issue of whether the UHN deferiprone zithromax online in canada ‘clinical trial design’ violated the TCPS harm-minimisation principle cannot be reached until those involved in conducting and monitoring clinical trials at UHN make available the relevant information. An independent public inquiry may be necessary to achieve the necessary degree of accountability.Reference has been made, above, to the TCPS core ethical requirement of harm-minimisation, applicable in Canada both to researchers and to REBs.

It is important to note, however, that TCPS2, like its predecessor, TCPS1 (and, indeed, like virtually every postwar code of research ethics) also stipulates as a second ‘core principle’ that ‘Researchers shall provide to prospective participants, or authorised third parties, full disclosure of all information necessary for making an informed decision’.19 Moreover, as the then-current TCPS guidelines make clear, ‘consent is an ongoing process’. So, assurance should be given to prospective participants that they ‘will be given in a timely manner throughout the zithromax online in canada course of the research project, information that is relevant to their decision to continue or withdraw from participation’.20 (My emphasis). Finally, TCPS2 imposes on researchers the additional ethical requirement that they disclose to research subjects ‘information concerning the possibility of commercialisation of research findings, and the presence of any real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research sponsors’.21 There is also an expectation that conflicts of interest will be disclosed to the REB.

Whether there was adequate disclosure of Apotex funding either to research subjects or to the UHN REB is still unknown.Thus, in order to assess the ethical adequacy of the putative UHN thalassaemia clinical trial one must inquire whether UHN patients/subjects were given adequate risk information when they were first enrolled, subsequently, when they were switched from treatment with zithromax online in canada deferasirox or deferoxamine to treatment with deferiprone and then, finally, when they experienced SAEs. That is, in order to know whether the putative deferiprone clinical trial conformed to established principles of research ethics, one would need to know whether patients/research subjects understood that they were being switched from licensed first-line drugs of proven efficacy to an unlicensed and unproven third-line drug. One would zithromax online in canada also need to know whether the deferiprone ‘research subjects’ were informed about conflicts of interest arising from Apotex donations (A) to the UHN.

(B) To the hospital’s thalassaemia programme,22 as well as the hoped-for commercialisation of deferiprone via Health Canada and FDA licensing.If there was a failure to obtain ongoing informed consent and/or a failure to disclose conflicts of interest (to patients and to the REB) then this would constitute a violation of research ethics. Unfortunately, my attempts to elicit the clinical trial’s consent to research information from the UHN and its thalassaemia clinic met with as little success as earlier attempts made by the PLOS ONE authors.23REB review. Safety monitoringAlthough every clinical trial requires safety monitoring, those trials which involve zithromax online in canada non-negligible risk of significant harm to patients/subjects require especially rigorous safety monitoring.24 Because the exposure of deferiprone to UHN patients posed risks of organ dysfunction and death, the need for safety monitoring was exigent.

As the TCPS1 and TCPS2 both make clear, those who conduct research have an obligation to monitor and protect the safety of their research subjects.Moreover, it is now widely recognised that individuals closely involved with the design and conduct of a trial may not be able to be fully objective in reviewing interim data for any emerging concerns.25 Hence the importance of REBs, part of whose role is to provide safety monitoring initially and, for ongoing trials, over the entire period of the trial. In order to assess the adequacy of the safety monitoring for the UHN ‘deferiprone trial’ one would need to know whether the hospital’s REB was provided with regular and accurate reports of SAEs zithromax online in canada and what actions this REB took in response to those reports.It has become common practice in North America ‘that for any controlled trial of any size that will compare rates of mortality or major morbidity’, a data safety monitoring board (DSMB) will be established.26,11 12 A DSMB is constituted by a panel of independent (and otherwise unbiased) individuals with expertise pertinent to reviewing trial data on a regular ongoing basis. Its role is to advise the sponsors regarding the safety of trial subjects and to recommend early termination where indicated, for example, on grounds of patient safety.27Since there are no specifically Canadian requirements with respect to the establishment of DSMBs, Canadian REBs tend to follow FDA guidelines.

Those guidelines recommend that a DSMB zithromax online in canada should be established when the study end point is such that a highly favourable or unfavourable result at an interim analysis might ethically require termination of the study. Advance information suggesting the possibility of serious toxicity with the study treatment is another a priori reason for safety concern that would justify the establishment of a DSMB.12For reasons given above, the UHN deferiprone trial appears to have been a prime candidate for the establishment of a DSMB. But it is not known whether the study’s research protocol, purportedly submitted for approval to the hospital’s REB, included a DSMB.

Nor is it known whether a DSMB was established and zithromax online in canada reported regularly to the trial’s sponsors. Data on the toxicity of deferiprone, provided by Olivieri et al from their retrospective study of UHN patient records, suggest that had a DSMB existed for this putative clinical trial the trial might, on grounds of patient safety, have been a candidate for premature cancellation. Lacunae in our knowledge of the safety monitoring provisions of the zithromax online in canada deferiprone ‘clinical trial’ make it difficult to reach any firm conclusion as to whether the ‘trial’ met prevailing safety monitoring requirements.The apparent unwillingness of the UHN to answer questions relating to safety monitoring might mean that an inquiry is needed to fill in our knowledge gaps and thereby make ethical evaluation possible.

For the findings of such an inquiry to be minimally credible it should be carried out by individuals who possess the requisite scientific/medical expertise and who are independent of the hospital and its thalassaemia clinic and who are demonstrably impartial. An inquiry carried out, for example, by someone whose research has been funded by Apotex and/or by an expert with close zithromax online in canada professional and personal ties to one or more of the physicians in the UHN thalassaemia clinic would not satisfy the hospital’s duty of accountability for patient safety.Ethical concernsA RecapitulationThe serious complications experienced by deferiprone-exposed UHN patients, as described by Olivieri et al in their PLOS ONE article, raise a number of ethically important questions. How could an unlicensed drug of unproven efficacy and safety—a drug that has been questioned by regulatory agencies such that it is licensed only as a “last resort” therapy—have been administered to so many patients over a period of so many years when two licensed drugs, both proven adequately safe and effective and licensed as first-line therapies, were available?.

How did UHN physicians gain access to deferiprone from Health Canada when there is little evidence in UHN patient records that the deferiprone-exposed patients satisfied Health Canada’s criteria for Special Access?. Why was a zithromax online in canada putative UHN REB-approved research study involving deferiprone not registered as a clinical trial?. Did the trial design include a DSMB, to protect patient safety and, if not, why not?.

Were SAEs reported to zithromax online in canada the UHN REB and to regulators, as required?. Were deferiprone-treated UHN patients with thalassaemia adequately informed of the unlicensed status, unproven efficacy and reported toxicities of deferiprone?. Were deferiprone-exposed patients informed of harms they themselves had sustained during deferiprone zithromax online in canada from this exposure?.

28 Did the evidence of systematic treatment failure, as outlined in the PLOS ONE paper, raise red flags for thalassaemia clinic physicians and for the REB of UHN?. And if serious problems were flagged what actions were taken to protect patient safety?. Institutional conflict of interestThe literature on biomedical conflicts of interest tends to focus on the ways in which financial support of individual researchers by the pharmaceutical industry can adversely affect both research integrity and patient safety.13–16 But similar ethical problems arise at the macro level when institutions, such as hospitals and clinics, depend on drug company funding to support patient care and clinical research.13 15 Notable scandals associated with institutional conflicts of interest include the David Healy/Eli Lilly scandal at Toronto’s Centre for Addictions and Mental Health (CAMH),13 the Aubrey Blumsohn/Proctor and Gamble scandal at Sheffield University (UK)17 and the Carl Elliott/Janssen Pharmaceuticals scandal at the University of Minnesota.17 The underlying pattern in each of these scandals involves (A) a biomedical zithromax online in canada researcher who is concerned about patient safety coming into conflict with (B) a pharmaceutical company which funds both the researcher’s hospital and university and (C) a failure by the institutions involved vigorously to defend patient safety and research integrity when doing so might offend a wealthy sponsor.It should not be assumed that corporate influence on university medical centres is necessarily exerted by means of threats or other direct forms of intervention.

The mere presence of corporate funding can be sufficient to produce a corporate-friendly result. This point is illustrated by a recent STAT article, a propos the financial support which Purdue Pharma provided to Massachusetts zithromax online in canada General Hospital. The very title of the article encapsulates the ethical problem of institutional conflict of interest.

€˜Purdue Pharma cemented ties with universities and hospitals to expand opioid sales, documents contend’.18 Nor zithromax online in canada should it be supposed that the problem of institutional conflict of interest arises exclusively in the context of biomedical research. A recent Guardian article on the Mobil Oil Corporation describes how ‘Oil giant Mobil sought to make tax-exempt donations to leading universities … to promote the company’s interests and undermine environmental regulation, according to internal documents from the early 1990s obtained by the Guardian’.19As mentioned above, deferiprone, whose safety and efficacy are the central concern of Olivieri et al’s PLOS ONE paper, is manufactured by Apotex. When we seek to understand why deferiprone was so frequently prescribed to UHN patients, from 2009 to 2016, despite its being unlicensed and despite evidence of poor patient outcomes,3 it may be relevant to note that Apotex provided substantial funding to the UHN thalassaemia clinic.29 Moreover, a publicly displayed UHN banner lists ‘Apotex Inc – Barry and Honey Sherman’ as having donated between $1 million and $5 million to the hospital itself.30As every biomedical researcher understands, zithromax online in canada correlation is not causation.

Nevertheless, the correlation between industry funding of hospitals, on the one hand, and industry-friendly decisions made by researchers and administrators at those hospitals, on the other, is worth pondering. Physicians and researchers who speak or write critically of drugs manufactured by wealthy donor companies may find that their careers are jeopardised. Nancy Olivieri’s dismissal from two Apotex-funded teaching hospitals illustrates this phenomenon as does the termination of psychiatrist David Healy from Toronto’s CAMH.13 Healy’s appointment as Head of the CAMH Mood Disorders Clinic was rescinded almost immediately after he gave a public lecture at zithromax online in canada the hospital—a lecture in which he called for further research into the potentially adverse effects of Eli Lilly’s antidepressant drug, Prozac.

Healy was particularly concerned about SSRI-induced suicidal ideation. After his zithromax online in canada lecture the hospital decided that he was not ‘a good fit’ with their programme and terminated his appointment. Shortly thereafter the hospital opened its Eli Lilly wing.13UHN, like every other research and teaching hospital in Canada, receives most of its funding, directly or indirectly, from governments.20 ,31 Nevertheless, UHN, again like other hospitals, faces ongoing pressure to find additional sources of revenue to support both patient care and clinical research.32 The pharmaceutical industry is a prime source of much-needed ‘top-up’ financial support for Canadian hospital research and clinical care.21 Hospital administrators, researchers and clinicians are thereby placed, willy nilly, in a conflict-of-interest situation.

Because of funding exigencies, hospitals and other healthcare institutions, like individual physicians and researchers, have zithromax online in canada a strong vested interest in pleasing corporate sponsors and encouraging their ongoing support. Moreover, institutional administrators, not unlike individual researchers and clinicians, typically experience a need to express their gratitude to donors by returning kindness for kindness and benefit for benefit. Thus, both the need for ongoing corporate sponsorship and the need to reciprocate for past corporate generosity create for hospital administrators (as well as for researchers and clinicians who work within hospitals) a conflict-of-interest situation in which their decision making may be skewed, consciously or unconsciously, in favour of the benefactors’ products.13 15 16 21Here’s an example of the manner in which an institutional conflict-of-interest situation can potentially bias the judgement of hospital administrators.

Hospitals are required to exercise their disinterested judgement zithromax online in canada in the appointment of medical and scientific staff and in the ethical monitoring of research. This moral obligation follows directly from their fundamental commitment to promote and defend patient safety and research integrity. To illustrate zithromax online in canada.

UHN’s website, under the heading Purpose, Values and Principles, declares that ‘[o]ur Primary Value and above all else. The needs of patients come first’.22 It would be difficult zithromax online in canada to find any hospital whose Mission Statement did not proclaim a similar commitment to the primacy of patient well-being. In a similar vein, the UHN website, under the heading Information for Patients, subheaded Our Mission, declares.

€˜We believe that health equity is achieved when each person is. Enabled to choose the zithromax online in canada best care and treatment based on the most current knowledge available’.From this fundamental commitment, it follows that healthcare institutions are obliged rigorously to monitor the quality of care provided to their patients and research subjects. As an important element of protecting patient safety, hospitals are required to appoint the most qualified and competent candidates to clinical and research positions.

But, as noted above, conflicts of interest are a risk factor for bias, conscious or unconscious, in personnel decisions.22 So, when a research hospital depends on zithromax online in canada corporate donations there is a risk that physicians and researchers may be appointed to key positions because they are known to be sympathetic to the donors’ product(s) rather than because they are the best qualified and the most competent. Contrariwise, physicians and researchers believed to be unsympathetic to the donors’ products are at risk of losing their jobs or of not being hired in the first place. The cases of Olivieri, Healy and Blumsohn illustrate this point.13 17As explained above, we know from the extensive literature on conflict of interest that when research and clinical zithromax online in canada care are funded by industry there is a marked tendency for both to favour the sponsors’/donors’ products.13 15 16 18 Significantly, the UHN itself explicitly recognises the danger to patient safety posed by systemic biases.

Its Mission Statement commits the hospital to ensuring that every patient is ‘[m]ade aware of existing systemic biases to support the best possible health decisions’.22 Unfortunately, it is not possible at present to ascertain whether UHN conformed to this ethical commitment in the case of its deferiprone research/treatment clinic. In order to make such an ethical determination we would need to know the mechanism by which the UHN thalassaemia clinic gained access to deferiprone and whether the clinic provided information about systemic bias to patients with thalassaemia and to the hospital’s REB.ConclusionsHospitals worldwide proclaim that their primary commitment is to meet the needs of their patients. Institutional codes zithromax online in canada of ethics and mission statements insist that patient needs come first.

Indeed, meeting ‘patient needs’ is agreed to be the fundamental value to which all other hospital goals should be subordinated. Toronto’s UHN declares unequivocally that zithromax online in canada it shares this value. €˜[t]he needs of patients come first’.22Although patients have many and various needs, the need for safety must be counted as the sine qua non.

If the need for safety is not met then other needs become zithromax online in canada irrelevant.The findings of Olivieri et al in their PLOS ONE paper raise many troubling questions about the safety of patients in UHN’s thalassaemia clinic. One would expect that when top UHN officials became aware of the PLOS ONE data they would immediately have recognised the ethical red flags. Hospitals are ethically obliged both to investigate thoroughly possible safety failures and to rectify any problems identified.Over a period of several years, both before and after the publication of their research findings, Drs Olivieri and Gallie communicated regularly with UHN officials (https://inthepatientsinterest.org/).

Multiple safety concerns were brought to the zithromax online in canada hospital’s attention. Numerous questions were asked by the PLOS ONE authors and specific concerns were raised. To date, the hospital has not definitively addressed these zithromax online in canada issues.

I posed a series of ethically salient questions to these same hospital officials (see online supplementary appendix A). My queries were zithromax online in canada ignored. There was no response from UHN.Supplemental materialIf a healthcare institution such as UHN claims that patient safety is its top priority then when safety issues are raised, it necessarily incurs an obligation of accountability.

It would, for example, scarcely be adequate for a hospital, such as UHN, unilaterally to investigate alleged failures, declare that there has been no violation of patient care standards, and then to stonewall all further inquiries, whether those inquiries originate from its own medical staff, as was the case with Olivieri and Gallie, or from outside scholars, as was the case with me.When an unlicensed drug is prescribed to hospital patients, over a period of years, as happened in the UHN thalassaemia programme, it is surely the hospital’s obligation to answer questions about how and why this extraordinary practice occurred. When hospital records reveal that patients switched zithromax online in canada from licensed to unlicensed medication, have experienced serious harms, up to and including death, it is surely the hospital’s obligation to answer in a conscientious and complete manner all the ethically troubling questions that have been identified. This obligation of accountability is owed both to patients and to staff.

Thus far, UHN has not been willing to accept the implications of its own mission statement (https://www.uhn.ca/corporate/AboutUHN/Quality_Patient_Safety).The PLOS ONE Study by Olivieri Sabouhanian and Gallie spurs us to inquire whether the benefits zithromax online in canada which accrue to society from corporate sponsorship of healthcare institutions may, on balance, be outweighed by the associated harms. Admittedly, for governments committed to constraining public expenditures, the transfer of substantial healthcare costs to private corporations represents a benefit for public finances. But, as we have seen, when one considers this financial benefit, one ought also to take into account the spectrum zithromax online in canada of negative consequences potentially generated by institutional conflicts of interest.

The price for our continued acceptance of corporate funding of scientific research and clinical care may be the erosion of public trust. Arguably, it would be preferable if our research hospital were to aim instead for the complete elimination of systemic biases.Data availability statementAll data relevant to the study are included in the article or uploaded as supplementary informationEthics statementsPatient consent for publicationNot required.AcknowledgmentsThe author thanks the editors of JME and two JME reviewers for their criticisms of and suggestions for change to an earlier version of this paper..

Zithromax and alcohol side effects

Start Preamble Health zithromax and alcohol side effects Resources and Services Administration (HRSA), Department http://www.ec-sand.ac-strasbourg.fr/adm/?page_id=140 of Health and Human Services (HHS). Notice. In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME or Council) will hold public meetings for the 2021 calendar year (CY) zithromax and alcohol side effects. Information about COGME, agendas, and materials for these meetings can be found on the COGME website at https://www.hrsa.gov/​advisory-committees/​graduate-medical-edu/​index.html.

COGME meetings will be held on April 14, 2021, 8:30 a.m.-5:00 p.m. Eastern Time (ET) and zithromax and alcohol side effects April 15, 2021, 8:30 a.m.-2:00 p.m. ET. August 19, 2021, 10:00 a.m.-5:00 zithromax and alcohol side effects p.m.

ET. Meetings may be held in-person, by teleconference, and/or Adobe Connect webinar. For updates on how the meeting will be held, visit the COGME website 30 business days before the date of the meeting where zithromax and alcohol side effects instructions for joining meetings either in-person or remotely will also be posted. In-person meetings will be held at 5600 Fishers Lane, Rockville, Maryland 20857.

For meeting information updates, go to the COGME website meeting page at https://www.hrsa.gov/​advisory-committees/​graduate-medical-edu/​meetings/​index.html. Start Further Info Shane Rogers, Designated Federal Official, Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Room 15N142, Rockville, zithromax and alcohol side effects Maryland 20857. 301-443-5260. Or SRogers@hrsa.gov zithromax and alcohol side effects.

End Further Info End Preamble Start Supplemental Information COGME makes recommendations to the Secretary of HHS (Secretary) and Congress on policy, program development, and other matters of significance as specified by section 762 of Title VII of the Public Health Service (PHS) Act. Issues addressed by COGME include the supply and distribution of the physician workforce in the United States, including any projected shortages or excesses. Foreign medical zithromax and alcohol side effects school graduates. The nature and financing of undergraduate and graduate medical education.

Appropriation levels zithromax and alcohol side effects for certain programs under Title VII of the PHS Act. And deficiencies in databases of the supply and distribution of the physician workforce and postgraduate programs for training physicians. COGME submits reports to the Secretary of HHS. The Senate zithromax and alcohol side effects Committee on Health, Education, Labor and Pensions.

And the House of Representatives Committee on Energy and Commerce. Additionally, COGME encourages entities providing graduate medical education to conduct activities to voluntarily achieve the recommendations of the Council. Since priorities dictate meeting times, be advised that start times, end times, and agenda items are subject to change zithromax and alcohol side effects. For CY 2021 meetings, agenda items may include, but are not limited to, discussion on topics surrounding rural health workforce and training.

Refer to the COGME website listed above for all current and updated information concerning the CY 2021 COGME meetings, including draft agendas and meeting materials that will be posted 30 calendar days zithromax and alcohol side effects before the meeting. Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting(s). Oral comments will be honored in the order zithromax and alcohol side effects they are requested and may be limited as time allows.

Requests to submit a written statement or make oral comments to COGME should be sent to Shane Rogers using the contact information above at least 5 business days before the meeting date(s). Individuals who need special assistance or another reasonable accommodation should notify Shane Rogers using the contact information listed above at zithromax and alcohol side effects least 10 business days before the meeting(s) they wish to attend. If a meeting is held in-person, it will occur in a federal government building and attendees must go through a security check to enter. Non-U.S.

Citizen attendees must notify HRSA of their planned attendance at an in-person meeting at least zithromax and alcohol side effects 20 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry. Start Signature Maria G. Button, Director, zithromax and alcohol side effects Executive Secretariat.

End Signature End Supplemental Information [FR Doc. 2021-00058 Filed zithromax and alcohol side effects 1-7-21. 8:45 am]BILLING CODE 4165-15-PStart Preamble Start Printed Page 1676 U.S. Citizenship and Immigration Services, Department of Homeland Security.

Final rule zithromax and alcohol side effects. The Department of Homeland Security (DHS or the Department) is amending its regulations governing the process by which U.S. Citizenship and Immigration Services (USCIS) selects H-1B registrations for the filing of H-1B cap-subject petitions (or H-1B petitions for any year in which the registration requirement is suspended), by generally first selecting registrations based on the highest Occupational Employment Statistics (OES) prevailing wage level that the proffered wage equals or exceeds for the relevant Standard Occupational Classification (SOC) code and area(s) of intended employment. This final zithromax and alcohol side effects rule is effective March 9, 2021.

Start Further Info Charles L. Nimick, Chief, Business and Foreign Workers Division, Office zithromax and alcohol side effects of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security, 5900 Capital Gateway Drive, Camp Springs, MD 20746. Telephone 240-721-3000 (this is not a toll-free number).

Individuals with hearing or speech impairments may access the telephone numbers above via TTY by calling the toll-free Federal Information Relay zithromax and alcohol side effects Service at 1-877-889-5627 (TTY/TDD). End Further Info End Preamble Start Supplemental Information I. Table of Contents zithromax and alcohol side effects I. Table of Contents II.

Table of Abbreviations III. Background and Discussion A zithromax and alcohol side effects. Purpose and Summary of the Regulatory Action B. Legal Authority C.

Summary of Changes From the zithromax and alcohol side effects Notice of Proposed Rulemaking D. Implementation E. The H-1B zithromax and alcohol side effects Visa Program F. Current Selection Process G.

Final Rule IV. Response to Public Comments on the Proposed zithromax and alcohol side effects Rule A. Overview of Comments and General Feedback on the Proposed Rule 1. General Support for the zithromax and alcohol side effects Proposed Rule a.

Positive Impacts on New Graduates and Entry-Level Workers b. Positive Impacts on Healthcare Workforce c. Positive Impacts on zithromax and alcohol side effects the Economy 2. General Opposition to the Proposed Rule a.

Immigration Policy Concerns b. Negative Impacts on New Graduates and Entry-Level Workers, Academic Institutions, Healthcare Workers and Facilities, Employers, and the Economy i zithromax and alcohol side effects. New Graduates and Entry-Level Workers ii. Academic Institutions zithromax and alcohol side effects iii.

Healthcare Workforce and Facilities iv. Employers v. Economy c zithromax and alcohol side effects. General Wage-Based Selection Concerns 3.

Other General Feedback zithromax and alcohol side effects B. Basis for Rule 1. DHS Statutory/Legal Authority 2. Substantive Comments on the Need for the Rule/DHS zithromax and alcohol side effects Justification a.

Support for the DHS Rationale b. Rule Is Based on False Premises/Rationale c. Lack of zithromax and alcohol side effects Evidence To Support Rulemaking C. Proposed Changes to the Registration Process for H-1B Cap-Subject Petitions 1.

Proposed Wage-Based Selection (Selection Process for Regular Cap and zithromax and alcohol side effects Advanced Degree Exemption, Preservation of Random Selection Within a Prevailing Wage) 2. Required Information From Petitioners a. OES Wage Level i. Highest OES zithromax and alcohol side effects Wage Level That the Proffered Wage Would Equal or Exceed ii.

Highest OES Wage Level When There Is No Current OES Prevailing Wage Information iii. Lowest OES Wage Level That the Proffered Wage Would Equal or Exceed When Beneficiary Would Work in Multiple Locations or Positions iv. Other Comments on OES Wage zithromax and alcohol side effects Level b. Attestation to the Veracity of the Contents of the Registration and Petition (Including Comments on Rejections, Denials, and Revocations) 3.

Requests for Comments on Alternatives D zithromax and alcohol side effects. Other Issues Relating to Rule 1. Requests To Extend the Comment Period 2. Rulemaking Process zithromax and alcohol side effects a.

Multiple H-1B Rulemakings b. Other Rulemaking Process Comments 3 zithromax and alcohol side effects. Effective Date and Implementation E. Statutory and Regulatory Requirements 1.

Impacts and zithromax and alcohol side effects Benefits (E.O. 12866, 13563, and 13771) a. Methodology and Adequacy of the Cost-Benefit Analysis b. Costs c zithromax and alcohol side effects.

Benefits 2. Paperwork Reduction Act F zithromax and alcohol side effects. Out of Scope V. Statutory and Regulatory Requirements A.

Executive Orders 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), and Executive Order zithromax and alcohol side effects 13771 (Reducing Regulation and Controlling Regulatory Costs) 1. Summary of Economic Effects 2. Background and Purpose of the Final zithromax and alcohol side effects Rule 3. Historic Population 4.

Cost-Benefit Analysis a. Costs and Cost Savings of Regulatory zithromax and alcohol side effects Changes to Petitioners i. Methodology Based on Historic FYs 2019-2020 ii. FY 2021 Data iii.

Unquantified Costs zithromax and alcohol side effects &. Benefits iv. Costs of Filing Form I-129 Petitions zithromax and alcohol side effects v. Costs of Submitting Registrations as Modified by This Final Rule vi.

Familiarization Cost b. Total Estimated Costs of Regulatory Changes c zithromax and alcohol side effects. Costs to the Federal Government B. Regulatory Flexibility Act zithromax and alcohol side effects 1.

A Statement of Need for, and Objectives of, This Final Rule 2. A Statement of Significant Issues Raised by the Public Comments in Response to the Initial Regulatory Flexibility Analysis, a Statement of Assessment of Any Changes Made in the Proposed Rule as a Result of Such Comments 3. The Response of the Agency to zithromax and alcohol side effects Any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration in Response to the Rule, and a Detailed Statement of Any Change Made to the Final Rule as a Result of the Comments 4. A Description of and an Estimate of the Number of Small Entities to Which This Final Rule Will Apply or an Explanation of Why No Such Estimate Is Available 5.

A Description of the Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Final Rule, Including an Estimate of the Classes of Small Entities That Will Be Subject to the Requirement and the Types of Professional Skills Necessary for Preparation of the Report or Record 6. Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of the Applicable Statues, Including a Statement of Factual, Policy, and Legal Reasons for Selecting the Alternative Adopted in the Final Rule and Why Each One of the Other zithromax and alcohol side effects Significant Alternatives to the Rule Considered by the Agency Which Affect the Impact on Small Entities Was Rejected C. Congressional Review Act D. Unfunded Mandates Reform Act of 1995 E zithromax and alcohol side effects.

Executive Order 13132 (Federalism) F. Executive Order 12988 (Civil Justice Reform) G. Executive Order zithromax and alcohol side effects 13175 (Consultation and Coordination With Indian Tribal Governments) H. National Environmental Policy Act (NEPA) I.

Paperwork Reduction Act 1. USCIS H-1B zithromax and alcohol side effects Registration Tool 2. USCIS Form I-129 J. Signature II zithromax and alcohol side effects.

Table of Abbreviations BLS—U.S. Bureau of Labor Statistics CEQ—Council on Environmental Quality CNMI—Commonwealth of the Northern Mariana Islands CRA—Congressional Review ActStart Printed Page 1677 DHS—U.S. Department of Homeland zithromax and alcohol side effects Security DOD—U.S. Department of Defense DOL—U.S.

Department of zithromax and alcohol side effects Labor DOS—U.S. Department of State EA—Environmental Assessment EIS—Environmental Impact Statement E.O.—Executive Order FEMA—Federal Emergency Management Agency FQHC—Federally Qualified Healthcare Center FRFA—Final Regulatory Flexibility Analysis FVRA—Federal Vacancies Reform Act FY—Fiscal Year GAO—U.S. Government Accountability Office HHS—U.S. Department of Health and Human Services HPSA—Health Professional Shortage Area HSA—Homeland Security Act of 2002 ICE—U.S zithromax and alcohol side effects.

Immigration and Customs Enforcement IMG—International Medical Graduate INA—Immigration and Nationality Act INS—Immigration and Naturalization Service IT—Information Technology LCA—Labor Condition Application NAICS—North American Industry Classification System NEPA—National Environmental Policy Act NPRM—Notice of Proposed Rulemaking OES—Occupational Employment Statistics OMB—Office of Management and Budget OPT—Optional Practical Training R&D—Research and Development SOC—Standard Occupational Classification STEM—Science, Technology, Engineering, and Mathematics UMRA—Unfunded Mandates Reform Act of 1995 USCIS—U.S. Citizenship and Immigration Services VA—U.S. Department of Veterans Affairs zithromax and alcohol side effects III. Background and Discussion A.

Purpose and Summary zithromax and alcohol side effects of the Regulatory Action DHS is amending its regulations governing the selection of registrations submitted by prospective petitioners seeking to file H-1B cap-subject petitions (or the selection of petitions, if the registration process is suspended), which includes petitions subject to the regular cap and those asserting eligibility for the advanced degree exemption, to allow for ranking and selection based on wage levels. When applicable, USCIS will rank and select the registrations received generally on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. The proffered wage is the wage that the employer intends to pay the beneficiary. This ranking process will zithromax and alcohol side effects not alter the prevailing wage levels associated with a given position for U.S.

Department of Labor (DOL) purposes, which are informed by a comparison of the requirements for the proffered position to the normal requirements for the occupational classification. This final rule will not affect the order of selection zithromax and alcohol side effects as between the regular cap and the advanced degree exemption. The wage level ranking will occur first for the regular cap selection and then for the advanced degree exemption. Rote ordering of petitions leads to impossible results because petitions are submitted simultaneously.

While administering a random lottery system is reasonable, it is inconsiderate of Congress's statutory zithromax and alcohol side effects purposes for the H-1B program and its administration. Instead, a registration system that faithfully implements the Immigration and Nationality Act (INA) while prioritizing registrations based on wage level within each cap will incentivize H-1B employers to offer higher wages, or to petition for positions requiring higher skills and higher-skilled aliens that are commensurate with higher wage levels, to increase the likelihood of selection and eligibility to file an H-1B cap-subject petition. Moreover, it will maximize H-1B cap allocations, so that they more likely will go to the best and brightest workers. And it will disincentivize abuse of the H-1B program to zithromax and alcohol side effects fill relatively lower-paid, lower-skilled positions, which is a significant problem under the present selection system.[] B.

Legal Authority The Secretary of Homeland Security's authority for these regulatory amendments is found in various sections of the Immigration and Nationality Act (INA), 8 U.S.C. 1101 et seq., and the Homeland Security Act of 2002 zithromax and alcohol side effects (HSA), Public Law 107-296, 116 Stat. 2135, 6 U.S.C. 101 et seq.

General authority for issuing this final rule is found in zithromax and alcohol side effects INA section 103(a), 8 U.S.C. 1103(a), which authorizes the Secretary to administer and enforce the immigration and nationality laws, as well as HSA section 102, 6 U.S.C. 112, which vests all of the functions of DHS in the Secretary and authorizes the Secretary to issue regulations.[] zithromax and alcohol side effects Further authority for these regulatory amendments is found in. INA section 101(a)(15)(H)(i)(b), 8 U.S.C.

1101(a)(15)(H)(i)(b), which classifies as nonimmigrants aliens coming temporarily to the United States to perform services in a specialty occupation or as a fashion model with distinguished merit and ability. INA section 214(a)(1), zithromax and alcohol side effects 8 U.S.C. 1184(a)(1), which authorizes the Secretary to prescribe by regulation the terms and conditions of the admission of nonimmigrants. INA section 214(c), 8 U.S.C.

1184(c), which, among other things, authorizes the Secretary to prescribe how an importing employer may petition for an H nonimmigrant worker, and the zithromax and alcohol side effects information that an importing employer must provide in the petition. And INA section 214(g), 8 U.S.C. 1184(g), which, among other things, prescribes the H-1B numerical limitations, various exceptions to those limitations, and criteria concerning the order of processing H-1B zithromax and alcohol side effects petitions. INA section 214(i), 8 U.S.C.

1184(i), which defines the term “specialty occupation,” referenced in INA section (101)(a)(15)(H)(i)(B), 8 U.S.C. 1101(a)(15)(H)(i)(B), a zithromax and alcohol side effects requirement for the classification. Further, under HSA section 101, 6 U.S.C. 111(b)(1)(F), a primary mission of DHS is to “ensure that the overall economic security of the United States is not diminished by efforts, activities, and programs aimed at securing the homeland.”Start Printed Page 1678 Finally, as explained above, “Congress left to the discretion of USCIS how to handle simultaneous submissions.” [] Accordingly, “USCIS has discretion to decide how best to order those petitions” in furtherance of Congress' legislative purpose.[] C.

Summary of Changes From the Notice of Proposed Rulemaking Following careful consideration of public comments received, including relevant data provided, DHS has declined to modify the regulatory text proposed in the Notice of Proposed Rulemaking (NPRM) published in the Federal Register on November 2, 2020.[] Therefore, DHS is publishing this final rule as proposed zithromax and alcohol side effects in the NPRM. D. Implementation The changes in this final rule will apply to all registrations (or petitions, in the event that registration is suspended), including those for the advanced degree exemption, submitted on or after the effective date of the final zithromax and alcohol side effects rule. The treatment of registrations and petitions filed prior to the effective date of this final rule will be based on the regulatory requirements in place at the time the registration or petition, as applicable, is properly submitted.

DHS has determined that this manner of implementation best balances operational considerations with fairness to the public. USCIS will engage in public outreach and provide training to the regulated public on the modified registration system in advance of zithromax and alcohol side effects its implementation. E. The H-1B Visa Program The H-1B zithromax and alcohol side effects visa program allows U.S.

Employers to temporarily hire foreign workers to perform services in a specialty occupation, services related to a U.S. Department of Defense (DOD) cooperative research and development project or coproduction project, or services of distinguished merit and ability in the field of fashion modeling.[] A specialty occupation is defined as an occupation that requires the (1) theoretical and practical application of a body of highly specialized knowledge and (2) attainment of a bachelor's or higher degree in the specific specialty (or its equivalent) as a minimum qualification for entry into the occupation in the United States.[] Congress has established limits on the number of foreign workers who may be granted initial H-1B nonimmigrant visas or status each fiscal year (FY).[] This limitation, commonly referred to as the “H-1B cap,” generally does not apply to H-1B petitions filed on behalf of certain aliens who have previously been counted against the cap.[] The total number of foreign workers who may be granted initial H-1B nonimmigrant status during any FY currently may not exceed 65,000.[] Certain petitions are exempt from the 65,000 numerical limitation.[] The annual exemption from the 65,000 cap for H-1B workers who have earned a qualifying U.S. Master's or higher degree may not exceed 20,000 foreign workers.[] Moreover, zithromax and alcohol side effects H-1B petitions for aliens who are employed or have received offers of employment at institutions of higher education, nonprofit entities related to or affiliated with institutions of higher education, or nonprofit research organizations or government research organizations, are also exempt from the cap.[] F. Current Selection Process DHS implemented the current H-1B registration process by regulation after determining that it could introduce a cost-saving, innovative solution to facilitate the selection of H-1B cap-subject petitions toward the annual numerical allocations.

Under the current selection process, all petitioners seeking to file an H-1B cap-subject petition must first electronically submit a registration for each beneficiary on whose behalf they seek to file an H-1B cap-subject petition, unless USCIS suspends the registration requirement. A prospective petitioner whose registration is selected is then eligible to file an H-1B cap-subject zithromax and alcohol side effects petition for the selected registration during the associated filing period. USCIS monitors the number of H-1B registrations it receives during the announced registration period and, at the conclusion of that period, if more registrations are submitted than projected as needed to reach the numerical allocations, randomly selects from among properly submitted registrations the number of registrations projected as needed to reach the H-1B numerical allocations. USCIS first selects registrations zithromax and alcohol side effects submitted on behalf of all beneficiaries, including those eligible for the advanced degree exemption.

USCIS then selects from the remaining registrations a sufficient number projected as needed to reach the advanced degree exemption. A prospective petitioner whose registration is selected is notified of the selection and instructed that the petitioner is eligible to file an H-1B cap-subject petition for the beneficiary named in the selected registration within a filing period that is at least 90 days in duration and begins no earlier than 6 months ahead of the actual date of need (commonly referred to as the employment start date).[] When registration is required, a petitioner seeking to file an H-1B cap-subject petition is not eligible to file the petition unless the petition is based on a valid, selected registration for the beneficiary named in the petition.[] G. Final Rule Following careful consideration of all public comments received, DHS is issuing this final rule as proposed zithromax and alcohol side effects in the NPRM, without modifications to the regulatory text. IV.

Response to Public zithromax and alcohol side effects Comments on the Proposed Rule A. Overview of Comments and General Feedback on the Proposed Rule In response to the rulemaking, DHS received 1103 comments during the 30-day public comment period, and 388 comments on the rule's information collection requirements before the comment period ended. A large majority of public comments received are form letter copies rather than unique submissions. Commenters consisted primarily of individuals, zithromax and alcohol side effects including anonymous submissions.

DHS received the remaining submissions from professional associations, trade or Start Printed Page 1679business associations, employers/companies, law firms, advocacy groups, schools/universities, attorneys/lawyers, joint submissions, research institutes/organizations, and a union. DHS reviewed all of the public comments received in response to the proposed rule and is addressing substantive comments relevant to the proposed rule (i.e., comments that are pertinent to the proposed rule and DHS's role in administering the registration requirement for petitioners seeking to file H-1B petitions on behalf of cap-subject beneficiaries) in this section IV, grouped by subject area. While DHS provides a brief overview zithromax and alcohol side effects of comments deemed out of scope of this rulemaking in section IV.F. (e.g., comments seeking changes in U.S.

Laws, or regulations and agency policies unrelated to the changes proposed in the NPRM), zithromax and alcohol side effects DHS is not providing substantive responses to those comments. Public comments may be reviewed in their entirety at the Federal Docket Management System (FDMS) at http://www.regulations.gov, docket number USCIS-2020-0019-0001. 1. General Support for the Proposed Rule Comments zithromax and alcohol side effects.

Multiple commenters expressed general support for the rule, providing the following rationale. The proposed rule should be implemented as soon zithromax and alcohol side effects as possible. The proposed rule is a step in the right direction. The proposed rule is necessary to protect U.S.

Workers. The proposed rule is a well-guided and legal attempt to strengthen the economy and legal immigration of workers. Wage-based H-1B allocation can help economic growth. Salary is the best and most reasonable criteria, since it is not practical to compare the skills of one professional with another.

People with higher salaries should be prioritized to receive H-1B visas. The United States should increase the possibility of obtaining a visa for people with higher degrees or wages. The proposed rule would ensure more visas were allocated to the best workers. The proposed rule would keep high-level, meritorious employees in the United States.

H-1B allocation should be merit-based. The proposed rule would ensure that workers who were to contribute most would get to stay in the United States while other workers still would have the same chance of being selected as previous years. If companies were willing to pay a higher salary for some workers, it would mean that they would deserve a better chance to stay and work in the United States. People with more professional experience should not have the same chance of staying in the United States as college graduates or less experienced professionals.

The proposed rule would preserve the true intent of the H-1B program, which was to allow U.S. Companies to seek out the best foreign talent. There would be less duplication of H-1B petitions for the same employees. Every year, many highly qualified workers have had to leave the United States because they have not been selected in the existing lottery system.

Entry-level recruitment of U.S. Citizens to fill roles occupied by H-1B beneficiaries can and should be done in high schools, vocational schools, and college campuses. The proposed rule would increase the average and median wage levels of H-1B beneficiaries. The current lottery process makes it difficult for employers to plan for their staffing needs, so the proposed rule will benefit both employers and employees.

Response. DHS thanks these commenters for their support and agrees with commenters that the proposed rule should be implemented as soon as possible. The proposed rule is a step in the right direction. The proposed rule is necessary to better protect U.S.

Workers, particularly those U.S. Workers competing against H-1B workers for entry-level jobs. And this rule is a well-guided and legal attempt to improve the H-1B cap selection process. DHS further agrees that relative salary generally is a reasonable proxy for skill level and the wage level that a proffered wage equals or exceeds is a reasonable criterion for registration.

DHS also agrees that this rule may lead to the selection of the most-skilled or most-valued H-1B beneficiaries. May lead to an increase in wages for H-1B beneficiaries. May increase access to entry-level positions for available and qualified U.S. Workers.

And is expected to reduce uncertainty about selection resulting from a purely randomized process. Prioritizing wage levels in the registration selection process is expected to incentivize employers to offer higher wages, or to petition for positions requiring higher skills and higher-skilled aliens that are commensurate with higher wage levels, to increase the likelihood of selection for cap-subject petition filings. In doing so, prioritization, as compared to a purely random selection process, may reduce uncertainty about selection. In turn, U.S.

Employers that might have petitioned for cap-subject H-1B workers to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S. Workers for those positions. Comments. Several commenters expressed support for the rule and the need to stop visa fraud, abuse, and flooding of petitions by certain staffing or consulting companies.

One commenter said the proposed rule would disincentivize companies from abusing the H-1B program and harming U.S. Workers. Other commenters stated that. The proposed rule would decrease potential visa abuse by employers and make sure all workers were paid according to their skillset as employers no longer would be able to lower labor expenses by hiring foreign workers.

The proposed rule would have a positive impact on U.S. Employees and college-educated U.S. Citizens who take out loans for their education by making it harder for technology companies to discriminate against U.S. Citizens.

U.S. Workers are being laid off in large numbers because corporations are outsourcing for profits. And the proposed rule is necessary because Indian corporations are acquiring U.S. Jobs.

Response. DHS agrees that this rule will reduce abuse and provide incentives for employers to use the H-1B program to primarily fill relatively lower-paid, lower-skilled positions.[] Prioritizing registrations or petitions, as applicable, reflecting higher wage levels for positions requiring higher skills and higher-skilled or more valued aliens will further Congressional intent for the program by helping U.S. Employers fill labor shortages in positions requiring highly skilled and/or highly educated workers. A.

Positive Impacts on New Graduates and Entry-Level Workers Comments. An individual commenter wrote that this rule would be extremely beneficial to international students graduating from U.S. Universities. The commenter explained that, while recent graduates earning level I wages initially would be less likely to be selected in the lottery, many of those recent graduates actually would benefit from the rule over the long term.

The commenter said that recent graduates who were not initially selected likely would gain additional experience in future years, which would make them more competitive for selection at higher wage levels. The commenter indicated that Science, Technology, Engineering, and Mathematics (STEM) graduates generally have three chances at the existing H-1B lottery, and, ideally, new graduates should not stay in level I positions for all three years. On the other hand, non-STEM graduates Start Printed Page 1680already have low selection odds under the existing lottery and, thus, face difficulties finding suitable employment. With this proposed rule, however, non-STEM graduates now would have a probable path forward and would be able to negotiate with their employers to get H-1B sponsorship.

The commenter added that concerns that new graduate employees would not be able to receive an H-1B visa, even from large technology companies, are unfounded, knowing firsthand that new graduates regularly receive job offers at level II wages or above from large technology companies. A different commenter stated that there are many new graduates with greater academic achievements and capability who will be able to get job offers at level II wages or above. This commenter stated that, for graduates unable to get job offers with level II wages, this proposed rule could incentivize them to work hard to prove their value and be promoted. Response.

DHS agrees that this rule could be beneficial to international students, as the commenter explains. DHS recognizes that, under this final rule, it is less probable that USCIS will select registrations (or, if applicable, petitions) that reflect a wage level that is lower than the prevailing wage level II. DHS agrees with the comment that registrations (or, if applicable, petitions) reflecting prevailing wage levels II, III, and IV will have greater chances of being selected compared to the status quo. To the extent that recent foreign graduates, STEM-track or otherwise, in Optional Practical Training (OPT) can gain the necessary skills and experience to warrant prevailing wage levels II or above, the final rule may result in greater chances of selection of registrations (or, if applicable, petitions) for those beneficiaries.

Further, recent graduates with master's or higher degrees from U.S. Institutions of higher education already benefit from the advanced degree exemption and cap selection order, as eligibility for that exemption increases their chance of selection. A registration or petition, as applicable, submitted on behalf of an alien eligible for the advanced degree exemption is first included in the submissions that may be selected toward the regular cap projection. If not selected toward the regular cap projection, submissions eligible for the advanced degree exemption may be selected toward the advanced degree exemption projection.

This existing selection order increases the chance of selection for registrations or petitions submitted on behalf of aliens who have earned a master's or higher degree from a U.S. Institution of higher education. B. Positive Impacts on Healthcare Workforce Comments.

An individual commenter and a submission from U.S. Doctors indicated that thousands of U.S. Citizen medical graduates have been unemployed because residency positions have been filled by foreign doctors on H-1B and J-1 visas. A submission from U.S.

Physicians stated that it is inappropriate to hire non-citizen physicians at the taxpayer's expense for federally funded residency training positions instead of available and skilled U.S. Physicians. The commenter said the proposed rule is a step in the right direction to disincentivize a trend in the physician residency training programs that have favored foreign graduates and that have caused the displacement of several thousand qualified U.S. Citizen medical school graduates, which has been an ongoing problem for the past few decades.

The commenter explained that this displacement cripples the U.S. Economy as thousands of qualified U.S. Citizen doctors with federal student loan debt continue to go “unmatched.” Response. DHS agrees with commenters that there are more U.S.

Citizens who graduate from medical schools each year than are matched with residency programs. DHS believes that this final rule may lead to increased opportunities for entry-level positions for available and qualified U.S. Workers by incentivizing employers seeking cap-subject H-1B beneficiaries to offer higher wage levels to increase the chance for selection. This, in turn, may have the effect of freeing up entry-level cap-subject positions for U.S.

Workers, including U.S. Medical graduates in the event they are seeking to be employed in cap-subject positions.[] In turn, DHS hopes that increased opportunities for those U.S. Workers will benefit the U.S. Economy.

C. Positive Impacts on the Economy Comments. An individual commenter in support of this rule stated that the proposed rule would result in higher salaries for the H-1B population, which will lead to increased spending for the U.S. Economy.

The commenter also wrote that, under the proposed rule, employers would have access to higher wage and more talented employees increasing innovation and productivity. Another individual commenter similarly said the proposed rule would improve innovation because it would favor retaining more talented and highly paid individuals over less talented workers. The commenter said wages serve as a proxy for talent, and the proposed rule helps bring and retain talented individuals to the United States. Response.

DHS agrees with these commenters and believes that this rule may result in higher salaries for the H-1B population. This rule may also increase innovation and productivity,[] and help retain and attract talented aliens to the United States.[] DHS believes that facilitating the admission of more highly-paid and relatively higher-skilled workers “would benefit the economy and increase the United States' competitive edge in attracting the `best and the brightest' in the global labor market,” consistent with the goals of the H-1B program.[] 2. General Opposition to the Proposed Rule Comments generally opposing the proposed rule fell into various Start Printed Page 1681categories. Immigration policy concerns.

Negative impacts on new graduates and entry-level workers, academic institutions, healthcare workers and facilities, employers, and the economy. And general concerns about wage-based selection. In addition, some comments fell outside of the scope of these categories. A.

Immigration Policy Concerns Comments. A few commenters opposed the rule and expressed immigration policy concerns without substantive rationale, offering only that. The proposed rule “springs purely from nativism and no real concern for domestic workers”. The proposed rule is inconsistent with U.S.

Founding principles as a refuge for those seeking opportunity and freedom. And imposing a wage-based prioritization system is contrary to American values and would harm innovation. Response. DHS disagrees with the comment that the proposal “springs purely from nativism and no real concern for domestic workers[.]” This rule does not reduce the total number of aliens who will receive cap-subject H-1B status in a given fiscal year.

Instead, this rule will benefit those H-1B beneficiaries who are most highly paid and/or most highly skilled, relative to their SOC codes and areas of intended employment. DHS believes this rule will incentivize employers to offer higher wages and/or higher-skilled positions to H-1B workers and disincentivize the existing widespread use of the H-1B program to fill relatively lower-paid or lower-skilled positions, for which there may be available and qualified U.S. Workers. In general, DHS recognizes that the admission of higher paid and/or higher skilled workers is likely to benefit the economy and increase the United States' competitive edge in the global labor market.[] Further, this rule is intended to potentially increase employment opportunities for relatively lower-skilled unemployed or underemployed U.S.

Workers. Recent college graduates, some of who otherwise would serve as U.S. Workers, have the highest unemployment rate in decades, and the underemployment rate (which reflects the rate at which workers are accepting jobs lower than their academic or experience level) is at an all-time high.[] Roughly 53 percent of recent college graduates, some of who could potentially work in these jobs, are currently unemployed or underemployed.[] While the overall unemployment rates for college graduates is 3.8 percent, the unemployment rate is higher for graduates with majors in some fields common to the H-1B program such as computer science (5.2 percent), mathematics (4.9 percent) and information systems &. Management (4.9 percent).[] This rule is intended to potentially benefit the population of unemployed or underemployed U.S.

Workers. DHS further disagrees that this rule is inconsistent with U.S. Founding principles as a refuge for those seeking opportunity and freedom, and that instituting a ranking system is contrary to American values and would harm innovation. First, the H-1B program is a temporary, employment-based nonimmigrant program and not a form of humanitarian relief.

Additionally, by maximizing H-1B cap allocations, so that they more likely would go to the best and brightest workers, DHS believes that this rule likely would promote opportunity, innovation, and development. B. Negative Impacts on New Graduates and Entry-Level Workers, Academic Institutions, Healthcare Workers and Facilities, Employers, and the Economy Multiple commenters said the proposal would have negative impacts on new graduates and entry-level workers, academic institutions, healthcare workers and facilities, employers, and the economy. I.

New Graduates and Entry-Level Workers Comments. Commenters stated, without substantive rationale, that the proposed rule would negatively impact this population because. New foreign graduates would be disadvantaged by this rule. The proposed rule would prevent the future growth of new foreign graduates in the workplace.

The proposed rule would be unfair to immigrants who earn lower wages. It takes time to be promoted from entry level to a more senior level. It is “too difficult for most people to earn that much”. The proposed rule would dramatically reduce access to the H-1B visa program for early career professionals, including those who have completed master's or doctoral degrees at U.S.

Colleges and universities. The proposed rule would make it nearly impossible for entry-level employees with degrees in STEM majors to be eligible for H-1Bs. Non-STEM graduates would have a more difficult time obtaining H-1B classification under the proposed rule. The rule would unfairly discriminate against aliens who work in areas related to humanities, arts, or accounting that do not receive high starting wages.

The proposed rule would greatly decrease the number of H-1B visas that would be available to educators, translators, and other specialty positions. Doctors who recently graduated and entered medical residency programs would have no chance of obtaining H-1B classification under this proposed rule. The rule would negatively impact U.S. Biomedical research, as it would make it difficult for young scientists to study and conduct health research in the United States.

The computer science industry requires experience to get to a higher level, which is something new graduates do not typically have. It is harder to earn higher wages quickly in certain industries, such as mechanical engineering or medicine. Basing the selection on wage levels would be disadvantageous to people who work for small-sized companies, which offer lower wages. The proposed rule would send a message that the United States does not welcome talented foreign students.

The rule would divide international students because everyone would be “considering the interests of their own”. And pushing entry-level workers out in the beginning of their careers disobeys a fundamental economics principle, which states that Start Printed Page 1682laborers are underpaid in the early stage, but will make more with more experience and skillsets. Multiple commenters said the proposal would have negative impacts on new foreign graduates and entry-level workers, and they provided substantive rationale in support of those assertions. Specifically, several commenters, including a form letter campaign, said the rule would have a “direct and negative” impact on college-educated foreign-born professionals by “dramatically reducing” access to the H-1B visa program for early-career professionals because no aliens who are paid a level I wage would be selected to submit a petition.

A trade association stated that early-career workers in science, math, and engineering might be shut out by the proposed rule, but that those are the workers the U.S. Economy needs. Several commenters, including a university, a professional association, and a joint submission, argued that the proposed rule would reduce access to the H-1B program, negatively impacting graduating international students. A university stated that the proposed rule indirectly would affect F-1 and J-1 students and scholars by removing a pathway to employment after completion of educational or training experiences in the United States, which would also negatively impact the economy.

The university argued that almost all F-1 and J-1 visa holders enter at level I wages. Response. DHS disagrees with the assertions that this rule will either preclude or essentially preclude H-1B status for recent graduates, entry-level foreign workers, and young alien professionals. In general, registrations (or petitions, if applicable) will be selected according to the wage level that the proffered wage equals or exceeds.

Therefore, if an employer chooses to offer a recent foreign graduate a wage that equals or exceeds a particular wage level, the registration will be grouped at that wage level, regardless of the beneficiary's experience level or the requirements of the position. Further, as explained in the proposed rule, DHS believes that a purely random selection process is not optimal, and selection based on the highest wage level that a proffered wage equals or exceeds is more consistent with the primary purpose of the statute. DHS acknowledges that, under this rule, in years of excess demand, relatively lower-paid or lower-skilled positions will have a reduced chance of selection. However, DHS believes that selection in this manner is consistent with the primary purpose of the statute.

DHS further disagrees with the assertion that this rule will preclude recent foreign medical graduates from obtaining H-1B status. Importantly, according to DHS data, in FY 2019, more than 93 percent of H-1B petitions approved for initial employment for physicians, surgeons, and dentists were cap-exempt and thus not subject to the H-1B cap selection process.[] Thus, it is not accurate to say that recent foreign medical graduates, who may seek initial employment as physicians, would have “no chance” of obtaining H-1B status under this rule. DHS acknowledges that, under this rule, in years of excess demand, in the infrequent situation of recent foreign medical graduates seeking employment with a cap subject employer, recent foreign medical graduates may face a reduced chance of selection for cap-subject H-1B visas. However, because a significant majority of H-1B petitions filed for recent foreign medical graduates are cap-exempt, and thus not affected by this rule, this reduction likely will affect a minimal population, if any, of recent medical graduates.

Further, as explained in the proposed rule, DHS believes that a random selection is not optimal, and selection based on the highest wage level that a proffered wage equals or exceeds is more consistent with the primary purpose of the statute. In terms of STEM-specific concerns, DHS disagrees with comments that this rule will make it “harder” or “nearly impossible” for employers to hire entry-level employees with degrees in STEM majors. These types of potential foreign workers have multiple avenues to obtain employment in the United States. In general, foreign STEM graduates can apply for the regular 12-month OPT plus an additional 24-month extension of their post-completion OPT.[] The additional 24-month extension of OPT is available only to foreign STEM graduates.

During the 3-year cumulative OPT period, such a graduate can gain significant training and work experience with a U.S. Employer and can demonstrate their value to that employer. If the employer wants to continue their employment by way of H-1B classification, then the employer can choose to offer the worker a wage that will maximize their chance of selection. Additionally, an employer could directly petition for an employment-based immigrant visa for the alien at any time.

There is no statutory or regulatory requirement that an alien admitted on a F-1 nonimmigrant visa go through OPT and/or the H-1B program before being petitioned for an immigrant visa. Concerning the comments about non-STEM graduates who work in the humanities, arts, accounting, education, or other areas that generally may not receive as high of starting wages as other occupations, DHS does not believe these graduates will be unfairly impacted by this rule. Because USCIS will be ranking and selecting registrations (or petitions) generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code, this method of ranking takes into account wage variations by occupation. Ii.

Academic Institutions Comments. A few individual commenters generally stated that the proposed rule would harm schools and universities. Multiple commenters, including a university, law firm, and individual commenters, stated that this rule would negatively impact U.S. Universities' ability to recruit international students, which would affect enrollments, because U.S.

Institutions would be less attractive due to the lower possibility of remaining in the United States to work after completion of their studies or at the conclusion of their OPT. Similarly, several commenters said the proposal would make it difficult for universities to attract top talent that would contribute to the U.S. Economy. A trade association stated that the rule would restrict the ability of graduating talent to switch from F-1 student status to H-1B status, particularly when operating in conjunction with the DOL Interim Final Rule (IFR), Strengthening Wage Protections for the Temporary and Permanent Employment of Certain Start Printed Page 1683Aliens in the United States (DOL IFR).[] Another commenter stated that the DOL IFR also is aimed at pricing international students and others out of the U.S.

Labor market, while the Student and Exchange Visitor Program proposed rule [] to limit the time students are allowed to stay in the United States appears designed to deter foreign students from coming to U.S. Universities. A trade association stated, without evidence, that since graduating international students are unlikely to find employers who are willing to pay them the same rate as their median-wage workers, this would lead to U.S.-educated international students taking their knowledge and skills elsewhere. A university said that, if the proposed rule were implemented, the United States would lose “advanced science, technology, engineering, and mathematics knowledge and talent” because international students would choose to pursue their education in countries with more favorable immigration policies.

Another commenter claimed that international students would study elsewhere if they could not identify employment opportunities after graduation, which would “crippl[e] a critical pipeline of future community members, workers, innovators and entrepreneurs.” A few commenters stated that, under this rule, the United States would lose money, talent, and inventiveness by reducing the employment potential of foreign students upon graduation from a U.S. Educational institution, and the United States eventually would lose attractiveness and competitiveness because international students would go elsewhere. Some commenters provided specific figures to detail the contributions of foreign enrollment at U.S. Universities.

Specifically. Education service exports ranked sixth among service exports in 2019 according to data released by the U.S. Department of Commerce's Bureau of Economic Analysis. International students studying in the United States added an estimated $41 billion to the economy and supported over 458,000 jobs during the 2018 through 2019 academic year.

International students make up 5.5 percent of the total U.S. Higher education population and contributed $44.7 billion to the U.S. Economy in 2018. International students have founded approximately one-quarter of U.S.

Start-up companies worth $1 billion or more. The Institution for International Education (IIE) reports that international students contributed $482.5 million to the State of Minnesota during 2018 through 2019, supporting 4,497 jobs. International students and scholars contributed an estimated $304.2 million to the local Ithaca, New York, economy and supported nearly 4,000 jobs during the 2018 through 2019 academic year. And, in one commenter's experience, foreign students paid more than $10,000 per year full tuition compared to less than $4,000 for in-state residents, which provided major subsidies for low income resident students.

Some commenters expressed that this is not the time to be driving students away, as State and college/university budgets have suffered greatly as a result of buy antibiotics. One commenter cited data indicating a “shocking decline” in international student enrollment at U.S. Institutions of higher education for the Fall 2020 semester, as well as a study indicating that the overall economic impact generated by international students had already started to decline in 2019, down to $38.7 billion. The commenter said the declining enrollment numbers for 2020 are likely to perpetuate a large economic impact as we continue to deal with the economic fallout of the buy antibiotics zithromax.

A professional association stated that the proposed regulation would have a “monumentally negative” effect on U.S. Colleges and universities at a time when those institutions would be reeling from the impact of the buy antibiotics zithromax. The commenter cited statistics indicating that, in the current school year, new enrollment of international students dropped 43 percent because of buy antibiotics. The commenter concluded that the buy antibiotics zithromax, uncertainty about immigration status, and “anti-immigrant rhetoric[,]” compounded with this rule that would further destabilize the career progression of foreign students by eliminating a legal pathway to temporary employment opportunities in the United States post-graduation, would create a “perfect storm” that would devastate the U.S.

College and university system for years to come. Several commenters, including a university, advocacy group, and individual commenters, said restricting the H-1B program for foreign students, while competitor nations seek to expand their ability to attract international students, would lead talented students to choose other countries of study and decrease enrollments in U.S. Institutions. One of these commenters said countries such as Canada and Germany already are seeing increases in international student enrollment as U.S.

Restrictions to international students have led to waning interest from the future CEOs, inventors, and researchers of the world. An individual commenter said universities essentially would be training laborers for other countries. Some commenters stated that colleges and universities rely, in particular, on foreign students who pay full tuition to help make up for declining Federal and State support and to subsidize the cost of education for U.S. Students.

An attorney stated that U.S. Colleges, universities, and communities benefit financially from the attendance of foreign students, typically in F-1 foreign student nonimmigrant status or J-1 exchange visitor nonimmigrant status. The commenter said the economic and intellectual advancement of educational institutions and their communities is enhanced by the presence of these students from other countries. A university stated that international students and scholars are essential to a university's makeup, as students and faculty benefit from exposure to intercultural differences and the leadership opportunities that arise from global collaborations.

Another commenter stated that foreign national researchers and professors provide the needed diversity to help educate students to become the professionals they need, as they cannot compete globally if they do not have the ability to adapt culturally. An individual stated that this rule would make it impossible for some colleges to fill teaching positions that they cannot fill with qualified U.S. Workers. For example, the commenter stated that North Dakota colleges are not able to pay higher than the level I wage as that is the average salary paid to all of its beginning professors and researchers, and this rule would result in many of North Dakota colleges having unfilled teaching positions and a decrease in higher level class offerings, particularly in STEM fields, putting a strain on education in the state.

Multiple commenters offered similar concerns, but at other levels of academic institutions and owing to their less-desirable locations. Response. DHS appreciates the academic benefits, cultural value, and economic contributions that aliens make to academic institutions and local Start Printed Page 1684communities throughout the United States. DHS does not believe that this rule will negatively impact the ability of U.S.

Colleges and universities to recruit international students. Nor will the rule impact the ability of international students to study in the United States, which is the basis of their admission to the United States in that status. While increased employment opportunities, both in the United States and abroad, may be a factor in deciding whether to study in the United States, the reputation of the academic institutions themselves is also an important factor for the great majority of those choosing to study in the United States.[] Further, DHS notes that international students will continue to have significant employment opportunities in the United States under this rule. First, this rule has no impact on OPT, which allows for 12 months of employment for most aliens admitted in F-1 student status, plus an additional 24-month extension of post-completion OPT available only to STEM graduates.[] In addition, with the current random selection process, even the most talented foreign student may have less than a 50 percent chance of selection.

This rule will increase the chance of employment at the higher wage levels and thus may facilitate the selection of the best and brightest students for cap-subject H-1B status. To the extent that that this change does negatively affect the potential of some colleges and universities to recruit international students, DHS believes that any such harm will be outweighed by the benefits that this rule will provide for the economy overall.[] Facilitating the admission of higher-skilled foreign workers, as indicated by their earning of wages that equal or exceed higher prevailing wage levels, would benefit the economy and increase the United States' competitive edge in attracting the “best and the brightest” in the global labor market, consistent with the goals of the H-1B program discussed in the NPRM. Further, DHS disagrees that this rule will make it “impossible” for academic institutions to fill teaching and research positions. Congress already exempted from the annual H-1B cap aliens who are employed or have received offers of employment at institutions of higher education, nonprofit entities related to or affiliated with institutions of higher education, nonprofit research organizations or government research organizations.[] Therefore, many petitions for academic institutions will not be affected by this rule.[] In FY 2020 alone, USCIS approved over 41,000 petitions for petitioners that qualified under one of these cap exemptions.[] These cap exemptions mitigate these commenters' concerns or misunderstanding of the H-1B program.

Comments about the DOL IFR and the Student and Exchange Visitor Program proposed rule are out of scope, so DHS will not address them. Iii. Healthcare Workforce and Facilities (a) Impact on Healthcare Workers Comments. Some commenters expressed concern that the rule could prevent qualified and highly skilled entry-level health care workers and recent foreign-born graduates from medical school from obtaining an H-1B visa.

A professional association said this proposal would reduce the overall number of international medical graduates (IMGs) practicing in the United States, also stating that pricing H-1B visa holders out of the physician employment market would only exacerbate ongoing physician shortages and worsen barriers to care for patients. Another professional association cited data forecasting an increasing physician shortage and said H-1B physicians fulfill a “vital and irreplaceable role.” The commenter said stringent performance and pay thresholds already exist that must be met to even be considered for an H-1B visa and placing additional wage barriers on the cap would garner no benefit and, instead, would harm U.S. Patients and health care systems. A university and an individual commenter stated that physicians enter the field with a level I wage, despite high levels of education and training, and argued that, under the proposal, it would be “virtually impossible” for a new physician to obtain H-1B unless they are employed by a cap-exempt institution.

The university and the commenter cited a 2016 Journal of the American Medical Association (JAMA) study, which found that 29 percent of physicians were born outside of the United States, helping to fill the physician shortage, and that this rule ignores problems like this. Another professional association stated that it is an incorrect assumption that skill level is definitively associated with wage amount, as there are many situations where a highly skilled H-1B physician may choose to accept a lower wage (e.g., expand their skillset, altruistic motives, the potential to gain lawful permanent residency in a shorter time span). Therefore, the proposed rule would create a false presupposition that would stop highly qualified physicians from practicing in less affluent institutions. Thus, the proposed rule would create a situation where much needed physician positions remain vacant, only wealthy medical conglomerates are able to afford to sponsor H-1B physicians, or wages become so inflated that far fewer H-1B physicians can be hired.

A few individuals noted that a number of rural and/or underserved communities rely on foreign trained dentists, and that this rule would make it difficult to recruit dentist in rural and/or underserved areas. A couple of professional associations said the rule potentially could eliminate the H-1B visa option for recent graduates, including IMGs and postdoctoral researchers, with serious consequences for the U.S. Healthcare workforce. One of these commenters said IMGs compose nearly one-fourth of the U.S.

Physician workforce and one-fourth of the country's resident physicians in training. The commenter stated that, due to this rule, these highly qualified physicians may choose to go to other countries rather than risk being unable to complete training requirements, build up a medical practice, or perform clinical duties. A professional association wrote specifically about the impacts of the rule on the availability of primary care physicians. The commenter cited data indicating that the United States is facing a primary care physician shortage and stated that IMGs play a vital role in filling this gap.

The commenter went on to say that family medicine and other primary care physicians typically have lower annual salaries than specialty Start Printed Page 1685physicians, and, since this proposal favors H-1B petitioners with higher annual salaries, it also may discriminate against family physicians unfairly. Response. DHS disagrees with the assertion that this rule will prevent recent medical or dental graduates from obtaining H-1B status, as Congress already exempted from the H-1B cap any alien who is employed or has received an offer of employment at an institution of higher education, a related or affiliated non-profit entity, or a non-profit research organization or a governmental research organization.[] As stated above, in FY 2019, more than 93 percent of H-1B petitions approved for initial employment for physicians, surgeons, and dentists were cap-exempt and, thus, not subject to the H-1B cap selection process. Because a significant majority are not affected by this rule, this reduction likely will affect a minimal population, if any, of recent foreign medical graduates.

In addition, Congress has established programs meant to encourage certain recent foreign medical graduates to serve in the United States as H-1B nonimmigrants. These programs are exempt from the annual caps and unaffected by this rule. Certain J-1 exchange visitors are subject to a 2-year foreign residence requirement under INA section 212(e), 8 U.S.C. 1182(e), which requires them to return to their country of nationality or country of last residence for at least two years in the aggregate prior to being eligible to apply for an immigrant visa.

Adjustment of status. Or a nonimmigrant visa, such as an H-1B visa (with limited exceptions).[] However, INA section 214(l), 8 U.S.C. 1184(l), contains provisions authorizing waivers of the 2-year foreign residence requirement for certain aliens, including foreign medical graduates who agree to work full-time (at least 40 hours per week) in H-1B classification for not less than three years in a shortage area designated by the U.S. Department of Health and Human Services (HHS) with a request from an interested federal government agency or state agency of public health or its equivalent, or with the U.S.

Department of Veterans Affairs (VA).[] The petition requesting a change to H-1B nonimmigrant status for these physicians is not subject to the numerical limitations contained in INA section 214(g)(1)(A), 8 U.S.C. 1184(g)(1)(A).[] While participation in the Conrad State 30 program (relating to waivers based on requests from a state agency of public health or its equivalent for service in an HHS-designated shortage area) is limited to 30 participants per eligible jurisdiction annually, the other programs have no limits on the number of participants.[] Further, DHS disagrees with the comment that this rule may unfairly discriminate against family physicians and other primary care physicians who typically have lower annual salaries than specialty physicians. In general, family physicians or other primary care physicians have different SOC codes than specialty physicians. As DOL prevailing wage level calculations generally differ by SOC codes, when wage data is available, the corresponding wage level would necessarily account for the different occupational classification for primary care physicians as opposed to other types of physicians.

When such wage level data is unavailable, wage level ranking will be based on the skill, education, and experience requirements for the position, again taking into account the particulars of the relevant occupational classification, such that registrations or petitions for primary care physicians will be ranked in comparison to the normal requirements for primary care physicians and not in comparison to other types of physicians. As such, DHS does not believe that this rule will disadvantage registrations or petitions for primary care physicians or any other subset of physicians. (b) Rural and/or Underserved Communities Comments. Multiple commenters, including several professional associations, said the rule would negatively impact the U.S.

Health care system in areas that are rural and/or underserved where IMG and non-citizen physicians are particularly essential. A professional association cited data indicating that IMGs are more likely to become primary care physicians and practice in rural and other underserved areas where physician shortages are the direst and that rely heavily on family physicians for ambulatory and emergency care. A couple of professional associations similarly said IMGs typically serve in rural and/or medically underserved communities, providing care to many of our country's most at-risk citizens. One of these commenters stated that, although 20 percent of the country's population resides in rural areas, fewer than 10 percent of U.S.

Physicians actually practice in those communities, resulting in over 23 million rural Americans living in federally designated primary medical Health Professional Shortage Areas (HPSA). This commenter also stated that recently graduated H-1B physicians participating in pipeline programs in the beginning of their careers, such as Conrad State 30, fall within the first and second tiers of the prevailing wage determination. Therefore, the proposed rule would create a system that removes physicians who are willing and ready to practice in medically underserved areas and cuts off those patients who are most in need from receiving physician care. A professional association stated that Federally Qualified Healthcare Centers (FQHC), institutions that serve high-risk, medically underserved populations in HPSAs, do not qualify for exemption from the H-1B visa cap.

To fill the physician gap, FQHCs utilize H-1B physicians to care for patients in these health care underserved areas. The commenter stated that, if the proposed rule is enacted, these FQHCs would be unable to obtain early-career H-1B physicians and are unlikely to be able to compete with larger, more affluent organizations to offer a higher proffered wage to increase their chances of obtaining H-1B physician candidates and reducing the physician shortages identified by HPSA data. A company stated that rural hospitals and other health care facilities rely heavily on healthcare-staffing companies to fill their staffing needs, but the rates staffing companies are able to charge rural facilities usually are much lower than the rates they are able to charge facilities in affluent metropolitan areas. Thus, the rule would cause staffing companies to place their professionals where the staffing companies can charge the highest rates, so that staffing companies can maintain sufficient profitability and ensure that their workers are able to obtain H-1B visas.

The commenter concluded that the rule would decrease the supply of healthcare labor to rural and other underserved communities, where it is needed most. Response. DHS acknowledges the important role that early career and entry level foreign physicians may play in providing health care in rural and/or underserved communities. As explained in response to the previous comments, Congress has established programs meant to direct foreign medical graduates to those communities.Start Printed Page 1686 Also as noted above, physicians whose nonimmigrant status is changed to H-1B through their participation in any of the three waiver programs in INA section 214(l), 8 U.S.C.

1184(l), are not subject to the annual H-1B caps. The Conrad State 30 program (relating to waivers based on requests from a state agency of public health or its equivalent for service in an HHS-designated shortage area) is limited to 30 participants per eligible jurisdiction annually.[] However, there are no annual limits on the number of aliens who can obtain a waiver through service in an HHS-designated shortage area based on the request of a federal interested government agency. Since these programs are not subject to the annual H-1B caps, they will not be affected by this rule and the programs will continue to provide a pipeline for these physicians to serve in HHS-designated shortage areas. Congress has established a similar statute in the immigrant context, which also channels physicians to serve in HHS-designated shortage areas, commonly known as the Physician National Interest Waiver Program.[] That program has no limits on the number of physicians who can participate in a given fiscal year, though there are numerical limitations on the number of employment-based immigrant visas that can be allocated annually.

This program is unaffected by this rule and will continue to provide a pipeline for an unlimited number of physicians to serve in HHS-designated shortage areas. DHS agrees with the commenters who stated that medical institutions in rural and/or underserved areas may not be institutions of higher education, related or affiliated non-profit entities, or non-profit research organizations or governmental research organizations. As a result, aliens who are employed by or who have received an offer of employment from such medical institutions may not be exempt from the annual H-1B numerical limitations under INA section 214(g)(5), 8 U.S.C. 1184(g)(5).

However, some of those medical institutions do meet the requirements to be cap-exempt, and their employees will not be subject to the numerical limitations.[] DHS acknowledges that some alien physicians who currently serve in rural and/or underserved areas as H-1B nonimmigrants are not participating in the waiver programs of INA section 214(l), 8 U.S.C. 1184(l), and they are not working for cap-exempt employers. These physicians may be in positions categorized as prevailing wage levels I or II, depending on their individual circumstances. However, such physicians may avail themselves of alternative pathways to serve in these areas such as the Physician National Interest Waiver Program and not be subject to the annual H-1B numerical limitations.

Further, as with all other cap-subject H-1B visas, DHS will rank and select registrations for these positions generally according to the highest OES prevailing wage level that the proffered wage equals or exceeds, which necessarily takes into account the area of intended employment when such wage level data is available. Where there is no current OES prevailing wage information for the proffered position, which DHS recognizes is the case for some physician positions based on limitations in OES data, the registrant would follow DOL guidance on prevailing wage determinations to determine which OES wage level to select on the registration. The determination of the appropriate wage level in those instances would be based on the skill, education, and experience requirements of the position, and generally does not take into consideration the area of intended employment. Therefore, DHS does not believe that this rule necessarily will disadvantage rural and/or underserved communities relative to registrations or petitions based on offers of employment in other areas.

(c) buy antibiotics Comments. Several commenters stated that the rule would have particularly concerning impacts on the U.S. Healthcare workforce as the United States grapples with the buy antibiotics zithromax. A professional association said these visa cap requirements come at a most inopportune time, as the United States sustains some of the highest rates of buy antibiotics cases worldwide and depends on early career physicians to serve on the frontlines.

The commenter said H-1B physicians have played a large role in caring for those who are seriously ill from buy antibiotics, including those facing health complications following recovery from this disease. Similarly, another professional association cited data indicating that, currently, the States where H-1B physicians are providing care are also those with some of the highest buy antibiotics case counts. Response. DHS certainly appreciates the significant contributions of all healthcare professionals, especially during the current buy antibiotics zithromax, but DHS continues to note that many foreign medical professionals are eligible for cap-exempt H-1B status and are not impacted by this rule.

Additionally, DHS believes that this rule will provide benefits to the greater U.S. Workforce that outweigh any potential negative impacts on the relatively small subset of H-1B cap-subject healthcare workers. For example, DHS received submissions from unemployed and underemployed U.S. Citizen medical graduates who attested to the decades-long problem of displacement of several thousands of qualified U.S.

Citizen IMGs and graduates of U.S. Medical schools for federally funded residency training positions. This rule may benefit these unemployed and underemployed U.S. Citizen medical graduates by potentially increasing employment opportunities.

Further, DHS notes that this final rule is not a temporary rule that is limited in duration to the buy antibiotics zithromax. Moreover, this final rule will not have immediate impact on H-1B employment as it will first be applied to the FY 2022 registration and selection process, the beneficiaries of which will not be able to begin employment in H-1B classification until October 1, 2021. (d) Healthcare Facilities Comments. A professional association stated that larger, wealthier companies are much more likely to be able to pay augmented salaries to increase their chances of selection for filing of H-1B cap-subject petitions.

In comparison, smaller, less affluent medical practices would not be able to compete with these large conglomerates, despite having a much greater need for physicians. As such, larger hospital systems would be able to buy H-1B visas for their physicians, leaving mid to small size practices even more understaffed. A trade association stated that its members in the healthcare industry are very concerned about the impact this rule would have on their ability to continue hiring H-1B foreign medical graduates, who are critical for healthcare providers to meet the needs of their patients. The commenter said Start Printed Page 1687the disruptions caused by the rule would be profound on these employers, as they continue to struggle in confronting the ongoing buy antibiotics zithromax.

A law firm stated that the salary market in healthcare is not like the salary market in other fields and explained that, because so much of hospitals' reimbursement processes are governed by Medicare and a tiny handful of large insurance companies, it would be impossible for U.S. Healthcare facilities to negotiate reimbursement rates in a manner to significantly raise salaries. The commenter said that this rule is a “blunt object” that would lead to additional Silicon Valley, California, H-1B visas in place of visas that currently help the healthcare of U.S. Citizens, and rural facilities would suffer the brunt of this policy.

Response. DHS appreciates the significant contributions of all healthcare professionals, especially during the current buy antibiotics zithromax, but believes that this rule will provide benefits to the greater U.S. Workforce. DHS does not believe that the changes in this rule will have a disproportionately negative impact on small- to mid-sized medical practices as compared to larger hospital systems.

It is not necessarily the case that larger hospital systems are more willing or able to provide higher salaries to their employees.[] DHS also does not believe that the changes in this rule will have a disproportionately negative impact on rural facilities, as it is not necessarily the case that rural facilities are unwilling or unable to provide relatively higher salaries compared to facilities in other areas.[] With respect to the ability to offer increased wages generally, DHS acknowledges that employers of healthcare professionals, like employers in all industries, must consider a variety of factors in determining employee salaries. However, this rule does not require employers to pay a higher wage, and, as stated in the NPRM and above, employers that might have petitioned for a cap-subject H-1B worker to fill relatively lower-paid, lower-skilled positions may be incentivized to hire available and qualified U.S. Workers for those positions. Also as noted above, DHS believes that selecting by wage level in such years is more consistent with the dominant legislative purpose of the H-1B program, which is to help U.S.

Employers fill labor shortages in positions requiring highly skilled or highly educated workers. Iv. Employers Comments. Multiple commenters said the proposal would have the following negative impacts on employers without providing substantive rationale.

Many industries and companies benefit from entry-level employees who bring energy, innovation, and diversity. The proposal would reduce the number of H-1B workers “that employers can access”. The rule may incentivize employers to favor domestic applicants in the short term, but businesses may not be able to hire the people best suited for the job in the long run. Companies would suffer because foreign employees will not waste their time with companies that they do not think will be able to sponsor them for a visa.

To be competitive in the H-1B registration process, companies would have to pay double the costs for new hires. This rule would be beneficial for a few industries and create biases for other industries. The rule would jeopardize the employers' ability to meet business objectives, develop and provide new products to market, and stay competitive in a global market. This proposal would create “vicious competition cycles” among H-1B candidates and their employers.

And, if this proposal were implemented, there would be a shortage in the job market for junior level employees. Response. For the reasons explained above, DHS disagrees with the assertions that this rule will preclude or essentially preclude H-1B status for recent graduates and entry-level workers. The rule is not intended to, and DHS does not expect that it will, reduce the number of cap-subject H-1B workers.

As explained in the NPRM and above, DHS believes that the rule will maximize H-1B cap allocations so that they more likely will go to the best and brightest workers, consistent with Congressional intent. DHS believes that this rule will facilitate the admission of higher-skilled workers or those for whom employers proffer wages commensurate with higher prevailing wage levels, which will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program. Finally, as stated in the NPRM and above, employers that might have petitioned for a cap-subject H-1B worker to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S. Workers for those positions.

(a) Impacts on Companies Comments. A couple of professional associations stated that the proposal would have an adverse impact on petitioners in terms of employment, productivity loss, search and hire costs, lost profits resulting from labor turnover, and more. One of these professional associations added that the use of wage data for selection of H-1B registrants would unfairly discriminate against and burden law-abiding employers. The commenter also argued that the current H-1B registration has been beneficial to employers because it has a much earlier indication of the lottery's outcome, and that the proposal would “diminish predictability” for companies.

A trade association said the rule would place an excessive cost burden on petitioners because they would be required to offer dramatically increased wages to prospective H-1B employees, especially in conjunction with the new increased wage levels implemented through the DOL IFR.[] The commenter stated that employers would be “forced” to offer prevailing wages above the 95th percentile to equal or exceed level IV prevailing wages. Another trade association argued that the proposal, in conjunction with the DOL IFR, may result in pay that exceeds that of comparable U.S. Workers, which may result in personnel strains and new costs for U.S. Companies.

Several commenters, including a professional association, company, and research organization, stated that employers would be “forced” to either forego hiring foreign professionals or hire foreign workers at a salary level higher than U.S. Workers, which would cause problems for the employers such as internal equity issues. An individual commenter stated that the rule would create public relations problems for companies, arguing that “forcing” companies to pay foreign workers more than the market currently dictates would disenfranchise U.S. Workers in similar positions.

Response. DHS disagrees that this rule will unfairly discriminate against and burden law-abiding employers. While petitioners may initially spend more on search and hire costs to obtain foreign workers who command higher wages or have higher skill levels, DHS believes Start Printed Page 1688these petitioners will see an increase in productivity as a result of hiring such higher-skilled workers. Regarding the benefits of the registration process, this rule will continue to use the same registration process (with the added factor of ranking and selection by wage level), which will continue to provide predictability for companies in the H-1B cap selection process.

In fact, this rule may increase predictability for companies offering relatively higher wages in order to increase their chances of selection. As for the concern about offering prevailing wages above the 95th percentile, DHS notes that the DOL IFR was set aside and no longer is being implemented as of the publication of this final rule.[] As for the concerns about “internal equity issues” or “public relations problems” caused by paying foreign workers more than the U.S. Workers in similar positions, nothing in this rule requires an employer to offer an H-1B worker a higher wage than a U.S. Citizen worker for the same position.

(b) Impacts on Available Workforce Comments. Several commenters, including a professional association and a trade association, argued that the proposal would harm the ability of U.S. Companies to hire aliens for entry-level jobs. A company asserted that the NPRM would diminish U.S.

Companies' access to the full range of talent, across all career stages, necessary to build a complete workforce. An advocacy group similarly said that the rule does a disservice to companies struggling to fill talent gaps across multiple levels of employment. An individual commenter said the rule would end the H-1B program “for good” for many professions that are in short supply. An individual commenter argued that the proposal makes the H-1B process more challenging for both small and large employers who have relatively small numbers of H-1B workers compared to the overall workforce, and makes it “almost impossible” to fill certain positions without being able to supplement the U.S.

Workforce. A trade association said that the proposal is an example of “government heavy-handedness” which presents U.S. Companies with prospective difficulties in meeting workforce needs. An anonymous commenter said the rule would severely interrupt many U.S.

Companies' operations, as it would disqualify many foreign workers fulfilling specialty jobs and make it difficult for companies to find reasonable substitutes for the labor. The commenter stated that DHS' statement that these disadvantages would be offset by increased productivity and availability of higher wage H-1B petitioners is “optimistic” and lacks support. An individual commenter said their company would be impacted because entry-level STEM candidates have played critical roles throughout the organization, and the proposal would mean they would be unable to draw from the world's leading talent. In addition, some of their H-1B employees gain OPT through the company, and it would be detrimental to their business to be forced to terminate these employees after they have received training.

Response. DHS acknowledges that, under this final rule, an employer offering a level I wage under the regular cap, and an employer offering a level I or II wage under the advanced degree exemption, may have a reduced chance of selection than under the current random selection process. However, DHS believes that selecting based on wage level is necessary and consistent with the intent of the H-1B statutory scheme to utilize the numerical cap in a way that incentivizes a U.S. Employer's recruitment of beneficiaries for positions requiring the highest prevailing wage levels or proffering wages equaling or exceeding the highest prevailing wage levels relative to their SOC code and area of intended employment, either of which correlate with higher skill levels.[] Prospective employers who seek to “draw from the world's leading talent” may maximize their likelihood of selection by offering wages commensurate with such a high skill level rather than offering relatively low wages.

Further, DHS disagrees with suggestions that this rule would end the H-1B program's utility for certain companies or disqualify many foreign workers fulfilling specialty occupation jobs. This rule does not affect current H-1B employees (unless such workers become subject to the H-1B numerical allocations in the limited circumstance that their cap-exempt employment terminates) nor does the rule change the eligibility criteria to qualify for an H-1B visa. (c) Impacts on Specific Types of Employers Comments. A professional association said that the proposal would negatively impact the information technology (IT) industry, which already is facing a scarcity of high-skilled candidates.

The commenter cited a study, which found that there were over 650,000 unfilled computer-related jobs posted between September and October 2020, which often are filled with employees from abroad with degrees. The proposed rule would limit the ability of IT companies to hire foreign workers and would stifle U.S. Innovation, harm economic growth and, therefore, impact job opportunities for U.S. Workers.

An individual commenter discussed how the proposed rule actually would achieve the opposite of its desired outcome, which would be increased wages for H-1B workers, particularly in the IT sector. The commenter explained that companies are realizing that employees can accomplish their jobs at home during the buy antibiotics crisis. If this is the case, employers could avoid the costs associated with foreign worker sponsorship and, instead, employ H-1B workers at lower wages while they remain in their respective countries. A research institute explained that the proposed rule is targeting the IT industry to prevent employers in that industry from obtaining H-1B visas or making it too expensive for them to employ H-1B visa holders.

An individual argued that a financial technology company would be negatively impacted, giving the example of a Database Administrator position, which the commenter said does not require a level III or IV prevailing wage, but often is difficult to fill with U.S. Workers. A couple of individual commenters, an advocacy group, and a professional association said that companies need workers through the H-1B program because there are not enough qualified U.S. Workers in STEM fields.

Another individual commenter cited a STEM worker shortage, arguing that the United States should be “rolling out the welcome mat” for high-skilled talent. A professional association and an individual commenter also addressed the claimed current STEM shortage and explained how the proposed rule would further hurt employers' ability to hire college-educated foreign workers. A trade association stated that the proposed rule would make the H-1B visa program unusable for many engineering firms. The association, Start Printed Page 1689citing data from the National Science Foundation, asserted that the engineering workforce is growing slower than the demand for engineers, and is growing older.

Therefore, the engineering industry needs to be able to access labor from around the world to fill key positions. A company and a professional association said that U.S. Graduates with advanced degrees in STEM, such as computer science, IT, or industrial engineering, are predominately foreign students and that the NPRM would negatively harm companies seeking these employees. A medical device company that employs research and development (R&D) engineers stated that the rule would result in poorer talent to develop medical technologies or higher wages to international talent, which would reduce overall R&D resources and impact their ability to deliver the best healthcare technologies.

A trade association said that restricting H-1B visas to senior professionals with higher wages would negatively impact manufacturers and their ability to hire aliens with STEM education and training to fill roles as researchers, scientists, engineers, and technicians. The commenter explained that the NPRM may deter aliens from attending college in the United States and restrict the talent pipeline. Further, the commenter stated that manufacturers rely on a skilled and innovative workforce that allows them to remain competitive, and that this NPRM will provide other countries a competitive advantage. This is coupled with the claim that the workforce challenge is expected to get worse in the future, with studies showing that nearly half of the 4.6 million manufacturing jobs could go unfilled, according to the commenter.

A university and an individual stated that the proposed system would encourage employers to artificially inflate their job requirements to increase the chance of acceptance through the lottery, creating an unfair advantage for larger employers. An individual commenter similarly said the rule disproportionately favors companies willing to pay the most money to foreign workers. An individual commenter said the rule would pit companies against each other to provide the highest salary, which would give larger tech companies control over the H-1B selection lottery. A law firm stated that start-up companies would be negatively impacted because they do not have the capital to be able to offer “obscenely high salaries” to be competitive in this process.

A few commenters noted that the increased difficulty in obtaining H-1B workers could have a negative effect on R&D or innovation at their companies. For example, a professional association said that companies in the automotive sector that have committed hundreds of millions of dollars to developing fuel-efficient engines no longer would be able to hire and retain recent graduates who have the academic background necessary to drive innovation through the H-1B program. Another professional association wrote that the proposed rule would negatively impact companies developing products that strengthen national security, as it would diminish the ability of U.S. Employers to hire workers for the development of technology including artificial intelligence, quantum information science, robotics, and fifth-generation communications technology.

Response. DHS does not believe this rule will have a disparate negative impact on IT companies, financial technology companies, engineering firms, manufacturers, or companies in any particular industry. Additionally, DHS does not believe this rule will disadvantage companies developing products that strengthen national security or companies driving innovation in the automotive sector. Instead, DHS believes this rule will incentivize employers to proffer higher wages, or to petition for positions requiring higher skills and higher-skilled aliens that are commensurate with higher wage levels, thereby attracting the best and the brightest employees and promoting innovation across all industries.

Moreover, DHS disagrees with the assertion that this rule will make the H-1B visa program “unusable” for engineering firms. While DHS acknowledges that some data may show that the engineering workforce is growing slower than the demand for engineers, DHS disagrees with the commenter that this means engineering firms must hire entry-level foreign workers to fill this gap. In fact, DHS data shows that, for “Architecture and Engineering Occupations,” there has been a significant number of petitions filed for level III and IV positions. Specifically, for FYs 2018 and 2019, employers filed 11,519 and 7,045 petitions (total of 18,564) for level III and IV positions, respectively, compared to 15,625 and 25,147 petitions (total of 40,772) for level I and II positions, respectively.[] While registrations ranked according to prevailing wage level I and below likely will face reduced chances of selection, those ranked according to level II and greater stand increased chances of selection, as discussed in the NPRM.

DHS also disagrees that the rule will disadvantage the IT industry or stifle innovation. Conversely, DHS believes this rule may increase innovation and productivity.[] Notably, other commenters claimed that this rule would favor the IT industry (which DHS disputes as well). Again, and as made apparent through these conflicting comments, DHS does not believe this rule will have a disparate negative or positive impact on the IT industry or companies in any particular industry. Comment.

An individual commenter stated that the rule would negatively impact non-profit organizations and public schools because they would need to compete with and pay the prevailing wages offered by for-profit businesses. Another individual commenter said that non-profits do not operate to maximize profit, and that their budgets cannot accommodate level III or IV prevailing wages. The commenter also argued that there is a large need for immigrant social workers who are able to better connect with and relate to the large population of noncitizens in the United States. Another commenter claimed that, if the H-1B proposed changes go into effect, many school districts throughout the United States would have a difficult time finding teachers.

Response. DHS does not believe that this rule will have a significant negative impact on non-profit organizations or public schools. Congress already exempted from the H-1B cap any alien who is employed or has received an offer of employment at an institution of higher education, a related or affiliated non-profit entity, or a non-profit research organization or a governmental research organization.[] Thus, many petitions for non-profits will not be affected by this rule. Some public schools also are exempt from the H-1B cap based on their affiliation with Start Printed Page 1690institutions of higher education.[] For those non-profit entities or public school districts that are not cap-exempt and are unable to proffer wages that equal or exceed prevailing wage levels with greater chances of selection, they may be able to find available and qualified workers outside of the H-1B program.[] (d) Other Comments on Impacts on Employers Comments.

Multiple commenters argued that the rule likely would result in a significant and sudden downturn in immigration casework, and would cause immigration law firms to scale back operations and lay off staff, at a time when the U.S. Economy already is in a precarious position and unemployment is high. Response. DHS disagrees with these commenters as this rule is not intended or expected to result in fewer H-1B workers in the United States, and will not affect existing H-1B workers, unless such workers become subject to the numerical allocations, and therefore should not reduce workload for immigration law firms overall.

Employers with existing H-1B employees, who are not affected by this rule, may still need immigration law firm services. In addition, while some employers may opt not to participate in the H-1B program as a source for potential new employees and may not require immigration law firm services for those potential new employees as a result, given the high demand for H-1B visas, other employers may have the opportunity to begin participating in the program or to increase their existing participation in the program and may require increased services of immigration firms and attorneys. Therefore, DHS does not anticipate that this rule will have a negative overall impact on law firms and attorneys. Comments.

Multiple commenters reasoned that, with a focus on base wages, the proposed rule may result in employers abandoning the use of variable compensation, such as bonuses, profit-sharing payments, stock, and other incentives tied to performance. A commenter argued that variable pay can benefit a company by focusing organizations, business units, and individuals on specific goals and objectives. Alternatively, employers offering such compensation packages may be disadvantaged relative to others offering solely wage-based compensation. Response.

DHS recognizes that companies may offer various forms of benefits and benefits provided as compensation for services, such as cash bonuses, stock options, paid insurance, retirement and savings plans, and profit-sharing plans. While cash bonuses may, in limited circumstances, be counted towards the annual salary,[] other forms of benefits such as stock options, profit sharing plans, and flexible work schedules may not be readily quantifiable or guaranteed, which means that they cannot reliably be calculated into proffered wages. Further, as one commenter pointed out, if a beneficiary is highly valued, that beneficiary may be able to discuss with their employer changes to their compensation structure that could result in a more easily quantifiable proffered wage. V.

Economy Comments. Multiple commenters said the proposal would have the following negative impacts on the economy without providing substantive rationale. The rule would hurt the overall economy. The American public would assume the increased cost of labor through hidden corporate taxes or increased costs of services.

This would affect U.S. Economic development because many young people will be blocked by this new rule. This proposal would increase economic and cultural divisions that already exist because it would eliminate all “interactive possibilities from social and cultural disciplines”. The proposed rule would harm the U.S.

Economy because the United States needs international students to bring funds to the country to study and live. International students educated at U.S. Colleges have better acculturation to U.S. Society, which is very important for long-term growth of the economy.

An individual commenter stated that the proposal would “gut the system” and lead to further economic decline. Other commenters argued that this rule would hurt the economy during a global zithromax when the economy is suffering. An individual commenter said that, to rebound from the zithromax and meet the challenges that face the United States, the country must expand opportunities for skilled workers, particularly in the STEM and health professions. A few individual commenters asserted, without evidence, that the proposal is based on the “false premise” that individuals who earn more contribute more to the economy, and that the rule promotes falsities about the workers who strengthen the U.S.

Economy. A few individual commenters stated that the proposal provides no evidence that higher wages correspond with labor needs of employers or provide a greater economic benefit. Response. DHS does not agree that this rule will harm the U.S.

Economy or economic development, increase costs for the American public, or increase cultural or economic divisions. Instead, DHS believes that this rule will facilitate the admission of higher-skilled workers, which will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program. It may also benefit U.S. Workers, as employers that might have petitioned for cap-subject H-1B workers to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S.

Workers for those positions. Comments. A university said that foreign graduates do not take jobs from U.S. Citizens, but, rather, they create new jobs and contribute “billions” to the economy.

An individual commenter argued that attracting the best and brightest from around the world for education and employment helps to drive innovation and benefits the U.S. Economy and nation as a whole, but the proposed rule would not lead to that outcome. An individual cited numerous studies in arguing that the current framework, in contrast to a proposed “best and brightest” prioritization, generates more economic benefits of the type intended by Congress. Several other commenters argued that the rule would cause professionals to seek careers elsewhere.

A law firm stated that the rule could halt innovation in the United States, as studies have shown a positive correlation between foreign students and innovation. An advocacy group said that the rule would risk preventing highly skilled professionals from bringing their talents to the United States, despite their education and skill, which likely would result in the United States missing out on the contributions of needed talent across multiple industries. A trade association stated that “each facet” of the U.S. Workforce is enabled by an Start Printed Page 1691immigration system that allows access to foreign talent to allow employers to remain competitive, and argued that highly-skilled foreign executives and managers help run key aspects of U.S.

Companies that create thousands of jobs for domestic workers. The commenter said that it is this “synergy” between aliens and U.S. Residents that underpins the United States' “vibrant” economy. An attorney argued that the United States would lose the benefits that come with younger, recently educated professionals whose value already has been assessed against the ease of employing U.S.

Applicants. An advocacy group said that the U.S. Population is aging, and the country needs immigrants to help the economy grow. In addition, the commenter said that, for the United States' innovation future, the country needs international students.

An individual commenter stated that favoring aliens far into their careers over young professionals is “perverse” because they may have only a decade of their careers left, which is not in the country's best interest. Another commenter said that this proposal could result in future H-1B participants who are older, not necessarily high-skilled, and have no exposure to American culture. The commenter said international students and the H-1B program are key drivers of job growth and economic dynamism, and altering the H-1B program to exclude recent graduates may stymie these positive effects. Response.

DHS appreciates the economic contributions that highly skilled aliens make to the United States. Rather than reducing such contributions or halting innovation, DHS believes that this rule will incentivize employers to attract and recruit highly-skilled aliens, as opposed to the current random selection process that “favors companies hiring workers with interchangeable skills en masse over those with a pressing need to hire specific foreign experts,” [] and, thus, will benefit the economy overall.[] The rule is not intended to, and DHS does not expect that it will, reduce the number of H-1B workers. DHS also notes that this rule does not preclude recent graduates from obtaining H-1B status or employers from directly sponsoring a recent foreign graduate for an employment-based immigrant visa. Although this rule will reduce the chance of selection for those at lower wage levels in years of excess demand, DHS believes that selecting by wage level in such years is more consistent with the dominant legislative purpose of the H-1B program, which is to help U.S.

Employers fill labor shortages in positions requiring highly skilled or highly educated workers. Furthermore, DHS disagrees with the commenter that selecting higher paid and/or more highly skilled workers necessarily means that employers will be selecting those with less time left in their careers and thus those who will not be in the country's best interest. In addition, DHS does not believe that the time spent in the workforce determines the degree of contribution to the economy or the country. As explained in the NPRM and above, DHS believes that the rule will maximize H-1B cap allocations so that they more likely would go to the best and brightest workers.

Comments. Several commenters said that the proposal could have the unintended consequence of “forcing” entire businesses offshore. A professional association said that the proposal would result in more companies outsourcing jobs abroad and would discourage innovation. An individual commenter said that each job that is off-shored will take with it multiple other U.S.

Positions because the United States will lose the economic contributions of foreign workers, such as rented apartments, home mortgages, cares, groceries, and more. Another commenter said that this rule would make it more expensive for companies to hire in U.S. Locations, and they eventually would move entire sections of their operation overseas or outsource labor, hurting U.S. Workers in the long run.

Response. DHS disagrees with the commenters who state that this rule will cause employers to move operations to other countries. These commenters cited research [] suggesting that restricting H-1B immigration is likely to cause multinational firms to offshore their highly skilled labor as the basis for concerns about this rule. However, DHS disagrees that this rule restricts H-1B immigration.

Again, this rule does not affect the statutorily mandated annual H-1B cap, nor does it affect substantive eligibility requirements for an H-1B visa. While DHS acknowledges this rule may impose costs to individual employers, neither the comments nor sources cited address the countervailing impact on those level III and IV employers impacted or benefited by this rule. DHS believes that this rule, instead, will facilitate the admission of higher-skilled workers, which will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program. Comments.

A couple of commenters, including a trade association, said that, in many cases, the proposed rule would require employers to pay their H-1Bs more than the actual market wages for U.S. Citizens holding comparable positions. An individual commenter argued that prioritizing wages conflicts with the current DOL Prevailing Wage system, which ensures that H-1B holders do not depress the wages of U.S. Workers.

A company said that artificially raising the amount of money an employer must devote to paying H-1B workers would result in the company employing fewer workers overall, including U.S. Workers. The commenter's reasoning was that, as a salary-focused “arms race” begins, employers would rely less and less on labor and more on technology and other means to avoid the unsustainable wage levels. Another commenter said the proposal would create the issue of wage discrimination against U.S.

Employees because an employer would have to offer a higher level of pay to H-1B applicants than to citizens for the same position. Response. To the extent that these comments refer to wages required as a result of the DOL IFR, DHS notes that, on December 1, 2020, the U.S. District Court for the Northern District of California issued an order in Chamber of Commerce, et al.

V. DHS, et al., No. 20-cv-7331, setting aside the Interim Start Printed Page 1692Final Rule Strengthening Wage Protections for the Temporary and Permanent Employment of Certain Aliens in the United States, 85 FR 63872 (Oct. 8, 2020), which took effect on October 8, 2020, and implemented reforms to the prevailing wage methodology for the Permanent Employment Certification, H-1B, H-1B1, and E-3 visa programs.

Similarly, on December 3, 2020, the U.S. District Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No.

20-cv-14604, applying to the plaintiffs in that case. On December 3, 2020, DOL announced that it is taking necessary steps to comply with the courts' orders and is no longer implementing the IFR.[] As explained in the NPRM, the ranking process established by this rule does not alter the prevailing wage level associated with a given position for DOL purposes, which is informed by a comparison of the requirements for the proffered position to the normal requirements for the occupational classification. While DHS acknowledges that this final rule will result in more registrations (or petitions, as applicable) being selected for relatively higher paid, higher-skilled beneficiaries, the rule does not change, and does not conflict with, prevailing wage requirements. This final rule merely fills in a statutory gap regarding how to administer the H-1B numerical allocations in years of excess demand.

DHS disagrees with the contentions that, by raising salaries for H-1B workers, this rule will cause employers to reduce their overall workforce including U.S. Workers, rely less on labor, or pay their H-1B workers more than their U.S. Workers holding comparable positions. First, by incentivizing employers to use the H-1B program to fill positions requiring higher prevailing wage levels, or proffering wages commensurate with higher prevailing wage levels, employers may see a possible increase in productivity, as explained in the NPRM.

Because of the possible increase in productivity, it is not necessarily the case that employers would employ fewer workers overall or rely less on labor. DHS believes that this rule will facilitate the admission of higher-skilled workers, which will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program. Second, concerning the contentions that this rule would force employers to pay their H-1B workers more than their U.S. Workers or otherwise harm U.S.

Workers, this final rule does not mandate employers to pay more for their H-1B workers. Again, this rule merely fills in a statutory gap regarding how to administer the H-1B numerical allocations in years of excess demand. And as stated in the NPRM, this rule may provide increased opportunities for lower-skilled U.S. Workers in the labor market to compete for work as there would be fewer H-1B workers paid at the lower wage levels to compete with U.S.

Workers, and may incentivize employers to recruit available and qualified U.S. Workers. C. General Wage-Based Selection Concerns Comments.

Many commenters, mostly individual commenters, generally disagreed with the proposed rule and expressed wage-based selection concerns without providing substantive rationale, stating that. Wage is not the only factor to judge the value of a worker, and the rule erroneously assumes that salary is the best indicator of a worker's value to society. H-1B wages are commensurate with experience and should not be used to establish eligibility. Basing selection on wage levels violates U.S.

Values, such as fairness and justice. Every position has “many wages,” so it is better to distinguish people within a position rather than based on wages. Certain locations in the United States, such as rural areas, have lower wages compared to large cities with higher wage levels. The proposed rule would hamper regional development for rural areas because employers in these communities would not be able to pay the high wages to hire H-1B workers.

Whether an individual can get an H-1B visa depends on how important their work is to the country and does not depend on how much they can earn. The rule will damage U.S. Talent capital investments because “current price does not equal to final quality”. Ranking by wage is not an accurate reflection of one's skill level because it could simply be based on age or years of experience.

There are lower-paying jobs which still need to be filled by H-1B visa workers. Basing selection on salary is unfair because the salary starting point and growth speed are different for different industries. The proposed rule does not address abuse in the H-1B program, such as staffing companies filing multiple petitions for each person and full-time workers filing as part-time so that their salary on file is doubled. This proposal artificially could increase wages, and wages should be determined by supply and demand instead.

And, in some industries or locations, the beneficiaries' base salaries are similar enough to fall into one or two categories, which would make them likely to be the same as a random lottery under DOL's new prevailing wage level calculations. Response. DHS believes that an employer who offers a higher wage than required by the prevailing wage level does so because that higher wage is a clear reflection of the beneficiary's value to the employer, which reflects the unique qualities the beneficiary possesses. Thus, DHS believes this rule will benefit the best and brightest workers in all professions.

DHS does not agree that this rule will favor certain high-paying professions or companies, as the rule takes into account the wage level relative to the SOC code—as opposed to salary alone—when ranking registrations. Regarding the concern for depressed areas, the rule equalizes geographic differences in salary amounts by taking into account the area of intended employment when ranking registrations. Particularly, as stated in the final rule, USCIS will select H-1B registrations based on the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment. In ranking according to the wage level, the final rule makes it so that registrations for the same wage level will be ranked the same regardless of whether their proffered wages are different owing to their areas of intended employment.

Regarding the concerns about fairness, DHS believes that this rule is fair to U.S. Workers, H-1B workers, and petitioners. Conversely, the current random selection process is not fair to U.S. Workers whose wages may be adversely affected by an influx of relatively lower-paid H-1B workers, or to U.S.

Employers who have sought to petition for foreign workers at higher OES prevailing wage levels and are not selected. 3. Other General Feedback Comment. An immigration practitioner in Guam noted that many H-1B visas are awarded to engineers coming to perform projects for the military realignment in Guam, and that this rule poses a threat to those projects' timely completions.

Response. DHS disagrees with this commenter. H-1B workers in Guam (or the Commonwealth of the Northern Start Printed Page 1693Mariana Islands (CNMI)) are exempt from the statutory numerical limitation for H-1B classification until December 31, 2029.[] As this final rule simply modifies the registration requirement applicable to cap-subject H-1B petitions, it will not affect cap-exempt H-1B petitions for engineers or other H-1B workers coming to work in Guam (or the CNMI). B.

Basis for Rule 1. DHS Statutory/Legal Authority Comments. A few individuals supported the rule, saying that the changes to H-1B selection are consistent with Congressional intent and statutory language. Another commenter argued that the INA's silence is an “invitation” for USCIS to establish criteria to prioritize petitions.

Likewise, a research organization commented that the statutory language is ambiguous and USCIS' proposal would reasonably address the ambiguity. Response. DHS agrees with these comments that the rule is consistent with Congressional intent and statutory language. The statute is silent as to how USCIS must select H-1B petitions, or registrations, to be filed toward the numerical allocations in years of excess demand.

The term “filed” as used in INA section 214(g)(3), 8 U.S.C. 1184(g)(3), is ambiguous. And these changes are reasonable and within DHS' general authority. DHS, therefore, is relying on its general statutory authority to implement these regulations to design a selection system that prioritizes selection generally based on the highest prevailing wage level that a proffered wage equals or exceeds.

See INA section 103(a), 214(a) and (c)(1), 8 U.S.C. 1103(a), 1184(a) and (c)(1). Comment. A business association generally argued that Acting Secretary Chad Wolf's tenure is in violation of the Homeland Security Act and the Federal Vacancies Reform Act (FVRA).

Similarly, a professional association commented that Acting Secretary Wolf's tenure also violates Executive Order (E.O.) 13753, which established a DHS order of succession. The commenter added a citation to a U.S. Government Accountability Office (GAO) report concluding that Acting Secretary Wolf's appointment violated the order of succession. The commenter also provided citations to court decisions overturning DHS rulemakings based on Acting Secretary Wolf's authority.

Finally, the commenter argued that DHS's attempted corrections of issues concerning Acting Secretary Wolf's tenure are insufficient to cure rules promulgated under his authority. Response. DHS disagrees with the commenters that Acting Secretary Wolf's tenure is in violation of the HSA and the FVRA. Secretary Wolf is validly acting as Secretary of Homeland Security.

On April 9, 2019, then-Secretary Nielsen, who was Senate-confirmed, used the authority provided by 6 U.S.C. 113(g)(2) to establish the order of succession for the Secretary of Homeland Security.[] This change to the order of succession applied to any vacancy. This exercise of the authority to establish an order of succession for DHS pursuant to 6 U.S.C. 113(g)(2) superseded the FVRA and the order of succession found in Executive Order 13753, 81 FR 90667 (Dec.

9, 2016). As a result of this change, and pursuant to 6 U.S.C. 113(g)(2), Kevin K. McAleenan, who was Senate-confirmed as the Commissioner of U.S.

Customs and Border Protection, was the next successor and served as Acting Secretary without time limitation. Acting Secretary McAleenan subsequently amended the Secretary's order of succession pursuant to 6 U.S.C. 113(g)(2), placing the Under Secretary for Strategy, Policy, and Plans position third in the order of succession, below the positions of the Deputy Secretary and Under Secretary for Management.[] Because the Deputy Secretary and Under Secretary for Management positions were vacant when Mr. McAleenan resigned, Mr.

Wolf, as the Senate-confirmed Under Secretary for Strategy, Policy, and Plans, was the next successor and began serving as the Acting Secretary. Further, because he has been serving as the Acting Secretary pursuant to an order of succession established under 6 U.S.C. 113(g)(2), the FVRA's prohibition on a nominee's acting service while his or her nomination is pending does not apply, and Mr. Wolf remains the Acting Secretary notwithstanding President Trump's September 10, 2020, transmission to the Senate of Mr.

Wolf's nomination to serve as DHS Secretary.[] That said, there have been recent challenges to whether Mr. Wolf's service is invalid, resting on the erroneous contention that the orders of succession issued by former Secretary Nielsen and former Acting Secretary McAleenan were invalid. The Department believes those challenges are not based on an accurate view of the law. But even if those contentions are legally correct—meaning that neither former Secretary Nielsen nor former Acting Secretary McAleenan issued a valid order of succession—under 6 U.S.C.

113(g)(2)—then the FVRA would have applied, and Executive Order 13753 would have governed the order of succession for the Secretary of Homeland Security from the date of former Secretary Nielsen's resignation. The FVRA provides an alternative basis for an official to exercise the functions and duties of the Secretary temporarily in an acting capacity. In that alternate scenario, under the authority of the FVRA, Mr. Wolf would have been ineligible to serve as the Acting Secretary of DHS after his nomination was submitted to the Senate, 5 U.S.C.

3345(b)(1)(B), and Peter Gaynor, the Administrator of the Federal Emergency Management Agency (FEMA), would have—by operation of Executive Order 13753—become eligible to exercise the functions and duties of the Secretary temporarily in an acting capacity. This is because Executive Order 13753 pre-established the President's succession order for DHS when the FVRA applies. Mr. Gaynor would have been the most senior official eligible to exercise the functions and duties of the Secretary under that succession order, and thus would have become the official eligible to act as Secretary once Mr.

Wolf's nomination was submitted to the Senate.[] Then, in this alternate scenario in which, as assumed above, there was no valid succession order under 6 U.S.C. 113(g)(2), the submission of Mr. Wolf's nomination to the Senate would have restarted the FVRA's time limits. 5 U.S.C.

3346(a)(2). Out of an abundance of caution, and to minimize any disruption to DHS and to the Administration's goal of maintaining homeland security, on November 14, 2020, with Mr. Wolf's nomination still pending in the Senate, Mr. Gaynor exercised the authority of Acting Secretary that he would have had (in the absence of any governing succession order under 6 U.S.C.

113(g)(2)) to designate a new order of succession under 6 U.S.C. 113(g)(2) (the Start Printed Page 1694“Gaynor Order”).[] In particular, Mr. Gaynor issued an order of succession with the same ordering of positions listed in former Acting Secretary McAleenan's November 2019 order. The Gaynor Order thus placed the Under Secretary for Strategy, Policy, and Plans above the FEMA Administrator in the order of succession.

Once the Gaynor Order was executed, it superseded any authority Mr. Gaynor may have had under the FVRA and confirmed Mr. Wolf's authority to continue to serve as the Acting Secretary. Hence, regardless of whether Mr.

Wolf already possessed authority pursuant to the November 8, 2019, order of succession effectuated by former Acting Secretary McAleenan (as the Departments have previously concluded), the Gaynor Order provides an alternative basis for concluding that Mr. Wolf currently serves as the Acting Secretary.[] On November 16, 2020, Acting Secretary Wolf ratified any and all actions involving delegable duties that he took between November 13, 2019, through November 16, 2020, including the NPRM that is the subject of this rulemaking. Under section 103(a)(1) of the Act, 8 U.S.C. 1103(a)(1), the Secretary is charged with the administration and enforcement of the INA and all other immigration laws (except for the powers, functions, and duties of the President, the Attorney General, and certain consular, diplomatic, and Department of State officials).

The Secretary is also authorized to delegate his or her authority to any officer or employee of the agency and to designate other officers of the Department to serve as Acting Secretary.[] The Homeland Security Act further provides that every officer of the Department “shall perform the functions specified by law for the official's office or prescribed by the Secretary.” [] Comments. Multiple commenters asserted that this rule is ultra vires, inconsistent with Congressional intent, and a clear violation of the INA. Specifically, they contend that the INA sets forth the procedure for allocating visas and prioritizes the selection of H-1B cap-subject petitions in the “order in which they are filed[,]” which does not limit selection under the H-1B cap to those employers who pay the most or otherwise authorize DHS to impose substantive selection criteria. Several commenters stated that USCIS lacks the statutory authority to make such a change and cannot use the statute's purported silence as an invitation to adopt criteria, such as wage level or skill level, to prioritize the selection of H-1B cap subject visas.

Some of these commenters also disagreed with DHS about the statute's silence and stated that Congress has previously made specific modification to the way in which H-1B cap numbers are allocated, specifically, the American Competitiveness in the Twenty-First Century Act of 2000 providing for the numerically limited exemption for beneficiaries who have earned a master's or higher degree from a U.S. Institution of higher education. If Congress intended to make any other changes to the statutory language that H-1B cap numbers “shall be issued. .

. In the order in which petitions are filed[,]” it could have done so as part of that or subsequent legislation. One commenter cited several cases in arguing that general rulemaking authority and statutory silence on an issue is not tantamount to Congressional authorization for rulemaking on a given issue. Another commenter stated that the statute is neither silent nor ambiguous as it states that H-1B visas shall be issued, or H-1B status granted, “in order in which petitions are filed”.

And a trade association commented that the use of the term “shall” indicates that there is no ambiguity as to how petitions may be sorted. One commenter cited several INA provisions in arguing that, where it intended to do so, Congress made distinctions within classes of potential visa applicants, and thus the statute reflects Congressional intent not to distinguish on other bases. One commenter said that the proposed rule would be found unlawful in court, because the law does not make an allowance for basing H-1B visas on salary, and the rule is contrary to the plain language of the statute. A form letter campaign wrote that the law does not require employers to pay H-1B workers more than U.S.

Workers, and the law does not allow the agency to prioritize petitions for higher-wage applicants. Response. DHS disagrees with the commenters' assertions that the statute is not silent or ambiguous and that this rulemaking is ultra vires. As stated in the NPRM, this rule is consistent with and permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C.

1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C. 112.[] DHS created the registration requirement, based on its general statutory authority and its discretion to determine how best to handle simultaneous submissions in excess of the numerical allocations, to effectively and efficiently administer the H-1B cap selection process. Congress expressly authorized DHS to determine eligibility for H-1B classification upon petition by the importing employer, and to determine the form and information required to establish eligibility.[] “Moreover, INA section 214(g)(3) does not provide that petitions must be processed in the order `received,' `submitted,' or `delivered.' Instead, they must be processed in the order `filed.' What it means to `file' a petition and how to handle simultaneously received petitions are ambiguous and were not dictated by Congress in the INA.” [] Rather, these implementation details are entrusted to DHS to administer. So, while the statute provides annual limitations on the number of aliens who may be issued initial H-1B visas or otherwise provided H-1B nonimmigrant status, the statute does not specify how petitions must be Start Printed Page 1695selected and counted toward the numerical allocations when USCIS receives more petitions on the first day than are projected as needed to reach the H-1B numerical allocations.

Consequently, “Congress left to the discretion of USCIS how to handle simultaneous submissions” and “USCIS has discretion to decide how best to order those petitions.” [] DHS acknowledges that INA section 214(g)(3), 8 U.S.C. 1184(g)(3), states that aliens subject to the H-1B numerical limitation in INA section 214(g)(1), 8 U.S.C. 1184(g)(1), shall be issued H-1B visas or otherwise provided H-1B nonimmigrant status “in the order in which petitions are filed for such visas or status.” Contrary to the commenters' assertions, this statutory provision, and, more specifically the term “filed” as used in INA section 214(g)(3), 8 U.S.C. 1184(g)(3), is ambiguous.[] As discussed in the preamble to the Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Cap-Subject Aliens Final Rule (H-1B Registration Final Rule), an indiscriminate application of this statutory language would lead to absurd or arbitrary results.

The longstanding approach has been to project the number of petitions needed to reach the numerical allocations.[] A literal application of this statutory language, as suggested by various commenters, would lead to an absurd or impossible result. The Department of State (DOS) does not issue H-1B visas, and USCIS does not otherwise provide H-1B status, based on the order in which petitions are filed. Such a literal application would necessarily mean that processing delays pertaining to a petition earlier in the petition filing order would preclude issuance of a visa or provision of status to all other H-1B petitions later in the petition filing order. To avoid such an absurd result, the longstanding approach to implementing the numerical limitation has been to project the number of petitions needed to reach the numerical limitation.

The issue, however, is how to select registrations or petitions, as applicable, when the number of submissions exceeds the number projected as needed to reach the numerical limitation or the advanced degree exemption, particularly when those submissions all occur within the same narrow window of time. DHS is not changing the approach to administering the numerical allocations as it relates to the use of projections. DHS is, however, changing the selection process for selecting registrations or petitions, as applicable, to determine which petitions are properly filed and eligible for further processing consistent with INA section 214(g)(3), 8 U.S.C. 1184(g)(3).

DHS created the registration requirement based on its general statutory authority and its discretion to determine how best to handle simultaneous submissions in excess of the numerical allocations, to effectively and efficiently administer the H-1B cap selection process. As provided in the H-1B Registration Final Rule, unless suspended by USCIS, registration is an antecedent procedural step that must be completed by prospective petitioners before they are eligible to file an H-1B cap-subject petition. As with the filing of petitions, and as explained above, a first-come, first-served basis for submitting electronic registrations is unreasonable and practically impossible. While the random selection of registrations or petitions, as applicable, DHS established in the H-1B Registration Final Rule is reasonable, it is neither the optimal nor the exclusive method of selecting petitions or registrations toward the numerical allocations when more registrations or petitions, as applicable, are submitted than projected as needed to reach the numerical allocations.

In that vein, DHS concludes that prioritization and selection based on wage levels “is a reasonable and rational interpretation of USCIS' obligations under the INA to resolve the issues of processing H-1B petitions” [] in years of excess demand and is within DHS's existing statutory authority. Comment. Multiple commenters cited a USCIS response to a comment in the H-1B Registration Final Rule and wrote that USCIS previously supported the position that prioritization of selection based on salary or other substantive factors would require explicit Congressional authorization. Commenters also cited a 1991 rulemaking in arguing that Immigration and Naturalization Service (INS) previously acknowledged that the INA does not authorize establishing criteria to prioritize petitions.

These commenters also provided language from a 1990 INS rulemaking indicating that a statutory change would be necessary to exclude entry-level H-1B workers. A law firm argued that the Agency cannot reverse a position of this kind without providing a reasoned explanation. Response. DHS disagrees with the commenters that prior statements by INS or USCIS preclude DHS from making the changes set forth in this final rule.

DHS acknowledged in the proposed rule that the preamble to the H-1B Registration Final Rule states that prioritization of registration selection on factors other than degree level, such as salary, would require statutory changes. DHS also explained that the prior statement did not provide further analysis regarding that conclusion and that upon further review and consideration of the issue initially raised in comments to the Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Cap-Subject Aliens NPRM (H-1B Registration Proposed Rule),[] DHS concluded that the statute is silent as to how USCIS must select H-1B petitions, or registrations, to be filed toward the numerical allocations in years of excess demand. DHS continues to believe that the changes made in this final rule are within its general authority, consistent with the existing statute, and despite prior statements to the contrary, does not require statutory change or explicit congressional authorization. DHS is relying on its general statutory authority to implement the statute and, consistent with that authority, is revising the regulations to implement a selection system that realistically, effectively, efficiently, and more faithfully administers the cap selection process.

See INA section 103(a), 214(a) and (c)(1), 8 U.S.C. 1103(a), 1184(a) and (c)(1). Start Printed Page 1696 DHS disagrees with the assertion that this rule will exclude entry-level workers. This final rule merely revises how USCIS will select H-1B cap-subject petitions toward the H-1B numerical allocations to determine which petitions are “filed” and eligible for further processing.

The rule does not change substantive eligibility requirements. While DHS acknowledges that registrations or petitions, as applicable, based on a proffered wage that corresponds to a level I or level II wage likely will face a reduced chance of selection in the H-1B cap selection process, the rule does not preclude selection of registrations or petitions for entry-level workers. DHS also disagrees with the commenters' claim that the prior statements by INS in the preamble to the Temporary Alien Workers Seeking Classification Under the Immigration and Nationality Act final rule are relevant to this final rule.[] INS was responding to general comments about administering the numerical limitation, but was not considering how to administer the H-1B numerical allocations when the number of submitted petitions exceeds the numerical allocation. Such circumstances did not exist at the infancy of the H-1B program and when the numerical limitation was created, so this issue was not considered at that time.

Again, this final rule merely revises how USCIS will select H-1B cap-subject registrations or petitions, as applicable, toward the H-1B numerical allocations to determine which petitions are “filed” and thus eligible for further processing. In addition, this final rule addresses how USCIS will select registrations or petitions, as applicable, when the number of submitted registrations or petitions exceeds the projected number needed to reach the numerical allocations. Once properly filed, H-1B cap-subject petitions generally will be processed in order based on the assigned filing date. DHS also disagrees that comments made by INS in the preamble to the 1990 final rule,[] are relevant to the interpretation of DHS's authority to implement the numerical allocations under the existing statute.

The 1990 rule preceded the enactment of the Immigration Act of 1990 (IMMACT 90), Public Law 101-649, 104 Stat. 4978, the creation of the H-1B classification for specialty occupation workers, and the implementation of a numerical limitation on H-1B workers. As such, the statements cited by the commenter are not relevant to the interpretation of the existing statute, including the authority of DHS to administer the H-1B numerical allocations. Comment.

A company stated that USCIS' ability to interpret the term “filed” is not unlimited and that the proposed, complex prioritization scheme unambiguously exceeds the scope of the term. Similarly, a law firm and individual argued that, according to Walker Macy v. USCIS, USCIS does not have “unfettered” discretion to determine which petitions are filed, but, instead, must reasonably interpret the statute. The law firm said the proposed interpretation is unreasonable because of the impacts it would have on U.S.

Companies and innovation. Multiple commenters said that the current system of putting applicants in a lottery when they apply simultaneously comports with the INA's language, but that the proposed methodology would impermissibly deviate from the INA. Similarly, a company stated that Congress' guiding principal for selecting H-1B petitions is timing and that the current lottery system conforms to this principal. An individual commenter similarly argued, citing Walker Macy v.

USCIS, that the proposed rule deviates from the temporal principal without statutory or judicial basis. Other commenters asserted that USCIS' reference to the “dominant legislative purpose” of the statute, construed as prioritizing the application of the most skilled workers, is unreasonable. The commenters reasoned that the INA simply prioritizes filling labor shortages, without regard to wage levels. Several commenters stated that the allowance of H-1B visas for aliens with undergraduate degrees precludes prioritizing petitions based on wage levels.

Response. DHS disagrees with the commenters' assertions that this rule misstates the scope of the term “filed” or that the rule is based on an unreasonable interpretation of the statute. As stated in the NPRM and in response to other comments in this preamble, DHS believes that this rule is consistent with and permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C.

112.[] DHS created the registration requirement, based on its general statutory authority and its discretion to determine how best to handle simultaneous submissions in excess of the numerical allocations (i.e., situations where prioritizing petitions solely in a temporal manner is impossible), to effectively and efficiently administer the H-1B cap selection process. Congress expressly authorized DHS to determine eligibility for H-1B classification upon petition by the importing employer, and to determine the form and information required to establish eligibility.[] “Moreover, INA section 214(g)(3) does not provide that petitions must be processed in the order `received,' `submitted,' or `delivered.' Instead, they must be processed in the order `filed.' What it means to `file' a petition and how to handle simultaneously received petitions are ambiguous and were not dictated by Congress in the INA.” [] Rather, these implementation details are entrusted for DHS to administer. So, while the statute provides annual limitations on the number of aliens who may be issued initial H-1B visas or otherwise provided H-1B nonimmigrant status, the statute does not specify how petitions must be selected and counted toward the numerical allocations when USCIS receives more petitions on the first day than are projected as needed to reach the H-1B numerical allocations. Consequently, “Congress left to the discretion of USCIS how to handle simultaneous submissions” and “USCIS has discretion to decide how best to order those petitions.” [] DHS believes, contrary to commenters' assertions, that prioritization and selection generally based on the highest OES wage level that the proffered wage equals or exceeds “is a reasonable and rational interpretation of USCIS's obligations under the INA to resolve the issues of processing H-1B petitions” [] in years of excess demand and is within DHS's existing statutory authority.

€œIt is a cardinal canon of statutory construction that statutes should be interpreted harmoniously with their dominant legislative purpose.” [] Yet, under the Start Printed Page 1697current registration system the majority of H-1B cap-subject petitions have been filed for positions certified at the two lowest wage levels. I and II.[] This contradicts the dominant legislative purpose of the statute because the intent of the H-1B program is to help U.S. Employers fill labor shortages in positions requiring highly skilled or highly educated workers.[] By changing the selection process, for these years of excess demand, from a random lottery selection to a wage-level-based selection process, DHS will implement the statute more faithfully to its dominant legislative purpose, increasing the chance of selection for registrations or petitions seeking to employ beneficiaries at wages that would equal or exceed the level IV or level III prevailing wage for the applicable occupational classification. Comments.

A couple of commenters said the changes made by the rule should be decided by Congress. Similarly, a few commenters stated generally that the proposal is not authorized by Congress or is in violation of Congressional intent. A few commenters said that 8 U.S.C. 1184(g)(5)(C) (the exemption from the cap for beneficiaries who have earned a master's or higher degree from a U.S.

Institution of higher education) demonstrates that, where Congress intends to target petitions for highly skilled workers, it has done so explicitly. Others commented that, when this cap was legislated, it was clear that petitions still would exceed visa allocations and that the statute should be understood to have intentionally omitted any change to the priority of visa petitions. And one commenter added that the proposed rule would impact the ratio of advanced-degree holders to other H-1B recipients that Congress authorized when providing the 20,000 U.S. Advanced degree exemption.

A company stated that the proposal is untethered to statutory language, providing examples of Congressional “guidance” and reasoning that nowhere in such guidance or the INA is there reference to salary or the OES prevailing wage level as a basis for selecting H-1B petitions. A professional association stated that effectively imposing an additional wage requirement would be inappropriate, especially for physicians. Response. DHS disagrees with these comments.

As stated in the NPRM and as explained above, this rule is consistent with Congressional intent and is permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C. 112.[] Furthermore, DHS disagrees with the commenters' assertions that the statute, or legislative history, indicates that Congress has spoken to the specific issue addressed by this final rule. How to select petitions toward the numerical allocations when the number of petitions filed is greater than the number of petitions projected as needed to reach the H-1B numerical allocations.

As explained in the NPRM and in response to other comments, the statute is silent on this issue. DHS created the registration requirement, based on its general statutory authority and its discretion to determine how best to handle simultaneous submissions in excess of the numerical allocations, to effectively and efficiently administer the H-1B cap selection process. Congress expressly authorized DHS to determine eligibility for H-1B classification upon petition by the importing employer, and to determine the form and information required to establish eligibility.[] “Moreover, INA section 214(g)(3) does not provide that petitions must be processed in the order `received,' `submitted,' or `delivered.' Instead, they must be processed in the order `filed.' What it means to `file' a petition and how to handle simultaneously received petitions are ambiguous and were not dictated by Congress in the INA.” [] Rather, these implementation details are entrusted for DHS to administer. Nor should it be understood that Congress had spoken on this issue when the cap was legislated because it was not clear at that time that petitions would exceed visa allocations on the very first day that petitions could be filed, thus leading to a situation where prioritizing petitions solely in a temporal manner is impossible.

So, while the statute provides annual limitations on the number of aliens who may be issued initial H-1B visas or otherwise provided H-1B nonimmigrant status, the statute does not specify how petitions must be selected and counted toward the numerical allocations when USCIS receives more petitions on the first day than are projected as needed to reach the H-1B numerical allocations. Consequently, “Congress left to the discretion of USCIS how to handle simultaneous submissions” and “USCIS has discretion to decide how best to order those petitions.” [] Comments. Some commenters expressed that this rule is not consistent with the statutory framework Congress implemented for the admission of foreign workers into the United States, as Congress designated DOL to have the primary authority in protecting and enforcing the statute related to the U.S. Labor market and wages.

Multiple commenters stated that Congress did not intend for wage levels to serve as a basis for preferring certain petitions, as evidenced by the statute's prevailing wage requirement. An individual commented that the preamble's statement that “Congress expressly authorized DHS to determine eligibility for H-1B classification upon petition by the importing employer” fails to recognize that this authorization is for USCIS' determination regarding specific employers' applications, rather than for categorically determining which wages or jobs qualify for H-1B visas. Response. DHS disagrees with the commenters assertion that this rule is inconsistent with the statute.

As explained in the NPRM and in response to other comments, DHS believes that this rule is consistent with its statutory authority. DHS agrees that DOL has the primary authority to protect the wages and working conditions of U.S. Workers consistent with the provisions of INA section 212(n), 8 U.S.C. 1182(n), but Start Printed Page 1698those provisions are separate from INA section 214, 8 U.S.C.

1184, and the statutory provisions pertaining to the form and manner of submitting H-1B petitions and the administration of the H-1B numerical allocations, both of which are within DHS's authority consistent with INA section 214, 8 U.S.C. 1184. Further, the fact that Congress authorized DOL to administer and enforce a wage requirement, including setting prevailing wage levels for the H-1B program, does not speak to or limit DHS' authority to establish an orderly, efficient, and fair system for selecting registrations (or, if applicable, petitions), based on OES prevailing wage levels, toward the projected number needed to reach annual H-1B numerical allocations. Comments.

Multiple commenters, as part of a form letter campaign, stated that the legal impact of the proposed rule must be considered together with other recent rules, including the recently published DOL. Another commenter stated that USCIS should work with DOL to appropriately set up the wage levels. Response. On December 1, 2020, the U.S.

District Court for the Northern District of California issued an order in Chamber of Commerce, et al. V. DHS, et al., No. 20-cv-7331, setting aside the DOL IFR.

Similarly, on December 3, 2020, the U.S. District Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No.

20-cv-14604, applying to the plaintiffs in that case. DOL has taken necessary steps to comply with the courts' orders and is no longer implementing the DOL IFR. DHS, therefore, disagrees with the commenter's assertion that DHS must consider the DOL IFR in the context of this final rule. DHS also disagrees with the premise of the commenters' recommendation that DHS work with DOL to set appropriate wage levels.

This final rule is not setting wage levels. As explained in the NPRM and in response to other comments, this final rule changes how DHS will select registrations or petitions, as applicable, toward the projected number needed to reach the annual H-1B numerical allocations. While this final rule uses DOL wage levels to determine how to rank and select registrations or petitions, as applicable, based generally on the wage level that the proffered wage equals or exceeds, this final rule is not mandating employers pay a higher wage nor is it changing wage levels. Comments.

One commenter noted the proposal would make the H-1B process similar to that of the O-1 visa, but that Congress knowingly avoided doing so in 1990. According to the commenter, the new rule, in effect, is redrafting the 1990 legislation to make the H-1B visa more closely resemble the O-1 visa and Congress certainly could have ranked H-1Bs in 1990 if it wanted to do so. Other commenters also noted that the O-1 visa is for those with extraordinary ability, not those just starting their careers, and that the H-1B program serves different purposes. Another commenter also cited a House sponsor of the H-1B program as saying that the O-1 program, not H-1B, was the “best and brightest” program.

Response. DHS disagrees with the claim that it is reforming the H-1B classification to more closely resemble the O-1 classification.[] While DHS acknowledges that this rule will result in more registrations (or petitions, as applicable) being selected for relatively higher-paid, higher-skilled beneficiaries, the rule is not changing substantive eligibility requirements for the H-1B classification and is not, in any way, reforming the H-1B classification to more closely resemble the O-1 classification. This final rule merely fills in a statutory gap regarding how to administer the H-1B numerical allocations in years of excess demand. The statute provides annual limitations on the number of aliens who may be issued initial H-1B visas or otherwise provided H-1B nonimmigrant status, but it does not specify how petitions must be selected and counted toward the numerical allocations when USCIS receives more petitions on the first day than are projected as needed to reach the H-1B numerical allocations.

Consequently, “Congress left to the discretion of USCIS how to handle simultaneous submissions” and “USCIS has discretion to decide how best to order those petitions.” [] The current scheme of pure randomization of selectees does not optimally serve Congress' purpose for the H-1B program. Therefore, this rule will revise the H-1B cap selection process to better align with the purpose of the H-1B program and Congressional intent, taking into account the pervasive oversubscription of demand for registrations and petitions. Comment. An individual noted that Congress previously considered legislation called the I-Squared Act that sought to alter the selection process by ranking H-1Bs based on a number of factors rather than having a random lottery.

That legislation has not passed, which is an indicator that Congress does not see the change as a priority. Conversely, an individual commenter wrote that Congress intended to delegate H-1B visa allocation to USCIS and that the I-Squared bill failed because of other provisions it contained. Response. DHS disagrees with the assertion that the fate of the I-Squared bill is relevant to interpretation of the existing statute.

While Congress has considered such legislation, the failure of such legislation (or any other proposed legislation) to be passed and signed into law does not change the existing authority DHS has under the INA. As explained in response to other comments, DHS believes that selection of registrations or petitions, as applicable, based on corresponding wage level is consistent with the discretion provided to DHS in the current statute to administer the annual H-1B numerical allocations. Comment. A few commenters cited the Senate Report for The American Competitiveness Act as demonstrating Congressional opposition to granting H-1B visas on a preferential basis to the highest-paid aliens.

The commenters argued that the language of the Senate Report contradicts E.O. 13788 and that E.O. 13788 does not establish Congressional purpose or policy, and its emphasis on highly paid beneficiaries as applied in this context would be inconsistent with Congress' direction. Response.

DHS disagrees with these comments because they ignore the fact that DHS has proposed to modify the registration requirement within the context of the annual demand for H-1B cap-subject petitions, including those filed for the advanced degree exemption, consistently exceeding annual statutory allocations. Although Congress instructed that cap-subject H-1B visas (or H-1B nonimmigrant status) be allocated based on the order in which petitions are filed, it was silent with regard to the allocation of simultaneously submitted petitions. While the random lottery selection process is a reasonable solution, DHS believes that an allocation generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds better fulfills Congress' stated intent that the H-1B program help U.S. Employers fill labor shortages in positions requiring highly skilled workers.[] Start Printed Page 1699 This legislative history, as cited in the proposed rule, is consistent with the Senate Report the commenters cite.[] Both support the notion that Congress intended the H-1B program to fill labor shortages in positions requiring highly skilled workers.

Contrary to the commenter's assertion that DHS only cited to E.O. 13788 to support this priority, DHS cited to the legislative history of the Immigration Act of 1990, the legislation that created the H-1B program, to support the priority to allocate generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds.[] DHS cited to E.O. 13788 solely to note that a wage-level based selection was consistent with the administration's policy goals, not as legal authority for the proposed rule. Comment.

An individual commenter and a professional association argued that Presidential Proclamation 10052 is not authoritative to the extent that it conflicts with the INA, and that the proposal fails to explain how it “is consistent with applicable law or is practicable at this point in time,” especially in light of the forthcoming change in administration. Response. DHS disagrees with the assertion that Presidential Proclamation 10052 conflicts with the INA.[] In any event, the authority for this regulation stems not from that proclamation but from DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C.

112. Comment. One commenter stated that salary also is a proxy variable for age, as, in most industries, more experienced individuals get paid higher wages. This commenter asked whether USCIS has the authority to apply “salary” as a secondary sorting mechanism for H-1B registrations, and if so, what would prevent USCIS also from using arbitrary sorting mechanisms such as age, geography, country of birth, race, religion, or gender.

Response. DHS disagrees that salary is a proxy for age. While salary is a reasonable proxy for skill, level of skill is not necessarily correlated to age. DHS also disagrees with the commenter's implied assertion that wage level is an arbitrary sorting mechanism.

As explained in the NPRM and in response to other comments, corresponding wage level is an objective way to prioritize selection in a manner consistent with the general purpose of the H-1B classification. DHS has not proposed, and does not intend to propose, selecting registrations or petitions, as applicable, based on factors that are unreasonable, inappropriate, or inconsistent with the purpose of the H-1B classification. 2. Substantive Comments on the Need for the Rule/DHS Justification Comments.

An anonymous commenter wrote that the proposed rule's wage standard for H-1B visa eligibility is arbitrary and capricious. The commenter said that DHS does not explain the rationale behind making wages the sole indicator of a worker's eligibility for visa sponsorship. The commenter also argued that the rule's rationale is flawed because it would not protect U.S. Workers, since the H-1B visa applies only to specialty occupations.

Another commenter opined that this rule is an attempt to add a new wage requirement as a part of H-1B eligibility. This commenter stated that this attempt is inconsistent with Congressional intent and would be an abuse of discretion by the Department. Response. DHS believes these commenters misstate the scope of this rule.

This rule does not make “wages the sole indicator of a worker's eligibility for [H-1B] visa sponsorship” and does not otherwise change the substantive standards for H-1B eligibility. DHS stated in the NPRM that registration, when required, is merely an antecedent procedural step that must be completed by prospective petitioners before they are eligible to file an H-1B cap-subject petition (emphasis added).[] Even if registration were suspended, the rule merely revises how USCIS would select H-1B cap-subject petitions toward the H-1B numerical allocations to determine which petitions are “filed” and thus eligible for further processing. But the rule does not change substantive eligibility requirements. DHS also disagrees with the commenter's assertion that the rule would not better protect U.S.

Workers. As explained in response to other comments, prioritizing the selection of H-1B registrations or petitions, as applicable, based generally on the highest OES prevailing wage level that the proffered wage equals or exceeds will incentivize employers to offer higher wages or higher-skilled positions to H-1B workers and disincentivize the existing widespread use of the H-1B program to fill relatively lower-paid or lower-skilled positions, for which there may be available and qualified U.S. Workers. DHS, therefore, believes that this rule will benefit U.S.

Workers who compete against entry-level H-1B workers and will incentivize H-1B petitioners to offer higher wages, further benefiting U.S. Workers whose wages might otherwise be depressed by an influx of relatively lower-paid, lower-skilled H-1B workers. A. Support for the DHS Rationale Comments.

Many commenters expressed support for the proposed rule and DHS justification. Several commenters stated that the proposed rule is based on a true premise that salary equates with value. A research organization stated that there is no evidence to suggest that the H-1B program was designed to fill entry-level jobs at entry-level wages, and prioritizing H-1B petitions at high wage levels will safeguard U.S. Wage standards and increase labor efficiency.

The commenter went on to state that prioritizing higher H-1B wage levels will not undermine the program, but, rather, will incentivize recruitment and retention, while also helping U.S. Workers in labor categories that have seen stagnant wage growth in recent history. The commenter reasoned that, because employers do not have to test the market before hiring H-1B workers, wages are a good indicator of the actual market need for workers in a given field. Response.

DHS agrees with these commenters and thanks them for their support. B. Rule Is Based on False Premises/Rationale Comment. Many commenters, including those who participated in an orchestrated form letter campaign, stated that the proposal is based on the false premise that salary alone equates with value and that individuals who earn more in their profession contribute more to the economy.

An individual commenter discussed the fundamental flaw in associating level I and level II workers with low-paying, low-skilled work, where in reality, entry-level doctors, lawyers, engineers, and Start Printed Page 1700architects are professionals performing specialty occupations. A professional association stated that the salaries associated with each wage level do not fully capture an individual's contribution to society. In fact, there often is an inverse correlation. A professional association said DHS has created a condition where employers would be able to buy their way into the proposed H-1B visa cap selection system by offering a higher wage to the beneficiary regardless of skill, which would negate the stated purpose of the proposed rule to garner more high-skilled workers in the U.S.

Workforce. Some commenters said the proposed rule is based on the false premise that foreign workers depress wages and take away jobs from U.S. Workers. A university stated that the foreign workers this rule targets fill critical needs in the U.S.

Labor market, bolster innovation, create jobs, and drive economic growth. The commenter, along with an individual commenter, stated that some studies show foreign workers have a positive impact on wages overall. Similarly, an advocacy group said limiting the amount of high-skilled foreign workers in the United States does not mean that there will be more jobs available to U.S. Workers.

Rather, it would mean many companies would shift jobs overseas. The commenter stated that, if the H-1B program were expanded, it could result in up to 1.2 million new jobs for U.S. Workers. The commenter went on to state that the program does not have a “depressive effect” on U.S.

Worker wages, and concluded by saying that, by restricting the H-1B program, the proposed rule would not have the intended effects of boosting American jobs and wages. An individual commenter stated that USCIS already has protected U.S. Workers by increasing fees and updating the definition of “specialized knowledge,” and there is no need to distort the labor markets and harm U.S. Competitiveness at a time when the U.S.

Can once again be a leader in technology development. Response. DHS disagrees with these comments. DHS believes that salary generally is a reasonable proxy for skill level.[] As stated in the NPRM, in most cases where the proffered wage equals or exceeds the prevailing wage, a prevailing wage rate reflecting a higher wage level is a reasonable proxy for the higher level of skill required for the position, based on the way prevailing wage determinations are made.

DHS believes that an employer who offers a higher wage than required by the prevailing wage level does so because that higher wage is a clear reflection of the beneficiary's value to the employer, which, even if not related to the position's skill level per se, reflects the unique qualities the beneficiary possesses. While we believe that the rule may incentivize an employer to proffer a higher wage to increase their chances of selection, we also believe the employer only would do so if it was in their economic interest to do so based on the beneficiary's skill level and relative value to the employer. DHS acknowledges that aliens may be offered salaries at level I or level II prevailing wages to work in specialty occupations and may be eligible for H-1B status. However, DHS also believes that, in years of excess demand exceeding annual limits for H-1B visas subject to the numerical allocations, the current process of random selection does not optimally serve Congress' purpose for the H-1B program.

Instead, in years of excess demand, selection of H-1B cap-subject petitions on the basis of the highest OES prevailing wage level that the proffered wage equals or exceeds is more consistent with the purpose of the H-1B program and with the administration's goal of improving policies such that H-1B classification is more likely to be awarded to petitioners seeking to employ higher-skilled and higher-paid beneficiaries.[] DHS does not agree that the rule will limit or restrict the number of H-1B workers, and that is not the rule's intent. DHS also does not agree that this rule will result in companies shifting jobs overseas or will harm U.S. Competitiveness. Rather, DHS believes that the admission of higher-skilled workers would benefit the economy and increase the United States' competitive edge in the global labor market.

Comment. An individual commenter stated that the lowest paid H-1B worker makes more than H-2 workers, and yet, the administration has expanded the H-2 guest worker program and is presently seeking to lower prevailing wages for these workers, suggesting that “increasing the wages paid to foreign workers is not actually a consistent policy or priority for the administration.” The commenter also said the NPRM's reference to incidents of long-time U.S. Employees being laid off in favor of younger workers are actually more complicated and show the declining enrollment in IT and STEM fields by U.S. Students.

The commenter went on to say that H-1B workers are more costly than U.S. Workers, which demonstrates that there are not enough similarly situated U.S. Workers. Response.

DHS disagrees with the commenter's assertions. Regarding the H-2 program, DHS disagrees that the administration's policies have been inconsistent, as these programs serve different purposes. As DHS has stated above and in the NPRM, the intent of the H-1B program is to help U.S. Employers fill labor shortages in positions requiring highly skilled or highly educated workers.

DHS believes that this rule reflects that intent more faithfully than a random selection process. DHS also disagrees that the instances cited in the NPRM of U.S. Employers replacing qualified and skilled U.S. Workers with relatively lower-skilled H-1B workers shows declining enrollment in STEM fields by U.S.

Students, and does not agree with the commenter's assessment regarding insufficient U.S. Workers.[] Actually, Start Printed Page 1701the fact that more than a third of recent American graduates with STEM degrees do not obtain work in a STEM field indicates that there is no shortage of qualified recent American graduates to fill STEM jobs.[] Finally, concerning the comment that H-1B workers are more costly than U.S. Workers, DHS recognizes that employers often incur upfront costs to file H-1B petitions (including filing fees and preparation fees). However, DHS believes these upfront costs are offset by the employer's ability to legally pay their H-1B employees relatively low wages below the local median wage.

Data show that the majority of H-1B cap-subject petitions have been filed for positions certified at the level I or level II prevailing wages, both of which are set below the local median wage.[] Employers may realize additional cost savings over the span of several years as they continue to employ these H-1B workers at below-median wages without any statutory requirement to increase the workers' wage levels or wages beyond the minimum required wages. Unlike U.S. Workers, H-1B workers are tied to their specific employer, and, therefore, may lack the negotiating power of similarly skilled U.S. Workers to request wage increases.[] DHS believes that the random selection process is not fair to U.S.

Workers whose wages may be adversely impacted by relatively lower-paid H-1B workers. C. Lack of Evidence To Support Rulemaking Comments. An advocacy group stated that the evidence provided in the NPRM is not robust enough to justify such a dramatic change in policy.

According to the commenter, the agency failed to consider multiple sources that suggest the current H-1B program benefits U.S. Workers and the economy. Similarly, a trade association said that the Agency “selectively cherrypicked a small minority of studies” from sources that regularly object to the use of temporary highly-skilled foreign talent, asserting that, had USCIS completed a more comprehensive review of literature, it would have been clear that the H-1B visa program and workers make significant contributions to the U.S. Economy and society.

A joint submission from multiple organizations said that DHS even communicates its failure to gather sufficient evidence before publication, and that DHS appears to be operating under the misconception that anything can be published as an NPRM and the burden shifts to the public to analyze the potential impacts. The commenters said that DHS should gather more data before restarting the regulatory process. An individual commenter similarly said that the agency provides inadequate justifications for the proposed changes, while another individual commenter said that the proposed rule is “half-baked and flawed in a number of ways” and requires proper rule-making procedures. An individual commenter stated that the proposed rule does not explain how giving priority to higher wage levels is a more efficient allocation process than the current random lottery process.

The commenter said the H-1B lottery is a Visit Your URL fair solution to the issue of many petitions arriving on the same day or time, and the proposed rule would “go beyond the principle of fairness.” A trade association stated that the APA does not allow an agency to make significant change without completing an accurate cost-benefit analysis, which the agency did not do, nor did it allow sufficient time for stakeholders to conduct their own assessments. A company similarly stated that the Department's “scant justification” for wage-based selection of H-1B petitions violates the APA because a Level I or II prevailing wage does not mean that that the worker is not highly skilled or vital. The company said that the Department's reasoning for the proposed rule lacks a “rational connection between the facts found and the choice made.” An anonymous commenter wrote that the proposal is arbitrary and capricious, asserting that DHS does not explain the rationale behind making wages the sole indicator of a worker's eligibility for visa sponsorship. Response.

DHS disagrees with these comments. DHS conducted a comprehensive review of the issues, relying on both internal data and external studies and reports.[] DHS acknowledges the articles, studies, and reports submitted by commenters that purport to show the overall benefits of H-1B workers.[] DHS recognizes that some H-1B workers do fill gaps in the labor market and make contributions to the overall economy. However, while some studies show the benefits of H-1B workers overall, DHS also believes that sufficient evidence demonstrates that a prevalence of relatively lower-paid and lower-skilled H-1B workers is Start Printed Page 1702detrimental to U.S. Workers.[] As discussed in the NPRM and above, DHS further believes that the influx of relatively lower-skilled and lower-paid H-1B workers is not consistent with the dominant legislative purpose of the statute.

Prioritizing registrations based on wage level likely would increase the average and median wage levels of H-1B beneficiaries who would be selected for further processing under the H-1B allocations. Moreover, it would maximize H-1B cap allocations, so that they more likely would go to the best and brightest workers. Based on its comprehensive review of the submitted comments and available evidence, DHS has concluded that, by changing the selection process, in these years of excess demand, from a random lottery selection to selection generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds, DHS will implement the statute more faithfully to its dominant legislative purpose. DHS further believes that this will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program.

It may also benefit U.S. Workers as employers that might have petitioned for a cap-subject H-1B worker to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S. Workers for those positions. DHS believes that the available data and information support this rulemaking and that it is not necessary to gather more data or to restart the regulatory process.

C. Proposed Changes to the Registration Process for H-1B Cap-Subject Petitions 1. Proposed Wage-Based Selection (Selection Process for Regular Cap and Advanced Degree Exemption, Preservation of Random Selection Within a Prevailing Wage) Comment. A business association commented that adding in a non-random variable to the H-1B cap selection process would open the door to pre-adjudication, which may add new burdens to the petitioners and USCIS.

The commenter also said the addition of the wage factor may cause potential enforcement or audit actions if USCIS does not agree with a petitioner's assessment of “corresponding wage level,” either when adjudicating the petition or in the course of a post-adjudication audit. In addition, the commenter said the “corresponding wage level” listed on the lottery registration would not necessarily match the “wage level” designated on the Labor Condition Application (LCA) form, creating confusion. Response. DHS disagrees that ranking according to the highest OES prevailing wage level that the proffered wage equals or exceeds will be a pre-adjudication, as submission of the electronic registration is merely an antecedent procedural requirement to properly file the petition.

It is not intended to replace the petition adjudication process or assess substantive eligibility. With respect to new burdens resulting from the additional information provided, these are captured below in section V. Statutory and Regulatory Requirements. DHS believes that the additional burden, which is relatively small, is necessary to ensure that USCIS implements the registration system in a manner that realistically, effectively, efficiently, and more faithfully administers the cap selection process.

DHS acknowledges that the “wage level” listed by the petitioner on the registration form may not always match the “wage level” indicated on the LCA. However, DHS believes that the instructions provided in the registration system and on the H-1B petition are sufficiently clear to avoid confusion. Further, USCIS officers will be sufficiently trained on the reasons why the wage level on the registration form may not always match the LCA, and may request additional evidence from the petitioner, as appropriate, to resolve material discrepancies in this regard. However, DHS notes that USCIS may deny or revoke a petition if USCIS determines that the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct.[] Comment.

A professional association noted that DHS proposes to abruptly and unnecessarily change the selection process for H-1B cap-subject petitions by prioritizing registrants based on the highest OES prevailing wage level, and consider applicants solely based on the amount of money that they would be paid, rather than the utility that they would bring to the U.S. Workforce. Response. DHS believes that ranking and selecting by the highest OES prevailing wage level that the proffered wage equals or exceeds is a practical way to achieve the administration's goal of improving policies such that H-1B classification is more likely to be awarded to petitioners seeking to employ higher-skilled and higher-paid beneficiaries.

As stated previously, the new ranking system takes into account the wage level relative to the SOC code and area(s) of intended employment—as opposed to salary alone—when ranking registrations. While DHS agrees that the utility an H-1B beneficiary brings to the U.S. Workforce is important, there is no practical, objective way to measure utility such that DHS could use this quality to rank and select H-1B registrations or petitions. 2.

Required Information From Petitioners a. OES Wage Level i. Highest OES Wage Level That the Proffered Wage Would Equal or Exceed Comments. Several commenters said DHS should rank registrations at OES prevailing wage level I separate from those falling below OES prevailing wage level I, so that registrations who meet wage level I are prioritized for H-1B selection over those falling below level I.

Some commenters noted that the DOL IFR placed the level I wage at the 45th percentile (close to previous level III), creating vast differentiation within this large group. Therefore, the benefits of the rule of differentiating candidates would fail for at least 90 percent of registrations, as the DOL IFR would result in the prevailing wage level I and below group being much larger and DHS needing to select from that group completely at random. With that lack of differentiation, the new rule would not accomplish its purpose of retaining the best talent. Therefore, these commenters urged DHS to consider separating those registrations at or above level I wages from those falling below, as opposed to putting them into one giant group.

Response. DHS does not agree with the suggestions to separate OES wage level I from a wage below level I. DHS expects that all petitioners offering a wage lower than the OES wage level I wage will be using another legitimate source other than OES or an independent authoritative source, including a private wage survey. Therefore, such a change effectively could preclude petitioners that utilize one of those other sources from being selected for registration.

By grouping OES wage level I and below together, those petitioners have a fair chance of selection and are not precluded from using a private wage survey as appropriate. Since the DOL IFR was set Start Printed Page 1703aside on December 1, 2020, and is no longer being implemented, DHS will not be considering the impact of the DOL IFR in the context of this final rule.[] Comments. A professional association remarked that petitioners who use private survey data would be disadvantaged by the proposed rule and said that, even when private wage surveys provide an accurate prevailing wage, the proposed rule requires the employer to “downgrade” the H-1B registration to the lower OES prevailing wage level. The commenter concluded that, as a result, the proposed rule's artificial preference in the registration system to what is admittedly incomplete or possibly inaccurate OES wage data reduces the chance that employers intending to pay the H-1B required wage based on the statutory “best information available”—in this case a private industry survey—will see their registration selection chances materially reduced.

A law firm questioned which factors contributed to DHS's decision to use the OES wage levels as opposed to wage leveling from a permissible private wage survey. Response. DHS appreciates the commenter's question. When determining how to rank and select registrations (or petitions) by wage level, DHS decided to use OES prevailing wage levels because they are the most comprehensive and objective source for comparing wages.

The OES program produces employment and wage estimates annually for nearly 800 occupations.[] Additionally, most petitioners are familiar with the OES wage levels since they are used by DOL and have been used in the foreign labor certification process since 1998.[] OES wage level data is publicly available through the Foreign Labor Certification Data Center's Online Wage Library. Private wage surveys are not publicly available and do not always have four wage levels. DHS disagrees with the commenter's assertion that petitioners who use private survey data would be disadvantaged by the rule. Petitioners may continue to use private wage surveys, if they choose to do so, to establish that they will be paying the beneficiary a required wage.

This rule, however, will rank and select registrations or petitions, as applicable, based on the highest OES wage level that the proffered wage equals or exceeds as OES wage data is the most comprehensive and objective source for comparing wages. Comment. An individual commenter stated that the requirement to designate the wage level is confusing because DHS is asking petitioners to designate not the wage level associated with the job opportunity, but the highest OES wage level for which the proffered wage exceeds the OES wage. The commenter said asking petitioners to determine two different wage levels makes the process deliberately complex and ripe for error, which could be fatal given the proposed increased authority of USCIS to deny petitions for discrepancies in wage levels.

The commenter also expressed concern that the position, its substantive job duties, its occupational classification, the intended worksite, the prevailing wage, and the actual wage are now required at the registration stage in order to comply with the “complicated ranking-wage-level calculation.” Response. DHS does not agree with the comment stating that asking petitioners to specify the highest corresponding OES wage level that the proffered wage would equal or exceed on the registration is confusing or burdensome. Further, DHS disagrees with the comment stating that the position, its substantive job duties, its occupational classification, the intended worksite, the prevailing wage, and the actual wage are now required at the registration stage. In addition to the information required on the current electronic registration form (and on the H-1B petition) and for purposes of this selection process and to establish the ranking order, a registrant (or a petitioner if registration is suspended) would be required to provide only the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code in the area of intended employment.

While the OES wage level assessment would be based on the SOC code, area of intended employment, and proffered wage, the registrant would not need to supply the SOC code, area of intended employment, and proffered wage at the registration stage. Comment. A professional association asserted that the U.S. Bureau of Labor Statistics' (BLS) OES wage survey skews wage data higher for several professions, including physician specialties.

The commenter suggested that wage survey data collected from employees has significant issues, including that the data is collected voluntarily, wage data is grouped rather than provided for individual employees, larger urban centers are overrepresented compared to smaller practices, and physicians in rural areas are underreported. The association added that, in situations where there is less wage data, DHS will be unable to accurately adjudicate cap slots, citing data from the American Immigration Council and the Foreign Labor Certification Data Center. The association also said the DOL IFR increases the prevailing wage requirements and exacerbates the issue by establishing a default wage for physicians of $208,000 where data is unavailable. The professional association stated that the BLS prevailing wage does not comply with DHS's claim that higher skill level positions must be paid higher wages.

The association asserted that statistical analysis problems with the BLS OES survey would cause the population of H-1B physicians to be paid equally regardless of skill or experience. The commenter further stated that rural and other underserved areas will not meet the wage requirements and will lose access to critically needed physicians. Response. On December 1, 2020, the U.S.

District Court for the Northern District of California issued an order in Chamber of Commerce, et al. V. DHS, et al., No. 20-cv-7331, setting aside the DOL IFR, which took effect on October 8, 2020, and implemented reforms to the prevailing wage methodology for the Permanent Employment Certification, H-1B, H-1B1, and E-3 visa programs.

Similarly, on December 3, 2020, the U.S. District Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No.

20-cv-14604, applying to the plaintiffs in that case. On December 3, 2020, DOL announced that it was taking necessary steps to comply with the courts' orders and will no longer implement the IFR. These steps include making required technical changes to the Foreign Labor Application Gateway (FLAG) system to replace the October 8, 2020, through June 30, 2021, wage source year data that was implemented under the DOL IFR with the OES prevailing wage data that was in effect on October 7, 2020, and reflecting such data updates in the Foreign Labor Start Printed Page 1704Certification Data Center Online Wage Library [] at https://www.flcdatacenter.com/​ with the correct prevailing wage data for each SOC and area of intended employment through June 30, 2021.[] While prevailing wage level data remains unavailable for some SOC codes in some areas of intended employment, DHS believes that its solution in that limited circumstance, as proposed in the NPRM and retained in this final rule, still will allow DHS to select registrations according to the metric of the registrant's self-identified prevailing wage level as calculated using DOL's prevailing wage level guidance.[] DHS recognizes that this solution is imperfect as it does not provide a means for those registrants to proffer wages that equal or exceed higher prevailing wage levels than those commensurate with the position requirements. However, DHS concludes that it is the best available option to serve the overarching goal of revising the selection process to ensure that H-1B petitions are filed for positions requiring relatively higher skill levels or proffering wages commensurate with higher skill levels.

The commenter's statements that limitations in OES data would cause the population of H-1B physicians to be paid equally regardless of skill or experience, or that such limitations undermine the premise that higher skill level positions must be paid higher wages, is beyond the scope of this rulemaking. This rule does not require an employer to pay a certain wage. This rule merely pertains to ranking and selection of registrations or petitions, as applicable, based on corresponding wage level. In the limited instance where OES data is unavailable, the registrant would follow DOL guidance on prevailing wage determinations to determine which OES wage level to select on the registration, notwithstanding the proffered salary.

Ii. Highest OES Wage Level When There Is No Current OES Prevailing Wage Information Comment. A business association commented that, although using the prevailing wage worksheet to determine wage level makes sense, there is no way to escalate to a higher corresponding wage level by paying more, unlike when an OES wage is used. The commenter added that the unavailability of an OES wage may be an indication that a job is new or novel, and therefore may be even more in need of H-1B workers to fulfill employment needs.

Response. DHS recognizes that some occupations do not have current OES prevailing wage information available on DOL's Online Wage Library. In the limited instance where there is no current OES prevailing wage information for the proffered position, the registrant would follow DOL guidance on prevailing wage determinations to determine which OES wage level to select on the registration. While petitioners may not be able to increase their chance of selection by increasing the proffered wage, they can increase their chance of selection by petitioning for positions requiring higher skill, experience, or education levels.

DHS believes that, in the absence of current OES prevailing wage information, selecting according to wage level is the best way to ensure that registrations (or petitions) are selected consistent with the primary purpose of the H-1B program, which is to help U.S. Employers fill labor shortages in positions requiring highly skilled or highly educated workers. DHS data shows a correlation between higher salaries and higher wage levels.[] Thus, even in those limited instances where no OES prevailing wage information is available, DHS believes that selecting according to wage level is likely to result in selection of the highest-paid or highest-skilled beneficiaries, consistent with the goals of the H-1B program. DHS will not comment on whether the unavailability of OES wage indicates that a job is new, novel, or in more demand, as that is outside the scope of this rule.

Comment. One commenter asked, where the OES wage levels are missing, what penalties, if any, will be applied to petitioners or beneficiaries if USCIS disagrees with the wage level selected by the petitioner after selection has occurred. Response. DHS expects each registrant would be able to identify the appropriate SOC code for the proffered position because all petitioners are required to identify the appropriate SOC code for the proffered position on the LCA, even when there is no applicable wage level on the LCA.

Using the SOC code and established DOL guidance, all prospective petitioners would be able to determine the appropriate OES wage level for purposes of completing the registration or petition, as applicable, regardless of whether they were to specify an OES wage level or utilize the OES program as the prevailing wage source on an LCA. During the adjudication process, if USCIS disagrees with the wage level selected by the petitioner, USCIS will comply with 8 CFR 103.2(b)(8) and may provide the petitioner an opportunity to explain the selected wage level, as applicable. If USCIS determines that the petitioner failed to meet its burden of proof in establishing that it selected the appropriate SOC code for the position, or if USCIS determines that the petition was not based on a valid registration (e.g., if there is a discrepancy in wage levels between the registration and the petition), USCIS may deny the petition. If USCIS determines that the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct, USCIS may reject or deny the petition or, if approved, may revoke the approval of a petition that was filed based on that registration.[] If USCIS determines that the statement of facts contained in the petition or on the LCA was not true and correct, inaccurate, fraudulent, or misrepresented a material fact, USCIS may revoke the approval of that petition.[] Comment.

A professional association stated that, because the registration system does not contemplate a real-time adjudication of whether occupations lacking current OES prevailing wage information are correctly slotted under USCIS' selection system, there would be no fail-safe mechanism for employers to confirm that the wage-preference selection process in fact operated as USCIS predicted in the proposed rule. The commenter stated that, before any further rule is published, DHS, DOL and OMB should investigate and determine whether any proposed wage-preference H-1B selection process relying upon Start Printed Page 1705incomplete OES data can be established, notwithstanding these apparent data gaps and deficiencies. The commenter concluded that, despite the inadequacy or unavailability of OES data, the proposed rule ignores the requirement that wage data be sourced from “the best information available,” placing unwarranted and artificial reliance on OES data despite its faults or lack of availability. Response.

DHS recognizes that prevailing wage level data remains unavailable for some SOC codes in some areas of intended employment. However, DHS still believes that OES provides the most comprehensive and objective publicly available source for obtaining prevailing wage information and, thus, is still the best available option to serve the overarching goal of improving policies such that H-1B classification is more likely to be awarded to petitioners seeking to employ higher-skilled and higher-paid beneficiaries.[] iii. Lowest OES Wage Level That the Proffered Wage Would Equal or Exceed When Beneficiary Would Work in Multiple Locations or Positions Comment. A commenter said employers may relocate an employee to temporarily work remotely in a location where average salary is low to keep wages low while increasing the H-1B wage level and the chance of being selected.

The commenter suggested that the area code used for the selection of H-1B registrations only should be the registered official address of the company, instead of anywhere where the employee will work, concluding that employers should be fined for misrepresenting work locations to take advantage of lower wages. Response. DHS appreciates this commenter's concern, but believes the commenter misunderstood how the new H-1B cap selection process will work and the limitations contained in the proposed rule to limit the potential for abuse or gaming of the selection process. If the H-1B beneficiary will work in multiple locations or multiple positions, the registrant or petitioner must specify on the registration or petition, as applicable, the lowest corresponding OES wage level that the proffered wage will equal or exceed for the relevant SOC code in the area of intended employment, and USCIS will rank and select based on the lowest corresponding OES wage level.

DHS provides the following example for illustrative purposes only. A prospective employer intends to employ an H-1B beneficiary as a level I “Civil Engineer” position (SOC code 17-2051) at two locations. San Francisco, California and Montgomery, Alabama. The Alabama location was specifically chosen because of that locality's generally lower prevailing wages.

The required level I prevailing wage for each area of intended employment is $77,147 per year [] and $62,858 per year,[] respectively. In this scenario, to meet the level I prevailing wage for the San Francisco area of intended employment, the minimum annual wage the prospective petitioner must offer to the beneficiary is $77,147. While an annual salary of $77,147 would exceed the level II prevailing wage for the Montgomery, Alabama, area of intended employment,[] the prospective petitioner still must select Level I for purposes of the registration because that is the lowest corresponding OES wage level that the proffered wage will equal or exceed for the relevant SOC code in all areas of intended employment. This rule also includes provisions authorizing USCIS to deny an H-1B petition if USCIS determines that the statements on the registration or petition were inaccurate, fraudulent or misrepresented a material fact.[] USCIS also may deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the original petition.[] Comment.

A professional association expressed concern with the proposed rule's language stating, “if the beneficiary will work in multiple locations, or in multiple positions if the registrant is an agent, USCIS will rank and select the registration for the lowest corresponding OES wage level that the proffered wage will equal or exceed.” [] The commenter stated that, basing the chance for selection on the lower wage figure is an “arbitrary” protocol without explanation. Likewise, an individual commenter said the provision is unfairly discriminatory and lacks adequate justification, adding that it is “unconscionable to use an inverted system” for ranking. Response. DHS chose to use the lowest corresponding OES wage level that the proffered wage will equal or exceed in the case of multiple locations or multiple positions to prevent gaming of the registration process.

If DHS were to invert the process and rank based on the highest corresponding OES wage level that the proffered wage were to equal or exceed, then petitioners could place the beneficiary in a lower-paying position for most of the time and a higher-paying position for only a small percent of the time, but use that higher-paying position to rank higher in the selection process and increase their chances of being selected in the registration process. Similarly, in the case of multiple locations, petitioners could place the beneficiary in a higher-paying locality for only a small percent of time, but use that higher-paying locality to rank higher in the selection process and increase their chances of being selected in the registration process. Iv. Other Comments on OES Wage Level Comment.

Several commenters said that the proposed rule's changes to prevailing wage levels are in direct opposition to established guidance set forth in the DOL Employment and Start Printed Page 1706Training Administration Prevailing Wage Determination Policy Guidance.[] Response. This rule does not conflict with or change established DOL guidance. DHS clearly stated in the NPRM that this ranking and selection process will not alter the prevailing wage levels associated with a given position for DOL purposes, which are informed by a comparison of the requirements for the proffered position to the normal requirements for the occupational classification.[] Comment. A professional association wrote that the OES wage data has various shortcomings, and there are advantages to using a variety of wage data.

Prevailing wage data can originate from multiple sources, including wage surveys published by private organizations and employer-conducted surveys. The association said that BLS OES survey data used to calculate prevailing wages is not designed for foreign labor certification, and OES survey data captures no information about differences based on skills, training, experience or responsibility levels of the workers, all of which are factors the INA requires DHS to consider. The association said that the OES survey is the best available source of wage data for the Department's purposes, but it is not perfectly suited to the H-1B, H-1B1, and E-3 classifications, nor to the Permanent Labor Certification Program (PERM). The professional association also commented that the proposed rule does not describe the cases when OES prevailing wage data would be unavailable or how USCIS officials would be trained to interpret DOL guidance, and petitioners who cannot use Online Wage Library data would have no way to know whether USCIS officials misinterpreted the DOL guidance and mistakenly disagreed with an employer's wage level selection.

Response. When determining how to rank and select registrations (or petitions, as applicable) by the highest OES prevailing wage level that the proffered wage equals or exceeds, DHS decided to use OES prevailing wage levels because OES is the most comprehensive and objective source for comparing wages. The OES program produces employment and wage estimates annually for nearly 800 occupations.[] Additionally, most petitioners are familiar with the OES wage levels since they are used by DOL and have been used in the foreign labor certification process since 1998.[] During the adjudication process, if USCIS disagrees with the wage level selected by the petitioner, USCIS will comply with 8 CFR 103.2(b)(8) and may provide the petitioner an opportunity to explain the wage level, as applicable. If USCIS determines that the petitioner failed to meet its burden of proof in establishing that it selected the appropriate SOC code for the position, or if USCIS determines that the petition was not based on a valid registration (e.g., if there is a discrepancy in wage levels between the registration and the petition), USCIS may deny the petition.[] If USCIS determines that the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct, USCIS may reject or deny the petition or, if approved, may revoke the approval of a petition that was filed based on that registration.[] If USCIS determines that the statement of facts contained in the petition or on the LCA was not true and correct, inaccurate, fraudulent, or misrepresented a material fact, USCIS may revoke the approval of that petition.[] b.

Attestation to the Veracity of the Contents of the Registration and Petition (Including Comments on Rejections, Denials, and Revocations) Comments. One commenter noted the need to ensure that ranking and selection as described would not enable attempts to increase the chance of selection by representing one wage level at the registration stage and a lower wage level at the H-1B petition filing stage. Response. DHS appreciates and shares the commenter's concern.

New 8 CFR 214.2(h)(8)(iii)(D)(1)(iii), (h)(10)(ii), and (h)(11)(iii)(A)(2) address the concern that registrants could misrepresent wage levels at the registration stage to increase chances of selection. Specifically, this final rule empowers USCIS to deny a petition if USCIS determines that the statements on the registration or petition were inaccurate, fraudulent, or misrepresented a material fact. The rule also authorizes USCIS to deny or revoke approval of a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly decrease the proffered wage to an amount that would be equivalent to a lower wage level, after listing a higher wage level on the registration to increase the odds of selection. The ability to deny or revoke approval of an H-1B petition in such a context will defend against registrants and petitioners attempting to abuse the H-1B cap selection process by misrepresenting wage levels.

Comment. One commenter asked what factors DHS will use to determine if a petitioner attempted to circumvent the proposed rule by filing a subsequent new petition with a lower wage under a related entity, and whether DHS will consider that related entities may have different compensation ranges for similar positions in making this determination. Response. DHS thanks this commenter for the question.

Under new 8 CFR 214.2(h)(10)(ii), USCIS may deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the original petition. Whether the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process is an issue of fact that USCIS will determine based on the totality of the record. As such, DHS cannot provide an exclusive list of factors that USCIS will consider in such adjudications. In general, however, the petitioner or a related entity bears the burden of proof to demonstrate that.

The new or amended petition is not part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process. The initial H-1B petition and the underlying registration, when applicable, was based on a legitimate Start Printed Page 1707job offer; [] and the new or amended petition is nonfrivolous.[] Further, DHS notes that, under the current registration system, the petitioner identified at the registration stage must match the petitioner of the subsequently filed petition. 8 CFR 214.2(h)(8)(iii)(D) states that a petitioner may not substitute the beneficiary named in the original registration or transfer the registration to another petitioner. This rule has not changed this requirement.

Accordingly, USCIS may deny an H-1B cap-subject petition if an entity other than the petitioner identified at the registration stage, including a related entity, files the petition. Comment. An individual suggested allowing future H-1B extensions or renewals only with a wage level that is equal or greater than the wage level selected in the lottery for the first time. Response.

H-1B extensions or renewals are not impacted by this rule, and DHS declines to impose a universal requirement that all extension or renewal requests must be for a position at the equal or greater wage level. Employers are permitted to file an extension petition requesting continuation of previously approved employment without change with the same employer, which most likely involves a position at the same wage level. Furthermore, employers are permitted to file extension or amended petitions requesting new employment, change in previously approved employment, new concurrent employment, change of employer, or amended employment. All of these petition types could involve positions with different SOC codes, which makes a straight comparison of wage levels impractical.

However, under new 8 CFR 214.2(h)(10)(ii), USCIS may deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the original petition. Comment. An individual commenter said that the formal certification requirement, whereby the petitioner's authorized signatory certifies “that the proffered wage on the petition will equal or exceed the wage level on the applicable registration,” does not recognize that registrations are submitted in March for a fiscal year beginning the following October. Therefore, particularly in years such as FY 2021 where there is a second round of selections, H-1B cap petitions may be filed after OES wages have changed.

The commenter said the new question added to the registration seems to address this concern, by specifying “[a]s of the date of this submission. . . ,” but the formal certification that is binding on the employer does not make this distinction, which could lead to unnecessary and inappropriate liability.

The commenter said that the certification should be revised to reflect only an attestation that the wage “will equal or exceed the prevailing wage, in effect at the time of submission, that is associated with the wage level selected in the registration.” Response. DHS thanks the commenter, but declines to adopt the suggestion. As the commenter notes, the registration form makes sufficiently clear that the information provided on the registration is “as of the date of submission of this registration.” DHS believes that further changes to the form are unnecessary and could potentially lead to gaming of the registration system. 3.

Requests for Comments on Alternatives Comment. A research organization and a labor union recommended having staggered filing deadlines for petitions by wage levels as an alternative in case the proposed rule is met with legal challenges. Under this alternative, USCIS could have a first filing period, where only petitions with jobs paying level IV are considered. Once all the level IV petitions are submitted and approved, then a second filing period at a later date could be set to receive only petitions with jobs paying level III wages.

After those are collected and approved, if there are any visas remaining under the H-1B cap, then a filing period for level II wages would be next, and finally a filing period for level I. This way, all of the petitions would not be submitted at once, thereby still allowing DHS to adjudicate and allocate petitions “in the order in which” they were filed, as the statute requires. If there were more petitions than available H-1B slots at a particular wage level, there could be a “mini-lottery” within that wage level. Response.

DHS appreciates the commenters' suggestions to use staggered filing deadlines. However, DHS believes it is not necessary to create staggered filing deadlines since, as stated in the NPRM and as explained above, this rule is consistent with and permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C. 112.[] Further, DHS believes that staggered filing deadlines may create operational challenges for managing the cap and adjudicating petitions in a timely manner.

Staggered filing periods could also have unintended consequences for petitioners filing H-1B cap-subject petitions for beneficiaries who are in F-1 status and seeking a change of status.[] Therefore, DHS declines to adopt this suggestion. Comment. One commenter suggested using only the beneficiary's annual wage to prioritize the selection of registrations. Response.

DHS appreciates the commenter's suggestion to prioritize selection based on annual wage. However, DHS believes that selecting registrations or petitions, as applicable, solely based on the highest salary would unfairly favor certain professions, industries, or geographic locations. Therefore, DHS believes that prioritizing generally based on the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment is the better alternative. Comment.

Several commenters were concerned about the possibility of abuse by companies who would offer part-time positions at greater hourly wages, but would reduce overall working hours, to increase their chance of selection. Other commenters expressed similar concerns about potential abuse of part-time positions, indicating that review should be stricter for part-time H-1B applicants. Response. This final rule authorizes USCIS to reject or deny a petition or, if approved, revoke the approval of a petition, if the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct.[] Similarly, this final rule authorizes USCIS to deny or revoke approval of a subsequent new or Start Printed Page 1708amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly decrease the proffered wage to an amount that would be equivalent to a lower wage level, after listing a higher wage level on the registration to increase the odds of selection.[] Thus, if USCIS finds that an employer misrepresented the part-time or full-time nature of a position, the number of hours the beneficiary would work, or the proffered salary, then USCIS could deny or revoke the petition.

The ability to deny or revoke approval of an H-1B petition in this context will militate against registrants and petitioners attempting to abuse the H-1B cap selection process through misrepresentation. Comment. One commenter suggested that, if USCIS were to receive and rank more registrations (or petitions, in any year in which the registration process is suspended) at a particular prevailing wage level than the projected number needed to meet the numerical limitation, then USCIS should rank and choose registrations by the highest prevailing wage within that wage level. Another commenter stated that visas should be allocated by the prevailing wage, even within each level.

Response. DHS does not believe that selecting the highest prevailing wage within a wage level is a better alternative to randomly selecting within a single wage level when USCIS receives more registrations (or petitions, in any year in which the registration process is suspended) at a particular prevailing wage level than the projected number needed to meet the numerical limitation. DHS prefers to give all registrations ranked at the particular wage level the same chance of selection because those registrations generally would represent workers at the same skill level. If DHS were to select the highest prevailing wage within a wage level, that could unfairly advantage registrations or petitions for positions in higher-paying metropolitan areas or occupations.

Comment. One commenter suggested giving preference to beneficiaries with U.S. Degrees. Another commenter stated that DHS should consider adding an advantage to candidates who receive a U.S.

Education as this will benefit U.S. Institutions of higher education. Response. DHS declines to adopt the commenters' suggestions.

Registrations or petitions, as applicable, submitted for beneficiaries who have earned a master's or higher degree from a U.S. Institution of higher education already have a higher chance of selection through the administration of the selection process. DHS reversed the order in which USCIS selects registrations or petitions, as applicable, which was expected to result in an increase in the number of H-1B beneficiaries with a master's degree or higher from a U.S. Institution of higher education selected by up to 16 percent each year [] and resulted in an 11 percent increase in FY 2020.[] Comment.

Some commenters said that DHS should consider ranking by years of experience, rather than by wage. One commenter asked DHS to give an advantage to candidates who have work experience in the United States. Response. DHS declines to adopt these alternatives, as ranking by years of experience would not best accomplish the goal of attracting the most highly skilled workers.

DHS believes that salary, relative to others in the same occupational classification and area of intended employment, rather than years of experience, is generally more indicative of skill level and the relative value of the worker to the United States. Comment. A few commenters said that DHS should consider providing quotas for each wage level, rather than simply ranking and selecting in descending order by wage levels. Other commenters suggested setting a limit or quota on the number of registrations submitted by certain types of employers, such as staffing agencies or H-1B dependent companies.

Another commenter supported measures to prevent staffing companies from filing multiple registrations for offshore workers and stated that companies should not be able to submit more than one registration per beneficiary. Another commenter stated that it is “crucial” to regulate consulting companies and staffing agencies. Response. DHS declines to pursue the alternative of setting quotas for each wage level or for certain types of companies as this alternative would not best accomplish the goal of attracting the most highly skilled workers.

With respect to comments about prohibiting staffing companies from filing multiple registrations, DHS declines to adopt the commenters' suggestions as DHS regulations already prohibit an employer from submitting more than one registration per beneficiary in any fiscal year.[] Comments about the need to further regulate consulting and staffing companies are outside the scope of this final rule. Comment. A few commenters suggested that DHS prohibit multiple H-1B petitions for the same beneficiary by different employers. Response.

DHS regulations already prohibit a petitioner, or related entities, from submitting more than one H-1B cap-subject petition for the same beneficiary in the same fiscal year, absent a legitimate business need.[] Because registration is not intended to replace the petition adjudication process or to assess eligibility, USCIS cannot feasibly determine at the registration stage whether different entities that submit registrations on behalf of the same beneficiary are “related” or have a “legitimate business need.” Further, INA section 214(g)(7), 8 U.S.C. 1184(g)(7), allows for “multiple petitions [to be] approved for 1 alien.” For these reasons, DHS declines to adopt the commenters' suggestion. Comment. One commenter stated that DHS should consider increasing the numerical cap exemption for beneficiaries who have earned a master's or higher degree from a U.S.

Institution of higher education as most of the highly skilled positions do not depend entirely on the number of years of experience, but on the higher education degree requirements. Response. This rule does not affect either the statutorily mandated annual H-1B numerical limitation of 65,000 on the number of aliens who may be issued initial cap-subject H-1B visas or otherwise provided initial H-1B status, or the annual cap exemption for 20,000 aliens who have earned a master's or higher degree from a U.S. Institution of higher education.[] As the numerical allocations are set by statute, DHS lacks the authority to adopt the commenter's suggestion.

Comment. An individual suggested DHS implement a “market based cap and selection system” by first identifying areas of the job market, like medical workers, that are most in need at the moment and, from there, ranking by wage or wage level. Response. DHS believes that identifying areas of the job market that are most in need is not feasible, as it is subjective and would be subject to constant change.

This rule is not a Start Printed Page 1709temporary rule that is limited in duration to the buy antibiotics zithromax, and regularly adjusting selection criteria based on the needs of the job market would be administratively burdensome. Therefore, DHS declines to adopt the commenter's suggestion. Comments. A few commenters proposed that DHS prioritize selection based on multiple factors, including the prospective beneficiary's degree from a U.S.

Institution, the length of time legally studying or working in the United States, skills, wages, and other qualifications. Other commenters stated that the DHS should weigh other desirable factors, such as whether H-1B employees are U.S. University graduates and whether the petitioner is a small business contributing a significant amount of their income to wages. This would allow small businesses to compete for H-1B visas and prevent larger corporations from being the only employers to benefit from the H-1B program.

Another comment urged DHS to create a prioritization system that incentivizes employers to petition for permanence for H-1B workers, among other desirable employer behavior in addition to fair compensation. Response. DHS believes that identifying and weighing multiple factors is not feasible, as such an approach could be overly complicated, unpredictable, and subjective. Therefore, DHS declines to adopt the commenters' suggestions.

Comment. A professional association requested that DHS exempt physicians from this rule. An individual suggested providing exceptions or waivers for certain industries, such as the healthcare/pharmaceutical fields, due to the different experience requirements in those fields. Response.

DHS declines to exempt physicians or other specific occupations or fields from the rule. While DHS certainly appreciates the significant challenges faced by healthcare professionals, especially during the current buy antibiotics zithromax, DHS recognizes that there are many other occupations that can be considered critical now and at various times in the future. Carving out exceptions for some occupations would be highly problematic, particularly as this rule is not a temporary rule that is limited in duration to the buy antibiotics zithromax. Comment.

An individual commented on the alternative proposal of weighting registrations such that “a level IV position would have four times greater chance of selection than a level I position, a level III position would have three times greater chance of selection than a level I position, and so on.” The commenter questioned why DHS set the multiples at 4 times, 3 times, and 2 times. Response. The multiples of 4 times, 3 times, and 2 times, correspond to wage levels IV, III, and II, respectively. As this commenter did not provide additional rationale in support of or against this alternative, DHS will not further consider this alternative.

D. Other Issues Relating to Rule 1. Requests To Extend the Comment Period Comments. A few commenters and a professional association stated that the public has not been given sufficient time to comment on the proposed rule.

One commenter said that there is no substantiated reason to limit the comment period and that doing so degrades the rulemaking process. An individual commenter stated that implementing these changes for the FY 2022 H-1B cap filing season would cause even more uncertainty for international students who already have faced enough uncertainty over the past year due to buy antibiotics, the Student and Exchange Visitor Program proposed rule,[] and USCIS processing times. An individual commenter and a university requested that the comment period be extended to 60 days because of the proposed rule's magnitude and the impacts of buy antibiotics on employers' resources. A professional association requested the same extension to allow for meaningful public comment, citing the language of E.O.

12866 and E.O. 13563, explaining that those executive orders recommend a comment period of no less than 60 days. The association listed six issues for which the proposed rule requests feedback and asserted that a 30-day comment period does not allow adequate time to address these issues. The association also said that, since this rule was published during the Thanksgiving season, the comment period was effectively shortened even further, undercutting the purpose of the notice and comment process.

An individual commenter questioned why DHS was “rushing” the proposed rule during the holiday season as opposed to providing more time for public comment. Response. While DHS acknowledges that E.O. 12866 and 13563 indicate that agencies generally should provide 60 days for public comment, DHS believes that the 30-day comment period was sufficient and declines to extend the comment period.

This rule is narrow in scope, and 30 days was sufficient time for the public to determine the impacts of the proposed rule, if any, and to prepare and submit comments. The sufficiency of the 30-day comment period is demonstrated by the number of high-quality comments received from the public, including individuals, attorneys, employers, and organizations. Given the narrow scope of the rule, the quantity and quality of comments received in response to the proposed rule, and other publicly available information regarding the rule, DHS believes that the 30-day comment period has been sufficient. 2.

Rulemaking Process a. Multiple H-1B Rulemakings Comments. An anonymous commenter stated that the proposed rule does not discuss the DOL IFR,[] or explain whether DHS and DOL consulted with each other in drafting the rules. The commenter added that Congress has given DOL the primary authority in protecting U.S.

Labor, and the proposed rule does not address how it would interact with the DOL rule, or why the proposed rule was necessary given the DOL IFR. An advocacy group stated that the proposed rule should not be implemented while the DOL IFR and the DHS IFR, Strengthening the H-1B Nonimmigrant Visa Classification Program (H-1B Strengthening IFR),[] were pending and being challenged in court. The commenter said it would be impossible to comment on the proposed rule without considering the impacts of the other two rules that will affect the H-1B process as well. Similarly, a research organization wrote that recently proposed rules by Federal agencies with respect to wages for foreign workers in work visa programs have been inconsistent and confusing.

An anonymous commenter stated that their workplace has been overworked for months responding to the multiple regulatory changes to the H-1B program. Response. On December 1, 2020, the U.S. District Court for the Northern District of California issued an order in Chamber of Commerce, et al.

V. DHS, et al., No. 20-cv-7331, setting aside the DOL IFR and the DHS IFR. Similarly, on December 3, 2020, the U.S.

District Start Printed Page 1710Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No. 20-cv-14604, applying to the plaintiffs in that case.

DOL has taken necessary steps to comply with the courts' orders and is no longer implementing the DOL IFR. DHS also took necessary steps to comply with the order in Chamber of Commerce, et al. V. DHS, et al., and is not implementing the DHS IFR.

DHS, therefore, disagrees with the commenter's assertions that DHS must consider the DOL and DHS IFRs in the context of this final rule as both IFRs were set aside and are no longer being implemented. B. Other Rulemaking Process Comments Comments. A joint submission from multiple organizations opposed the proposed rule and said that they were willing to participate in an informal dialogue with DHS or formally participate in an Advance Notice of Proposed Rulemaking process to help DHS determine whether a rule is needed, what regulation to develop, and viable alternative suggestions.

A trade association also opposed the rule and advised USCIS to pursue a formal rulemaking effort that provides stakeholders with more input before the formal rulemaking process begins. Response. DHS believes that the public has had sufficient opportunity to review and comment on this rule, as demonstrated by the number of high-quality comments received from the public, including individuals, attorneys, employers, and organizations. Given the narrow scope of the rule, the quantity and quality of comments received in response to the proposed rule, and other publicly available information regarding the rule, DHS believes that the public has had sufficient opportunity to participate in the rulemaking process.

Comment. A professional association commented that the public had no advance notice that the proposed rule was forthcoming because it was never listed on the Unified Agenda. The association also said USCIS had previously concluded that the policy now being proposed was not a permissible agency action, and therefore stakeholders were not prepared to conduct the sophisticated analysis necessary to assess the policy now being proposed in this rule. Response.

DHS believes that the public has had sufficient opportunity to review and comment on this rule, as demonstrated by the number of high-quality comments received from the public, including individuals, attorneys, employers, and organizations. Further, DHS explained in the NPRM that this rule is consistent with and permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C. 112, and DHS believes that the comment period provided sufficient time to assess the rule.

Comment. A research organization wrote that the administration waited until the 2020 election to take substantive action on the H-1B program, and while DOL and USCIS have legal authority to make the regulatory changes, the timing and regulatory process have made them susceptible to legal challenges. An individual commenter said that the administration will change in a few weeks and suggested that the proposed rule is being rushed into implementation before that happens. An individual commenter said USCIS should wait to promulgate the rule until the new presidential administration takes over and the Senate confirms a new head of both USCIS and DHS.

Response. DHS agrees that it has the legal authority to amend its regulations governing the selection of registrations submitted by prospective petitioners seeking to file H-1B cap-subject petitions (or the selection of petitions, if the registration process is suspended). DHS believes that the public has had sufficient opportunity to review and comment on this rule, as demonstrated by the number of high-quality comments received from the public, including individuals, attorneys, employers, and organizations. DHS believes that the public has had sufficient opportunity to participate in the rulemaking process.

3. Effective Date and Implementation Comments. A few individual commenters supported the proposed rule's immediate implementation to protect U.S. Jobs.

Another individual commenter contradicted claims that it is too late in the year for employers to accommodate changes in the registration system, saying that many companies wait until the new year to reach out to employees anyway, and recent changes to the H-1B process have made it easier to petition. Response. DHS agrees that this rule is being published with sufficient time to implement it for the FY 2022 registration period. Comments.

Many commenters, including a form letter campaign, said that, if USCIS were to finalize the proposed rule, it should not implement the proposed rule for the FY 2022 H-1B cap filing season (set to begin in March 2021) because changes so close to the beginning of that season would adversely impact U.S. Employers, immigration lawyers, and individuals. Multiple commenters said companies have already made hiring decisions based on the existing registration system, so delaying implementation until the FY 2023 cap filing season (set to begin in March 2022) would give the regulated community time to adjust. A company commented that implementing the rule for the upcoming H-1B cap filing season would create uncertainty and confusion.

A few commenters added that stakeholders have had to adapt to the new online registration system, which has ongoing issues, so it is unlikely that further modifications to the registration system will be implemented to run smoothly for the upcoming H-1B season. An individual commenter opposed implementing the proposed rule at this time because the U.S. Economy needs time and stability to recover. Response.

DHS believes that this rule is being published with sufficient time to allow employers to plan appropriately prior to the start of the registration period for FY 2022. DHS does not believe that petitioners will face significant adverse impacts with the implementation of this change in the selection process and believes that employers have sufficient time to make any decisions they believe are needed as a result of this rule, such as increasing proffered wages to increase the odds of selection. Further, DHS believes that there is sufficient time to allow for testing and modification and that delaying implementation at this time is not necessary. E.

Statutory and Regulatory Requirements 1. Impacts and Benefits (E.O. 12866, 13563, and 13771) a. Methodology and Adequacy of the Cost-Benefit Analysis Comments.

Multiple commenters provided input on the wage data DHS used to analyze the impact of the proposed rule. A couple of commenters referenced that the economic analysis conducted in the proposed rule was based on previous OES wage levels, rather than the new ones implemented as a result of the DOL IFR. One of these commenters stated that, with the huge changes in the wage levels resulting from the DOL IFR, the H-1B data would be much more skewed, and the economic impact analysis in the proposed rule was completely invalid. Another commenter explained that all of the analysis done in the proposed rule was based on previous OES wage Start Printed Page 1711levels and there has not been any economic impact analysis based on the new wage rules.

One commenter expressed that this rule must be read in concert with the DOL IFR, which reset how prevailing wage levels were calculated for H-1Bs. To get selected in the H-1B registration process under the proposed rule, the employer would have to pay a level III or IV prevailing wage, but those wages would be so artificially high that employers would not be able to pay them. The commenter concluded that DHS should push the proposed rule back at least one year to allow time for next year's H-1B data to become available. Another commenter said 96 percent of total applicants still would fall into the new OES wage “level 1 below” and would be eligible for random selection, so the proposed rule would not have an impact.

A commenter echoed concerns about the use of previous OES wage levels, writing that DHS's analysis in the proposed rule was invalid. Response. The NPRM analysis was written using the appropriate baseline and the best information that was available to DHS at that time, which was prior to the publication of the DOL IFR.[] On December 1, 2020, the U.S. District Court for the Northern District of California issued an order in Chamber of Commerce, et al.

V. DHS, et al., No. 20-cv-7331, setting aside the DOL IFR. Similarly, on December 3, 2020, the U.S.

District Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No. 20-cv-14604, applying to the plaintiffs in that case.

DOL has taken necessary steps to comply with the courts' orders and no longer is implementing the DOL IFR. DHS, therefore, disagrees with the commenter's assertion that DHS must analyze the DOL IFR in the context of this final rule. This final rule does not require employers pay a higher wage, instead it prioritizes selection of registrations or petitions, as applicable, generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment. The selection of H-1B registrations or petitions, as applicable, will be based on the existing OES wage levels at the time of submission, and the economic analysis in the proposed rule properly accounted for OES prevailing wage levels that were in effect at the time the analysis was conducted and remain in effect at this time.

Comments. An anonymous commenter stated that Table 13 of the NPRM is inconsistent with the proposed rule's language. The commenter questioned why there would be level III and IV registrations selected in the advanced degree exemption if level III and IV registrations would be “100% selected” in the regular cap, and the proposed rule would not affect the order of selection between the regular cap and advanced degree exemption. Response.

This final rule will not affect the order of selection between the regular cap and advanced degree exemption or the number of registrations that will be selected for each allocation. USCIS first selects registrations toward the number projected as needed to reach the regular cap, from among all registrations properly submitted, including those indicating that the beneficiary will be eligible for the advance degree exemption. USCIS then selects registrations indicating eligibility for the advanced degree exemption using the same process. With the revised selection method based on corresponding OES wage level and ranking shown in Table 13, the approximated average indicates that all registrations with a proffered wage that corresponds to OES wage level IV or level III would be selected and 58,999, or 75 percent, of the registrations with a proffered wage that corresponds to OES wage level II would be selected toward the regular cap projections.

None of the registrations with a proffered wage that corresponds to OES wage level I or below would be selected toward the regular cap projections. For the advanced degree exemption, DHS estimates all registrations with a proffered wage that corresponds to OES wage levels IV and III would be selected and 12,744, or 20 percent, of the registrations with a proffered wage that corresponds to OES wage level II would be selected. DHS estimates that none of the registrations with a proffered wage that corresponds to OES wage level I or below would be selected. Comments.

A couple of commenters wrote that DHS took wage levels specified as “N/A” and consolidated them with level I wages in its Table 7 calculations even though there is no evidentiary basis for assuming that characterization or correlation to be accurate or appropriate. Wages negotiated under a collective bargaining agreement often exceed market rates, and private wage surveys frequently have more than 4 wage levels, which makes direct analogy to OES impractical, if not impossible. Since there was no way to determine the true ranking of the N/A petitions, they should have been excluded from the allocation rather than arbitrarily added to the level I share. Consolidating them had the prejudicial effect of attributing 31.5 percent of regular cap and 37 percent of advanced degree cap to level I, when, in fact, those numbers would have been 22.8 percent and 27.5 percent, respectively, had level I counts not included the petitions whose wage level was N/A.

An individual commenter similarly wrote that DHS's analysis incorrectly claims that a number of petitions are categorized as having a wage level of N/A due to modifications to DOL's SOC structure in 2018. The commenter stated that all FY 2019 and FY 2020 petitions were filed using the 2010 SOC structure and thus the 2018 SOC structure would not impact those petitions. The commenter said that the N/A designations are likely because Question 13 on Form 9035 only requires a designation of OES wage levels when relying on a prevailing wage and is left blank when petitions rely on a permissible alternative. This commenter also stated that, according to DHS's analysis in Table 6, the OES Wage Level was unavailable about 12 percent of the time for cap-subject H-1B petitions selected for adjudication in FYs 2019 and 2020.

DHS labels these petitions as ones where the OES Wage Level is “N/A” and then, curiously, includes all such “N/A” OES Wage Level petitions as level I petitions for purposes of its analysis when they are not particularly likely to be all or mostly level I jobs. Response. DHS understands and agrees with the commenter that N/A designations are likely when registrants rely on a permissible alternative private wage source that is not based on the OES survey. For these registrants choosing to rely on a prevailing wage that is not based on the OES survey, if the proffered wage is less than the corresponding level I OES wage, the registrant would select the “Wage Level I and below” box on the registration form.

DHS deliberately chose to group these registrations together with level I registrations so that petitioners relying on non-OES sources would have a fairer chance of selection than if they were ranked below level I registrations, and to avoid penalizing prospective petitioners who properly rely on a private wage survey to determine the required wage for the proffered position. As explained in response to other comments, DHS does not agree with the suggestions to separate OES prevailing wage level I from those falling below level I. DHS expects that all petitioners offering a wage lower than the OES wage level I wage will be using a legitimate source other than OES or an Start Printed Page 1712independent authoritative source, including a private wage survey. Therefore, such a change effectively could preclude petitioners that utilize one of those other sources from being selected for registration.

By grouping OES wage level I and below OES wage level I together, those petitioners have a fairer chance of selection. DHS was unable to estimate how many registrations, initially classified as N/A, would end up in each wage level classification as a result of this rule. Due to data limitations and missing data, DHS may have included some N/A wage information into OES wage level I and below that could be classified as a wage higher than level I in the future. If DHS did not incorporate the petitions that fell into the N/A category, then the overall total of petitions would have been understated.

DHS analysis used estimates in the Unquantified Costs &. Benefits section to show a possible outcome and distribution of registrations once this rule is implemented. Comments. A trade association wrote that DHS conducted insufficient data collection to assess the impact of the proposed rule, given that it has OES skill wage level data for only 56 percent of registered H-1B petitions selected in the lottery.

The commenter wrote that DHS should review data on all H-1B adjudications to better assess the relative distribution of H-1B petitions by OES level, or conduct a survey of H-1B employers to better quantify the impact of the proposed rule by OES level. Response. USCIS analyzed the impacts of this rule in an objective manner using the best available data at the time the analysis was written. DHS has OES wage level data only on the 56 percent of petitions that were selected toward the numerical allocations from FY 2019 and FY 2020.

DHS does not have the wage level break down for the 44 percent of petitions that were not selected since those petitions were returned to petitioners without entering data into DHS databases. The wage level break downs for the 56 percent that were selected for adjudication had a similar distribution for both FY 2019 and FY 2020. DHS used this distribution as an estimate of what the future registrations split out by wage levels may look like for the missing 44 percent of petitions. Comments.

An individual commenter said the proposed rule does not analyze the indirect impact the rule will have on the wages of employees, only those directly impacted by the rule. The commenter also wrote that the proposed rule does not consider its impact on employers whose higher marginal costs cause them to forego expansion or close down. An individual commenter said that DHS does not provide evidence to support its statement that the proposed rule will have no effect on wages or growth, writing that it is unlikely that the rule will not depress wages and growth. Response.

DHS acknowledges that some petitioners might be impacted in terms of employment, productivity loss, search and hire costs, and profits resulting from labor turnover. The current random lottery system does not guarantee registrants that they will be able to petition for H-1B workers, and it could have the same effects and cause companies to search for alternative options. In cases where companies cannot find reasonable substitutes for the labor the H-1B beneficiaries would have provided, if selected under the random lottery process, affected petitioners also could lose profits from the lost productivity. In such cases, employers would incur opportunity costs by having to choose the next best alternative to immediately fill the job the prospective H-1B worker would have filled.

The commenter provided neither an explanation nor a basis to support the claim that wages would be depressed. DHS acknowledges that some employers' growth (profit) could be affected. However, asserting that economic growth would be harmed fails to account for the fact that this rule will not reduce or otherwise affect the statutorily authorized number of initial H-1B visas granted per year. USCIS analyzed the impacts of this rule in an objective manner using the best available data at the time the analysis was written and does not have quantifiable data on the effect on wages or growth.

Comment. A law firm stated that the DHS does not sufficiently quantify the impact of costs to petitioners, including training, labor for substitute workers, loss of productivity, and loss of revenue. The commenter wrote that, to meet the requirements of E.O. 12866, DHS should explain its justification for proposing changes recognized to have a negative impact on productivity and revenue of petitioners.

The commenter also asked DHS to explain how the proposed rule was tailored to ensure it imposed the least possible burden on society as required under E.O. 12866. Response. Executive Orders 12866 and 13563 direct agencies to assess the costs, benefits, and transfers of available alternatives, and if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

DHS analyzed all potential costs, benefits, and transfers of this rule. While DHS understands there are costs to some populations, there also are benefits to other populations. Comment. An advocacy group wrote that DHS states that an increase in H-1B recipients with higher salaries will compensate for any loss in international students and early career professionals under the proposed rule.

However, the commenter states that DHS does not provide any analysis to this effect and should provide a more precise estimate of the costs associated with changes, particularly whether the rule would have an impact on the ability of employers to attract talented employees. Response. DHS does not believe that this rule will negatively impact the ability of employers to attract talented employees. Rather, DHS believes that this rule will allow employers to attract the best and the brightest employees.

Comment. A law firm said the costs of the proposal are inconsistent with the aggregate cost savings the agency expected unselected petitions and the government to realize from registration. OMB designated the proposed rule as an “economically significant” regulatory action. In the NPRM, DHS estimated that, for a ten-year implementation period, the costs to the public would be more than $15.9 million annualized at 3-percent, and more than $16 million annualized at 7-percent.

DHS also acknowledged the possibility that the proposed regulation “could result in private sector expenditures exceeding $100 million, adjusted for inflation to $168 million in 2019 dollars, in any 1 year.” The costs likely are higher, as the agency has grossly underestimated the time-burden of this proposed regulation, such as suggesting that it will take a mere 20 minutes more to prepare the registration. Response. DHS acknowledges that this final rule has been designated an economically significant regulatory action by the Office of Information and Regulatory Affairs (OIRA), of the Office of Management and Budget. However, OIRA has waived review of this regulation under E.O.

12866, section 6(a)(3)(A). DHS disagrees that it will take more than 20 minutes to complete the additional information collection associated with the registration tool. Registrants or petitioners, as applicable, only will be required to provide, in addition to the information already to be collected, the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code in the area of intended Start Printed Page 1713employment. In the limited instance where there is no current OES prevailing wage information for the proffered position, the registrant will follow DOL guidance on prevailing wage determinations to determine which OES wage level to select on the registration, and USCIS will rank and select based on the highest OES wage level.

B. Costs Comments. An individual commenter stated that, under the proposed rule, USCIS would incur additional costs related to maintaining records detailing how USCIS processed each H-1B petition to document the correct handling and prioritization of all petitions. The commenter also wrote that USCIS's cost for processing petitions will increase significantly, as it will have to review each petition for salary, location, and job code to determine sorting order.

Another commenter wrote that the proposed rule indicates that DHS would not incur additional costs to the government because the agency could increase filing fees to cover costs, but that, itself, indicates the proposed rule would result in costs to DHS that should have been fully analyzed. Response. The INA provides for the collection of fees through USCIS's biannual fee schedule review, at a level that will ensure recovery of the full costs of providing adjudication and naturalization services by DHS. This includes administrative costs and services provided without charge to certain applicants and petitioners.[] DHS notes the time necessary for USCIS to review the information submitted with the forms relevant to this final rule includes the time to adjudicate the benefit request.

These costs are captured in the fees collected for the benefit request from petitioners. DHS accounts for familiarization cost and additional costs due to the increased burden per response for the petitioners, which is shown as costs in the Regulatory Impact Analysis. Other form applications and petition fees will cover the increased adjudication costs until the fee rule is reassessed Comment. One commenter wrote that the proposed rule likely would require technical changes to USCIS's registration system that the agency has already implemented for the FY 2021 H-1B cap season.

The commenter added that it is noteworthy that the proposed rule follows a recent announcement that USCIS must furlough 70 percent of its workforce. Another commenter said that, if this rule is put in place, companies will stop hiring foreign workers and USCIS will lose the revenue from this program as it is already in a fiscal crisis. Response. The President of the United States signed into law the Continuing Appropriations Act, 2021 and Other Extensions Act, H.R.

8337,[] which became Public Law 116-159, on October 1, 2020. This public law includes language from the Emergency Stopgap USCIS Stabilization Act, which allows USCIS to establish and collect additional premium processing fees, and to use those additional funds for expanded purposes. Because of the authorization to increase premium processing fees, and cost-savings measures taken by the agency, USCIS is in a better place financially. As a result, USCIS was able to avoid all potential furloughs, and, barring unforeseen changes in circumstances, any potential furloughs in FY 2021.[] c.

Benefits Comment. An individual commenter wrote that the proposed rule has been criticized for favoring larger firms over smaller businesses and startups, but it is unlikely that these types of businesses would immediately need the types of high salaried workers who would qualify for an H-1B visa. Instead, the commenter said there should be sufficient domestic talent under this rule to meet those labor needs. An individual commenter wrote that the proposed rule would have the benefit of curbing the practice of employers underpaying H-1B petitioners by offering level I wages to those with sufficient experience for higher wages.

As a result, employers will not be able to favor cheaper international labor and would consider domestic labor. Response. DHS agrees with this commenter that there should be sufficient replacement labor available in the U.S. Workforce that can meet domestic labor needs.

This rule will help the U.S. Workforce, as employers that might have petitioned for cap-subject H-1B workers to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S. Workers for those positions. Comment.

Referencing DHS's suggestion that one of the proposed rule's unquantified benefits is increased opportunities for lower-skilled U.S. Workers in the labor market, an individual commenter stated that low-skilled workers cannot replace H-1B specialty occupation workers. Response. DHS disagrees.

If an employer is hiring an entry-level employee at a level I prevailing wage, then an available and qualified U.S. Worker can be a substitute. 2. Paperwork Reduction Act Comments.

A commenter stated that requiring an employer to provide a wage level at the time of electronic registration for the H-1B cap seems to violate the Paperwork Reduction Act (PRA), which generally only permits the collection of information needed to meet a legally supported objective. The commenter indicated DHS has not adequately explained how collecting the OES prevailing wage level at the time of electronic registration is consistent with the PRA, as employers are not required to obtain an LCA at the time of the electronic registration for the H-1B cap. Response. DHS disagrees that requiring the registrant to provide the wage level that the proffered wage corresponds to for the relevant SOC and area of employment, or that corresponds to the position requirements when OES wage data is unavailable, at the time of electronic registration for the H-1B cap would violate the PRA.

Once this rule becomes effective, collection of such information would be needed to implement the rule and to select registrations in accordance with this rule, and thus would be a legally supported objective. As noted in the NPRM, an LCA is not a requirement for registration. However, consistent with the registrant's attestation that the registration is submitted for a valid offer of employment, DHS expects each registrant (i.e., the prospective petitioner or the attorney or accredited representative submitting the registration for the prospective petitioner) to know and be able to provide the relevant corresponding wage level when submitting a registration, regardless of whether they have a certified LCA at that time. F.

Out of Scope An individual commenter called for relief for those who need housing and food, “instead of bringing in foreigners.” Another individual commenter said that the increase in H-1B visas and outsourcing to foreign contractors caused their spouse's wages to stagnate despite increased responsibility, and Start Printed Page 1714fewer U.S. Born entry-level employees were hired. Yet another individual commenter wrote that the agency should make it easier to report visa fraud, and that stricter, more comprehensive punishments should be in place for visa fraud. A few anonymous commenters said that the H-1B visa is a “scam.” A trade association wrote in opposition to two other rules related to the H-1B visa published by DOL and DHS, the latter of which revised the definition of “specialty occupations” eligible for H-1B visas, limited visas to one year for third party worksites, and expanded DHS worksite oversight.[] Another trade association also wrote in opposition to the DOL and DHS IFRs, objecting specifically to the DHS IFR's revisions to the definitions of “specialty occupations” and “U.S.

Employer,” the requirements for corroborating evidence for specialty occupations, and the amended validity period for third-party placement at worksites.[] The commenter provided background information and a summary of the DHS IFR. One commenter said the lottery system is unfair, and USCIS should instead focus on limiting fraud and abuse of the lottery system. Yet another trade association opposed the proposed rule and suggested that the Agency implement reforms as discussed in the National Association of Manufacturer's “A Way Forward” plan, including statutory changes to the H-1B program, border security measures, asylum, and other immigration programs. A union argued that due to the “timing and rushed nature” of the DOL IFR and this proposed rule, any changes are vulnerable to procedural challenge and are likely politically motivated.

The commenter went on to provide extensive feedback on the DOL and DHS IFRs and the H-1B program at large, calling for immigration reform and urging the Departments of Labor and Homeland Security to make structural changes to the H-1B program that protect workers' rights. A research organization wrote about the H-1B program in general, saying that allowing outsourcing companies to hire H-1B workers lets employers use the immigration system to “degrade labor standards for skilled workers” and exploit H-1B employees. Additionally, the commenter argued that outsourcing companies are using the H-1B program to underpay H-1B workers, replace U.S. Workers, and send tech jobs abroad.

A submission on behalf of U.S. Citizen medical graduates urged expanding the H-1B and J-1 visa ban to include the healthcare sector, prioritizing U.S. Citizens for placement in residency programs, or that the Accreditation Council for Graduate Medical Education (ACGME) consider opening up more residency spots and new residency programs. A professional association recommended that USCIS modify its regulation at 8 CFR 214.2(h)(8)(iii)(A)(4) (“Limitation on requested start date”) permitting a requested start date on or after the first day for the applicable fiscal year.

Response. DHS appreciates these comments. However, DHS did not propose to address these issues in the proposed rule, so these comments fall outside of the scope of this rulemaking. DHS is finalizing this rule as proposed.

V. Statutory and Regulatory Requirements A. Executive Orders 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), and Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) Executive Orders (E.O.) 12866 and 13563 direct agencies to assess the costs, benefits, and transfers of available alternatives, and if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

Pursuant to Executive Order 12866 (Regulatory Planning and Review), the Office of Information and Regulatory Affairs (OIRA), of the Office of Management and Budget, has determined that this final rule is an economically significant regulatory action. However, OIRA has waived review of this regulation under section 6(a)(3)(A) of Executive Order 12866. 1. Summary of Economic Effects DHS is amending its regulations governing the selection of registrants eligible to file H-1B cap-subject petitions, which includes petitions subject to the regular cap and those asserting eligibility for the advanced degree exemption, to allow for ranking and selection based on OES wage levels corresponding to their SOC codes.

USCIS will rank and select the registrations properly submitted (or petitions in any year in which the registration process is suspended) generally on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment. USCIS will begin with OES wage level IV and proceed in descending order with OES wage levels III, II, and I. DHS is amending the relevant sections of DHS regulations to reflect these changes. The described change in selection is expected to result in a different allocation of H-1B visas (or grants of initial H-1B status) favoring petitioners that proffer relatively higher wages.

In the analysis that follows, DHS presents its best estimate for how H-1B petitioners will be affected by and will respond to the increased probability of selection of registrations of petitions proffering the highest wages for a given occupation and area of employment. DHS estimates the net costs that will result from this final rule compared to the baseline of the H-1B visa program. For the 10-year implementation period of the rule, DHS estimates the annualized costs to the public would be $15,968,792 annualized at 3-percent, $16,089,770 annualized at 7-percent. Table 1 provides a more detailed summary of the final rule provisions and their impacts.Start Printed Page 1715 Table 1—Summary of Provisions and Economic Impacts of the Final RuleProvisionDescription of changes to provisionEstimated costs of provisionsEstimated benefits of provisionsCurrently, USCIS randomly selects H-1B registrations or cap-subject petitions, as applicable.

USCIS will change the selection process to prioritize selection of registrations or cap-subject petitions, as applicable, based on corresponding OES wage level DHS regulations currently address H-1B cap allocation in various contexts. 1. Fewer registrations than needed to meet the H-1B regular cap. 2.

Sufficient registrations to meet the H-1B regular cap during the initial registration period. 3. Fewer registrations than needed to meet the H-1B advanced degree exemption numerical limitation. 4.

Sufficient registrations to meet the H-1B advanced degree exemption numerical limitation during the initial registration period. 5. Increase to the number of registrations projected to meet the H-1B regular cap or advanced degree exemption allocations in a FY. 6.

H-1B cap-subject petition filing following registration—(1) Filing procedures. 7. Petition-based cap-subject selections in event of suspended registration process. 8.

Denial of petition. 9. Revocation of approval of petition.USCIS will rank and select H-1B registrations (or H-1B petitions if the registration requirement is suspended) generally based on the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment. This final rule will add instructions and a question to the registration form to select the appropriate wage level.

This final rule also will add instructions and questions to the H-1B petition seeking the same wage level information and other information concerning the proffered position to assess the prevailing wage level. This final rule will not affect the order of selection as between the regular cap and the advanced degree exemption. If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations needed to reach the numerical limitation. USCIS is authorized to deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary for a lower wage level if USCIS determines that the new or amended petition was filed to reduce the wage level listed on the original petition to unfairly increase the odds of selection during the registration selection process.

In any year in which USCIS suspends the H-1B electronic registration process for cap-subject petitions, USCIS will, instead, allow for the submission of H-1B cap-subject petitions. After USCIS receives a sufficient number of petitions to meet the H-1B regular cap and were to complete the selection process of petitions for the H-1B regular cap following the same method of ranking and selection based on corresponding OES wage level, USCIS will determine whether there is a sufficient number of remaining petitions to meet the H-1B advanced degree exemption numerical limitation.Quantitative. Petitioners— • $3,457,401 costs annually for petitioners completing and filing Form I-129 petitions with an additional time burden of 15 minutes. €¢ $11,795,997 costs annually for prospective petitioners submitting electronic registrations with an additional time burden of 20 minutes.

DHS/USCIS— • None. Qualitative. Petitioners— • Petitioners may incur costs to seek out and train other workers, or to induce workers with similar qualifications to consider changing industry or occupation. €¢ Petitioners that would have hired relatively low-paid H-1B workers, but were unable to do so because of non-selection (and ineligibility to file petitions), may incur reduced labor productivity and revenue.

€¢ Petitioners may incur costs from offering beneficiaries higher wages for the same work to achieve greater chances of selection. DHS/USCIS— • None.Quantitative. Petitioners— • None. DHS/USCIS— • None.

Qualitative. U.S. Workers— • A possible increase in employment opportunities for similarly skilled unemployed or underemployed U.S. Workers seeking employment in positions otherwise offered to H-1B cap-subject beneficiaries at wage levels corresponding to lower wage positions.

H-1B Workers— • A possible increase in productivity, measured in increased H-1B wages, resulting from the reallocation of a fixed number of visas from positions classified as lower-level work to employers able to pay the highest wages for the most highly skilled workers. €¢ A possible increase in wages for positions offered to H-1B cap-subject beneficiaries for the same work to improve the prospective petitioner's chance of selection. Petitioners— • Level I and level II beneficiaries may see increased wages. Companies who have historically paid level I wages may be incentivized to offer their H-1B employees higher wages, so that they could have a greater chance of selection at a level II or higher.

€¢ Employers who offer H-1B workers wages that corresponds with level III or level IV OES wages may have higher chances of selection. DHS/USCIS— • Submitting additional wage level information on both an electronic registration and on Form I-129 will allow USCIS to maintain the integrity of the H-1B cap selection and adjudication processes. €¢ Registrations or petitions, as applicable, will be more likely to be selected under the numerical allocations for the highest paid, and presumably highest skilled or highest-valued, beneficiaries.Familiarization CostFamiliarization costs comprise the opportunity cost of the time spent reading and understanding the details of a rule to fully comply with the new regulation(s).Quantitative. Petitioners— • One-time cost of $6,285,527 in FY 2022.

DHS/USCIS— • None. Qualitative. Petitioners— • None. DHS/USCIS— None.Quantitative.

Petitioners— • None. DHS/USCIS— • None. Qualitative. Petitioners— • None.

DHS/USCIS— • None. In addition to the impacts summarized here, Table 2 presents the accounting statement as required by OMB Circular A-4.[] Table 2—OMB A-4 Accounting Statement[$, 2019 for FY 2022-FY 2032]CategoryPrimary estimateMinimum estimateMaximum estimateSource citationBenefits:Annualized Monetized Benefits over 10 years (discount rate in parenthesis)N/A N/AN/A N/AN/A N/AStart Printed Page 1716Annualized quantified, but un-monetized, benefits000Unquantified BenefitsThis final rule will benefit petitioners agreeing to pay H-1B workers a proffered wage corresponding to OES wage level III or IV, by increasing their chance of selection in the H-1B cap selection process. These changes align with the Administration's goals of improving policies such that the H-1B classification more likely will be awarded to the highest paid or highest skilled beneficiaries. These changes will also better align the administration of the H-1B program with the dominant Congressional intent.RIA. This final rule may provide increased opportunities for similarly skilled U.S.

Workers in the labor market to compete for work as there will be fewer H-1B workers paid at the lower wage levels to compete with U.S. Workers.150 Further, assuming demand outpaces the 85,000 visas currently available for annual allocation, DHS believes that the potential reallocation of visas to favor those petitioners able to offer the highest wages to recruit the most highly skilled workers will result in increased marginal productivity of all H-1B workers. This final rule may provide increased wages for positions offered to H-1B cap-subject beneficiaries.Costs:Annualized monetized costs over 10 years (discount rate in parenthesis)(3 percent) $15,968,792 (7 percent) $16,089,770N/A N/AN/A N/ARIA.Annualized quantified, but un-monetized, costsN/AQualitative (unquantified) costsThis final rule is expected to reduce the number of petitions for lower wage H-1B workers. This may result in increased recruitment or training costs for petitioners that seek new pools of talent. Additionally, petitioners' labor costs or training costs for substitute workers may increase.

DHS also acknowledges that some petitioners might be impacted in terms of the employment, productivity loss, search and hire cost per employer of $4,398, and profits resulting from labor turnover. In cases where companies cannot find reasonable substitutions for the labor the H-1B beneficiary would have provided, affected petitioners will also lose profits from the lost productivity. In such cases, employers will incur opportunity costs by having to choose the next best alternative to immediately filling the job the prospective H-1B worker would have filled. There may be additional opportunity costs to employers such as search costs and training.RIA. Such possible disruptions to companies will depend on the interaction of a number of complex variables that are constantly in flux, including national, state, and local labor market conditions, economic and business factors, the type of occupations and skills involved, and the substitutability between H-1B workers and U.S.

Workers. Petitioners that would have hired relatively lower-paid H-1B workers, but were unable to do so because of non-selection (and ineligibility to file a petition), may incur reduced labor productivity and revenue.Transfers:Annualized monetized transfers. €œon budget”N/AN/AN/AFrom whom to whom?. €ƒAnnualized monetized transfers. €œoff-budget”N/AN/AN/AFrom whom to whom?.

N/AN/AN/AMiscellaneous analyses/categoryEffectsSource citationEffects on state, local, and/or tribal governmentsN/ARFA.Effects on small businessesN/ARFA.Effects on wagesN/ANone.Effects on growthN/ANone. 2. Background and Purpose of the Final Rule The H-1B visa program allows U.S. Employers to temporarily hire foreign workers to perform services in a specialty occupation, services related to a Department of Defense (DOD) cooperative research and development project or coproduction project, or services of distinguished merit and ability in the field of fashion modeling.[] A specialty occupation is defined as an occupation that requires the (1) theoretical and practical application of a body of highly specialized knowledge and (2) attainment of a bachelor's or higher degree in the specific specialty (or its equivalent) as a minimum qualification for entry into the occupation in the United States.[] The number of aliens who may be issued initial H-1B visas or otherwise provided initial H-1B nonimmigrant status during any FY has been capped at various levels by Congress over time, with the current numerical limit generally being 65,000 per FY.[] Congress has also provided for various exemptions from the annual numerical allocations, including an exemption for Start Printed Page 171720,000 aliens who have earned a master's or higher degree from a U.S.

Institution of higher education.[] Under the current regulation, all petitioners seeking to file an H-1B cap-subject petition must first electronically submit a registration for each beneficiary on whose behalf they seek to file an H-1B cap-subject petition, unless USCIS suspends the registration requirement.[] USCIS monitors the number of H-1B registrations submitted during the announced registration period of at least 14 days and, at the conclusion of that period, if more registrations are submitted than projected as needed to reach the numerical allocations, randomly selects from among properly submitted registrations the number of registrations projected as needed to reach the H-1B numerical allocations.[] Under this random H-1B registration selection process, USCIS first selects registrations submitted on behalf of all beneficiaries, including those eligible for the advanced degree exemption. USCIS then selects from the remaining registrations a sufficient number projected as needed to reach the advanced degree exemption. A prospective petitioner whose registration is selected is notified of the selection and instructed that the petitioner is eligible to file an H-1B cap-subject petition for the beneficiary named in the selected registration within a filing period that is at least 90 days in duration and begins no earlier than 6 months ahead of the actual date of need (commonly referred to as the employment start date).[] When registration is required, a petitioner seeking to file an H-1B cap-subject petition is not eligible to file the petition unless the petition is based on a valid, selected registration for the beneficiary named in the petition.[] Prior to filing an H-1B petition, the employer is required to obtain a certified Labor Condition Application (LCA) from the Department of Labor (DOL).[] The LCA form collects information about the employer and the occupation for the H-1B worker(s). The LCA requires certain attestations from the employer, including, among others, that the employer will pay the H-1B worker(s) at least the required wage.[] This final rule amends DHS regulations concerning the selection of electronic registrations submitted by or on behalf of prospective petitioners seeking to file H-1B cap-subject petitions (or the selection of petitions, if the registration process is suspended), which includes petitions subject to the regular cap and those asserting eligibility for the advanced degree exemption, to allow for ranking and selection based on OES wage levels.

When applicable, USCIS will rank and select the registrations received generally on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area(s) of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I and below.[] For registrants relying on a private wage survey, if the proffered wage is less than the corresponding level I OES wage, the registrant will select the “Wage Level I and below” box on the registration form.[] If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the applicable numerical allocation, USCIS will randomly select from all registrations within that wage level a sufficient number of registrations needed to reach the applicable numerical limitation.[] 3. Historic Population The historic population consists of petitioners who file on behalf of H-1B cap-subject beneficiaries (in other words, beneficiaries who are subject to the annual numerical limitation, including those eligible for the advanced degree exemption). DHS uses the 5-year average of H-1B cap-subject petitions received for FYs 2016 to 2020 (211,797) as the historic estimate of H-1B cap-subject petitions that were submitted annually.[] Prior to publication of U.S. Citizenship and Immigration Services Fee Schedule and Changes to Certain Other Immigration Benefit Request Requirements (Fee Schedule Final Rule),[] H-1B petitioners submit Form I-129 with applicable supplements for H-1B petitions.

Through the Fee Schedule Final Rule, DHS created a new Form I-129 for H-1B petitioners.[] Form I-129 does not include separate supplements as relevant data collection fields have been incorporated into Form I-129. DHS assumes that the number of petitioners who previously filled out the Form I-129 and H-1B supplements is the same as the number of petitioners who will complete the new Form I-129H1. Table 3—H-1B Cap-Subject Petitions Submitted to USCIS for FY 2016—FY 2020Fiscal yearTotal number of H-1B cap-subject petitions submittedTotal number of H-1B petitions selectedNumber of petitions filed with Form G-282016232,97397,71172,2922017236,44495,81868,7432018198,46095,92378,900Start Printed Page 17182019190,098110,37693,4952020201,011109,28392,396Total1,058,986509,111405,8265-year average211,797101,82281,165Source. Total Number of H-1B Cap-Subject Petitions Submitted FYs 2016-2020, USCIS Service Center Operations (SCOPS), June 2019.

Total Number of Selected Petitions data, USCIS Office of Performance and Qualify (OPQ), Performance Analysis and External Reporting (PAER), July 2020. Table 3 also shows historical Form G-28 filings by attorneys or accredited representatives accompanying selected H-1B cap-subject petitions. DHS notes that these forms are not mutually exclusive. Based on the 5-year average, DHS estimates 79.7 percent [] of selected petitions will be filed with a Form G-28.

Table 3 does not include data for FY 2021 as the registration requirement was first implemented for the FY 2021 H-1B cap selection process, and petition submission was ongoing at the time of this analysis. The H-1B selection process changed significantly after the publication of the H-1B Registration Final Rule.[] That rule established a mandatory electronic registration requirement that requires petitioners seeking to file cap-subject H-1B petitions, including those eligible for the advanced degree exemption, to first electronically register with USCIS during a designated registration period. That rule also reversed the order by which USCIS counts H-1B registrations (or petitions, for any year in which the registration requirement is suspended) toward the number projected to meet the H-1B numerical allocations, such that USCIS first selects registrations submitted on behalf of all beneficiaries, including those eligible for the advanced degree exemption. USCIS then selects from the remaining registrations a sufficient number projected as needed to reach the advanced degree exemption.

The registration requirement was first implemented for the FY 2021 H-1B cap. During the initial registration period for the FY 2021 H-1B cap selection process, DHS received 274,237 registrations. 4. Cost-Benefit Analysis Through these changes, petitioners will incur costs associated with additional time burden in completing the registration process and, if selected for filing, the petition process.

In this analysis, DHS estimates the opportunity cost of time for these occupations using average hourly wage rates of $32.58 for HR specialists and $69.86 for lawyers.[] However, average hourly wage rates do not account for worker benefits such as paid leave, insurance, and retirement. DHS accounts for worker benefits when estimating the opportunity cost of time by calculating a benefits-to-wage multiplier using the most recent DOL, BLS report detailing average compensation for all civilian workers in major occupational groups and industries. DHS estimates the benefits-to-wage multiplier is 1.46.[] For purposes of this final rule, DHS calculates the average total rate of compensation as $47.57 per hour for an HR specialist, where the average hourly wage is $32.58 per hour worked and average benefits are $14.99 per hour.[] Additionally, DHS calculates the average total rate of compensation as $102.00 per hour for an in-house lawyer, where the average hourly wage is $69.86 per hour worked and average benefits are $32.14 per hour.[] Moreover, DHS recognizes that a firm may choose, but is not required, to outsource the preparation and submission of registrations and filing of H-1B petitions to outsourced lawyers.[] Therefore, DHS calculates the average total rate of compensation as $174.65, which is the average hourly U.S. Wage rate for lawyers multiplied by 2.5 to approximate an hourly billing rate for an outsourced lawyer.[] Table 4 summarizes the compensation rates used in this analysis.

Table 4—Summary of Estimated Wages for Form I-129 Filers by Type of Filer Hourly compensation rateHuman Resources (HR) Specialist$47.57In-house lawyer102.00Outsourced lawyer174.65Source. USCIS analysis. A. Costs and Cost Savings of Regulatory Changes to Petitioners i.

Methodology Based on Historic FYs 2019-2020 This final rule primarily will change the manner in which USCIS selects H-1B registrations (or H-1B petitions for any year in which the registration requirement is suspended), by first Start Printed Page 1719selecting registrations generally based on the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment. In April 2019, DHS added an electronic registration requirement for petitioners seeking to file H-1B petitions on behalf of cap-subject aliens.[] Under the current regulation, all petitioners seeking to file an H-1B cap-subject petition must first electronically submit a registration for each beneficiary on whose behalf they seek to file an H-1B cap-subject petition, unless the registration requirement is suspended. If the registration is selected, the petitioner is eligible to file an H-1B cap-subject petition for the beneficiary named in the selected registration during the associated filing period. The registration requirement was suspended for the FY 2020 H-1B cap and first implemented for the FY 2021 H-1B cap.

The initial H-1B registration period for the FY 2021 H-1B cap was March 1, 2020, through March 20, 2020. A total of 274,237 registrations were submitted during the initial registration period, of which 123,244 [] registrations were for beneficiaries eligible for the advanced degree exemption and 145,950 were for beneficiaries under the regular cap.[] Prior to implementing the registration requirement, USCIS administered the H-1B cap by projecting the number of petitions needed to reach the numerical allocations. H-1B cap-subject petitions were randomly selected when the number of petitions received on the final receipt date exceeded the number projected as needed to reach the numerical allocations. All petitions eligible for the advanced degree exemption had an equal chance of being selected toward the advanced degree exemption, and all remaining petitions had an equal chance of being selected toward the regular cap.

In FY 2019, USCIS first selected petitions toward the number of petitions projected as needed to reach the advanced degree exemption. If the petition was not selected under the advanced degree exemption, those cases then were added back to the pool and had a second chance of selection under the regular cap. In FY 2020, the selection order was reversed, such that USCIS first selected petitions toward the number projected as needed to reach the regular cap from among all petitions received. USCIS then selected toward the number of petitions projected as needed to reach the advanced degree exemption from among those petitions eligible for the advanced degree exemption, but that were not selected toward the number projected as needed to reach the regular cap.

Table 5 shows the number of petitions submitted and selected in FYs 2019 and 2020. It also displays the approximated 2-year averages of the petitions that were submitted and selected for the H-1B regular cap or advanced degree exemption. On average, DHS selected 56 percent [] of the H-1B cap-subject petitions submitted, with 82,900 toward the regular cap and 26,930 toward the advanced degree exemption. Table 5—H-1B Cap-Subject Petitions Submitted to USCIS, for FY 2019-FY 2020Fiscal yearTotal number of H-1B cap-subject petitions submittedTotal petitions selectedRegular capAdvanced degree exemption2019190,098110,37682,95627,4202020201,011109,28382,84326,440Total391,109219,659165,79953,8602-Year Average195,555109,83082,90026,930Source.

USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. July 21, 2020 &. USCIS Analysis DHS does not have data on the OES wage levels for selected petitions prior to FY 2019.[] While there are some challenges to using OES wage data as a timeseries, DHS uses the wage data to provide some insight.[] Table 6 shows the petitions that were selected for FYs 2019 and 2020, categorized by OES wage level. The main difference between the FY 2019 and FY 2020 data sets is that there are more petitions classified as not applicable (N/A) in the FY 2019 data compared to the FY 2020 data.

Since DOL's Standard Occupational Classification (SOC) [] structure was modified in 2018, some petitions were categorized as N/A in FY 2019. In 2019, DOL started to use a hybrid OES [] occupational structure for classifying the petitions for FY 2020. Another data limitation was that some of the FY 2020 data was incomplete with missing fields, and could not be classified into the specific wage levels. Therefore, the petitions were categorized as N/A.

DHS expects each registrant that is classified as N/A will be able to identify the appropriate SOC code for the proffered position because all petitioners are required to identify the appropriate SOC code for the proffered position on the LCA, even when there is no applicable wage level on the LCA. Using the SOC code and the above-mentioned DOL guidance, all registrants will be able to determine the appropriate OES wage level for purposes of completing the registration, regardless of whether they specify an Start Printed Page 1720OES wage level or utilize the OES program as the prevailing wage source on an LCA. While there are limitations to the data used, DHS believes that the estimates are helpful to see the current wage levels and estimate the future populations in each wage level. Table 6—Selected Petitions by Wage Level FY 2019-FY 2020 Level ILevel IILevel IIILevel IVN/ATotalAdvanced Degree Exemption:FY 20197,36313,8952,0165533,59327,420FY 20207,45314,4672,3116941,51526,440Total14,81628,3624,3271,2475,10853,8602-Year Average7,40814,1812,1646232,55426,930Regular Cap:FY 201918,55742,6218,4473,5409,79182,956FY 202019,23246,4398,7963,6774,69982,843Total37,78989,06017,2437,21714,490165,7992-Year Average18,89544,5308,6223,6087,24582,900Source.

USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. July 21, 2020 &. USCIS Analysis. DHS has OES wage level data only on the petitions that were selected toward the numerical allocations and does not have the wage level break down for the 85,725 [] (44 percent) of petitions that were not selected since those petitions were returned to petitioners without entering data into DHS databases.

Due to data limitations, DHS estimated the wage level break down for the 44 percent of petitions that were not selected because wage levels vary significantly between occupations and localities. Table 7 shows the 2-year approximated average of H-1B cap-subject petitions that were selected, separated by OES wage level, and percentages of accepted petitions by each wage category. The wage category with the most petitions, as estimated, is OES wage level II. Table 7—Current Estimated Number of Selected Petitions by Wage Level and Cap Type FY 2019-FY 2020LevelRegular capAdvanced degree exemptionSelected% of totalSelected% of totalLevel I &.

N/A26,14031.509,96236.99Level II44,53053.7014,18152.66Level III8,62210.402,1648.04Level IV3,6084.406232.31Total82,90010026,930100Source. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. July 21, 2020 &. USCIS Analysis ii.

FY 2021 Data [] The population affected by this final rule consists of prospective petitioners seeking to file H-1B cap-subject petitions, including those eligible for the advanced degree exemption. DHS regulations require all petitioners seeking to file H-1B cap-subject petitions to first electronically submit a registration for each beneficiary on whose behalf they seek to file an H-1B cap-subject petition, unless USCIS suspends the registration requirement.[] A prospective petitioner whose registration is selected is eligible to file an H-1B cap-subject petition for the beneficiary named in the selected registration during the associated filing period.[] Under the current H-1B registration selection process, USCIS first randomly selects registrations submitted on behalf of all beneficiaries, including those eligible for the advanced degree exemption.[] USCIS then randomly selects from the remaining registrations a sufficient number projected as needed to reach the advanced degree exemption.[] Prior to the implementation of the H-1B registration requirement for the FY 2021 H-1B cap selection process, petitioners submitted an annual average of 211,797 cap-subject H-1B petitions over FYs 2016 through 2020. The number of registrations submitted for the FY 2021 H-1B cap selection process, however, was 274,237. Because the number of registrations submitted for the FY 2021 H-1B cap selection process was significantly higher than the number of petitions submitted in prior years, DHS will use the total number of registrations submitted for the FY 2021 H-1B cap selection process as the population to estimate certain costs for this final rule.[] There were many factors that led to an increased number of registrations for FY 2021.

One possible factor is that the cost and burden to submit the registration is less than the Start Printed Page 1721cost and burden to submit complete Form I-129 packages. For the FY 2021 H-1B cap selection process, 106,100 registrations initially were selected to submit a petition. Prospective petitioners with selected registrations only were eligible to file H-1B petitions based on the selected registrations during a 90-day filing window. USCIS did not receive enough H-1B petitions during the initial filing period to meet the number of petitions projected as needed to reach the H-1B numerical allocations, so the selection process was run again in August 2020.

An additional 18,315 registrations were selected in August 2020 for a total of 124,415 selected registrations for FY 2021. While the current number of registrations selected toward the FY 2021 numerical allocations is 124,415, DHS estimates certain costs for this final rule using the number of registrations initially selected (106,100) as the best estimate of the number of petitions needed to reach the numerical allocations. Table 8—H-1B Cap-Subject Registrations Submitted, for FY 2021Fiscal yearTotal number of H-1B registrations submittedRound 1 number of H-1B registrations selectedRound 2 number of H-1B registrations selectedTotal number of H-1B registrations selected *Number of registrations submitted with form G-28 **2021274,237106,10018,315124,415N/ATotal274,237106,10018,315124,415N/ASource. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3.

August 31, 2020 USCIS Analysis.* Note. USCIS administered the selection process twice because an insufficient number of petitions were filed following initial registration selection to reach the number of petitions projected as needed to reach the numerical allocations. USCIS has not finished processing H-1B cap-subject petitions for FY 2021.** Note. Complete data is still unavailable for FY 2021.

USCIS used FYs 2019-2020 from Table 3 to estimate the percentage of submitted G-28s below. Table 3 shows historical Form G-28 filings by attorneys or accredited representatives accompanying selected H-1B cap-subject petitions. DHS notes that these forms are not mutually exclusive. Based on the historical 5-year average from earlier in this analysis, DHS estimates 79.7 percent [] of selected registrations will include Form G-28.

DHS applies those percentages to the number of total registrations and estimates 218,567 [] Form G-28 were submitted with total registrations received. DHS uses the total registrations received for the FY 2021 H-1B cap selection process (274,237) as the estimate of registrations that will be received annually. Additionally, DHS assumes that petitioners may use human resources (HR) specialists (or entities that provide equivalent services) (hereafter HR specialist) or use lawyers or accredited representatives [] to complete and file H-1B petitions. A lawyer or accredited representative appearing before DHS must file Form G-28 to establish their eligibility and authorization to represent a client (applicant, petitioner, requestor, beneficiary or derivative, or respondent) in an immigration matter before DHS.

DHS estimates that approximately 80 percent [] of H-1B petitions typically will be completed and filed by a lawyer or other accredited representative (hereafter lawyer). DHS assumes the remaining 20 percent of H-1B petitions will be completed and filed by HR specialists. Petitioners who use lawyers to complete and file H-1B petitions may either use an in-house lawyer or hire an outsourced lawyer. Of the total number of H-1B petitions filed in FY 2021, DHS estimates that 26 percent were filed by in-house lawyers, while the remaining 54 percent were filed by outsourced lawyers.[] Table 9—Summary of Estimated Average Number of Petitions/Registrations Submitted Annually by Type of FilerAffected populationEstimated average population affectedNumber of petitions/registrations submitted by HR specialistsNumber of petitions/registrations submitted by in-house lawyersNumber of petitions/registrations submitted by outsourced lawyers AB = A × 20%C = A × 26%D = A × 54%Estimated number of H-1B registrations submitted annually274,23754,84771,302148,088Start Printed Page 1722Estimated number of H-1B registrations selected to file H-1B cap petitions annually106,10021,22027,58657,294Source.

USCIS analysis. Based on the total estimated number of affected populations shown in Table 9, DHS further estimates the number of entities that will be affected by each requirement of this final rule to estimate the costs arising from the regulatory changes in the cost-benefit analysis section. Additionally, DHS uses the same proportion of HR specialists, in-house lawyers, and outsourced lawyers (20, 26, and 54 percent, respectively) to estimate the population that will be affected by the various requirements of this final rule. Iii.

Unquantified Costs &. Benefits Given that the demand for H-1B cap-subject visas, including those filed for the advanced degree exemption, frequently has exceeded the annual H-1B numerical allocations, this final rule will increase the chance of selection for registrations (or petitions, if registration were suspended) seeking to employ beneficiaries at level IV or level III wages. DHS believes this incentive for petitioners to offer wages that maximize their probability of selection is necessary to address the risk that greater numbers of U.S. Employers could rely on the program to access relatively lower-cost labor, precluding other employers from benefitting from the H-1B program's intended purpose of providing high-skilled nonimmigrant labor to supplement domestic labor.

This final rule could result in higher proffered wages or a reduction in the downward pressure on wages in industries and occupations with concentrations of relatively lower-paid H-1B workers. Additionally, this final rule may lead to an increase in employment opportunities for unemployed or underemployed U.S. Workers seeking employment in positions otherwise offered to H-1B cap-subject beneficiaries at wage levels corresponding to lower wage positions. Employers that offer H-1B workers wages that correspond with level IV or level III OES wages will have higher chances of selection.

For the FY 2021 H-1B cap selection process, USCIS initially selected 106,100 (39 percent) [] of H-1B registrations submitted toward the numerical allocations. Of those 80,600 were selected toward the number projected as needed to reach the regular cap, and 25,500 were selected toward the number projected as needed to reach the advanced degree exemption. The total number of H-1B registrations submitted was 274,237. However, 5,043 were invalid.

Of the 269,194 valid registrations, 145,950 were submitted toward the regular cap and 123,244 were eligible for selection under the advanced degree exemption. Table 10—H-1B Cap-Subject Registrations Submitted for FY 2021Fiscal yearTotal number of valid H-1B registrations submittedRegular capAdvanced degree exemption2021269,194145,950123,244Total269,194145,950123,244Source. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. August 31, 2020 &.

USCIS &. Analysis.* Note. The total number of registrations in this table does not equal 274,237 because 5,043 of the registrations were invalid. DHS estimated the wage level distribution for FY 2021 based on the average distribution observed in FYs 2019 and 2020.

At the time of analysis, the wage level data was unavailable for FY 2021 because the petition filing process was ongoing. Table 11 displays the historic 2-year (FY 2019 and FY 2020) approximated average of H-1B cap-subject petitions that were selected, separated by OES wage level, and percentages of selected petitions by each wage category. Table 11—Historic Number of Selected Petitions by Wage Level and Cap TypeLevelRegular capAdvanced degree exemptionSelected% of totalSelected% of totalLevel I &. Below26,14031.509,96236.99Level II44,53053.7014,18152.66Level III8,62210.402,1648.04Start Printed Page 1723Level IV3,6084.406232.31Total82,90010026,930100Source.

USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. July 21, 2020 &. USCIS Analysis.* Note. Totals are based on 2-year averages of petitions randomly selected in FYs 2019-2020, Table 11 is replicated from Table 7.

DHS assumes that FY 2021 wage level distribution of registrations will equal the wage level distribution observed in FYs 2019 through 2020 data. DHS multiplied the percentage of selected petitions by level from Table 11 to estimate the breakdown of registrations by wage level. For example, DHS multiplied 145,950 by 4.4 percent to estimate that a total of 6,422 registrations would have been categorized as wage level IV under the regular cap. Table 12—Current Estimated Number of Registrations by Wage Level and Cap TypeLevelRegular capAdvanced degree exemptionEstimated registrations% of registrationsEstimated registrations% of registrationsLevel I &.

Below45,97431.5045,58836.99Level II78,37553.7064,90052.66Level III15,17910.409,9098.04Level IV6,4224.402,8472.31Total145,950100123,244100Source. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. August 31, 2020 &. USCIS Analysis* Note.

Totals are based on FY 2021 data This final rule will change the H-1B cap selection process, but will leave in place selecting first toward the regular cap and second toward the advanced degree exemption. USCIS now will rank and select the registrations received (or petitions, as applicable) generally on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I and below. As a result of the approximated 2-year average from above, DHS displays the projected selection percentages for registrations under the regular cap and advanced degree exemption in Table 13. With the revised selection method based on corresponding OES wage level and ranking, the approximated average indicates that all registrations with a proffered wage that corresponds to OES wage level IV or level III will be selected and 58,999, or 75 percent, of the registrations with a proffered wage that corresponds to OES wage level II will be selected toward the regular cap projections.

None of the registrations with a proffered wage that corresponds to OES wage level I or below will be selected toward the regular cap projections. For the advanced degree exemption, DHS estimates all registrations with a proffered wage that corresponds to OES wage levels IV and III will be selected and 12,744, or 20 percent, of the registrations with a proffered wage that corresponds to OES wage level II will be selected. DHS estimates that none of the registrations with a proffered wage that corresponds to OES wage level I or below will be selected. DHS is using the approximated 2-year average from above to illustrate the expected distribution of future selected registration percentages by corresponding wage level.

However, DHS is unable to quantify the actual outcome because DHS cannot predict the actual number of registrations that will be received at each wage level because employers may change the number of registrations they choose to submit and the wages they offer in response to the changes in this rule. Table 13—New Estimated Number of Selected Registrations by Wage Level and Cap TypeLevelRegular capAdvanced degree exemptionTotal registrationsSelected registrations% SelectedTotal registrationsSelected registrations% SelectedLevel I &. Below45,9740045,58800Level II78,37558,9997564,90012,74420Level III15,17915,1791009,9099,909100Level IV6,4226,4221002,8472,847100Total145,95080,600123,24425,500Source. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3.

August 31, 2020 &. USCIS Analysis.* Note. Totals are based on FY 2021 data. Start Printed Page 1724 This final rule may primarily affect prospective petitioners seeking to file H-1B cap-subject petitions with a proffered wage that corresponds to OES wage level II, I, and below.[] As Table 13 shows, this final rule is expected to result in a reduced likelihood that registrations for level II will be selected, as well as the likelihood that registrations for level I and below wages will not be selected.

A prospective petitioner, however, could choose to increase the proffered wage, so that it corresponds to a higher wage level. Another possible effect is that employers will not fill vacant positions that would have been filled by H-1B workers. These employers may be unable to find qualified U.S. Workers, or may leave those positions vacant because they cannot justify raising the wage to stand greater chances of selection in the H-1B cap selection process.

That, in turn, could result in fewer registrations and H-1B cap-subject petitions with a proffered wage that corresponds to OES wage level II and below. DHS acknowledges that this final rule might result in more registrations (or petitions, if registration is suspended) with a proffered wage that corresponds to level IV and level III OES wages for H-1B cap-subject beneficiaries. DHS believes a benefit of this final rule may be that some petitioners may choose to increase proffered wages for H-1B cap-subject beneficiaries, so that the petitioners may have greater chances of selection. This change will, in turn, benefit H-1B beneficiaries who ultimately will receive a higher rate of pay than they otherwise would have in the absence of this rule.

However, DHS is not able to estimate the magnitude of such benefits. DHS acknowledges the change in the selection procedure resulting from this final rule will create distributional effects and costs. DHS is unable to quantify the extent or determine the probability of H-1B petitioner behavioral changes. Therefore, DHS does not know the portion of overall impacts of this rule that will be benefits or costs.

As a result of this final rule, costs will be borne by prospective petitioners that would hire lower wage level H-1B cap-subject beneficiaries, but are unable to do so because of a reduced chance of selection in the H-1B selection process compared to the random lottery process. Such employers also may incur additional costs to find available replacement workers. DHS estimates costs incurred associated with loss of productivity from not being able to hire H-1B workers, or the need to search for and hire U.S. Workers to replace H-1B workers.

Although DHS does not have data to estimate the costs resulting from productivity loss for these employers, DHS provides an estimate of the search and hiring costs for the replacement workers. Accordingly, based on the result of the study conducted by the Society for Human Resource Management (SHRM) in 2016, DHS assumes that an entity whose H-1B petition is denied will incur an average cost of $4,398 per worker (in 2019 dollars) [] to search for and hire a U.S. Worker in place of an H-1B worker during the period of this economic analysis. If petitioners cannot find suitable replacements for the labor H-1B cap-subject beneficiaries would have provided if selected and, ultimately, granted H-1B status, this final rule primarily will be a cost to these petitioners through lost productivity and profits.

DHS also acknowledges that some petitioners might be impacted in terms of the employment, productivity loss, search and hire costs, and profits resulting from labor turnover. In cases where companies cannot find reasonable substitutes for the labor H-1B beneficiaries would have provided, affected petitioners also will lose profits from the lost productivity. In such cases, employers will incur opportunity costs by having to choose the next best alternative to fill the job prospective H-1B workers would have filled. There may be additional opportunity costs to employers such as search costs and training.

Such possible disruptions to companies will depend on the interaction of a number of complex variables that constantly are in flux, including national, state, and local labor market conditions, economic and business factors, the type of occupations and skills involved, and the substitutability between H-1B workers and U.S. Workers. These costs to petitioners are expected to be offset by increased productivity and reduced costs to find available workers for petitioners of higher wage level H-1B beneficiaries. DHS uses the compensation to H-1B employees as a measure of the overall impact of the provisions.

While DHS expects wages paid to H-1B beneficiaries to be higher in light of this final rule, DHS is unable to quantify the benefit of increased compensation because not all of the wage increases will correspond with productivity increases. This final rule may indirectly benefit prospective petitioners submitting registrations with a proffered wage that corresponds to OES wage Level I and II registrations. The indirect benefit will be present during the buy antibiotics zithromax and the ensuing economic recovery if the prospective petitioners are able to find replacement workers accepting a lower wage and factoring in the replacement cost of $4,398 per worker in the United States. Similarly, prospective petitioners that will be submitting registrations with a proffered wage that will correspond to OES wage level I and II and that substitute toward unemployed or underemployed individuals in the U.S.

Labor force will create an additional indirect benefit from this rule. This will benefit those in the U.S. Labor force if petitioners decide to select a U.S. Worker rather than a prevailing wage level I or II H-1B worker.

DHS notes that, although the buy antibiotics zithromax is widespread, the severity of its impacts varies by locality and industry, and there may be structural impediments to the national and local labor market. Accordingly, DHS cannot quantify with confidence, the net benefit of the redistribution of H-1B cap selections detailed in this analysis. DHS also is changing the filing procedures to allow USCIS to deny or revoke approval of a subsequent new or amended petition filed by the petitioner, Start Printed Page 1725or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly decrease the proffered wage to an amount that is equivalent to a lower wage level, after listing a higher wage level on the registration (or petition, if registration is suspended) to increase the odds of selection. DHS is unable to quantify the cost of these changes to petitioners.

Iv. Costs of Filing Form I-129 Petitions DHS is amending Form I-129, which must be filed by petitioners on behalf of H-1B beneficiaries, to align with the regulatory changes DHS is making in this final rule. The changes to Form I-129 will result in an increased time burden to complete and submit the form. Absent the changes implemented through this final rule, the current estimated time burden to complete and file Form I-129 is 2.84 hours per petition.

As a result of the changes in this final rule, DHS estimates the total time burden to complete and file Form I-129 will be 3.09 hours per petition, to account for the additional time petitioners will spend reviewing instructions, gathering the required documentation and information, completing the petition, preparing statements, attaching necessary documentation, and submitting the petition. DHS estimates the time burden will increase by a total of 15 minutes (0.25 hours) per petition for completing a Form I-129 petition.[] To estimate the additional cost of filing Form I-129, DHS applies the additional estimated time burden to complete and file Form 1-129 (0.25 hours) to the respective total population and compensation rate of who may file, including an HR specialist, in-house lawyer, or outsourced lawyer. As shown in Table 14, DHS estimates, the total additional annual opportunity cost of time to petitioners completing and filing Form I-129 petitions will be approximately $3,457,401. Table 14—Additional Opportunity Costs of Time to Petitioners for Filing Form I-129 Petitions From an Increase in Time BurdenCost itemsTotal affected populationAdditional time burden to complete Form I-129 (hours)Compensation rateTotal cost ABCD = A × B × COpportunity cost of time to complete Form I-129 for H-1B petitions by:HR specialist21,2200.25$47.57$252,359In-house lawyer27,5860.25102.00703,443Outsourced lawyer57,2940.25174.652,501,599Total106,1003,457,401Source.

USCIS analysis. V. Costs of Submitting Registrations as Modified by This Final Rule DHS is amending the required information on the H-1B Registration Tool. In addition to the information required on the current registration tool, a registrant will be required to provide the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code in the area of intended employment, if such data is available.

The proffered wage is the wage that the employer intends to pay the beneficiary. The SOC code and area of intended employment would be indicated on the LCA filed with the petition. For registrants relying on a private wage survey, if the proffered wage is less than the corresponding level I OES wage, the registrant will select the “Wage Level I and below” box on the registration tool. If the registration indicates that the H-1B beneficiary will work in multiple locations, or in multiple positions if the prospective petitioner is an agent, USCIS will rank and select the registration based on the lowest corresponding OES wage level that the proffered wage equals or exceeds.

In the limited instance where there is no current OES prevailing wage information for the proffered position, the registrant will follow DOL guidance on prevailing wage determinations to select the OES wage level on the registration, and USCIS will rank and select based on the highest OES wage level. The changes to this registration requirement will impose increased opportunity costs of time to registrants, by adding additional information to their registration. The current estimated time burden to complete and file an electronic registration is 30 minutes (0.5 hours) per registration.[] DHS estimates the total time burden to complete and file a registration in light of this final rule will be 50 minutes (0.83 hours) per registration, which amounts to an additional time burden of 20 minutes (0.33 hours) per registration. The additional time burden accounts for the additional time a registrant will spend reviewing instructions, completing the registration, and submitting the registration.

To estimate the additional cost of submitting a registration, DHS applies the additional estimated time burden to complete and submit the registration (0.33 hours) to the respective total population and total rate of compensation of who may file, including HR specialists, in-house lawyers, or outsourced lawyers. As shown in Table 15, DHS estimates the total additional annual opportunity cost of time to the prospective petitioners of completing and submitting registrations will be approximately $11,795,997.Start Printed Page 1726 Table 15—Additional Cost of Submitting RegistrationsCost itemsTotal affected populationAdditional time burden to submit registrations (hours)Compensation rateTotal cost ABCD = A × B × COpportunity cost of time to complete registrations by:HR specialist54,8470.33$47.57$860,994In-house lawyer71,3020.33102.002,400,025Outsourced lawyer148,0880.33174.658,534,978Total274,23711,795,997Source. USCIS analysis. While the expectation is that the registration process will be run on an annual basis, USCIS may suspend the H-1B registration requirement, in its discretion, if it determines that the registration process is inoperable for any reason.

The selection process also allows for selection based solely on the submission of petitions in any year in which the registration process is suspended due to technical or other issues. In years when registration is suspended, DHS estimates, based on the 5-year average of H-1B cap-subject petitions received for FYs 2016 to 2020, that 211,797 H-1B cap-subject petitions will be submitted annually. In the event registration is suspended and 211,797 H-1B cap-subject petitions are submitted, DHS estimates that 106,100 petitions will be selected for adjudication to meet the numerical allocations and 105,697 petitions will be rejected. For FY 2021, DHS selected 124,415 registrations to generate the 106,100 petitions projected to meet the numerical allocations.

Therefore, DHS estimates that the additional cost to petitioners for preparing and submitting H-1B cap-subject petitions in light of this final rule will be significantly higher in the event registration is suspended because more petitions will be prepared and submitted in this scenario. However, if registration is suspended there will be no costs associated with registration, so the overall additional cost of this final rule to petitioners will be less (stated another way, the estimated added cost for submitting approximately 212,000 petitions if registration is suspended will be less than the added costs based on approximately 274,000 registrations and 106,000 petitions for those with selected registrations). Since the expectation is that registration will be run on an annual basis, and because the estimated additional costs resulting from this final rule will be less if registration is suspended, DHS is not separately estimating the costs for years when registration will be suspended and, instead, is relying on the additional costs created by this final rule when registration will be required to estimate total costs of this final rule to petitioners seeking to file H-1B cap-subject petitions. Vi.

Familiarization Cost Familiarization costs comprise the opportunity cost of the time spent reading and understanding the details of a rule to fully comply with the new regulation(s). To the extent that an individual or entity directly regulated by the rule incurs familiarization costs, those familiarization costs are a direct cost of the rule. The entities directly regulated by this rule are the employers who file H-1B petitions. Using FY 2020 internal data on actual filings of Form I-129 H-1B petitions, DHS identified 24,111 [] unique entities.

DHS assumes that the petitioners require approximately two hours to familiarize themselves with the rule. Using the average total rate of compensation of HR specialists, In-house lawyers, and Outsourced lawyers from Table 4, and assuming one person at each entity familiarizes themself with the rule, DHS estimates a one-time total familiarization cost of $6,285,527 in FY 2022. Table 16—Familiarization Costs to the PetitionersCost itemsTotal affected populationAdditional time burden to familiarize (hours)Compensation rateTotal cost ABCD = A × B × COpportunity cost of time to familiarize the rule by:HR specialist4,8222$47.57$458,765In-house lawyer6,2692102.001,278,876Outsourced lawyer13,0202174.654,547,886Total24,1116,285,527Source. USCIS analysis.

Start Printed Page 1727 b. Total Estimated Costs of Regulatory Changes In this section, DHS presents the total annual costs of this final rule annualized over a 10-year implementation period. Table 17 details the total annual costs of this final rule to petitioners will be $21,538,925 in FY 2022 and $15,253,398 in FY 2023 through 2032. Table 17—Summary of Estimated Annual Costs to Petitioners in This Final RuleCostsTotal estimated annual costPetitioners' additional opportunity cost of time in filing Form I-129 petitions$3,457,401Petitioners' additional opportunity cost of time in submitting information on the registration11,795,997Familiarization Cost (Year 1 only FY 2022)6,285,527Total Annual Costs (undiscounted) = FY 202221,538,925Total Annual Cost (undiscounted) = FY 2023-FY 203215,253,398 Table 18 shows costs over the 10-year implementation period of this final rule.

DHS estimates the 10-year total net cost of the rule to petitioners to be approximately $158,819,507 undiscounted, $136,217,032 discounted at 3-percent, and $113,007,809 discounted at 7-percent. Over the 10-year implementation period of the rule, DHS estimates the annualized costs of the rule to be $15,968,792 annualized at 3-percent, $16,089,770 annualized at 7-percent. Table 18—Total Costs of This Final RuleYearTotal estimated costs$21,538,925 (year 1). $15,253,398 (year 2-10)Discounted at 3-percentDiscounted at 7-percent1$20,911,578$20,129,836214,377,79113,322,909313,959,02012,451,316413,552,44711,636,744513,157,71510,875,462612,774,48110,163,983712,402,4089,499,050812,041,1738,877,617911,690,4598,296,8381011,349,9617,754,054Total136,217,032113,007,809Annualized15,968,79216,089,770 E.O.

13771 directs agencies to reduced regulation and control regulatory costs. This final rule is expected to be an E.O. 13771 regulatory action. DHS estimates the total cost of this rule will be $10,515,740 annualized using a 7- percent discount rate over a perpetual time horizon, in 2016 dollars, and discounted back to 2016.

C. Costs to the Federal Government DHS is revising the process and system by which H-1B registrations or petitions, as applicable, will be selected toward the annual numerical allocations. This final rule will require updates to USCIS IT systems and additional time spent by USCIS on H-1B registrations or petitions. The INA provides for the collection of fees at a level that will ensure recovery of the full costs of providing adjudication and naturalization services by DHS, including administrative costs and services provided without charge to certain applicants and petitioners.[] DHS notes USCIS establishes its fees by assigning costs to an adjudication based on its relative adjudication burden and use of USCIS resources.

Fees are established at an amount that is necessary to recover these assigned costs such as salaries and benefits of clerical staff, officers, and managers, plus an amount to recover unassigned overhead (such as facility rent, IT equipment and systems, or other expenses) and immigration services provided without charge. Consequently, since USCIS immigration fees are based on resource expenditures related to the benefit in question, USCIS uses the fee associated with an information collection as a reasonable measure of the collection's costs to USCIS. DHS notes the time necessary for USCIS to review the information submitted with the forms relevant to this final rule includes the time to adjudicate the benefit request. These costs are captured in the fees collected for the benefit request from petitioners.

B. Regulatory Flexibility Act The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121 (March 29, 1996), requires Federal agencies to consider the potential impact of regulations on Start Printed Page 1728small entities during the development of their rules. €œSmall entities” are small businesses, not-for-profit organizations that are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

An “individual” is not considered a small entity, and costs to an individual from a rule are not considered for RFA purposes. In addition, the courts have held that the RFA requires an agency to perform an initial regulatory flexibility analysis (IRFA) of small entity impacts only when a rule directly regulates small entities. Consequently, any indirect impacts from a rule to a small entity are not considered as costs for RFA purposes. Although individuals, rather than small entities, submit the majority of immigration and naturalization benefit applications and petitions, this final rule will affect entities that file and pay fees for H-1B non-immigrant benefit requests.

The USCIS forms that are subject to an RFA analysis for this final rule are Form I-129, Petition for a Nonimmigrant Worker and the Registration H-1B Tool. DHS does not believe that the changes in this final rule will have a significant economic impact on a substantial number of small entities that will file H-1B petitions. A Final Regulatory Flexibility Analysis (FRFA) follows. 1.

A Statement of Need for, and Objectives of, This Final Rule DHS's objectives and legal authority for this final rule are discussed earlier in the preamble. DHS is amending its regulations governing H-1B specialty occupation workers. The purpose of this final rule is to better ensure that H-1B classification is more likely to be awarded to petitioners seeking to employ relatively higher-skilled and higher-paid beneficiaries. DHS believes these changes will disincentivize use of the H-1B program to fill relatively lower-paid, lower-skilled positions.

2. A Statement of Significant Issues Raised by the Public Comments in Response to the Initial Regulatory Flexibility Analysis, a Statement of Assessment of Any Changes Made in the Proposed Rule as a Result of Such Comments Comments. A professional association wrote that DHS claimed that no small entities would be significantly impacted by the proposed rule, but DHS also estimated that 80.1 percent of those that filed Form I-129 were small entities. An individual commenter wrote that DHS incorrectly concluded that the proposed rule would not have a significant impact on small entities because small businesses would be unlikely to have the legal expertise or institutional knowledge to navigate the H-1B system.

Response. DHS estimates the economic impact for each small entity, based on the additional cost and time associated with the changes to the form, in percentages, is the sum of the impacts of the final rule divided by the entity's sales revenue.[] DHS constructed the distribution of economic impact of the final rule based on a sample of 312 small entities. Across all 312 small entities, the increase in cost to a small entity will range from 0.00000026 percent to 2.5 percent of that entity's FY 2020 revenue. Of the 312 small entities, 0 percent (0 small entities) will experience a cost increase that is greater than 5 percent of revenues.

Comments. Some commenters generally stated that the proposed rule would harm small businesses. Multiple commenters, including a trade association, employer, and individuals, wrote that the proposed rule would harm small and emerging businesses who, often, could not offer higher salaries compared to larger firms. Other commenters said the proposed rule would favor larger firms at the expense of small and medium sized businesses.

An individual commenter wrote that the proposed rule would harm small technology companies and start-ups that are dependent on recruiting young talent, as they would be required to offer such employees level III and level IV wages when level I and level II wages would be more appropriate. Another individual commenter said companies would suffer because many small information technology or financial companies could not provide as high of salaries to their foreign workers as big companies could. An individual commenter wrote that the proposed rule would harm small businesses that often could not find the appropriate talent domestically and would have a legitimate need to hire H-1B workers, while another commenter argued the proposed rule would shrink the hiring talent pool for small businesses. An individual commenter wrote that, under the proposed rule, small businesses would not be able to operate due to an inability to find suitable employees.

Similarly, an individual commenter wrote that the proposed rule would ensure that H-1B visas would go to “the highest bidders” and would discriminate against smaller businesses with a genuine need for H-1B employees. An individual commenter wrote that the proposed rule would encourage larger employers who could afford to pay higher wages to employees to artificially inflate their job requirements and increase their chance of selection through the ranked selection process. Another commenter asserted that smaller companies in non-metropolitan areas, who might have difficulty finding domestic candidates for positions, would be negatively impacted by the proposed rule. Response.

DHS acknowledges that an employer offering a level I or below wage under the regular cap, and an employer offering a level II, I, or below wage under the advanced degree exemption, may have a lesser chance of selection than under the current random selection process. DHS does not believe that the changes in this final rule will have a significant economic impact on a substantial number of small businesses. As explained in the NPRM, DHS conducted an RFA and found that the changes in this rule would not have a significant economic impact on a substantial number of small entities. Additionally, this rule does not treat people who work for small-sized entities differently than those who work for large companies.

While DHS recognizes that some small businesses may operate on smaller margins than larger companies, if an employer values a beneficiary's work and the unique qualities the beneficiary possesses, the employer can offer a higher wage than required by the prevailing wage level to reflect that value. If a small company is unable to pay an employee at wage level III or IV for a greater chance of selection, they could then try to find a substitute U.S. Worker. Comments.

An individual commenter wrote that rural areas and smaller towns depend on entry-level H-1B workers at a level I wage, but those communities would not be able to justify hiring such H-1B workers at level III and level IV wages. Another individual commenter said the rule would harm employers in rural areas where wages, often, would be lower. A professional association wrote that small and medium sized medical practices, often serving rural or Start Printed Page 1729low-income areas, depend on new or inexperienced physicians at the level I or level II wage rate and would be unable to compete for H-1B cap slots for these employees under the proposed rule. An employer wrote that rural healthcare providers would not be able to meet the wage rates necessary to attract workers on H-1B visas, and, as a result, the proposed rule would decrease the supply of healthcare labor to rural communities.

Response. The rule takes the geographic area into account when ranking registrations or petitions, and, therefore, DHS does not agree that this rule will harm employers in rural or other areas where wages often are lower. Particularly, as stated in the proposed rule, USCIS will select H-1B registrations or petitions, as applicable, based on the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment (emphasis added). The prevailing wage already accounts for wage variations by location.

Additionally, this rule does not treat foreign workers who work for small-sized entities differently than those who work for large companies. 3. The Response of the Agency to Any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration in Response to the Rule, and a Detailed Statement of Any Change Made to the Final Rule as a Result of the Comments DHS did not receive comments on this rule from the Chief Counsel for Advocacy of the Small Business Administration. 4.

A Description of and an Estimate of the Number of Small Entities to Which This Final Rule Will Apply or an Explanation of Why No Such Estimate Is Available For this analysis, DHS conducted a sample analysis of historical Form I-129 H-1B petitions to estimate the number of small entities impacted by this final rule. DHS utilized a subscription-based online database of U.S. Entities, ReferenceUSA, as well as three other open-access, free databases of public and private entities, Manta, Cortera, and Guidestar, to determine the North American Industry Classification System (NAICS) code,[] revenue, and employee count for each entity in the sample. To determine whether an entity is small for purposes of the RFA, DHS first classified the entity by its NAICS code and, then, used SBA size standards guidelines [] to classify the revenue or employee count threshold for each entity.

Based on the NAICS codes, some entities were classified as small based on their annual revenue, and some by their numbers of employees. Once as many entities as possible were matched, those that had relevant data were compared to the size standards provided by the SBA to determine whether they were small or not. Those that could not be matched or compared were assumed to be small under the presumption that non-small entities would have been identified by one of the databases at some point in their existence. Using FY 2020 internal data on actual filings of Form I-129 H-1B petitions, DHS identified 24,111 [] unique entities.

DHS devised a methodology to conduct the small entity analysis based on a representative, random sample of the potentially impacted population. DHS first determined the minimum sample size necessary to achieve a 95 percent confidence level estimation for the impacted population of entities using the standard statistical formula at a 5 percent margin of error. Then, DHS created a sample size greater than the minimum necessary to increase the likelihood that our matches would meet or exceed the minimum required sample. DHS randomly selected a sample of 473 entities from the population of 24,111 entities that filed Form I-129 for H-1B petitions in FY 2020.

Of the 473 entities, 406 entities returned a successful match of a filing entity in the ReferenceUSA, Manta, Cortera, and Guidestar databases. 67 entities did not return a match. Using these databases' revenue or employee count and their assigned North American Industry Classification System (NAICS) code, DHS determined 312 of the 406 matches to be small entities, 94 to be non-small entities. Based on previous experience conducting RFAs, DHS assumes filing entities without database matches or missing revenue/employee count data are likely to be small entities.

As a result, to prevent underestimating the number of small entities this rule will affect, DHS conservatively considers all the non-matched and missing entities as small entities for the purpose of this analysis. Therefore, DHS conservatively classifies 379 of 473 entities as small entities, including combined non-matches (67), and small entity matches (312). Thus, DHS estimates that 80.1% (379 of 473) of the entities filing Form I-129 H-1B petitions are small entities. In this analysis DHS assumes that the distribution of firm size for our sample is the same as the entire population of Form I-129.

Thus, DHS estimates the number of small entities to be 80.1% of the population of 24,111 entities that filed Form I-129 under the H-1B classification, as summarized in Table 19 below. The annual numeric estimate of the small entities impacted by this final rule is 19,319 entities.[] Table 19—Number of Small Entities for Form I-129 for H-1B, FY 2020PopulationNumber of small entitiesProportion of population (percent)24,11119,31980.1 Following the distributional assumptions above, DHS uses the set of 312 small entities with matched revenue data to estimate the economic impact of this final rule on each small entity. The economic impact on each small entity, in percentages, is the sum of the impacts of the final rule divided by the entity's sales revenue.[] DHS constructed the distribution of economic impact of the final rule based on the sample of 312 small entities. Across all 312 small Start Printed Page 1730entities, the increase in cost to a small entity will range from 0.00000026 percent to 2.5 percent of that entity's FY 2020 revenue.

Of the 312 small entities, 0 percent (0 small entities) will experience a cost increase that is greater than 5 percent of revenues. Extrapolating to the population of 19,319 small entities and assuming an economic impact significance threshold of 5 percent of annual revenues, DHS estimates no small entities will be significantly affected by this final rule. Based on this analysis, DHS does not believe that this final rule will have a significant economic impact on a substantial number of small entities that file H-1B petitions. 5.

A Description of the Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Final Rule, Including an Estimate of the Classes of Small Entities That Will Be Subject to the Requirement and the Types of Professional Skills Necessary for Preparation of the Report or Record As stated above in the preamble, this final rule will impose additional reporting, recordkeeping, or other compliance requirements on entities that could be small entities. 6. Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of the Applicable Statues, Including a Statement of Factual, Policy, and Legal Reasons for Selecting the Alternative Adopted in the Final Rule and Why Each One of the Other Significant Alternatives to the Rule Considered by the Agency Which Affect the Impact on Small Entities Was Rejected DHS requested comments on, including potential alternatives to, the proposed ranking and selection of registrations based on the OES prevailing wage level that corresponds to the requirements of the proffered position in situations where there is no current OES prevailing wage information. In the RFA context, DHS sought comments on alternatives that would accomplish the objectives of the proposed rule without unduly burdening small entities.

DHS also welcomed any public comments or data on the number of small entities that would be petitioning for an H-1B employee and any direct impacts on those small entities. Comment. Some commenters said that DHS should consider ranking by years of experience, rather than by wage. One commenter asked DHS to give an advantage to candidates who have work experience in the United States.

Response. DHS declines to adopt these alternatives, as ranking and selection by years of experience would not best accomplish the goal of attracting the best and brightest workers. DHS believes that the salary, relative to others in the same occupational classification and area of intended employment, rather than years of experience, is generally more indicative of skill level and relative value/productivity of the worker to the United States. See section 3.3 Requests for comments on alternatives for additional suggested alternatives.

C. Congressional Review Act The Office of Information and Regulatory Affairs has determined that this final rule is a major rule, as defined in 5 U.S.C. 804, also known as the “Congressional Review Act” (CRA), as enacted in section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, sec. 251, 110 Stat.

868, 873, and codified at 5 U.S.C. 801 et seq. Therefore, the rule requires at least a 60-day delayed effective date. DHS has complied with the CRA's reporting requirements and has sent this final rule to Congress and to the Comptroller General as required by 5 U.S.C.

801(a)(1). D. Unfunded Mandates Reform Act of 1995 The Unfunded Mandates Reform Act of 1995 (UMRA) is intended, among other things, to curb the practice of imposing unfunded federal mandates on State, local, and tribal governments. Title II of the UMRA requires each federal agency to prepare a written statement assessing the effects of any federal mandate in a proposed or final agency rule that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector.

Based on the Consumer Price Index for All Urban Consumers (CPI-U), the value equivalent of $100 million in 1995 adjusted for inflation to 2019 levels is approximately $168 million.[] This rule does not contain a “Federal mandate” as defined in UMRA that may result in $100 million or more expenditures (adjusted annually for inflation—$168 million in 2019 dollars) in any one year by State, local and tribal governments or the private sector. This rule also does not uniquely affect small governments. Accordingly, Title II of UMRA requires no further agency action or analysis. E.

Executive Order 13132 (Federalism) This final rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, DHS has determined that this final rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. F. Executive Order 12988 (Civil Justice Reform) This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

G. Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments) This final rule does not have “tribal implications” because it does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Accordingly, E.O. 13175, Consultation and Coordination with Indian Tribal Governments, requires no further agency action or analysis.

H. National Environmental Policy Act (NEPA) DHS analyzes actions to determine whether the National Environmental Policy Act, Public Law 91-190, 42 U.S.C. 4321 through 4347 (NEPA), applies to them and, if so, what degree of analysis is required. DHS Directive 023-01 Rev.

01 (Directive) and Instruction Manual 023-01-001-01 Rev. 01, Implementation of the National Environmental Policy Act (Instruction Manual) establish the policies and procedures that DHS and its Start Printed Page 1731components use to comply with NEPA and the Council on Environmental Quality (CEQ) regulations for implementing NEPA, 40 CFR parts 1500-1508. The CEQ regulations allow federal agencies to establish, with CEQ review and concurrence, categories of actions (“categorical exclusions”) that experience has shown do not individually or cumulatively have a significant effect on the human environment and, therefore, do not require an Environmental Assessment (EA) or Environmental Impact Statement (EIS).[] Categorical exclusions established by DHS are set forth in Appendix A of the Instruction Manual. Under DHS NEPA implementing procedures, for an action to be categorically excluded, it must satisfy each of the following three conditions.

(1) The entire action clearly fits within one or more of the categorical exclusions. (2) the action is not a piece of a larger action. And (3) no extraordinary circumstances exist that create the potential for a significant environmental effect.[] As discussed in more detail throughout this final rule, DHS is amending regulations governing the selection of registrations or petitions, as applicable, toward the annual H-1B numerical allocations. This final rule establishes that, if more registrations are received during the annual initial registration period (or petition filing period, if applicable) than necessary to reach the applicable numerical allocation, USCIS will rank and select the registrations (or petitions, if the registration process is suspended) received on the basis of the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I and below.

If a proffered wage falls below an OES wage level I, because the proffered wage is based on a prevailing wage from another legitimate source (other than OES) or an independent authoritative source, USCIS will rank the registration in the same category as OES wage level I.[] Generally, DHS believes NEPA does not apply to a rule intended to change a discrete aspect of a visa program because any attempt to analyze its potential impacts would be largely speculative, if not completely so. This final rule does not propose to alter the statutory limitations on the numbers of nonimmigrants who. May be issued initial H-1B visas or granted initial H-1B nonimmigrant status, consequently will be admitted into the United States as H-1B nonimmigrants, will be allowed to change their status to H-1B, or will extend their stay in H-1B status. DHS cannot reasonably estimate whether the wage level-based ranking approach to select H-1B registrations (or petitions in any year in which the registration requirement were suspended) that DHS is implementing will affect how many petitions will be filed for workers to be employed in specialty occupations or whether the regulatory amendments herein will result in an overall change in the number of H-1B petitions that ultimately will be approved, and the number of H-1B workers who will be employed in the United States in any FY.

DHS has no reason to believe that these amendments to H-1B regulations will change the environmental effect, if any, of the existing regulations. Therefore, DHS has determined that, even if NEPA applied to this action, this final rule clearly fits within categorical exclusion A3(d) in the Instruction Manual, which provides an exclusion for “promulgation of rules. . .

That amend an existing regulation without changing its environmental effect.” This final rule will maintain the current human environment by proposing improvements to the H-1B program that will take effect during the economic crisis caused by buy antibiotics in a way that more effectively will prevent an adverse impact from the employment of H-1B workers on the wages and working conditions of similarly employed U.S. Workers. This final rule is not a part of a larger action and presents no extraordinary circumstances creating the potential for significant environmental effects. Therefore, this action is categorically excluded and no further NEPA analysis is required.

I. Paperwork Reduction Act Under the Paperwork Reduction Act of 1995 (PRA) Public Law 104-13, 44 U.S.C. 3501, et seq., all Departments are required to submit to the Office of Management and Budget, for review and approval, any reporting requirements inherent in a rule. In compliance with the PRA, DHS published a notice of proposed rulemaking on November 2, 2020, in which it requested comments on the revisions to the information collections associated with this rulemaking.[] DHS responded to those comments in Section IV.E.2.

Of this final rule. The following is an overview of the information collections associated with this final rule. 1. USCIS H-1B Registration Tool (1) Type of Information Collection.

Revision of a Currently Approved Collection. (2) Title of the Form/Collection. H-1B Registration Tool. (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection.

OMB-64. USCIS. (4) Affected public who will be asked or required to respond, as well as a brief abstract. Primary.

Business or other for-profit. USCIS will use the data collected through the H-1B Registration Tool to select a sufficient number of registrations projected as needed to meet the applicable H-1B cap allocations and to notify registrants whether their registrations were selected. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond. The estimated total number of respondents for the information collection H-1B Registration Tool is 275,000, and the estimated hour burden per response is 0.833 hours.

(6) An estimate of the total public burden (in hours) associated with the collection. The total estimated annual hour burden associated with this collection of information is 229,075 hours. (7) An estimate of the total public burden (in cost) associated with the collection. The estimated total annual cost burden associated with this collection of information is $0.

2. USCIS Form I-129 (1) Type of Information Collection. Revision of a Currently Approved Collection. (2) Title of the Form/Collection.

Petition for a Nonimmigrant Worker. (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection. I-129. USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract. Primary. Business or other for-profit. USCIS uses the data collected on this form to determine eligibility for the requested nonimmigrant petition and/or requests to extend or change nonimmigrant status.

An employer (or agent, where applicable) uses this form to petition USCIS for an alien to Start Printed Page 1732temporarily enter as a nonimmigrant. An employer (or agent, where applicable) also uses this form to request an extension of stay or change of status on behalf of the alien worker. The form serves the purpose of standardizing requests for nonimmigrant workers and ensuring that basic information required for assessing eligibility is provided by the petitioner while requesting that beneficiaries be classified under certain nonimmigrant employment categories. It also assists USCIS in compiling information required by Congress annually to assess effectiveness and utilization of certain nonimmigrant classifications.

USCIS also uses the data to determine continued eligibility. For example, the data collected is used in compliance reviews and other inspections to ensure that all program requirements are being met. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond. I-129 is 294,751 and the estimated hour burden per response is 3.09 hours.

The estimated total number of respondents for the information collection E-1/E-2 Classification Supplement to Form I-129 is 4,760 and the estimated hour burden per response is 0.67 hours. The estimated total number of respondents for the information collection Trade Agreement Supplement to Form I-129 is 3,057 and the estimated hour burden per response is 0.67 hours. The estimated total number of respondents for the information collection H Classification Supplement to Form I-129 is 96,291 and the estimated hour burden per response is 2 hours. The estimated total number of respondents for the information collection H-1B and H-1B1 Data Collection and Filing Fee Exemption Supplement is 96,291 and the estimated hour burden per response is 1 hour.

The estimated total number of respondents for the information collection L Classification Supplement to Form I-129 is 37,831 and the estimated hour burden per response is 1.34 hours. The estimated total number of respondents for the information collection O and P Classifications Supplement to Form I-129 is 22,710 and the estimated hour burden per response is 1 hour. The estimated total number of respondents for the information collection Q-1 Classification Supplement to Form I-129 is 155 and the estimated hour burden per response is 0.34 hours. The estimated total number of respondents for the information collection R-1 Classification Supplement to Form I-129 is 6,635 and the estimated hour burden per response is 2.34 hours.

(6) An estimate of the total public burden (in hours) associated with the collection. The total estimated annual hour burden associated with this collection of information is 1,293,873 hours. (7) An estimate of the total public burden (in cost) associated with the collection. The estimated total annual cost burden associated with this collection of information is $70,681,290.

J. Signature The Acting Secretary of Homeland Security, Chad F. Wolf, having reviewed and approved this document, is delegating the authority to electronically sign this document to Ian J. Brekke, who is the Senior Official Performing the Duties of the General Counsel for DHS, for purposes of publication in the Federal Register.

Start List of Subjects Administrative practice and procedureAliensCultural exchange programsEmploymentForeign officialsHealth professionsReporting and recordkeeping requirementsStudents End List of Subjects Accordingly, DHS amends part 214 of chapter I of title 8 of the Code of Federal Regulations as follows. Start Part End Part Start Amendment Part1. The authority citation for part 214 continues to read as follows. End Amendment Part Start Authority 6 U.S.C.

202, 236. 8 U.S.C. 1101, 1102, 1103, 1182, 1184, 1186a, 1187, 1221, 1281, 1282, 1301-1305 and 1372. Sec.

Section 141 of the Compacts of Free Association with the Federated States of Micronesia and the Republic of the Marshall Islands, and with the Government of Palau, 48 U.S.C. 1901 note and 1931 note, respectively. 48 U.S.C. 1806.

End Authority Start Amendment Part2. Section 214.2 is amended by. End Amendment Part Start Amendment Parta. Revising the first sentence of paragraph (h)(8)(iii)(A)( 1) introductory text;End Amendment Part Start Amendment Partb.

Adding paragraphs (h)(8)(iii)(A)( 1)(i) and (ii);End Amendment Part Start Amendment Partc. In paragraph (h)(8)(iii)(A)( 5)(i), revising the last two sentences and adding a sentence at the end;End Amendment Part Start Amendment Partd. In paragraph (h)(8)(iii)(A)( 5)(ii), revising the last two sentences and adding a sentence at the end;End Amendment Part Start Amendment Parte. In paragraph (h)(8)(iii)(A)( 6)(i), revising the last two sentences and adding a sentence at the end;End Amendment Part Start Amendment Partf.

In paragraph (h)(8)(iii)(A)( 6)(ii), revising the last two sentences and adding a sentence at the end;End Amendment Part Start Amendment Partg. Revising paragraphs (h)(8)(iii)(A)( 7) and (h)(8)(iii)(D)(1);End Amendment Part Start Amendment Parth. In paragraph (h)(8)(iv)(B)( 1), revising the last three sentences and adding three sentences at the end;End Amendment Part Start Amendment Parti. Revising paragraph (h)(8)(iv)(B)( 2);End Amendment Part Start Amendment Partj.

Removing and reserving paragraph (h)(8)(v). End Amendment Part Start Amendment Partk. Revising paragraph (h)(10)(ii). End Amendment Part Start Amendment Partl.

Revising paragraph (h)(11)(iii)(A)( 2);End Amendment Part Start Amendment Partm. Redesignating paragraphs (h)(11)(iii)(A)( 3) through (5) as (h)(11)(iii)(A)(4) through (6). AndEnd Amendment Part Start Amendment Partn. Adding a new paragraph (h)(11)(iii)(A)( 3) and paragraph (h)(24)(i).End Amendment Part The revisions and additions read as follows.

Special requirements for admission, extension, and maintenance of status. * * * * * (h) * * * (8) * * * (iii) * * * (A) * * * (1) * * * Except as provided in paragraph (h)(8)(iv) of this section, before a petitioner is eligible to file an H-1B cap-subject petition for a beneficiary who may be counted under section 214(g)(1)(A) of the Act (“H-1B regular cap”) or eligible for exemption under section 214(g)(5)(C) of the Act (“H-1B advanced degree exemption”), the prospective petitioner or its attorney or accredited representative must register to file a petition on behalf of an alien beneficiary electronically through the USCIS website (www.uscis.gov). * * * (i) Ranking by wage levels. USCIS will rank and select registrations as set forth in paragraphs (h)(8)(iii)(A)(5) and (6) of this section.

For purposes of the ranking and selection process, USCIS will use the highest corresponding Occupational Employment Statistics (OES) wage level that the proffered wage will equal or exceed for the relevant Standard Occupational Classification (SOC) code and area(s) of intended employment. If the proffered wage is lower than the OES wage level I, because it is based on a prevailing wage from another legitimate source (other than OES) or an independent authoritative source, USCIS will rank the registration in the same category as OES wage level I. If the H-1B beneficiary will work in multiple locations, or in multiple positions if the registrant is an agent, USCIS will rank and select the registration based on the lowest corresponding OES wage level that the proffered wage will equal or exceed. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and Start Printed Page 1733select the registration based on the OES wage level that corresponds to the requirements of the proffered position.

(ii) [Reserved] * * * * * (5) * * * (i) * * * If USCIS has received more registrations on the final registration date than necessary to meet the H-1B regular cap under Section 214(g)(1)(A) of the Act, USCIS will rank and select from among all registrations properly submitted on the final registration date on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position. If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations needed to reach the numerical limitation. (ii) * * * If USCIS has received more than a sufficient number of registrations to meet the H-1B regular cap under Section 214(g)(1)(A) of the Act, USCIS will rank and select from among all registrations properly submitted during the initial registration period on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I.

Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position. If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations needed to reach the numerical limitation. (6) * * * (i) * * * If on the final registration date, USCIS has received more registrations than necessary to meet the H-1B advanced degree exemption limitation under Section 214(g)(5)(C) of the Act, USCIS will rank and select, from among the registrations properly submitted on the final registration date that may be counted against the advanced degree exemption, the number of registrations necessary to reach the H-1B advanced degree exemption on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position.

If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations necessary to reach the H-1B advanced degree exemption. (ii) * * * USCIS will rank and select, from among the remaining registrations properly submitted during the initial registration period that may be counted against the advanced degree exemption numerical limitation, the number of registrations necessary to reach the H-1B advanced degree exemption on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position. If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations necessary to reach the H-1B advanced degree exemption.

(7) Increase to the number of registrations projected to meet the H-1B regular cap or advanced degree exemption allocations in a fiscal year. Unselected registrations will remain on reserve for the applicable fiscal year. If USCIS determines that it needs to select additional registrations to receive the number of petitions projected to meet the numerical limitations, USCIS will select from among the registrations that are on reserve a sufficient number to meet the H-1B regular cap or advanced degree exemption numerical limitation, as applicable. If all of the registrations on reserve are selected and there are still fewer registrations than needed to reach the H-1B regular cap or advanced degree exemption numerical limitation, as applicable, USCIS may reopen the applicable registration period until USCIS determines that it has received a sufficient number of registrations projected to meet the H-1B regular cap or advanced degree exemption numerical limitation.

USCIS will monitor the number of registrations received and will notify the public of the date that USCIS has received the necessary number of registrations (the new “final registration date”). The day the public is notified will not control the applicable final registration date. When selecting additional registrations under this paragraph, USCIS will rank and select properly submitted registrations in accordance with paragraphs (h)(8)(iii)(A)(1), (5), and (6) of this section. If the registration period will be re-opened, USCIS will announce the start of the re-opened registration period on the USCIS website at www.uscis.gov.

* * * * * (D) * * * (1) Filing procedures. In addition to any other applicable requirements, a petitioner may file an H-1B petition for a beneficiary that may be counted under section 214(g)(1)(A) or eligible for exemption under section 214(g)(5)(C) of the Act only if the petition is based on a valid registration submitted by the petitioner, or its designated representative, on behalf of the beneficiary that was selected beforehand by USCIS. The petition must be filed within the filing period indicated in the selection notice. A petitioner may not substitute the beneficiary named in the original registration or transfer the registration to another petitioner.

(i) If a petitioner files an H-1B cap-subject petition based on a registration that was not selected beforehand by USCIS, based on a registration for a different beneficiary than the beneficiary named in the petition, or based on a registration considered by USCIS to be invalid, the H-1B cap-subject petition will be rejected or denied. USCIS will consider a registration to be invalid if the registration fee associated with the registration is declined, rejected, or canceled after submission as the registration fee is non-refundable and Start Printed Page 1734due at the time the registration is submitted. (ii) If USCIS determines that the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct, USCIS may reject or deny the petition or, if approved, may revoke the approval of a petition that was filed based on that registration. (iii) USCIS also may deny or revoke approval of a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly decrease the proffered wage to an amount that would be equivalent to a lower wage level, after listing a higher wage level on the registration to increase the odds of selection.

USCIS will not deny or revoke approval of such an amended or new petition solely on the basis of a different proffered wage if that wage does not correspond to a lower OES wage level than the wage level on which the registration selection was based. * * * * * (iv) * * * (B) * * * (1) * * * If the final receipt date is any of the first five business days on which petitions subject to the H-1B regular cap may be received, USCIS will select from among all the petitions properly submitted during the first five business days the number of petitions deemed necessary to meet the H-1B regular cap. If USCIS has received more petitions than necessary to meet the numerical limitation for the H-1B regular cap, USCIS will rank and select the petitions received on the basis of the highest Occupational Employment Statistics (OES) wage level that the proffered wage equals or exceeds for the relevant Standard Occupational Classification (SOC) code in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position.

If the wage falls below an OES wage level I, USCIS will rank the petition in the same category as OES wage level I. USCIS will rank the petition in the same manner even if, instead of obtaining an OES prevailing wage, a petitioner elects to obtain a prevailing wage using another legitimate source (other than OES) or an independent authoritative source. If USCIS receives and ranks more petitions at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from among all eligible petitions within that particular wage level a sufficient number of petitions needed to reach the numerical limitation. (2) Advanced degree exemption selection in event of suspended registration process.

After USCIS has received a sufficient number of petitions to meet the H-1B regular cap and, as applicable, completed the selection process of petitions for the H-1B regular cap, USCIS will determine whether there is a sufficient number of remaining petitions to meet the H-1B advanced degree exemption numerical limitation. When calculating the number of petitions needed to meet the H-1B advanced degree exemption numerical limitation USCIS will take into account historical data related to approvals, denials, revocations, and other relevant factors. USCIS will monitor the number of petitions received and will announce on its website the date that it receives the number of petitions projected as needed to meet the H-1B advanced degree exemption numerical limitation (the “final receipt date”). The date the announcement is posted will not control the final receipt date.

If the final receipt date is any of the first five business days on which petitions subject to the H-1B advanced degree exemption may be received (in other words, if the numerical limitation is reached on any one of the first five business days that filings can be made), USCIS will select from among all the petitions properly submitted during the first five business days the number of petitions deemed necessary to meet the H-1B advanced degree exemption numerical limitation. If USCIS has received more petitions than necessary to meet the numerical limitation for the H-1B advanced degree exemption, USCIS will rank and select the petitions received on the basis of the highest Occupational Employment Statistics (OES) wage level that the proffered wage equals or exceeds for the relevant Standard Occupational Classification (SOC) code in the area of intended employment, beginning with OES wage level IV and proceeding with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position. If the proffered wage is below an OES wage level I, USCIS will rank the petition in the same category as OES wage level I.

USCIS will rank the petition in the same manner even if, instead of obtaining an OES prevailing wage, a petitioner elects to obtain a prevailing wage using another legitimate source (other than OES) or an independent authoritative source. If USCIS receives and ranks more petitions at a particular wage level than necessary to meet the numerical limitation for the H-1B advanced degree exemption, USCIS will randomly select from among all eligible petitions within that particular wage level a sufficient number of petitions needed to reach the numerical limitation. * * * * * (10) * * * (ii) Notice of denial. The petitioner shall be notified of the reasons for the denial and of the right to appeal the denial of the petition under 8 CFR part 103.

The petition may be denied if it is determined that the statements on the registration or petition were inaccurate. The petition will be denied if it is determined that the statements on the registration or petition were fraudulent or misrepresented a material fact. A petition also may be denied if it is not based on a valid registration submitted by the petitioner (or its designated representative), or a successor in interest, for the beneficiary named in the petition. A valid registration must represent a legitimate job offer.

USCIS also may deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the original petition. USCIS will not deny such an amended or new petition solely on the basis of a different proffered wage if that wage does not correspond to a lower OES wage level than the wage level on which the registration or petition selection, as applicable, was based. There is no appeal from a decision to deny an extension of stay to the alien. (11) * * * (iii) * * * (A) * * * (2) The statement of facts contained in the petition.

The registration, if applicable. Or on the temporary labor certification or labor condition application. Was not true and correct, Start Printed Page 1735inaccurate, fraudulent, or misrepresented a material fact. Or (3) The petitioner, or a related entity, filed a new or amended petition on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the registration, or the original petition if the registration process was suspended.

USCIS will not revoke approval of such an amended or new petition solely on the basis of a different proffered wage if that wage does not correspond to a lower OES wage level than the wage level on which the registration or petition selection, as applicable, was based. Or * * * * * (24) * * * (i) The requirement to submit a registration for an H-1B cap-subject petition and the selection process based on properly submitted registrations under paragraph (h)(8)(iii) of this section are intended to be severable from paragraph (h)(8)(iv) of this section. In the event paragraph (h)(8)(iii) is not implemented, or in the event that paragraph (h)(8)(iv) is not implemented, DHS intends that either of those provisions be implemented as an independent rule, without prejudice to petitioners in the United States under this section, as consistent with law. * * * * * Start Signature Ian J.

Brekke, Senior Official Performing the Duties of the General Counsel, U.S. Department of Homeland Security. End Signature End Supplemental Information [FR Doc. 2021-00183 Filed 1-7-21.

Start Preamble Health Resources and Services Administration (HRSA), Department of zithromax online in canada Health and Human Services read this (HHS). Notice. In accordance zithromax online in canada with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME or Council) will hold public meetings for the 2021 calendar year (CY). Information about COGME, agendas, and materials for these meetings can be found on the COGME website at https://www.hrsa.gov/​advisory-committees/​graduate-medical-edu/​index.html.

COGME meetings will be held on April 14, 2021, 8:30 a.m.-5:00 p.m. Eastern Time (ET) and April 15, 2021, 8:30 a.m.-2:00 p.m zithromax online in canada. ET. August 19, 2021, 10:00 a.m.-5:00 p.m zithromax online in canada.

ET. Meetings may be held in-person, by teleconference, and/or Adobe Connect webinar. For updates on how the meeting will be held, visit the COGME website 30 business days zithromax online in canada before the date of the meeting where instructions for joining meetings either in-person or remotely will also be posted. In-person meetings will be held at 5600 Fishers Lane, Rockville, Maryland 20857.

For meeting information updates, go to the COGME website meeting page at https://www.hrsa.gov/​advisory-committees/​graduate-medical-edu/​meetings/​index.html. Start Further zithromax online in canada Info Shane Rogers, Designated Federal Official, Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Room 15N142, Rockville, Maryland 20857. 301-443-5260. Or SRogers@hrsa.gov zithromax online in canada.

End Further Info End Preamble Start Supplemental Information COGME makes recommendations to the Secretary of HHS (Secretary) and Congress on policy, program development, and other matters of significance as specified by section 762 of Title VII of the Public Health Service (PHS) Act. Issues addressed by COGME include the supply and distribution of the physician workforce in the United States, including any projected shortages or excesses. Foreign medical zithromax online in canada school graduates. The nature and financing of undergraduate and graduate medical education.

Appropriation levels for certain zithromax online in canada programs under Title VII of the PHS Act. And deficiencies in databases of the supply and distribution of the physician workforce and postgraduate programs for training physicians. COGME submits reports to the Secretary of HHS. The Senate Committee on zithromax online in canada Health, Education, Labor and Pensions.

And the House of Representatives Committee on Energy and Commerce. Additionally, COGME encourages entities providing graduate medical education to conduct activities to voluntarily achieve the recommendations of the Council. Since priorities dictate meeting times, zithromax online in canada be advised that start times, end times, and agenda items are subject to change. For CY 2021 meetings, agenda items may include, but are not limited to, discussion on topics surrounding rural health workforce and training.

Refer to the COGME zithromax online in canada website listed above for all current and updated information concerning the CY 2021 COGME meetings, including draft agendas and meeting materials that will be posted 30 calendar days before the meeting. Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting(s). Oral comments will be honored in the order they zithromax online in canada are requested and may be limited as time allows.

Requests to submit a written statement or make oral comments to COGME should be sent to Shane Rogers using the contact information above at least 5 business days before the meeting date(s). Individuals who need special assistance or another reasonable accommodation should notify Shane Rogers using the contact information listed above at least zithromax online in canada 10 business days before the meeting(s) they wish to attend. If a meeting is held in-person, it will occur in a federal government building and attendees must go through a security check to enter. Non-U.S.

Citizen attendees must notify HRSA of their planned attendance at an in-person meeting at least 20 business days prior to the meeting zithromax online in canada in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry. Start Signature Maria G. Button, Director, Executive zithromax online in canada Secretariat.

End Signature End Supplemental Information [FR Doc. 2021-00058 Filed zithromax online in canada 1-7-21. 8:45 am]BILLING CODE 4165-15-PStart Preamble Start Printed Page 1676 U.S. Citizenship and Immigration Services, Department of Homeland Security.

Final rule zithromax online in canada. The Department of Homeland Security (DHS or the Department) is amending its regulations governing the process by which U.S. Citizenship and Immigration Services (USCIS) selects H-1B registrations for the filing of H-1B cap-subject petitions (or H-1B petitions for any year in which the registration requirement is suspended), by generally first selecting registrations based on the highest Occupational Employment Statistics (OES) prevailing wage level that the proffered wage equals or exceeds for the relevant Standard Occupational Classification (SOC) code and area(s) of intended employment. This final rule is effective March 9, 2021 zithromax online in canada.

Start Further Info Charles L. Nimick, Chief, Business and Foreign Workers zithromax online in canada Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security, 5900 Capital Gateway Drive, Camp Springs, MD 20746. Telephone 240-721-3000 (this is not a toll-free number).

Individuals with hearing or speech impairments may access the telephone numbers above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 zithromax online in canada (TTY/TDD). End Further Info End Preamble Start Supplemental Information I. Table of zithromax online in canada Contents I. Table of Contents II.

Table of Abbreviations III. Background and zithromax online in canada Discussion A. Purpose and Summary of the Regulatory Action B. Legal Authority C.

Summary of Changes From the Notice of zithromax online in canada Proposed Rulemaking D. Implementation E. The H-1B Visa zithromax online in canada Program F. Current Selection Process G.

Final Rule IV. Response to Public Comments on the Proposed Rule A zithromax online in canada. Overview of Comments and General Feedback on the Proposed Rule 1. General Support for the zithromax online in canada Proposed Rule a.

Positive Impacts on New Graduates and Entry-Level Workers b. Positive Impacts on Healthcare Workforce c. Positive Impacts on the zithromax online in canada Economy 2. General Opposition to the Proposed Rule a.

Immigration Policy Concerns b. Negative Impacts on New zithromax online in canada Graduates and Entry-Level Workers, Academic Institutions, Healthcare Workers and Facilities, Employers, and the Economy i. New Graduates and Entry-Level Workers ii. Academic Institutions iii zithromax online in canada.

Healthcare Workforce and Facilities iv. Employers v. Economy c zithromax online in canada. General Wage-Based Selection Concerns 3.

Other General zithromax online in canada Feedback B. Basis for Rule 1. DHS Statutory/Legal Authority 2. Substantive Comments on the Need zithromax online in canada for the Rule/DHS Justification a.

Support for the DHS Rationale b. Rule Is Based on False Premises/Rationale c. Lack of zithromax online in canada Evidence To Support Rulemaking C. Proposed Changes to the Registration Process for H-1B Cap-Subject Petitions 1.

Proposed Wage-Based Selection (Selection Process for zithromax online in canada Regular Cap and Advanced Degree Exemption, Preservation of Random Selection Within a Prevailing Wage) 2. Required Information From Petitioners a. OES Wage Level i. Highest OES Wage Level That the Proffered Wage Would zithromax online in canada Equal or Exceed ii.

Highest OES Wage Level When There Is No Current OES Prevailing Wage Information iii. Lowest OES Wage Level That the Proffered Wage Would Equal or Exceed When Beneficiary Would Work in Multiple Locations or Positions iv. Other Comments on zithromax online in canada OES Wage Level b. Attestation to the Veracity of the Contents of the Registration and Petition (Including Comments on Rejections, Denials, and Revocations) 3.

Requests for Comments on Alternatives D zithromax online in canada. Other Issues Relating to Rule 1. Requests To Extend the Comment Period 2. Rulemaking Process zithromax online in canada a.

Multiple H-1B Rulemakings b. Other Rulemaking Process Comments zithromax online in canada 3. Effective Date and Implementation E. Statutory and Regulatory Requirements 1.

Impacts and zithromax online in canada Benefits (E.O. 12866, 13563, and 13771) a. Methodology and Adequacy of the Cost-Benefit Analysis b. Costs c zithromax online in canada.

Benefits 2. Paperwork Reduction zithromax online in canada Act F. Out of Scope V. Statutory and Regulatory Requirements A.

Executive Orders zithromax online in canada 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), and Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) 1. Summary of Economic Effects 2. Background and Purpose of zithromax online in canada the Final Rule 3. Historic Population 4.

Cost-Benefit Analysis a. Costs and Cost zithromax online in canada Savings of Regulatory Changes to Petitioners i. Methodology Based on Historic FYs 2019-2020 ii. FY 2021 Data iii.

Unquantified Costs zithromax online in canada &. Benefits iv. Costs of Filing Form I-129 Petitions v zithromax online in canada. Costs of Submitting Registrations as Modified by This Final Rule vi.

Familiarization Cost b. Total Estimated Costs of zithromax online in canada Regulatory Changes c. Costs to the Federal Government B. Regulatory Flexibility zithromax online in canada Act 1.

A Statement of Need for, and Objectives of, This Final Rule 2. A Statement of Significant Issues Raised by the Public Comments in Response to the Initial Regulatory Flexibility Analysis, a Statement of Assessment of Any Changes Made in the Proposed Rule as a Result of Such Comments 3. The Response of the Agency to Any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration in Response to the Rule, and zithromax online in canada a Detailed Statement of Any Change Made to the Final Rule as a Result of the Comments 4. A Description of and an Estimate of the Number of Small Entities to Which This Final Rule Will Apply or an Explanation of Why No Such Estimate Is Available 5.

A Description of the Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Final Rule, Including an Estimate of the Classes of Small Entities That Will Be Subject to the Requirement and the Types of Professional Skills Necessary for Preparation of the Report or Record 6. Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of the Applicable Statues, Including a Statement of Factual, Policy, and Legal Reasons for Selecting the Alternative Adopted in zithromax online in canada the Final Rule and Why Each One of the Other Significant Alternatives to the Rule Considered by the Agency Which Affect the Impact on Small Entities Was Rejected C. Congressional Review Act D. Unfunded Mandates zithromax online in canada Reform Act of 1995 E.

Executive Order 13132 (Federalism) F. Executive Order 12988 (Civil Justice Reform) G. Executive Order 13175 (Consultation and zithromax online in canada Coordination With Indian Tribal Governments) H. National Environmental Policy Act (NEPA) I.

Paperwork Reduction Act 1. USCIS H-1B Registration Tool 2 zithromax online in canada. USCIS Form I-129 J. Signature II zithromax online in canada.

Table of Abbreviations BLS—U.S. Bureau of Labor Statistics CEQ—Council on Environmental Quality CNMI—Commonwealth of the Northern Mariana Islands CRA—Congressional Review ActStart Printed Page 1677 DHS—U.S. Department of zithromax online in canada Homeland Security DOD—U.S. Department of Defense DOL—U.S.

Department of Labor zithromax online in canada DOS—U.S. Department of State EA—Environmental Assessment EIS—Environmental Impact Statement E.O.—Executive Order FEMA—Federal Emergency Management Agency FQHC—Federally Qualified Healthcare Center FRFA—Final Regulatory Flexibility Analysis FVRA—Federal Vacancies Reform Act FY—Fiscal Year GAO—U.S. Government Accountability Office HHS—U.S. Department of Health and Human Services HPSA—Health Professional Shortage Area HSA—Homeland Security Act of zithromax online in canada 2002 ICE—U.S.

Immigration and Customs Enforcement IMG—International Medical Graduate INA—Immigration and Nationality Act INS—Immigration and Naturalization Service IT—Information Technology LCA—Labor Condition Application NAICS—North American Industry Classification System NEPA—National Environmental Policy Act NPRM—Notice of Proposed Rulemaking OES—Occupational Employment Statistics OMB—Office of Management and Budget OPT—Optional Practical Training R&D—Research and Development SOC—Standard Occupational Classification STEM—Science, Technology, Engineering, and Mathematics UMRA—Unfunded Mandates Reform Act of 1995 USCIS—U.S. Citizenship and Immigration Services VA—U.S. Department of Veterans zithromax online in canada Affairs III. Background and Discussion A.

Purpose and Summary of the Regulatory Action DHS is amending its regulations governing the selection of registrations submitted by prospective petitioners seeking zithromax online in canada to file H-1B cap-subject petitions (or the selection of petitions, if the registration process is suspended), which includes petitions subject to the regular cap and those asserting eligibility for the advanced degree exemption, to allow for ranking and selection based on wage levels. When applicable, USCIS will rank and select the registrations received generally on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. The proffered wage is the wage that the employer intends to pay the beneficiary. This ranking process will not alter the prevailing wage levels associated with a zithromax online in canada given position for U.S.

Department of Labor (DOL) purposes, which are informed by a comparison of the requirements for the proffered position to the normal requirements for the occupational classification. This final zithromax online in canada rule will not affect the order of selection as between the regular cap and the advanced degree exemption. The wage level ranking will occur first for the regular cap selection and then for the advanced degree exemption. Rote ordering of petitions leads to impossible results because petitions are submitted simultaneously.

While administering a random lottery system is reasonable, it is inconsiderate of Congress's statutory zithromax online in canada purposes for the H-1B program and its administration. Instead, a registration system that faithfully implements the Immigration and Nationality Act (INA) while prioritizing registrations based on wage level within each cap will incentivize H-1B employers to offer higher wages, or to petition for positions requiring higher skills and higher-skilled aliens that are commensurate with higher wage levels, to increase the likelihood of selection and eligibility to file an H-1B cap-subject petition. Moreover, it will maximize H-1B cap allocations, so that they more likely will go to the best and brightest workers. And it will disincentivize abuse of the H-1B program to fill relatively lower-paid, lower-skilled positions, which is a significant problem under the present selection system.[] B zithromax online in canada.

Legal Authority The Secretary of Homeland Security's authority for these regulatory amendments is found in various sections of the Immigration and Nationality Act (INA), 8 U.S.C. 1101 et seq., zithromax online in canada and the Homeland Security Act of 2002 (HSA), Public Law 107-296, 116 Stat. 2135, 6 U.S.C. 101 et seq.

General authority for issuing this final rule is zithromax online in canada found in INA section 103(a), 8 U.S.C. 1103(a), which authorizes the Secretary to administer and enforce the immigration and nationality laws, as well as HSA section 102, 6 U.S.C. 112, which vests all of the functions of DHS zithromax online in canada in the Secretary and authorizes the Secretary to issue regulations.[] Further authority for these regulatory amendments is found in. INA section 101(a)(15)(H)(i)(b), 8 U.S.C.

1101(a)(15)(H)(i)(b), which classifies as nonimmigrants aliens coming temporarily to the United States to perform services in a specialty occupation or as a fashion model with distinguished merit and ability. INA section 214(a)(1), zithromax online in canada 8 U.S.C. 1184(a)(1), which authorizes the Secretary to prescribe by regulation the terms and conditions of the admission of nonimmigrants. INA section 214(c), 8 U.S.C.

1184(c), which, among other things, authorizes the Secretary to prescribe how an importing employer may petition for an H zithromax online in canada nonimmigrant worker, and the information that an importing employer must provide in the petition. And INA section 214(g), 8 U.S.C. 1184(g), which, among other things, prescribes the H-1B numerical limitations, various exceptions to those zithromax online in canada limitations, and criteria concerning the order of processing H-1B petitions. INA section 214(i), 8 U.S.C.

1184(i), which defines the term “specialty occupation,” referenced in INA section (101)(a)(15)(H)(i)(B), 8 U.S.C. 1101(a)(15)(H)(i)(B), a requirement zithromax online in canada for the classification. Further, under HSA section 101, 6 U.S.C. 111(b)(1)(F), a primary mission of DHS is to “ensure that the overall economic security of the United States is not diminished by efforts, activities, and programs aimed at securing the homeland.”Start Printed Page 1678 Finally, as explained above, “Congress left to the discretion of USCIS how to handle simultaneous submissions.” [] Accordingly, “USCIS has discretion to decide how best to order those petitions” in furtherance of Congress' legislative purpose.[] C.

Summary of Changes From the Notice of Proposed Rulemaking Following careful consideration of public comments received, including relevant data provided, DHS has declined to modify the regulatory text proposed in the Notice of Proposed Rulemaking (NPRM) published in the Federal Register on November 2, 2020.[] Therefore, DHS is publishing zithromax online in canada this final rule as proposed in the NPRM. D. Implementation The changes in this final rule will apply to all registrations (or petitions, in the event that registration is suspended), including those for the advanced degree exemption, zithromax online in canada submitted on or after the effective date of the final rule. The treatment of registrations and petitions filed prior to the effective date of this final rule will be based on the regulatory requirements in place at the time the registration or petition, as applicable, is properly submitted.

DHS has determined that this manner of implementation best balances operational considerations with fairness to the public. USCIS will engage in public outreach and provide training to the zithromax online in canada regulated public on the modified registration system in advance of its implementation. E. The H-1B Visa Program The zithromax online in canada H-1B visa program allows U.S.

Employers to temporarily hire foreign workers to perform services in a specialty occupation, services related to a U.S. Department of Defense (DOD) cooperative research and development project or coproduction project, or services of distinguished merit and ability in the field of fashion modeling.[] A specialty occupation is defined as an occupation that requires the (1) theoretical and practical application of a body of highly specialized knowledge and (2) attainment of a bachelor's or higher degree in the specific specialty (or its equivalent) as a minimum qualification for entry into the occupation in the United States.[] Congress has established limits on the number of foreign workers who may be granted initial H-1B nonimmigrant visas or status each fiscal year (FY).[] This limitation, commonly referred to as the “H-1B cap,” generally does not apply to H-1B petitions filed on behalf of certain aliens who have previously been counted against the cap.[] The total number of foreign workers who may be granted initial H-1B nonimmigrant status during any FY currently may not exceed 65,000.[] Certain petitions are exempt from the 65,000 numerical limitation.[] The annual exemption from the 65,000 cap for H-1B workers who have earned a qualifying U.S. Master's or higher degree zithromax online in canada may not exceed 20,000 foreign workers.[] Moreover, H-1B petitions for aliens who are employed or have received offers of employment at institutions of higher education, nonprofit entities related to or affiliated with institutions of higher education, or nonprofit research organizations or government research organizations, are also exempt from the cap.[] F. Current Selection Process DHS implemented the current H-1B registration process by regulation after determining that it could introduce a cost-saving, innovative solution to facilitate the selection of H-1B cap-subject petitions toward the annual numerical allocations.

Under the current selection process, all petitioners seeking to file an H-1B cap-subject petition must first electronically submit a registration for each beneficiary on whose behalf they seek to file an H-1B cap-subject petition, unless USCIS suspends the registration requirement. A prospective petitioner whose zithromax online in canada registration is selected is then eligible to file an H-1B cap-subject petition for the selected registration during the associated filing period. USCIS monitors the number of H-1B registrations it receives during the announced registration period and, at the conclusion of that period, if more registrations are submitted than projected as needed to reach the numerical allocations, randomly selects from among properly submitted registrations the number of registrations projected as needed to reach the H-1B numerical allocations. USCIS first selects registrations submitted on zithromax online in canada behalf of all beneficiaries, including those eligible for the advanced degree exemption.

USCIS then selects from the remaining registrations a sufficient number projected as needed to reach the advanced degree exemption. A prospective petitioner whose registration is selected is notified of the selection and instructed that the petitioner is eligible to file an H-1B cap-subject petition for the beneficiary named in the selected registration within a filing period that is at least 90 days in duration and begins no earlier than 6 months ahead of the actual date of need (commonly referred to as the employment start date).[] When registration is required, a petitioner seeking to file an H-1B cap-subject petition is not eligible to file the petition unless the petition is based on a valid, selected registration for the beneficiary named in the petition.[] G. Final Rule Following careful consideration of all public comments received, DHS is issuing this final rule as proposed in the NPRM, without modifications to the zithromax online in canada regulatory text. IV.

Response to Public Comments zithromax online in canada on the Proposed Rule A. Overview of Comments and General Feedback on the Proposed Rule In response to the rulemaking, DHS received 1103 comments during the 30-day public comment period, and 388 comments on the rule's information collection requirements before the comment period ended. A large majority of public comments received are form letter copies rather than unique submissions. Commenters consisted zithromax online in canada primarily of individuals, including anonymous submissions.

DHS received the remaining submissions from professional associations, trade or Start Printed Page 1679business associations, employers/companies, law firms, advocacy groups, schools/universities, attorneys/lawyers, joint submissions, research institutes/organizations, and a union. DHS reviewed all of the public comments received in response to the proposed rule and is addressing substantive comments relevant to the proposed rule (i.e., comments that are pertinent to the proposed rule and DHS's role in administering the registration requirement for petitioners seeking to file H-1B petitions on behalf of cap-subject beneficiaries) in this section IV, grouped by subject area. While DHS provides a brief zithromax online in canada overview of comments deemed out of scope of this rulemaking in section IV.F. (e.g., comments seeking changes in U.S.

Laws, or regulations and agency policies zithromax online in canada unrelated to the changes proposed in the NPRM), DHS is not providing substantive responses to those comments. Public comments may be reviewed in their entirety at the Federal Docket Management System (FDMS) at http://www.regulations.gov, docket number USCIS-2020-0019-0001. 1. General Support for the zithromax online in canada Proposed Rule Comments.

Multiple commenters expressed general support for the rule, providing the following rationale. The proposed rule should zithromax online in canada be implemented as soon as possible. The proposed rule is a step in the right direction. The proposed rule is necessary to protect U.S.

Workers. The proposed rule is a well-guided and legal attempt to strengthen the economy and legal immigration of workers. Wage-based H-1B allocation can help economic growth. Salary is the best and most reasonable criteria, since it is not practical to compare the skills of one professional with another.

People with higher salaries should be prioritized to receive H-1B visas. The United States should increase the possibility of obtaining a visa for people with higher degrees or wages. The proposed rule would ensure more visas were allocated to the best workers. The proposed rule would keep high-level, meritorious employees in the United States.

H-1B allocation should be merit-based. The proposed rule would ensure that workers who were to contribute most would get to stay in the United States while other workers still would have the same chance of being selected as previous years. If companies were willing to pay a higher salary for some workers, it would mean that they would deserve a better chance to stay and work in the United States. People with more professional experience should not have the same chance of staying in the United States as college graduates or less experienced professionals.

The proposed rule would preserve the true intent of the H-1B program, which was to allow U.S. Companies to seek out the best foreign talent. There would be less duplication of H-1B petitions for the same employees. Every year, many highly qualified workers have had to leave the United States because they have not been selected in the existing lottery system.

Entry-level recruitment of U.S. Citizens to fill roles occupied by H-1B beneficiaries can and should be done in high schools, vocational schools, and college campuses. The proposed rule would increase the average and median wage levels of H-1B beneficiaries. The current lottery process makes it difficult for employers to plan for their staffing needs, so the proposed rule will benefit both employers and employees.

Response. DHS thanks these commenters for their support and agrees with commenters that the proposed rule should be implemented as soon as possible. The proposed rule is a step in the right direction. The proposed rule is necessary to better protect U.S.

Workers, particularly those U.S. Workers competing against H-1B workers for entry-level jobs. And this rule is a well-guided and legal attempt to improve the H-1B cap selection process. DHS further agrees that relative salary generally is a reasonable proxy for skill level and the wage level that a proffered wage equals or exceeds is a reasonable criterion for registration.

DHS also agrees that this rule may lead to the selection of the most-skilled or most-valued H-1B beneficiaries. May lead to an increase in wages for H-1B beneficiaries. May increase access to entry-level positions for available and qualified U.S. Workers.

And is expected to reduce uncertainty about selection resulting from a purely randomized process. Prioritizing wage levels in the registration selection process is expected to incentivize employers to offer higher wages, or to petition for positions requiring higher skills and higher-skilled aliens that are commensurate with higher wage levels, to increase the likelihood of selection for cap-subject petition filings. In doing so, prioritization, as compared to a purely random selection process, may reduce uncertainty about selection. In turn, U.S.

Employers that might have petitioned for cap-subject H-1B workers to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S. Workers for those positions. Comments. Several commenters expressed support for the rule and the need to stop visa fraud, abuse, and flooding of petitions by certain staffing or consulting companies.

One commenter said the proposed rule would disincentivize companies from abusing the H-1B program and harming U.S. Workers. Other commenters stated that. The proposed rule would decrease potential visa abuse by employers and make sure all workers were paid according to their skillset as employers no longer would be able to lower labor expenses by hiring foreign workers.

The proposed rule would have a positive impact on U.S. Employees and college-educated U.S. Citizens who take out loans for their education by making it harder for technology companies to discriminate against U.S. Citizens.

U.S. Workers are being laid off in large numbers because corporations are outsourcing for profits. And the proposed rule is necessary because Indian corporations are acquiring U.S. Jobs.

Response. DHS agrees that this rule will reduce abuse and provide incentives for employers to use the H-1B program to primarily fill relatively lower-paid, lower-skilled positions.[] Prioritizing registrations or petitions, as applicable, reflecting higher wage levels for positions requiring higher skills and higher-skilled or more valued aliens will further Congressional intent for the program by helping U.S. Employers fill labor shortages in positions requiring highly skilled and/or highly educated workers. A.

Positive Impacts on New Graduates and Entry-Level Workers Comments. An individual commenter wrote that this rule would be extremely beneficial to international students graduating from U.S. Universities. The commenter explained that, while recent graduates earning level I wages initially would be less likely to be selected in the lottery, many of those recent graduates actually would benefit from the rule over the long term.

The commenter said that recent graduates who were not initially selected likely would gain additional experience in future years, which would make them more competitive for selection at higher wage levels. The commenter indicated that Science, Technology, Engineering, and Mathematics (STEM) graduates generally have three chances at the existing H-1B lottery, and, ideally, new graduates should not stay in level I positions for all three years. On the other hand, non-STEM graduates Start Printed Page 1680already have low selection odds under the existing lottery and, thus, face difficulties finding suitable employment. With this proposed rule, however, non-STEM graduates now would have a probable path forward and would be able to negotiate with their employers to get H-1B sponsorship.

The commenter added that concerns that new graduate employees would not be able to receive an H-1B visa, even from large technology companies, are unfounded, knowing firsthand that new graduates regularly receive job offers at level II wages or above from large technology companies. A different commenter stated that there are many new graduates with greater academic achievements and capability who will be able to get job offers at level II wages or above. This commenter stated that, for graduates unable to get job offers with level II wages, this proposed rule could incentivize them to work hard to prove their value and be promoted. Response.

DHS agrees that this rule could be beneficial to international students, as the commenter explains. DHS recognizes that, under this final rule, it is less probable that USCIS will select registrations (or, if applicable, petitions) that reflect a wage level that is lower than the prevailing wage level II. DHS agrees with the comment that registrations (or, if applicable, petitions) reflecting prevailing wage levels II, III, and IV will have greater chances of being selected compared to the status quo. To the extent that recent foreign graduates, STEM-track or otherwise, in Optional Practical Training (OPT) can gain the necessary skills and experience to warrant prevailing wage levels II or above, the final rule may result in greater chances of selection of registrations (or, if applicable, petitions) for those beneficiaries.

Further, recent graduates with master's or higher degrees from U.S. Institutions of higher education already benefit from the advanced degree exemption and cap selection order, as eligibility for that exemption increases their chance of selection. A registration or petition, as applicable, submitted on behalf of an alien eligible for the advanced degree exemption is first included in the submissions that may be selected toward the regular cap projection. If not selected toward the regular cap projection, submissions eligible for the advanced degree exemption may be selected toward the advanced degree exemption projection.

This existing selection order increases the chance of selection for registrations or petitions submitted on behalf of aliens who have earned a master's or higher degree from a U.S. Institution of higher education. B. Positive Impacts on Healthcare Workforce Comments.

An individual commenter and a submission from U.S. Doctors indicated that thousands of U.S. Citizen medical graduates have been unemployed because residency positions have been filled by foreign doctors on H-1B and J-1 visas. A submission from U.S.

Physicians stated that it is inappropriate to hire non-citizen physicians at the taxpayer's expense for federally funded residency training positions instead of available and skilled U.S. Physicians. The commenter said the proposed rule is a step in the right direction to disincentivize a trend in the physician residency training programs that have favored foreign graduates and that have caused the displacement of several thousand qualified U.S. Citizen medical school graduates, which has been an ongoing problem for the past few decades.

The commenter explained that this displacement cripples the U.S. Economy as thousands of qualified U.S. Citizen doctors with federal student loan debt continue to go “unmatched.” Response. DHS agrees with commenters that there are more U.S.

Citizens who graduate from medical schools each year than are matched with residency programs. DHS believes that this final rule may lead to increased opportunities for entry-level positions for available and qualified U.S. Workers by incentivizing employers seeking cap-subject H-1B beneficiaries to offer higher wage levels to increase the chance for selection. This, in turn, may have the effect of freeing up entry-level cap-subject positions for U.S.

Workers, including U.S. Medical graduates in the event they are seeking to be employed in cap-subject positions.[] In turn, DHS hopes that increased opportunities for those U.S. Workers will benefit the U.S. Economy.

C. Positive Impacts on the Economy Comments. An individual commenter in support of this rule stated that the proposed rule would result in higher salaries for the H-1B population, which will lead to increased spending for the U.S. Economy.

The commenter also wrote that, under the proposed rule, employers would have access to higher wage and more talented employees increasing innovation and productivity. Another individual commenter similarly said the proposed rule would improve innovation because it would favor retaining more talented and highly paid individuals over less talented workers. The commenter said wages serve as a proxy for talent, and the proposed rule helps bring and retain talented individuals to the United States. Response.

DHS agrees with these commenters and believes that this rule may result in higher salaries for the H-1B population. This rule may also increase innovation and productivity,[] and help retain and attract talented aliens to the United States.[] DHS believes that facilitating the admission of more highly-paid and relatively higher-skilled workers “would benefit the economy and increase the United States' competitive edge in attracting the `best and the brightest' in the global labor market,” consistent with the goals of the H-1B program.[] 2. General Opposition to the Proposed Rule Comments generally opposing the proposed rule fell into various Start Printed Page 1681categories. Immigration policy concerns.

Negative impacts on new graduates and entry-level workers, academic institutions, healthcare workers and facilities, employers, and the economy. And general concerns about wage-based selection. In addition, some comments fell outside of the scope of these categories. A.

Immigration Policy Concerns Comments. A few commenters opposed the rule and expressed immigration policy concerns without substantive rationale, offering only that. The proposed rule “springs purely from nativism and no real concern for domestic workers”. The proposed rule is inconsistent with U.S.

Founding principles as a refuge for those seeking opportunity and freedom. And imposing a wage-based prioritization system is contrary to American values and would harm innovation. Response. DHS disagrees with the comment that the proposal “springs purely from nativism and no real concern for domestic workers[.]” This rule does not reduce the total number of aliens who will receive cap-subject H-1B status in a given fiscal year.

Instead, this rule will benefit those H-1B beneficiaries who are most highly paid and/or most highly skilled, relative to their SOC codes and areas of intended employment. DHS believes this rule will incentivize employers to offer higher wages and/or higher-skilled positions to H-1B workers and disincentivize the existing widespread use of the H-1B program to fill relatively lower-paid or lower-skilled positions, for which there may be available and qualified U.S. Workers. In general, DHS recognizes that the admission of higher paid and/or higher skilled workers is likely to benefit the economy and increase the United States' competitive edge in the global labor market.[] Further, this rule is intended to potentially increase employment opportunities for relatively lower-skilled unemployed or underemployed U.S.

Workers. Recent college graduates, some of who otherwise would serve as U.S. Workers, have the highest unemployment rate in decades, and the underemployment rate (which reflects the rate at which workers are accepting jobs lower than their academic or experience level) is at an all-time high.[] Roughly 53 percent of recent college graduates, some of who could potentially work in these jobs, are currently unemployed or underemployed.[] While the overall unemployment rates for college graduates is 3.8 percent, the unemployment rate is higher for graduates with majors in some fields common to the H-1B program such as computer science (5.2 percent), mathematics (4.9 percent) and information systems &. Management (4.9 percent).[] This rule is intended to potentially benefit the population of unemployed or underemployed U.S.

Workers. DHS further disagrees that this rule is inconsistent with U.S. Founding principles as a refuge for those seeking opportunity and freedom, and that instituting a ranking system is contrary to American values and would harm innovation. First, the H-1B program is a temporary, employment-based nonimmigrant program and not a form of humanitarian relief.

Additionally, by maximizing H-1B cap allocations, so that they more likely would go to the best and brightest workers, DHS believes that this rule likely would promote opportunity, innovation, and development. B. Negative Impacts on New Graduates and Entry-Level Workers, Academic Institutions, Healthcare Workers and Facilities, Employers, and the Economy Multiple commenters said the proposal would have negative impacts on new graduates and entry-level workers, academic institutions, healthcare workers and facilities, employers, and the economy. I.

New Graduates and Entry-Level Workers Comments. Commenters stated, without substantive rationale, that the proposed rule would negatively impact this population because. New foreign graduates would be disadvantaged by this rule. The proposed rule would prevent the future growth of new foreign graduates in the workplace.

The proposed rule would be unfair to immigrants who earn lower wages. It takes time to be promoted from entry level to a more senior level. It is “too difficult for most people to earn that much”. The proposed rule would dramatically reduce access to the H-1B visa program for early career professionals, including those who have completed master's or doctoral degrees at U.S.

Colleges and universities. The proposed rule would make it nearly impossible for entry-level employees with degrees in STEM majors to be eligible for H-1Bs. Non-STEM graduates would have a more difficult time obtaining H-1B classification under the proposed rule. The rule would unfairly discriminate against aliens who work in areas related to humanities, arts, or accounting that do not receive high starting wages.

The proposed rule would greatly decrease the number of H-1B visas that would be available to educators, translators, and other specialty positions. Doctors who recently graduated and entered medical residency programs would have no chance of obtaining H-1B classification under this proposed rule. The rule would negatively impact U.S. Biomedical research, as it would make it difficult for young scientists to study and conduct health research in the United States.

The computer science industry requires experience to get to a higher level, which is something new graduates do not typically have. It is harder to earn higher wages quickly in certain industries, such as mechanical engineering or medicine. Basing the selection on wage levels would be disadvantageous to people who work for small-sized companies, which offer lower wages. The proposed rule would send a message that the United States does not welcome talented foreign students.

The rule would divide international students because everyone would be “considering the interests of their own”. And pushing entry-level workers out in the beginning of their careers disobeys a fundamental economics principle, which states that Start Printed Page 1682laborers are underpaid in the early stage, but will make more with more experience and skillsets. Multiple commenters said the proposal would have negative impacts on new foreign graduates and entry-level workers, and they provided substantive rationale in support of those assertions. Specifically, several commenters, including a form letter campaign, said the rule would have a “direct and negative” impact on college-educated foreign-born professionals by “dramatically reducing” access to the H-1B visa program for early-career professionals because no aliens who are paid a level I wage would be selected to submit a petition.

A trade association stated that early-career workers in science, math, and engineering might be shut out by the proposed rule, but that those are the workers the U.S. Economy needs. Several commenters, including a university, a professional association, and a joint submission, argued that the proposed rule would reduce access to the H-1B program, negatively impacting graduating international students. A university stated that the proposed rule indirectly would affect F-1 and J-1 students and scholars by removing a pathway to employment after completion of educational or training experiences in the United States, which would also negatively impact the economy.

The university argued that almost all F-1 and J-1 visa holders enter at level I wages. Response. DHS disagrees with the assertions that this rule will either preclude or essentially preclude H-1B status for recent graduates, entry-level foreign workers, and young alien professionals. In general, registrations (or petitions, if applicable) will be selected according to the wage level that the proffered wage equals or exceeds.

Therefore, if an employer chooses to offer a recent foreign graduate a wage that equals or exceeds a particular wage level, the registration will be grouped at that wage level, regardless of the beneficiary's experience level or the requirements of the position. Further, as explained in the proposed rule, DHS believes that a purely random selection process is not optimal, and selection based on the highest wage level that a proffered wage equals or exceeds is more consistent with the primary purpose of the statute. DHS acknowledges that, under this rule, in years of excess demand, relatively lower-paid or lower-skilled positions will have a reduced chance of selection. However, DHS believes that selection in this manner is consistent with the primary purpose of the statute.

DHS further disagrees with the assertion that this rule will preclude recent foreign medical graduates from obtaining H-1B status. Importantly, according to DHS data, in FY 2019, more than 93 percent of H-1B petitions approved for initial employment for physicians, surgeons, and dentists were cap-exempt and thus not subject to the H-1B cap selection process.[] Thus, it is not accurate to say that recent foreign medical graduates, who may seek initial employment as physicians, would have “no chance” of obtaining H-1B status under this rule. DHS acknowledges that, under this rule, in years of excess demand, in the infrequent situation of recent foreign medical graduates seeking employment with a cap subject employer, recent foreign medical graduates may face a reduced chance of selection for cap-subject H-1B visas. However, because a significant majority of H-1B petitions filed for recent foreign medical graduates are cap-exempt, and thus not affected by this rule, this reduction likely will affect a minimal population, if any, of recent medical graduates.

Further, as explained in the proposed rule, DHS believes that a random selection is not optimal, and selection based on the highest wage level that a proffered wage equals or exceeds is more consistent with the primary purpose of the statute. In terms of STEM-specific concerns, DHS disagrees with comments that this rule will make it “harder” or “nearly impossible” for employers to hire entry-level employees with degrees in STEM majors. These types of potential foreign workers have multiple avenues to obtain employment in the United States. In general, foreign STEM graduates can apply for the regular 12-month OPT plus an additional 24-month extension of their post-completion OPT.[] The additional 24-month extension of OPT is available only to foreign STEM graduates.

During the 3-year cumulative OPT period, such a graduate can gain significant training and work experience with a U.S. Employer and can demonstrate their value to that employer. If the employer wants to continue their employment by way of H-1B classification, then the employer can choose to offer the worker a wage that will maximize their chance of selection. Additionally, an employer could directly petition for an employment-based immigrant visa for the alien at any time.

There is no statutory or regulatory requirement that an alien admitted on a F-1 nonimmigrant visa go through OPT and/or the H-1B program before being petitioned for an immigrant visa. Concerning the comments about non-STEM graduates who work in the humanities, arts, accounting, education, or other areas that generally may not receive as high of starting wages as other occupations, DHS does not believe these graduates will be unfairly impacted by this rule. Because USCIS will be ranking and selecting registrations (or petitions) generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code, this method of ranking takes into account wage variations by occupation. Ii.

Academic Institutions Comments. A few individual commenters generally stated that the proposed rule would harm schools and universities. Multiple commenters, including a university, law firm, and individual commenters, stated that this rule would negatively impact U.S. Universities' ability to recruit international students, which would affect enrollments, because U.S.

Institutions would be less attractive due to the lower possibility of remaining in the United States to work after completion of their studies or at the conclusion of their OPT. Similarly, several commenters said the proposal would make it difficult for universities to attract top talent that would contribute to the U.S. Economy. A trade association stated that the rule would restrict the ability of graduating talent to switch from F-1 student status to H-1B status, particularly when operating in conjunction with the DOL Interim Final Rule (IFR), Strengthening Wage Protections for the Temporary and Permanent Employment of Certain Start Printed Page 1683Aliens in the United States (DOL IFR).[] Another commenter stated that the DOL IFR also is aimed at pricing international students and others out of the U.S.

Labor market, while the Student and Exchange Visitor Program proposed rule [] to limit the time students are allowed to stay in the United States appears designed to deter foreign students from coming to U.S. Universities. A trade association stated, without evidence, that since graduating international students are unlikely to find employers who are willing to pay them the same rate as their median-wage workers, this would lead to U.S.-educated international students taking their knowledge and skills elsewhere. A university said that, if the proposed rule were implemented, the United States would lose “advanced science, technology, engineering, and mathematics knowledge and talent” because international students would choose to pursue their education in countries with more favorable immigration policies.

Another commenter claimed that international students would study elsewhere if they could not identify employment opportunities after graduation, which would “crippl[e] a critical pipeline of future community members, workers, innovators and entrepreneurs.” A few commenters stated that, under this rule, the United States would lose money, talent, and inventiveness by reducing the employment potential of foreign students upon graduation from a U.S. Educational institution, and the United States eventually would lose attractiveness and competitiveness because international students would go elsewhere. Some commenters provided specific figures to detail the contributions of foreign enrollment at U.S. Universities.

Specifically. Education service exports ranked sixth among service exports in 2019 according to data released by the U.S. Department of Commerce's Bureau of Economic Analysis. International students studying in the United States added an estimated $41 billion to the economy and supported over 458,000 jobs during the 2018 through 2019 academic year.

International students make up 5.5 percent of the total U.S. Higher education population and contributed $44.7 billion to the U.S. Economy in 2018. International students have founded approximately one-quarter of U.S.

Start-up companies worth $1 billion or more. The Institution for International Education (IIE) reports that international students contributed $482.5 million to the State of Minnesota during 2018 through 2019, supporting 4,497 jobs. International students and scholars contributed an estimated $304.2 million to the local Ithaca, New York, economy and supported nearly 4,000 jobs during the 2018 through 2019 academic year. And, in one commenter's experience, foreign students paid more than $10,000 per year full tuition compared to less than $4,000 for in-state residents, which provided major subsidies for low income resident students.

Some commenters expressed that this is not the time to be driving students away, as State and college/university budgets have suffered greatly as a result of buy antibiotics. One commenter cited data indicating a “shocking decline” in international student enrollment at U.S. Institutions of higher education for the Fall 2020 semester, as well as a study indicating that the overall economic impact generated by international students had already started to decline in 2019, down to $38.7 billion. The commenter said the declining enrollment numbers for 2020 are likely to perpetuate a large economic impact as we continue to deal with the economic fallout of the buy antibiotics zithromax.

A professional association stated that the proposed regulation would have a “monumentally negative” effect on U.S. Colleges and universities at a time when those institutions would be reeling from the impact of the buy antibiotics zithromax. The commenter cited statistics indicating that, in the current school year, new enrollment of international students dropped 43 percent because of buy antibiotics. The commenter concluded that the buy antibiotics zithromax, uncertainty about immigration status, and “anti-immigrant rhetoric[,]” compounded with this rule that would further destabilize the career progression of foreign students by eliminating a legal pathway to temporary employment opportunities in the United States post-graduation, would create a “perfect storm” that would devastate the U.S.

College and university system for years to come. Several commenters, including a university, advocacy group, and individual commenters, said restricting the H-1B program for foreign students, while competitor nations seek to expand their ability to attract international students, would lead talented students to choose other countries of study and decrease enrollments in U.S. Institutions. One of these commenters said countries such as Canada and Germany already are seeing increases in international student enrollment as U.S.

Restrictions to international students have led to waning interest from the future CEOs, inventors, and researchers of the world. An individual commenter said universities essentially would be training laborers for other countries. Some commenters stated that colleges and universities rely, in particular, on foreign students who pay full tuition to help make up for declining Federal and State support and to subsidize the cost of education for U.S. Students.

An attorney stated that U.S. Colleges, universities, and communities benefit financially from the attendance of foreign students, typically in F-1 foreign student nonimmigrant status or J-1 exchange visitor nonimmigrant status. The commenter said the economic and intellectual advancement of educational institutions and their communities is enhanced by the presence of these students from other countries. A university stated that international students and scholars are essential to a university's makeup, as students and faculty benefit from exposure to intercultural differences and the leadership opportunities that arise from global collaborations.

Another commenter stated that foreign national researchers and professors provide the needed diversity to help educate students to become the professionals they need, as they cannot compete globally if they do not have the ability to adapt culturally. An individual stated that this rule would make it impossible for some colleges to fill teaching positions that they cannot fill with qualified U.S. Workers. For example, the commenter stated that North Dakota colleges are not able to pay higher than the level I wage as that is the average salary paid to all of its beginning professors and researchers, and this rule would result in many of North Dakota colleges having unfilled teaching positions and a decrease in higher level class offerings, particularly in STEM fields, putting a strain on education in the state.

Multiple commenters offered similar concerns, but at other levels of academic institutions and owing to their less-desirable locations. Response. DHS appreciates the academic benefits, cultural value, and economic contributions that aliens make to academic institutions and local Start Printed Page 1684communities throughout the United States. DHS does not believe that this rule will negatively impact the ability of U.S.

Colleges and universities to recruit international students. Nor will the rule impact the ability of international students to study in the United States, which is the basis of their admission to the United States in that status. While increased employment opportunities, both in the United States and abroad, may be a factor in deciding whether to study in the United States, the reputation of the academic institutions themselves is also an important factor for the great majority of those choosing to study in the United States.[] Further, DHS notes that international students will continue to have significant employment opportunities in the United States under this rule. First, this rule has no impact on OPT, which allows for 12 months of employment for most aliens admitted in F-1 student status, plus an additional 24-month extension of post-completion OPT available only to STEM graduates.[] In addition, with the current random selection process, even the most talented foreign student may have less than a 50 percent chance of selection.

This rule will increase the chance of employment at the higher wage levels and thus may facilitate the selection of the best and brightest students for cap-subject H-1B status. To the extent that that this change does negatively affect the potential of some colleges and universities to recruit international students, DHS believes that any such harm will be outweighed by the benefits that this rule will provide for the economy overall.[] Facilitating the admission of higher-skilled foreign workers, as indicated by their earning of wages that equal or exceed higher prevailing wage levels, would benefit the economy and increase the United States' competitive edge in attracting the “best and the brightest” in the global labor market, consistent with the goals of the H-1B program discussed in the NPRM. Further, DHS disagrees that this rule will make it “impossible” for academic institutions to fill teaching and research positions. Congress already exempted from the annual H-1B cap aliens who are employed or have received offers of employment at institutions of higher education, nonprofit entities related to or affiliated with institutions of higher education, nonprofit research organizations or government research organizations.[] Therefore, many petitions for academic institutions will not be affected by this rule.[] In FY 2020 alone, USCIS approved over 41,000 petitions for petitioners that qualified under one of these cap exemptions.[] These cap exemptions mitigate these commenters' concerns or misunderstanding of the H-1B program.

Comments about the DOL IFR and the Student and Exchange Visitor Program proposed rule are out of scope, so DHS will not address them. Iii. Healthcare Workforce and Facilities (a) Impact on Healthcare Workers Comments. Some commenters expressed concern that the rule could prevent qualified and highly skilled entry-level health care workers and recent foreign-born graduates from medical school from obtaining an H-1B visa.

A professional association said this proposal would reduce the overall number of international medical graduates (IMGs) practicing in the United States, also stating that pricing H-1B visa holders out of the physician employment market would only exacerbate ongoing physician shortages and worsen barriers to care for patients. Another professional association cited data forecasting an increasing physician shortage and said H-1B physicians fulfill a “vital and irreplaceable role.” The commenter said stringent performance and pay thresholds already exist that must be met to even be considered for an H-1B visa and placing additional wage barriers on the cap would garner no benefit and, instead, would harm U.S. Patients and health care systems. A university and an individual commenter stated that physicians enter the field with a level I wage, despite high levels of education and training, and argued that, under the proposal, it would be “virtually impossible” for a new physician to obtain H-1B unless they are employed by a cap-exempt institution.

The university and the commenter cited a 2016 Journal of the American Medical Association (JAMA) study, which found that 29 percent of physicians were born outside of the United States, helping to fill the physician shortage, and that this rule ignores problems like this. Another professional association stated that it is an incorrect assumption that skill level is definitively associated with wage amount, as there are many situations where a highly skilled H-1B physician may choose to accept a lower wage (e.g., expand their skillset, altruistic motives, the potential to gain lawful permanent residency in a shorter time span). Therefore, the proposed rule would create a false presupposition that would stop highly qualified physicians from practicing in less affluent institutions. Thus, the proposed rule would create a situation where much needed physician positions remain vacant, only wealthy medical conglomerates are able to afford to sponsor H-1B physicians, or wages become so inflated that far fewer H-1B physicians can be hired.

A few individuals noted that a number of rural and/or underserved communities rely on foreign trained dentists, and that this rule would make it difficult to recruit dentist in rural and/or underserved areas. A couple of professional associations said the rule potentially could eliminate the H-1B visa option for recent graduates, including IMGs and postdoctoral researchers, with serious consequences for the U.S. Healthcare workforce. One of these commenters said IMGs compose nearly one-fourth of the U.S.

Physician workforce and one-fourth of the country's resident physicians in training. The commenter stated that, due to this rule, these highly qualified physicians may choose to go to other countries rather than risk being unable to complete training requirements, build up a medical practice, or perform clinical duties. A professional association wrote specifically about the impacts of the rule on the availability of primary care physicians. The commenter cited data indicating that the United States is facing a primary care physician shortage and stated that IMGs play a vital role in filling this gap.

The commenter went on to say that family medicine and other primary care physicians typically have lower annual salaries than specialty Start Printed Page 1685physicians, and, since this proposal favors H-1B petitioners with higher annual salaries, it also may discriminate against family physicians unfairly. Response. DHS disagrees with the assertion that this rule will prevent recent medical or dental graduates from obtaining H-1B status, as Congress already exempted from the H-1B cap any alien who is employed or has received an offer of employment at an institution of higher education, a related or affiliated non-profit entity, or a non-profit research organization or a governmental research organization.[] As stated above, in FY 2019, more than 93 percent of H-1B petitions approved for initial employment for physicians, surgeons, and dentists were cap-exempt and, thus, not subject to the H-1B cap selection process. Because a significant majority are not affected by this rule, this reduction likely will affect a minimal population, if any, of recent foreign medical graduates.

In addition, Congress has established programs meant to encourage certain recent foreign medical graduates to serve in the United States as H-1B nonimmigrants. These programs are exempt from the annual caps and unaffected by this rule. Certain J-1 exchange visitors are subject to a 2-year foreign residence requirement under INA section 212(e), 8 U.S.C. 1182(e), which requires them to return to their country of nationality or country of last residence for at least two years in the aggregate prior to being eligible to apply for an immigrant visa.

Adjustment of status. Or a nonimmigrant visa, such as an H-1B visa (with limited exceptions).[] However, INA section 214(l), 8 U.S.C. 1184(l), contains provisions authorizing waivers of the 2-year foreign residence requirement for certain aliens, including foreign medical graduates who agree to work full-time (at least 40 hours per week) in H-1B classification for not less than three years in a shortage area designated by the U.S. Department of Health and Human Services (HHS) with a request from an interested federal government agency or state agency of public health or its equivalent, or with the U.S.

Department of Veterans Affairs (VA).[] The petition requesting a change to H-1B nonimmigrant status for these physicians is not subject to the numerical limitations contained in INA section 214(g)(1)(A), 8 U.S.C. 1184(g)(1)(A).[] While participation in the Conrad State 30 program (relating to waivers based on requests from a state agency of public health or its equivalent for service in an HHS-designated shortage area) is limited to 30 participants per eligible jurisdiction annually, the other programs have no limits on the number of participants.[] Further, DHS disagrees with the comment that this rule may unfairly discriminate against family physicians and other primary care physicians who typically have lower annual salaries than specialty physicians. In general, family physicians or other primary care physicians have different SOC codes than specialty physicians. As DOL prevailing wage level calculations generally differ by SOC codes, when wage data is available, the corresponding wage level would necessarily account for the different occupational classification for primary care physicians as opposed to other types of physicians.

When such wage level data is unavailable, wage level ranking will be based on the skill, education, and experience requirements for the position, again taking into account the particulars of the relevant occupational classification, such that registrations or petitions for primary care physicians will be ranked in comparison to the normal requirements for primary care physicians and not in comparison to other types of physicians. As such, DHS does not believe that this rule will disadvantage registrations or petitions for primary care physicians or any other subset of physicians. (b) Rural and/or Underserved Communities Comments. Multiple commenters, including several professional associations, said the rule would negatively impact the U.S.

Health care system in areas that are rural and/or underserved where IMG and non-citizen physicians are particularly essential. A professional association cited data indicating that IMGs are more likely to become primary care physicians and practice in rural and other underserved areas where physician shortages are the direst and that rely heavily on family physicians for ambulatory and emergency care. A couple of professional associations similarly said IMGs typically serve in rural and/or medically underserved communities, providing care to many of our country's most at-risk citizens. One of these commenters stated that, although 20 percent of the country's population resides in rural areas, fewer than 10 percent of U.S.

Physicians actually practice in those communities, resulting in over 23 million rural Americans living in federally designated primary medical Health Professional Shortage Areas (HPSA). This commenter also stated that recently graduated H-1B physicians participating in pipeline programs in the beginning of their careers, such as Conrad State 30, fall within the first and second tiers of the prevailing wage determination. Therefore, the proposed rule would create a system that removes physicians who are willing and ready to practice in medically underserved areas and cuts off those patients who are most in need from receiving physician care. A professional association stated that Federally Qualified Healthcare Centers (FQHC), institutions that serve high-risk, medically underserved populations in HPSAs, do not qualify for exemption from the H-1B visa cap.

To fill the physician gap, FQHCs utilize H-1B physicians to care for patients in these health care underserved areas. The commenter stated that, if the proposed rule is enacted, these FQHCs would be unable to obtain early-career H-1B physicians and are unlikely to be able to compete with larger, more affluent organizations to offer a higher proffered wage to increase their chances of obtaining H-1B physician candidates and reducing the physician shortages identified by HPSA data. A company stated that rural hospitals and other health care facilities rely heavily on healthcare-staffing companies to fill their staffing needs, but the rates staffing companies are able to charge rural facilities usually are much lower than the rates they are able to charge facilities in affluent metropolitan areas. Thus, the rule would cause staffing companies to place their professionals where the staffing companies can charge the highest rates, so that staffing companies can maintain sufficient profitability and ensure that their workers are able to obtain H-1B visas.

The commenter concluded that the rule would decrease the supply of healthcare labor to rural and other underserved communities, where it is needed most. Response. DHS acknowledges the important role that early career and entry level foreign physicians may play in providing health care in rural and/or underserved communities. As explained in response to the previous comments, Congress has established programs meant to direct foreign medical graduates to those communities.Start Printed Page 1686 Also as noted above, physicians whose nonimmigrant status is changed to H-1B through their participation in any of the three waiver programs in INA section 214(l), 8 U.S.C.

1184(l), are not subject to the annual H-1B caps. The Conrad State 30 program (relating to waivers based on requests from a state agency of public health or its equivalent for service in an HHS-designated shortage area) is limited to 30 participants per eligible jurisdiction annually.[] However, there are no annual limits on the number of aliens who can obtain a waiver through service in an HHS-designated shortage area based on the request of a federal interested government agency. Since these programs are not subject to the annual H-1B caps, they will not be affected by this rule and the programs will continue to provide a pipeline for these physicians to serve in HHS-designated shortage areas. Congress has established a similar statute in the immigrant context, which also channels physicians to serve in HHS-designated shortage areas, commonly known as the Physician National Interest Waiver Program.[] That program has no limits on the number of physicians who can participate in a given fiscal year, though there are numerical limitations on the number of employment-based immigrant visas that can be allocated annually.

This program is unaffected by this rule and will continue to provide a pipeline for an unlimited number of physicians to serve in HHS-designated shortage areas. DHS agrees with the commenters who stated that medical institutions in rural and/or underserved areas may not be institutions of higher education, related or affiliated non-profit entities, or non-profit research organizations or governmental research organizations. As a result, aliens who are employed by or who have received an offer of employment from such medical institutions may not be exempt from the annual H-1B numerical limitations under INA section 214(g)(5), 8 U.S.C. 1184(g)(5).

However, some of those medical institutions do meet the requirements to be cap-exempt, and their employees will not be subject to the numerical limitations.[] DHS acknowledges that some alien physicians who currently serve in rural and/or underserved areas as H-1B nonimmigrants are not participating in the waiver programs of INA section 214(l), 8 U.S.C. 1184(l), and they are not working for cap-exempt employers. These physicians may be in positions categorized as prevailing wage levels I or II, depending on their individual circumstances. However, such physicians may avail themselves of alternative pathways to serve in these areas such as the Physician National Interest Waiver Program and not be subject to the annual H-1B numerical limitations.

Further, as with all other cap-subject H-1B visas, DHS will rank and select registrations for these positions generally according to the highest OES prevailing wage level that the proffered wage equals or exceeds, which necessarily takes into account the area of intended employment when such wage level data is available. Where there is no current OES prevailing wage information for the proffered position, which DHS recognizes is the case for some physician positions based on limitations in OES data, the registrant would follow DOL guidance on prevailing wage determinations to determine which OES wage level to select on the registration. The determination of the appropriate wage level in those instances would be based on the skill, education, and experience requirements of the position, and generally does not take into consideration the area of intended employment. Therefore, DHS does not believe that this rule necessarily will disadvantage rural and/or underserved communities relative to registrations or petitions based on offers of employment in other areas.

(c) buy antibiotics Comments. Several commenters stated that the rule would have particularly concerning impacts on the U.S. Healthcare workforce as the United States grapples with the buy antibiotics zithromax. A professional association said these visa cap requirements come at a most inopportune time, as the United States sustains some of the highest rates of buy antibiotics cases worldwide and depends on early career physicians to serve on the frontlines.

The commenter said H-1B physicians have played a large role in caring for those who are seriously ill from buy antibiotics, including those facing health complications following recovery from this disease. Similarly, another professional association cited data indicating that, currently, the States where H-1B physicians are providing care are also those with some of the highest buy antibiotics case counts. Response. DHS certainly appreciates the significant contributions of all healthcare professionals, especially during the current buy antibiotics zithromax, but DHS continues to note that many foreign medical professionals are eligible for cap-exempt H-1B status and are not impacted by this rule.

Additionally, DHS believes that this rule will provide benefits to the greater U.S. Workforce that outweigh any potential negative impacts on the relatively small subset of H-1B cap-subject healthcare workers. For example, DHS received submissions from unemployed and underemployed U.S. Citizen medical graduates who attested to the decades-long problem of displacement of several thousands of qualified U.S.

Citizen IMGs and graduates of U.S. Medical schools for federally funded residency training positions. This rule may benefit these unemployed and underemployed U.S. Citizen medical graduates by potentially increasing employment opportunities.

Further, DHS notes that this final rule is not a temporary rule that is limited in duration to the buy antibiotics zithromax. Moreover, this final rule will not have immediate impact on H-1B employment as it will first be applied to the FY 2022 registration and selection process, the beneficiaries of which will not be able to begin employment in H-1B classification until October 1, 2021. (d) Healthcare Facilities Comments. A professional association stated that larger, wealthier companies are much more likely to be able to pay augmented salaries to increase their chances of selection for filing of H-1B cap-subject petitions.

In comparison, smaller, less affluent medical practices would not be able to compete with these large conglomerates, despite having a much greater need for physicians. As such, larger hospital systems would be able to buy H-1B visas for their physicians, leaving mid to small size practices even more understaffed. A trade association stated that its members in the healthcare industry are very concerned about the impact this rule would have on their ability to continue hiring H-1B foreign medical graduates, who are critical for healthcare providers to meet the needs of their patients. The commenter said Start Printed Page 1687the disruptions caused by the rule would be profound on these employers, as they continue to struggle in confronting the ongoing buy antibiotics zithromax.

A law firm stated that the salary market in healthcare is not like the salary market in other fields and explained that, because so much of hospitals' reimbursement processes are governed by Medicare and a tiny handful of large insurance companies, it would be impossible for U.S. Healthcare facilities to negotiate reimbursement rates in a manner to significantly raise salaries. The commenter said that this rule is a “blunt object” that would lead to additional Silicon Valley, California, H-1B visas in place of visas that currently help the healthcare of U.S. Citizens, and rural facilities would suffer the brunt of this policy.

Response. DHS appreciates the significant contributions of all healthcare professionals, especially during the current buy antibiotics zithromax, but believes that this rule will provide benefits to the greater U.S. Workforce. DHS does not believe that the changes in this rule will have a disproportionately negative impact on small- to mid-sized medical practices as compared to larger hospital systems.

It is not necessarily the case that larger hospital systems are more willing or able to provide higher salaries to their employees.[] DHS also does not believe that the changes in this rule will have a disproportionately negative impact on rural facilities, as it is not necessarily the case that rural facilities are unwilling or unable to provide relatively higher salaries compared to facilities in other areas.[] With respect to the ability to offer increased wages generally, DHS acknowledges that employers of healthcare professionals, like employers in all industries, must consider a variety of factors in determining employee salaries. However, this rule does not require employers to pay a higher wage, and, as stated in the NPRM and above, employers that might have petitioned for a cap-subject H-1B worker to fill relatively lower-paid, lower-skilled positions may be incentivized to hire available and qualified U.S. Workers for those positions. Also as noted above, DHS believes that selecting by wage level in such years is more consistent with the dominant legislative purpose of the H-1B program, which is to help U.S.

Employers fill labor shortages in positions requiring highly skilled or highly educated workers. Iv. Employers Comments. Multiple commenters said the proposal would have the following negative impacts on employers without providing substantive rationale.

Many industries and companies benefit from entry-level employees who bring energy, innovation, and diversity. The proposal would reduce the number of H-1B workers “that employers can access”. The rule may incentivize employers to favor domestic applicants in the short term, but businesses may not be able to hire the people best suited for the job in the long run. Companies would suffer because foreign employees will not waste their time with companies that they do not think will be able to sponsor them for a visa.

To be competitive in the H-1B registration process, companies would have to pay double the costs for new hires. This rule would be beneficial for a few industries and create biases for other industries. The rule would jeopardize the employers' ability to meet business objectives, develop and provide new products to market, and stay competitive in a global market. This proposal would create “vicious competition cycles” among H-1B candidates and their employers.

And, if this proposal were implemented, there would be a shortage in the job market for junior level employees. Response. For the reasons explained above, DHS disagrees with the assertions that this rule will preclude or essentially preclude H-1B status for recent graduates and entry-level workers. The rule is not intended to, and DHS does not expect that it will, reduce the number of cap-subject H-1B workers.

As explained in the NPRM and above, DHS believes that the rule will maximize H-1B cap allocations so that they more likely will go to the best and brightest workers, consistent with Congressional intent. DHS believes that this rule will facilitate the admission of higher-skilled workers or those for whom employers proffer wages commensurate with higher prevailing wage levels, which will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program. Finally, as stated in the NPRM and above, employers that might have petitioned for a cap-subject H-1B worker to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S. Workers for those positions.

(a) Impacts on Companies Comments. A couple of professional associations stated that the proposal would have an adverse impact on petitioners in terms of employment, productivity loss, search and hire costs, lost profits resulting from labor turnover, and more. One of these professional associations added that the use of wage data for selection of H-1B registrants would unfairly discriminate against and burden law-abiding employers. The commenter also argued that the current H-1B registration has been beneficial to employers because it has a much earlier indication of the lottery's outcome, and that the proposal would “diminish predictability” for companies.

A trade association said the rule would place an excessive cost burden on petitioners because they would be required to offer dramatically increased wages to prospective H-1B employees, especially in conjunction with the new increased wage levels implemented through the DOL IFR.[] The commenter stated that employers would be “forced” to offer prevailing wages above the 95th percentile to equal or exceed level IV prevailing wages. Another trade association argued that the proposal, in conjunction with the DOL IFR, may result in pay that exceeds that of comparable U.S. Workers, which may result in personnel strains and new costs for U.S. Companies.

Several commenters, including a professional association, company, and research organization, stated that employers would be “forced” to either forego hiring foreign professionals or hire foreign workers at a salary level higher than U.S. Workers, which would cause problems for the employers such as internal equity issues. An individual commenter stated that the rule would create public relations problems for companies, arguing that “forcing” companies to pay foreign workers more than the market currently dictates would disenfranchise U.S. Workers in similar positions.

Response. DHS disagrees that this rule will unfairly discriminate against and burden law-abiding employers. While petitioners may initially spend more on search and hire costs to obtain foreign workers who command higher wages or have higher skill levels, DHS believes Start Printed Page 1688these petitioners will see an increase in productivity as a result of hiring such higher-skilled workers. Regarding the benefits of the registration process, this rule will continue to use the same registration process (with the added factor of ranking and selection by wage level), which will continue to provide predictability for companies in the H-1B cap selection process.

In fact, this rule may increase predictability for companies offering relatively higher wages in order to increase their chances of selection. As for the concern about offering prevailing wages above the 95th percentile, DHS notes that the DOL IFR was set aside and no longer is being implemented as of the publication of this final rule.[] As for the concerns about “internal equity issues” or “public relations problems” caused by paying foreign workers more than the U.S. Workers in similar positions, nothing in this rule requires an employer to offer an H-1B worker a higher wage than a U.S. Citizen worker for the same position.

(b) Impacts on Available Workforce Comments. Several commenters, including a professional association and a trade association, argued that the proposal would harm the ability of U.S. Companies to hire aliens for entry-level jobs. A company asserted that the NPRM would diminish U.S.

Companies' access to the full range of talent, across all career stages, necessary to build a complete workforce. An advocacy group similarly said that the rule does a disservice to companies struggling to fill talent gaps across multiple levels of employment. An individual commenter said the rule would end the H-1B program “for good” for many professions that are in short supply. An individual commenter argued that the proposal makes the H-1B process more challenging for both small and large employers who have relatively small numbers of H-1B workers compared to the overall workforce, and makes it “almost impossible” to fill certain positions without being able to supplement the U.S.

Workforce. A trade association said that the proposal is an example of “government heavy-handedness” which presents U.S. Companies with prospective difficulties in meeting workforce needs. An anonymous commenter said the rule would severely interrupt many U.S.

Companies' operations, as it would disqualify many foreign workers fulfilling specialty jobs and make it difficult for companies to find reasonable substitutes for the labor. The commenter stated that DHS' statement that these disadvantages would be offset by increased productivity and availability of higher wage H-1B petitioners is “optimistic” and lacks support. An individual commenter said their company would be impacted because entry-level STEM candidates have played critical roles throughout the organization, and the proposal would mean they would be unable to draw from the world's leading talent. In addition, some of their H-1B employees gain OPT through the company, and it would be detrimental to their business to be forced to terminate these employees after they have received training.

Response. DHS acknowledges that, under this final rule, an employer offering a level I wage under the regular cap, and an employer offering a level I or II wage under the advanced degree exemption, may have a reduced chance of selection than under the current random selection process. However, DHS believes that selecting based on wage level is necessary and consistent with the intent of the H-1B statutory scheme to utilize the numerical cap in a way that incentivizes a U.S. Employer's recruitment of beneficiaries for positions requiring the highest prevailing wage levels or proffering wages equaling or exceeding the highest prevailing wage levels relative to their SOC code and area of intended employment, either of which correlate with higher skill levels.[] Prospective employers who seek to “draw from the world's leading talent” may maximize their likelihood of selection by offering wages commensurate with such a high skill level rather than offering relatively low wages.

Further, DHS disagrees with suggestions that this rule would end the H-1B program's utility for certain companies or disqualify many foreign workers fulfilling specialty occupation jobs. This rule does not affect current H-1B employees (unless such workers become subject to the H-1B numerical allocations in the limited circumstance that their cap-exempt employment terminates) nor does the rule change the eligibility criteria to qualify for an H-1B visa. (c) Impacts on Specific Types of Employers Comments. A professional association said that the proposal would negatively impact the information technology (IT) industry, which already is facing a scarcity of high-skilled candidates.

The commenter cited a study, which found that there were over 650,000 unfilled computer-related jobs posted between September and October 2020, which often are filled with employees from abroad with degrees. The proposed rule would limit the ability of IT companies to hire foreign workers and would stifle U.S. Innovation, harm economic growth and, therefore, impact job opportunities for U.S. Workers.

An individual commenter discussed how the proposed rule actually would achieve the opposite of its desired outcome, which would be increased wages for H-1B workers, particularly in the IT sector. The commenter explained that companies are realizing that employees can accomplish their jobs at home during the buy antibiotics crisis. If this is the case, employers could avoid the costs associated with foreign worker sponsorship and, instead, employ H-1B workers at lower wages while they remain in their respective countries. A research institute explained that the proposed rule is targeting the IT industry to prevent employers in that industry from obtaining H-1B visas or making it too expensive for them to employ H-1B visa holders.

An individual argued that a financial technology company would be negatively impacted, giving the example of a Database Administrator position, which the commenter said does not require a level III or IV prevailing wage, but often is difficult to fill with U.S. Workers. A couple of individual commenters, an advocacy group, and a professional association said that companies need workers through the H-1B program because there are not enough qualified U.S. Workers in STEM fields.

Another individual commenter cited a STEM worker shortage, arguing that the United States should be “rolling out the welcome mat” for high-skilled talent. A professional association and an individual commenter also addressed the claimed current STEM shortage and explained how the proposed rule would further hurt employers' ability to hire college-educated foreign workers. A trade association stated that the proposed rule would make the H-1B visa program unusable for many engineering firms. The association, Start Printed Page 1689citing data from the National Science Foundation, asserted that the engineering workforce is growing slower than the demand for engineers, and is growing older.

Therefore, the engineering industry needs to be able to access labor from around the world to fill key positions. A company and a professional association said that U.S. Graduates with advanced degrees in STEM, such as computer science, IT, or industrial engineering, are predominately foreign students and that the NPRM would negatively harm companies seeking these employees. A medical device company that employs research and development (R&D) engineers stated that the rule would result in poorer talent to develop medical technologies or higher wages to international talent, which would reduce overall R&D resources and impact their ability to deliver the best healthcare technologies.

A trade association said that restricting H-1B visas to senior professionals with higher wages would negatively impact manufacturers and their ability to hire aliens with STEM education and training to fill roles as researchers, scientists, engineers, and technicians. The commenter explained that the NPRM may deter aliens from attending college in the United States and restrict the talent pipeline. Further, the commenter stated that manufacturers rely on a skilled and innovative workforce that allows them to remain competitive, and that this NPRM will provide other countries a competitive advantage. This is coupled with the claim that the workforce challenge is expected to get worse in the future, with studies showing that nearly half of the 4.6 million manufacturing jobs could go unfilled, according to the commenter.

A university and an individual stated that the proposed system would encourage employers to artificially inflate their job requirements to increase the chance of acceptance through the lottery, creating an unfair advantage for larger employers. An individual commenter similarly said the rule disproportionately favors companies willing to pay the most money to foreign workers. An individual commenter said the rule would pit companies against each other to provide the highest salary, which would give larger tech companies control over the H-1B selection lottery. A law firm stated that start-up companies would be negatively impacted because they do not have the capital to be able to offer “obscenely high salaries” to be competitive in this process.

A few commenters noted that the increased difficulty in obtaining H-1B workers could have a negative effect on R&D or innovation at their companies. For example, a professional association said that companies in the automotive sector that have committed hundreds of millions of dollars to developing fuel-efficient engines no longer would be able to hire and retain recent graduates who have the academic background necessary to drive innovation through the H-1B program. Another professional association wrote that the proposed rule would negatively impact companies developing products that strengthen national security, as it would diminish the ability of U.S. Employers to hire workers for the development of technology including artificial intelligence, quantum information science, robotics, and fifth-generation communications technology.

Response. DHS does not believe this rule will have a disparate negative impact on IT companies, financial technology companies, engineering firms, manufacturers, or companies in any particular industry. Additionally, DHS does not believe this rule will disadvantage companies developing products that strengthen national security or companies driving innovation in the automotive sector. Instead, DHS believes this rule will incentivize employers to proffer higher wages, or to petition for positions requiring higher skills and higher-skilled aliens that are commensurate with higher wage levels, thereby attracting the best and the brightest employees and promoting innovation across all industries.

Moreover, DHS disagrees with the assertion that this rule will make the H-1B visa program “unusable” for engineering firms. While DHS acknowledges that some data may show that the engineering workforce is growing slower than the demand for engineers, DHS disagrees with the commenter that this means engineering firms must hire entry-level foreign workers to fill this gap. In fact, DHS data shows that, for “Architecture and Engineering Occupations,” there has been a significant number of petitions filed for level III and IV positions. Specifically, for FYs 2018 and 2019, employers filed 11,519 and 7,045 petitions (total of 18,564) for level III and IV positions, respectively, compared to 15,625 and 25,147 petitions (total of 40,772) for level I and II positions, respectively.[] While registrations ranked according to prevailing wage level I and below likely will face reduced chances of selection, those ranked according to level II and greater stand increased chances of selection, as discussed in the NPRM.

DHS also disagrees that the rule will disadvantage the IT industry or stifle innovation. Conversely, DHS believes this rule may increase innovation and productivity.[] Notably, other commenters claimed that this rule would favor the IT industry (which DHS disputes as well). Again, and as made apparent through these conflicting comments, DHS does not believe this rule will have a disparate negative or positive impact on the IT industry or companies in any particular industry. Comment.

An individual commenter stated that the rule would negatively impact non-profit organizations and public schools because they would need to compete with and pay the prevailing wages offered by for-profit businesses. Another individual commenter said that non-profits do not operate to maximize profit, and that their budgets cannot accommodate level III or IV prevailing wages. The commenter also argued that there is a large need for immigrant social workers who are able to better connect with and relate to the large population of noncitizens in the United States. Another commenter claimed that, if the H-1B proposed changes go into effect, many school districts throughout the United States would have a difficult time finding teachers.

Response. DHS does not believe that this rule will have a significant negative impact on non-profit organizations or public schools. Congress already exempted from the H-1B cap any alien who is employed or has received an offer of employment at an institution of higher education, a related or affiliated non-profit entity, or a non-profit research organization or a governmental research organization.[] Thus, many petitions for non-profits will not be affected by this rule. Some public schools also are exempt from the H-1B cap based on their affiliation with Start Printed Page 1690institutions of higher education.[] For those non-profit entities or public school districts that are not cap-exempt and are unable to proffer wages that equal or exceed prevailing wage levels with greater chances of selection, they may be able to find available and qualified workers outside of the H-1B program.[] (d) Other Comments on Impacts on Employers Comments.

Multiple commenters argued that the rule likely would result in a significant and sudden downturn in immigration casework, and would cause immigration law firms to scale back operations and lay off staff, at a time when the U.S. Economy already is in a precarious position and unemployment is high. Response. DHS disagrees with these commenters as this rule is not intended or expected to result in fewer H-1B workers in the United States, and will not affect existing H-1B workers, unless such workers become subject to the numerical allocations, and therefore should not reduce workload for immigration law firms overall.

Employers with existing H-1B employees, who are not affected by this rule, may still need immigration law firm services. In addition, while some employers may opt not to participate in the H-1B program as a source for potential new employees and may not require immigration law firm services for those potential new employees as a result, given the high demand for H-1B visas, other employers may have the opportunity to begin participating in the program or to increase their existing participation in the program and may require increased services of immigration firms and attorneys. Therefore, DHS does not anticipate that this rule will have a negative overall impact on law firms and attorneys. Comments.

Multiple commenters reasoned that, with a focus on base wages, the proposed rule may result in employers abandoning the use of variable compensation, such as bonuses, profit-sharing payments, stock, and other incentives tied to performance. A commenter argued that variable pay can benefit a company by focusing organizations, business units, and individuals on specific goals and objectives. Alternatively, employers offering such compensation packages may be disadvantaged relative to others offering solely wage-based compensation. Response.

DHS recognizes that companies may offer various forms of benefits and benefits provided as compensation for services, such as cash bonuses, stock options, paid insurance, retirement and savings plans, and profit-sharing plans. While cash bonuses may, in limited circumstances, be counted towards the annual salary,[] other forms of benefits such as stock options, profit sharing plans, and flexible work schedules may not be readily quantifiable or guaranteed, which means that they cannot reliably be calculated into proffered wages. Further, as one commenter pointed out, if a beneficiary is highly valued, that beneficiary may be able to discuss with their employer changes to their compensation structure that could result in a more easily quantifiable proffered wage. V.

Economy Comments. Multiple commenters said the proposal would have the following negative impacts on the economy without providing substantive rationale. The rule would hurt the overall economy. The American public would assume the increased cost of labor through hidden corporate taxes or increased costs of services.

This would affect U.S. Economic development because many young people will be blocked by this new rule. This proposal would increase economic and cultural divisions that already exist because it would eliminate all “interactive possibilities from social and cultural disciplines”. The proposed rule would harm the U.S.

Economy because the United States needs international students to bring funds to the country to study and live. International students educated at U.S. Colleges have better acculturation to U.S. Society, which is very important for long-term growth of the economy.

An individual commenter stated that the proposal would “gut the system” and lead to further economic decline. Other commenters argued that this rule would hurt the economy during a global zithromax when the economy is suffering. An individual commenter said that, to rebound from the zithromax and meet the challenges that face the United States, the country must expand opportunities for skilled workers, particularly in the STEM and health professions. A few individual commenters asserted, without evidence, that the proposal is based on the “false premise” that individuals who earn more contribute more to the economy, and that the rule promotes falsities about the workers who strengthen the U.S.

Economy. A few individual commenters stated that the proposal provides no evidence that higher wages correspond with labor needs of employers or provide a greater economic benefit. Response. DHS does not agree that this rule will harm the U.S.

Economy or economic development, increase costs for the American public, or increase cultural or economic divisions. Instead, DHS believes that this rule will facilitate the admission of higher-skilled workers, which will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program. It may also benefit U.S. Workers, as employers that might have petitioned for cap-subject H-1B workers to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S.

Workers for those positions. Comments. A university said that foreign graduates do not take jobs from U.S. Citizens, but, rather, they create new jobs and contribute “billions” to the economy.

An individual commenter argued that attracting the best and brightest from around the world for education and employment helps to drive innovation and benefits the U.S. Economy and nation as a whole, but the proposed rule would not lead to that outcome. An individual cited numerous studies in arguing that the current framework, in contrast to a proposed “best and brightest” prioritization, generates more economic benefits of the type intended by Congress. Several other commenters argued that the rule would cause professionals to seek careers elsewhere.

A law firm stated that the rule could halt innovation in the United States, as studies have shown a positive correlation between foreign students and innovation. An advocacy group said that the rule would risk preventing highly skilled professionals from bringing their talents to the United States, despite their education and skill, which likely would result in the United States missing out on the contributions of needed talent across multiple industries. A trade association stated that “each facet” of the U.S. Workforce is enabled by an Start Printed Page 1691immigration system that allows access to foreign talent to allow employers to remain competitive, and argued that highly-skilled foreign executives and managers help run key aspects of U.S.

Companies that create thousands of jobs for domestic workers. The commenter said that it is this “synergy” between aliens and U.S. Residents that underpins the United States' “vibrant” economy. An attorney argued that the United States would lose the benefits that come with younger, recently educated professionals whose value already has been assessed against the ease of employing U.S.

Applicants. An advocacy group said that the U.S. Population is aging, and the country needs immigrants to help the economy grow. In addition, the commenter said that, for the United States' innovation future, the country needs international students.

An individual commenter stated that favoring aliens far into their careers over young professionals is “perverse” because they may have only a decade of their careers left, which is not in the country's best interest. Another commenter said that this proposal could result in future H-1B participants who are older, not necessarily high-skilled, and have no exposure to American culture. The commenter said international students and the H-1B program are key drivers of job growth and economic dynamism, and altering the H-1B program to exclude recent graduates may stymie these positive effects. Response.

DHS appreciates the economic contributions that highly skilled aliens make to the United States. Rather than reducing such contributions or halting innovation, DHS believes that this rule will incentivize employers to attract and recruit highly-skilled aliens, as opposed to the current random selection process that “favors companies hiring workers with interchangeable skills en masse over those with a pressing need to hire specific foreign experts,” [] and, thus, will benefit the economy overall.[] The rule is not intended to, and DHS does not expect that it will, reduce the number of H-1B workers. DHS also notes that this rule does not preclude recent graduates from obtaining H-1B status or employers from directly sponsoring a recent foreign graduate for an employment-based immigrant visa. Although this rule will reduce the chance of selection for those at lower wage levels in years of excess demand, DHS believes that selecting by wage level in such years is more consistent with the dominant legislative purpose of the H-1B program, which is to help U.S.

Employers fill labor shortages in positions requiring highly skilled or highly educated workers. Furthermore, DHS disagrees with the commenter that selecting higher paid and/or more highly skilled workers necessarily means that employers will be selecting those with less time left in their careers and thus those who will not be in the country's best interest. In addition, DHS does not believe that the time spent in the workforce determines the degree of contribution to the economy or the country. As explained in the NPRM and above, DHS believes that the rule will maximize H-1B cap allocations so that they more likely would go to the best and brightest workers.

Comments. Several commenters said that the proposal could have the unintended consequence of “forcing” entire businesses offshore. A professional association said that the proposal would result in more companies outsourcing jobs abroad and would discourage innovation. An individual commenter said that each job that is off-shored will take with it multiple other U.S.

Positions because the United States will lose the economic contributions of foreign workers, such as rented apartments, home mortgages, cares, groceries, and more. Another commenter said that this rule would make it more expensive for companies to hire in U.S. Locations, and they eventually would move entire sections of their operation overseas or outsource labor, hurting U.S. Workers in the long run.

Response. DHS disagrees with the commenters who state that this rule will cause employers to move operations to other countries. These commenters cited research [] suggesting that restricting H-1B immigration is likely to cause multinational firms to offshore their highly skilled labor as the basis for concerns about this rule. However, DHS disagrees that this rule restricts H-1B immigration.

Again, this rule does not affect the statutorily mandated annual H-1B cap, nor does it affect substantive eligibility requirements for an H-1B visa. While DHS acknowledges this rule may impose costs to individual employers, neither the comments nor sources cited address the countervailing impact on those level III and IV employers impacted or benefited by this rule. DHS believes that this rule, instead, will facilitate the admission of higher-skilled workers, which will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program. Comments.

A couple of commenters, including a trade association, said that, in many cases, the proposed rule would require employers to pay their H-1Bs more than the actual market wages for U.S. Citizens holding comparable positions. An individual commenter argued that prioritizing wages conflicts with the current DOL Prevailing Wage system, which ensures that H-1B holders do not depress the wages of U.S. Workers.

A company said that artificially raising the amount of money an employer must devote to paying H-1B workers would result in the company employing fewer workers overall, including U.S. Workers. The commenter's reasoning was that, as a salary-focused “arms race” begins, employers would rely less and less on labor and more on technology and other means to avoid the unsustainable wage levels. Another commenter said the proposal would create the issue of wage discrimination against U.S.

Employees because an employer would have to offer a higher level of pay to H-1B applicants than to citizens for the same position. Response. To the extent that these comments refer to wages required as a result of the DOL IFR, DHS notes that, on December 1, 2020, the U.S. District Court for the Northern District of California issued an order in Chamber of Commerce, et al.

V. DHS, et al., No. 20-cv-7331, setting aside the Interim Start Printed Page 1692Final Rule Strengthening Wage Protections for the Temporary and Permanent Employment of Certain Aliens in the United States, 85 FR 63872 (Oct. 8, 2020), which took effect on October 8, 2020, and implemented reforms to the prevailing wage methodology for the Permanent Employment Certification, H-1B, H-1B1, and E-3 visa programs.

Similarly, on December 3, 2020, the U.S. District Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No.

20-cv-14604, applying to the plaintiffs in that case. On December 3, 2020, DOL announced that it is taking necessary steps to comply with the courts' orders and is no longer implementing the IFR.[] As explained in the NPRM, the ranking process established by this rule does not alter the prevailing wage level associated with a given position for DOL purposes, which is informed by a comparison of the requirements for the proffered position to the normal requirements for the occupational classification. While DHS acknowledges that this final rule will result in more registrations (or petitions, as applicable) being selected for relatively higher paid, higher-skilled beneficiaries, the rule does not change, and does not conflict with, prevailing wage requirements. This final rule merely fills in a statutory gap regarding how to administer the H-1B numerical allocations in years of excess demand.

DHS disagrees with the contentions that, by raising salaries for H-1B workers, this rule will cause employers to reduce their overall workforce including U.S. Workers, rely less on labor, or pay their H-1B workers more than their U.S. Workers holding comparable positions. First, by incentivizing employers to use the H-1B program to fill positions requiring higher prevailing wage levels, or proffering wages commensurate with higher prevailing wage levels, employers may see a possible increase in productivity, as explained in the NPRM.

Because of the possible increase in productivity, it is not necessarily the case that employers would employ fewer workers overall or rely less on labor. DHS believes that this rule will facilitate the admission of higher-skilled workers, which will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program. Second, concerning the contentions that this rule would force employers to pay their H-1B workers more than their U.S. Workers or otherwise harm U.S.

Workers, this final rule does not mandate employers to pay more for their H-1B workers. Again, this rule merely fills in a statutory gap regarding how to administer the H-1B numerical allocations in years of excess demand. And as stated in the NPRM, this rule may provide increased opportunities for lower-skilled U.S. Workers in the labor market to compete for work as there would be fewer H-1B workers paid at the lower wage levels to compete with U.S.

Workers, and may incentivize employers to recruit available and qualified U.S. Workers. C. General Wage-Based Selection Concerns Comments.

Many commenters, mostly individual commenters, generally disagreed with the proposed rule and expressed wage-based selection concerns without providing substantive rationale, stating that. Wage is not the only factor to judge the value of a worker, and the rule erroneously assumes that salary is the best indicator of a worker's value to society. H-1B wages are commensurate with experience and should not be used to establish eligibility. Basing selection on wage levels violates U.S.

Values, such as fairness and justice. Every position has “many wages,” so it is better to distinguish people within a position rather than based on wages. Certain locations in the United States, such as rural areas, have lower wages compared to large cities with higher wage levels. The proposed rule would hamper regional development for rural areas because employers in these communities would not be able to pay the high wages to hire H-1B workers.

Whether an individual can get an H-1B visa depends on how important their work is to the country and does not depend on how much they can earn. The rule will damage U.S. Talent capital investments because “current price does not equal to final quality”. Ranking by wage is not an accurate reflection of one's skill level because it could simply be based on age or years of experience.

There are lower-paying jobs which still need to be filled by H-1B visa workers. Basing selection on salary is unfair because the salary starting point and growth speed are different for different industries. The proposed rule does not address abuse in the H-1B program, such as staffing companies filing multiple petitions for each person and full-time workers filing as part-time so that their salary on file is doubled. This proposal artificially could increase wages, and wages should be determined by supply and demand instead.

And, in some industries or locations, the beneficiaries' base salaries are similar enough to fall into one or two categories, which would make them likely to be the same as a random lottery under DOL's new prevailing wage level calculations. Response. DHS believes that an employer who offers a higher wage than required by the prevailing wage level does so because that higher wage is a clear reflection of the beneficiary's value to the employer, which reflects the unique qualities the beneficiary possesses. Thus, DHS believes this rule will benefit the best and brightest workers in all professions.

DHS does not agree that this rule will favor certain high-paying professions or companies, as the rule takes into account the wage level relative to the SOC code—as opposed to salary alone—when ranking registrations. Regarding the concern for depressed areas, the rule equalizes geographic differences in salary amounts by taking into account the area of intended employment when ranking registrations. Particularly, as stated in the final rule, USCIS will select H-1B registrations based on the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment. In ranking according to the wage level, the final rule makes it so that registrations for the same wage level will be ranked the same regardless of whether their proffered wages are different owing to their areas of intended employment.

Regarding the concerns about fairness, DHS believes that this rule is fair to U.S. Workers, H-1B workers, and petitioners. Conversely, the current random selection process is not fair to U.S. Workers whose wages may be adversely affected by an influx of relatively lower-paid H-1B workers, or to U.S.

Employers who have sought to petition for foreign workers at higher OES prevailing wage levels and are not selected. 3. Other General Feedback Comment. An immigration practitioner in Guam noted that many H-1B visas are awarded to engineers coming to perform projects for the military realignment in Guam, and that this rule poses a threat to those projects' timely completions.

Response. DHS disagrees with this commenter. H-1B workers in Guam (or the Commonwealth of the Northern Start Printed Page 1693Mariana Islands (CNMI)) are exempt from the statutory numerical limitation for H-1B classification until December 31, 2029.[] As this final rule simply modifies the registration requirement applicable to cap-subject H-1B petitions, it will not affect cap-exempt H-1B petitions for engineers or other H-1B workers coming to work in Guam (or the CNMI). B.

Basis for Rule 1. DHS Statutory/Legal Authority Comments. A few individuals supported the rule, saying that the changes to H-1B selection are consistent with Congressional intent and statutory language. Another commenter argued that the INA's silence is an “invitation” for USCIS to establish criteria to prioritize petitions.

Likewise, a research organization commented that the statutory language is ambiguous and USCIS' proposal would reasonably address the ambiguity. Response. DHS agrees with these comments that the rule is consistent with Congressional intent and statutory language. The statute is silent as to how USCIS must select H-1B petitions, or registrations, to be filed toward the numerical allocations in years of excess demand.

The term “filed” as used in INA section 214(g)(3), 8 U.S.C. 1184(g)(3), is ambiguous. And these changes are reasonable and within DHS' general authority. DHS, therefore, is relying on its general statutory authority to implement these regulations to design a selection system that prioritizes selection generally based on the highest prevailing wage level that a proffered wage equals or exceeds.

See INA section 103(a), 214(a) and (c)(1), 8 U.S.C. 1103(a), 1184(a) and (c)(1). Comment. A business association generally argued that Acting Secretary Chad Wolf's tenure is in violation of the Homeland Security Act and the Federal Vacancies Reform Act (FVRA).

Similarly, a professional association commented that Acting Secretary Wolf's tenure also violates Executive Order (E.O.) 13753, which established a DHS order of succession. The commenter added a citation to a U.S. Government Accountability Office (GAO) report concluding that Acting Secretary Wolf's appointment violated the order of succession. The commenter also provided citations to court decisions overturning DHS rulemakings based on Acting Secretary Wolf's authority.

Finally, the commenter argued that DHS's attempted corrections of issues concerning Acting Secretary Wolf's tenure are insufficient to cure rules promulgated under his authority. Response. DHS disagrees with the commenters that Acting Secretary Wolf's tenure is in violation of the HSA and the FVRA. Secretary Wolf is validly acting as Secretary of Homeland Security.

On April 9, 2019, then-Secretary Nielsen, who was Senate-confirmed, used the authority provided by 6 U.S.C. 113(g)(2) to establish the order of succession for the Secretary of Homeland Security.[] This change to the order of succession applied to any vacancy. This exercise of the authority to establish an order of succession for DHS pursuant to 6 U.S.C. 113(g)(2) superseded the FVRA and the order of succession found in Executive Order 13753, 81 FR 90667 (Dec.

9, 2016). As a result of this change, and pursuant to 6 U.S.C. 113(g)(2), Kevin K. McAleenan, who was Senate-confirmed as the Commissioner of U.S.

Customs and Border Protection, was the next successor and served as Acting Secretary without time limitation. Acting Secretary McAleenan subsequently amended the Secretary's order of succession pursuant to 6 U.S.C. 113(g)(2), placing the Under Secretary for Strategy, Policy, and Plans position third in the order of succession, below the positions of the Deputy Secretary and Under Secretary for Management.[] Because the Deputy Secretary and Under Secretary for Management positions were vacant when Mr. McAleenan resigned, Mr.

Wolf, as the Senate-confirmed Under Secretary for Strategy, Policy, and Plans, was the next successor and began serving as the Acting Secretary. Further, because he has been serving as the Acting Secretary pursuant to an order of succession established under 6 U.S.C. 113(g)(2), the FVRA's prohibition on a nominee's acting service while his or her nomination is pending does not apply, and Mr. Wolf remains the Acting Secretary notwithstanding President Trump's September 10, 2020, transmission to the Senate of Mr.

Wolf's nomination to serve as DHS Secretary.[] That said, there have been recent challenges to whether Mr. Wolf's service is invalid, resting on the erroneous contention that the orders of succession issued by former Secretary Nielsen and former Acting Secretary McAleenan were invalid. The Department believes those challenges are not based on an accurate view of the law. But even if those contentions are legally correct—meaning that neither former Secretary Nielsen nor former Acting Secretary McAleenan issued a valid order of succession—under 6 U.S.C.

113(g)(2)—then the FVRA would have applied, and Executive Order 13753 would have governed the order of succession for the Secretary of Homeland Security from the date of former Secretary Nielsen's resignation. The FVRA provides an alternative basis for an official to exercise the functions and duties of the Secretary temporarily in an acting capacity. In that alternate scenario, under the authority of the FVRA, Mr. Wolf would have been ineligible to serve as the Acting Secretary of DHS after his nomination was submitted to the Senate, 5 U.S.C.

3345(b)(1)(B), and Peter Gaynor, the Administrator of the Federal Emergency Management Agency (FEMA), would have—by operation of Executive Order 13753—become eligible to exercise the functions and duties of the Secretary temporarily in an acting capacity. This is because Executive Order 13753 pre-established the President's succession order for DHS when the FVRA applies. Mr. Gaynor would have been the most senior official eligible to exercise the functions and duties of the Secretary under that succession order, and thus would have become the official eligible to act as Secretary once Mr.

Wolf's nomination was submitted to the Senate.[] Then, in this alternate scenario in which, as assumed above, there was no valid succession order under 6 U.S.C. 113(g)(2), the submission of Mr. Wolf's nomination to the Senate would have restarted the FVRA's time limits. 5 U.S.C.

3346(a)(2). Out of an abundance of caution, and to minimize any disruption to DHS and to the Administration's goal of maintaining homeland security, on November 14, 2020, with Mr. Wolf's nomination still pending in the Senate, Mr. Gaynor exercised the authority of Acting Secretary that he would have had (in the absence of any governing succession order under 6 U.S.C.

113(g)(2)) to designate a new order of succession under 6 U.S.C. 113(g)(2) (the Start Printed Page 1694“Gaynor Order”).[] In particular, Mr. Gaynor issued an order of succession with the same ordering of positions listed in former Acting Secretary McAleenan's November 2019 order. The Gaynor Order thus placed the Under Secretary for Strategy, Policy, and Plans above the FEMA Administrator in the order of succession.

Once the Gaynor Order was executed, it superseded any authority Mr. Gaynor may have had under the FVRA and confirmed Mr. Wolf's authority to continue to serve as the Acting Secretary. Hence, regardless of whether Mr.

Wolf already possessed authority pursuant to the November 8, 2019, order of succession effectuated by former Acting Secretary McAleenan (as the Departments have previously concluded), the Gaynor Order provides an alternative basis for concluding that Mr. Wolf currently serves as the Acting Secretary.[] On November 16, 2020, Acting Secretary Wolf ratified any and all actions involving delegable duties that he took between November 13, 2019, through November 16, 2020, including the NPRM that is the subject of this rulemaking. Under section 103(a)(1) of the Act, 8 U.S.C. 1103(a)(1), the Secretary is charged with the administration and enforcement of the INA and all other immigration laws (except for the powers, functions, and duties of the President, the Attorney General, and certain consular, diplomatic, and Department of State officials).

The Secretary is also authorized to delegate his or her authority to any officer or employee of the agency and to designate other officers of the Department to serve as Acting Secretary.[] The Homeland Security Act further provides that every officer of the Department “shall perform the functions specified by law for the official's office or prescribed by the Secretary.” [] Comments. Multiple commenters asserted that this rule is ultra vires, inconsistent with Congressional intent, and a clear violation of the INA. Specifically, they contend that the INA sets forth the procedure for allocating visas and prioritizes the selection of H-1B cap-subject petitions in the “order in which they are filed[,]” which does not limit selection under the H-1B cap to those employers who pay the most or otherwise authorize DHS to impose substantive selection criteria. Several commenters stated that USCIS lacks the statutory authority to make such a change and cannot use the statute's purported silence as an invitation to adopt criteria, such as wage level or skill level, to prioritize the selection of H-1B cap subject visas.

Some of these commenters also disagreed with DHS about the statute's silence and stated that Congress has previously made specific modification to the way in which H-1B cap numbers are allocated, specifically, the American Competitiveness in the Twenty-First Century Act of 2000 providing for the numerically limited exemption for beneficiaries who have earned a master's or higher degree from a U.S. Institution of higher education. If Congress intended to make any other changes to the statutory language that H-1B cap numbers “shall be issued. .

. In the order in which petitions are filed[,]” it could have done so as part of that or subsequent legislation. One commenter cited several cases in arguing that general rulemaking authority and statutory silence on an issue is not tantamount to Congressional authorization for rulemaking on a given issue. Another commenter stated that the statute is neither silent nor ambiguous as it states that H-1B visas shall be issued, or H-1B status granted, “in order in which petitions are filed”.

And a trade association commented that the use of the term “shall” indicates that there is no ambiguity as to how petitions may be sorted. One commenter cited several INA provisions in arguing that, where it intended to do so, Congress made distinctions within classes of potential visa applicants, and thus the statute reflects Congressional intent not to distinguish on other bases. One commenter said that the proposed rule would be found unlawful in court, because the law does not make an allowance for basing H-1B visas on salary, and the rule is contrary to the plain language of the statute. A form letter campaign wrote that the law does not require employers to pay H-1B workers more than U.S.

Workers, and the law does not allow the agency to prioritize petitions for higher-wage applicants. Response. DHS disagrees with the commenters' assertions that the statute is not silent or ambiguous and that this rulemaking is ultra vires. As stated in the NPRM, this rule is consistent with and permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C.

1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C. 112.[] DHS created the registration requirement, based on its general statutory authority and its discretion to determine how best to handle simultaneous submissions in excess of the numerical allocations, to effectively and efficiently administer the H-1B cap selection process. Congress expressly authorized DHS to determine eligibility for H-1B classification upon petition by the importing employer, and to determine the form and information required to establish eligibility.[] “Moreover, INA section 214(g)(3) does not provide that petitions must be processed in the order `received,' `submitted,' or `delivered.' Instead, they must be processed in the order `filed.' What it means to `file' a petition and how to handle simultaneously received petitions are ambiguous and were not dictated by Congress in the INA.” [] Rather, these implementation details are entrusted to DHS to administer. So, while the statute provides annual limitations on the number of aliens who may be issued initial H-1B visas or otherwise provided H-1B nonimmigrant status, the statute does not specify how petitions must be Start Printed Page 1695selected and counted toward the numerical allocations when USCIS receives more petitions on the first day than are projected as needed to reach the H-1B numerical allocations.

Consequently, “Congress left to the discretion of USCIS how to handle simultaneous submissions” and “USCIS has discretion to decide how best to order those petitions.” [] DHS acknowledges that INA section 214(g)(3), 8 U.S.C. 1184(g)(3), states that aliens subject to the H-1B numerical limitation in INA section 214(g)(1), 8 U.S.C. 1184(g)(1), shall be issued H-1B visas or otherwise provided H-1B nonimmigrant status “in the order in which petitions are filed for such visas or status.” Contrary to the commenters' assertions, this statutory provision, and, more specifically the term “filed” as used in INA section 214(g)(3), 8 U.S.C. 1184(g)(3), is ambiguous.[] As discussed in the preamble to the Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Cap-Subject Aliens Final Rule (H-1B Registration Final Rule), an indiscriminate application of this statutory language would lead to absurd or arbitrary results.

The longstanding approach has been to project the number of petitions needed to reach the numerical allocations.[] A literal application of this statutory language, as suggested by various commenters, would lead to an absurd or impossible result. The Department of State (DOS) does not issue H-1B visas, and USCIS does not otherwise provide H-1B status, based on the order in which petitions are filed. Such a literal application would necessarily mean that processing delays pertaining to a petition earlier in the petition filing order would preclude issuance of a visa or provision of status to all other H-1B petitions later in the petition filing order. To avoid such an absurd result, the longstanding approach to implementing the numerical limitation has been to project the number of petitions needed to reach the numerical limitation.

The issue, however, is how to select registrations or petitions, as applicable, when the number of submissions exceeds the number projected as needed to reach the numerical limitation or the advanced degree exemption, particularly when those submissions all occur within the same narrow window of time. DHS is not changing the approach to administering the numerical allocations as it relates to the use of projections. DHS is, however, changing the selection process for selecting registrations or petitions, as applicable, to determine which petitions are properly filed and eligible for further processing consistent with INA section 214(g)(3), 8 U.S.C. 1184(g)(3).

DHS created the registration requirement based on its general statutory authority and its discretion to determine how best to handle simultaneous submissions in excess of the numerical allocations, to effectively and efficiently administer the H-1B cap selection process. As provided in the H-1B Registration Final Rule, unless suspended by USCIS, registration is an antecedent procedural step that must be completed by prospective petitioners before they are eligible to file an H-1B cap-subject petition. As with the filing of petitions, and as explained above, a first-come, first-served basis for submitting electronic registrations is unreasonable and practically impossible. While the random selection of registrations or petitions, as applicable, DHS established in the H-1B Registration Final Rule is reasonable, it is neither the optimal nor the exclusive method of selecting petitions or registrations toward the numerical allocations when more registrations or petitions, as applicable, are submitted than projected as needed to reach the numerical allocations.

In that vein, DHS concludes that prioritization and selection based on wage levels “is a reasonable and rational interpretation of USCIS' obligations under the INA to resolve the issues of processing H-1B petitions” [] in years of excess demand and is within DHS's existing statutory authority. Comment. Multiple commenters cited a USCIS response to a comment in the H-1B Registration Final Rule and wrote that USCIS previously supported the position that prioritization of selection based on salary or other substantive factors would require explicit Congressional authorization. Commenters also cited a 1991 rulemaking in arguing that Immigration and Naturalization Service (INS) previously acknowledged that the INA does not authorize establishing criteria to prioritize petitions.

These commenters also provided language from a 1990 INS rulemaking indicating that a statutory change would be necessary to exclude entry-level H-1B workers. A law firm argued that the Agency cannot reverse a position of this kind without providing a reasoned explanation. Response. DHS disagrees with the commenters that prior statements by INS or USCIS preclude DHS from making the changes set forth in this final rule.

DHS acknowledged in the proposed rule that the preamble to the H-1B Registration Final Rule states that prioritization of registration selection on factors other than degree level, such as salary, would require statutory changes. DHS also explained that the prior statement did not provide further analysis regarding that conclusion and that upon further review and consideration of the issue initially raised in comments to the Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Cap-Subject Aliens NPRM (H-1B Registration Proposed Rule),[] DHS concluded that the statute is silent as to how USCIS must select H-1B petitions, or registrations, to be filed toward the numerical allocations in years of excess demand. DHS continues to believe that the changes made in this final rule are within its general authority, consistent with the existing statute, and despite prior statements to the contrary, does not require statutory change or explicit congressional authorization. DHS is relying on its general statutory authority to implement the statute and, consistent with that authority, is revising the regulations to implement a selection system that realistically, effectively, efficiently, and more faithfully administers the cap selection process.

See INA section 103(a), 214(a) and (c)(1), 8 U.S.C. 1103(a), 1184(a) and (c)(1). Start Printed Page 1696 DHS disagrees with the assertion that this rule will exclude entry-level workers. This final rule merely revises how USCIS will select H-1B cap-subject petitions toward the H-1B numerical allocations to determine which petitions are “filed” and eligible for further processing.

The rule does not change substantive eligibility requirements. While DHS acknowledges that registrations or petitions, as applicable, based on a proffered wage that corresponds to a level I or level II wage likely will face a reduced chance of selection in the H-1B cap selection process, the rule does not preclude selection of registrations or petitions for entry-level workers. DHS also disagrees with the commenters' claim that the prior statements by INS in the preamble to the Temporary Alien Workers Seeking Classification Under the Immigration and Nationality Act final rule are relevant to this final rule.[] INS was responding to general comments about administering the numerical limitation, but was not considering how to administer the H-1B numerical allocations when the number of submitted petitions exceeds the numerical allocation. Such circumstances did not exist at the infancy of the H-1B program and when the numerical limitation was created, so this issue was not considered at that time.

Again, this final rule merely revises how USCIS will select H-1B cap-subject registrations or petitions, as applicable, toward the H-1B numerical allocations to determine which petitions are “filed” and thus eligible for further processing. In addition, this final rule addresses how USCIS will select registrations or petitions, as applicable, when the number of submitted registrations or petitions exceeds the projected number needed to reach the numerical allocations. Once properly filed, H-1B cap-subject petitions generally will be processed in order based on the assigned filing date. DHS also disagrees that comments made by INS in the preamble to the 1990 final rule,[] are relevant to the interpretation of DHS's authority to implement the numerical allocations under the existing statute.

The 1990 rule preceded the enactment of the Immigration Act of 1990 (IMMACT 90), Public Law 101-649, 104 Stat. 4978, the creation of the H-1B classification for specialty occupation workers, and the implementation of a numerical limitation on H-1B workers. As such, the statements cited by the commenter are not relevant to the interpretation of the existing statute, including the authority of DHS to administer the H-1B numerical allocations. Comment.

A company stated that USCIS' ability to interpret the term “filed” is not unlimited and that the proposed, complex prioritization scheme unambiguously exceeds the scope of the term. Similarly, a law firm and individual argued that, according to Walker Macy v. USCIS, USCIS does not have “unfettered” discretion to determine which petitions are filed, but, instead, must reasonably interpret the statute. The law firm said the proposed interpretation is unreasonable because of the impacts it would have on U.S.

Companies and innovation. Multiple commenters said that the current system of putting applicants in a lottery when they apply simultaneously comports with the INA's language, but that the proposed methodology would impermissibly deviate from the INA. Similarly, a company stated that Congress' guiding principal for selecting H-1B petitions is timing and that the current lottery system conforms to this principal. An individual commenter similarly argued, citing Walker Macy v.

USCIS, that the proposed rule deviates from the temporal principal without statutory or judicial basis. Other commenters asserted that USCIS' reference to the “dominant legislative purpose” of the statute, construed as prioritizing the application of the most skilled workers, is unreasonable. The commenters reasoned that the INA simply prioritizes filling labor shortages, without regard to wage levels. Several commenters stated that the allowance of H-1B visas for aliens with undergraduate degrees precludes prioritizing petitions based on wage levels.

Response. DHS disagrees with the commenters' assertions that this rule misstates the scope of the term “filed” or that the rule is based on an unreasonable interpretation of the statute. As stated in the NPRM and in response to other comments in this preamble, DHS believes that this rule is consistent with and permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C.

112.[] DHS created the registration requirement, based on its general statutory authority and its discretion to determine how best to handle simultaneous submissions in excess of the numerical allocations (i.e., situations where prioritizing petitions solely in a temporal manner is impossible), to effectively and efficiently administer the H-1B cap selection process. Congress expressly authorized DHS to determine eligibility for H-1B classification upon petition by the importing employer, and to determine the form and information required to establish eligibility.[] “Moreover, INA section 214(g)(3) does not provide that petitions must be processed in the order `received,' `submitted,' or `delivered.' Instead, they must be processed in the order `filed.' What it means to `file' a petition and how to handle simultaneously received petitions are ambiguous and were not dictated by Congress in the INA.” [] Rather, these implementation details are entrusted for DHS to administer. So, while the statute provides annual limitations on the number of aliens who may be issued initial H-1B visas or otherwise provided H-1B nonimmigrant status, the statute does not specify how petitions must be selected and counted toward the numerical allocations when USCIS receives more petitions on the first day than are projected as needed to reach the H-1B numerical allocations. Consequently, “Congress left to the discretion of USCIS how to handle simultaneous submissions” and “USCIS has discretion to decide how best to order those petitions.” [] DHS believes, contrary to commenters' assertions, that prioritization and selection generally based on the highest OES wage level that the proffered wage equals or exceeds “is a reasonable and rational interpretation of USCIS's obligations under the INA to resolve the issues of processing H-1B petitions” [] in years of excess demand and is within DHS's existing statutory authority.

€œIt is a cardinal canon of statutory construction that statutes should be interpreted harmoniously with their dominant legislative purpose.” [] Yet, under the Start Printed Page 1697current registration system the majority of H-1B cap-subject petitions have been filed for positions certified at the two lowest wage levels. I and II.[] This contradicts the dominant legislative purpose of the statute because the intent of the H-1B program is to help U.S. Employers fill labor shortages in positions requiring highly skilled or highly educated workers.[] By changing the selection process, for these years of excess demand, from a random lottery selection to a wage-level-based selection process, DHS will implement the statute more faithfully to its dominant legislative purpose, increasing the chance of selection for registrations or petitions seeking to employ beneficiaries at wages that would equal or exceed the level IV or level III prevailing wage for the applicable occupational classification. Comments.

A couple of commenters said the changes made by the rule should be decided by Congress. Similarly, a few commenters stated generally that the proposal is not authorized by Congress or is in violation of Congressional intent. A few commenters said that 8 U.S.C. 1184(g)(5)(C) (the exemption from the cap for beneficiaries who have earned a master's or higher degree from a U.S.

Institution of higher education) demonstrates that, where Congress intends to target petitions for highly skilled workers, it has done so explicitly. Others commented that, when this cap was legislated, it was clear that petitions still would exceed visa allocations and that the statute should be understood to have intentionally omitted any change to the priority of visa petitions. And one commenter added that the proposed rule would impact the ratio of advanced-degree holders to other H-1B recipients that Congress authorized when providing the 20,000 U.S. Advanced degree exemption.

A company stated that the proposal is untethered to statutory language, providing examples of Congressional “guidance” and reasoning that nowhere in such guidance or the INA is there reference to salary or the OES prevailing wage level as a basis for selecting H-1B petitions. A professional association stated that effectively imposing an additional wage requirement would be inappropriate, especially for physicians. Response. DHS disagrees with these comments.

As stated in the NPRM and as explained above, this rule is consistent with Congressional intent and is permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C. 112.[] Furthermore, DHS disagrees with the commenters' assertions that the statute, or legislative history, indicates that Congress has spoken to the specific issue addressed by this final rule. How to select petitions toward the numerical allocations when the number of petitions filed is greater than the number of petitions projected as needed to reach the H-1B numerical allocations.

As explained in the NPRM and in response to other comments, the statute is silent on this issue. DHS created the registration requirement, based on its general statutory authority and its discretion to determine how best to handle simultaneous submissions in excess of the numerical allocations, to effectively and efficiently administer the H-1B cap selection process. Congress expressly authorized DHS to determine eligibility for H-1B classification upon petition by the importing employer, and to determine the form and information required to establish eligibility.[] “Moreover, INA section 214(g)(3) does not provide that petitions must be processed in the order `received,' `submitted,' or `delivered.' Instead, they must be processed in the order `filed.' What it means to `file' a petition and how to handle simultaneously received petitions are ambiguous and were not dictated by Congress in the INA.” [] Rather, these implementation details are entrusted for DHS to administer. Nor should it be understood that Congress had spoken on this issue when the cap was legislated because it was not clear at that time that petitions would exceed visa allocations on the very first day that petitions could be filed, thus leading to a situation where prioritizing petitions solely in a temporal manner is impossible.

So, while the statute provides annual limitations on the number of aliens who may be issued initial H-1B visas or otherwise provided H-1B nonimmigrant status, the statute does not specify how petitions must be selected and counted toward the numerical allocations when USCIS receives more petitions on the first day than are projected as needed to reach the H-1B numerical allocations. Consequently, “Congress left to the discretion of USCIS how to handle simultaneous submissions” and “USCIS has discretion to decide how best to order those petitions.” [] Comments. Some commenters expressed that this rule is not consistent with the statutory framework Congress implemented for the admission of foreign workers into the United States, as Congress designated DOL to have the primary authority in protecting and enforcing the statute related to the U.S. Labor market and wages.

Multiple commenters stated that Congress did not intend for wage levels to serve as a basis for preferring certain petitions, as evidenced by the statute's prevailing wage requirement. An individual commented that the preamble's statement that “Congress expressly authorized DHS to determine eligibility for H-1B classification upon petition by the importing employer” fails to recognize that this authorization is for USCIS' determination regarding specific employers' applications, rather than for categorically determining which wages or jobs qualify for H-1B visas. Response. DHS disagrees with the commenters assertion that this rule is inconsistent with the statute.

As explained in the NPRM and in response to other comments, DHS believes that this rule is consistent with its statutory authority. DHS agrees that DOL has the primary authority to protect the wages and working conditions of U.S. Workers consistent with the provisions of INA section 212(n), 8 U.S.C. 1182(n), but Start Printed Page 1698those provisions are separate from INA section 214, 8 U.S.C.

1184, and the statutory provisions pertaining to the form and manner of submitting H-1B petitions and the administration of the H-1B numerical allocations, both of which are within DHS's authority consistent with INA section 214, 8 U.S.C. 1184. Further, the fact that Congress authorized DOL to administer and enforce a wage requirement, including setting prevailing wage levels for the H-1B program, does not speak to or limit DHS' authority to establish an orderly, efficient, and fair system for selecting registrations (or, if applicable, petitions), based on OES prevailing wage levels, toward the projected number needed to reach annual H-1B numerical allocations. Comments.

Multiple commenters, as part of a form letter campaign, stated that the legal impact of the proposed rule must be considered together with other recent rules, including the recently published DOL. Another commenter stated that USCIS should work with DOL to appropriately set up the wage levels. Response. On December 1, 2020, the U.S.

District Court for the Northern District of California issued an order in Chamber of Commerce, et al. V. DHS, et al., No. 20-cv-7331, setting aside the DOL IFR.

Similarly, on December 3, 2020, the U.S. District Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No.

20-cv-14604, applying to the plaintiffs in that case. DOL has taken necessary steps to comply with the courts' orders and is no longer implementing the DOL IFR. DHS, therefore, disagrees with the commenter's assertion that DHS must consider the DOL IFR in the context of this final rule. DHS also disagrees with the premise of the commenters' recommendation that DHS work with DOL to set appropriate wage levels.

This final rule is not setting wage levels. As explained in the NPRM and in response to other comments, this final rule changes how DHS will select registrations or petitions, as applicable, toward the projected number needed to reach the annual H-1B numerical allocations. While this final rule uses DOL wage levels to determine how to rank and select registrations or petitions, as applicable, based generally on the wage level that the proffered wage equals or exceeds, this final rule is not mandating employers pay a higher wage nor is it changing wage levels. Comments.

One commenter noted the proposal would make the H-1B process similar to that of the O-1 visa, but that Congress knowingly avoided doing so in 1990. According to the commenter, the new rule, in effect, is redrafting the 1990 legislation to make the H-1B visa more closely resemble the O-1 visa and Congress certainly could have ranked H-1Bs in 1990 if it wanted to do so. Other commenters also noted that the O-1 visa is for those with extraordinary ability, not those just starting their careers, and that the H-1B program serves different purposes. Another commenter also cited a House sponsor of the H-1B program as saying that the O-1 program, not H-1B, was the “best and brightest” program.

Response. DHS disagrees with the claim that it is reforming the H-1B classification to more closely resemble the O-1 classification.[] While DHS acknowledges that this rule will result in more registrations (or petitions, as applicable) being selected for relatively higher-paid, higher-skilled beneficiaries, the rule is not changing substantive eligibility requirements for the H-1B classification and is not, in any way, reforming the H-1B classification to more closely resemble the O-1 classification. This final rule merely fills in a statutory gap regarding how to administer the H-1B numerical allocations in years of excess demand. The statute provides annual limitations on the number of aliens who may be issued initial H-1B visas or otherwise provided H-1B nonimmigrant status, but it does not specify how petitions must be selected and counted toward the numerical allocations when USCIS receives more petitions on the first day than are projected as needed to reach the H-1B numerical allocations.

Consequently, “Congress left to the discretion of USCIS how to handle simultaneous submissions” and “USCIS has discretion to decide how best to order those petitions.” [] The current scheme of pure randomization of selectees does not optimally serve Congress' purpose for the H-1B program. Therefore, this rule will revise the H-1B cap selection process to better align with the purpose of the H-1B program and Congressional intent, taking into account the pervasive oversubscription of demand for registrations and petitions. Comment. An individual noted that Congress previously considered legislation called the I-Squared Act that sought to alter the selection process by ranking H-1Bs based on a number of factors rather than having a random lottery.

That legislation has not passed, which is an indicator that Congress does not see the change as a priority. Conversely, an individual commenter wrote that Congress intended to delegate H-1B visa allocation to USCIS and that the I-Squared bill failed because of other provisions it contained. Response. DHS disagrees with the assertion that the fate of the I-Squared bill is relevant to interpretation of the existing statute.

While Congress has considered such legislation, the failure of such legislation (or any other proposed legislation) to be passed and signed into law does not change the existing authority DHS has under the INA. As explained in response to other comments, DHS believes that selection of registrations or petitions, as applicable, based on corresponding wage level is consistent with the discretion provided to DHS in the current statute to administer the annual H-1B numerical allocations. Comment. A few commenters cited the Senate Report for The American Competitiveness Act as demonstrating Congressional opposition to granting H-1B visas on a preferential basis to the highest-paid aliens.

The commenters argued that the language of the Senate Report contradicts E.O. 13788 and that E.O. 13788 does not establish Congressional purpose or policy, and its emphasis on highly paid beneficiaries as applied in this context would be inconsistent with Congress' direction. Response.

DHS disagrees with these comments because they ignore the fact that DHS has proposed to modify the registration requirement within the context of the annual demand for H-1B cap-subject petitions, including those filed for the advanced degree exemption, consistently exceeding annual statutory allocations. Although Congress instructed that cap-subject H-1B visas (or H-1B nonimmigrant status) be allocated based on the order in which petitions are filed, it was silent with regard to the allocation of simultaneously submitted petitions. While the random lottery selection process is a reasonable solution, DHS believes that an allocation generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds better fulfills Congress' stated intent that the H-1B program help U.S. Employers fill labor shortages in positions requiring highly skilled workers.[] Start Printed Page 1699 This legislative history, as cited in the proposed rule, is consistent with the Senate Report the commenters cite.[] Both support the notion that Congress intended the H-1B program to fill labor shortages in positions requiring highly skilled workers.

Contrary to the commenter's assertion that DHS only cited to E.O. 13788 to support this priority, DHS cited to the legislative history of the Immigration Act of 1990, the legislation that created the H-1B program, to support the priority to allocate generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds.[] DHS cited to E.O. 13788 solely to note that a wage-level based selection was consistent with the administration's policy goals, not as legal authority for the proposed rule. Comment.

An individual commenter and a professional association argued that Presidential Proclamation 10052 is not authoritative to the extent that it conflicts with the INA, and that the proposal fails to explain how it “is consistent with applicable law or is practicable at this point in time,” especially in light of the forthcoming change in administration. Response. DHS disagrees with the assertion that Presidential Proclamation 10052 conflicts with the INA.[] In any event, the authority for this regulation stems not from that proclamation but from DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C.

112. Comment. One commenter stated that salary also is a proxy variable for age, as, in most industries, more experienced individuals get paid higher wages. This commenter asked whether USCIS has the authority to apply “salary” as a secondary sorting mechanism for H-1B registrations, and if so, what would prevent USCIS also from using arbitrary sorting mechanisms such as age, geography, country of birth, race, religion, or gender.

Response. DHS disagrees that salary is a proxy for age. While salary is a reasonable proxy for skill, level of skill is not necessarily correlated to age. DHS also disagrees with the commenter's implied assertion that wage level is an arbitrary sorting mechanism.

As explained in the NPRM and in response to other comments, corresponding wage level is an objective way to prioritize selection in a manner consistent with the general purpose of the H-1B classification. DHS has not proposed, and does not intend to propose, selecting registrations or petitions, as applicable, based on factors that are unreasonable, inappropriate, or inconsistent with the purpose of the H-1B classification. 2. Substantive Comments on the Need for the Rule/DHS Justification Comments.

An anonymous commenter wrote that the proposed rule's wage standard for H-1B visa eligibility is arbitrary and capricious. The commenter said that DHS does not explain the rationale behind making wages the sole indicator of a worker's eligibility for visa sponsorship. The commenter also argued that the rule's rationale is flawed because it would not protect U.S. Workers, since the H-1B visa applies only to specialty occupations.

Another commenter opined that this rule is an attempt to add a new wage requirement as a part of H-1B eligibility. This commenter stated that this attempt is inconsistent with Congressional intent and would be an abuse of discretion by the Department. Response. DHS believes these commenters misstate the scope of this rule.

This rule does not make “wages the sole indicator of a worker's eligibility for [H-1B] visa sponsorship” and does not otherwise change the substantive standards for H-1B eligibility. DHS stated in the NPRM that registration, when required, is merely an antecedent procedural step that must be completed by prospective petitioners before they are eligible to file an H-1B cap-subject petition (emphasis added).[] Even if registration were suspended, the rule merely revises how USCIS would select H-1B cap-subject petitions toward the H-1B numerical allocations to determine which petitions are “filed” and thus eligible for further processing. But the rule does not change substantive eligibility requirements. DHS also disagrees with the commenter's assertion that the rule would not better protect U.S.

Workers. As explained in response to other comments, prioritizing the selection of H-1B registrations or petitions, as applicable, based generally on the highest OES prevailing wage level that the proffered wage equals or exceeds will incentivize employers to offer higher wages or higher-skilled positions to H-1B workers and disincentivize the existing widespread use of the H-1B program to fill relatively lower-paid or lower-skilled positions, for which there may be available and qualified U.S. Workers. DHS, therefore, believes that this rule will benefit U.S.

Workers who compete against entry-level H-1B workers and will incentivize H-1B petitioners to offer higher wages, further benefiting U.S. Workers whose wages might otherwise be depressed by an influx of relatively lower-paid, lower-skilled H-1B workers. A. Support for the DHS Rationale Comments.

Many commenters expressed support for the proposed rule and DHS justification. Several commenters stated that the proposed rule is based on a true premise that salary equates with value. A research organization stated that there is no evidence to suggest that the H-1B program was designed to fill entry-level jobs at entry-level wages, and prioritizing H-1B petitions at high wage levels will safeguard U.S. Wage standards and increase labor efficiency.

The commenter went on to state that prioritizing higher H-1B wage levels will not undermine the program, but, rather, will incentivize recruitment and retention, while also helping U.S. Workers in labor categories that have seen stagnant wage growth in recent history. The commenter reasoned that, because employers do not have to test the market before hiring H-1B workers, wages are a good indicator of the actual market need for workers in a given field. Response.

DHS agrees with these commenters and thanks them for their support. B. Rule Is Based on False Premises/Rationale Comment. Many commenters, including those who participated in an orchestrated form letter campaign, stated that the proposal is based on the false premise that salary alone equates with value and that individuals who earn more in their profession contribute more to the economy.

An individual commenter discussed the fundamental flaw in associating level I and level II workers with low-paying, low-skilled work, where in reality, entry-level doctors, lawyers, engineers, and Start Printed Page 1700architects are professionals performing specialty occupations. A professional association stated that the salaries associated with each wage level do not fully capture an individual's contribution to society. In fact, there often is an inverse correlation. A professional association said DHS has created a condition where employers would be able to buy their way into the proposed H-1B visa cap selection system by offering a higher wage to the beneficiary regardless of skill, which would negate the stated purpose of the proposed rule to garner more high-skilled workers in the U.S.

Workforce. Some commenters said the proposed rule is based on the false premise that foreign workers depress wages and take away jobs from U.S. Workers. A university stated that the foreign workers this rule targets fill critical needs in the U.S.

Labor market, bolster innovation, create jobs, and drive economic growth. The commenter, along with an individual commenter, stated that some studies show foreign workers have a positive impact on wages overall. Similarly, an advocacy group said limiting the amount of high-skilled foreign workers in the United States does not mean that there will be more jobs available to U.S. Workers.

Rather, it would mean many companies would shift jobs overseas. The commenter stated that, if the H-1B program were expanded, it could result in up to 1.2 million new jobs for U.S. Workers. The commenter went on to state that the program does not have a “depressive effect” on U.S.

Worker wages, and concluded by saying that, by restricting the H-1B program, the proposed rule would not have the intended effects of boosting American jobs and wages. An individual commenter stated that USCIS already has protected U.S. Workers by increasing fees and updating the definition of “specialized knowledge,” and there is no need to distort the labor markets and harm U.S. Competitiveness at a time when the U.S.

Can once again be a leader in technology development. Response. DHS disagrees with these comments. DHS believes that salary generally is a reasonable proxy for skill level.[] As stated in the NPRM, in most cases where the proffered wage equals or exceeds the prevailing wage, a prevailing wage rate reflecting a higher wage level is a reasonable proxy for the higher level of skill required for the position, based on the way prevailing wage determinations are made.

DHS believes that an employer who offers a higher wage than required by the prevailing wage level does so because that higher wage is a clear reflection of the beneficiary's value to the employer, which, even if not related to the position's skill level per se, reflects the unique qualities the beneficiary possesses. While we believe that the rule may incentivize an employer to proffer a higher wage to increase their chances of selection, we also believe the employer only would do so if it was in their economic interest to do so based on the beneficiary's skill level and relative value to the employer. DHS acknowledges that aliens may be offered salaries at level I or level II prevailing wages to work in specialty occupations and may be eligible for H-1B status. However, DHS also believes that, in years of excess demand exceeding annual limits for H-1B visas subject to the numerical allocations, the current process of random selection does not optimally serve Congress' purpose for the H-1B program.

Instead, in years of excess demand, selection of H-1B cap-subject petitions on the basis of the highest OES prevailing wage level that the proffered wage equals or exceeds is more consistent with the purpose of the H-1B program and with the administration's goal of improving policies such that H-1B classification is more likely to be awarded to petitioners seeking to employ higher-skilled and higher-paid beneficiaries.[] DHS does not agree that the rule will limit or restrict the number of H-1B workers, and that is not the rule's intent. DHS also does not agree that this rule will result in companies shifting jobs overseas or will harm U.S. Competitiveness. Rather, DHS believes that the admission of higher-skilled workers would benefit the economy and increase the United States' competitive edge in the global labor market.

Comment. An individual commenter stated that the lowest paid H-1B worker makes more than H-2 workers, and yet, the administration has expanded the H-2 guest worker program and is presently seeking to lower prevailing wages for these workers, suggesting that “increasing the wages paid to foreign workers is not actually a consistent policy or priority for the administration.” The commenter also said the NPRM's reference to incidents of long-time U.S. Employees being laid off in favor of younger workers are actually more complicated and show the declining enrollment in IT and STEM fields by U.S. Students.

The commenter went on to say that H-1B workers are more costly than U.S. Workers, which demonstrates that there are not enough similarly situated U.S. Workers. Response.

DHS disagrees with the commenter's assertions. Regarding the H-2 program, DHS disagrees that the administration's policies have been inconsistent, as these programs serve different purposes. As DHS has stated above and in the NPRM, the intent of the H-1B program is to help U.S. Employers fill labor shortages in positions requiring highly skilled or highly educated workers.

DHS believes that this rule reflects that intent more faithfully than a random selection process. DHS also disagrees that the instances cited in the NPRM of U.S. Employers replacing qualified and skilled U.S. Workers with relatively lower-skilled H-1B workers shows declining enrollment in STEM fields by U.S.

Students, and does not agree with the commenter's assessment regarding insufficient U.S. Workers.[] Actually, Start Printed Page 1701the fact that more than a third of recent American graduates with STEM degrees do not obtain work in a STEM field indicates that there is no shortage of qualified recent American graduates to fill STEM jobs.[] Finally, concerning the comment that H-1B workers are more costly than U.S. Workers, DHS recognizes that employers often incur upfront costs to file H-1B petitions (including filing fees and preparation fees). However, DHS believes these upfront costs are offset by the employer's ability to legally pay their H-1B employees relatively low wages below the local median wage.

Data show that the majority of H-1B cap-subject petitions have been filed for positions certified at the level I or level II prevailing wages, both of which are set below the local median wage.[] Employers may realize additional cost savings over the span of several years as they continue to employ these H-1B workers at below-median wages without any statutory requirement to increase the workers' wage levels or wages beyond the minimum required wages. Unlike U.S. Workers, H-1B workers are tied to their specific employer, and, therefore, may lack the negotiating power of similarly skilled U.S. Workers to request wage increases.[] DHS believes that the random selection process is not fair to U.S.

Workers whose wages may be adversely impacted by relatively lower-paid H-1B workers. C. Lack of Evidence To Support Rulemaking Comments. An advocacy group stated that the evidence provided in the NPRM is not robust enough to justify such a dramatic change in policy.

According to the commenter, the agency failed to consider multiple sources that suggest the current H-1B program benefits U.S. Workers and the economy. Similarly, a trade association said that the Agency “selectively cherrypicked a small minority of studies” from sources that regularly object to the use of temporary highly-skilled foreign talent, asserting that, had USCIS completed a more comprehensive review of literature, it would have been clear that the H-1B visa program and workers make significant contributions to the U.S. Economy and society.

A joint submission from multiple organizations said that DHS even communicates its failure to gather sufficient evidence before publication, and that DHS appears to be operating under the misconception that anything can be published as an NPRM and the burden shifts to the public to analyze the potential impacts. The commenters said that DHS should gather more data before restarting the regulatory process. An individual commenter similarly said that the agency provides inadequate justifications for the proposed changes, while another individual commenter said that the proposed rule is “half-baked and flawed in a number of ways” and requires proper rule-making procedures. An individual commenter stated that the proposed rule does not explain how giving priority to higher wage levels is a more efficient allocation process than the current random lottery process.

The commenter said the H-1B lottery is a fair solution to the issue of many petitions arriving on the same day or time, and the proposed rule would “go beyond the principle of fairness.” A trade association stated that the APA does not allow an agency to make significant change without completing an accurate cost-benefit analysis, which the agency did not do, nor did it allow sufficient time for stakeholders to conduct their own assessments. A company similarly stated that the Department's “scant justification” for wage-based selection of H-1B petitions violates the APA because a Level I or II prevailing wage does not mean that that the worker is not highly skilled or vital. The company said that the Department's reasoning for the proposed rule lacks a “rational connection between the facts found and the choice made.” An anonymous commenter wrote that the proposal is arbitrary and capricious, asserting that DHS does not explain the rationale behind making wages the sole indicator of a worker's eligibility for visa sponsorship. Response.

DHS disagrees with these comments. DHS conducted a comprehensive review of the issues, relying on both internal data and external studies and reports.[] DHS acknowledges the articles, studies, and reports submitted by commenters that purport to show the overall benefits of H-1B workers.[] DHS recognizes that some H-1B workers do fill gaps in the labor market and make contributions to the overall economy. However, while some studies show the benefits of H-1B workers overall, DHS also believes that sufficient evidence demonstrates that a prevalence of relatively lower-paid and lower-skilled H-1B workers is Start Printed Page 1702detrimental to U.S. Workers.[] As discussed in the NPRM and above, DHS further believes that the influx of relatively lower-skilled and lower-paid H-1B workers is not consistent with the dominant legislative purpose of the statute.

Prioritizing registrations based on wage level likely would increase the average and median wage levels of H-1B beneficiaries who would be selected for further processing under the H-1B allocations. Moreover, it would maximize H-1B cap allocations, so that they more likely would go to the best and brightest workers. Based on its comprehensive review of the submitted comments and available evidence, DHS has concluded that, by changing the selection process, in these years of excess demand, from a random lottery selection to selection generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds, DHS will implement the statute more faithfully to its dominant legislative purpose. DHS further believes that this will benefit the economy and increase the United States' competitive edge in attracting the best and the brightest in the global labor market, consistent with the goals of the H-1B program.

It may also benefit U.S. Workers as employers that might have petitioned for a cap-subject H-1B worker to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S. Workers for those positions. DHS believes that the available data and information support this rulemaking and that it is not necessary to gather more data or to restart the regulatory process.

C. Proposed Changes to the Registration Process for H-1B Cap-Subject Petitions 1. Proposed Wage-Based Selection (Selection Process for Regular Cap and Advanced Degree Exemption, Preservation of Random Selection Within a Prevailing Wage) Comment. A business association commented that adding in a non-random variable to the H-1B cap selection process would open the door to pre-adjudication, which may add new burdens to the petitioners and USCIS.

The commenter also said the addition of the wage factor may cause potential enforcement or audit actions if USCIS does not agree with a petitioner's assessment of “corresponding wage level,” either when adjudicating the petition or in the course of a post-adjudication audit. In addition, the commenter said the “corresponding wage level” listed on the lottery registration would not necessarily match the “wage level” designated on the Labor Condition Application (LCA) form, creating confusion. Response. DHS disagrees that ranking according to the highest OES prevailing wage level that the proffered wage equals or exceeds will be a pre-adjudication, as submission of the electronic registration is merely an antecedent procedural requirement to properly file the petition.

It is not intended to replace the petition adjudication process or assess substantive eligibility. With respect to new burdens resulting from the additional information provided, these are captured below in section V. Statutory and Regulatory Requirements. DHS believes that the additional burden, which is relatively small, is necessary to ensure that USCIS implements the registration system in a manner that realistically, effectively, efficiently, and more faithfully administers the cap selection process.

DHS acknowledges that the “wage level” listed by the petitioner on the registration form may not always match the “wage level” indicated on the LCA. However, DHS believes that the instructions provided in the registration system and on the H-1B petition are sufficiently clear to avoid confusion. Further, USCIS officers will be sufficiently trained on the reasons why the wage level on the registration form may not always match the LCA, and may request additional evidence from the petitioner, as appropriate, to resolve material discrepancies in this regard. However, DHS notes that USCIS may deny or revoke a petition if USCIS determines that the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct.[] Comment.

A professional association noted that DHS proposes to abruptly and unnecessarily change the selection process for H-1B cap-subject petitions by prioritizing registrants based on the highest OES prevailing wage level, and consider applicants solely based on the amount of money that they would be paid, rather than the utility that they would bring to the U.S. Workforce. Response. DHS believes that ranking and selecting by the highest OES prevailing wage level that the proffered wage equals or exceeds is a practical way to achieve the administration's goal of improving policies such that H-1B classification is more likely to be awarded to petitioners seeking to employ higher-skilled and higher-paid beneficiaries.

As stated previously, the new ranking system takes into account the wage level relative to the SOC code and area(s) of intended employment—as opposed to salary alone—when ranking registrations. While DHS agrees that the utility an H-1B beneficiary brings to the U.S. Workforce is important, there is no practical, objective way to measure utility such that DHS could use this quality to rank and select H-1B registrations or petitions. 2.

Required Information From Petitioners a. OES Wage Level i. Highest OES Wage Level That the Proffered Wage Would Equal or Exceed Comments. Several commenters said DHS should rank registrations at OES prevailing wage level I separate from those falling below OES prevailing wage level I, so that registrations who meet wage level I are prioritized for H-1B selection over those falling below level I.

Some commenters noted that the DOL IFR placed the level I wage at the 45th percentile (close to previous level III), creating vast differentiation within this large group. Therefore, the benefits of the rule of differentiating candidates would fail for at least 90 percent of registrations, as the DOL IFR would result in the prevailing wage level I and below group being much larger and DHS needing to select from that group completely at random. With that lack of differentiation, the new rule would not accomplish its purpose of retaining the best talent. Therefore, these commenters urged DHS to consider separating those registrations at or above level I wages from those falling below, as opposed to putting them into one giant group.

Response. DHS does not agree with the suggestions to separate OES wage level I from a wage below level I. DHS expects that all petitioners offering a wage lower than the OES wage level I wage will be using another legitimate source other than OES or an independent authoritative source, including a private wage survey. Therefore, such a change effectively could preclude petitioners that utilize one of those other sources from being selected for registration.

By grouping OES wage level I and below together, those petitioners have a fair chance of selection and are not precluded from using a private wage survey as appropriate. Since the DOL IFR was set Start Printed Page 1703aside on December 1, 2020, and is no longer being implemented, DHS will not be considering the impact of the DOL IFR in the context of this final rule.[] Comments. A professional association remarked that petitioners who use private survey data would be disadvantaged by the proposed rule and said that, even when private wage surveys provide an accurate prevailing wage, the proposed rule requires the employer to “downgrade” the H-1B registration to the lower OES prevailing wage level. The commenter concluded that, as a result, the proposed rule's artificial preference in the registration system to what is admittedly incomplete or possibly inaccurate OES wage data reduces the chance that employers intending to pay the H-1B required wage based on the statutory “best information available”—in this case a private industry survey—will see their registration selection chances materially reduced.

A law firm questioned which factors contributed to DHS's decision to use the OES wage levels as opposed to wage leveling from a permissible private wage survey. Response. DHS appreciates the commenter's question. When determining how to rank and select registrations (or petitions) by wage level, DHS decided to use OES prevailing wage levels because they are the most comprehensive and objective source for comparing wages.

The OES program produces employment and wage estimates annually for nearly 800 occupations.[] Additionally, most petitioners are familiar with the OES wage levels since they are used by DOL and have been used in the foreign labor certification process since 1998.[] OES wage level data is publicly available through the Foreign Labor Certification Data Center's Online Wage Library. Private wage surveys are not publicly available and do not always have four wage levels. DHS disagrees with the commenter's assertion that petitioners who use private survey data would be disadvantaged by the rule. Petitioners may continue to use private wage surveys, if they choose to do so, to establish that they will be paying the beneficiary a required wage.

This rule, however, will rank and select registrations or petitions, as applicable, based on the highest OES wage level that the proffered wage equals or exceeds as OES wage data is the most comprehensive and objective source for comparing wages. Comment. An individual commenter stated that the requirement to designate the wage level is confusing because DHS is asking petitioners to designate not the wage level associated with the job opportunity, but the highest OES wage level for which the proffered wage exceeds the OES wage. The commenter said asking petitioners to determine two different wage levels makes the process deliberately complex and ripe for error, which could be fatal given the proposed increased authority of USCIS to deny petitions for discrepancies in wage levels.

The commenter also expressed concern that the position, its substantive job duties, its occupational classification, the intended worksite, the prevailing wage, and the actual wage are now required at the registration stage in order to comply with the “complicated ranking-wage-level calculation.” Response. DHS does not agree with the comment stating that asking petitioners to specify the highest corresponding OES wage level that the proffered wage would equal or exceed on the registration is confusing or burdensome. Further, DHS disagrees with the comment stating that the position, its substantive job duties, its occupational classification, the intended worksite, the prevailing wage, and the actual wage are now required at the registration stage. In addition to the information required on the current electronic registration form (and on the H-1B petition) and for purposes of this selection process and to establish the ranking order, a registrant (or a petitioner if registration is suspended) would be required to provide only the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code in the area of intended employment.

While the OES wage level assessment would be based on the SOC code, area of intended employment, and proffered wage, the registrant would not need to supply the SOC code, area of intended employment, and proffered wage at the registration stage. Comment. A professional association asserted that the U.S. Bureau of Labor Statistics' (BLS) OES wage survey skews wage data higher for several professions, including physician specialties.

The commenter suggested that wage survey data collected from employees has significant issues, including that the data is collected voluntarily, wage data is grouped rather than provided for individual employees, larger urban centers are overrepresented compared to smaller practices, and physicians in rural areas are underreported. The association added that, in situations where there is less wage data, DHS will be unable to accurately adjudicate cap slots, citing data from the American Immigration Council and the Foreign Labor Certification Data Center. The association also said the DOL IFR increases the prevailing wage requirements and exacerbates the issue by establishing a default wage for physicians of $208,000 where data is unavailable. The professional association stated that the BLS prevailing wage does not comply with DHS's claim that higher skill level positions must be paid higher wages.

The association asserted that statistical analysis problems with the BLS OES survey would cause the population of H-1B physicians to be paid equally regardless of skill or experience. The commenter further stated that rural and other underserved areas will not meet the wage requirements and will lose access to critically needed physicians. Response. On December 1, 2020, the U.S.

District Court for the Northern District of California issued an order in Chamber of Commerce, et al. V. DHS, et al., No. 20-cv-7331, setting aside the DOL IFR, which took effect on October 8, 2020, and implemented reforms to the prevailing wage methodology for the Permanent Employment Certification, H-1B, H-1B1, and E-3 visa programs.

Similarly, on December 3, 2020, the U.S. District Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No.

20-cv-14604, applying to the plaintiffs in that case. On December 3, 2020, DOL announced that it was taking necessary steps to comply with the courts' orders and will no longer implement the IFR. These steps include making required technical changes to the Foreign Labor Application Gateway (FLAG) system to replace the October 8, 2020, through June 30, 2021, wage source year data that was implemented under the DOL IFR with the OES prevailing wage data that was in effect on October 7, 2020, and reflecting such data updates in the Foreign Labor Start Printed Page 1704Certification Data Center Online Wage Library [] at https://www.flcdatacenter.com/​ with the correct prevailing wage data for each SOC and area of intended employment through June 30, 2021.[] While prevailing wage level data remains unavailable for some SOC codes in some areas of intended employment, DHS believes that its solution in that limited circumstance, as proposed in the NPRM and retained in this final rule, still will allow DHS to select registrations according to the metric of the registrant's self-identified prevailing wage level as calculated using DOL's prevailing wage level guidance.[] DHS recognizes that this solution is imperfect as it does not provide a means for those registrants to proffer wages that equal or exceed higher prevailing wage levels than those commensurate with the position requirements. However, DHS concludes that it is the best available option to serve the overarching goal of revising the selection process to ensure that H-1B petitions are filed for positions requiring relatively higher skill levels or proffering wages commensurate with higher skill levels.

The commenter's statements that limitations in OES data would cause the population of H-1B physicians to be paid equally regardless of skill or experience, or that such limitations undermine the premise that higher skill level positions must be paid higher wages, is beyond the scope of this rulemaking. This rule does not require an employer to pay a certain wage. This rule merely pertains to ranking and selection of registrations or petitions, as applicable, based on corresponding wage level. In the limited instance where OES data is unavailable, the registrant would follow DOL guidance on prevailing wage determinations to determine which OES wage level to select on the registration, notwithstanding the proffered salary.

Ii. Highest OES Wage Level When There Is No Current OES Prevailing Wage Information Comment. A business association commented that, although using the prevailing wage worksheet to determine wage level makes sense, there is no way to escalate to a higher corresponding wage level by paying more, unlike when an OES wage is used. The commenter added that the unavailability of an OES wage may be an indication that a job is new or novel, and therefore may be even more in need of H-1B workers to fulfill employment needs.

Response. DHS recognizes that some occupations do not have current OES prevailing wage information available on DOL's Online Wage Library. In the limited instance where there is no current OES prevailing wage information for the proffered position, the registrant would follow DOL guidance on prevailing wage determinations to determine which OES wage level to select on the registration. While petitioners may not be able to increase their chance of selection by increasing the proffered wage, they can increase their chance of selection by petitioning for positions requiring higher skill, experience, or education levels.

DHS believes that, in the absence of current OES prevailing wage information, selecting according to wage level is the best way to ensure that registrations (or petitions) are selected consistent with the primary purpose of the H-1B program, which is to help U.S. Employers fill labor shortages in positions requiring highly skilled or highly educated workers. DHS data shows a correlation between higher salaries and higher wage levels.[] Thus, even in those limited instances where no OES prevailing wage information is available, DHS believes that selecting according to wage level is likely to result in selection of the highest-paid or highest-skilled beneficiaries, consistent with the goals of the H-1B program. DHS will not comment on whether the unavailability of OES wage indicates that a job is new, novel, or in more demand, as that is outside the scope of this rule.

Comment. One commenter asked, where the OES wage levels are missing, what penalties, if any, will be applied to petitioners or beneficiaries if USCIS disagrees with the wage level selected by the petitioner after selection has occurred. Response. DHS expects each registrant would be able to identify the appropriate SOC code for the proffered position because all petitioners are required to identify the appropriate SOC code for the proffered position on the LCA, even when there is no applicable wage level on the LCA.

Using the SOC code and established DOL guidance, all prospective petitioners would be able to determine the appropriate OES wage level for purposes of completing the registration or petition, as applicable, regardless of whether they were to specify an OES wage level or utilize the OES program as the prevailing wage source on an LCA. During the adjudication process, if USCIS disagrees with the wage level selected by the petitioner, USCIS will comply with 8 CFR 103.2(b)(8) and may provide the petitioner an opportunity to explain the selected wage level, as applicable. If USCIS determines that the petitioner failed to meet its burden of proof in establishing that it selected the appropriate SOC code for the position, or if USCIS determines that the petition was not based on a valid registration (e.g., if there is a discrepancy in wage levels between the registration and the petition), USCIS may deny the petition. If USCIS determines that the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct, USCIS may reject or deny the petition or, if approved, may revoke the approval of a petition that was filed based on that registration.[] If USCIS determines that the statement of facts contained in the petition or on the LCA was not true and correct, inaccurate, fraudulent, or misrepresented a material fact, USCIS may revoke the approval of that petition.[] Comment.

A professional association stated that, because the registration system does not contemplate a real-time adjudication of whether occupations lacking current OES prevailing wage information are correctly slotted under USCIS' selection system, there would be no fail-safe mechanism for employers to confirm that the wage-preference selection process in fact operated as USCIS predicted in the proposed rule. The commenter stated that, before any further rule is published, DHS, DOL and OMB should investigate and determine whether any proposed wage-preference H-1B selection process relying upon Start Printed Page 1705incomplete OES data can be established, notwithstanding these apparent data gaps and deficiencies. The commenter concluded that, despite the inadequacy or unavailability of OES data, the proposed rule ignores the requirement that wage data be sourced from “the best information available,” placing unwarranted and artificial reliance on OES data despite its faults or lack of availability. Response.

DHS recognizes that prevailing wage level data remains unavailable for some SOC codes in some areas of intended employment. However, DHS still believes that OES provides the most comprehensive and objective publicly available source for obtaining prevailing wage information and, thus, is still the best available option to serve the overarching goal of improving policies such that H-1B classification is more likely to be awarded to petitioners seeking to employ higher-skilled and higher-paid beneficiaries.[] iii. Lowest OES Wage Level That the Proffered Wage Would Equal or Exceed When Beneficiary Would Work in Multiple Locations or Positions Comment. A commenter said employers may relocate an employee to temporarily work remotely in a location where average salary is low to keep wages low while increasing the H-1B wage level and the chance of being selected.

The commenter suggested that the area code used for the selection of H-1B registrations only should be the registered official address of the company, instead of anywhere where the employee will work, concluding that employers should be fined for misrepresenting work locations to take advantage of lower wages. Response. DHS appreciates this commenter's concern, but believes the commenter misunderstood how the new H-1B cap selection process will work and the limitations contained in the proposed rule to limit the potential for abuse or gaming of the selection process. If the H-1B beneficiary will work in multiple locations or multiple positions, the registrant or petitioner must specify on the registration or petition, as applicable, the lowest corresponding OES wage level that the proffered wage will equal or exceed for the relevant SOC code in the area of intended employment, and USCIS will rank and select based on the lowest corresponding OES wage level.

DHS provides the following example for illustrative purposes only. A prospective employer intends to employ an H-1B beneficiary as a level I “Civil Engineer” position (SOC code 17-2051) at two locations. San Francisco, California and Montgomery, Alabama. The Alabama location was specifically chosen because of that locality's generally lower prevailing wages.

The required level I prevailing wage for each area of intended employment is $77,147 per year [] and $62,858 per year,[] respectively. In this scenario, to meet the level I prevailing wage for the San Francisco area of intended employment, the minimum annual wage the prospective petitioner must offer to the beneficiary is $77,147. While an annual salary of $77,147 would exceed the level II prevailing wage for the Montgomery, Alabama, area of intended employment,[] the prospective petitioner still must select Level I for purposes of the registration because that is the lowest corresponding OES wage level that the proffered wage will equal or exceed for the relevant SOC code in all areas of intended employment. This rule also includes provisions authorizing USCIS to deny an H-1B petition if USCIS determines that the statements on the registration or petition were inaccurate, fraudulent or misrepresented a material fact.[] USCIS also may deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the original petition.[] Comment.

A professional association expressed concern with the proposed rule's language stating, “if the beneficiary will work in multiple locations, or in multiple positions if the registrant is an agent, USCIS will rank and select the registration for the lowest corresponding OES wage level that the proffered wage will equal or exceed.” [] The commenter stated that, basing the chance for selection on the lower wage figure is an “arbitrary” protocol without explanation. Likewise, an individual commenter said the provision is unfairly discriminatory and lacks adequate justification, adding that it is “unconscionable to use an inverted system” for ranking. Response. DHS chose to use the lowest corresponding OES wage level that the proffered wage will equal or exceed in the case of multiple locations or multiple positions to prevent gaming of the registration process.

If DHS were to invert the process and rank based on the highest corresponding OES wage level that the proffered wage were to equal or exceed, then petitioners could place the beneficiary in a lower-paying position for most of the time and a higher-paying position for only a small percent of the time, but use that higher-paying position to rank higher in the selection process and increase their chances of being selected in the registration process. Similarly, in the case of multiple locations, petitioners could place the beneficiary in a higher-paying locality for only a small percent of time, but use that higher-paying locality to rank higher in the selection process and increase their chances of being selected in the registration process. Iv. Other Comments on OES Wage Level Comment.

Several commenters said that the proposed rule's changes to prevailing wage levels are in direct opposition to established guidance set forth in the DOL Employment and Start Printed Page 1706Training Administration Prevailing Wage Determination Policy Guidance.[] Response. This rule does not conflict with or change established DOL guidance. DHS clearly stated in the NPRM that this ranking and selection process will not alter the prevailing wage levels associated with a given position for DOL purposes, which are informed by a comparison of the requirements for the proffered position to the normal requirements for the occupational classification.[] Comment. A professional association wrote that the OES wage data has various shortcomings, and there are advantages to using a variety of wage data.

Prevailing wage data can originate from multiple sources, including wage surveys published by private organizations and employer-conducted surveys. The association said that BLS OES survey data used to calculate prevailing wages is not designed for foreign labor certification, and OES survey data captures no information about differences based on skills, training, experience or responsibility levels of the workers, all of which are factors the INA requires DHS to consider. The association said that the OES survey is the best available source of wage data for the Department's purposes, but it is not perfectly suited to the H-1B, H-1B1, and E-3 classifications, nor to the Permanent Labor Certification Program (PERM). The professional association also commented that the proposed rule does not describe the cases when OES prevailing wage data would be unavailable or how USCIS officials would be trained to interpret DOL guidance, and petitioners who cannot use Online Wage Library data would have no way to know whether USCIS officials misinterpreted the DOL guidance and mistakenly disagreed with an employer's wage level selection.

Response. When determining how to rank and select registrations (or petitions, as applicable) by the highest OES prevailing wage level that the proffered wage equals or exceeds, DHS decided to use OES prevailing wage levels because OES is the most comprehensive and objective source for comparing wages. The OES program produces employment and wage estimates annually for nearly 800 occupations.[] Additionally, most petitioners are familiar with the OES wage levels since they are used by DOL and have been used in the foreign labor certification process since 1998.[] During the adjudication process, if USCIS disagrees with the wage level selected by the petitioner, USCIS will comply with 8 CFR 103.2(b)(8) and may provide the petitioner an opportunity to explain the wage level, as applicable. If USCIS determines that the petitioner failed to meet its burden of proof in establishing that it selected the appropriate SOC code for the position, or if USCIS determines that the petition was not based on a valid registration (e.g., if there is a discrepancy in wage levels between the registration and the petition), USCIS may deny the petition.[] If USCIS determines that the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct, USCIS may reject or deny the petition or, if approved, may revoke the approval of a petition that was filed based on that registration.[] If USCIS determines that the statement of facts contained in the petition or on the LCA was not true and correct, inaccurate, fraudulent, or misrepresented a material fact, USCIS may revoke the approval of that petition.[] b.

Attestation to the Veracity of the Contents of the Registration and Petition (Including Comments on Rejections, Denials, and Revocations) Comments. One commenter noted the need to ensure that ranking and selection as described would not enable attempts to increase the chance of selection by representing one wage level at the registration stage and a lower wage level at the H-1B petition filing stage. Response. DHS appreciates and shares the commenter's concern.

New 8 CFR 214.2(h)(8)(iii)(D)(1)(iii), (h)(10)(ii), and (h)(11)(iii)(A)(2) address the concern that registrants could misrepresent wage levels at the registration stage to increase chances of selection. Specifically, this final rule empowers USCIS to deny a petition if USCIS determines that the statements on the registration or petition were inaccurate, fraudulent, or misrepresented a material fact. The rule also authorizes USCIS to deny or revoke approval of a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly decrease the proffered wage to an amount that would be equivalent to a lower wage level, after listing a higher wage level on the registration to increase the odds of selection. The ability to deny or revoke approval of an H-1B petition in such a context will defend against registrants and petitioners attempting to abuse the H-1B cap selection process by misrepresenting wage levels.

Comment. One commenter asked what factors DHS will use to determine if a petitioner attempted to circumvent the proposed rule by filing a subsequent new petition with a lower wage under a related entity, and whether DHS will consider that related entities may have different compensation ranges for similar positions in making this determination. Response. DHS thanks this commenter for the question.

Under new 8 CFR 214.2(h)(10)(ii), USCIS may deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the original petition. Whether the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process is an issue of fact that USCIS will determine based on the totality of the record. As such, DHS cannot provide an exclusive list of factors that USCIS will consider in such adjudications. In general, however, the petitioner or a related entity bears the burden of proof to demonstrate that.

The new or amended petition is not part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process. The initial H-1B petition and the underlying registration, when applicable, was based on a legitimate Start Printed Page 1707job offer; [] and the new or amended petition is nonfrivolous.[] Further, DHS notes that, under the current registration system, the petitioner identified at the registration stage must match the petitioner of the subsequently filed petition. 8 CFR 214.2(h)(8)(iii)(D) states that a petitioner may not substitute the beneficiary named in the original registration or transfer the registration to another petitioner. This rule has not changed this requirement.

Accordingly, USCIS may deny an H-1B cap-subject petition if an entity other than the petitioner identified at the registration stage, including a related entity, files the petition. Comment. An individual suggested allowing future H-1B extensions or renewals only with a wage level that is equal or greater than the wage level selected in the lottery for the first time. Response.

H-1B extensions or renewals are not impacted by this rule, and DHS declines to impose a universal requirement that all extension or renewal requests must be for a position at the equal or greater wage level. Employers are permitted to file an extension petition requesting continuation of previously approved employment without change with the same employer, which most likely involves a position at the same wage level. Furthermore, employers are permitted to file extension or amended petitions requesting new employment, change in previously approved employment, new concurrent employment, change of employer, or amended employment. All of these petition types could involve positions with different SOC codes, which makes a straight comparison of wage levels impractical.

However, under new 8 CFR 214.2(h)(10)(ii), USCIS may deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the original petition. Comment. An individual commenter said that the formal certification requirement, whereby the petitioner's authorized signatory certifies “that the proffered wage on the petition will equal or exceed the wage level on the applicable registration,” does not recognize that registrations are submitted in March for a fiscal year beginning the following October. Therefore, particularly in years such as FY 2021 where there is a second round of selections, H-1B cap petitions may be filed after OES wages have changed.

The commenter said the new question added to the registration seems to address this concern, by specifying “[a]s of the date of this submission. . . ,” but the formal certification that is binding on the employer does not make this distinction, which could lead to unnecessary and inappropriate liability.

The commenter said that the certification should be revised to reflect only an attestation that the wage “will equal or exceed the prevailing wage, in effect at the time of submission, that is associated with the wage level selected in the registration.” Response. DHS thanks the commenter, but declines to adopt the suggestion. As the commenter notes, the registration form makes sufficiently clear that the information provided on the registration is “as of the date of submission of this registration.” DHS believes that further changes to the form are unnecessary and could potentially lead to gaming of the registration system. 3.

Requests for Comments on Alternatives Comment. A research organization and a labor union recommended having staggered filing deadlines for petitions by wage levels as an alternative in case the proposed rule is met with legal challenges. Under this alternative, USCIS could have a first filing period, where only petitions with jobs paying level IV are considered. Once all the level IV petitions are submitted and approved, then a second filing period at a later date could be set to receive only petitions with jobs paying level III wages.

After those are collected and approved, if there are any visas remaining under the H-1B cap, then a filing period for level II wages would be next, and finally a filing period for level I. This way, all of the petitions would not be submitted at once, thereby still allowing DHS to adjudicate and allocate petitions “in the order in which” they were filed, as the statute requires. If there were more petitions than available H-1B slots at a particular wage level, there could be a “mini-lottery” within that wage level. Response.

DHS appreciates the commenters' suggestions to use staggered filing deadlines. However, DHS believes it is not necessary to create staggered filing deadlines since, as stated in the NPRM and as explained above, this rule is consistent with and permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C. 112.[] Further, DHS believes that staggered filing deadlines may create operational challenges for managing the cap and adjudicating petitions in a timely manner.

Staggered filing periods could also have unintended consequences for petitioners filing H-1B cap-subject petitions for beneficiaries who are in F-1 status and seeking a change of status.[] Therefore, DHS declines to adopt this suggestion. Comment. One commenter suggested using only the beneficiary's annual wage to prioritize the selection of registrations. Response.

DHS appreciates the commenter's suggestion to prioritize selection based on annual wage. However, DHS believes that selecting registrations or petitions, as applicable, solely based on the highest salary would unfairly favor certain professions, industries, or geographic locations. Therefore, DHS believes that prioritizing generally based on the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment is the better alternative. Comment.

Several commenters were concerned about the possibility of abuse by companies who would offer part-time positions at greater hourly wages, but would reduce overall working hours, to increase their chance of selection. Other commenters expressed similar concerns about potential abuse of part-time positions, indicating that review should be stricter for part-time H-1B applicants. Response. This final rule authorizes USCIS to reject or deny a petition or, if approved, revoke the approval of a petition, if the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct.[] Similarly, this final rule authorizes USCIS to deny or revoke approval of a subsequent new or Start Printed Page 1708amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly decrease the proffered wage to an amount that would be equivalent to a lower wage level, after listing a higher wage level on the registration to increase the odds of selection.[] Thus, if USCIS finds that an employer misrepresented the part-time or full-time nature of a position, the number of hours the beneficiary would work, or the proffered salary, then USCIS could deny or revoke the petition.

The ability to deny or revoke approval of an H-1B petition in this context will militate against registrants and petitioners attempting to abuse the H-1B cap selection process through misrepresentation. Comment. One commenter suggested that, if USCIS were to receive and rank more registrations (or petitions, in any year in which the registration process is suspended) at a particular prevailing wage level than the projected number needed to meet the numerical limitation, then USCIS should rank and choose registrations by the highest prevailing wage within that wage level. Another commenter stated that visas should be allocated by the prevailing wage, even within each level.

Response. DHS does not believe that selecting the highest prevailing wage within a wage level is a better alternative to randomly selecting within a single wage level when USCIS receives more registrations (or petitions, in any year in which the registration process is suspended) at a particular prevailing wage level than the projected number needed to meet the numerical limitation. DHS prefers to give all registrations ranked at the particular wage level the same chance of selection because those registrations generally would represent workers at the same skill level. If DHS were to select the highest prevailing wage within a wage level, that could unfairly advantage registrations or petitions for positions in higher-paying metropolitan areas or occupations.

Comment. One commenter suggested giving preference to beneficiaries with U.S. Degrees. Another commenter stated that DHS should consider adding an advantage to candidates who receive a U.S.

Education as this will benefit U.S. Institutions of higher education. Response. DHS declines to adopt the commenters' suggestions.

Registrations or petitions, as applicable, submitted for beneficiaries who have earned a master's or higher degree from a U.S. Institution of higher education already have a higher chance of selection through the administration of the selection process. DHS reversed the order in which USCIS selects registrations or petitions, as applicable, which was expected to result in an increase in the number of H-1B beneficiaries with a master's degree or higher from a U.S. Institution of higher education selected by up to 16 percent each year [] and resulted in an 11 percent increase in FY 2020.[] Comment.

Some commenters said that DHS should consider ranking by years of experience, rather than by wage. One commenter asked DHS to give an advantage to candidates who have work experience in the United States. Response. DHS declines to adopt these alternatives, as ranking by years of experience would not best accomplish the goal of attracting the most highly skilled workers.

DHS believes that salary, relative to others in the same occupational classification and area of intended employment, rather than years of experience, is generally more indicative of skill level and the relative value of the worker to the United States. Comment. A few commenters said that DHS should consider providing quotas for each wage level, rather than simply ranking and selecting in descending order by wage levels. Other commenters suggested setting a limit or quota on the number of registrations submitted by certain types of employers, such as staffing agencies or H-1B dependent companies.

Another commenter supported measures to prevent staffing companies from filing multiple registrations for offshore workers and stated that companies should not be able to submit more than one registration per beneficiary. Another commenter stated that it is “crucial” to regulate consulting companies and staffing agencies. Response. DHS declines to pursue the alternative of setting quotas for each wage level or for certain types of companies as this alternative would not best accomplish the goal of attracting the most highly skilled workers.

With respect to comments about prohibiting staffing companies from filing multiple registrations, DHS declines to adopt the commenters' suggestions as DHS regulations already prohibit an employer from submitting more than one registration per beneficiary in any fiscal year.[] Comments about the need to further regulate consulting and staffing companies are outside the scope of this final rule. Comment. A few commenters suggested that DHS prohibit multiple H-1B petitions for the same beneficiary by different employers. Response.

DHS regulations already prohibit a petitioner, or related entities, from submitting more than one H-1B cap-subject petition for the same beneficiary in the same fiscal year, absent a legitimate business need.[] Because registration is not intended to replace the petition adjudication process or to assess eligibility, USCIS cannot feasibly determine at the registration stage whether different entities that submit registrations on behalf of the same beneficiary are “related” or have a “legitimate business need.” Further, INA section 214(g)(7), 8 U.S.C. 1184(g)(7), allows for “multiple petitions [to be] approved for 1 alien.” For these reasons, DHS declines to adopt the commenters' suggestion. Comment. One commenter stated that DHS should consider increasing the numerical cap exemption for beneficiaries who have earned a master's or higher degree from a U.S.

Institution of higher education as most of the highly skilled positions do not depend entirely on the number of years of experience, but on the higher education degree requirements. Response. This rule does not affect either the statutorily mandated annual H-1B numerical limitation of 65,000 on the number of aliens who may be issued initial cap-subject H-1B visas or otherwise provided initial H-1B status, or the annual cap exemption for 20,000 aliens who have earned a master's or higher degree from a U.S. Institution of higher education.[] As the numerical allocations are set by statute, DHS lacks the authority to adopt the commenter's suggestion.

Comment. An individual suggested DHS implement a “market based cap and selection system” by first identifying areas of the job market, like medical workers, that are most in need at the moment and, from there, ranking by wage or wage level. Response. DHS believes that identifying areas of the job market that are most in need is not feasible, as it is subjective and would be subject to constant change.

This rule is not a Start Printed Page 1709temporary rule that is limited in duration to the buy antibiotics zithromax, and regularly adjusting selection criteria based on the needs of the job market would be administratively burdensome. Therefore, DHS declines to adopt the commenter's suggestion. Comments. A few commenters proposed that DHS prioritize selection based on multiple factors, including the prospective beneficiary's degree from a U.S.

Institution, the length of time legally studying or working in the United States, skills, wages, and other qualifications. Other commenters stated that the DHS should weigh other desirable factors, such as whether H-1B employees are U.S. University graduates and whether the petitioner is a small business contributing a significant amount of their income to wages. This would allow small businesses to compete for H-1B visas and prevent larger corporations from being the only employers to benefit from the H-1B program.

Another comment urged DHS to create a prioritization system that incentivizes employers to petition for permanence for H-1B workers, among other desirable employer behavior in addition to fair compensation. Response. DHS believes that identifying and weighing multiple factors is not feasible, as such an approach could be overly complicated, unpredictable, and subjective. Therefore, DHS declines to adopt the commenters' suggestions.

Comment. A professional association requested that DHS exempt physicians from this rule. An individual suggested providing exceptions or waivers for certain industries, such as the healthcare/pharmaceutical fields, due to the different experience requirements in those fields. Response.

DHS declines to exempt physicians or other specific occupations or fields from the rule. While DHS certainly appreciates the significant challenges faced by healthcare professionals, especially during the current buy antibiotics zithromax, DHS recognizes that there are many other occupations that can be considered critical now and at various times in the future. Carving out exceptions for some occupations would be highly problematic, particularly as this rule is not a temporary rule that is limited in duration to the buy antibiotics zithromax. Comment.

An individual commented on the alternative proposal of weighting registrations such that “a level IV position would have four times greater chance of selection than a level I position, a level III position would have three times greater chance of selection than a level I position, and so on.” The commenter questioned why DHS set the multiples at 4 times, 3 times, and 2 times. Response. The multiples of 4 times, 3 times, and 2 times, correspond to wage levels IV, III, and II, respectively. As this commenter did not provide additional rationale in support of or against this alternative, DHS will not further consider this alternative.

D. Other Issues Relating to Rule 1. Requests To Extend the Comment Period Comments. A few commenters and a professional association stated that the public has not been given sufficient time to comment on the proposed rule.

One commenter said that there is no substantiated reason to limit the comment period and that doing so degrades the rulemaking process. An individual commenter stated that implementing these changes for the FY 2022 H-1B cap filing season would cause even more uncertainty for international students who already have faced enough uncertainty over the past year due to buy antibiotics, the Student and Exchange Visitor Program proposed rule,[] and USCIS processing times. An individual commenter and a university requested that the comment period be extended to 60 days because of the proposed rule's magnitude and the impacts of buy antibiotics on employers' resources. A professional association requested the same extension to allow for meaningful public comment, citing the language of E.O.

12866 and E.O. 13563, explaining that those executive orders recommend a comment period of no less than 60 days. The association listed six issues for which the proposed rule requests feedback and asserted that a 30-day comment period does not allow adequate time to address these issues. The association also said that, since this rule was published during the Thanksgiving season, the comment period was effectively shortened even further, undercutting the purpose of the notice and comment process.

An individual commenter questioned why DHS was “rushing” the proposed rule during the holiday season as opposed to providing more time for public comment. Response. While DHS acknowledges that E.O. 12866 and 13563 indicate that agencies generally should provide 60 days for public comment, DHS believes that the 30-day comment period was sufficient and declines to extend the comment period.

This rule is narrow in scope, and 30 days was sufficient time for the public to determine the impacts of the proposed rule, if any, and to prepare and submit comments. The sufficiency of the 30-day comment period is demonstrated by the number of high-quality comments received from the public, including individuals, attorneys, employers, and organizations. Given the narrow scope of the rule, the quantity and quality of comments received in response to the proposed rule, and other publicly available information regarding the rule, DHS believes that the 30-day comment period has been sufficient. 2.

Rulemaking Process a. Multiple H-1B Rulemakings Comments. An anonymous commenter stated that the proposed rule does not discuss the DOL IFR,[] or explain whether DHS and DOL consulted with each other in drafting the rules. The commenter added that Congress has given DOL the primary authority in protecting U.S.

Labor, and the proposed rule does not address how it would interact with the DOL rule, or why the proposed rule was necessary given the DOL IFR. An advocacy group stated that the proposed rule should not be implemented while the DOL IFR and the DHS IFR, Strengthening the H-1B Nonimmigrant Visa Classification Program (H-1B Strengthening IFR),[] were pending and being challenged in court. The commenter said it would be impossible to comment on the proposed rule without considering the impacts of the other two rules that will affect the H-1B process as well. Similarly, a research organization wrote that recently proposed rules by Federal agencies with respect to wages for foreign workers in work visa programs have been inconsistent and confusing.

An anonymous commenter stated that their workplace has been overworked for months responding to the multiple regulatory changes to the H-1B program. Response. On December 1, 2020, the U.S. District Court for the Northern District of California issued an order in Chamber of Commerce, et al.

V. DHS, et al., No. 20-cv-7331, setting aside the DOL IFR and the DHS IFR. Similarly, on December 3, 2020, the U.S.

District Start Printed Page 1710Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No. 20-cv-14604, applying to the plaintiffs in that case.

DOL has taken necessary steps to comply with the courts' orders and is no longer implementing the DOL IFR. DHS also took necessary steps to comply with the order in Chamber of Commerce, et al. V. DHS, et al., and is not implementing the DHS IFR.

DHS, therefore, disagrees with the commenter's assertions that DHS must consider the DOL and DHS IFRs in the context of this final rule as both IFRs were set aside and are no longer being implemented. B. Other Rulemaking Process Comments Comments. A joint submission from multiple organizations opposed the proposed rule and said that they were willing to participate in an informal dialogue with DHS or formally participate in an Advance Notice of Proposed Rulemaking process to help DHS determine whether a rule is needed, what regulation to develop, and viable alternative suggestions.

A trade association also opposed the rule and advised USCIS to pursue a formal rulemaking effort that provides stakeholders with more input before the formal rulemaking process begins. Response. DHS believes that the public has had sufficient opportunity to review and comment on this rule, as demonstrated by the number of high-quality comments received from the public, including individuals, attorneys, employers, and organizations. Given the narrow scope of the rule, the quantity and quality of comments received in response to the proposed rule, and other publicly available information regarding the rule, DHS believes that the public has had sufficient opportunity to participate in the rulemaking process.

Comment. A professional association commented that the public had no advance notice that the proposed rule was forthcoming because it was never listed on the Unified Agenda. The association also said USCIS had previously concluded that the policy now being proposed was not a permissible agency action, and therefore stakeholders were not prepared to conduct the sophisticated analysis necessary to assess the policy now being proposed in this rule. Response.

DHS believes that the public has had sufficient opportunity to review and comment on this rule, as demonstrated by the number of high-quality comments received from the public, including individuals, attorneys, employers, and organizations. Further, DHS explained in the NPRM that this rule is consistent with and permissible under DHS's general statutory authority provided in INA sections 103(a), 214(a) and (c), 8 U.S.C. 1103(a), 1184(a) and (c), and HSA section 102, 6 U.S.C. 112, and DHS believes that the comment period provided sufficient time to assess the rule.

Comment. A research organization wrote that the administration waited until the 2020 election to take substantive action on the H-1B program, and while DOL and USCIS have legal authority to make the regulatory changes, the timing and regulatory process have made them susceptible to legal challenges. An individual commenter said that the administration will change in a few weeks and suggested that the proposed rule is being rushed into implementation before that happens. An individual commenter said USCIS should wait to promulgate the rule until the new presidential administration takes over and the Senate confirms a new head of both USCIS and DHS.

Response. DHS agrees that it has the legal authority to amend its regulations governing the selection of registrations submitted by prospective petitioners seeking to file H-1B cap-subject petitions (or the selection of petitions, if the registration process is suspended). DHS believes that the public has had sufficient opportunity to review and comment on this rule, as demonstrated by the number of high-quality comments received from the public, including individuals, attorneys, employers, and organizations. DHS believes that the public has had sufficient opportunity to participate in the rulemaking process.

3. Effective Date and Implementation Comments. A few individual commenters supported the proposed rule's immediate implementation to protect U.S. Jobs.

Another individual commenter contradicted claims that it is too late in the year for employers to accommodate changes in the registration system, saying that many companies wait until the new year to reach out to employees anyway, and recent changes to the H-1B process have made it easier to petition. Response. DHS agrees that this rule is being published with sufficient time to implement it for the FY 2022 registration period. Comments.

Many commenters, including a form letter campaign, said that, if USCIS were to finalize the proposed rule, it should not implement the proposed rule for the FY 2022 H-1B cap filing season (set to begin in March 2021) because changes so close to the beginning of that season would adversely impact U.S. Employers, immigration lawyers, and individuals. Multiple commenters said companies have already made hiring decisions based on the existing registration system, so delaying implementation until the FY 2023 cap filing season (set to begin in March 2022) would give the regulated community time to adjust. A company commented that implementing the rule for the upcoming H-1B cap filing season would create uncertainty and confusion.

A few commenters added that stakeholders have had to adapt to the new online registration system, which has ongoing issues, so it is unlikely that further modifications to the registration system will be implemented to run smoothly for the upcoming H-1B season. An individual commenter opposed implementing the proposed rule at this time because the U.S. Economy needs time and stability to recover. Response.

DHS believes that this rule is being published with sufficient time to allow employers to plan appropriately prior to the start of the registration period for FY 2022. DHS does not believe that petitioners will face significant adverse impacts with the implementation of this change in the selection process and believes that employers have sufficient time to make any decisions they believe are needed as a result of this rule, such as increasing proffered wages to increase the odds of selection. Further, DHS believes that there is sufficient time to allow for testing and modification and that delaying implementation at this time is not necessary. E.

Statutory and Regulatory Requirements 1. Impacts and Benefits (E.O. 12866, 13563, and 13771) a. Methodology and Adequacy of the Cost-Benefit Analysis Comments.

Multiple commenters provided input on the wage data DHS used to analyze the impact of the proposed rule. A couple of commenters referenced that the economic analysis conducted in the proposed rule was based on previous OES wage levels, rather than the new ones implemented as a result of the DOL IFR. One of these commenters stated that, with the huge changes in the wage levels resulting from the DOL IFR, the H-1B data would be much more skewed, and the economic impact analysis in the proposed rule was completely invalid. Another commenter explained that all of the analysis done in the proposed rule was based on previous OES wage Start Printed Page 1711levels and there has not been any economic impact analysis based on the new wage rules.

One commenter expressed that this rule must be read in concert with the DOL IFR, which reset how prevailing wage levels were calculated for H-1Bs. To get selected in the H-1B registration process under the proposed rule, the employer would have to pay a level III or IV prevailing wage, but those wages would be so artificially high that employers would not be able to pay them. The commenter concluded that DHS should push the proposed rule back at least one year to allow time for next year's H-1B data to become available. Another commenter said 96 percent of total applicants still would fall into the new OES wage “level 1 below” and would be eligible for random selection, so the proposed rule would not have an impact.

A commenter echoed concerns about the use of previous OES wage levels, writing that DHS's analysis in the proposed rule was invalid. Response. The NPRM analysis was written using the appropriate baseline and the best information that was available to DHS at that time, which was prior to the publication of the DOL IFR.[] On December 1, 2020, the U.S. District Court for the Northern District of California issued an order in Chamber of Commerce, et al.

V. DHS, et al., No. 20-cv-7331, setting aside the DOL IFR. Similarly, on December 3, 2020, the U.S.

District Court for the District of New Jersey issued a preliminary injunction in ITServe Alliance, Inc., et al. V. Scalia, et al., No. 20-cv-14604, applying to the plaintiffs in that case.

DOL has taken necessary steps to comply with the courts' orders and no longer is implementing the DOL IFR. DHS, therefore, disagrees with the commenter's assertion that DHS must analyze the DOL IFR in the context of this final rule. This final rule does not require employers pay a higher wage, instead it prioritizes selection of registrations or petitions, as applicable, generally based on the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment. The selection of H-1B registrations or petitions, as applicable, will be based on the existing OES wage levels at the time of submission, and the economic analysis in the proposed rule properly accounted for OES prevailing wage levels that were in effect at the time the analysis was conducted and remain in effect at this time.

Comments. An anonymous commenter stated that Table 13 of the NPRM is inconsistent with the proposed rule's language. The commenter questioned why there would be level III and IV registrations selected in the advanced degree exemption if level III and IV registrations would be “100% selected” in the regular cap, and the proposed rule would not affect the order of selection between the regular cap and advanced degree exemption. Response.

This final rule will not affect the order of selection between the regular cap and advanced degree exemption or the number of registrations that will be selected for each allocation. USCIS first selects registrations toward the number projected as needed to reach the regular cap, from among all registrations properly submitted, including those indicating that the beneficiary will be eligible for the advance degree exemption. USCIS then selects registrations indicating eligibility for the advanced degree exemption using the same process. With the revised selection method based on corresponding OES wage level and ranking shown in Table 13, the approximated average indicates that all registrations with a proffered wage that corresponds to OES wage level IV or level III would be selected and 58,999, or 75 percent, of the registrations with a proffered wage that corresponds to OES wage level II would be selected toward the regular cap projections.

None of the registrations with a proffered wage that corresponds to OES wage level I or below would be selected toward the regular cap projections. For the advanced degree exemption, DHS estimates all registrations with a proffered wage that corresponds to OES wage levels IV and III would be selected and 12,744, or 20 percent, of the registrations with a proffered wage that corresponds to OES wage level II would be selected. DHS estimates that none of the registrations with a proffered wage that corresponds to OES wage level I or below would be selected. Comments.

A couple of commenters wrote that DHS took wage levels specified as “N/A” and consolidated them with level I wages in its Table 7 calculations even though there is no evidentiary basis for assuming that characterization or correlation to be accurate or appropriate. Wages negotiated under a collective bargaining agreement often exceed market rates, and private wage surveys frequently have more than 4 wage levels, which makes direct analogy to OES impractical, if not impossible. Since there was no way to determine the true ranking of the N/A petitions, they should have been excluded from the allocation rather than arbitrarily added to the level I share. Consolidating them had the prejudicial effect of attributing 31.5 percent of regular cap and 37 percent of advanced degree cap to level I, when, in fact, those numbers would have been 22.8 percent and 27.5 percent, respectively, had level I counts not included the petitions whose wage level was N/A.

An individual commenter similarly wrote that DHS's analysis incorrectly claims that a number of petitions are categorized as having a wage level of N/A due to modifications to DOL's SOC structure in 2018. The commenter stated that all FY 2019 and FY 2020 petitions were filed using the 2010 SOC structure and thus the 2018 SOC structure would not impact those petitions. The commenter said that the N/A designations are likely because Question 13 on Form 9035 only requires a designation of OES wage levels when relying on a prevailing wage and is left blank when petitions rely on a permissible alternative. This commenter also stated that, according to DHS's analysis in Table 6, the OES Wage Level was unavailable about 12 percent of the time for cap-subject H-1B petitions selected for adjudication in FYs 2019 and 2020.

DHS labels these petitions as ones where the OES Wage Level is “N/A” and then, curiously, includes all such “N/A” OES Wage Level petitions as level I petitions for purposes of its analysis when they are not particularly likely to be all or mostly level I jobs. Response. DHS understands and agrees with the commenter that N/A designations are likely when registrants rely on a permissible alternative private wage source that is not based on the OES survey. For these registrants choosing to rely on a prevailing wage that is not based on the OES survey, if the proffered wage is less than the corresponding level I OES wage, the registrant would select the “Wage Level I and below” box on the registration form.

DHS deliberately chose to group these registrations together with level I registrations so that petitioners relying on non-OES sources would have a fairer chance of selection than if they were ranked below level I registrations, and to avoid penalizing prospective petitioners who properly rely on a private wage survey to determine the required wage for the proffered position. As explained in response to other comments, DHS does not agree with the suggestions to separate OES prevailing wage level I from those falling below level I. DHS expects that all petitioners offering a wage lower than the OES wage level I wage will be using a legitimate source other than OES or an Start Printed Page 1712independent authoritative source, including a private wage survey. Therefore, such a change effectively could preclude petitioners that utilize one of those other sources from being selected for registration.

By grouping OES wage level I and below OES wage level I together, those petitioners have a fairer chance of selection. DHS was unable to estimate how many registrations, initially classified as N/A, would end up in each wage level classification as a result of this rule. Due to data limitations and missing data, DHS may have included some N/A wage information into OES wage level I and below that could be classified as a wage higher than level I in the future. If DHS did not incorporate the petitions that fell into the N/A category, then the overall total of petitions would have been understated.

DHS analysis used estimates in the Unquantified Costs &. Benefits section to show a possible outcome and distribution of registrations once this rule is implemented. Comments. A trade association wrote that DHS conducted insufficient data collection to assess the impact of the proposed rule, given that it has OES skill wage level data for only 56 percent of registered H-1B petitions selected in the lottery.

The commenter wrote that DHS should review data on all H-1B adjudications to better assess the relative distribution of H-1B petitions by OES level, or conduct a survey of H-1B employers to better quantify the impact of the proposed rule by OES level. Response. USCIS analyzed the impacts of this rule in an objective manner using the best available data at the time the analysis was written. DHS has OES wage level data only on the 56 percent of petitions that were selected toward the numerical allocations from FY 2019 and FY 2020.

DHS does not have the wage level break down for the 44 percent of petitions that were not selected since those petitions were returned to petitioners without entering data into DHS databases. The wage level break downs for the 56 percent that were selected for adjudication had a similar distribution for both FY 2019 and FY 2020. DHS used this distribution as an estimate of what the future registrations split out by wage levels may look like for the missing 44 percent of petitions. Comments.

An individual commenter said the proposed rule does not analyze the indirect impact the rule will have on the wages of employees, only those directly impacted by the rule. The commenter also wrote that the proposed rule does not consider its impact on employers whose higher marginal costs cause them to forego expansion or close down. An individual commenter said that DHS does not provide evidence to support its statement that the proposed rule will have no effect on wages or growth, writing that it is unlikely that the rule will not depress wages and growth. Response.

DHS acknowledges that some petitioners might be impacted in terms of employment, productivity loss, search and hire costs, and profits resulting from labor turnover. The current random lottery system does not guarantee registrants that they will be able to petition for H-1B workers, and it could have the same effects and cause companies to search for alternative options. In cases where companies cannot find reasonable substitutes for the labor the H-1B beneficiaries would have provided, if selected under the random lottery process, affected petitioners also could lose profits from the lost productivity. In such cases, employers would incur opportunity costs by having to choose the next best alternative to immediately fill the job the prospective H-1B worker would have filled.

The commenter provided neither an explanation nor a basis to support the claim that wages would be depressed. DHS acknowledges that some employers' growth (profit) could be affected. However, asserting that economic growth would be harmed fails to account for the fact that this rule will not reduce or otherwise affect the statutorily authorized number of initial H-1B visas granted per year. USCIS analyzed the impacts of this rule in an objective manner using the best available data at the time the analysis was written and does not have quantifiable data on the effect on wages or growth.

Comment. A law firm stated that the DHS does not sufficiently quantify the impact of costs to petitioners, including training, labor for substitute workers, loss of productivity, and loss of revenue. The commenter wrote that, to meet the requirements of E.O. 12866, DHS should explain its justification for proposing changes recognized to have a negative impact on productivity and revenue of petitioners.

The commenter also asked DHS to explain how the proposed rule was tailored to ensure it imposed the least possible burden on society as required under E.O. 12866. Response. Executive Orders 12866 and 13563 direct agencies to assess the costs, benefits, and transfers of available alternatives, and if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

DHS analyzed all potential costs, benefits, and transfers of this rule. While DHS understands there are costs to some populations, there also are benefits to other populations. Comment. An advocacy group wrote that DHS states that an increase in H-1B recipients with higher salaries will compensate for any loss in international students and early career professionals under the proposed rule.

However, the commenter states that DHS does not provide any analysis to this effect and should provide a more precise estimate of the costs associated with changes, particularly whether the rule would have an impact on the ability of employers to attract talented employees. Response. DHS does not believe that this rule will negatively impact the ability of employers to attract talented employees. Rather, DHS believes that this rule will allow employers to attract the best and the brightest employees.

Comment. A law firm said the costs of the proposal are inconsistent with the aggregate cost savings the agency expected unselected petitions and the government to realize from registration. OMB designated the proposed rule as an “economically significant” regulatory action. In the NPRM, DHS estimated that, for a ten-year implementation period, the costs to the public would be more than $15.9 million annualized at 3-percent, and more than $16 million annualized at 7-percent.

DHS also acknowledged the possibility that the proposed regulation “could result in private sector expenditures exceeding $100 million, adjusted for inflation to $168 million in 2019 dollars, in any 1 year.” The costs likely are higher, as the agency has grossly underestimated the time-burden of this proposed regulation, such as suggesting that it will take a mere 20 minutes more to prepare the registration. Response. DHS acknowledges that this final rule has been designated an economically significant regulatory action by the Office of Information and Regulatory Affairs (OIRA), of the Office of Management and Budget. However, OIRA has waived review of this regulation under E.O.

12866, section 6(a)(3)(A). DHS disagrees that it will take more than 20 minutes to complete the additional information collection associated with the registration tool. Registrants or petitioners, as applicable, only will be required to provide, in addition to the information already to be collected, the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code in the area of intended Start Printed Page 1713employment. In the limited instance where there is no current OES prevailing wage information for the proffered position, the registrant will follow DOL guidance on prevailing wage determinations to determine which OES wage level to select on the registration, and USCIS will rank and select based on the highest OES wage level.

B. Costs Comments. An individual commenter stated that, under the proposed rule, USCIS would incur additional costs related to maintaining records detailing how USCIS processed each H-1B petition to document the correct handling and prioritization of all petitions. The commenter also wrote that USCIS's cost for processing petitions will increase significantly, as it will have to review each petition for salary, location, and job code to determine sorting order.

Another commenter wrote that the proposed rule indicates that DHS would not incur additional costs to the government because the agency could increase filing fees to cover costs, but that, itself, indicates the proposed rule would result in costs to DHS that should have been fully analyzed. Response. The INA provides for the collection of fees through USCIS's biannual fee schedule review, at a level that will ensure recovery of the full costs of providing adjudication and naturalization services by DHS. This includes administrative costs and services provided without charge to certain applicants and petitioners.[] DHS notes the time necessary for USCIS to review the information submitted with the forms relevant to this final rule includes the time to adjudicate the benefit request.

These costs are captured in the fees collected for the benefit request from petitioners. DHS accounts for familiarization cost and additional costs due to the increased burden per response for the petitioners, which is shown as costs in the Regulatory Impact Analysis. Other form applications and petition fees will cover the increased adjudication costs until the fee rule is reassessed Comment. One commenter wrote that the proposed rule likely would require technical changes to USCIS's registration system that the agency has already implemented for the FY 2021 H-1B cap season.

The commenter added that it is noteworthy that the proposed rule follows a recent announcement that USCIS must furlough 70 percent of its workforce. Another commenter said that, if this rule is put in place, companies will stop hiring foreign workers and USCIS will lose the revenue from this program as it is already in a fiscal crisis. Response. The President of the United States signed into law the Continuing Appropriations Act, 2021 and Other Extensions Act, H.R.

8337,[] which became Public Law 116-159, on October 1, 2020. This public law includes language from the Emergency Stopgap USCIS Stabilization Act, which allows USCIS to establish and collect additional premium processing fees, and to use those additional funds for expanded purposes. Because of the authorization to increase premium processing fees, and cost-savings measures taken by the agency, USCIS is in a better place financially. As a result, USCIS was able to avoid all potential furloughs, and, barring unforeseen changes in circumstances, any potential furloughs in FY 2021.[] c.

Benefits Comment. An individual commenter wrote that the proposed rule has been criticized for favoring larger firms over smaller businesses and startups, but it is unlikely that these types of businesses would immediately need the types of high salaried workers who would qualify for an H-1B visa. Instead, the commenter said there should be sufficient domestic talent under this rule to meet those labor needs. An individual commenter wrote that the proposed rule would have the benefit of curbing the practice of employers underpaying H-1B petitioners by offering level I wages to those with sufficient experience for higher wages.

As a result, employers will not be able to favor cheaper international labor and would consider domestic labor. Response. DHS agrees with this commenter that there should be sufficient replacement labor available in the U.S. Workforce that can meet domestic labor needs.

This rule will help the U.S. Workforce, as employers that might have petitioned for cap-subject H-1B workers to fill relatively lower-paid, lower-skilled positions, may be incentivized to hire available and qualified U.S. Workers for those positions. Comment.

Referencing DHS's suggestion that one of the proposed rule's unquantified benefits is increased opportunities for lower-skilled U.S. Workers in the labor market, an individual commenter stated that low-skilled workers cannot replace H-1B specialty occupation workers. Response. DHS disagrees.

If an employer is hiring an entry-level employee at a level I prevailing wage, then an available and qualified U.S. Worker can be a substitute. 2. Paperwork Reduction Act Comments.

A commenter stated that requiring an employer to provide a wage level at the time of electronic registration for the H-1B cap seems to violate the Paperwork Reduction Act (PRA), which generally only permits the collection of information needed to meet a legally supported objective. The commenter indicated DHS has not adequately explained how collecting the OES prevailing wage level at the time of electronic registration is consistent with the PRA, as employers are not required to obtain an LCA at the time of the electronic registration for the H-1B cap. Response. DHS disagrees that requiring the registrant to provide the wage level that the proffered wage corresponds to for the relevant SOC and area of employment, or that corresponds to the position requirements when OES wage data is unavailable, at the time of electronic registration for the H-1B cap would violate the PRA.

Once this rule becomes effective, collection of such information would be needed to implement the rule and to select registrations in accordance with this rule, and thus would be a legally supported objective. As noted in the NPRM, an LCA is not a requirement for registration. However, consistent with the registrant's attestation that the registration is submitted for a valid offer of employment, DHS expects each registrant (i.e., the prospective petitioner or the attorney or accredited representative submitting the registration for the prospective petitioner) to know and be able to provide the relevant corresponding wage level when submitting a registration, regardless of whether they have a certified LCA at that time. F.

Out of Scope An individual commenter called for relief for those who need housing and food, “instead of bringing in foreigners.” Another individual commenter said that the increase in H-1B visas and outsourcing to foreign contractors caused their spouse's wages to stagnate despite increased responsibility, and Start Printed Page 1714fewer U.S. Born entry-level employees were hired. Yet another individual commenter wrote that the agency should make it easier to report visa fraud, and that stricter, more comprehensive punishments should be in place for visa fraud. A few anonymous commenters said that the H-1B visa is a “scam.” A trade association wrote in opposition to two other rules related to the H-1B visa published by DOL and DHS, the latter of which revised the definition of “specialty occupations” eligible for H-1B visas, limited visas to one year for third party worksites, and expanded DHS worksite oversight.[] Another trade association also wrote in opposition to the DOL and DHS IFRs, objecting specifically to the DHS IFR's revisions to the definitions of “specialty occupations” and “U.S.

Employer,” the requirements for corroborating evidence for specialty occupations, and the amended validity period for third-party placement at worksites.[] The commenter provided background information and a summary of the DHS IFR. One commenter said the lottery system is unfair, and USCIS should instead focus on limiting fraud and abuse of the lottery system. Yet another trade association opposed the proposed rule and suggested that the Agency implement reforms as discussed in the National Association of Manufacturer's “A Way Forward” plan, including statutory changes to the H-1B program, border security measures, asylum, and other immigration programs. A union argued that due to the “timing and rushed nature” of the DOL IFR and this proposed rule, any changes are vulnerable to procedural challenge and are likely politically motivated.

The commenter went on to provide extensive feedback on the DOL and DHS IFRs and the H-1B program at large, calling for immigration reform and urging the Departments of Labor and Homeland Security to make structural changes to the H-1B program that protect workers' rights. A research organization wrote about the H-1B program in general, saying that allowing outsourcing companies to hire H-1B workers lets employers use the immigration system to “degrade labor standards for skilled workers” and exploit H-1B employees. Additionally, the commenter argued that outsourcing companies are using the H-1B program to underpay H-1B workers, replace U.S. Workers, and send tech jobs abroad.

A submission on behalf of U.S. Citizen medical graduates urged expanding the H-1B and J-1 visa ban to include the healthcare sector, prioritizing U.S. Citizens for placement in residency programs, or that the Accreditation Council for Graduate Medical Education (ACGME) consider opening up more residency spots and new residency programs. A professional association recommended that USCIS modify its regulation at 8 CFR 214.2(h)(8)(iii)(A)(4) (“Limitation on requested start date”) permitting a requested start date on or after the first day for the applicable fiscal year.

Response. DHS appreciates these comments. However, DHS did not propose to address these issues in the proposed rule, so these comments fall outside of the scope of this rulemaking. DHS is finalizing this rule as proposed.

V. Statutory and Regulatory Requirements A. Executive Orders 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), and Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) Executive Orders (E.O.) 12866 and 13563 direct agencies to assess the costs, benefits, and transfers of available alternatives, and if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

Pursuant to Executive Order 12866 (Regulatory Planning and Review), the Office of Information and Regulatory Affairs (OIRA), of the Office of Management and Budget, has determined that this final rule is an economically significant regulatory action. However, OIRA has waived review of this regulation under section 6(a)(3)(A) of Executive Order 12866. 1. Summary of Economic Effects DHS is amending its regulations governing the selection of registrants eligible to file H-1B cap-subject petitions, which includes petitions subject to the regular cap and those asserting eligibility for the advanced degree exemption, to allow for ranking and selection based on OES wage levels corresponding to their SOC codes.

USCIS will rank and select the registrations properly submitted (or petitions in any year in which the registration process is suspended) generally on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment. USCIS will begin with OES wage level IV and proceed in descending order with OES wage levels III, II, and I. DHS is amending the relevant sections of DHS regulations to reflect these changes. The described change in selection is expected to result in a different allocation of H-1B visas (or grants of initial H-1B status) favoring petitioners that proffer relatively higher wages.

In the analysis that follows, DHS presents its best estimate for how H-1B petitioners will be affected by and will respond to the increased probability of selection of registrations of petitions proffering the highest wages for a given occupation and area of employment. DHS estimates the net costs that will result from this final rule compared to the baseline of the H-1B visa program. For the 10-year implementation period of the rule, DHS estimates the annualized costs to the public would be $15,968,792 annualized at 3-percent, $16,089,770 annualized at 7-percent. Table 1 provides a more detailed summary of the final rule provisions and their impacts.Start Printed Page 1715 Table 1—Summary of Provisions and Economic Impacts of the Final RuleProvisionDescription of changes to provisionEstimated costs of provisionsEstimated benefits of provisionsCurrently, USCIS randomly selects H-1B registrations or cap-subject petitions, as applicable.

USCIS will change the selection process to prioritize selection of registrations or cap-subject petitions, as applicable, based on corresponding OES wage level DHS regulations currently address H-1B cap allocation in various contexts. 1. Fewer registrations than needed to meet the H-1B regular cap. 2.

Sufficient registrations to meet the H-1B regular cap during the initial registration period. 3. Fewer registrations than needed to meet the H-1B advanced degree exemption numerical limitation. 4.

Sufficient registrations to meet the H-1B advanced degree exemption numerical limitation during the initial registration period. 5. Increase to the number of registrations projected to meet the H-1B regular cap or advanced degree exemption allocations in a FY. 6.

H-1B cap-subject petition filing following registration—(1) Filing procedures. 7. Petition-based cap-subject selections in event of suspended registration process. 8.

Denial of petition. 9. Revocation of approval of petition.USCIS will rank and select H-1B registrations (or H-1B petitions if the registration requirement is suspended) generally based on the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment. This final rule will add instructions and a question to the registration form to select the appropriate wage level.

This final rule also will add instructions and questions to the H-1B petition seeking the same wage level information and other information concerning the proffered position to assess the prevailing wage level. This final rule will not affect the order of selection as between the regular cap and the advanced degree exemption. If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations needed to reach the numerical limitation. USCIS is authorized to deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary for a lower wage level if USCIS determines that the new or amended petition was filed to reduce the wage level listed on the original petition to unfairly increase the odds of selection during the registration selection process.

In any year in which USCIS suspends the H-1B electronic registration process for cap-subject petitions, USCIS will, instead, allow for the submission of H-1B cap-subject petitions. After USCIS receives a sufficient number of petitions to meet the H-1B regular cap and were to complete the selection process of petitions for the H-1B regular cap following the same method of ranking and selection based on corresponding OES wage level, USCIS will determine whether there is a sufficient number of remaining petitions to meet the H-1B advanced degree exemption numerical limitation.Quantitative. Petitioners— • $3,457,401 costs annually for petitioners completing and filing Form I-129 petitions with an additional time burden of 15 minutes. €¢ $11,795,997 costs annually for prospective petitioners submitting electronic registrations with an additional time burden of 20 minutes.

DHS/USCIS— • None. Qualitative. Petitioners— • Petitioners may incur costs to seek out and train other workers, or to induce workers with similar qualifications to consider changing industry or occupation. €¢ Petitioners that would have hired relatively low-paid H-1B workers, but were unable to do so because of non-selection (and ineligibility to file petitions), may incur reduced labor productivity and revenue.

€¢ Petitioners may incur costs from offering beneficiaries higher wages for the same work to achieve greater chances of selection. DHS/USCIS— • None.Quantitative. Petitioners— • None. DHS/USCIS— • None.

Qualitative. U.S. Workers— • A possible increase in employment opportunities for similarly skilled unemployed or underemployed U.S. Workers seeking employment in positions otherwise offered to H-1B cap-subject beneficiaries at wage levels corresponding to lower wage positions.

H-1B Workers— • A possible increase in productivity, measured in increased H-1B wages, resulting from the reallocation of a fixed number of visas from positions classified as lower-level work to employers able to pay the highest wages for the most highly skilled workers. €¢ A possible increase in wages for positions offered to H-1B cap-subject beneficiaries for the same work to improve the prospective petitioner's chance of selection. Petitioners— • Level I and level II beneficiaries may see increased wages. Companies who have historically paid level I wages may be incentivized to offer their H-1B employees higher wages, so that they could have a greater chance of selection at a level II or higher.

€¢ Employers who offer H-1B workers wages that corresponds with level III or level IV OES wages may have higher chances of selection. DHS/USCIS— • Submitting additional wage level information on both an electronic registration and on Form I-129 will allow USCIS to maintain the integrity of the H-1B cap selection and adjudication processes. €¢ Registrations or petitions, as applicable, will be more likely to be selected under the numerical allocations for the highest paid, and presumably highest skilled or highest-valued, beneficiaries.Familiarization CostFamiliarization costs comprise the opportunity cost of the time spent reading and understanding the details of a rule to fully comply with the new regulation(s).Quantitative. Petitioners— • One-time cost of $6,285,527 in FY 2022.

DHS/USCIS— • None. Qualitative. Petitioners— • None. DHS/USCIS— None.Quantitative.

Petitioners— • None. DHS/USCIS— • None. Qualitative. Petitioners— • None.

DHS/USCIS— • None. In addition to the impacts summarized here, Table 2 presents the accounting statement as required by OMB Circular A-4.[] Table 2—OMB A-4 Accounting Statement[$, 2019 for FY 2022-FY 2032]CategoryPrimary estimateMinimum estimateMaximum estimateSource citationBenefits:Annualized Monetized Benefits over 10 years (discount rate in parenthesis)N/A N/AN/A N/AN/A N/AStart Printed Page 1716Annualized quantified, but un-monetized, benefits000Unquantified BenefitsThis final rule will benefit petitioners agreeing to pay H-1B workers a proffered wage corresponding to OES wage level III or IV, by increasing their chance of selection in the H-1B cap selection process. These changes align with the Administration's goals of improving policies such that the H-1B classification more likely will be awarded to the highest paid or highest skilled beneficiaries. These changes will also better align the administration of the H-1B program with the dominant Congressional intent.RIA. This final rule may provide increased opportunities for similarly skilled U.S.

Workers in the labor market to compete for work as there will be fewer H-1B workers paid at the lower wage levels to compete with U.S. Workers.150 Further, assuming demand outpaces the 85,000 visas currently available for annual allocation, DHS believes that the potential reallocation of visas to favor those petitioners able to offer the highest wages to recruit the most highly skilled workers will result in increased marginal productivity of all H-1B workers. This final rule may provide increased wages for positions offered to H-1B cap-subject beneficiaries.Costs:Annualized monetized costs over 10 years (discount rate in parenthesis)(3 percent) $15,968,792 (7 percent) $16,089,770N/A N/AN/A N/ARIA.Annualized quantified, but un-monetized, costsN/AQualitative (unquantified) costsThis final rule is expected to reduce the number of petitions for lower wage H-1B workers. This may result in increased recruitment or training costs for petitioners that seek new pools of talent. Additionally, petitioners' labor costs or training costs for substitute workers may increase.

DHS also acknowledges that some petitioners might be impacted in terms of the employment, productivity loss, search and hire cost per employer of $4,398, and profits resulting from labor turnover. In cases where companies cannot find reasonable substitutions for the labor the H-1B beneficiary would have provided, affected petitioners will also lose profits from the lost productivity. In such cases, employers will incur opportunity costs by having to choose the next best alternative to immediately filling the job the prospective H-1B worker would have filled. There may be additional opportunity costs to employers such as search costs and training.RIA. Such possible disruptions to companies will depend on the interaction of a number of complex variables that are constantly in flux, including national, state, and local labor market conditions, economic and business factors, the type of occupations and skills involved, and the substitutability between H-1B workers and U.S.

Workers. Petitioners that would have hired relatively lower-paid H-1B workers, but were unable to do so because of non-selection (and ineligibility to file a petition), may incur reduced labor productivity and revenue.Transfers:Annualized monetized transfers. €œon budget”N/AN/AN/AFrom whom to whom?. €ƒAnnualized monetized transfers. €œoff-budget”N/AN/AN/AFrom whom to whom?.

N/AN/AN/AMiscellaneous analyses/categoryEffectsSource citationEffects on state, local, and/or tribal governmentsN/ARFA.Effects on small businessesN/ARFA.Effects on wagesN/ANone.Effects on growthN/ANone. 2. Background and Purpose of the Final Rule The H-1B visa program allows U.S. Employers to temporarily hire foreign workers to perform services in a specialty occupation, services related to a Department of Defense (DOD) cooperative research and development project or coproduction project, or services of distinguished merit and ability in the field of fashion modeling.[] A specialty occupation is defined as an occupation that requires the (1) theoretical and practical application of a body of highly specialized knowledge and (2) attainment of a bachelor's or higher degree in the specific specialty (or its equivalent) as a minimum qualification for entry into the occupation in the United States.[] The number of aliens who may be issued initial H-1B visas or otherwise provided initial H-1B nonimmigrant status during any FY has been capped at various levels by Congress over time, with the current numerical limit generally being 65,000 per FY.[] Congress has also provided for various exemptions from the annual numerical allocations, including an exemption for Start Printed Page 171720,000 aliens who have earned a master's or higher degree from a U.S.

Institution of higher education.[] Under the current regulation, all petitioners seeking to file an H-1B cap-subject petition must first electronically submit a registration for each beneficiary on whose behalf they seek to file an H-1B cap-subject petition, unless USCIS suspends the registration requirement.[] USCIS monitors the number of H-1B registrations submitted during the announced registration period of at least 14 days and, at the conclusion of that period, if more registrations are submitted than projected as needed to reach the numerical allocations, randomly selects from among properly submitted registrations the number of registrations projected as needed to reach the H-1B numerical allocations.[] Under this random H-1B registration selection process, USCIS first selects registrations submitted on behalf of all beneficiaries, including those eligible for the advanced degree exemption. USCIS then selects from the remaining registrations a sufficient number projected as needed to reach the advanced degree exemption. A prospective petitioner whose registration is selected is notified of the selection and instructed that the petitioner is eligible to file an H-1B cap-subject petition for the beneficiary named in the selected registration within a filing period that is at least 90 days in duration and begins no earlier than 6 months ahead of the actual date of need (commonly referred to as the employment start date).[] When registration is required, a petitioner seeking to file an H-1B cap-subject petition is not eligible to file the petition unless the petition is based on a valid, selected registration for the beneficiary named in the petition.[] Prior to filing an H-1B petition, the employer is required to obtain a certified Labor Condition Application (LCA) from the Department of Labor (DOL).[] The LCA form collects information about the employer and the occupation for the H-1B worker(s). The LCA requires certain attestations from the employer, including, among others, that the employer will pay the H-1B worker(s) at least the required wage.[] This final rule amends DHS regulations concerning the selection of electronic registrations submitted by or on behalf of prospective petitioners seeking to file H-1B cap-subject petitions (or the selection of petitions, if the registration process is suspended), which includes petitions subject to the regular cap and those asserting eligibility for the advanced degree exemption, to allow for ranking and selection based on OES wage levels.

When applicable, USCIS will rank and select the registrations received generally on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area(s) of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I and below.[] For registrants relying on a private wage survey, if the proffered wage is less than the corresponding level I OES wage, the registrant will select the “Wage Level I and below” box on the registration form.[] If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the applicable numerical allocation, USCIS will randomly select from all registrations within that wage level a sufficient number of registrations needed to reach the applicable numerical limitation.[] 3. Historic Population The historic population consists of petitioners who file on behalf of H-1B cap-subject beneficiaries (in other words, beneficiaries who are subject to the annual numerical limitation, including those eligible for the advanced degree exemption). DHS uses the 5-year average of H-1B cap-subject petitions received for FYs 2016 to 2020 (211,797) as the historic estimate of H-1B cap-subject petitions that were submitted annually.[] Prior to publication of U.S. Citizenship and Immigration Services Fee Schedule and Changes to Certain Other Immigration Benefit Request Requirements (Fee Schedule Final Rule),[] H-1B petitioners submit Form I-129 with applicable supplements for H-1B petitions.

Through the Fee Schedule Final Rule, DHS created a new Form I-129 for H-1B petitioners.[] Form I-129 does not include separate supplements as relevant data collection fields have been incorporated into Form I-129. DHS assumes that the number of petitioners who previously filled out the Form I-129 and H-1B supplements is the same as the number of petitioners who will complete the new Form I-129H1. Table 3—H-1B Cap-Subject Petitions Submitted to USCIS for FY 2016—FY 2020Fiscal yearTotal number of H-1B cap-subject petitions submittedTotal number of H-1B petitions selectedNumber of petitions filed with Form G-282016232,97397,71172,2922017236,44495,81868,7432018198,46095,92378,900Start Printed Page 17182019190,098110,37693,4952020201,011109,28392,396Total1,058,986509,111405,8265-year average211,797101,82281,165Source. Total Number of H-1B Cap-Subject Petitions Submitted FYs 2016-2020, USCIS Service Center Operations (SCOPS), June 2019.

Total Number of Selected Petitions data, USCIS Office of Performance and Qualify (OPQ), Performance Analysis and External Reporting (PAER), July 2020. Table 3 also shows historical Form G-28 filings by attorneys or accredited representatives accompanying selected H-1B cap-subject petitions. DHS notes that these forms are not mutually exclusive. Based on the 5-year average, DHS estimates 79.7 percent [] of selected petitions will be filed with a Form G-28.

Table 3 does not include data for FY 2021 as the registration requirement was first implemented for the FY 2021 H-1B cap selection process, and petition submission was ongoing at the time of this analysis. The H-1B selection process changed significantly after the publication of the H-1B Registration Final Rule.[] That rule established a mandatory electronic registration requirement that requires petitioners seeking to file cap-subject H-1B petitions, including those eligible for the advanced degree exemption, to first electronically register with USCIS during a designated registration period. That rule also reversed the order by which USCIS counts H-1B registrations (or petitions, for any year in which the registration requirement is suspended) toward the number projected to meet the H-1B numerical allocations, such that USCIS first selects registrations submitted on behalf of all beneficiaries, including those eligible for the advanced degree exemption. USCIS then selects from the remaining registrations a sufficient number projected as needed to reach the advanced degree exemption.

The registration requirement was first implemented for the FY 2021 H-1B cap. During the initial registration period for the FY 2021 H-1B cap selection process, DHS received 274,237 registrations. 4. Cost-Benefit Analysis Through these changes, petitioners will incur costs associated with additional time burden in completing the registration process and, if selected for filing, the petition process.

In this analysis, DHS estimates the opportunity cost of time for these occupations using average hourly wage rates of $32.58 for HR specialists and $69.86 for lawyers.[] However, average hourly wage rates do not account for worker benefits such as paid leave, insurance, and retirement. DHS accounts for worker benefits when estimating the opportunity cost of time by calculating a benefits-to-wage multiplier using the most recent DOL, BLS report detailing average compensation for all civilian workers in major occupational groups and industries. DHS estimates the benefits-to-wage multiplier is 1.46.[] For purposes of this final rule, DHS calculates the average total rate of compensation as $47.57 per hour for an HR specialist, where the average hourly wage is $32.58 per hour worked and average benefits are $14.99 per hour.[] Additionally, DHS calculates the average total rate of compensation as $102.00 per hour for an in-house lawyer, where the average hourly wage is $69.86 per hour worked and average benefits are $32.14 per hour.[] Moreover, DHS recognizes that a firm may choose, but is not required, to outsource the preparation and submission of registrations and filing of H-1B petitions to outsourced lawyers.[] Therefore, DHS calculates the average total rate of compensation as $174.65, which is the average hourly U.S. Wage rate for lawyers multiplied by 2.5 to approximate an hourly billing rate for an outsourced lawyer.[] Table 4 summarizes the compensation rates used in this analysis.

Table 4—Summary of Estimated Wages for Form I-129 Filers by Type of Filer Hourly compensation rateHuman Resources (HR) Specialist$47.57In-house lawyer102.00Outsourced lawyer174.65Source. USCIS analysis. A. Costs and Cost Savings of Regulatory Changes to Petitioners i.

Methodology Based on Historic FYs 2019-2020 This final rule primarily will change the manner in which USCIS selects H-1B registrations (or H-1B petitions for any year in which the registration requirement is suspended), by first Start Printed Page 1719selecting registrations generally based on the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment. In April 2019, DHS added an electronic registration requirement for petitioners seeking to file H-1B petitions on behalf of cap-subject aliens.[] Under the current regulation, all petitioners seeking to file an H-1B cap-subject petition must first electronically submit a registration for each beneficiary on whose behalf they seek to file an H-1B cap-subject petition, unless the registration requirement is suspended. If the registration is selected, the petitioner is eligible to file an H-1B cap-subject petition for the beneficiary named in the selected registration during the associated filing period. The registration requirement was suspended for the FY 2020 H-1B cap and first implemented for the FY 2021 H-1B cap.

The initial H-1B registration period for the FY 2021 H-1B cap was March 1, 2020, through March 20, 2020. A total of 274,237 registrations were submitted during the initial registration period, of which 123,244 [] registrations were for beneficiaries eligible for the advanced degree exemption and 145,950 were for beneficiaries under the regular cap.[] Prior to implementing the registration requirement, USCIS administered the H-1B cap by projecting the number of petitions needed to reach the numerical allocations. H-1B cap-subject petitions were randomly selected when the number of petitions received on the final receipt date exceeded the number projected as needed to reach the numerical allocations. All petitions eligible for the advanced degree exemption had an equal chance of being selected toward the advanced degree exemption, and all remaining petitions had an equal chance of being selected toward the regular cap.

In FY 2019, USCIS first selected petitions toward the number of petitions projected as needed to reach the advanced degree exemption. If the petition was not selected under the advanced degree exemption, those cases then were added back to the pool and had a second chance of selection under the regular cap. In FY 2020, the selection order was reversed, such that USCIS first selected petitions toward the number projected as needed to reach the regular cap from among all petitions received. USCIS then selected toward the number of petitions projected as needed to reach the advanced degree exemption from among those petitions eligible for the advanced degree exemption, but that were not selected toward the number projected as needed to reach the regular cap.

Table 5 shows the number of petitions submitted and selected in FYs 2019 and 2020. It also displays the approximated 2-year averages of the petitions that were submitted and selected for the H-1B regular cap or advanced degree exemption. On average, DHS selected 56 percent [] of the H-1B cap-subject petitions submitted, with 82,900 toward the regular cap and 26,930 toward the advanced degree exemption. Table 5—H-1B Cap-Subject Petitions Submitted to USCIS, for FY 2019-FY 2020Fiscal yearTotal number of H-1B cap-subject petitions submittedTotal petitions selectedRegular capAdvanced degree exemption2019190,098110,37682,95627,4202020201,011109,28382,84326,440Total391,109219,659165,79953,8602-Year Average195,555109,83082,90026,930Source.

USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. July 21, 2020 &. USCIS Analysis DHS does not have data on the OES wage levels for selected petitions prior to FY 2019.[] While there are some challenges to using OES wage data as a timeseries, DHS uses the wage data to provide some insight.[] Table 6 shows the petitions that were selected for FYs 2019 and 2020, categorized by OES wage level. The main difference between the FY 2019 and FY 2020 data sets is that there are more petitions classified as not applicable (N/A) in the FY 2019 data compared to the FY 2020 data.

Since DOL's Standard Occupational Classification (SOC) [] structure was modified in 2018, some petitions were categorized as N/A in FY 2019. In 2019, DOL started to use a hybrid OES [] occupational structure for classifying the petitions for FY 2020. Another data limitation was that some of the FY 2020 data was incomplete with missing fields, and could not be classified into the specific wage levels. Therefore, the petitions were categorized as N/A.

DHS expects each registrant that is classified as N/A will be able to identify the appropriate SOC code for the proffered position because all petitioners are required to identify the appropriate SOC code for the proffered position on the LCA, even when there is no applicable wage level on the LCA. Using the SOC code and the above-mentioned DOL guidance, all registrants will be able to determine the appropriate OES wage level for purposes of completing the registration, regardless of whether they specify an Start Printed Page 1720OES wage level or utilize the OES program as the prevailing wage source on an LCA. While there are limitations to the data used, DHS believes that the estimates are helpful to see the current wage levels and estimate the future populations in each wage level. Table 6—Selected Petitions by Wage Level FY 2019-FY 2020 Level ILevel IILevel IIILevel IVN/ATotalAdvanced Degree Exemption:FY 20197,36313,8952,0165533,59327,420FY 20207,45314,4672,3116941,51526,440Total14,81628,3624,3271,2475,10853,8602-Year Average7,40814,1812,1646232,55426,930Regular Cap:FY 201918,55742,6218,4473,5409,79182,956FY 202019,23246,4398,7963,6774,69982,843Total37,78989,06017,2437,21714,490165,7992-Year Average18,89544,5308,6223,6087,24582,900Source.

USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. July 21, 2020 &. USCIS Analysis. DHS has OES wage level data only on the petitions that were selected toward the numerical allocations and does not have the wage level break down for the 85,725 [] (44 percent) of petitions that were not selected since those petitions were returned to petitioners without entering data into DHS databases.

Due to data limitations, DHS estimated the wage level break down for the 44 percent of petitions that were not selected because wage levels vary significantly between occupations and localities. Table 7 shows the 2-year approximated average of H-1B cap-subject petitions that were selected, separated by OES wage level, and percentages of accepted petitions by each wage category. The wage category with the most petitions, as estimated, is OES wage level II. Table 7—Current Estimated Number of Selected Petitions by Wage Level and Cap Type FY 2019-FY 2020LevelRegular capAdvanced degree exemptionSelected% of totalSelected% of totalLevel I &.

N/A26,14031.509,96236.99Level II44,53053.7014,18152.66Level III8,62210.402,1648.04Level IV3,6084.406232.31Total82,90010026,930100Source. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. July 21, 2020 &. USCIS Analysis ii.

FY 2021 Data [] The population affected by this final rule consists of prospective petitioners seeking to file H-1B cap-subject petitions, including those eligible for the advanced degree exemption. DHS regulations require all petitioners seeking to file H-1B cap-subject petitions to first electronically submit a registration for each beneficiary on whose behalf they seek to file an H-1B cap-subject petition, unless USCIS suspends the registration requirement.[] A prospective petitioner whose registration is selected is eligible to file an H-1B cap-subject petition for the beneficiary named in the selected registration during the associated filing period.[] Under the current H-1B registration selection process, USCIS first randomly selects registrations submitted on behalf of all beneficiaries, including those eligible for the advanced degree exemption.[] USCIS then randomly selects from the remaining registrations a sufficient number projected as needed to reach the advanced degree exemption.[] Prior to the implementation of the H-1B registration requirement for the FY 2021 H-1B cap selection process, petitioners submitted an annual average of 211,797 cap-subject H-1B petitions over FYs 2016 through 2020. The number of registrations submitted for the FY 2021 H-1B cap selection process, however, was 274,237. Because the number of registrations submitted for the FY 2021 H-1B cap selection process was significantly higher than the number of petitions submitted in prior years, DHS will use the total number of registrations submitted for the FY 2021 H-1B cap selection process as the population to estimate certain costs for this final rule.[] There were many factors that led to an increased number of registrations for FY 2021.

One possible factor is that the cost and burden to submit the registration is less than the Start Printed Page 1721cost and burden to submit complete Form I-129 packages. For the FY 2021 H-1B cap selection process, 106,100 registrations initially were selected to submit a petition. Prospective petitioners with selected registrations only were eligible to file H-1B petitions based on the selected registrations during a 90-day filing window. USCIS did not receive enough H-1B petitions during the initial filing period to meet the number of petitions projected as needed to reach the H-1B numerical allocations, so the selection process was run again in August 2020.

An additional 18,315 registrations were selected in August 2020 for a total of 124,415 selected registrations for FY 2021. While the current number of registrations selected toward the FY 2021 numerical allocations is 124,415, DHS estimates certain costs for this final rule using the number of registrations initially selected (106,100) as the best estimate of the number of petitions needed to reach the numerical allocations. Table 8—H-1B Cap-Subject Registrations Submitted, for FY 2021Fiscal yearTotal number of H-1B registrations submittedRound 1 number of H-1B registrations selectedRound 2 number of H-1B registrations selectedTotal number of H-1B registrations selected *Number of registrations submitted with form G-28 **2021274,237106,10018,315124,415N/ATotal274,237106,10018,315124,415N/ASource. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3.

August 31, 2020 USCIS Analysis.* Note. USCIS administered the selection process twice because an insufficient number of petitions were filed following initial registration selection to reach the number of petitions projected as needed to reach the numerical allocations. USCIS has not finished processing H-1B cap-subject petitions for FY 2021.** Note. Complete data is still unavailable for FY 2021.

USCIS used FYs 2019-2020 from Table 3 to estimate the percentage of submitted G-28s below. Table 3 shows historical Form G-28 filings by attorneys or accredited representatives accompanying selected H-1B cap-subject petitions. DHS notes that these forms are not mutually exclusive. Based on the historical 5-year average from earlier in this analysis, DHS estimates 79.7 percent [] of selected registrations will include Form G-28.

DHS applies those percentages to the number of total registrations and estimates 218,567 [] Form G-28 were submitted with total registrations received. DHS uses the total registrations received for the FY 2021 H-1B cap selection process (274,237) as the estimate of registrations that will be received annually. Additionally, DHS assumes that petitioners may use human resources (HR) specialists (or entities that provide equivalent services) (hereafter HR specialist) or use lawyers or accredited representatives [] to complete and file H-1B petitions. A lawyer or accredited representative appearing before DHS must file Form G-28 to establish their eligibility and authorization to represent a client (applicant, petitioner, requestor, beneficiary or derivative, or respondent) in an immigration matter before DHS.

DHS estimates that approximately 80 percent [] of H-1B petitions typically will be completed and filed by a lawyer or other accredited representative (hereafter lawyer). DHS assumes the remaining 20 percent of H-1B petitions will be completed and filed by HR specialists. Petitioners who use lawyers to complete and file H-1B petitions may either use an in-house lawyer or hire an outsourced lawyer. Of the total number of H-1B petitions filed in FY 2021, DHS estimates that 26 percent were filed by in-house lawyers, while the remaining 54 percent were filed by outsourced lawyers.[] Table 9—Summary of Estimated Average Number of Petitions/Registrations Submitted Annually by Type of FilerAffected populationEstimated average population affectedNumber of petitions/registrations submitted by HR specialistsNumber of petitions/registrations submitted by in-house lawyersNumber of petitions/registrations submitted by outsourced lawyers AB = A × 20%C = A × 26%D = A × 54%Estimated number of H-1B registrations submitted annually274,23754,84771,302148,088Start Printed Page 1722Estimated number of H-1B registrations selected to file H-1B cap petitions annually106,10021,22027,58657,294Source.

USCIS analysis. Based on the total estimated number of affected populations shown in Table 9, DHS further estimates the number of entities that will be affected by each requirement of this final rule to estimate the costs arising from the regulatory changes in the cost-benefit analysis section. Additionally, DHS uses the same proportion of HR specialists, in-house lawyers, and outsourced lawyers (20, 26, and 54 percent, respectively) to estimate the population that will be affected by the various requirements of this final rule. Iii.

Unquantified Costs &. Benefits Given that the demand for H-1B cap-subject visas, including those filed for the advanced degree exemption, frequently has exceeded the annual H-1B numerical allocations, this final rule will increase the chance of selection for registrations (or petitions, if registration were suspended) seeking to employ beneficiaries at level IV or level III wages. DHS believes this incentive for petitioners to offer wages that maximize their probability of selection is necessary to address the risk that greater numbers of U.S. Employers could rely on the program to access relatively lower-cost labor, precluding other employers from benefitting from the H-1B program's intended purpose of providing high-skilled nonimmigrant labor to supplement domestic labor.

This final rule could result in higher proffered wages or a reduction in the downward pressure on wages in industries and occupations with concentrations of relatively lower-paid H-1B workers. Additionally, this final rule may lead to an increase in employment opportunities for unemployed or underemployed U.S. Workers seeking employment in positions otherwise offered to H-1B cap-subject beneficiaries at wage levels corresponding to lower wage positions. Employers that offer H-1B workers wages that correspond with level IV or level III OES wages will have higher chances of selection.

For the FY 2021 H-1B cap selection process, USCIS initially selected 106,100 (39 percent) [] of H-1B registrations submitted toward the numerical allocations. Of those 80,600 were selected toward the number projected as needed to reach the regular cap, and 25,500 were selected toward the number projected as needed to reach the advanced degree exemption. The total number of H-1B registrations submitted was 274,237. However, 5,043 were invalid.

Of the 269,194 valid registrations, 145,950 were submitted toward the regular cap and 123,244 were eligible for selection under the advanced degree exemption. Table 10—H-1B Cap-Subject Registrations Submitted for FY 2021Fiscal yearTotal number of valid H-1B registrations submittedRegular capAdvanced degree exemption2021269,194145,950123,244Total269,194145,950123,244Source. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. August 31, 2020 &.

USCIS &. Analysis.* Note. The total number of registrations in this table does not equal 274,237 because 5,043 of the registrations were invalid. DHS estimated the wage level distribution for FY 2021 based on the average distribution observed in FYs 2019 and 2020.

At the time of analysis, the wage level data was unavailable for FY 2021 because the petition filing process was ongoing. Table 11 displays the historic 2-year (FY 2019 and FY 2020) approximated average of H-1B cap-subject petitions that were selected, separated by OES wage level, and percentages of selected petitions by each wage category. Table 11—Historic Number of Selected Petitions by Wage Level and Cap TypeLevelRegular capAdvanced degree exemptionSelected% of totalSelected% of totalLevel I &. Below26,14031.509,96236.99Level II44,53053.7014,18152.66Level III8,62210.402,1648.04Start Printed Page 1723Level IV3,6084.406232.31Total82,90010026,930100Source.

USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. July 21, 2020 &. USCIS Analysis.* Note. Totals are based on 2-year averages of petitions randomly selected in FYs 2019-2020, Table 11 is replicated from Table 7.

DHS assumes that FY 2021 wage level distribution of registrations will equal the wage level distribution observed in FYs 2019 through 2020 data. DHS multiplied the percentage of selected petitions by level from Table 11 to estimate the breakdown of registrations by wage level. For example, DHS multiplied 145,950 by 4.4 percent to estimate that a total of 6,422 registrations would have been categorized as wage level IV under the regular cap. Table 12—Current Estimated Number of Registrations by Wage Level and Cap TypeLevelRegular capAdvanced degree exemptionEstimated registrations% of registrationsEstimated registrations% of registrationsLevel I &.

Below45,97431.5045,58836.99Level II78,37553.7064,90052.66Level III15,17910.409,9098.04Level IV6,4224.402,8472.31Total145,950100123,244100Source. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3. August 31, 2020 &. USCIS Analysis* Note.

Totals are based on FY 2021 data This final rule will change the H-1B cap selection process, but will leave in place selecting first toward the regular cap and second toward the advanced degree exemption. USCIS now will rank and select the registrations received (or petitions, as applicable) generally on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I and below. As a result of the approximated 2-year average from above, DHS displays the projected selection percentages for registrations under the regular cap and advanced degree exemption in Table 13. With the revised selection method based on corresponding OES wage level and ranking, the approximated average indicates that all registrations with a proffered wage that corresponds to OES wage level IV or level III will be selected and 58,999, or 75 percent, of the registrations with a proffered wage that corresponds to OES wage level II will be selected toward the regular cap projections.

None of the registrations with a proffered wage that corresponds to OES wage level I or below will be selected toward the regular cap projections. For the advanced degree exemption, DHS estimates all registrations with a proffered wage that corresponds to OES wage levels IV and III will be selected and 12,744, or 20 percent, of the registrations with a proffered wage that corresponds to OES wage level II will be selected. DHS estimates that none of the registrations with a proffered wage that corresponds to OES wage level I or below will be selected. DHS is using the approximated 2-year average from above to illustrate the expected distribution of future selected registration percentages by corresponding wage level.

However, DHS is unable to quantify the actual outcome because DHS cannot predict the actual number of registrations that will be received at each wage level because employers may change the number of registrations they choose to submit and the wages they offer in response to the changes in this rule. Table 13—New Estimated Number of Selected Registrations by Wage Level and Cap TypeLevelRegular capAdvanced degree exemptionTotal registrationsSelected registrations% SelectedTotal registrationsSelected registrations% SelectedLevel I &. Below45,9740045,58800Level II78,37558,9997564,90012,74420Level III15,17915,1791009,9099,909100Level IV6,4226,4221002,8472,847100Total145,95080,600123,24425,500Source. USCIS, Office of Policy and Strategy, Policy Research Division (PRD), Claims 3.

August 31, 2020 &. USCIS Analysis.* Note. Totals are based on FY 2021 data. Start Printed Page 1724 This final rule may primarily affect prospective petitioners seeking to file H-1B cap-subject petitions with a proffered wage that corresponds to OES wage level II, I, and below.[] As Table 13 shows, this final rule is expected to result in a reduced likelihood that registrations for level II will be selected, as well as the likelihood that registrations for level I and below wages will not be selected.

A prospective petitioner, however, could choose to increase the proffered wage, so that it corresponds to a higher wage level. Another possible effect is that employers will not fill vacant positions that would have been filled by H-1B workers. These employers may be unable to find qualified U.S. Workers, or may leave those positions vacant because they cannot justify raising the wage to stand greater chances of selection in the H-1B cap selection process.

That, in turn, could result in fewer registrations and H-1B cap-subject petitions with a proffered wage that corresponds to OES wage level II and below. DHS acknowledges that this final rule might result in more registrations (or petitions, if registration is suspended) with a proffered wage that corresponds to level IV and level III OES wages for H-1B cap-subject beneficiaries. DHS believes a benefit of this final rule may be that some petitioners may choose to increase proffered wages for H-1B cap-subject beneficiaries, so that the petitioners may have greater chances of selection. This change will, in turn, benefit H-1B beneficiaries who ultimately will receive a higher rate of pay than they otherwise would have in the absence of this rule.

However, DHS is not able to estimate the magnitude of such benefits. DHS acknowledges the change in the selection procedure resulting from this final rule will create distributional effects and costs. DHS is unable to quantify the extent or determine the probability of H-1B petitioner behavioral changes. Therefore, DHS does not know the portion of overall impacts of this rule that will be benefits or costs.

As a result of this final rule, costs will be borne by prospective petitioners that would hire lower wage level H-1B cap-subject beneficiaries, but are unable to do so because of a reduced chance of selection in the H-1B selection process compared to the random lottery process. Such employers also may incur additional costs to find available replacement workers. DHS estimates costs incurred associated with loss of productivity from not being able to hire H-1B workers, or the need to search for and hire U.S. Workers to replace H-1B workers.

Although DHS does not have data to estimate the costs resulting from productivity loss for these employers, DHS provides an estimate of the search and hiring costs for the replacement workers. Accordingly, based on the result of the study conducted by the Society for Human Resource Management (SHRM) in 2016, DHS assumes that an entity whose H-1B petition is denied will incur an average cost of $4,398 per worker (in 2019 dollars) [] to search for and hire a U.S. Worker in place of an H-1B worker during the period of this economic analysis. If petitioners cannot find suitable replacements for the labor H-1B cap-subject beneficiaries would have provided if selected and, ultimately, granted H-1B status, this final rule primarily will be a cost to these petitioners through lost productivity and profits.

DHS also acknowledges that some petitioners might be impacted in terms of the employment, productivity loss, search and hire costs, and profits resulting from labor turnover. In cases where companies cannot find reasonable substitutes for the labor H-1B beneficiaries would have provided, affected petitioners also will lose profits from the lost productivity. In such cases, employers will incur opportunity costs by having to choose the next best alternative to fill the job prospective H-1B workers would have filled. There may be additional opportunity costs to employers such as search costs and training.

Such possible disruptions to companies will depend on the interaction of a number of complex variables that constantly are in flux, including national, state, and local labor market conditions, economic and business factors, the type of occupations and skills involved, and the substitutability between H-1B workers and U.S. Workers. These costs to petitioners are expected to be offset by increased productivity and reduced costs to find available workers for petitioners of higher wage level H-1B beneficiaries. DHS uses the compensation to H-1B employees as a measure of the overall impact of the provisions.

While DHS expects wages paid to H-1B beneficiaries to be higher in light of this final rule, DHS is unable to quantify the benefit of increased compensation because not all of the wage increases will correspond with productivity increases. This final rule may indirectly benefit prospective petitioners submitting registrations with a proffered wage that corresponds to OES wage Level I and II registrations. The indirect benefit will be present during the buy antibiotics zithromax and the ensuing economic recovery if the prospective petitioners are able to find replacement workers accepting a lower wage and factoring in the replacement cost of $4,398 per worker in the United States. Similarly, prospective petitioners that will be submitting registrations with a proffered wage that will correspond to OES wage level I and II and that substitute toward unemployed or underemployed individuals in the U.S.

Labor force will create an additional indirect benefit from this rule. This will benefit those in the U.S. Labor force if petitioners decide to select a U.S. Worker rather than a prevailing wage level I or II H-1B worker.

DHS notes that, although the buy antibiotics zithromax is widespread, the severity of its impacts varies by locality and industry, and there may be structural impediments to the national and local labor market. Accordingly, DHS cannot quantify with confidence, the net benefit of the redistribution of H-1B cap selections detailed in this analysis. DHS also is changing the filing procedures to allow USCIS to deny or revoke approval of a subsequent new or amended petition filed by the petitioner, Start Printed Page 1725or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly decrease the proffered wage to an amount that is equivalent to a lower wage level, after listing a higher wage level on the registration (or petition, if registration is suspended) to increase the odds of selection. DHS is unable to quantify the cost of these changes to petitioners.

Iv. Costs of Filing Form I-129 Petitions DHS is amending Form I-129, which must be filed by petitioners on behalf of H-1B beneficiaries, to align with the regulatory changes DHS is making in this final rule. The changes to Form I-129 will result in an increased time burden to complete and submit the form. Absent the changes implemented through this final rule, the current estimated time burden to complete and file Form I-129 is 2.84 hours per petition.

As a result of the changes in this final rule, DHS estimates the total time burden to complete and file Form I-129 will be 3.09 hours per petition, to account for the additional time petitioners will spend reviewing instructions, gathering the required documentation and information, completing the petition, preparing statements, attaching necessary documentation, and submitting the petition. DHS estimates the time burden will increase by a total of 15 minutes (0.25 hours) per petition for completing a Form I-129 petition.[] To estimate the additional cost of filing Form I-129, DHS applies the additional estimated time burden to complete and file Form 1-129 (0.25 hours) to the respective total population and compensation rate of who may file, including an HR specialist, in-house lawyer, or outsourced lawyer. As shown in Table 14, DHS estimates, the total additional annual opportunity cost of time to petitioners completing and filing Form I-129 petitions will be approximately $3,457,401. Table 14—Additional Opportunity Costs of Time to Petitioners for Filing Form I-129 Petitions From an Increase in Time BurdenCost itemsTotal affected populationAdditional time burden to complete Form I-129 (hours)Compensation rateTotal cost ABCD = A × B × COpportunity cost of time to complete Form I-129 for H-1B petitions by:HR specialist21,2200.25$47.57$252,359In-house lawyer27,5860.25102.00703,443Outsourced lawyer57,2940.25174.652,501,599Total106,1003,457,401Source.

USCIS analysis. V. Costs of Submitting Registrations as Modified by This Final Rule DHS is amending the required information on the H-1B Registration Tool. In addition to the information required on the current registration tool, a registrant will be required to provide the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code in the area of intended employment, if such data is available.

The proffered wage is the wage that the employer intends to pay the beneficiary. The SOC code and area of intended employment would be indicated on the LCA filed with the petition. For registrants relying on a private wage survey, if the proffered wage is less than the corresponding level I OES wage, the registrant will select the “Wage Level I and below” box on the registration tool. If the registration indicates that the H-1B beneficiary will work in multiple locations, or in multiple positions if the prospective petitioner is an agent, USCIS will rank and select the registration based on the lowest corresponding OES wage level that the proffered wage equals or exceeds.

In the limited instance where there is no current OES prevailing wage information for the proffered position, the registrant will follow DOL guidance on prevailing wage determinations to select the OES wage level on the registration, and USCIS will rank and select based on the highest OES wage level. The changes to this registration requirement will impose increased opportunity costs of time to registrants, by adding additional information to their registration. The current estimated time burden to complete and file an electronic registration is 30 minutes (0.5 hours) per registration.[] DHS estimates the total time burden to complete and file a registration in light of this final rule will be 50 minutes (0.83 hours) per registration, which amounts to an additional time burden of 20 minutes (0.33 hours) per registration. The additional time burden accounts for the additional time a registrant will spend reviewing instructions, completing the registration, and submitting the registration.

To estimate the additional cost of submitting a registration, DHS applies the additional estimated time burden to complete and submit the registration (0.33 hours) to the respective total population and total rate of compensation of who may file, including HR specialists, in-house lawyers, or outsourced lawyers. As shown in Table 15, DHS estimates the total additional annual opportunity cost of time to the prospective petitioners of completing and submitting registrations will be approximately $11,795,997.Start Printed Page 1726 Table 15—Additional Cost of Submitting RegistrationsCost itemsTotal affected populationAdditional time burden to submit registrations (hours)Compensation rateTotal cost ABCD = A × B × COpportunity cost of time to complete registrations by:HR specialist54,8470.33$47.57$860,994In-house lawyer71,3020.33102.002,400,025Outsourced lawyer148,0880.33174.658,534,978Total274,23711,795,997Source. USCIS analysis. While the expectation is that the registration process will be run on an annual basis, USCIS may suspend the H-1B registration requirement, in its discretion, if it determines that the registration process is inoperable for any reason.

The selection process also allows for selection based solely on the submission of petitions in any year in which the registration process is suspended due to technical or other issues. In years when registration is suspended, DHS estimates, based on the 5-year average of H-1B cap-subject petitions received for FYs 2016 to 2020, that 211,797 H-1B cap-subject petitions will be submitted annually. In the event registration is suspended and 211,797 H-1B cap-subject petitions are submitted, DHS estimates that 106,100 petitions will be selected for adjudication to meet the numerical allocations and 105,697 petitions will be rejected. For FY 2021, DHS selected 124,415 registrations to generate the 106,100 petitions projected to meet the numerical allocations.

Therefore, DHS estimates that the additional cost to petitioners for preparing and submitting H-1B cap-subject petitions in light of this final rule will be significantly higher in the event registration is suspended because more petitions will be prepared and submitted in this scenario. However, if registration is suspended there will be no costs associated with registration, so the overall additional cost of this final rule to petitioners will be less (stated another way, the estimated added cost for submitting approximately 212,000 petitions if registration is suspended will be less than the added costs based on approximately 274,000 registrations and 106,000 petitions for those with selected registrations). Since the expectation is that registration will be run on an annual basis, and because the estimated additional costs resulting from this final rule will be less if registration is suspended, DHS is not separately estimating the costs for years when registration will be suspended and, instead, is relying on the additional costs created by this final rule when registration will be required to estimate total costs of this final rule to petitioners seeking to file H-1B cap-subject petitions. Vi.

Familiarization Cost Familiarization costs comprise the opportunity cost of the time spent reading and understanding the details of a rule to fully comply with the new regulation(s). To the extent that an individual or entity directly regulated by the rule incurs familiarization costs, those familiarization costs are a direct cost of the rule. The entities directly regulated by this rule are the employers who file H-1B petitions. Using FY 2020 internal data on actual filings of Form I-129 H-1B petitions, DHS identified 24,111 [] unique entities.

DHS assumes that the petitioners require approximately two hours to familiarize themselves with the rule. Using the average total rate of compensation of HR specialists, In-house lawyers, and Outsourced lawyers from Table 4, and assuming one person at each entity familiarizes themself with the rule, DHS estimates a one-time total familiarization cost of $6,285,527 in FY 2022. Table 16—Familiarization Costs to the PetitionersCost itemsTotal affected populationAdditional time burden to familiarize (hours)Compensation rateTotal cost ABCD = A × B × COpportunity cost of time to familiarize the rule by:HR specialist4,8222$47.57$458,765In-house lawyer6,2692102.001,278,876Outsourced lawyer13,0202174.654,547,886Total24,1116,285,527Source. USCIS analysis.

Start Printed Page 1727 b. Total Estimated Costs of Regulatory Changes In this section, DHS presents the total annual costs of this final rule annualized over a 10-year implementation period. Table 17 details the total annual costs of this final rule to petitioners will be $21,538,925 in FY 2022 and $15,253,398 in FY 2023 through 2032. Table 17—Summary of Estimated Annual Costs to Petitioners in This Final RuleCostsTotal estimated annual costPetitioners' additional opportunity cost of time in filing Form I-129 petitions$3,457,401Petitioners' additional opportunity cost of time in submitting information on the registration11,795,997Familiarization Cost (Year 1 only FY 2022)6,285,527Total Annual Costs (undiscounted) = FY 202221,538,925Total Annual Cost (undiscounted) = FY 2023-FY 203215,253,398 Table 18 shows costs over the 10-year implementation period of this final rule.

DHS estimates the 10-year total net cost of the rule to petitioners to be approximately $158,819,507 undiscounted, $136,217,032 discounted at 3-percent, and $113,007,809 discounted at 7-percent. Over the 10-year implementation period of the rule, DHS estimates the annualized costs of the rule to be $15,968,792 annualized at 3-percent, $16,089,770 annualized at 7-percent. Table 18—Total Costs of This Final RuleYearTotal estimated costs$21,538,925 (year 1). $15,253,398 (year 2-10)Discounted at 3-percentDiscounted at 7-percent1$20,911,578$20,129,836214,377,79113,322,909313,959,02012,451,316413,552,44711,636,744513,157,71510,875,462612,774,48110,163,983712,402,4089,499,050812,041,1738,877,617911,690,4598,296,8381011,349,9617,754,054Total136,217,032113,007,809Annualized15,968,79216,089,770 E.O.

13771 directs agencies to reduced regulation and control regulatory costs. This final rule is expected to be an E.O. 13771 regulatory action. DHS estimates the total cost of this rule will be $10,515,740 annualized using a 7- percent discount rate over a perpetual time horizon, in 2016 dollars, and discounted back to 2016.

C. Costs to the Federal Government DHS is revising the process and system by which H-1B registrations or petitions, as applicable, will be selected toward the annual numerical allocations. This final rule will require updates to USCIS IT systems and additional time spent by USCIS on H-1B registrations or petitions. The INA provides for the collection of fees at a level that will ensure recovery of the full costs of providing adjudication and naturalization services by DHS, including administrative costs and services provided without charge to certain applicants and petitioners.[] DHS notes USCIS establishes its fees by assigning costs to an adjudication based on its relative adjudication burden and use of USCIS resources.

Fees are established at an amount that is necessary to recover these assigned costs such as salaries and benefits of clerical staff, officers, and managers, plus an amount to recover unassigned overhead (such as facility rent, IT equipment and systems, or other expenses) and immigration services provided without charge. Consequently, since USCIS immigration fees are based on resource expenditures related to the benefit in question, USCIS uses the fee associated with an information collection as a reasonable measure of the collection's costs to USCIS. DHS notes the time necessary for USCIS to review the information submitted with the forms relevant to this final rule includes the time to adjudicate the benefit request. These costs are captured in the fees collected for the benefit request from petitioners.

B. Regulatory Flexibility Act The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121 (March 29, 1996), requires Federal agencies to consider the potential impact of regulations on Start Printed Page 1728small entities during the development of their rules. €œSmall entities” are small businesses, not-for-profit organizations that are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

An “individual” is not considered a small entity, and costs to an individual from a rule are not considered for RFA purposes. In addition, the courts have held that the RFA requires an agency to perform an initial regulatory flexibility analysis (IRFA) of small entity impacts only when a rule directly regulates small entities. Consequently, any indirect impacts from a rule to a small entity are not considered as costs for RFA purposes. Although individuals, rather than small entities, submit the majority of immigration and naturalization benefit applications and petitions, this final rule will affect entities that file and pay fees for H-1B non-immigrant benefit requests.

The USCIS forms that are subject to an RFA analysis for this final rule are Form I-129, Petition for a Nonimmigrant Worker and the Registration H-1B Tool. DHS does not believe that the changes in this final rule will have a significant economic impact on a substantial number of small entities that will file H-1B petitions. A Final Regulatory Flexibility Analysis (FRFA) follows. 1.

A Statement of Need for, and Objectives of, This Final Rule DHS's objectives and legal authority for this final rule are discussed earlier in the preamble. DHS is amending its regulations governing H-1B specialty occupation workers. The purpose of this final rule is to better ensure that H-1B classification is more likely to be awarded to petitioners seeking to employ relatively higher-skilled and higher-paid beneficiaries. DHS believes these changes will disincentivize use of the H-1B program to fill relatively lower-paid, lower-skilled positions.

2. A Statement of Significant Issues Raised by the Public Comments in Response to the Initial Regulatory Flexibility Analysis, a Statement of Assessment of Any Changes Made in the Proposed Rule as a Result of Such Comments Comments. A professional association wrote that DHS claimed that no small entities would be significantly impacted by the proposed rule, but DHS also estimated that 80.1 percent of those that filed Form I-129 were small entities. An individual commenter wrote that DHS incorrectly concluded that the proposed rule would not have a significant impact on small entities because small businesses would be unlikely to have the legal expertise or institutional knowledge to navigate the H-1B system.

Response. DHS estimates the economic impact for each small entity, based on the additional cost and time associated with the changes to the form, in percentages, is the sum of the impacts of the final rule divided by the entity's sales revenue.[] DHS constructed the distribution of economic impact of the final rule based on a sample of 312 small entities. Across all 312 small entities, the increase in cost to a small entity will range from 0.00000026 percent to 2.5 percent of that entity's FY 2020 revenue. Of the 312 small entities, 0 percent (0 small entities) will experience a cost increase that is greater than 5 percent of revenues.

Comments. Some commenters generally stated that the proposed rule would harm small businesses. Multiple commenters, including a trade association, employer, and individuals, wrote that the proposed rule would harm small and emerging businesses who, often, could not offer higher salaries compared to larger firms. Other commenters said the proposed rule would favor larger firms at the expense of small and medium sized businesses.

An individual commenter wrote that the proposed rule would harm small technology companies and start-ups that are dependent on recruiting young talent, as they would be required to offer such employees level III and level IV wages when level I and level II wages would be more appropriate. Another individual commenter said companies would suffer because many small information technology or financial companies could not provide as high of salaries to their foreign workers as big companies could. An individual commenter wrote that the proposed rule would harm small businesses that often could not find the appropriate talent domestically and would have a legitimate need to hire H-1B workers, while another commenter argued the proposed rule would shrink the hiring talent pool for small businesses. An individual commenter wrote that, under the proposed rule, small businesses would not be able to operate due to an inability to find suitable employees.

Similarly, an individual commenter wrote that the proposed rule would ensure that H-1B visas would go to “the highest bidders” and would discriminate against smaller businesses with a genuine need for H-1B employees. An individual commenter wrote that the proposed rule would encourage larger employers who could afford to pay higher wages to employees to artificially inflate their job requirements and increase their chance of selection through the ranked selection process. Another commenter asserted that smaller companies in non-metropolitan areas, who might have difficulty finding domestic candidates for positions, would be negatively impacted by the proposed rule. Response.

DHS acknowledges that an employer offering a level I or below wage under the regular cap, and an employer offering a level II, I, or below wage under the advanced degree exemption, may have a lesser chance of selection than under the current random selection process. DHS does not believe that the changes in this final rule will have a significant economic impact on a substantial number of small businesses. As explained in the NPRM, DHS conducted an RFA and found that the changes in this rule would not have a significant economic impact on a substantial number of small entities. Additionally, this rule does not treat people who work for small-sized entities differently than those who work for large companies.

While DHS recognizes that some small businesses may operate on smaller margins than larger companies, if an employer values a beneficiary's work and the unique qualities the beneficiary possesses, the employer can offer a higher wage than required by the prevailing wage level to reflect that value. If a small company is unable to pay an employee at wage level III or IV for a greater chance of selection, they could then try to find a substitute U.S. Worker. Comments.

An individual commenter wrote that rural areas and smaller towns depend on entry-level H-1B workers at a level I wage, but those communities would not be able to justify hiring such H-1B workers at level III and level IV wages. Another individual commenter said the rule would harm employers in rural areas where wages, often, would be lower. A professional association wrote that small and medium sized medical practices, often serving rural or Start Printed Page 1729low-income areas, depend on new or inexperienced physicians at the level I or level II wage rate and would be unable to compete for H-1B cap slots for these employees under the proposed rule. An employer wrote that rural healthcare providers would not be able to meet the wage rates necessary to attract workers on H-1B visas, and, as a result, the proposed rule would decrease the supply of healthcare labor to rural communities.

Response. The rule takes the geographic area into account when ranking registrations or petitions, and, therefore, DHS does not agree that this rule will harm employers in rural or other areas where wages often are lower. Particularly, as stated in the proposed rule, USCIS will select H-1B registrations or petitions, as applicable, based on the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code and area(s) of intended employment (emphasis added). The prevailing wage already accounts for wage variations by location.

Additionally, this rule does not treat foreign workers who work for small-sized entities differently than those who work for large companies. 3. The Response of the Agency to Any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration in Response to the Rule, and a Detailed Statement of Any Change Made to the Final Rule as a Result of the Comments DHS did not receive comments on this rule from the Chief Counsel for Advocacy of the Small Business Administration. 4.

A Description of and an Estimate of the Number of Small Entities to Which This Final Rule Will Apply or an Explanation of Why No Such Estimate Is Available For this analysis, DHS conducted a sample analysis of historical Form I-129 H-1B petitions to estimate the number of small entities impacted by this final rule. DHS utilized a subscription-based online database of U.S. Entities, ReferenceUSA, as well as three other open-access, free databases of public and private entities, Manta, Cortera, and Guidestar, to determine the North American Industry Classification System (NAICS) code,[] revenue, and employee count for each entity in the sample. To determine whether an entity is small for purposes of the RFA, DHS first classified the entity by its NAICS code and, then, used SBA size standards guidelines [] to classify the revenue or employee count threshold for each entity.

Based on the NAICS codes, some entities were classified as small based on their annual revenue, and some by their numbers of employees. Once as many entities as possible were matched, those that had relevant data were compared to the size standards provided by the SBA to determine whether they were small or not. Those that could not be matched or compared were assumed to be small under the presumption that non-small entities would have been identified by one of the databases at some point in their existence. Using FY 2020 internal data on actual filings of Form I-129 H-1B petitions, DHS identified 24,111 [] unique entities.

DHS devised a methodology to conduct the small entity analysis based on a representative, random sample of the potentially impacted population. DHS first determined the minimum sample size necessary to achieve a 95 percent confidence level estimation for the impacted population of entities using the standard statistical formula at a 5 percent margin of error. Then, DHS created a sample size greater than the minimum necessary to increase the likelihood that our matches would meet or exceed the minimum required sample. DHS randomly selected a sample of 473 entities from the population of 24,111 entities that filed Form I-129 for H-1B petitions in FY 2020.

Of the 473 entities, 406 entities returned a successful match of a filing entity in the ReferenceUSA, Manta, Cortera, and Guidestar databases. 67 entities did not return a match. Using these databases' revenue or employee count and their assigned North American Industry Classification System (NAICS) code, DHS determined 312 of the 406 matches to be small entities, 94 to be non-small entities. Based on previous experience conducting RFAs, DHS assumes filing entities without database matches or missing revenue/employee count data are likely to be small entities.

As a result, to prevent underestimating the number of small entities this rule will affect, DHS conservatively considers all the non-matched and missing entities as small entities for the purpose of this analysis. Therefore, DHS conservatively classifies 379 of 473 entities as small entities, including combined non-matches (67), and small entity matches (312). Thus, DHS estimates that 80.1% (379 of 473) of the entities filing Form I-129 H-1B petitions are small entities. In this analysis DHS assumes that the distribution of firm size for our sample is the same as the entire population of Form I-129.

Thus, DHS estimates the number of small entities to be 80.1% of the population of 24,111 entities that filed Form I-129 under the H-1B classification, as summarized in Table 19 below. The annual numeric estimate of the small entities impacted by this final rule is 19,319 entities.[] Table 19—Number of Small Entities for Form I-129 for H-1B, FY 2020PopulationNumber of small entitiesProportion of population (percent)24,11119,31980.1 Following the distributional assumptions above, DHS uses the set of 312 small entities with matched revenue data to estimate the economic impact of this final rule on each small entity. The economic impact on each small entity, in percentages, is the sum of the impacts of the final rule divided by the entity's sales revenue.[] DHS constructed the distribution of economic impact of the final rule based on the sample of 312 small entities. Across all 312 small Start Printed Page 1730entities, the increase in cost to a small entity will range from 0.00000026 percent to 2.5 percent of that entity's FY 2020 revenue.

Of the 312 small entities, 0 percent (0 small entities) will experience a cost increase that is greater than 5 percent of revenues. Extrapolating to the population of 19,319 small entities and assuming an economic impact significance threshold of 5 percent of annual revenues, DHS estimates no small entities will be significantly affected by this final rule. Based on this analysis, DHS does not believe that this final rule will have a significant economic impact on a substantial number of small entities that file H-1B petitions. 5.

A Description of the Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Final Rule, Including an Estimate of the Classes of Small Entities That Will Be Subject to the Requirement and the Types of Professional Skills Necessary for Preparation of the Report or Record As stated above in the preamble, this final rule will impose additional reporting, recordkeeping, or other compliance requirements on entities that could be small entities. 6. Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of the Applicable Statues, Including a Statement of Factual, Policy, and Legal Reasons for Selecting the Alternative Adopted in the Final Rule and Why Each One of the Other Significant Alternatives to the Rule Considered by the Agency Which Affect the Impact on Small Entities Was Rejected DHS requested comments on, including potential alternatives to, the proposed ranking and selection of registrations based on the OES prevailing wage level that corresponds to the requirements of the proffered position in situations where there is no current OES prevailing wage information. In the RFA context, DHS sought comments on alternatives that would accomplish the objectives of the proposed rule without unduly burdening small entities.

DHS also welcomed any public comments or data on the number of small entities that would be petitioning for an H-1B employee and any direct impacts on those small entities. Comment. Some commenters said that DHS should consider ranking by years of experience, rather than by wage. One commenter asked DHS to give an advantage to candidates who have work experience in the United States.

Response. DHS declines to adopt these alternatives, as ranking and selection by years of experience would not best accomplish the goal of attracting the best and brightest workers. DHS believes that the salary, relative to others in the same occupational classification and area of intended employment, rather than years of experience, is generally more indicative of skill level and relative value/productivity of the worker to the United States. See section 3.3 Requests for comments on alternatives for additional suggested alternatives.

C. Congressional Review Act The Office of Information and Regulatory Affairs has determined that this final rule is a major rule, as defined in 5 U.S.C. 804, also known as the “Congressional Review Act” (CRA), as enacted in section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, sec. 251, 110 Stat.

868, 873, and codified at 5 U.S.C. 801 et seq. Therefore, the rule requires at least a 60-day delayed effective date. DHS has complied with the CRA's reporting requirements and has sent this final rule to Congress and to the Comptroller General as required by 5 U.S.C.

801(a)(1). D. Unfunded Mandates Reform Act of 1995 The Unfunded Mandates Reform Act of 1995 (UMRA) is intended, among other things, to curb the practice of imposing unfunded federal mandates on State, local, and tribal governments. Title II of the UMRA requires each federal agency to prepare a written statement assessing the effects of any federal mandate in a proposed or final agency rule that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector.

Based on the Consumer Price Index for All Urban Consumers (CPI-U), the value equivalent of $100 million in 1995 adjusted for inflation to 2019 levels is approximately $168 million.[] This rule does not contain a “Federal mandate” as defined in UMRA that may result in $100 million or more expenditures (adjusted annually for inflation—$168 million in 2019 dollars) in any one year by State, local and tribal governments or the private sector. This rule also does not uniquely affect small governments. Accordingly, Title II of UMRA requires no further agency action or analysis. E.

Executive Order 13132 (Federalism) This final rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, DHS has determined that this final rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. F. Executive Order 12988 (Civil Justice Reform) This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

G. Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments) This final rule does not have “tribal implications” because it does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Accordingly, E.O. 13175, Consultation and Coordination with Indian Tribal Governments, requires no further agency action or analysis.

H. National Environmental Policy Act (NEPA) DHS analyzes actions to determine whether the National Environmental Policy Act, Public Law 91-190, 42 U.S.C. 4321 through 4347 (NEPA), applies to them and, if so, what degree of analysis is required. DHS Directive 023-01 Rev.

01 (Directive) and Instruction Manual 023-01-001-01 Rev. 01, Implementation of the National Environmental Policy Act (Instruction Manual) establish the policies and procedures that DHS and its Start Printed Page 1731components use to comply with NEPA and the Council on Environmental Quality (CEQ) regulations for implementing NEPA, 40 CFR parts 1500-1508. The CEQ regulations allow federal agencies to establish, with CEQ review and concurrence, categories of actions (“categorical exclusions”) that experience has shown do not individually or cumulatively have a significant effect on the human environment and, therefore, do not require an Environmental Assessment (EA) or Environmental Impact Statement (EIS).[] Categorical exclusions established by DHS are set forth in Appendix A of the Instruction Manual. Under DHS NEPA implementing procedures, for an action to be categorically excluded, it must satisfy each of the following three conditions.

(1) The entire action clearly fits within one or more of the categorical exclusions. (2) the action is not a piece of a larger action. And (3) no extraordinary circumstances exist that create the potential for a significant environmental effect.[] As discussed in more detail throughout this final rule, DHS is amending regulations governing the selection of registrations or petitions, as applicable, toward the annual H-1B numerical allocations. This final rule establishes that, if more registrations are received during the annual initial registration period (or petition filing period, if applicable) than necessary to reach the applicable numerical allocation, USCIS will rank and select the registrations (or petitions, if the registration process is suspended) received on the basis of the highest OES prevailing wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I and below.

If a proffered wage falls below an OES wage level I, because the proffered wage is based on a prevailing wage from another legitimate source (other than OES) or an independent authoritative source, USCIS will rank the registration in the same category as OES wage level I.[] Generally, DHS believes NEPA does not apply to a rule intended to change a discrete aspect of a visa program because any attempt to analyze its potential impacts would be largely speculative, if not completely so. This final rule does not propose to alter the statutory limitations on the numbers of nonimmigrants who. May be issued initial H-1B visas or granted initial H-1B nonimmigrant status, consequently will be admitted into the United States as H-1B nonimmigrants, will be allowed to change their status to H-1B, or will extend their stay in H-1B status. DHS cannot reasonably estimate whether the wage level-based ranking approach to select H-1B registrations (or petitions in any year in which the registration requirement were suspended) that DHS is implementing will affect how many petitions will be filed for workers to be employed in specialty occupations or whether the regulatory amendments herein will result in an overall change in the number of H-1B petitions that ultimately will be approved, and the number of H-1B workers who will be employed in the United States in any FY.

DHS has no reason to believe that these amendments to H-1B regulations will change the environmental effect, if any, of the existing regulations. Therefore, DHS has determined that, even if NEPA applied to this action, this final rule clearly fits within categorical exclusion A3(d) in the Instruction Manual, which provides an exclusion for “promulgation of rules. . .

That amend an existing regulation without changing its environmental effect.” This final rule will maintain the current human environment by proposing improvements to the H-1B program that will take effect during the economic crisis caused by buy antibiotics in a way that more effectively will prevent an adverse impact from the employment of H-1B workers on the wages and working conditions of similarly employed U.S. Workers. This final rule is not a part of a larger action and presents no extraordinary circumstances creating the potential for significant environmental effects. Therefore, this action is categorically excluded and no further NEPA analysis is required.

I. Paperwork Reduction Act Under the Paperwork Reduction Act of 1995 (PRA) Public Law 104-13, 44 U.S.C. 3501, et seq., all Departments are required to submit to the Office of Management and Budget, for review and approval, any reporting requirements inherent in a rule. In compliance with the PRA, DHS published a notice of proposed rulemaking on November 2, 2020, in which it requested comments on the revisions to the information collections associated with this rulemaking.[] DHS responded to those comments in Section IV.E.2.

Of this final rule. The following is an overview of the information collections associated with this final rule. 1. USCIS H-1B Registration Tool (1) Type of Information Collection.

Revision of a Currently Approved Collection. (2) Title of the Form/Collection. H-1B Registration Tool. (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection.

OMB-64. USCIS. (4) Affected public who will be asked or required to respond, as well as a brief abstract. Primary.

Business or other for-profit. USCIS will use the data collected through the H-1B Registration Tool to select a sufficient number of registrations projected as needed to meet the applicable H-1B cap allocations and to notify registrants whether their registrations were selected. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond. The estimated total number of respondents for the information collection H-1B Registration Tool is 275,000, and the estimated hour burden per response is 0.833 hours.

(6) An estimate of the total public burden (in hours) associated with the collection. The total estimated annual hour burden associated with this collection of information is 229,075 hours. (7) An estimate of the total public burden (in cost) associated with the collection. The estimated total annual cost burden associated with this collection of information is $0.

2. USCIS Form I-129 (1) Type of Information Collection. Revision of a Currently Approved Collection. (2) Title of the Form/Collection.

Petition for a Nonimmigrant Worker. (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection. I-129. USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract. Primary. Business or other for-profit. USCIS uses the data collected on this form to determine eligibility for the requested nonimmigrant petition and/or requests to extend or change nonimmigrant status.

An employer (or agent, where applicable) uses this form to petition USCIS for an alien to Start Printed Page 1732temporarily enter as a nonimmigrant. An employer (or agent, where applicable) also uses this form to request an extension of stay or change of status on behalf of the alien worker. The form serves the purpose of standardizing requests for nonimmigrant workers and ensuring that basic information required for assessing eligibility is provided by the petitioner while requesting that beneficiaries be classified under certain nonimmigrant employment categories. It also assists USCIS in compiling information required by Congress annually to assess effectiveness and utilization of certain nonimmigrant classifications.

USCIS also uses the data to determine continued eligibility. For example, the data collected is used in compliance reviews and other inspections to ensure that all program requirements are being met. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond. I-129 is 294,751 and the estimated hour burden per response is 3.09 hours.

The estimated total number of respondents for the information collection E-1/E-2 Classification Supplement to Form I-129 is 4,760 and the estimated hour burden per response is 0.67 hours. The estimated total number of respondents for the information collection Trade Agreement Supplement to Form I-129 is 3,057 and the estimated hour burden per response is 0.67 hours. The estimated total number of respondents for the information collection H Classification Supplement to Form I-129 is 96,291 and the estimated hour burden per response is 2 hours. The estimated total number of respondents for the information collection H-1B and H-1B1 Data Collection and Filing Fee Exemption Supplement is 96,291 and the estimated hour burden per response is 1 hour.

The estimated total number of respondents for the information collection L Classification Supplement to Form I-129 is 37,831 and the estimated hour burden per response is 1.34 hours. The estimated total number of respondents for the information collection O and P Classifications Supplement to Form I-129 is 22,710 and the estimated hour burden per response is 1 hour. The estimated total number of respondents for the information collection Q-1 Classification Supplement to Form I-129 is 155 and the estimated hour burden per response is 0.34 hours. The estimated total number of respondents for the information collection R-1 Classification Supplement to Form I-129 is 6,635 and the estimated hour burden per response is 2.34 hours.

(6) An estimate of the total public burden (in hours) associated with the collection. The total estimated annual hour burden associated with this collection of information is 1,293,873 hours. (7) An estimate of the total public burden (in cost) associated with the collection. The estimated total annual cost burden associated with this collection of information is $70,681,290.

J. Signature The Acting Secretary of Homeland Security, Chad F. Wolf, having reviewed and approved this document, is delegating the authority to electronically sign this document to Ian J. Brekke, who is the Senior Official Performing the Duties of the General Counsel for DHS, for purposes of publication in the Federal Register.

Start List of Subjects Administrative practice and procedureAliensCultural exchange programsEmploymentForeign officialsHealth professionsReporting and recordkeeping requirementsStudents End List of Subjects Accordingly, DHS amends part 214 of chapter I of title 8 of the Code of Federal Regulations as follows. Start Part End Part Start Amendment Part1. The authority citation for part 214 continues to read as follows. End Amendment Part Start Authority 6 U.S.C.

202, 236. 8 U.S.C. 1101, 1102, 1103, 1182, 1184, 1186a, 1187, 1221, 1281, 1282, 1301-1305 and 1372. Sec.

Section 141 of the Compacts of Free Association with the Federated States of Micronesia and the Republic of the Marshall Islands, and with the Government of Palau, 48 U.S.C. 1901 note and 1931 note, respectively. 48 U.S.C. 1806.

End Authority Start Amendment Part2. Section 214.2 is amended by. End Amendment Part Start Amendment Parta. Revising the first sentence of paragraph (h)(8)(iii)(A)( 1) introductory text;End Amendment Part Start Amendment Partb.

Adding paragraphs (h)(8)(iii)(A)( 1)(i) and (ii);End Amendment Part Start Amendment Partc. In paragraph (h)(8)(iii)(A)( 5)(i), revising the last two sentences and adding a sentence at the end;End Amendment Part Start Amendment Partd. In paragraph (h)(8)(iii)(A)( 5)(ii), revising the last two sentences and adding a sentence at the end;End Amendment Part Start Amendment Parte. In paragraph (h)(8)(iii)(A)( 6)(i), revising the last two sentences and adding a sentence at the end;End Amendment Part Start Amendment Partf.

In paragraph (h)(8)(iii)(A)( 6)(ii), revising the last two sentences and adding a sentence at the end;End Amendment Part Start Amendment Partg. Revising paragraphs (h)(8)(iii)(A)( 7) and (h)(8)(iii)(D)(1);End Amendment Part Start Amendment Parth. In paragraph (h)(8)(iv)(B)( 1), revising the last three sentences and adding three sentences at the end;End Amendment Part Start Amendment Parti. Revising paragraph (h)(8)(iv)(B)( 2);End Amendment Part Start Amendment Partj.

Removing and reserving paragraph (h)(8)(v). End Amendment Part Start Amendment Partk. Revising paragraph (h)(10)(ii). End Amendment Part Start Amendment Partl.

Revising paragraph (h)(11)(iii)(A)( 2);End Amendment Part Start Amendment Partm. Redesignating paragraphs (h)(11)(iii)(A)( 3) through (5) as (h)(11)(iii)(A)(4) through (6). AndEnd Amendment Part Start Amendment Partn. Adding a new paragraph (h)(11)(iii)(A)( 3) and paragraph (h)(24)(i).End Amendment Part The revisions and additions read as follows.

Special requirements for admission, extension, and maintenance of status. * * * * * (h) * * * (8) * * * (iii) * * * (A) * * * (1) * * * Except as provided in paragraph (h)(8)(iv) of this section, before a petitioner is eligible to file an H-1B cap-subject petition for a beneficiary who may be counted under section 214(g)(1)(A) of the Act (“H-1B regular cap”) or eligible for exemption under section 214(g)(5)(C) of the Act (“H-1B advanced degree exemption”), the prospective petitioner or its attorney or accredited representative must register to file a petition on behalf of an alien beneficiary electronically through the USCIS website (www.uscis.gov). * * * (i) Ranking by wage levels. USCIS will rank and select registrations as set forth in paragraphs (h)(8)(iii)(A)(5) and (6) of this section.

For purposes of the ranking and selection process, USCIS will use the highest corresponding Occupational Employment Statistics (OES) wage level that the proffered wage will equal or exceed for the relevant Standard Occupational Classification (SOC) code and area(s) of intended employment. If the proffered wage is lower than the OES wage level I, because it is based on a prevailing wage from another legitimate source (other than OES) or an independent authoritative source, USCIS will rank the registration in the same category as OES wage level I. If the H-1B beneficiary will work in multiple locations, or in multiple positions if the registrant is an agent, USCIS will rank and select the registration based on the lowest corresponding OES wage level that the proffered wage will equal or exceed. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and Start Printed Page 1733select the registration based on the OES wage level that corresponds to the requirements of the proffered position.

(ii) [Reserved] * * * * * (5) * * * (i) * * * If USCIS has received more registrations on the final registration date than necessary to meet the H-1B regular cap under Section 214(g)(1)(A) of the Act, USCIS will rank and select from among all registrations properly submitted on the final registration date on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position. If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations needed to reach the numerical limitation. (ii) * * * If USCIS has received more than a sufficient number of registrations to meet the H-1B regular cap under Section 214(g)(1)(A) of the Act, USCIS will rank and select from among all registrations properly submitted during the initial registration period on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I.

Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position. If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations needed to reach the numerical limitation. (6) * * * (i) * * * If on the final registration date, USCIS has received more registrations than necessary to meet the H-1B advanced degree exemption limitation under Section 214(g)(5)(C) of the Act, USCIS will rank and select, from among the registrations properly submitted on the final registration date that may be counted against the advanced degree exemption, the number of registrations necessary to reach the H-1B advanced degree exemption on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position.

If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations necessary to reach the H-1B advanced degree exemption. (ii) * * * USCIS will rank and select, from among the remaining registrations properly submitted during the initial registration period that may be counted against the advanced degree exemption numerical limitation, the number of registrations necessary to reach the H-1B advanced degree exemption on the basis of the highest OES wage level that the proffered wage equals or exceeds for the relevant SOC code and in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position. If USCIS receives and ranks more registrations at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from all registrations within that particular wage level a sufficient number of registrations necessary to reach the H-1B advanced degree exemption.

(7) Increase to the number of registrations projected to meet the H-1B regular cap or advanced degree exemption allocations in a fiscal year. Unselected registrations will remain on reserve for the applicable fiscal year. If USCIS determines that it needs to select additional registrations to receive the number of petitions projected to meet the numerical limitations, USCIS will select from among the registrations that are on reserve a sufficient number to meet the H-1B regular cap or advanced degree exemption numerical limitation, as applicable. If all of the registrations on reserve are selected and there are still fewer registrations than needed to reach the H-1B regular cap or advanced degree exemption numerical limitation, as applicable, USCIS may reopen the applicable registration period until USCIS determines that it has received a sufficient number of registrations projected to meet the H-1B regular cap or advanced degree exemption numerical limitation.

USCIS will monitor the number of registrations received and will notify the public of the date that USCIS has received the necessary number of registrations (the new “final registration date”). The day the public is notified will not control the applicable final registration date. When selecting additional registrations under this paragraph, USCIS will rank and select properly submitted registrations in accordance with paragraphs (h)(8)(iii)(A)(1), (5), and (6) of this section. If the registration period will be re-opened, USCIS will announce the start of the re-opened registration period on the USCIS website at www.uscis.gov.

* * * * * (D) * * * (1) Filing procedures. In addition to any other applicable requirements, a petitioner may file an H-1B petition for a beneficiary that may be counted under section 214(g)(1)(A) or eligible for exemption under section 214(g)(5)(C) of the Act only if the petition is based on a valid registration submitted by the petitioner, or its designated representative, on behalf of the beneficiary that was selected beforehand by USCIS. The petition must be filed within the filing period indicated in the selection notice. A petitioner may not substitute the beneficiary named in the original registration or transfer the registration to another petitioner.

(i) If a petitioner files an H-1B cap-subject petition based on a registration that was not selected beforehand by USCIS, based on a registration for a different beneficiary than the beneficiary named in the petition, or based on a registration considered by USCIS to be invalid, the H-1B cap-subject petition will be rejected or denied. USCIS will consider a registration to be invalid if the registration fee associated with the registration is declined, rejected, or canceled after submission as the registration fee is non-refundable and Start Printed Page 1734due at the time the registration is submitted. (ii) If USCIS determines that the statement of facts contained on the registration form is inaccurate, fraudulent, misrepresents any material fact, or is not true and correct, USCIS may reject or deny the petition or, if approved, may revoke the approval of a petition that was filed based on that registration. (iii) USCIS also may deny or revoke approval of a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly decrease the proffered wage to an amount that would be equivalent to a lower wage level, after listing a higher wage level on the registration to increase the odds of selection.

USCIS will not deny or revoke approval of such an amended or new petition solely on the basis of a different proffered wage if that wage does not correspond to a lower OES wage level than the wage level on which the registration selection was based. * * * * * (iv) * * * (B) * * * (1) * * * If the final receipt date is any of the first five business days on which petitions subject to the H-1B regular cap may be received, USCIS will select from among all the petitions properly submitted during the first five business days the number of petitions deemed necessary to meet the H-1B regular cap. If USCIS has received more petitions than necessary to meet the numerical limitation for the H-1B regular cap, USCIS will rank and select the petitions received on the basis of the highest Occupational Employment Statistics (OES) wage level that the proffered wage equals or exceeds for the relevant Standard Occupational Classification (SOC) code in the area of intended employment, beginning with OES wage level IV and proceeding in descending order with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position.

If the wage falls below an OES wage level I, USCIS will rank the petition in the same category as OES wage level I. USCIS will rank the petition in the same manner even if, instead of obtaining an OES prevailing wage, a petitioner elects to obtain a prevailing wage using another legitimate source (other than OES) or an independent authoritative source. If USCIS receives and ranks more petitions at a particular wage level than the projected number needed to meet the numerical limitation, USCIS will randomly select from among all eligible petitions within that particular wage level a sufficient number of petitions needed to reach the numerical limitation. (2) Advanced degree exemption selection in event of suspended registration process.

After USCIS has received a sufficient number of petitions to meet the H-1B regular cap and, as applicable, completed the selection process of petitions for the H-1B regular cap, USCIS will determine whether there is a sufficient number of remaining petitions to meet the H-1B advanced degree exemption numerical limitation. When calculating the number of petitions needed to meet the H-1B advanced degree exemption numerical limitation USCIS will take into account historical data related to approvals, denials, revocations, and other relevant factors. USCIS will monitor the number of petitions received and will announce on its website the date that it receives the number of petitions projected as needed to meet the H-1B advanced degree exemption numerical limitation (the “final receipt date”). The date the announcement is posted will not control the final receipt date.

If the final receipt date is any of the first five business days on which petitions subject to the H-1B advanced degree exemption may be received (in other words, if the numerical limitation is reached on any one of the first five business days that filings can be made), USCIS will select from among all the petitions properly submitted during the first five business days the number of petitions deemed necessary to meet the H-1B advanced degree exemption numerical limitation. If USCIS has received more petitions than necessary to meet the numerical limitation for the H-1B advanced degree exemption, USCIS will rank and select the petitions received on the basis of the highest Occupational Employment Statistics (OES) wage level that the proffered wage equals or exceeds for the relevant Standard Occupational Classification (SOC) code in the area of intended employment, beginning with OES wage level IV and proceeding with OES wage levels III, II, and I. Where there is no current OES prevailing wage information for the proffered position, USCIS will rank and select petitions based on the appropriate wage level that corresponds to the requirements of the proffered position. If the proffered wage is below an OES wage level I, USCIS will rank the petition in the same category as OES wage level I.

USCIS will rank the petition in the same manner even if, instead of obtaining an OES prevailing wage, a petitioner elects to obtain a prevailing wage using another legitimate source (other than OES) or an independent authoritative source. If USCIS receives and ranks more petitions at a particular wage level than necessary to meet the numerical limitation for the H-1B advanced degree exemption, USCIS will randomly select from among all eligible petitions within that particular wage level a sufficient number of petitions needed to reach the numerical limitation. * * * * * (10) * * * (ii) Notice of denial. The petitioner shall be notified of the reasons for the denial and of the right to appeal the denial of the petition under 8 CFR part 103.

The petition may be denied if it is determined that the statements on the registration or petition were inaccurate. The petition will be denied if it is determined that the statements on the registration or petition were fraudulent or misrepresented a material fact. A petition also may be denied if it is not based on a valid registration submitted by the petitioner (or its designated representative), or a successor in interest, for the beneficiary named in the petition. A valid registration must represent a legitimate job offer.

USCIS also may deny a subsequent new or amended petition filed by the petitioner, or a related entity, on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the original petition. USCIS will not deny such an amended or new petition solely on the basis of a different proffered wage if that wage does not correspond to a lower OES wage level than the wage level on which the registration or petition selection, as applicable, was based. There is no appeal from a decision to deny an extension of stay to the alien. (11) * * * (iii) * * * (A) * * * (2) The statement of facts contained in the petition.

The registration, if applicable. Or on the temporary labor certification or labor condition application. Was not true and correct, Start Printed Page 1735inaccurate, fraudulent, or misrepresented a material fact. Or (3) The petitioner, or a related entity, filed a new or amended petition on behalf of the same beneficiary, if USCIS determines that the filing of the new or amended petition is part of the petitioner's attempt to unfairly increase the odds of selection during the registration or petition selection process, as applicable, such as by reducing the proffered wage to an amount that would be equivalent to a lower wage level than that indicated on the registration, or the original petition if the registration process was suspended.

USCIS will not revoke approval of such an amended or new petition solely on the basis of a different proffered wage if that wage does not correspond to a lower OES wage level than the wage level on which the registration or petition selection, as applicable, was based. Or * * * * * (24) * * * (i) The requirement to submit a registration for an H-1B cap-subject petition and the selection process based on properly submitted registrations under paragraph (h)(8)(iii) of this section are intended to be severable from paragraph (h)(8)(iv) of this section. In the event paragraph (h)(8)(iii) is not implemented, or in the event that paragraph (h)(8)(iv) is not implemented, DHS intends that either of those provisions be implemented as an independent rule, without prejudice to petitioners in the United States under this section, as consistent with law. * * * * * Start Signature Ian J.

Brekke, Senior Official Performing the Duties of the General Counsel, U.S. Department of Homeland Security. End Signature End Supplemental Information [FR Doc. 2021-00183 Filed 1-7-21.

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Evidence and mass casualty events“I sat among the dead, dying and those fighting for life, I observed the pain will 500mg of zithromax cure chlamydia and suffering and endured my own. I need to hear the truth to be able to move forward and I have to be there for those who didn't make it, they do not have a say in this, so I must speak up for them and for my own mental well-being, I cannot rest until the truth is told and evidence is shown to me…”I would urge all readers this month to consider carefully these words from an innocent victim of the 2017 Manchester Arena bombing. Among these harrowing words, we should be mindful of the use of the word “evidence,” as we consider the theme of several of our papers in this addition of Mass Casualty Events will 500mg of zithromax cure chlamydia. The first of these papers, our Editor’s choice from Dark and colleagues, considers evidence from a national trauma registry patient case series and hospital performance data from the Manchester bombing itself. In this important work, Dark presents routinely collected injury, management and outcome data from will 500mg of zithromax cure chlamydia 153 patients who attended hospital after this incident.

While this powerful data provides an objective evaluation of a system wide response and offers important learnings for systems moving forward, we should be mindful that the interpretation of what is evidence may be different for us as readers and most importantly the victims of such incidents. Objective numbers can never describe pain and suffering. We discuss the ethical implications of the data presented within this manuscript, together with the outstanding community engagement will 500mg of zithromax cure chlamydia work undertaken by Dark’s team within our accompanying editorial.Skryabina and colleagues, provide an alternative form of evidence in their mixed methods study involving interviews with healthcare staff who took part in responses to three terrorist attacks in the UK. It is pleasing to see patient and public involvement from victims again here, in informing interview design. With this work we can identify themes that will be helpful to systems in planning for such will 500mg of zithromax cure chlamydia events such as effective team working, communication and robust Major Incident Plans.

Although one interview quote stands out. €œWe underestimate the post-trauma of it and that’s the one thing I definitely took away from this event is we are not prepared for the stress and trauma it caused.” As the authors highlight, the need for psychosocial support after such events is clearly underestimated. A Short Report, by Mawhinney et al, demonstrates through a survey of nearly 200 doctors working in hospitals across the UK, that having a Major Incident Plan in place does will 500mg of zithromax cure chlamydia not necessarily translate to preparedness and knowledge in the handling of mass casualty events. There is certainly work to do in terms of education here.Our final Mass Casualty Event themed paper this month takes an entirely different approach to evidence. By reviewing extensive written, photographic and video evidence from will 500mg of zithromax cure chlamydia the Hillsborough Disaster (a crowd crush at a football stadium in the UK in 1989), Jerry Nolan and expert colleagues provide a unique clinical insight into compression asphyxia in their Practice Review.

Again, it is impressive to see engagement with the Hillsborough Families who gave permission for publication of this potentially emotive manuscript.Safety and service organisationCurrent daily clinical work in Emergency Departments (ED) across the world continues to be pressured. Lynsey Flowerdew identifies some familiar risks in our practice, in survey work covering over 1000 UK will 500mg of zithromax cure chlamydia clinicians. Risks posed by interruptions, negative effects of targets, deficient mental healthcare and ED crowding are identified but an encouraging safety culture is also revealed. Our Reader’s Choice also explores risks at a more granular level, in a prospective observational study of risk events during intrahospital transport from Australia. While risk events occur in almost 40% of patient journeys, with many resulting in harm, will 500mg of zithromax cure chlamydia prior preparation would appear to prevent poor performance.One initiative to mitigate risk in EDs that are facing unprecedented demands, continues to be the integration of primary care/general practitioners within an ED setting (GPED).

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They showed that clinical guidelines are designed to fit an “ideal” rather than being more pragmatic for use in existing environments. Finally, an interesting Short Report from Davies and colleagues in Scotland explores the utility of exercise induced hypoxia in evaluating patients with buy antibiotics will 500mg of zithromax cure chlamydia and offers a standardised approach to this using a 1 min sit-to-stand test. Readers may want to put this into perspective by looking at the secondary analysis from the PRIEST study, published in the EMJ earlier this year, which found post exertional oxygen saturations to be only a modest prognostic variable. Perhaps a standardised approach is key here." data-icon-position data-hide-link-title="0">Ethics statementsPatient consent for publicationNot required..

Evidence and mass casualty events“I sat among the dead, dying and those fighting for life, I observed the pain and suffering zithromax online in canada and endured my own. I need to hear the truth to be able to move forward and I have to be there for those who didn't make it, they do not have a say in this, so I must speak up for them and for my own mental well-being, I cannot rest until the truth is told and evidence is shown to me…”I would urge all readers this month to consider carefully these words from an innocent victim of the 2017 Manchester Arena bombing. Among these harrowing zithromax online in canada words, we should be mindful of the use of the word “evidence,” as we consider the theme of several of our papers in this addition of Mass Casualty Events.

The first of these papers, our Editor’s choice from Dark and colleagues, considers evidence from a national trauma registry patient case series and hospital performance data from the Manchester bombing itself. In this important work, Dark presents zithromax online in canada routinely collected injury, management and outcome data from 153 patients who attended hospital after this incident. While this powerful data provides an objective evaluation of a system wide response and offers important learnings for systems moving forward, we should be mindful that the interpretation of what is evidence may be different for us as readers and most importantly the victims of such incidents.

Objective numbers can never describe pain and suffering. We discuss the ethical implications of the data presented within this manuscript, together with the outstanding zithromax online in canada community engagement work undertaken by Dark’s team within our accompanying editorial.Skryabina and colleagues, provide an alternative form of evidence in their mixed methods study involving interviews with healthcare staff who took part in responses to three terrorist attacks in the UK. It is pleasing to see patient and public involvement from victims again here, in informing interview design.

With this work we can identify themes that will be helpful to systems in planning zithromax online in canada for such events such as effective team working, communication and robust Major Incident Plans. Although one interview quote stands out. €œWe underestimate the post-trauma of it and that’s the one thing I definitely took away from this event is we are not prepared for the stress and trauma it caused.” As the authors highlight, the need for psychosocial support after such events is clearly underestimated.

A Short Report, by Mawhinney et al, demonstrates through a survey of nearly 200 doctors working in hospitals across the UK, that having a Major Incident Plan in place does not necessarily translate to preparedness and knowledge in zithromax online in canada the handling of mass casualty events. There is certainly work to do in terms of education here.Our final Mass Casualty Event themed paper this month takes an entirely different approach to evidence. By reviewing extensive written, photographic and video evidence from the Hillsborough Disaster (a crowd crush at a football stadium in the UK in 1989), zithromax online in canada Jerry Nolan and expert colleagues provide a unique clinical insight into compression asphyxia in their Practice Review.

Again, it is impressive to see engagement with the Hillsborough Families who gave permission for publication of this potentially emotive manuscript.Safety and service organisationCurrent daily clinical work in Emergency Departments (ED) across the world continues to be pressured. Lynsey Flowerdew identifies some familiar risks in our practice, in survey work covering zithromax online in canada over 1000 UK clinicians. Risks posed by interruptions, negative effects of targets, deficient mental healthcare and ED crowding are identified but an encouraging safety culture is also revealed.

Our Reader’s Choice also explores risks at a more granular level, in a prospective observational study of risk events during intrahospital transport from Australia. While risk events occur in almost 40% of zithromax online in canada patient journeys, with many resulting in harm, prior preparation would appear to prevent poor performance.One initiative to mitigate risk in EDs that are facing unprecedented demands, continues to be the integration of primary care/general practitioners within an ED setting (GPED). It is therefore a pleasure to see preliminary work mapping GPED published in the EMJ, led by my colleagues from the University of West of England, Bristol, UK.

While the majority of zithromax online in canada UK ED’s have adopted a GPED model, there appears heterogeneity in the type of model used and the relative effectiveness of these models remains unknown. There is more to come from this excellent project, that should provide answers. In a similar vein, Lasserson and colleagues identify significant heterogeneity in referral rates (between 1%–21% of patients seen) from out of hours primary care to the ED using operations research methods.

There is clearly still much work to be done to reduce variations in practice and maximise efficiency in this area.buy antibioticsAs we continue zithromax online in canada to see high volumes of patients with buy antibiotics attending EDs across the world, work by Douillet et al highlights limitations in current structural design of departments in France to facilitate robust organisational responses. They showed that clinical guidelines are designed to fit an “ideal” rather than being more pragmatic for use in existing environments. Finally, an interesting Short Report from Davies and colleagues in Scotland explores the zithromax online in canada utility of exercise induced hypoxia in evaluating patients with buy antibiotics and offers a standardised approach to this using a 1 min sit-to-stand test.

Readers may want to put this into perspective by looking at the secondary analysis from the PRIEST study, published in the EMJ earlier this year, which found post exertional oxygen saturations to be only a modest prognostic variable. Perhaps a standardised approach is key here." data-icon-position data-hide-link-title="0">Ethics statementsPatient consent for publicationNot required..

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