Securing Updated and Necessary Statutory Evaluations Timely; Administrative Delay of Effective Date; Correction

Citation86 FR 15404
CourtCenters For Medicare And Medicaid Services, Food And Drug Administration, Public Health Service, The Inspector General Office
Publication Date23 Mar 2021
Record Number2021-05907
Federal Register, Volume 86 Issue 54 (Tuesday, March 23, 2021)
[Federal Register Volume 86, Number 54 (Tuesday, March 23, 2021)]
                [Rules and Regulations]
                [Pages 15404-15408]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-05907]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                21 CFR Part 6
                Public Health Service
                42 CFR Part 1
                Centers for Medicare and Medicaid Services
                42 CFR Part 404
                Office of the Inspector General
                42 CFR Part 1000
                Office of the Secretary
                45 CFR Part 8
                Administration for Children and Families
                45 CFR Parts 200, 300, 403, 1010, and 1300
                [Docket No. HHS-OS-2020-0012]
                RIN 0991-AC24
                Securing Updated and Necessary Statutory Evaluations Timely;
                Administrative Delay of Effective Date; Correction
                AGENCY: Department of Health and Human Services (HHS).
                ACTION: Final rule; delay of effective date and correction.
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                SUMMARY: The Department of Health and Human Services (HHS or
                Department) is postponing, pending judicial review, the effective date
                of a final rule entitled ``Securing Updated and Necessary Statutory
                Evaluations Timely'' (SUNSET final rule) and published in the Federal
                Register of January 19, 2021. This document also corrects certain
                errors in the SUNSET final rule.
                DATES: As of March 19, 2021, the effective date of the final rule
                published January 19, 2021 (86 FR 5694), is delayed pursuant to 5
                U.S.C. 705 for one year until March 22, 2022.
                 This correction is effective as of March 22, 2022, and amendatory
                instruction #10 in FR 2021-00597 (86 FR 5694), published on January 19,
                2021, is corrected.
                FOR FURTHER INFORMATION CONTACT: Daniel J. Barry, Acting General
                Counsel, 200 Independence Avenue SW, Washington, DC 20201; or by email
                at [email protected]; or by telephone at 1-877-696-6775.
                [[Page 15405]]
                SUPPLEMENTARY INFORMATION: The SUNSET final rule was scheduled to take
                effect on March 22, 2021. On March 9, 2021, a lawsuit was filed seeking
                to overturn the SUNSET final rule. HHS finds that the interests of
                justice require that the SUNSET final rule's effective date be
                postponed pending judicial review because: Based on HHS's initial
                review of the Complaint, HHS believes that the Court could find merit
                in some of Plaintiffs' claims; Plaintiffs' allegations of harm are
                credible; a postponement will permit HHS to review the SUNSET final
                rule in light of the claims raised in the litigation; and the balance
                of equities and the public interest warrant postponement of the
                effective date to preserve the status quo while the Court considers the
                challenge to the SUNSET final rule. This document also corrects certain
                errors in the SUNSET final rule.
                 In the Federal Register of November 4, 2020 (85 FR 70096), HHS
                published a notice of proposed rulemaking entitled ``Securing Updated
                and Necessary Statutory Evaluations Timely'' (SUNSET). Under the rule
                as proposed, subject to certain exceptions, Department regulations
                would expire at the end of (1) two calendar years after the year that
                the SUNSET rule first became effective, (2) ten calendar years after
                the year of the regulation's promulgation, or (3) ten calendar years
                after the last year in which the Department ``assessed'' and, if
                required, ``reviewed'' the regulation, whichever was latest. Thus,
                under the proposed rule, unless HHS ``assessed'' and, if required,
                ``reviewed'' most of its regulations within a certain timeframe
                specified in the rule (for most existing regulations, within two years)
                and every ten years thereafter, the regulations would expire. The
                proposed rule also provided that if a ``review'' led to a finding that
                a regulation should be amended or rescinded, the Department must amend
                or rescind the regulation within a specified timeframe (generally two
                years). In addition, the proposed rule contained certain publication
                requirements, including that (1) the Department publish the results of
                all ``assessments'' and ``reviews,'' including the full underlying
                analyses and data used to support the results, in the Federal Register,
                and (2) the Department announce the commencement of an ``assessment''
                or ``review'' of a particular regulation on the agency website, with an
                opportunity for public comment. The proposed rule provided that
                comments could be submitted until December 4, 2020, except for comments
                on the portion of the rule amending 42 CFR parts 400-429 and parts 475-
                499, which were due by January 4, 2021.
                 In the Federal Register of November 16, 2020 (85 FR 73007), HHS
                announced a public hearing, scheduled for November 23, 2020, to receive
                information and views on the proposed rule (Public Hearing).
                 In the Federal Register of January 19, 2021 (86 FR 5694), HHS
                issued the SUNSET final rule. The final rule provides that all
                regulations, subject to certain exceptions, issued by the Secretary of
                the Department of Health and Human Services (Secretary) or their
                delegates or sub-delegates in titles 21, 42, and 45 of the CFR shall
                expire at the end of (1) five calendar years after the year that the
                SUNSET final rule first becomes effective, (2) ten calendar years after
                the year of the regulation's promulgation, or (3) ten calendar years
                after the last year in which the Department ``assessed'' and, if
                required, ``reviewed'' the regulation, whichever is latest. Thus, the
                final rule contains the same basic expiration framework as the proposed
                rule, but extends the timeframe for ``assessment'' and any applicable
                ``review'' of most existing regulations from two calendar years to five
                calendar years. The final rule also provides for ``continuation'' of a
                regulation that is subject to expiration if the Secretary makes a
                written determination that the public interest requires continuation.
                In addition, the final rule contains exemptions for a small set of
                certain Food and Drug Administration (FDA) regulations. The final rule
                maintains the timeframe for amendment or rescission of regulations, as
                well as the publication requirements, and includes a new Federal
                Register publication requirement. The final rule also expands its reach
                to include additional provisions regarding parts of HHS not
                specifically included in the proposed rule. The final rule states that
                its effective date is March 22, 2021.
                 On March 9, 2021, the County of Santa Clara, California Tribal
                Families Coalition, National Association of Pediatric Nurse
                Practitioners, American Lung Association, Center for Science in the
                Public Interest, and Natural Resources Defense Council sued the
                Department seeking to overturn the SUNSET final rule under the
                Administrative Procedure Act (APA). Complaint, County of Santa Clara v.
                HHS, Case No. 5:21-cv-01655-BLF (N.D. Cal.). Plaintiffs allege that the
                SUNSET final rule is ultra vires, see id. ]] 123-30; arbitrary and
                capricious, see id. ]] 131-33; in violation of the APA's notice-and-
                comment requirements, see id. ]] 134-39; and in violation of HHS's
                Tribal Consultation Policy, see id. ]] 140-44. Plaintiffs further
                allege that the SUNSET final rule threatens imminent and irreparable
                harm to them and the general public, including by creating regulatory
                confusion and uncertainty that will impede their ongoing operations,
                budgeting, and planning activities. See, e.g., id. ]] 100-02; see
                generally id. ]] 95-122.
                 Under 5 U.S.C. 705 of the APA, an agency ``may postpone the
                effective date of action taken by it, pending judicial review,'' when
                the ``agency finds that justice so requires.'' HHS has concluded that
                the interests of justice require that the SUNSET final rule be stayed
                pending judicial review. As discussed in greater detail below, HHS
                believes that the Court may find merit in some of Plaintiffs' claims,
                that Plaintiffs' allegations of harm are credible, and that the balance
                of equities and the public interest warrant postponement of the
                effective date pending judicial review. Accordingly, the interests of
                justice require a postponement in order to preserve the status quo,
                because, if the rule took effect while HHS was evaluating the rule in
                light of the claims raised in litigation, it could create significant
                obligations for HHS, cause confusion for the public, including
                Plaintiffs, and may lead to compliance costs as entities, including
                Plaintiffs, plan steps necessary to deal with the rule's
                implementation, as explained below. HHS is unaware of any benefits from
                the implementation of the SUNSET final rule that would be significantly
                curtailed from a stay of its effective date.
                 The Department is taking a fresh and critical look at the SUNSET
                final rule in light of the allegations in the Complaint (although many
                of these concerns were also raised during the comment period on the
                proposed rule). The Complaint alleges serious legal vulnerabilities of
                the rule, and, while HHS does not concede any of these claims at this
                time, HHS requires additional time to evaluate the SUNSET final rule
                given the pending litigation. In addition, the Complaint raises the
                question as to whether the SUNSET final rule, issued in the final days
                of the last administration, is consistent with the policies and goals
                of the current administration, both in terms of the appropriate role of
                regulatory oversight of the health care industry and necessary
                engagement with the public, including tribal organizations.
                 The Complaint makes numerous allegations that the substantive
                provisions of SUNSET final rule violate the law. The Complaint alleges
                that the SUNSET final rule is contrary to and
                [[Page 15406]]
                exceeds the Department's authority under the APA, substantive organic
                statutes, and the Regulatory Flexibility Act (RFA) because it schedules
                the rescission of thousands of regulations that were required by
                statute, amends regulations without the same level of process and
                statutory considerations required for the original regulations, and
                provides for automatic elimination of regulations without considering
                the requirements of the RFA. The Complaint further alleges that the
                SUNSET final rule is arbitrary and capricious and lacks a rational
                basis because, among other reasons, it assumes that HHS will conduct
                RFA reviews at an implausible pace; does not adequately consider the
                extreme degree of regulatory uncertainty the SUNSET final rule creates;
                underestimates the burden imposed on Plaintiffs for monitoring HHS
                regulations to ensure they do not expire; and fails to consider the
                specific regulations being amended to automatically expire.
                 Given the volume of HHS agency regulations that the Department
                would need to assess and, as applicable, review in a short period of
                time, HHS now believes it is likely some regulations would expire
                without any additional administrative process (contrary to the
                conclusions reached in the SUNSET final rule). Under the SUNSET final
                rule, for each covered regulation, HHS agencies would need to: Collect
                data to conduct the relevant evaluation, perform an assessment and
                possibly a review, consider any comments to the public docket related
                to the evaluation, publish the results of this process in the Federal
                Register (``including the full underlying analyses and data used to
                support the results,'' 86 FR at 5712), and, if warranted, complete a
                rulemaking to amend or rescind the regulation, which would itself
                require an additional investment of agencies' resources and public
                input. If the work is unable to be conducted within the final rule's
                time frames, the regulations would expire.
                 That outcome could raise interrelated administrative law questions
                regarding: Whether regulations promulgated through notice and comment
                rulemaking can be terminated through an umbrella rule without
                individualized consideration of the expiring regulations, including any
                reliance interests of parties affected by them; and, if so, whether the
                proposed/final rule provided an adequate justification for implementing
                a process of automatic expiration.
                 The expiration component of the SUNSET final rule also raises
                significant policy and public health questions concerning the value of
                the assessment and review processes and whether those processes are so
                important that they outweigh the value of the regulations that would
                likely expire.
                 The potential automatic expiration of regulatory programs could
                create uncertainty and unpredictability regarding large swathes of the
                rules governing health care, which would upend the status quo and in
                turn could result in compliance costs to HHS grantees, contractors, and
                health care providers and suppliers, many of whom may have structured
                matters such as financial arrangements and business operations to
                satisfy the conditions set forth in the current regulations. The
                resulting disruption in the marketplace could impact stakeholders who
                rely on the regulatory functions of each HHS agency. This uncertainty
                could have serious implications for insurance markets, hospitals,
                physicians, and patients, among other affected parties, which could
                lead physicians and other regulated entities to forgo future
                investments because of the lack of clarity. In addition, because States
                depend on HHS to set national standards and have built vast regulatory
                systems within that framework, the possibility that many regulations
                would lapse could pose a direct threat to the States' healthcare
                systems and the health and safety of individuals. The expiration of
                regulations could also muddle the clarity and predictability of
                existing regulations, which in turn would impede program implementation
                and reduce HHS's overall efficiency.
                 HHS is similarly concerned that the SUNSET final rule may have
                significantly underestimated the burden of the assessments and reviews
                for this magnitude of regulations and fails to account for the
                substantial resources that would be needed for the HHS agencies to
                simultaneously evaluate thousands of regulations in a short period of
                time. For example, the Regulatory Impact Analysis (RIA) included in the
                final rule appears to focus on the number of staff and staff hours
                required for ``reviews,'' but provides an incomplete estimate for the
                cost of the initial ``assessment'' phase. That raises questions
                regarding whether the RIA significantly underestimated the costs that
                will be incurred by agencies and overestimates the purported cost
                savings. Currently, there is no accurate impact analysis of the
                substantial redirection of resources (both financial and employee)
                required to provide the necessary expertise and input from economists,
                epidemiologists, medical officers, legal and regulatory counsel, and
                other subject matter experts.
                 The Complaint also alleges that the promulgation of the SUNSET
                final rule suffered from procedural deficiencies. Plaintiffs allege
                that, despite widespread requests for more time, HHS issued the SUNSET
                final rule after providing 30 days to comment on the rule's effect on
                non-Medicare regulations and 60 days to comment on its effects on
                Medicare regulations, seriously interfering with meaningful public
                participation. The comments likewise raised concerns about the adequacy
                of the comment period for a rule with this magnitude of impact and the
                timing of the proposal, particularly during the COVID-19 pandemic, both
                of which may have impeded the full and deliberate consideration of all
                of the potential issues related to the SUNSET rule. For example, at the
                Public Hearing, almost all commenters agreed that HHS should have
                lengthened the comment period, and offered several reasons in support
                of a longer comment period, all of which were expressed by multiple
                commenters: That a proposal with this breadth, scope, and potential
                harmful impact, including unintended detrimental consequences to
                regulated industries, merited more time for thoughtful public input;
                that impacted stakeholders included small businesses that would not be
                able to digest and comment on a rule of this breadth in such a short
                period of time; that it was irresponsible for HHS to engage in this
                rulemaking during the height of the pandemic when stakeholder resources
                were devoted to addressing the public health emergency; and that the
                already short comment period included Thanksgiving weekend, which
                exacerbated the time-crunch for commenters. See Transcript, Public
                Hearing on the Securing Updated and Necessary Statutory Evaluations
                Timely Notice of Proposed Rulemaking (Public Hearing Transcript) (Nov.
                23, 2020) (available at https://www.regulations.gov/document/HHS-OS-2020-0012-0501). As with Plaintiffs' above substantive claims, HHS
                requires additional time to review the SUNSET final rule's compliance
                with these procedural obligations, in light of Plaintiffs' claims,
                before determining how to proceed in litigation and before creating
                uncertainty among the regulated community. The SUNSET final rule is
                uniquely situated in that it affects an extraordinarily large number of
                regulations, which lends support for Plaintiffs' procedural claims.
                 The Complaint also alleges that, despite the SUNSET final rule's
                sweeping scope and tribal implications, the Department neglected to
                consult
                [[Page 15407]]
                with tribal governments. Again, these same concerns were raised in the
                written comments on the SUNSET proposed rule. Under Executive Order
                13175, entitled ``Consultation and Coordination With Indian Tribal
                Governments,'' HHS is required, before any action is taken that will
                significantly affect Indian Tribes, to consult with Indian Tribes in
                the development of the proposed rule to the extent practicable and
                permitted by law. 65 FR 67249 (Nov. 6, 2000). This required
                consultation is in recognition that Tribes should be afforded an
                opportunity to comment meaningfully on the rule's impact. However,
                multiple comments from representatives of several Tribes and related
                groups explained that, despite the enormous impact that this rule, if
                implemented, would have on Tribes, HHS failed to consult with Tribal
                governments (or even notify them regarding the proposal), contrary to
                procedures required under Executive Order 13175. See, e.g., Comments
                from the: Saint Regis Mohawk Tribe; Chickahominy Indian Tribe; Jena
                Band of Choctaw Indians; Nez Perce Tribe; Affiliated Tribes of
                Northwest Indians; Mohegan Tribe of Connecticut; Tanana Chiefs
                Conference; Chippewa Cree Tribe of the Rocky Boy's Reservation; Alaska
                Native Tribal Health Consortium; United South and Eastern Tribes
                Sovereignty Protection Fund; Northwest Portland Area Indian Health
                Board; Quinault Indian Nation; California Tribal Families Coalition;
                National Indian Child Welfare Association; Tribal Law and Policy
                Institute; Tribal Technical Advisory Group; Native American Rights
                Fund, and the National Congress of American Indians, available at
                https://www.regulations.gov/document/HHS-OS-2020-0012-0001/comment. In
                light of the allegations in the Complaint, we need to reconsider the
                conclusion in the SUNSET final rule that the rule does not
                significantly affect Indian Tribes or have Tribal implications.
                Accordingly, HHS requires additional time to review the SUNSET final
                rule in light of the pending litigation.
                 In publishing the SUNSET final rule, the Department previously took
                the position that the rule complies with the APA and that the comment
                period was adequate, among other things. The Department's conclusions
                rested on certain assumptions that the Complaint challenges. For
                example, the Department expressed a view that it has the resources to
                complete assessments and reviews and avoid expiration, thus avoiding
                many of the legal concerns related to automatic repeal of regulations.
                See, e.g., 86 FR 5694, 5705 (``The regulatory impact analysis in this
                final rule explains how HHS has the resources and personnel to perform
                the Assessments and Reviews called for by this final rule.''); id. at
                5710 (``HHS does not intend to allow a regulation to simply expire.'');
                id. at 5711 (``HHS believes that this final rule does not significantly
                affect Indian Tribes or have Tribal implications . . . HHS intends that
                all rules will be Assessed and (if necessary) Reviewed timely.
                Therefore, this final rule would have no direct impact on Indian
                Tribes''); id. at 5714 (``The Department does not intend for any
                regulations to inadvertently sunset, and it is unlikely that any
                regulations with significant benefits would slip through the
                cracks.''). However, the Complaint alleges that ``there is no realistic
                probability that the Department will be able to conduct the number of
                reviews required to prevent automatic rescission,'' based in part on
                the quantity of analyses that would be required in the first five years
                and the agency's past practices. Complaint, ]] 84-85. As noted above,
                the Department now believes that the RIA developed for the SUNSET final
                rule may not have fully taken into account all of the resource
                implications of this rule and therefore misjudged the likely expiration
                of existing regulations, elevating the administrative law concerns and
                concerns about the adequacy of the RIA.
                 In addition, the Department previously took the view that a 30-day
                comment period was adequate. However, the Complaint challenges the
                sufficiency of a 30-day comment period for complex rules, Complaint, ]
                54, and the SUNSET rule's unique breadth, affecting an extraordinarily
                large number of regulations, could add force to such claims. The
                Department also took the view that the lack of tribal consultation was
                mitigated by the fact that Tribes will be able to comment on
                regulations during the Assessment and Review processes, 86 FR at 5711,
                but, as noted above, HHS is reconsidering that conclusion in light of
                the claims raised in the Complaint.
                 The Complaint also alleges that Plaintiffs and others are
                immediately harmed by the SUNSET final rule. The Complaint alleges that
                the uncertainty resulting from its implementation impacts the entire
                healthcare sector, which accounts for nearly one-fifth of the U.S.
                economy and secures individual and community health for hundreds of
                millions of Americans, and that participants in every single industry
                the Department regulates, including Plaintiffs, must plan their futures
                and operations without knowing what regulations will govern their
                businesses in these notoriously complex regulatory arenas. See
                Complaint, ]] 2, 95-122. While HHS does not concede that Plaintiffs
                would establish irreparable harm in litigation, HHS agrees that it is
                appropriate to postpone the effective date of the SUNSET final rule to
                preserve the status quo and to ensure that HHS has time to evaluate the
                rule before it takes effect to avoid the possibility of confusion among
                the regulated community.
                 In addition, given the scope of work and timeframes set forth in
                the SUNSET final rule, the review required under the rule would divert
                the Department's resources from mission-critical endeavors for HHS
                agencies. For example, based on a count cited in the SUNSET final rule,
                under the timeline and definitions provided in the final rule, over
                7,000 sections of the Code of Federal Regulations promulgated by the
                Food and Drug Administration (FDA) are more than ten years old or would
                become more than ten years old during the first five years the rule
                would be in effect, representing over 95 percent of its current
                regulations. Unless one of the exemptions applied, these regulations
                would need to be assessed within five years and, if applicable,
                reviewed, or be subject to expiration. If the SUNSET final rule were to
                become effective as scheduled on March 22, 2021, then, in order to meet
                these new obligations within the specified timeframe to avoid automatic
                expiration of its regulations, FDA and the Department would need to
                immediately divert resources toward assessment and review during the
                ongoing COVID-19 public health emergency. In that event, FDA's reviews
                of medical product applications, fulfillment of user fee commitments,
                and actions to address urgent public health matters such as ongoing
                COVID-19 pandemic relief efforts, outbreaks of foodborne illness,
                inspections, recalls, and other public health priorities would be
                significantly impacted. This concentration of resources in conducting
                regulatory review pursuant to the SUNSET rule could prevent FDA from
                modernizing its regulatory oversight more efficiently and addressing
                new regulatory needs. These considerations further support HHS's
                determination that justice requires a postponement of the SUNSET final
                rule's effective date. See 5 U.S.C. 705.
                 The SUNSET final rule presents similar burdens for HHS's seven
                other Public Health Service agencies and three human services agencies,
                such as the Centers for Medicare & Medicaid Services (CMS), with
                implications for
                [[Page 15408]]
                many initiatives. For example, comments at the Public Hearing from the
                American College of Obstetricians and Gynecologists, Center on Budget
                and Policy Priorities, National Immigration Law Center, and Service
                Employees International Union raised concerns that the SUNSET rule
                would undermine the regulations underpinning the Affordable Care Act,
                potentially with catastrophic consequences for the health care of
                millions of individuals and families. See Public Hearing Transcript. As
                another example, Medicare regulations are numerous and have an
                expansive reach, affecting many health care providers and suppliers in
                this country. Permitting the rule to go into effect would require CMS
                to assess thousands of regulations within a relatively short timeframe,
                and would likely entail a massive expenditure of resources and
                significantly increase the Department's workload. The rule would also
                likely result in significant uncertainty and compliance costs to
                Medicare providers and suppliers, many of which are small businesses.
                In addition, this rule could cause the loss of program protections to
                the beneficiaries of HHS programs and create uncertainty for
                individuals and entities subject to administrative sanctions, or those
                who seek reinstatement after exclusion from participation in Federal
                health care programs. The National Health Law Program also commented at
                the Public Hearing that the rule would create havoc in the Medicaid
                industry. See Public Hearing Transcript. All of these potential
                consequences would be detrimental to the public health, underscoring
                that justice requires a postponement of the SUNSET final rule's
                effective date pursuant to 5 U.S.C. 705.
                 Because of these public health concerns, and the harms alleged by
                the Plaintiffs and echoed in the comments, the balance of equities and
                the public interest favor the issuance of a stay of the effective date
                of the SUNSET final rule to preserve the status quo and allow for
                judicial review of its legality before any implementation.
                 Accordingly, HHS is issuing this stay of the effective date of this
                final rule pending judicial review. This postponement applies to all of
                the regulations established under the SUNSET final rule. As noted
                above, the Complaint alleges that the SUNSET final rule suffers from a
                variety of defects, including procedural defects related to its
                promulgation. The Department believes it is appropriate to review the
                entire rule in light of the claims raised in the litigation. Thus, this
                postponement reaches the full rule, consistent with the Complaint's
                prayer for relief.
                 Separately, this document addresses and corrects several technical
                errors identified by the Office of the Federal Register in the SUNSET
                final rule.
                Corrections
                 In FR 2021-00597 (86 FR 5694), published on January 19, 2021, the
                following corrections are made:
                 1. On page 5694, first column, the list of CFR citations in the
                heading under ``Administration for Children and Families'' that reads
                ``45 CFR parts 200, 300, 403, 1010, and 1390'' is corrected to read
                ``45 CFR parts 200, 300, 403, 1010, and 1300.''
                 2. On page 5751, first column, the reference to ``45 CFR part
                1390'' in the List of Subjects is corrected to read ``45 CFR part
                1300.''
                SUBCHAPTER A [Corrected]
                0
                3. On page 5763, first column, in instruction 10, the heading for
                subchapter A and the table of contents for part 1300 are corrected to
                read as follows:
                SUBCHAPTER A--Administrative Matters
                PART 1300--REVIEW OF REGULATIONS
                Sec.
                1300.1 Retrospective Review of Existing Regulations.
                1300.2 through 1300.5 [Reserved]
                Norris Cochran,
                Acting Secretary.
                [FR Doc. 2021-05907 Filed 3-18-21; 4:15 pm]
                BILLING CODE 4150-26-P