Securing Updated and Necessary Statutory Evaluations Timely

CourtCenters For Medicare And Medicaid Services,Public Health Service,The Inspector General Office
Citation86 FR 5694
Record Number2021-00597
Publication Date19 Jan 2021
Federal Register, Volume 86 Issue 11 (Tuesday, January 19, 2021)
[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
                [Rules and Regulations]
                [Pages 5694-5764]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-00597]
                [[Page 5693]]
                Vol. 86
                Tuesday,
                No. 11
                January 19, 2021
                Part VII Department of Health and Human Services-----------------------------------------------------------------------21 CFR Part 6
                42 CFR Parts 1, 404, et al.
                45 CFR Parts 8, 200, et al.-----------------------------------------------------------------------Securing Updated and Necessary Statutory Evaluations Timely; Final Rule
                Federal Register / Vol. 86 , No. 11 / Tuesday, January 19, 2021 /
                Rules and Regulations
                [[Page 5694]]
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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 1390
                [Docket No. HHS-OS-2020-0012]
                RIN 0991-AC24
                Securing Updated and Necessary Statutory Evaluations Timely
                AGENCY: Department of Health and Human Services (HHS).
                ACTION: Final rule.
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                SUMMARY: The Regulatory Flexibility Act (RFA) requires agencies to
                publish plans to conduct periodic reviews of certain of their
                regulations. Multiple Executive Orders also require agencies to submit
                plans for periodic reviews of certain regulations. To further comply
                with the RFA and Executive Orders, and to ensure the Department's
                regulations have appropriate impacts, the U.S. Department of Health and
                Human Services (HHS or the Department) issues this final rule amending
                its regulations to set expiration dates for the Department's
                regulations (subject to certain exceptions), unless the Department
                periodically assesses the regulations to determine if they are subject
                to the RFA, and if they are, performs a review that satisfies the
                criteria in the RFA.
                DATES: This final rule is effective on March 22, 2021.
                FOR FURTHER INFORMATION CONTACT: James Lawrence, 200 Independence
                Avenue SW, Washington, DC 20201; or by email at [email protected]; or
                by telephone at 1-877-696-6775.
                SUPPLEMENTARY INFORMATION: This final rule is organized as follows:
                Table of Contents
                I. Summary
                II. Background
                III. Statutory Authority and Legal Basis for This Final Rule
                IV. Provisions of Proposed Rule and Response to Public Comments
                V. Regulatory Impact Analysis
                I. Summary
                 On November 4, 2020, HHS published in the Federal Register a notice
                of proposed rulemaking titled ``Department of Health and Human Services
                Securing Updated and Necessary Statutory Evaluations Timely''
                (hereinafter, ``proposed rule'').\1\ On November 23, 2020, the
                Department held a public hearing on the proposed rule.\2\ For the
                reasons described herein, after considering public comments on the
                proposed rule, HHS now finalizes the proposed rule as amended. This
                final rule will enhance the Department's implementation of section 3(a)
                of the Regulatory Flexibility Act (RFA), 5 U.S.C. 610, and various
                executive orders, and improve accountability and the performance of its
                regulations.\3\ The RFA requires federal agencies to publish in the
                Federal Register ``a plan for the periodic review of the rules issued
                by the agency which have or will have a significant economic impact
                upon a substantial number of small entities'' in order ``to determine
                whether such rules should be continued without change, or should be
                amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant impact of the rules
                upon a substantial number of small entities.'' 5 U.S.C. 610(a). In
                conducting this retrospective review, agencies must consider a variety
                of factors, including the continued need for the rule, legal issues,
                public input, overlap and duplication with other federal or State and
                local governmental rules, and technological, economic, or other
                changes. 5 U.S.C. 610(b). Agency compliance with 5 U.S.C. 610 may be
                subject to judicial review. See 5 U.S.C. 611(a).
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                 \1\ 85 FR 70096 (Nov. 4, 2020).
                 \2\ The transcript of the public hearing is available on the
                docket for the proposed rule. See https://beta.regulations.gov/docket/HHS-OS-2020-0012/document.
                 \3\ Unless otherwise indicated, all references to HHS in this
                proposed rule include HHS' constituent agencies and other
                components.
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                 Several Executive Orders have also directed agencies to submit
                plans for the periodic review of certain of their regulations.\4\
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                 \4\ See, e.g., Exec. Order No. 12866 of Sept. 30, 1993, 58 FR
                51735 (Oct. 4, 1993), Exec. Order No. 13563 of Jan. 18, 2011, 76 FR
                3821 (Jan. 21, 2011).
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                 The Department has tried to carry out the evidence-based approach
                to regulation prescribed by Congress and the executive orders, but HHS'
                efforts have met varying levels of success. Several States, as well as
                jurisdictions outside the United States, have experimented with
                different ways of ensuring agencies engage in retrospective regulatory
                reviews so that legal requirements are updated in view of emerging
                evidence and changed circumstances. Among the lessons that have emerged
                is that while statutory mandates are helpful, one of the most important
                factors for ensuring agencies conduct retrospective reviews of their
                regulations is to provide for the sunset or automatic expiration of
                certain regulatory requirements after a period of time unless a
                retrospective review determines that the regulations should be
                maintained.
                 Therefore, in order to ensure evidence-based regulation that does
                not become outdated as conditions change, HHS finalizes this rule to
                provide that, subject to certain exceptions, all regulations issued by
                the Secretary or his 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 this final rule first becomes effective, (2) ten calendar
                years after the year of the Section's promulgation, or (3) ten calendar
                years after the last year in which the Department Assessed and, if
                required, Reviewed \5\ the Section, whichever is latest. The RFA and
                executive orders have only resulted in limited retrospective review by
                the Department. The Department believes this final rule will effectuate
                the desire for periodic retrospective reviews expressed in the RFA and
                Executive Orders, as well as ensure the Department's regulations are
                having appropriate impacts and have not become outdated. The literature
                and the Department's experience suggest that many regulations are
                having estimated impacts that, over time, differ from what was
                estimated at the time the regulations were promulgated. This final rule
                will enhance both (1) the fulfillment of the existing policies that led
                to the Department's regulations and (2) the Department's longstanding
                desire
                [[Page 5695]]
                to comply with the RFA and periodically review its regulations.
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                 \5\ ``Section,'' ``Assess,'' and ``Review'' are capitalized in
                this preamble where those terms have the definitions ascribed to
                them in the text of this final rule.
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                II. Background
                A. The Regulatory Flexibility Act
                 In 1980, Congress enacted the Regulatory Flexibility Act (RFA),
                Public Law 96-354, 94 Stat. 1164 (1980) (codified as amended at 5
                U.S.C. 601-612). Congress stated that ``the purpose of this Act [is] to
                establish as a principle of regulatory issuance that agencies shall
                endeavor, consistent with the objectives of the rule and of applicable
                statutes, to fit regulatory and informational requirements to the scale
                of the businesses, organizations, and governmental jurisdictions
                subject to regulation.'' 94 Stat. at 1165. Consistent with this
                purpose, section 3(a) of the RFA requires agencies to publish in the
                Federal Register a ``plan for the periodic review of rules which have
                or will have a significant economic impact upon a substantial number of
                small entities.'' 5 U.S.C. 610(a). The ``purpose of the review shall be
                to determine whether such rules should be continued without change, or
                should be amended or rescinded . . . to minimize any significant
                economic impact of the rules upon a substantial number of small
                entities.'' Id. In conducting this review, Congress provided that
                agencies ``shall consider the following factors'':
                 (a) The continued need for the rule;
                 (b) The nature of complaints or comments received concerning the
                rule from the public;
                 (c) The complexity of the rule;
                 (d) The extent to which the rule overlaps, duplicates or conflicts
                with other Federal rules, and, to the extent feasible, with State and
                local governmental rules; and
                 (e) The length of time since the rule has been evaluated or the
                degree to which technology, economic conditions, or other factors have
                changed in the area affected by the rule.
                 5 U.S.C. 610(b)(1)-(5). Congress required agencies to conduct an
                initial review within ten years of the effective date of the RFA, as
                well as subsequent reviews ``within ten years of the publication of''
                future final rules. 5 U.S.C. 610(a).
                 The retrospective review provided for in 5 U.S.C. 610 is a
                congressional mandate. Under the plain terms of the Act, having a plan
                for such reviews is not optional. Congress fashioned a private right of
                action for small entities to ensure agencies satisfy 5 U.S.C. 610. See
                5 U.S.C. 611(a)(1) (``For any rule subject to this chapter, a small
                entity that is adversely affected or aggrieved by final agency action
                is entitled to judicial review of agency compliance with the
                requirements of sections 601, 604, 605(b), 608(b), and 610 in
                accordance with chapter 7.''). Originally, as one commentator
                explained, the RFA ``contain[ed] an extremely qualified and ambiguous
                provision for judicial review.'' \6\ In 1996, Congress amended the RFA
                to more clearly provide for judicial review of violations of 5 U.S.C.
                610.\7\ As one House Committee report explained, the lack of judicial
                review made ``agencies completely unaccountable for their failure to
                comply with its requirements,'' a problem the amendment attempted to
                solve.\8\
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                 \6\ Paul R. Verkuil, A Critical Guide to the Regulatory
                Flexibility Act, 1982 Duke L.J. 213, 259 (1982).
                 \7\ Contract with America Advancement Act of 1996, Public Law
                104-121, 110 Stat. 847, 865-66 (1996).
                 \8\ H.R. Rep. No. 104-500, at 3 (1996).
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                B. Executive Orders Directing Agencies To Review Existing Regulations
                 Other efforts to conduct retrospective regulatory review both
                predate and have continued after passage of the RFA. In 1978, President
                Carter issued an executive order on improving federal regulations.\9\
                The order directed agencies to ``periodically review their existing
                regulations.'' \10\ In determining which existing regulations to
                review, the order required agencies to consider, among other things,
                whether ``technology, economic conditions or other factors have changed
                in the area affected by the regulation.'' \11\ The Executive Order
                considered suggestions from the public that all regulations be
                reviewed, usually 3-5 years after issuance. But the Carter
                Administration instead instructed that, due to agency resource
                limitations, agencies should concentrate their reviews on those
                regulations which no longer serve their intended purpose, that have
                caused administrative difficulties, or that have been affected by new
                developments.\12\ The executive order also considered, but rejected,
                the idea of including a sunset provision in regulations on the ground
                that agencies cannot entirely eliminate regulations unless the law that
                authorized the regulations allows it.\13\ However, the Department
                believes that executive order did not consider that the authorizing
                statutes for many regulations permit those regulations to be rescinded.
                Moreover, as discussed below, experience since 1978 has shown it is
                difficult to adequately conduct retrospective regulatory review if
                regulations do not contain sunset provisions.
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                 \9\ Exec. Order No. 12044 of Mar. 23, 1978, 43 FR 12661 (Mar.
                24, 1978) (revoked by Exec. Order No. 12291 of Feb. 17, 1981, 46 FR
                13193 (Feb. 19, 1981)).
                 \10\ 43 FR at 12663.
                 \11\ Id.
                 \12\ Id. at 12669. As discussed below, the Department is
                reviewing a different subset of its regulations than was directed by
                Exec. Order No. 12044, in part because the RFA's directive to review
                regulations that have a significant economic impact upon a
                substantial number of small entities had not yet been enacted at the
                time of Exec. Order No. 12044. Moreover, Exec. Order No. 12044 was
                responding to suggestions that the review be performed every three
                to five years. The Department's reviews will be performed every ten
                years (except for regulations that have already been in effect for
                ten years), which should lessen the burden on the Department's
                resources.
                 \13\ Id. at 12669.
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                 Like the Carter Administration, every subsequent administration has
                directed agencies to engage in retrospective review of existing
                regulations. In 1981, President Reagan ordered agencies to ``review[ ]
                existing regulations'' in view of cost-benefit principles and potential
                alternatives.\14\ In 1992, President George H.W. Bush issued a
                memorandum instructing agencies to conduct a 90-day review ``to
                evaluate existing regulations and programs and to identify and
                accelerate action on initiatives that will eliminate any unnecessary
                regulatory burden or otherwise promote economic growth.'' \15\
                President Clinton similarly called for review of existing regulations
                to determine whether they have become ``unjustified or unnecessary as a
                result of changed circumstances,'' and ``to confirm that regulations
                are both compatible with each other and [are] not duplicative or
                inappropriately burdensome in the aggregate.'' \16\ Specifically, that
                Executive Order required agencies to submit to the Office of
                Information and Regulatory Affairs (OIRA) a program under which the
                agency ``will periodically review its existing significant regulations
                to determine whether any such regulations should be modified or
                eliminated so as to make the agency's regulatory program more effective
                in achieving the regulatory objectives, less burdensome, or in greater
                alignment with the President's priorities and the principles set forth
                in this Executive Order.'' \17\ The George W. Bush Administration's
                Acting OIRA Administrator noted that the Bush Administration was ``in
                the
                [[Page 5696]]
                process of reviewing a variety of existing regulations and regulatory
                programs in an effort to identify areas where sensible changes will
                yield greater benefits for the public at lower costs.'' \18\
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                 \14\ Exec. Order No. 12291 of Feb. 17, 1981, 46 FR 13193, 13193
                (Feb. 19, 1981) (revoked by Exec. Order 12866 of Sept. 30, 1993, 58
                FR 51735 (Oct. 4, 1993)); see also Exec. Order 12498 of Jan. 4,
                1985, 50 FR 1036 (Jan. 8, 1985) (creating annual regulatory planning
                program), revoked by Exec. Order 12866 of Sept. 30, 1993, 58 FR
                51735 (Oct. 4, 1993).
                 \15\ Memorandum on Reducing the Burden of Government Regulation
                (Jan. 28, 1992).
                 \16\ Exec. Order No. 12866 of Sept. 30, 1993, 58 FR 51735 (Oct.
                4, 1993).
                 \17\ Id.
                 \18\ Draft Report to Congress on the Costs and Benefits of
                Federal Regulations Introduction, 66 FR 22041, 22054 (May 2, 2001).
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                 President Obama also instructed agencies to engage in retrospective
                regulatory review. In 2011, President Obama issued an executive order
                ordering agencies ``[t]o facilitate the periodic review of existing
                significant regulations . . . to promote retrospective analysis of
                rules that may be outmoded, ineffective, insufficient, or excessively
                burdensome, and to modify, streamline, expand, or repeal them in
                accordance with what has been learned.'' \19\ Similarly, in 2012,
                President Obama noted that retrospective review has particular
                relevance ``[d]uring challenging economic times,'' and that agencies
                should consider whether regulations ``should be modified or streamlined
                in light of changed circumstances, including the rise of new
                technologies.'' \20\
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                 \19\ Exec. Order No. 13563 of Jan. 18, 2011, 76 FR 3821, 3822
                (Jan. 21, 2011); see also Exec. Order No. 13579 of July 11, 2011, 76
                FR 41587, 41587 (July 14, 2011) (applying the same requirement to
                independent regulatory agencies).
                 \20\ Exec. Order No. 13610 of May 10, 2012, 77 FR 28469, 28469
                (May 14, 2012).
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                 President Trump has attempted to identify existing undue regulatory
                burdens and facilitate retrospective review of regulations. For
                example, in January 2017, President Trump issued an executive order
                requiring agencies to identify at least two regulations to be repealed
                for every one regulation proposed or otherwise promulgated.\21\
                Similarly, a 2017 OIRA report to Congress explained, ``Rules should be
                written and designed to facilitate retrospective analysis of their
                effects, including consideration of the data that will be needed for
                future evaluation of the rules' ex post costs and benefits.'' \22\ In
                May 2020, in response to the COVID-19 pandemic, President Trump ordered
                agencies to ``identify regulatory standards that may inhibit economic
                recovery'' and to ``consider taking appropriate action, consistent with
                applicable law,'' including modifying, waiving, or rescinding those
                regulatory requirements.\23\
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                 \21\ Exec. Order No. 13771 of Jan. 30, 2017, 82 FR 9339, 9339
                (Feb. 3, 2017).
                 \22\ Office of Mgmt. & Budget, 2017 Report to Congress on the
                Benefits and Costs of Federal Regulations and Agency Compliance with
                the Unfunded Mandates Reform Act at 5 (2017), https://www.whitehouse.gov/wp-content/uploads/2019/12/2019-CATS-5885-REV_DOC-2017Cost_BenefitReport11_18_2019.docx.pdf; see also id. at
                16 (``[I]t is important to consider retrospective, as opposed to ex
                ante, estimates of both benefits and costs.'').
                 \23\ Exec. Order No. 13924 of May 19, 2020, 85 FR 31353, 31354
                (May 22, 2020).
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                 In addition to the executive orders, other executive branch actions
                have sought to spur agencies to conduct the reviews called for by 5
                U.S.C. 610. One example was the Regulatory Review and Reform (r3)
                initiative, which the Small Business Administration launched in part to
                improve compliance with 5 U.S.C. 610 and further the goals of periodic
                reviews. The r3 initiative was a long-term project to help agencies
                pinpoint existing federal rules that warrant review--and to revise
                those rules if they are found to be ineffective, duplicative, out of
                date, or otherwise deficient.\24\
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                 \24\ Testimony of The Hon. Thomas M. Sullivan, Chief Counsel for
                Advocacy, U.S. SBA, U.S. House of Representatives Comm. on Small
                Bus. Subcomm. on Reg.'s, Health Care and Trade (July 30, 2008),
                https://www.sba.gov/sites/default/files/files/test08_0730.pdf
                (``Historically, federal agency compliance with section 610 has been
                limited.'').
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                 Consistent with these actions, HHS has conducted retrospective
                reviews of some of its regulations. For example, pursuant to Executive
                Order 13563, HHS published a list of regulations the Department
                identified as candidates for retrospective review.\25\ The Department
                also took action. For example, HHS, citing Executive Order 13563,
                eliminated certain restrictions on the use of telemedicine in rural
                areas.\26\
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                 \25\ See also Retrospective Review of Existing Rules, U.S. Dept.
                of Health & Human Servs., https://www.hhs.gov/open/retrospective-review/index.html.
                 \26\ See Medicare and Medicaid Programs: Changes Affecting
                Hospital and Critical Access Hospital Conditions of Participation:
                Telemedicine Credentialing and Privileging, 76 FR 25550 (May 5,
                2011); see also Medicare and Medicaid Programs; Regulatory
                Provisions To Promote Program Efficiency, Transparency, and Burden
                Reduction; Part II, 79 FR 27106 (May 12, 2014) (finalizing several
                rules to remove unnecessary regulatory and reporting requirements
                previously imposed on hospitals and other health care providers).
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                 Nonetheless, the Department has only conducted retrospective review
                of regulations to a very limited extent. One academic analysis
                determined that, in response to Executive Order 13563, the Department
                planned 83 retrospective analyses in 2012 and completed 33 analyses
                with final action by August 31, 2013.\27\ By contrast, the Department
                issued 247 rules between the date Executive Order 13563 was issued and
                August 31, 2013.\28\ As of July 2016, the Department had 40 planned
                retrospective analyses and by April 2017 had completed analyses with
                final action on 19 of them.\29\ These findings are consistent with
                government assessments that the Department's efforts to comply with 5
                U.S.C. 610 have at times been lacking.\30\
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                 \27\ Connor Raso, Assessing regulatory retrospective review
                under the Obama administration, Brookings Inst., (Jun. 15, 2017),
                https://www.brookings.edu/research/assessing-regulatory-retrospective-review-under-the-obama-administration/.
                 \28\ Id.
                 \29\ Id.
                 \30\ See, e.g., Curtis W. Copeland, Cong. Rsch. Serv., RL32801,
                Reexamining Rules: Section 610 of the Regulatory Flexibility Act 7-8
                (2008); U.S. Gov't Accountability Off., GAO/GGD-94-105, Regulatory
                Flexibility Act: Status of Agencies' Compliance 12 (1994) (quoting a
                1983 Small Business Administration report that stated that the
                Department's section 610 review plan was `` `very general,' and, as
                a result, `it is difficult to measure progress and to make
                recommendations with respect to future review' ''); see also
                Testimony of The Hon. Thomas M. Sullivan, Chief Counsel for
                Advocacy, U.S. SBA, U.S. House of Representatives Comm. on Small
                Bus. Subcomm. on Reg.'s, Health Care and Trade (July 30, 2008),
                https://www.sba.gov/sites/default/files/files/test08_0730.pdf
                (``Historically, federal agency compliance with section 610 has been
                limited.'').
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                 Commenters on the proposed rule listed the following as examples of
                regulations that they and/or Congress have requested the Department to
                review, but that the commenters claimed were not reviewed:
                 Regulations mandated for review by the 21st Century Cures
                Act, Public Law 114-255, sec. 2034, 130 Stat. 1033 (2016). Section 2034
                of that Act, according to the commenters, requires the Secretary to
                lead a review by research funding agencies of all regulations and
                policies related to the disclosure and reporting of financial conflicts
                of interest to reduce administrative burden on federally funded
                researchers. It also calls for the Secretary to harmonize the
                differences between the Basic HHS Policy for the Protection of Human
                Research Subjects (45 CFR part 46, subpart A) and the FDA regulations
                for the protection of human subjects (21 CFR parts 50 and 56).
                Commenters stated that these regulations are well overdue for
                assessment and review.
                 Regulations covering access to skilled therapy services,
                which commenters say must be updated to reflect the national settlement
                in the Jimmo v. Sebelius litigation to codify the fact that skilled
                services are covered for Medicare beneficiaries not just to improve
                function, but to maintain or prevent deterioration in function.
                 The dockets established by FDA's Center for Food Safety
                and Applied Nutrition and Center for Veterinary Medicine on Sept. 8,
                2017,\31\ in which the Centers requested comments and
                [[Page 5697]]
                information to assist in identifying existing regulations and related
                paperwork requirements that could be modified, repealed or replaced,
                consistent with the law, to achieve meaningful burden reduction while
                allowing FDA to achieve its public health mission and fulfill statutory
                obligations. The commenters stated these were examples of incomplete
                regulatory review initiatives.\32\ Commenters stated that despite
                submitting extensive comments that detailed numerous regulations that
                they believe could be modified, repealed or replaced, the agency did
                not take any further action.
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                 \31\ E.g., Nonrulemaking Docket FDA-2017-N-5093: Review of
                Existing General Regulatory and Information Collection Requirements
                of the Food and Drug Administration, https://beta.regulations.gov/docket/FDA-2017-N-5093.
                 \32\ See Review of Existing General Regulatory and Information
                Collection Requirements of the Food and Drug Administration, 82 FR
                42506 (Sept. 8, 2017); FDA-2017-N-5093, https://beta.regulations.gov/docket/FDA-2017-N-5093.
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                 A review conducted for the Department in 2019 (discussed in more
                detail in Section C) concluded that related good governance stewardship
                actions were deprioritized and relegated to ``rainy day'' activities
                that Department operating divisions would get around to when they
                could.\33\ However, the rainy day in many cases has never arrived.
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                 \33\ See infra n.68 and accompanying text.
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                 Scholars have also posited reasons why agencies may be reluctant to
                perform retrospective reviews. One administrative law expert now at
                Northwestern University has written:
                 [E]ven with sufficient resources, agencies may not be properly
                incentivized. They are less likely to be found at fault for not
                conducting rigorous periodic reviews. Many rules, even those with
                significant effects, are often not on the public's radar once
                adopted. Challenging agency regulation under the RFA is more
                difficult than under the Administrative Procedure Act (APA) because
                there is no comment process and standing is granted to more limited
                parties. The harm to the public resulting from a cursory analysis is
                also much less clear. If sufficient interests exist to modify the
                rule, strong interest groups will directly lobby the agency to
                modify the rule. But in this case, a brand new rulemaking effort
                emerges.
                 There are also political reasons and moral hazard concerns
                associated with performing retrospective analyses. In most cases,
                retrospective analyses of existing regulations are routine business
                matters left to be handled by staff members, rather than political
                appointees. Political appointees, such as agency heads, tend to come
                with specific regulatory agendas of their own. By contrast, staff
                members at regulatory agencies are best viewed as career members who
                have a vested interest in seeing their agencies continue to exist
                and thrive. All else equal, they are not inclined to acknowledge
                that the work of their agency is inefficient or unnecessary, and
                even less inclined to conduct analyses that may lead to a curtailing
                of the agency's authority. Whatever the reasons may be, serious ex
                post reviews are few and far between. A majority of rules, once
                adopted, will likely persist without significant ex post
                modification. As to how many agency rules currently implemented may
                be costing more resources than yielding benefits is anyone's
                guess.\34\
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                 \34\ Yoon-Ho Alex Lee, An Options Approach to Agency Rulemaking,
                65 Admin. L. Rev. 881, 895-96 (2013).
                Thus, the Department concludes that it needs to impose a strong
                incentive on itself to perform retrospective review, given these
                countervailing incentives to not perform such reviews and the limited
                number of retrospective reviews that the Department has performed over
                the last 40 years. As discussed in more detail in the regulatory impact
                analysis infra, the Department has the resources to periodically review
                the impacts of its regulations.
                C. Limitations in Government Projections Counsel in Favor of Widespread
                Retrospective Regulatory Review
                 The Congressional and Presidential directives to periodically
                review existing regulations are sound policy. When the Department first
                issues a regulation, it makes an educated guess about the regulation's
                impact. Several years after the regulation is promulgated, the
                Department has a somewhat greater basis for assessing its real-world
                impacts and can refine the regulation or agency enforcement practices,
                as appropriate. This would further democratic values such as
                accountability, administrative simplification, transparency, and
                performance measurement and evaluation.
                 Indeed, the literature indicates that government projections of
                regulatory impacts would benefit from refinement based on experience
                after the regulations are implemented. The literature suggests the need
                for refinement is widespread, so widespread review would yield greater
                benefits than review of a handful of regulations. In 2005, the Office
                of Management and Budget (OMB) provided an overview of a sample of
                retrospective analyses based on an examination of forty-seven case
                studies.\35\ OMB considered a pre-regulation estimate to be accurate if
                the post-regulation estimate was within +/- 25 percent of the pre-
                regulation estimate.\36\ This measure of accuracy reveals the
                difficulty and uncertainty inherent in prospective cost-benefit
                analysis. OMB found that agencies often inaccurately estimated the
                benefits of regulations in its sample of regulations, and agencies were
                more likely to overestimate benefits than to underestimate them, where
                benefits were estimated.\37\ Agencies overestimated benefits in 19 of
                39 sampled regulations, whereas they underestimated benefits in only
                two of the 39 regulations.\38\ In two cases, agencies overestimated
                benefits by a factor of 10.\39\ Second, agencies sometimes
                overestimated the benefit-cost ratio, and in that sense were a bit too
                optimistic about the consequences of their rules. Agency estimates were
                accurate in only 11 rules, while the ratio was overestimated in 22
                rules and underestimated in 14 rules.\40\ Third, agencies also
                overestimated and, less frequently, underestimated costs in the sampled
                regulations. Agency cost estimates were accurate for only 12 rules,
                overestimated for 16 rules, underestimated for 12 rules, and not
                estimated for seven rules.\41\
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                 \35\ Office of Mgmt. & Budget, Validating Regulatory Analysis:
                2005 Report to Congress on the Costs and Benefits of Federal
                Regulations and Unfunded Mandates on State, Local, and Tribal
                Entities, at 46-47 (2005), http://perma.cc/R8LX-BQMJ (collecting
                studies comparing ex ante and ex post analyses of regulations' costs
                and benefits, including examples where cost and benefit estimates
                were off by more than a factor of ten).
                 \36\ Id. at 42.
                 \37\ Id. at 43-46.
                 \38\ Id. at 47.
                 \39\ Id. at 43.
                 \40\ Id. at 47.
                 \41\ Id.
                ---------------------------------------------------------------------------
                 Academic studies have also identified inaccuracies in agency
                estimates, relative to an ex post re-estimation. For example, one study
                of sixty-one rules for which benefit-cost ratios could be compared
                before and after the fact (including some not included in the OMB
                review) found that the estimated ratios were essentially accurate in
                only sixteen of the sixty-one cases, though the study found no bias in
                estimates of benefit-cost ratios.\42\ In this analysis, Dr. Harrington
                criticized certain aspects of the OMB analysis. But it is notable that,
                even though OMB and Dr. Harrington used somewhat differing methods and
                reviewed samples of regulations that did not completely overlap, they
                both found ex ante estimates to be in many cases lacking. Dr.
                Harrington concluded his analysis by noting that ``the results
                [[Page 5698]]
                demonstrate the value of ex post analysis. It is frustrating that there
                is so little of it, especially when so many close observers, from all
                points of view, claim to be in favor of it.'' \43\
                ---------------------------------------------------------------------------
                 \42\ Winston Harrington, Grading Estimates of the Benefits and
                Costs of Federal Regulation, Res. for the Future, Discussion Paper
                06-39, 2006, at 33, http://papers.ssrn.com/sol3/papers.cfm?abstract_id=937357. Dr. Harrington used the same measure
                of accuracy as OMB. While both OMB and Dr. Harrington noted that
                using +/- 25% as the measure of accuracy could be arbitrary, it is
                nonetheless informative that in many cases the ex ante estimates in
                the sampled regulations differed from ex post estimates by more than
                +/-25%.
                 \43\ Id. at 34.
                ---------------------------------------------------------------------------
                 A more recent study of a sample of federal regulations found that
                of the eight regulations for which the author was able to make ex ante
                and ex post cost comparisons, six regulations involved overestimates of
                costs, two involved underestimates of costs, and none were deemed
                accurate.\44\ A regulation was deemed accurate if the regulation's
                regulatory impact analysis fell roughly within +2/-5% of the ex post
                observation.\45\ Of the 18 regulatory requirements for which the author
                was able to compare benefits (also referred to as ``effectiveness'' in
                the study) estimates on an ex ante and ex post basis, he found that 10
                involved overestimates, six were underestimates, and two were
                relatively accurate.\46\
                ---------------------------------------------------------------------------
                 \44\ Richard Morgenstern, Retrospective Analysis of U.S. Federal
                Environmental Regulation, 9 J. of Benefit Cost Anal., no. 2, 2018,
                at 294, https://www.cambridge.org/core/services/aop-cambridge-core/content/view/891E36D3DBCEB79C969278488E5E1897/S2194588817000173a.pdf/retrospective_analysis_of_us_federal_environmental_regulation.pdf.
                 \45\ Id.
                 \46\ Id.; see also Cynthia Morgan & Nathalie B. Simon, National
                primary drinking water regulation for arsenic: A retrospective
                assessment of costs, 5 J. Benefit Cost Anal. no. 2, 2014, at 259-84,
                https://www.cambridge.org/core/services/aop-cambridge-core/content/view/A7B29CE98E650B424E92FF292A8FFC89/S2194588800000774a.pdf/national_primary_drinking_water_regulation_for_arsenic_a_retrospective_assessment_of_costs.pdf (finding that the EPA methodology
                overestimated predicted capital costs from its arsenic rule in most
                studied cases, especially as the size of the system increases (as
                measured by the design flow rate)).
                ---------------------------------------------------------------------------
                 These studies all found that in most cases the sampled ex ante
                estimates were not within +/-25% of the ex post observations. The
                studies suggest many federal regulations are estimated after the fact
                to have real-world impacts that differ from the estimated impacts at
                the time the regulations were promulgated. Although these samples were
                not necessarily representative, it would not be unreasonable to think
                that the Department could make major improvements by conducting
                widespread review of its regulations, rather than merely reviewing the
                small number of regulations that interested parties ask the Department
                to consider revising.\47\
                ---------------------------------------------------------------------------
                 \47\ This is not to suggest that prospective regulatory impact
                analyses are not helpful. To the contrary, they add tremendous value
                and greatly improve agency rule makings. But as explained elsewhere
                herein, even when an agency's cost-benefit analysis uses sound
                science and the best available information to estimate the costs,
                benefits or other impacts associated with a rule, technological
                innovation or subsequent changes in the law, among other things, can
                result in an ex post assessment of impacts differing from the
                agency's estimates at the time it promulgated the rule.
                ---------------------------------------------------------------------------
                Reasons Regulatory Projections Differ From Regulations' Real-World
                Impacts
                 There are several reasons why regulations' ex ante cost-benefit
                estimates tend to be inaccurate. First, changes in the legal landscape
                can cause government projections to become obsolete. For example, in
                February 2010, officials in the Centers for Medicare and Medicaid
                Services' Office of the Actuary (OACT) issued health spending and
                coverage projections through 2019.\48\ A month later, Congress enacted
                the Patient Protection and Affordable Care Act, Public Law 111-148, 124
                Stat. 119 (``ACA''), and the Health Care and Education Reconciliation
                Act of 2010, Public Law 111-152, 124 Stat. 1029. Largely as a result of
                the ACA's passage, in October 2010 OACT issued revised projections
                forecasting that by 2019 the insured share of the population would be
                92.7 percent--roughly ten percentage points higher than OACT projected
                nine months earlier.\49\
                ---------------------------------------------------------------------------
                 \48\ See Truffer CJ, et al. Health Spending Projections Through
                2019: The Recession's Impact Continues, 29 Health Aff. no. 3, 2010,
                at 522-29, https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2009.1074.
                 \49\ See Sisko, et al., National Health Spending Projections:
                The Estimated Impact Of Reforms Through 2019, 29 Health Aff. no. 10,
                at 1936, https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2010.0788.
                ---------------------------------------------------------------------------
                 Second, changes in technology can also render projections
                inaccurate. One study has noted that even when an agency's benefit-cost
                analysis uses sound science and the best available information to
                estimate the costs associated with a rule, technological innovation can
                result in an ex post assessment of costs differing from the agency's
                cost estimates at the time it promulgated the rule.\50\ As an example
                of technology's impact on regulations, in 2019 the Food and Drug
                Administration (FDA) issued a rule amending requirements for medical
                device premarket submissions to remove requirements for paper and
                multiple copies, and replace these requirements with requirements for a
                single submission in electronic format.\51\ Changes in technology had
                rendered the requirement for multiple copies, whether in electronic
                format or paper form, no longer necessary.\52\ Had the Department
                reviewed more of its regulations, it might have learned of additional
                instances where technological changes counsel in favor of amendment. In
                addition, some scholars have suggested that in some cases changes in
                technology can reduce the costs of complying with regulatory
                mandates.\53\ If retrospective reviews conclude that technology has
                reduced compliance costs, that can inform the Department's decision
                about if or how to amend a regulation.
                ---------------------------------------------------------------------------
                 \50\ Cynthia Morgan & Nathalie B. Simon, National primary
                drinking water regulation for arsenic: A retrospective assessment of
                costs, 5 J. Benefit Cost Anal. no. 2, 2014, at 259-84, https://www.cambridge.org/core/services/aop-cambridge-core/content/view/A7B29CE98E650B424E92FF292A8FFC89/S2194588800000774a.pdf/national_primary_drinking_water_regulation_for_arsenic_a_retrospective_assessment_of_costs.pdf. One example referred to in this study is
                that technological innovation or regulatory or technical constraints
                could result in water systems using different treatment technologies
                for arsenic removal than assumed by the agency when it promulgated a
                regulation.
                 \51\ Medical Device Submissions: Amending Premarket Regulations
                That Require Multiple Copies and Specify Paper Copies To Be Required
                in Electronic Format, 84 FR 68334 (Dec. 16, 2019).
                 \52\ Id. at 68334.
                 \53\ See, e.g., Cass R. Sunstein, The Regulatory Lookback, 94
                B.U. L. Rev. 579, 599 (2014).
                ---------------------------------------------------------------------------
                 Yet another reason for potential divergence between prospective and
                retrospective regulatory impact estimates is non-compliance with the
                regulation being assessed. One study found differing accuracy for
                prospective per-unit cost estimates and prospective aggregate cost
                estimates; where there is substantial non-compliance with the
                regulation being analyzed, cost estimates per unit can sometimes be
                reasonably accurate while aggregates are simultaneously
                overestimated.\54\ (Non-compliance would, of course, also affect the
                accuracy of benefits estimates.\55\) As such, ex post analysis has the
                potential to inform not just decisions about codified regulatory
                requirements but also about agency enforcement practices.
                ---------------------------------------------------------------------------
                 \54\ Winston Harrington, Richard D. Morgenstern and Peter
                Nelson, On the Accuracy of Regulatory Cost Estimates, J. Policy
                Anal. & Management 2000, 19(2): 297-322.
                 \55\ See, e.g., Si Kyung Seong and John Mendeloff, Assessing the
                Accuracy of OSHA's Projections of the Benefits of New Safety
                Standards, Am. J. Industrial Medicine 2004, 45(4): 313-328.
                ---------------------------------------------------------------------------
                Institutionalizing Retrospective Review To Refine Projections That Were
                Lacking
                 While the prospective cost-benefit analyses performed in connection
                with the promulgation of rules are quite useful, former OIRA
                Administrator Cass Sunstein has explained that ``[w]hen agencies issue
                rules, they have to speculate about benefits and costs.'' \56\
                Therefore,[a]fter rules are in place, [agencies] should test those
                speculations, and they should use what they learn when revisiting a
                regulation
                [[Page 5699]]
                or issuing a new one.'' \57\ Professor Sunstein described this as ``one
                of the most important steps imaginable'' for regulatory reform, ``not
                least because it can reduce cumulative burdens and promote the goal of
                simplification.'' \58\ He has noted that agencies' failure ``until very
                recently . . . to gather, let alone act on'' retrospective reviews is
                ``an astonishing fact.'' \59\
                ---------------------------------------------------------------------------
                 \56\ Cass R. Sunstein, The Regulatory Lookback, 94 B.U. L. Rev.
                579, 591 (2014).
                 \57\ Id.
                 \58\ Id.
                 \59\ Id. at 588.
                ---------------------------------------------------------------------------
                 Michael Greenstone, who served as Chief Economist on the Council of
                Economic Advisors between 2009 and 2010, similarly concluded that the
                ``single greatest problem with the current system is that most
                regulations are subject to a cost-benefit analysis only in advance of
                their implementation. This is the point when the least is known and any
                analysis must rest on many unverifiable and potentially controversial
                assumptions.'' \60\ According to Professor Greenstone, the lack of a
                regulatory lookback created a system ``largely based on faith, rather
                than evidence,'' where the agency ``all too frequently takes shots in
                the dark and we all too infrequently fail to find out if we have hit
                anything--or even worse, we only find out when things have gone
                horribly wrong.'' \61\ As he explained, ``it is nearly impossible to
                imagine'' only prospective, and not retrospective, evaluations ``being
                used in other contexts where people's lives are on the line. For
                example, I am confident that there would be a deafening uproar of
                protest if the FDA announced that it would approve drugs without
                testing them in advance. Yet, this is largely what we do with
                regulations that affect our health and well-being.'' \62\
                ---------------------------------------------------------------------------
                 \60\ Michael Greenstone, Toward a Culture of Persistent
                Regulatory Experimentation and Evaluation, in New Perspectives on
                Regulation 111, 113 (David Moss & John Cisternino eds., 2009). It
                should not be inferred, however, that retrospective analysis is free
                of assumptions (including potentially controversial assumptions) or
                is generally without challenges, especially with respect to
                establishing relevant counterfactuals. For discussion and recent
                examples related to just two of the many areas of Department
                regulatory activity, see Trinided Beleche et al., Are Graphic
                Warning Labels Stopping Millions of Smokers? A Comment on Huang,
                Chaloupka, and Fong, 15 Econ Journal Watch 129 (2018) and Aaron
                Kearsley et al., A Retrospective and Commentary on FDA's Bar Code
                Rule, 9 J. Benefit-Cost Analysis 496 (2018). Moreover, to the extent
                that retrospective analysis is used to inform policy choices going
                forward, it becomes, or is at least being used as, prospective
                analysis and thus relies on assumptions about the future, including
                as regards technology and the legal and regulatory landscape. But
                since retrospective analysis is conducted after some real-world
                experience living under the regulation, it can in many cases be an
                improvement over earlier prospective analysis.
                 \61\ Michael Greenstone, Toward a Culture of Persistent
                Regulatory Experimentation and Evaluation, in New Perspectives on
                Regulation 111, 111-12 (David Moss & John Cisternino eds., 2009);
                see also Office of Mgmt. & Budget, 2017 Report to Congress on the
                Benefits and Costs of Federal Regulations and Agency Compliance with
                the Unfunded Mandates Reform Act at 5 (2017), https://www.whitehouse.gov/wp-content/uploads/2019/12/2019-CATS-5885-REV_DOC-2017Cost_BenefitReport11_18_2019.docx.pdf (``The aim of
                retrospective analysis is to understand and improve the accuracy of
                prospective analysis and to provide a basis for potentially
                modifying rules as a result of ex post evaluations.'').
                 \62\ Michael Greenstone, Toward a Culture of Persistent
                Regulatory Experimentation and Evaluation, in New Perspectives on
                Regulation 111, 114 (David Moss & John Cisternino eds., 2009).
                ---------------------------------------------------------------------------
                 If retrospective analysis ``could be firmly institutionalized,''
                Professor Sunstein observed, then it ``would count as the most
                important structural change in regulatory policy since the original
                requirement of prospective analysis during the Reagan Administration.''
                \63\
                ---------------------------------------------------------------------------
                 \63\ Cass R. Sunstein, The Regulatory Lookback, 94 B.U. L. Rev.
                579, 589 (2014).
                ---------------------------------------------------------------------------
                 Other administrative law experts have also urged agencies to more
                robustly institutionalize retrospective review of regulations. The
                Administrative Conference of the United States (ACUS) has ``urge[d]
                agencies to remain mindful of their existing body of regulations and
                the ever-present possibility that those regulations may need to be
                modified, strengthened, or eliminated in order to achieve statutory
                goals while minimizing regulatory burdens.'' \64\ More recently, the
                American Bar Association Section of Administrative Law and Regulatory
                Practice, has ``urge[d] [the Administration] to build on the efforts of
                previous administration[s] and take steps to institutionalize careful,
                in-depth retrospective review of existing rules.'' \65\
                ---------------------------------------------------------------------------
                 \64\ Administrative Conference of the United States,
                Recommendation 2014-5, Appendix--Recommendations of the
                Administrative Conference of the United States, 79 FR 75114, 75114
                (Dec. 17, 2014); see also ABA Sec. of Admin. Law & Reg. Prac.,
                Improving the Administrative Process: A Report to the President-
                Elect of the United States (2016), 69 Admin. L. Rev. 205 (2017).
                 \65\ ABA Sec. of Admin. Law & Reg. Prac., Improving the
                Administrative Process: A Report to the President-Elect of the
                United States (2016), 69 Admin. L. Rev. 205, 219 (2017) (emphasis in
                original).
                ---------------------------------------------------------------------------
                The Need for a Greater Incentive To Institutionalize Retrospective
                Review
                 Despite these many calls for retrospective review, as noted in
                section II.B., the Department has had limited success in implementing
                retrospective review in practice.\66\ In 2019, the Department piloted
                an approach to augment expert policy insights with artificial
                intelligence-driven data analysis of its regulations, which showed the
                need to more firmly institutionalize retrospective review. The
                artificial intelligence review found that 85% of Department regulations
                created before 1990 have not been edited; the Department has nearly 300
                broken citation references in the CFR (i.e. CFR sections that reference
                other CFR sections that no longer exist); more than 50 instances of
                regulatory requirements to submit paper documents in triplicate or
                quadruplicate; and 114 parts in the CFR with no regulatory entity
                listed, 17 of which may be misplaced.\67\ The Department concluded that
                some good governance stewardship recommendations ``were deprioritized
                and relegated to rainy day activities that [Department operating
                divisions] would get around to when they could.'' \68\ Unfortunately,
                in many cases the Department has for years not gotten around to
                addressing these issues.
                ---------------------------------------------------------------------------
                 \66\ See also Yoon-Ho Alex Lee, An Options Approach to Agency
                Rulemaking, 65 Admin. L. Rev. 881, 894 (2013), (``one might think
                that agencies would faithfully take advantage of [] opportunities to
                conduct rigorous retrospective [cost-benefit analyses] of their
                existing regulations and test their effectiveness and efficiency.
                This would be the surest way of incorporating ex post learning in
                rule implementation. This is far from the truth in practice,
                however.'').
                 \67\ Regulatory Streamlining & Analysis (Mar. 2019).
                 \68\ Id. at 18
                ---------------------------------------------------------------------------
                 As one observer recently explained:
                 Retrospective review of existing regulations . . . is a
                perennial favorite target for advice on how to improve OIRA's
                processes. Every administration since President Carter has developed
                some program to modify, streamline, or expand existing regulations,
                and there is no shortage of advice on how to make the process run
                more efficiently. Yet, despite a few notable one-off successes from
                past retrospective review efforts, no past retrospective review
                campaign has ever truly succeeded in creating a long-term culture of
                retrospective review or of prospectively embedding into new
                regulations a process for data collection and pre-set targets for
                future lookbacks. Any future efforts around retrospective review,
                therefore, should be clear-eyed about past failures.\69\
                ---------------------------------------------------------------------------
                 \69\ Jason Schwartz, Enhancing the Social Benefits of Regulatory
                Review, Institute for Policy Integrity, at 30 (Oct. 2020), https://policyintegrity.org/files/publications/Enhancing_the_Social_Benefits_of_Regulatory_Review.pdf. Several
                weeks after publishing this article, the author submitted a comment
                opposing the proposed rule. For the reasons discussed in the
                responses to public comments, the Department did not find those
                arguments compelling, but believes the quoted passage is a fair
                description of the problem this final rule aims to solve. The
                Department is trying to be clear-eyed about past failures, and has
                concluded that a strong incentive, such as that included in this
                final rule, is commensurate with the problem to be solved and to
                more firmly institutionalize retrospective review.
                 For the reasons discussed in this final rule, the Department
                believes a stronger
                [[Page 5700]]
                incentive is needed to achieve the benefits of retrospective
                review.\70\ This final rule creates a mechanism to more firmly
                institutionalize the retrospective reviews that Professors Sunstein and
                Greenstone, as well as ACUS and others, have called for.
                ---------------------------------------------------------------------------
                 \70\ Regulatory Streamlining & Analysis (Mar. 2019) (it
                ``appears the current set of governance structures, incentives and
                processes to promulgate regulatory reform need strengthening to be
                more effective'').
                ---------------------------------------------------------------------------
                D. The Experiences of States and Other Jurisdictions With Automatic
                Expiration or ``Sunset'' Provisions
                 This mechanism is based in part on the experiences of States and
                other jurisdictions. Several States incorporate retrospective
                regulatory review into their laws. New York, for example, requires
                retrospective review of regulations ``no later than in the fifth
                calendar year after the year in which the rule is adopted,'' and
                requires that rules be ``re-reviewed at five-year intervals''
                thereafter. N.Y. A.P.A. Law sec. 207. Similarly, Texas requires State
                agencies to review rules four years after they go into effect and then
                subsequently at four-year intervals. Tex. Gov't Code sec. 2001.039. In
                addition to New York and Texas, State law requires some form of
                retrospective regulatory review in at least Alabama, Arizona, Illinois,
                Iowa, Michigan, Missouri, New Jersey, New Mexico, North Carolina, North
                Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, and
                Washington.\71\
                ---------------------------------------------------------------------------
                 \71\ Ala. Code 41-22-5.2; Ariz. Rev. Stat. 41-1056; 5 Ill. Comp.
                Stat. Ann. 100/5-130; Iowa Code Ann. 17A.33; Mich. Comp. Laws
                10.151; Missouri Rev. Stat., Title XXXVI Sec. 536.175.5; N.J. Stat.
                Ann. 52:14B-5.1; N.M. Stat. 14-4A-6; N.C. Gen. Stat. 150B-21.3A;
                N.D. Cent. Code 28-32-18.1; Ohio Rev. Code Ann. 106.03; Okla. Stat.
                Ann. tit. 75, 307.1; 71 Pa. Stat. Ann. 745.2; R.I. Gen. Laws Ann.
                tit. 42, ch. 64.13; Tenn. Code Ann. 4-56-102; Wash Rev. Code Ann.
                43.70.041, 43.22.052.
                ---------------------------------------------------------------------------
                 Some States with retrospective review requirements allow
                regulations to automatically expire or sunset after a period of time,
                unless reviewed or readopted. In New Jersey, regulations automatically
                expire ``seven years following the effective date of the rule'' unless
                extended by the agency. N.J. Stat. Ann. sec. 52:14B-5.1(b).\72\ Indiana
                allows regulations to expire on January 1 following the seven-year
                anniversary of their effective dates. Ind. Code sec. 4-22-2.5-2. The
                Governor of Florida recently instructed Florida government agencies to
                ``include a sunset provision in all proposed or amended rules,'' which
                ``may not exceed five years unless otherwise required by existing
                statute.'' \73\
                ---------------------------------------------------------------------------
                 \72\ Although the New Jersey law permits the Governor, within
                five days of the expiration of a rule, to restore it, the Department
                does not include a similar provision in this proposed rule. That is
                because the RFA contains no such similar provision and the
                Department is giving itself ten years, as opposed to seven years, to
                perform Assessments and (when required) Reviews of Regulations.
                 \73\ Letter from Gov. Ron DeSantis to Florida Agency Heads (Nov.
                11, 2019), https://www.floridahasarighttoknow.myflorida.com/content/download/147113/980326/FINAL_Directive_to_Agencies_11.19.pdf.
                ---------------------------------------------------------------------------
                 Experience in the States suggests that sunset provisions can be an
                important tool to ensure reviews take place. An analysis of regulation
                in all 50 States found that for a reduction in both regulatory creation
                and enforcement, ``[t]he single most important policy in a state is the
                presence of a sunset provision.'' \74\ On the other hand, one report
                stated that, despite their initial popularity in the States,\75\ sunset
                provisions fell out of favor, not because they did not produce more
                cost-effective, cost-justified regulation, but because sunset
                requirements did not provide sufficient legislative control over
                executive agencies.\76\ But that observation is inapplicable to the
                Department, because this final rule concerns the Department's review of
                its own regulations. Noting the benefits of sunset provisions, the
                report added that sunset ``provisions have been responsible for the
                analysis of thousands of state regulations and, on average, the repeal
                of twenty to thirty percent of existing regulations and the
                modification of another forty percent.'' \77\
                ---------------------------------------------------------------------------
                 \74\ Russell S. Sobel & John A. Dove, State Regulatory Review: A
                50 State Analysis of Effectiveness 36 (Mercatus Ctr., Working Paper
                No. 12-18, 2012), https://www.mercatus.org/system/files/State-Regulatory-Review-50-State-Analysis-Effectiveness.pdf.
                 \75\ Jason A. Schwartz, 52 Experiments with Regulatory Review:
                The Political and Economic Inputs into State Rulemakings, Inst. for
                Policy Integrity, Rep. No. 6, at 33 (Nov. 2010), https://policyintegrity.org/files/publications/52_Experiments_with_Regulatory_Review.pdf.
                 \76\ See id. (noting that ``North Carolina was first to repeal
                its sunset law, and many other states quickly followed suit'' after
                concluding that ``sunset provisions quickly proved to be an
                expensive, cumbersome, and disappointing method for enhancing
                legislative control'').
                 \77\ Id. at 23-24. The report added, without citing a great deal
                of empirical evidence, that ``sunset requirements produce
                perfunctory reviews and waste resources.'' This appears to be based
                on a law review article that noted, not that retrospective reviews
                were per se perfunctory, but that ``unless adequate resources are
                provided, the reviews may be relatively perfunctory and meaningless,
                wasting whatever resources are expended.'' See Neil R. Eisner &
                Judith S. Kaleta, Federal Agency Reviews of Existing Regulations, 48
                Admin. L. Rev. 139, 160 (1996) (emphasis added). But this law review
                article noted that adding ``sunset'' dates to regulations unless
                they are reviewed was ``likely to ensure that a review is done.''
                Id. As explained herein, the Department intends to commit adequate
                resources to its reviews if this proposed rule were to be finalized.
                The law review article said that sunset provisions should be used
                only in narrowly focused situations where it is determined that it
                is necessary to apply some ``pressure'' and only where assessments
                are made of the available resources and the benefits to be derived
                from the review. Id. But the article was written in 1996. As
                discussed herein, subsequent experience with efforts short of a
                forcing mechanism suggest that forcing mechanisms are needed to
                ensure review of a wide array of Department regulations, and that
                the benefits from these retrospective reviews would be substantial.
                ---------------------------------------------------------------------------
                 Experience outside the United States also suggests the utility of
                sunset provisions. The Office for Economic Co-Operation and Development
                (OECD) analyzed regulatory practices in the European Union. In a 2010
                report, the OECD recommended, for ``[t]he management and
                rationalization of existing regulations,'' that Germany ``[k]eep up the
                `spring cleaning' of legislation at regular intervals'' and ``consider
                the inclusion of a review mechanism in individual draft regulations, or
                even [include] a sunset clause (beyond which the law automatically
                expires) where appropriate.'' \78\ With respect to the United Kingdom's
                regulatory program, the OECD noted ``sunset clauses are also helpful''
                in order ``to remove unnecessary burdens in legislation.'' \79\
                Throughout the 2010 report, the OECD repeatedly noted the value of
                retrospective regulatory review.\80\
                ---------------------------------------------------------------------------
                 \78\ OECD, Better Regulation in Europe: Executive Summaries,
                GOV/RPC (2010)13, at 113, http://www.oecd.org/gov/regulatory-policy/45079126.pdf.
                 \79\ Id. at 46.
                 \80\ See, e.g., id. at 107 (``The ex post evaluation of
                regulations which is provided for in the impact assessment process
                provides a framework in principle for checking what really happens,
                and whether regulations have actually achieved the objectives
                originally set.'').
                ---------------------------------------------------------------------------
                 In 2019, the OECD published an additional survey regarding
                regulatory review practices in the European Union. The OECD again noted
                the utility of sunset provisions, describing them as a ``useful
                `failsafe' mechanism to ensure the entire stock of subordinate
                regulation remains fit for purpose over time.'' \81\ The report noted
                as of its 2019 date that sunset provisions are in place for at least
                some regulations in nine different countries, including the United
                Kingdom, France, and Germany.\82\
                ---------------------------------------------------------------------------
                 \81\ OECD, Better Regulation Practices across the European
                Union, at ch. 4, Box 4.1 (2019), https://www.oecd-ilibrary.org/sites/9789264311732-en/1/2/4/index.html?itemId=/content/publication/9789264311732-en&_csp_=07701faff9659027b81a5b5ae2ff041c&itemIGO=oecd&itemContentType=book.
                 \82\ Id. at ch. 4, Table 4.1.
                ---------------------------------------------------------------------------
                 In 2009, the Republic of Korea (ROK) enacted a law under which
                about 20% of the existing regulations are to be reviewed on a regular
                basis (about every 3 to 5 years) and become invalid if they
                [[Page 5701]]
                are found to lack feasibility.\83\ Under the ROK's ``review and
                sunset,'' there is a duty to carry out a review of a regulation on a
                specified schedule. This sunset clause was established upon the idea
                that even a rational regulation needs to be examined periodically to
                determine its grounds for remaining in force, as its validity may be
                compromised under any change in circumstances or its
                characteristics.\84\ An OECD report stated that ``[g]iven such
                rationale, the sunset clause is considered as a critical component of
                efforts in regulatory quality improvement.'' \85\
                ---------------------------------------------------------------------------
                 \83\ OECD, Latest Developments on Korea's Regulatory Policy, at
                2, https://www.oecd.org/gov/regulatory-policy/45347364.pdf.
                 \84\ OECD Reviews of Regulatory Reform, Regulatory Policy in
                Korea, Toward Better Regulation, at 86 (2017), https://publicadministration.un.org/unpsa/Portals/0/UNPSA_Submitted_Docs/2019/4cd3e219-c819-40f3-8246-7a024d9a82a9/2020%20UNPSA_the%20Regulatory%20Reform%20Sinmungo_Evaluation%20Report_27112019_032807_e4d166a9-f6ef-4a6c-9aaf-99748fa94284.pdf?ver=2019-11-27-032807-637.
                 \85\ Id.
                ---------------------------------------------------------------------------
                 These authorities indicate an emerging awareness that sunset
                provisions are useful in ensuring retrospective regulatory review. This
                is consistent with the Department's experience over the last 40 years,
                which suggests that, absent a sunset provision or automatic expiration
                date, Congressional and Presidential directives to perform periodic
                retrospective reviews of regulations have limited success.
                 Indeed, previous Administrations have recognized the benefits of
                sunset provisions. In a June 2015 report, the Department of Treasury's
                Office of Economic Policy, the Obama Administration's Council of
                Economic Advisors, and the Department of Labor discussed sunset
                provisions as applied to occupational licensing.\86\ That report found
                evidence that sunset reviews that automatically terminate regulatory
                boards and agencies absent legislative action assist with ``removing
                unnecessary licensing.'' \87\ The report explained that sunset review
                can be ``useful because, even if licensing was justified when first
                introduced, technological and economic changes may have rendered it
                unnecessary or overly restrictive.'' \88\ The report found ``[p]eriodic
                examination of existing rules is thus helpful in maintaining the
                quality of occupational regulation.'' \89\
                ---------------------------------------------------------------------------
                 \86\ Occupational Licensing: A Framework for Policymakers, The
                White House, at 48-50 (July 2015), https://obamawhitehouse.archives.gov/sites/default/files/docs/licensing_report_final_nonembargo.pdf.
                 \87\ Id. at 48.
                 \88\ Id. at 49.
                 \89\ Id. The report also suggests that to strengthen sunset
                provisions in the States, sunset commissions responsible for
                conducting the cost-benefit analysis should be provided adequate
                resources; the cost-benefit review process should be insulated
                against political interference; a minimum number of votes should be
                required to overrule the sunrise agency's recommendation; and
                specialized committees within legislatures be appointed to work with
                the agency in charge of conducting the review. See id. at 42. As
                discussed herein, the Department believes it has adequate resources
                to conduct the required reviews. As discussed in footnote 92, it is
                not clear that a federal agency can legally completely insulate its
                reviews from supervision by the agency's leadership, but the
                Department believes that its retrospective reviews will generally be
                performed by career civil servants. Lastly, the Department cannot
                require Congress to appoint committees to work with the Department
                officials performing the retrospective reviews, but the Department
                would welcome the opportunity to discuss reviews with Congressional
                staff if Congress so chose. The report also suggested ``sunrise''
                reviews can be more effective than sunset reviews. But for already-
                existing regulations, the Department cannot perform sunrise reviews,
                so the Department is has decided to take advantage of the benefits
                of sunset reviews. Moreover, the Department already engages in
                ``sunrise review'' to some extent when it develops regulatory
                flexibility analyses, see 5 U.S.C. 603, 604, and regulatory impact
                analyses (notably, such reviews did not occur for regulations that
                preceded the RFA, many of which still remain in effect).
                ---------------------------------------------------------------------------
                 Professor Greenstone has similarly recommended the automatic repeal
                of regulations if their benefits and costs are not periodically
                assessed:
                [Another] step in reforming our regulatory system is to require that
                all regulations contain rules specifying the date by which the
                regulatory review board has to assess their costs and benefits. If
                the regulatory review board fails to meet one of these deadlines,
                then the regulation should be repealed by default. The purpose of
                this sunset provision is to ensure that all regulations are
                evaluated carefully and do not stay on the books just because they
                have been on the books in the past.\90\
                ---------------------------------------------------------------------------
                 \90\ Greenstone, Toward a Culture of Persistent Regulatory
                Experimentation and Evaluation, in New Perspectives on Regulation
                111, 121 (David Moss & John Cisternino eds., 2009).
                 Professor Greenstone suggested that this review could cause the
                regulation to be expanded if supported by evidence.\91\ According to
                Professor Greenstone, this would ``ensure that ineffective regulations
                are removed and that society fully benefits from the effective ones.''
                \92\
                ---------------------------------------------------------------------------
                 \91\ Id.
                 \92\ Id. at 123. Professor Greenstone made a separate suggestion
                that a regulatory review board be created with the authority to
                assess the effectiveness of regulations and repeal regulations
                deemed ineffective. The Department considered this in the proposed
                rule. First, the Department is concerned that such a board raises
                legal concerns, since many Department regulations can only be
                repealed by the Secretary, not by an independent board. Second,
                Professor Greenstone proposed the independent review board on the
                grounds that (1) it would remove the board's functions as much as
                possible from political control, and (2) those most deeply involved
                in implementing a regulation are likely to see the benefits more
                clearly than the costs. Id. at 119-121. While these concerns are
                understandable, the Department believes it is capable of performing
                the Review. As an initial matter, those who conduct the Review would
                not necessarily be those in the Department who implement the Section
                being Reviewed. Moreover, as described herein, Reviews must be
                performed in such a manner that they can withstand judicial review
                under the arbitrary and capricious standard. This would require the
                Reviews to meet a minimum standard of rigor and require them to
                consider relevant factors. Moreover, many regulations legally cannot
                be amended or repealed without authorization by a political
                appointee.
                ---------------------------------------------------------------------------
                 This final rule seeks to advance democratic values and apply the
                lessons learned from States, foreign jurisdictions, and the academic
                community. This final rule would apply the benefits of automatic-
                expiration-absent-periodic-review to a broader array of regulations
                than is currently being reviewed by the Department.
                E. The Need for Widespread Retrospective Review
                 The evidence suggests the Department should conduct retrospective
                review on a broad scale to improve impact estimates and enhance the
                Department's ability to fulfil the goals motivating its regulations. As
                explained in Section C, studies of federal regulations consistently
                find that, in most sampled regulations, the ex ante estimate of costs
                and benefits is not within +/-25% of the ex post observation. Although
                these samples were not necessarily representative, taken together they
                suggest that many federal regulations are estimated after the fact to
                have real-world impacts that differ from the estimated impacts at the
                time the regulations were promulgated. Therefore, HHS believes that
                review should be done on a broad scale, rather than reviewing a handful
                of regulations that happen to be brought to the Department's attention.
                 The artificial intelligence review described in this final rule
                also suggests that large numbers of Department regulations would
                benefit from retrospective review. The artificial intelligence review
                identified that 85% of Department regulations created before 1990 have
                not been edited; the Department has nearly 300 broken citation
                references \93\ in the CFR; and there are more than 50 instances of HHS
                regulatory requirements to submit paper documents in triplicate or
                quadruplicate.\94\ This suggests that humans performing a comprehensive
                review of Department regulations would find large numbers of
                requirements that
                [[Page 5702]]
                would benefit from review, and possibly amendment or rescission.
                ---------------------------------------------------------------------------
                 \93\ As discussed below, HHS has roughly 18,000 regulations
                total.
                 \94\ 85 FR 70102.
                ---------------------------------------------------------------------------
                 The HHS response to the COVID-19 pandemic also indicates that the
                Department should perform widespread retrospective reviews. During the
                COVID-19 pandemic, the Department's response has largely consisted of
                waiving regulatory requirements or exercising enforcement discretion to
                not enforce certain regulatory requirements to enhance the Nation's
                response to the pandemic. Examples include waivers to increase hospital
                capacity, ease restrictions on services rendered by medical residents,
                and allowing patients to seek more services via telehealth.\95\ On
                November 25, 2020, the Department published in the Federal Register a
                non-exhaustive list of 382 enforcement discretion announcements,
                waivers or changes to regulations, agency guidance materials, or
                compliance obligations made to respond to the COVID-19 pandemic and its
                impact on the healthcare industry. See Regulatory Relief to Support
                Economic Recovery; Request for Information (RFI), 85 FR 75720 (Nov. 25,
                2020) at Attachment A. The Department should learn from the pandemic
                and conduct widespread reviews to determine whether these or other
                regulatory requirements could hinder the Nation's response to a future
                emergency, or otherwise should be amended or rescinded. Determining
                whether the Department's existing 18,000 regulations are having
                appropriate impacts is a worthwhile enterprise, even if it somewhat
                reduces the time spent issuing new regulations. Some commenters at the
                November 23, 2020 public hearing on the proposed rule suggested that
                the proposed rule was akin to using a missile to kill a mouse. But the
                literature and the Department's experience indicate the problem is not
                a mere mouse.
                ---------------------------------------------------------------------------
                 \95\ See, e.g., Coronavirus waivers and flexibilities, CMS.gov,
                https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.
                ---------------------------------------------------------------------------
                 Thus, there is a need for widespread retrospective review, but it
                is nearly impossible to see how a satisfyingly comprehensive review
                could occur without a sunset mechanism. The Department recognizes that
                in many cases the Department had strong reasons for issuing its
                regulations. Examples of such motivations might include enhancing food
                safety,\96\ increasing access to health insurance,\97\ or increasing
                the incentive for Temporary Assistance for Needy Families recipients to
                work.\98\ These are all important policy goals that the Department
                wishes to achieve. This final rule is intended to further these goals,
                as well as the other goals motivating the Department's regulations. The
                literature and the Department's experience suggest that large numbers
                of regulations are having impacts that, over time, differ from what was
                estimated at the time the regulations were promulgated. Therefore, the
                Department needs to conduct periodic reviews of its regulations to
                determine whether the policy goals behind the regulations are in fact
                being effected (and if amending those regulations could more
                effectively further those goals).
                ---------------------------------------------------------------------------
                 \96\ E.g., 21 CFR part 112.
                 \97\ E.g., 45 CFR part 147.
                 \98\ 45 CFR part 261.
                ---------------------------------------------------------------------------
                 This final rule is not a reversal of a prior Department policy, but
                in fact an effort to enhance both (1) the fulfillment of the existing
                policies that led to the Department's regulations and (2) the
                Department's longstanding desire to comply with the RFA and
                periodically review its regulations. In any event, this final rule
                provides the reasoned explanation that would be required if it were a
                change in policy.\99\
                ---------------------------------------------------------------------------
                 \99\ See FCC v. Fox TV Stations, Inc., 556 U.S. 502, 515-16
                (2009) (``[A] reasoned explanation is needed for disregarding facts
                and circumstances that underlay or were engendered by the prior
                policy,'' but the agency ``need not demonstrate to a court's
                satisfaction that the reasons for the new policy are better than the
                reasons for the old one; it suffices that the new policy is
                permissible under the statute, that there are good reasons for it,
                and that the agency believes it to be better, which the conscious
                change of course adequately indicates'') (emphasis in original).
                ---------------------------------------------------------------------------
                F. Operationalization of This Final Rule
                 In this section, the Department summarizes aspects of how it will
                operationalize this final rule.
                 The proposed rule proposed creating a website where the Department
                would announce when it has commenced Assessments or Reviews. The
                proposed rule further proposed that the public could comment on
                regulations and submit comments requesting that the Department Assess
                or Review a regulation.\100\
                ---------------------------------------------------------------------------
                 \100\ See, e.g., 85 FR 70120.
                ---------------------------------------------------------------------------
                 In light of public comments, the Department is making these
                procedures more robust. Under this final rule, when the Department
                commences the process of performing an Assessment or Review, it shall
                state on a Department-managed website the sections of the Code of
                Federal Regulations whose Assessment or Review it is commencing. The
                Department shall also announce once a month in the Federal Register
                those new Assessments or Reviews that it has commenced in the last
                month. Some comments on the proposed rule said that announcements
                should be made in the Federal Register, which the public already
                monitors, rather than a separate website. Therefore, in response to
                these comments, in this final rule the Department commits to announcing
                once a month in the Federal Register which new Assessments and Reviews
                it has commenced. The Department will also create a docket on
                Regulations.gov for each Assessment or Review that the Department is
                conducting. These docket numbers will be referenced in the Federal
                Register announcements. The public will be able to submit comments to
                the dockets of each rulemaking being Assessed or Reviewed. Each docket
                shall specify the date by which comments must be received. There shall
                also be a general docket on Regulations.gov where the public can submit
                comments requesting that the Department Assess or Review a regulation.
                This addresses the commenters' concern about commenting on a Department
                website, rather than via the regular Federal Register method. The
                Department anticipates that the process will be similar to that
                currently used by the EPA.\101\ The Department also intends to publish
                the results of the Assessments and Reviews in the dockets for the
                applicable regulations.
                ---------------------------------------------------------------------------
                 \101\ See, e.g., Regulatory Flexibility Act Section 610 Review
                of the Testing and Labeling Regulations Pertaining to Product
                Certification of Children's Products, Including Reliance on
                Component Part Testing, 85 FR 52078 (Aug. 24, 2020).
                ---------------------------------------------------------------------------
                 To further aid the public and the Department, the Department is
                placing at https://www.hhs.gov/regulations/federal-registry/index.html
                a list of Department rule makings; the year they were initially
                promulgated; the last year the rule making was amended; and the Federal
                Register citation from the time the rule making was amended. This list
                was generated with artificial intelligence and the Department believes
                it is accurate, but it is conceivable that some Department regulations
                are not included. This list includes all Department regulations,
                including those that may be exempt from this final rule. The Department
                believes it would be informative to the public to provide a list of all
                Department regulations, as well as their Federal Register citations and
                promulgation dates. The Department intends to update this list annually
                with newly-issued regulations.
                 In addition, the Department intends to create on its website a
                dashboard that shows its progress on its Assessments and Reviews,
                including when it commenced those Assessments and Reviews; its
                progress; and when it expects them to be completed. If they so
                [[Page 5703]]
                choose, the public can view this dashboard to see the Department's
                progress on its Assessments and Reviews of particular regulations. The
                dashboard will also help to keep the Department on track to timely
                complete Assessments and Reviews.\102\
                ---------------------------------------------------------------------------
                 \102\ The Department's information technology personnel are
                currently undertaking a large data migration that had been planned
                for a long time. Therefore, the dashboard will not be active as of
                the date this final rule is published. But the Department intends
                for this dashboard to be active well in advance of 2026, when the
                first Assessments and Reviews must be completed.
                ---------------------------------------------------------------------------
                 Finally, the Department will, within nine months of publication of
                this final rule, publish in the Federal Register its schedule for
                conducting Assessments and Reviews. The Department's goal is to provide
                the public with more information on which regulations it intends to
                Assess or Review in the next 24 months, so that the public can plan
                ahead for any desired engagement on those regulations. The Department
                will subsequently publish in the Federal Register its schedule for
                conducting Assessments and Reviews of regulations that the Department
                does not intend to review in the first 24 months. However, the
                Department expects that this schedule will be aspirational in nature to
                ensure Departmental flexibility to depart from the plan if needed to
                respond to changing circumstances. The Department will update the plan
                at appropriate intervals based on its progress.
                III. Statutory Authority and Legal Basis for This Final Rule
                 The statutory authorities supporting this final rule are the
                statutory authorities for the Department's existing regulations.\103\
                85 FR 70103. The Department finalizes herein its proposal to amend its
                regulations to add expiration dates unless the Department periodically
                conducts the required Assessment or Review of the regulations, or an
                exception applies. Some of the Department's primary rulemaking
                authorities include:
                ---------------------------------------------------------------------------
                 \103\ Including certain ones inadvertently not listed in the
                proposed rule.
                ---------------------------------------------------------------------------
                 Section 701(a) of the Federal Food Drug and Cosmetic Act
                (FD&C Act), 21 U.S.C. 371(a), which authorizes the Secretary to
                ``promulgate regulations for the efficient enforcement of [the FD&C
                Act], except as otherwise provided in this section'';
                 Section 1102 of the Social Security Act, 42 U.S.C. 1302,
                which provides that the Secretary ``shall make and publish such rules
                and regulations, not inconsistent with this Act, as may be necessary to
                the efficient administration of the functions with which [he] is
                charged under this Act'';
                 Section 1871 of the Social Security Act, 42 U.S.C. 1395hh,
                which provides that ``the Secretary shall prescribe such regulations as
                may be necessary to carry out the administration of the insurance
                programs under this title''; and
                 5 U.S.C. 301, which provides that ``[t]he head of an
                Executive department or military department may prescribe regulations
                for the government of his department, the conduct of its employees, the
                distribution and performance of its business, and the custody, use, and
                preservation of its records, papers, and property. This section does
                not authorize withholding information from the public or limiting the
                availability of records to the public.''
                 It complies with the Administrative Procedure Act (APA) to amend
                regulations to add dates by which the regulations expire unless a
                review of the regulation is timely performed. An agency can, through
                notice-and-comment rulemaking, amend its regulations to provide that
                they expire at a future date.\104\ An agency can also provide that its
                regulations expire when an event occurs or ceases to occur.\105\ That
                is what this final rule does.
                ---------------------------------------------------------------------------
                 \104\ See, e.g., Amendment to the Interim Final Regulation for
                Mental Health Parity, 70 FR 42276, 42277 (July 22, 2005) (amending
                interim final rule to provide that ``the requirements of the MHPA
                interim final regulation apply to group health plans and health
                insurance issuers offering health insurance coverage in connection
                with a group health plan during the period commencing August 22,
                2005 through December 31, 2005. Under the extended sunset date, MHPA
                requirements do not apply to benefits for services furnished after
                December 31, 2005.''); see generally Clean Air Council v. Pruitt,
                862 F.3d 1, 9 (D.C. Cir. 2017) (an agency can amend or revoke a
                legislative rule through notice-and-comment rulemaking).
                 \105\ See, e.g., Control of Communicable Diseases; Foreign
                Quarantine, 85 FR 7874, 7874 (Feb. 12, 2020) (providing that, unless
                extended, interim final rule ``will cease to be in effect on the
                earlier of (1) the date that is two incubation periods after the
                last known case of 2019-nCoV, or (2) when the Secretary determines
                there is no longer a need for this interim final rule''); Medicare
                and Medicaid Programs, Clinical Laboratory Improvement Amendments
                (CLIA), and Patient Protection and Affordable Care Act; Additional
                Policy and Regulatory Revisions in Response to the COVID-19 Public
                Health Emergency, 85 FR 54820, 54820 (Sept. 2, 2020) (providing that
                an interim final rule applies ``for the duration of the [public
                health emergency] for COVID-19''); U.S. Dep't of Transp., Final
                Regulatory Impact Analysis: Amendment to Federal Motor Vehicle
                Safety Standard 208 Passenger Car Front Seat Occupant Protection, at
                XII-35 (July 11, 1984), http://www-nrd.nhtsa.dot.gov/Pubs/806572.pdf
                (explaining that ``[i]f mandatory use laws are passed that will
                cover 67 percent of the population effective September 1, 1989, the
                rule will be rescinded'').
                ---------------------------------------------------------------------------
                 Moreover, Agencies can--and often do--issue one rule that applies
                to many other agency rules, rather than amending or rescinding each
                affected regulation individually. To take one example, in 2008 the
                Department revised the definition of ``entity'' at 42 CFR 411.351. See
                73 FR 48434, 48751 (Aug. 19, 2008). The revised definition had the
                effect of changing the meaning of ``entity'' each time it was used in
                42 CFR part 411, subpart J. It would be burdensome to specify the
                meaning of ``entity'' each time it appears in Subpart J, so the
                Department issued one definition that broadly applied to all sections
                of Subpart J.
                 There are many other examples where an Agency issues a regulation
                that applies to, amends, rescinds, or supersedes many other
                regulations.\106\ This avoids an unnecessarily cumbersome process. A
                court ruling that agencies must amend each individual regulation would
                call into question large numbers of agency regulations and impose
                substantial burdens on agencies (and the Office of the Federal
                Register, which would be required to print the same text over and over)
                when promulgating future regulations.
                ---------------------------------------------------------------------------
                 \106\ See, e.g., 21 CFR 1.1(b) (``the definitions and
                interpretations of terms contained in sections 201 and 900 of the
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 and 387) shall
                be applicable also to such terms when used in regulations
                promulgated under that act''); 7 CFR 786.113 (``Notwithstanding any
                other regulation, interest will be due from the date of the
                disbursement to the producer or other recipient of the funds''); 40
                CFR 455.21
                 (``Notwithstanding any other regulation, process wastewater
                flow for the purposes of this subpart does not include wastewaters
                from the production of intermediate chemicals''); 45 CFR 611.12
                (``All regulations . . . heretofore issued by any officer of the
                Foundation which impose requirements designed to prohibit any
                discrimination against individuals on the ground of race, color, or
                national origin under any program to which this part applies, and
                which authorize the suspension or termination of or refusal to grant
                or to continue Federal financial assistance to any applicant for or
                recipient of such assistance for failure to comply with such
                requirements, are hereby superseded to the extent that such
                discrimination is prohibited by this part,'' with certain
                exceptions); 7 CFR 3430.1 (``In cases where regulations of this part
                conflict with existing regulations of NIFA in Title 7 (i.e., 7 CFR
                parts 3400 through 3499) of the Code of Federal Regulations,
                regulations of this part shall supersede''); 24 CFR 943.118 (``The
                participating PHAs must adopt the same fiscal year so that the
                applicable periods for submission and review of the joint PHA Plan
                are the same. Notwithstanding any other regulation, PHAs proposing
                to form consortia may request and HUD may approve changes in PHA
                fiscal years to make this possible'') (emphasis added).
                ---------------------------------------------------------------------------
                 Moreover, in this rule making the Department considered each
                individual Department regulation, and, as discussed further, decided to
                exempt certain regulations. The Department concluded that this final
                rule should apply to and amend its remaining regulations, because this
                final rule will enhance both (1) the fulfillment of the existing
                policies that led to those
                [[Page 5704]]
                regulations and (2) the Department's longstanding desire to comply with
                the RFA and periodically review its regulations. There is a need for
                widespread retrospective review, but it is nearly impossible to see how
                a satisfyingly comprehensive review could occur without a sunset
                mechanism. The Department recognizes that in many cases the Department
                had strong reasons for issuing its regulations. Examples of such
                motivations might include enhancing food safety,\107\ increasing access
                to health insurance,\108\ or increasing the incentive for Temporary
                Assistance for Needy Families recipients to work.\109\ These are all
                important policy goals that the Department wishes to achieve. This
                final rule is intended to further these goals, as well as the other
                goals motivating the Department's regulations. The literature and the
                Department's experience suggest that large numbers of regulations are
                having impacts that, over time, differ from what was estimated at the
                time the regulations were promulgated. Therefore, the Department needs
                to conduct periodic reviews of its regulations to determine whether the
                policy goals behind the regulations are in fact being effected (and if
                amending those regulations could more effectively further those goals).
                The Department concluded that the benefits of retrospective review, and
                need to more strongly incentivize it, justified this course of action.
                Forty years of experience since the RFA's enactment; the decades since
                relevant Executive Orders were enacted; and other Federal government
                efforts to spur the Department to conduct more retrospective reviews
                indicate that, absent this final rule's pushing mechanism, the
                Department will not conduct as many retrospective reviews as desired.
                In addition, the Department will consider each individual Section when
                conducting Assessments and (if needed) Reviews.
                ---------------------------------------------------------------------------
                 \107\ E.g., 21 CFR part 112.
                 \108\ E.g., 45 CFR part 147.
                 \109\ 45 CFR part 261.
                ---------------------------------------------------------------------------
                 The Department also notes the text of 5 U.S.C. 610 indicates
                Congress believed agencies had the authority to periodically review at
                least those regulations that have a significant economic impact upon a
                substantial number of small entities (and that the agency had the
                authority to assess which of its regulations have such an impact).
                 The Department received comments on the statutory authority for the
                proposed rule. Below the Department summarizes these comments and
                responds to them.
                IV. Provisions of Proposed Rule and Response to Public Comments \110\
                ---------------------------------------------------------------------------
                 \110\ The Department proposed to add substantively identical
                provisions to Titles 21, 42, and 45. For concision, in this section
                the Department describes these provisions once, rather than
                repeating the same substantive provisions several times. The
                Department uses the phrase ``[XX]'' to refer to the fact that
                substantively identical provisions will be added to chapters in
                Titles 21, 42, and 45.
                ---------------------------------------------------------------------------
                 On November 4, 2020, HHS published in the Federal Register the
                proposed rule.\111\ Part of the proposed rule had a 30-day public
                comment period, and part of it had a 60-day comment period to comply
                with 42 U.S.C. 1395hh(b). In response to the publication of that
                proposed rule, HHS received 486 comments from industry trade
                organizations, healthcare providers, businesses, legal/policy think
                tanks, non-profit public interest groups, and members of the U.S.
                Congress during the initial 30-day public comment period, and 532
                comments total throughout the 60-day comment period. Commenters
                generally opposed the proposed rule, although some commenters supported
                it. Roughly a quarter of commenters requested that the Department
                withdraw the proposed rule. Some commenters requested that the
                Department extend the public comment period.
                ---------------------------------------------------------------------------
                 \111\ See 85 FR 70096.
                ---------------------------------------------------------------------------
                 The Department also held a public hearing on the proposed rule on
                November 23, 2020. Twenty-one members of the public, all representing
                either unions, public-interest groups, or industry trade organizations,
                spoke. The speakers at the public hearing all either expressed concerns
                about the proposed rule, opposed it, or requested that the Department
                withdraw it. Both a transcript and recording of the public hearing are
                available at https://beta.regulations.gov/docket/HHS-OS-2020-0012/document.
                 In the following sections, HHS includes a summary of the provisions
                of the proposed rule, the public comments received, HHS's responses to
                the comments, and any changes made to the regulatory text as a result.
                General Purpose of the Proposal and General Comments
                 5 U.S.C. 610 and Executive Orders 12866 and 13563 direct agencies
                to devise plans to periodically review certain of their regulations
                using certain criteria. By requiring the Department to periodically
                perform such reviews, this final rule implements Congress's and the
                President's desires for retrospective review of regulations. This final
                rule will lead to the amendment or rescission, where appropriate, of
                Department regulations that have a significant economic impact upon a
                substantial number of small entities. This final rule also furthers
                democratic values such as accountability, administrative
                simplification, transparency, and performance measurement and
                evaluation.
                General Comments and Responses
                 Comment: A few commenters stated that the retrospective review of
                regulations proposed by the rule is an important and necessary tool for
                improving agency regulation and minimizing unnecessary regulatory
                burdens. Commenters listed the many benefits of this approach,
                including the refining of regulations using real-world data and
                experience, improving government accountability, avoiding the natural
                tendency of agency officials charged with achieving public benefits to
                focus on pursuing those benefits and not on reducing the burdens of
                their regulation to the public, and preventing the continued
                enforcement of obsolete, outdated, and even unintentionally harmful
                regulations. Some commenters stated that it is axiomatic that periodic
                retrospective review is essential to the proper functioning of the
                executive branch.
                 Response: The Department agrees, and believes this final rule will
                achieve these benefits.
                 Comment: A few commenters stated that beyond simply cutting
                regulatory burdens, the scheduled assessments and, when necessary,
                reviews of existing HHS regulations afford HHS the opportunity to keep
                regulations up to date with modern trends. Commenters noted that not
                only will this rule establish an opportunity for the Department to
                terminate obsolete regulations that are no longer fit for purpose or
                that are judged to be ineffective, but it will also give HHS and the
                public a reliable framework and a set of tools to continually keep
                regulations up to date with evolving circumstances.
                 Response: The Department agrees and emphasizes that the benefits of
                retrospective review--some of which are cited by these commenters--are
                substantial. As the proposed rule noted, Professor Cass Sunstein, who
                served as OIRA Administrator from 2009 to 2012, has observed that ``the
                requirement of retrospective analysis,'' if ``firmly
                institutionalized,'' ``would count as the most important structural
                change in regulatory policy since the original
                [[Page 5705]]
                requirement of prospective analysis during the Reagan Administration.''
                \112\
                ---------------------------------------------------------------------------
                 \112\ Cass R. Sunstein, The Regulatory Lookback, 94 B.U. L. Rev.
                579, 584 (2014).
                ---------------------------------------------------------------------------
                 Comment: A large number of commenters stated that the proposed rule
                will cause an additional burden to the Department and a diversion of
                the Department's personnel resources. Some of these commenters
                suggested that the regulatory review process could adversely affect the
                Department's ability to focus on the administration of current
                programs, to issue new regulations, and to appropriately review current
                regulations needing modification. Commenters also raised specific
                concern about the initial review of regulations that are over ten years
                old within two years after the calendar year in which this rule is
                finalized. Those commenters expressed concern that HHS would be unable
                to Assess or Review all 12,400 regulations that the Department
                estimates will fall under this category because of the high volume of
                regulations. A number of commenters stated that two years is an
                arbitrary and inadequate timeline for all 12,400 regulations to be
                Assessed or Reviewed, and some regulations could expire simply because
                the Department did not have enough time to conduct an Assessment or
                Review. Several commenters also stated that they believe the
                Department's estimate that 12,400 of its regulations are over ten years
                old is lower than the actual number, although no commenter provided an
                independent count of HHS regulations to support this assertion. A few
                commenters pointed out that after an Assessment or Review occurs, there
                may be additional need for rulemaking or revision of regulations, which
                is an additional cost the Department does not contemplate in its
                estimate. A few commenters stated that it was unclear where HHS plans
                to obtain the funding and personnel resources needed to implement this
                regulatory review process.
                 Response: The Department has considered the public comments, and
                decided that, for regulations that are more than ten years old on the
                effective date of this final rule, the Department shall have five
                years, rather two as proposed in the proposed rule, to complete the
                Assessments and (if needed) Reviews. This will spread out the initial
                burden and provide the opportunity for more robust Assessments and
                Reviews. 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. Moreover, the Regulatory
                Flexibility Act already calls for the Department to assess which of its
                regulations have a significant economic impact upon a substantial
                number of small entities, and to review those regulations every ten
                years. Therefore, assuming full compliance with the RFA, this rule does
                not impose any additional burden on the Department beyond what was
                already called for in the RFA.
                 To the extent there are additional burdens resulting from this
                regulation, HHS believes widespread retrospective review is a
                worthwhile enterprise. The literature and the Department's experience
                suggest that large numbers of regulations are having impacts that, over
                time, differ from what was estimated at the time of promulgation. The
                Department should conduct periodic reviews to determine whether the
                policy goals behind the regulations are in fact being effected (and if
                amending those regulations could more effectively further those goals).
                Thus, it is sensible to periodically review existing regulations, even
                if it takes some time away from issuing new regulations (many of which,
                the literature suggests, would have impacts that differ from their
                estimated impacts at the time of promulgation).
                 HHS also notes that courts ``have no basis for reordering agency
                priorities. The agency is in a unique--and authoritative--position to
                view its projects as a whole, estimate the prospects for each, and
                allocate its resources in the optimal way.'' In re Barr Labs., Inc.,
                930 F.2d 72, 76 (D.C. Cir. 1991). For the reasons discussed herein, the
                Department has done this, and determined that Reviews and Assessments
                should be a priority.
                 Lastly, we note that the COVID-19 pandemic imposed a tremendous,
                unforeseen burden on the Department, yet there has been no material
                drop in the Department's ability to promulgate new regulations or
                enforce existing regulations. This suggests that after the pandemic,
                the Department will be resourceful enough to perform Assessments and
                Reviews, as well as promulgate new regulations that need to be
                promulgated and appropriately enforce existing regulations.
                 Comment: A few commenters stated that the benefits of this final
                rule are difficult to fully anticipate, and there are a number of
                reasons to believe that the benefits of this rulemaking will vastly
                outweigh the costs. For example, if HHS were to find cost savings worth
                0.0025 percent of departmental spending or 0.0007 percent of national
                spending, the regulation would pay for itself and pass a cost-benefit
                test at the higher end of cost estimates.
                 Response: The regulatory impact analysis for this final rule
                describes what the Department expects to be the primary impacts
                resulting from this final rule.
                 Comment: A large number of commenters stated that, as proposed,
                this rule would divert resources from the Department's COVID-19
                pandemic response efforts. Many of these commenters stated that it is
                irresponsible for the Department to create a retrospective regulatory
                review process at a time when it should be devoting all of its
                resources to combatting COVID-19.
                 Response: HHS respectfully disagrees with this comment. Due to the
                changes made from the proposed rule, under this final rule the first
                Assessments and Reviews need not be completed until the end of 2026.
                The Department believes the pandemic will be over by then.
                 In fact, the COVID-19 pandemic has reinforced the need for this
                final rule. The Department's response to the pandemic has largely
                consisted of waiving regulatory requirements or exercising enforcement
                discretion to not enforce certain regulatory requirements during the
                pandemic. See, e.g., Coronavirus waivers and flexibilities, CMS.gov,
                https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers; Regulatory Relief
                to Support Economic Recovery; Request for Information (RFI), 85 FR
                75720 (Nov. 25, 2020) at Attachment A (non-exhaustive list of
                enforcement discretion announcements or changes to regulations, agency
                guidance materials, or compliance obligations made to respond to the
                COVID-19 pandemic and its impact on the healthcare industry). The
                Department should learn from the pandemic and consider whether to
                retain regulatory requirements that were waived or where flexibility
                was provided during the Nation's response to COVID-19, as well as
                consider the impact its regulations could have on the response to a
                future pandemic or other emergency.
                 Comment: A large number of commenters viewed the 30-day comment
                period (which began on November 4, 2020, the day that the Federal
                Register published the proposed rule and the day after the rule went on
                public display) as too short. A large number of these commenters stated
                that the proposed rule should be withdrawn for various reasons, or in
                the alternative, requested a longer comment period if the proposed rule
                was not withdrawn. Commenters' reasons for asking for an extension
                included lack of
                [[Page 5706]]
                advanced notice of the proposed rule, the perceived magnitude of the
                rule, fewer resources available to commenters due to the COVID-19
                pandemic and the Thanksgiving holiday, and the number of topics on
                which the Department requested comment.
                 A large number of commenters stated that the 30-day comment period
                violates the Administrative Procedure Act (``APA'') because it denies
                meaningful ``opportunity to participate in the rule making'' required
                by 5 U.S.C. 553(c).\113\ A few commenters specifically mentioned that
                while there is no established minimum comment period prescribed by the
                APA, Executive Order 12866 states that the public's opportunity to
                comment, ``in most cases should include a comment period of not less
                than 60 days,'' although shorter comment periods have been upheld in
                the face of exigent circumstances.\114\ Other commenters said the
                Department should not finalize the rule until the next Administration
                enters office.
                ---------------------------------------------------------------------------
                 \113\ See N.C. Growers' Ass'n, Inc. v. United Farm Workers, 702
                F.3d 755, 770 (4th Cir. 2012) (APA requires ``meaningful''
                opportunity to comment); Petry v. Block, 737 F.2d 1193, 1201 (D.C.
                Cir. 1984) (relying on Administrative Conference of the United
                States' view that 30-day comment period is inadequate and 60-day
                comment period is the reasonable minimum time for comment).
                 \114\ Exec. Order No. 12866 of Sept. 30, 1993, 58 FR 190 (Oct.
                4, 1993).
                ---------------------------------------------------------------------------
                 Response: While HHS understands the commenters' desire for more
                time, the comment period was adequate. Neither the APA, nor any other
                statute requires a longer comment period for the proposed rule.
                Instead, the APA merely requires that ``[a]fter notice required by this
                section, the agency shall give interested persons an opportunity to
                participate in the rule making through submission of written data,
                views, or arguments with or without opportunity for oral
                presentation.'' 5 U.S.C. 553(c). This occurred here. The comment period
                provided ample time for the submission of 486 comments by a variety of
                interested parties, including extensive comments by a number of
                entities just by the end of the 30-day period. Those comments offer a
                broad array of perspectives on the proposed rule. The number and
                comprehensiveness of the comments received disprove commenters' claim
                that the 30-day comment period was insufficient time for commenters to
                provide meaningful comment. Accordingly, after reviewing the public
                comments and the requests for additional time, the Department does not
                believe that extending the comment period is or was necessary for the
                public to receive sufficient notice of, and opportunity to meaningfully
                comment on, the proposed rule. Nor is there anything that would have
                required additional outreach outside of the public notice and comment
                process and the comment period.
                 Moreover, under this final rule, the public will have a robust
                opportunity to comment on each regulation during the Assessment or
                Review process.
                 HHS respectfully disagrees that Executive Order 12866 requires a
                60-day comment period for this rule. Executive Order 12866 repeats the
                baseline requirement that ``each agency should afford the public a
                meaningful opportunity to comment on any proposed regulation,'' which
                ``in most cases should include a comment period of not less than 60
                days.'' \115\ Neither Executive Order mandates a 60-day comment period.
                That is why many HHS, and other agency, regulations are issued with
                shorter comment periods. No commenter pointed to a court decision
                vacating a rule based on a failure to comply with an Executive Order's
                supposed 60-day comment period requirement. As explained above, the
                volume of comments received demonstrates that the public has been
                afforded a meaningful opportunity to comment.\116\
                ---------------------------------------------------------------------------
                 \115\ See also Exec. Order No. 13563 of Jan. 18, 2011, 76 FR
                3821 (Jan. 21, 2011) (``To the extent feasible and permitted by law,
                each agency shall afford the public a meaningful opportunity to
                comment through the internet on any proposed regulation, with a
                comment period that should generally be at least 60 days.'').
                 \116\ A commenter pointed to 21 CFR 10.40(b)(2) as counseling in
                favor of a 60-day comment period. But that provision by its terms
                applies only to the FDA Commissioner. The proposed rule was issued
                by the Secretary.
                ---------------------------------------------------------------------------
                 Moreover, a portion of the proposed rule had a 60-day public
                comment period because 42 U.S.C. 1395hh(b) requires a 60-day comment
                period before issuing or amending certain Medicare regulations. The
                Department did not finalize this rule until after the 60-day comment
                period closed, and the Department has considered all comments,
                including those received throughout the 60-day comment period, before
                finalizing this rule. In all, the Department received 532 comments by
                the end of the 60-day comment period.
                 Lastly, past practice has often been to finalize rules that are
                ready for finalization without waiting for the incoming Administration
                to take office.\117\
                ---------------------------------------------------------------------------
                 \117\ For example, fifty-six (56) new rules were finalized in
                the final two (2) full days of the previous Administration. See
                Federal Register, https://www.federalregister.gov/documents/search?conditions%5Bpublication_date%5D%5Bgte%5D=1%2F18%2F2017&conditions%5Bpublication_date%5D%5Blte%5D=1%2F20%2F2017&conditions%5Btype%5D%5B%5D=RULE.
                ---------------------------------------------------------------------------
                 Comment: A few commenters viewed the 30-day comment period as
                insufficient because some of the regulations that will be amended by
                this final rule had a comment period that lasted more than 30 days when
                they were originally promulgated.
                 Response: HHS respectfully disagrees with these commenters. Not
                only did the Department not finalize this rule until after the 60-day
                comment period closed, but the APA does not specify a required length
                for comment periods when issuing or amending regulations. The APA has
                already ``established the maximum procedural requirements which
                Congress was willing to have the courts impose upon agencies in
                conducting rulemaking procedures.'' Vt. Yankee Nuclear Power Corp. v.
                Natural Res. Def. Council, Inc., 435 U.S. 519, 524 (1978). Neither
                courts nor regulated entities may ``impose upon [an] agency its own
                notion of which procedures are `best' or most likely to further some
                vague, undefined public good.'' Id. at 549. The number and
                comprehensiveness of the comments received disprove commenters' claim
                that the comment period was insufficient. A portion of the proposed
                rule had a 60-day public comment period because 42 U.S.C. 1395hh(b)
                requires a 60-day comment period before issuing or amending certain
                Medicare regulations. But for many other Department regulations,
                Congress has enacted no requirement specifying a particular comment
                period.
                 Comment: Several commenters stated that they found it unfair that
                the proposed rule had a 30-day comment period, but parties regulated by
                CMS have 60 days to comment on the portion of the proposed rule
                pertaining to certain CMS regulations. Commenters mentioned that they
                believed this could present a fundamental due process issue.
                 Response: As stated in the proposed rule, Congress required a 60-
                day public comment period before issuing or amending certain Medicare
                regulations. See 42 U.S.C. 1395hh(b); 85 FR at 70104 n.87. No similar
                statutory requirement applies to most other Department regulations.
                 Comment: Several commenters stated that seven days' notice prior to
                the public hearing on the proposed rule was insufficient time to
                prepare remarks for the public hearing. The same commenters also stated
                that holding the public hearing 10 days before the close of the comment
                period on the rule was insufficient time for commenters to
                [[Page 5707]]
                meaningfully incorporate the testimony and learnings from the public
                hearing into their written comments.
                 Response: HHS respectfully disagrees. While the specific date of
                the hearing (November 23, 2020) was published in the Federal Register
                on November 16, 2020, notice that a hearing would be held was provided
                in the proposed rule itself.\118\ Thus, commenters were on notice 19
                days (November 4, 2020, to November 23, 2020) prior to the hearing and
                had 19 days to prepare remarks for the hearing. And as these comments
                themselves show, choosing the date for the public hearing requires a
                balance between, first, giving the public sufficient time to review the
                proposed rule, and second, giving the public adequate time to review
                comments made at the hearing before submitting written comments.
                Scheduling the hearing on November 23, 2020 reflected an appropriate
                balance of these considerations.
                ---------------------------------------------------------------------------
                 \118\ 85 FR at 70097.
                ---------------------------------------------------------------------------
                 Comment: Several commenters were supportive of the rule and
                expressed that the provisions of the Regulatory Flexibility Act should
                be followed to increase transparency, public participation, and
                administrative accountability. These commenters appreciated the
                Department's efforts to ensure recurring attention to the impact of its
                rules on small and independent businesses, and minimize the regulatory
                burden it imposes on these entities. These commenters also stated that
                regulatory review is a laudable goal that administrative agencies
                should be aiming for.
                 Several commenters emphasized the importance of periodically
                reviewing old regulations to determine whether they should be updated
                to adapt to changing circumstances. For instance, a few commenters
                stated that the COVID-19 pandemic drew attention to the fact that many
                of the Health Insurance Portability and Accountability Act (HIPAA)
                regulations are out-of-date. Some commenters also stated that the
                process for developing regulatory impact analyses could be improved if,
                after each regulation is fully implemented, public comments were
                solicited on the accuracy of the assumptions underlying the original
                impact analysis. These commenters appreciated the Department's efforts
                to consider and update its regulatory review process.
                 Response: HHS agrees with these commenters that the final rule will
                implement the important goals of the Regulatory Flexibility Act,
                including transparency, public participation, administrative
                accountability, and a more streamlined regulatory structure. The
                process set out in the proposed rule that is now being finalized will
                create a structured plan to operationalize the Department's
                longstanding goals of reviewing and updating its regulations and--where
                needed--eliminating regulations that no longer serve their intended
                purpose(s) and unduly burden both small entities or the public at
                large. Requiring the solicitation of comments on the assumptions in
                regulatory impact analyses is beyond the scope of this final rule, but
                the public is welcome to submit such comments to the dockets of
                regulations being Assessed or Reviewed.
                 Comment: A few commenters stated that the proposed rule does not
                provide sufficient examples of how this approach has worked in the
                past. A few commenters point out that the proposed rule cites an
                article that indicates that states have adopted and then abandoned
                similar approaches to adding automatic expirations dates. They also
                state that HHS dismisses this fact in the proposed rule without
                providing a compelling reason. Commenters stated that the examples
                where this approach has been used that the Department cites to in the
                proposed rule (U.S. states, the European Union, and the Republic of
                Korea) have no bearing or authority over federal rulemaking in the
                United States, where Congress through the APA has established
                procedures and standards for promulgating, updating, and rescinding
                regulations. They also stated that the executive actions reviewing
                regulations that are cited to in the proposed rule underscore that the
                Department does not need this rule to compel periodic regulatory
                review.
                 Response: HHS respectfully disagrees. As explained in the proposed
                rule, 85 FR at 70102 & nn.66-69, to the extent that states abandoned
                automatic expiration dates, they did so for reasons that are
                inapplicable to this situation, namely, the provisions' failure to
                enhance legislative control. As explained in the regulatory impact
                analysis, at least one state that undid its sunset provision (North
                Carolina) subsequently reenacted a sunset process for regulations. The
                article that one commenter referenced \119\ did not cite any empirical
                support for the proposition that automatic expirations produce
                ineffective or inadequate retrospective reviews where sufficient
                resources and staff are provided (as is the Department's intent
                here).\120\
                ---------------------------------------------------------------------------
                 \119\ Jason A. Schwartz, 52 Experiments with Regulatory Review:
                The Political and Economic Inputs into State Rulemakings, Inst. for
                Policy Integrity, Rep. No. 6, at 33 (Nov. 2010), https://policyintegrity.org/files/publications/52_Experiments_with_Regulatory_Review.pdf.
                 \120\ See 85 FR at 70102 n.69.
                ---------------------------------------------------------------------------
                 Second, the proposed rule referred to other jurisdictions' sunsets
                to illustrate that (1) adding sunset provisions does not wreak havoc or
                cause undue uncertainty and (2) experience shows sunset provisions can
                be effective in achieving the benefits from robust retrospective review
                of regulations. The legal framework of federal rulemaking under the APA
                may differ from other jurisdictions, but that does not detract from the
                point that other jurisdictions' experience shows that sunset provisions
                can be effective and do not lead to havoc or tremendous uncertainty.
                For the reasons explained in the proposed rule and this final rule,
                this final rule complies with the APA.
                 The Department also disagrees with the commenters' suggestion that
                the existence of limited and sporadic instances of retrospective review
                demonstrate this rule is not necessary. As explained in the proposed
                rule, the Department has failed to engage in comprehensive
                retrospective review of its rules notwithstanding the RFA and long-
                standing Executive Orders calling for such reviews. This history of
                limited compliance shows that the proposed rule being finalized is
                appropriate.
                 Comment: Several commenters stated that the proposed rule was a
                political effort to cause difficulties for the incoming Biden
                Administration, which will be tasked with implementing this final rule.
                 Response: HHS respectfully disagrees with these commenters because
                the purpose of this final rule is to require the Department to
                periodically review its regulations. The rule is not politically
                motivated, but is instead an effort to ensure the Department
                periodically reviews its regulations that have a significant economic
                impact upon a substantial number of small entities. In any event, based
                in part on comments received on the proposed rule, in this final rule
                the Department has extended the deadline to five calendar years to
                complete the Assessments and (if necessary) Reviews of regulations that
                are more than ten years old. Thus, the initial deadline will not occur
                in the next Presidential term.
                 Comment: A few commenters stated that this rule is advancing the
                Trump Administration's conservative agenda at the expense of good
                regulations that regulate health and safety for patients and consumers.
                Many of these commenters also indicated that the rule would put the
                interests of Wall Street ahead of the individual Americans who
                [[Page 5708]]
                are affected by HHS regulations and benefit from the regulatory
                structures they create.
                 Response: HHS respectfully disagrees. As emphasized in the proposed
                rule, (and this final rule) the Department intends to timely Assess and
                Review all covered regulations. Moreover, this final rule does not
                favor regulations of any particular ideological bent; it applies to all
                Department regulations, subject to the exceptions listed herein.
                Regulations that meet the RFA's criteria will not be modified or
                rescinded. The focus and anticipated result of the proposed rule is to
                eliminate or streamline unnecessary regulatory burdens on small
                entities. Retrospective review enjoys bipartisan support and benefits
                all Americans. Some regulations may bestow privileges upon narrow
                constituencies by creating barriers to entry in their industry. Such
                regulations may also disproportionately burden small businesses,
                because small businesses may be the new entrants such regulations are
                intended to keep out. If these regulations do not meet the RFA's
                criteria and are amended, small businesses and consumers may benefit
                from increased competition.
                 Comment: A few commenters stated that regulations issued after this
                rule is finalized should include the date of promulgation to make it
                easy for the public to determine how old the regulation is and when it
                will be reviewed.
                 Response: Rules already include their date of promulgation. To the
                extent the commenter requests that amendments to existing rules include
                the original date of promulgation, the Department may include this date
                in prospective rulemakings. Moreover, in conjunction with this final
                rule, the Department is placing at https://www.hhs.gov/regulations/federal-registry/index.html a list of Department rulemakings, the year
                they were initially promulgated, the last year the rules were amended,
                and the Federal Register citation from the time the rule was last
                amended. This list was generated with artificial intelligence and the
                Department believes it is accurate, but it is conceivable that some
                Department regulations are not included. This list includes all
                Department regulations, including those that may be exempt from this
                final rule. The Department believes it would be informative to the
                public to provide a list of all Department regulations, as well as
                their Federal Register citations and promulgation dates. The Department
                intends to update this list annually with newly-issued regulations.
                 Comment: One commenter stated that instead of the Department's
                proposed schedule of regulatory review, each agency within HHS should
                include retrospective review compliance into its annual objectives and,
                perhaps, even into periodic Congressional reports.
                 Response: The Department thanks the commenter for this suggestion,
                but experience suggests it would not be adequate to solve the problem.
                As noted in the proposed rule, the failure to adequately review
                existing significant regulations has already been well documented to
                Congress.\121\ It is also public knowledge.\122\ Nonetheless, such
                ``public shaming,'' if that is what the commenter intends, has not
                resulted in the Department adequately conducting retrospective review.
                ---------------------------------------------------------------------------
                 \121\ See, e.g., Curtis W. Copeland, Cong. Rsch. Serv., RL32801,
                Reexamining Rules: Section 610 of the Regulatory Flexibility Act 7-8
                (2008); U.S. Gov't Accountability Off., GAO/GGD-94-105, Regulatory
                Flexibility Act: Status of Agencies' Compliance 12 (1994) (quoting a
                1983 Small Business Administration report that stated that the
                Department's section 610 review plan was `` `very general,' and, as
                a result, `it is difficult to measure progress and to make
                recommendations with respect to future review' ''); see also
                Testimony of The Hon. Thomas M. Sullivan, Chief Counsel for
                Advocacy, U.S. SBA, U.S. House of Representatives Comm. on Small
                Bus. Subcomm. on Reg.'s, Health Care and Trade (July 30, 2008),
                 \122\ See, e.g., Connor Raso, Assessing regulatory retrospective
                review under the Obama administration, Brookings Inst., (Jun. 15,
                2017), https://www.brookings.edu/research/assessing-regulatory-retrospective-review-under-the-obama-administration/.
                ---------------------------------------------------------------------------
                 Comment: A large number of commenters stated that the proposed rule
                would be unnecessary and duplicative of the Department's existing
                efforts to review its regulations. These commenters stated that the
                Department already updates some of its rules annually, and has updated
                other non-annual rules in the past. Other commenters believe that HHS
                is already doing a fulsome review as required by the RFA. Several
                commenters stated that in 2011, the Department posted its final plan
                for retrospective review of existing regulations, and from 2012-2016 it
                provided semi-annual updates on its website listing the rules
                undergoing or scheduled for review. Some commenters suggested that
                previous executive orders that called for periodic review of existing
                regulations are a sufficient means of ensuring the Department is
                conducting these periodic reviews. Commenters suggested that the
                Department continue to conduct retrospective reviews using its already
                established process and provide regular updates to the public on its
                progress. Other commenters stated that the Department does not address
                why it failed to perform the required regulatory reviews in the past,
                nor how the process proposed in the proposed rule will make a
                difference.
                 A few commenters noted that even though previous executive orders
                have prioritized regulatory reviews, most observers to date note that
                these kinds of reviews have failed to be institutionalized by agencies,
                including HHS. These commenters cited evidence suggesting that despite
                efforts to review regulations over the years and to reduce regulatory
                burdens, the total number of regulatory restrictions that have been
                issued by HHS continues to grow year after year, except for two brief
                periods around 1980 and during the mid-1990s (perhaps as part of
                deregulatory efforts).
                 Response: The Department respectfully disagrees that this final
                rule is unnecessary and duplicative. While commenters are correct that
                HHS annually updates the annual Medicare payment rules, those rules and
                certain other rules that are updated annually are exempt from this
                final rule. This final rule also exempts the rules at 42 CFR part 73,
                since those are periodically reviewed. Regarding the 2011-2016
                retrospective review plan and reviews, that effort was helpful but
                sporadic, not sustained. As explained in the proposed rule, these
                efforts only resulted in review of a small fraction of rules. See 85 FR
                at 70099. The failure to institutionalize retrospective review further
                underscores the need for this final rule and the review process it is
                implementing. A few instances of the Department taking the initiative
                to review its regulations cannot reasonably be considered a sufficient
                regulatory review when thousands of regulations that have been
                promulgated over the decades have not been touched.\123\
                ---------------------------------------------------------------------------
                 \123\ See, e.g., 85 FR at 70111 (explaining that as of 2019, 85%
                of Department regulations created before 1990 had not been edited,
                and the Department had nearly 300 broken citation references in the
                CFR).
                ---------------------------------------------------------------------------
                 Comment: Many commenters questioned the Department's plan for
                personnel resources to conduct the Reviews prescribed by this final
                rule. These commenters believe that the Department underestimated the
                number of people who would be needed to conduct the Reviews, and stated
                that the personnel resources would be better utilized on other
                projects. For example, some commenters stated that the Department is
                already too slow in promulgating certain regulations, and should task
                its employees with carrying out the Department's existing duties.
                 Response: The regulatory impact analysis for this final rule
                describes the personnel resources that the Department envisions being
                used to conduct Assessments and Reviews. The
                [[Page 5709]]
                sensitivity analysis therein addresses the possibility that costs could
                be lower than estimated in the proposed rule. Periodically reviewing
                regulations with a significant economic impact upon a substantial
                number of small entities is an existing Department duty. Moreover, as
                discussed elsewhere herein, retrospective review can yield tremendous
                benefits. The literature and the Department's experience suggest that
                large numbers of regulations are having impacts that, over time, differ
                from what was estimated at the time the regulations were promulgated.
                Therefore, the Department should prioritize conducting periodic reviews
                of its regulations to determine whether the policy goals behind the
                regulations are in fact being effected (and if amending those
                regulations could more effectively further those goals).
                 Comment: A few commenters questioned whether the Department should
                have employees Assess or Review regulations if those employees are not
                responsible for implementing them. These commenters stated that if
                reviewers have not worked on matters connected with the regulations
                they are Reviewing, those reviewers may not have an adequate
                understanding of the regulations, which could lead to the expiration of
                regulations that are essential to the successful operation of the
                Department's programs.
                 One commenter also disagreed with the premise of the Department's
                use of career civil servants to conduct regulatory reviews. This
                commenter stated that the proposed rule was logically inconsistent
                because it ``maligned'' career public servants at the Department for
                not reviewing the Department's regulations, but also proposes to task
                these same individuals with carrying out the proposed review process.
                 Response: Which Department officials Assess or Review particular
                regulations will be decided on a case-by-case basis, but those
                conducting Assessments and Reviews will generally be employees who are
                familiar with those regulations, as well as technical experts,
                including economists. The Department strongly disagrees with the
                comment that the proposed rule ``maligned'' career civil servants. The
                proposed rule quoted a law professor who was suggesting several reasons
                why retrospective reviews do not occur as often as desired. The
                Department believes career civil servants can capably Assess and Review
                regulations, just as they capably conduct regulatory impact analyses
                and regulatory flexibility analyses.
                 Comment: Several commenters stated that the two-year timeline for
                review of all regulations over ten years old was insufficient. A number
                of commenters suggested that the timeline be extended to five years.
                 Response: The Department has considered these comments and has
                decided to revise the rule in light of them. Under this final rule,
                regulations issued more than ten years prior to the final rule's
                effective date will not expire if Assessed and (if necessary) Reviewed
                within five calendar years of the effective date of this final rule.
                Moreover, under this final rule, if the Secretary makes a written
                determination that the public interest requires continuation of the
                Section (as defined in the text of the final rule) in force beyond the
                date on which the Section otherwise would expire, the Secretary may
                continue the Section in force one time for a period stated in the
                determination, which period shall not to exceed one year.
                 Comment: Several commenters stated that the proposed rule would
                cause significant regulatory uncertainty in the healthcare industry,
                which would not know which regulations may or may not expire. Some
                commenters stated that the proposed rule would cause uncertainty for
                states, which implement Federal programs and rely on Federal
                regulations and funding. Potential regulatory changes could create
                additional compliance and regulatory costs for healthcare providers
                which may be forced to adapt to a changing regulatory framework.
                Changes may also trigger regulated entities to forgo future investments
                because they lack regulatory clarity. For example, some commenters
                stated that the uncertainty created around the expiration of
                regulations, including those that guide eligibility for Medicaid,
                Medicare provider reimbursements, or certification of hospitals and
                clinics, could disrupt the efficient operation of critical safety-net
                programs, create regulatory gaps and inconsistent application of the
                law, and make accessing safety-net services for our most vulnerable
                populations even more complicated and difficult than it is today. Some
                commenters said the poor, people of color, and/or the LGBTQ community,
                would be particularly affected. Additionally, some commenters stated
                that the proposed rule would make it difficult for them to advise
                clients on how to comply with the Department's regulations. These
                commenters stated that if HHS determined that a regulation required
                modification, it should clearly publicize its intention to exercise
                enforcement discretion in not enforcing the then-current iteration of
                the regulation while the particular regulation is being modified.
                 Other commenters stated that the regulatory review process set
                forth in this rule would ensure that HHS reviews regulations as
                required by the RFA, which means that if HHS were currently complying
                with the RFA in a satisfactory manner, there would be little additional
                uncertainty stemming from the proposed rule.
                 Response: The Department notes that there is always a possibility
                that regulations could be amended or rescinded, even absent this rule.
                The Department does not believe uncertainty among the regulated
                community will add significantly to the costs of this rulemaking for
                the following reasons. The Department's sporadic use of periodic
                retrospective review--notwithstanding the RFA and Executive Orders--
                itself leads to ``uncertainty'' about how robustly the Department
                implements directives that make for good policy.\124\ To the extent
                that the Department can maintain compliance with its obligations, this
                should build trust in the Department and reduce uncertainty (offsetting
                some or all of the uncertainty discussed by the commenters, if such
                uncertainty exists). Further, as noted above, the Department plans to
                release information about the 18,000 regulations under its authority
                and when they were adopted, such that any uncertainty surrounding the
                expiration dates of the Department's various rulemakings will be
                reduced substantially, if not entirely. Additional measures to mitigate
                private costs are discussed in the ``Operationalization of This Final
                Rule'' section of this final rule. Second, the Department notes that
                many states and foreign jurisdictions have sunset provisions that are a
                routine part of their regulatory processes. If the sunset reviews in
                these other jurisdictions do not create tremendous uncertainty, it
                stands to reason that neither will this final rule. The regulatory
                impact analysis for this final rule describes in more detail the sunset
                provisions from these other jurisdictions.
                ---------------------------------------------------------------------------
                 \124\ To the extent this uncertainty has been lessened because
                the public has seen how the Department has implemented these
                directives over the course of many years, the same can be said for
                this final rule once it has been implemented for several years.
                ---------------------------------------------------------------------------
                 Under this final rule, the regulated community has five years to
                adjust to the changes made by this final rule, so any reliance
                interests are significantly reduced as compared to the proposed rule.
                Where appropriate, the Department would announce the regulations for
                [[Page 5710]]
                which it is exercising enforcement discretion.
                 Comment: A few commenters stated that the Department should allow
                reasonable reliance on a regulation while that regulation is under
                review, and for a reasonable time after a decision to amend, rescind or
                allow a regulation to expire. These commenters also stated that the
                final rule should allow the Department to extend a regulation for any
                period of time reasonably necessary for regulated entities relying the
                regulation to adjust their business practices.
                 Response: HHS appreciates the commenters' concern regarding the
                reliance interests of regulated entities; however, HHS respectfully
                disagrees with the premises of these comments. First, HHS does not
                intend to allow a regulation to simply expire. And as explained in the
                proposed rule, the public will have the opportunity to provide comments
                identifying regulations that the public believes need to be Assessed
                and Reviewed, which mitigates the risk of inadvertent expiration.
                 Second, with respect to Sections that, after Review, the Department
                determines should be amended or rescinded, such Sections will be
                amended or rescinded through a separate notice-and-comment rulemaking
                process. Considerations about the effective dates of such amendments or
                rescissions, including the need to allow adequate time for transition,
                will be taken into account in that separate rulemaking process.
                Finally, Review under this final rule expressly considers ``the
                continued need for the Section,'' so regulated entities' reliance
                interests will be taken into account during Reviews.
                 Comment: Several commenters stated that the use of artificial
                intelligence and machine learning technology in regulatory review is a
                novel and innovative approach, and members of the public should have
                been afforded notice of the Deloitte research project and the
                opportunity to comment on the use of this technology. In particular,
                these commenters wanted to understand if and how the technology would
                be used by HHS to identify the regulations that will be reviewed. Some
                commenters asked HHS to provide additional information regarding the
                methodology used, and the underlying algorithm. A few commenters stated
                that all code should be posted on a publicly-accessible website,
                consistent with best practices among academic researchers in data
                science.
                 Response: The Department agrees that the use of artificial
                intelligence machine learning technology in regulatory review is a
                novel and innovative approach. The technology discussed in the proposed
                rule was initially used to perform an internal assessment of Department
                regulations, which is why the Department did not previously notify the
                public about this research project. Artificial intelligence will not be
                used to perform Assessments and Reviews pursuant to this final rule.
                While artificial intelligence can determine if a regulation has been
                amended in the last thirty years, it cannot at this time easily
                determine if a regulation satisfies the criteria listed in 5 U.S.C.
                610. The artificial intelligence review was useful, because it
                suggested that large numbers of Department regulations would benefit
                from retrospective review. The technology identified that 85% of
                Department regulations created before 1990 have not been edited; the
                Department has nearly 300 broken citation references in the CFR; and
                there are more than 50 instances of HHS regulatory requirements to
                submit paper documents in triplicate or quadruplicate. This suggests
                humans performing a comprehensive review of Department regulations
                would find large numbers of requirements that would benefit from
                review, and possibly amendment or rescission.
                 Regarding the technology used to perform the 2019 analysis, the
                analysis was performed using a tool called RegExplorer. RegExplorer is
                an ``augmented intelligence'' tool, meaning it is designed to use
                artificial intelligence in conjunction with subject matter experts.
                While RegExplorer is proprietary technology, some of the models
                deployed within RegExplorer include keyword technology (a structured
                and iterative approach to process, analyze, and return keyword search
                results); a clustering algorithm (a cluster is a machine-generated
                group of regulatory documents that have been algorithmically gathered
                together based on a set of similar characteristics, such as the
                relevant sub-agency, placement of text within the regulatory dataset,
                similarity of text content, and text format and structure); citation
                extraction and mapping; and similar section analysis.
                 Comment: A few commenters asked why HHS chose to redact some of the
                ``Regulatory Streamlining & Analysis'' published by Deloitte in March
                2019 that the Department cites in support of the proposed rule. These
                commenters pointed out that two of three bullet points in the
                ``executive summary'' slide, and all but 25 of the document's 170 pages
                are redacted. These commenters asked why this information was not made
                available to the public, and why HHS did not have a public meeting to
                discuss the Deloitte findings and solicit feedback on its regulatory
                reform ideas back in 2019.
                 Response: The Department was transparent by including the Deloitte
                analysis in the docket for this rulemaking. The redacted information is
                information protected by applicable privileges, is confidential
                information, trade secret information, or not relevant to this
                rulemaking. As can be seen from the Table of Contents for the analysis,
                the redacted information does not relate to the machine learning
                analysis that was conducted to enhance regulatory reform that was
                discussed in the proposed rule. In November 2020, the Department held a
                public hearing on the proposed rule, which referred to the Deloitte
                presentation. The public was able to opine on the analysis at that
                public hearing. The Department did not have a public meeting to discuss
                the Deloitte findings and solicit feedback in 2019, because the
                Department was at the time still undergoing its internal deliberative
                process.
                 Comment: A few commenters stated that ideally the systematic
                evaluation of regulations should be a regular part of the rulemaking
                process, with the evaluation criteria and timeline embedded within each
                new rule so that the regulated community has an opportunity to opine on
                how and when each regulation will be reviewed. Commenters suggested
                that HHS identify up front what data it will use to track the progress
                of the regulation, and commit to continually collecting the same kinds
                of data over time. Such a process would make future evaluation of
                regulations and programs easier. It would also improve public
                accountability because the public would have a clearer sense of what
                the regulation is designed to achieve, and can monitor HHS's progress.
                 Response: HHS agrees with the commenters' focus on the need to
                systematically evaluate the effectiveness of agency regulations--
                indeed, the Department has proposed the instant rule in order to make
                such evaluations more frequent and comprehensive. The timeline for
                Review of a given Section is set forth in section [XX](c)(1), and the
                criteria for Review are set forth in [XX](d). As is current practice,
                the Department intends to explain in the preambles to future rules what
                goals the rules are intended to achieve. This will enable the public to
                know what goals each regulation is designed to achieve. However, the
                data necessary to evaluate a particular rule will differ from rule to
                rule, and the Department cannot
                [[Page 5711]]
                generally commit to such collection in advance and in the abstract,
                although it may be useful to do so in particular cases.
                 Comment: One commenter suggested that HHS consider performing a
                cost-savings analysis for regulations receiving a Review under the
                proposed rule, or for that subset of Assessed regulations that are
                deemed significant or economically significant. Such analysis could
                include estimates of the costs, cost savings, and the net cost savings
                of the regulation.
                 Response: For purposes of this final rule, the Department has
                decided to limit the Review criteria to the criteria listed in 5 U.S.C.
                610, plus whether the regulation complies with applicable law. These
                are the criteria that Congress directed the Department to use in its
                periodic reviews, plus a review for compliance with the law.
                Determining the regulation's costs, as well as cost savings from
                amendment or rescission, will often be subsumed in the five criteria
                listed in 5 U.S.C. 610.
                 Comment: A large number of commenters stated that the proposed rule
                would negatively impact programs if review efforts are underfunded, or
                that the proposed rule was costly and unfunded.
                 Response: The Department disagrees that regulatory review efforts
                would be underfunded. As explained in the regulatory impact analysis,
                this final rule will impose relatively low costs on the Department.
                 Comment: Several commenters, including Tribal governments and
                representatives, affiliated groups of Indian Tribes, and the IHS Tribal
                Self-Governance Advisory Committee, stated that the Department should
                have consulted with Tribal governments on the rule and failed to notify
                Tribal leaders and representatives of the proposed rule in violation of
                HHS's duty as a federal agency to consult with Tribal nations under
                Exec. Order No. 13175 of Nov. 6, 2000, 65 FR 67249 (Nov. 9, 2000) (E.O.
                13175) and the Department's own Tribal consultation policy.
                 Response: The Department and Indian Tribes share the goal to
                establish clear policies to further the government-to-government
                relationship between the Federal Government and Indian Tribes. True and
                effective consultation shall result in information exchange, mutual
                understanding, and informed decision-making on behalf of the Tribal
                governments involved and the Federal Government. The importance of
                consultation with Indian Tribes was affirmed through Presidential
                Memoranda in 1994, 2004 and 2009,\125\ and E.O. 13175. HHS believes
                that neither the proposed nor the final rule violate the Department's
                Tribal consultation policy or E.O. 13175. Subject to certain
                exceptions, the policy and E.O. 13175 require consultation before any
                action that will significantly affect Indian Tribes, or before
                promulgating any regulation that has Tribal implications. HHS believes
                that this final rule does not significantly affect Indian Tribes or
                have Tribal implications, as those terms are used in the policy and
                E.O. 13175. This final rule amends existing regulations to provide that
                the regulations will expire if not Assessed and (if necessary) Reviewed
                by certain dates. 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, beyond their costs of participation in
                the monitoring, Assessment, and Review processes. As explained in this
                final rule's regulatory impact analysis, the estimated total monitoring
                costs to the public over ten years is estimated to range from $52.2
                million to $156.7 million using a 7% discount rate, or $58.8 million to
                $176.3 million over ten years using a 3% discount rate (all figures
                using $2020). The U.S. Census estimates that in 2019, 1.7% of the U.S.
                population was all or partially American Indian or Alaska Native.\126\
                1.7% of the estimated monitoring costs would be roughly $887,400 to
                $2.66 million over ten years using a 7% discount rate, or $999,600 to
                roughly $3 million over ten years using a 3% discount rate (and the
                cost to Tribes could be less since not every American Indian or Alaska
                Native is affiliated with a Tribe). Tribes will be able to comment on
                regulations during the Assessment and Review processes.
                ---------------------------------------------------------------------------
                 \125\ Presidential Memoranda on Government-to-Government
                Relations With Native American Tribal Governments, 85 FR 22951 (May
                4, 1994), Presidential Memorandum, Government-to-Government
                Relationship with Tribal Governments, September 23, 2004, https://www.govinfo.gov/content/pkg/WCPD-2004-09-27/pdf/WCPD-2004-09-27-Pg2106.pdf, Presidential Memorandum on Tribal Consultation, 74 FR
                57879 (Nov. 9, 2009).
                 \126\ ACS Demographic and Housing Estimates, U.S. Census Bureau,
                https://data.census.gov/cedsci/table?q=United%20States&g=0100000US&tid=ACSDP1Y2019.DP05&hidePreview=true.
                ---------------------------------------------------------------------------
                 Comment: A commenter stated that the rule would allow for the
                sunset of regulations that merely implement statutory requirements,
                such as Indian preference. The commenter cited as examples 42 CFR
                136.41-43, 42 CFR 121, 42 CFR 136a.41-43, all of which, the commenter
                stated, are mandated by 25 U.S.C. 5117.
                 Response: The Department respectfully disagrees. This final rule
                exempts from the Assessment and Review requirement ``Sections whose
                expiration pursuant to this section would violate any other Federal
                law.'' See Section [XX](g). In any event, the Department is not
                convinced the statutory provision cited by the commenter mandates the
                cited regulations. There is no obligation imposed on HHS in 25 U.S.C.
                5117 to prescribe any particular regulations on Indian preference.
                Rather, section 5117 provides that ``any employee entitled to Indian
                preference who is within a retention category established under
                regulations prescribed under such subsection to provide due effect to
                military preference shall be entitled to be retained in preference to
                other employees not entitled to Indian preference who are within such
                retention category.'' Neither 25 U.S.C. 5117 nor 25 U.S.C. 5116 (which
                is referenced in 25 U.S.C. 5117) are cited as statutory authorities for
                the regulations cited by the commenter.
                 Comment: A few commenters stated that agencies (including HHS) have
                long ignored the retrospective review mandate of the RFA and have
                failed to perform such reviews. One reason for this, according to the
                commenters, is that the RFA does not create incentives for federal
                agencies to review their regulations. These commenters stated that this
                final rule would solve that problem by providing a clear incentive for
                agencies within HHS to review their regulations to prevent their
                automatic expiration. Commenters stated that without such a
                consequence, agencies will continue to fail to conduct retrospective
                reviews of their regulations.
                 Response: The Department cannot speak for other federal agencies
                and would not state that the Department has completely ignored
                retrospective review. But the Department would agree that it has not
                performed reviews as often as Congress intended. The Department agrees
                that this final rule will address this problem by providing an
                incentive to perform retrospective reviews.
                 Comment: A few commenters stated that the Department failed to
                analyze the potential costs of rescinding regulations, and only focuses
                on the costs of conducting voluntary Assessments and Reviews. A few
                commenters stated that HHS did not assess the potential forgone
                benefits of expired regulations.
                 Response: This is addressed in the regulatory impact analysis for
                this final rule.
                [[Page 5712]]
                 Comment: A few commenters stated that the Department should
                consider doing a regulatory impact analysis when reviewing rulemakings
                that predate the Regulatory Flexibility Act and have a significant
                economic impact upon a substantial number of small entities
                (``SEISNOSE''). These commenters also noted that conducting additional
                regulatory impact analyses would impose an additional cost to the
                Department, which it should account for if it chooses to do additional
                analysis on Pre-RFA rulemakings.
                 Response: As explained in the proposed rule, more resources will be
                required to review regulations that predate the RFA.\127\ The
                regulatory impact analysis for this final rule accounts for the
                additional resources required to conduct Reviews of rule makings that
                predate the RFA. But the criteria listed in 5 U.S.C. 610 are the
                criteria that Congress directed the Department to use when reviewing
                regulations that predate the RFA. Therefore, for rule makings that
                predate the RFA and have a SEISNOSE, this final rule requires that the
                Review consider the factors listed in 5 U.S.C. 610, as well as whether
                the component Sections within those rulemakings comply with applicable
                law.
                ---------------------------------------------------------------------------
                 \127\ See 85 FR 70115 (``Of the 273 rulemakings subject to
                Reviews in the first two years, the Department estimates roughly
                16%, or 44, of those rulemakings were promulgated prior to the
                requirement for prospective regulatory flexibility analyses. As
                described further below, those 44 Reviews will require more
                Department resources than the estimated 229 Reviews of rulemakings
                promulgated after the prospective analysis requirement went into
                effect'').
                ---------------------------------------------------------------------------
                 Comment: A few commenters asked for clarification on whether a
                regulation that is identified for amendment through the regulatory
                review process set forth in this final rule would be prioritized over
                new regulations the Department is promulgating.
                 Response: In the scenario described by commenters, the Department
                would aim to amend the referenced regulation and also promulgate new
                regulations that the Department believes should be promulgated.
                Experience shows the Department is able to amend existing regulations
                and promulgate new ones at the same time.
                 Comment: A few commenters asked if regulations that are sunset
                because they were not Assessed or Reviewed by the deadline would have
                to go through notice-and-comment rule making to be reissued if they
                were otherwise unchanged. These commenters also asked how these
                regulations would be prioritized by the Department.
                 Response: As explained throughout the proposed rule (and this final
                rule), the Department is committed to dedicating adequate resources to
                timely Assess and Review its regulations. If a regulation did
                automatically expire, though, the Department would be required to
                undertake notice-and-comment rule making to reissue the regulation,
                unless one of the exceptions to notice-and-comment rule making in 5
                U.S.C. 553 applies.
                 Furthermore, allowing for automatic reissuance of an expired
                regulation threatens to undermine the efficacy of this final rule. If
                there were no costs or obstacles to simply resurrecting an expired
                regulation in its original, pre-expiration form, then there would be no
                compelling incentive to timely Assess and Review Department
                regulations.
                 It is impossible to say at this point how the Department might
                ``prioritize'' re-issuance of expired regulations, without knowing
                which regulation is at issue and what other competing priorities the
                Department might have at the time. That said, the Department
                anticipates it will prioritize re-issuance of expired regulations in
                line with the public need for such regulation, balancing the same
                considerations it always does in allocating its policy-making
                resources. As noted above, the risk that important, ``priority''
                regulations--those that meaningfully impact regulated entities--will
                expire is mitigated by the fact that interested members of the public
                can alert the Department to a needed Assessment or Review. Commenters
                have also flagged regulations to review during the public comment
                process on this rule.
                 Comment: A few commenters stated that the Department should clarify
                how it will reconcile or update applicable guidance documents
                associated with rescinded regulations. If guidance documents remain in
                existence or are not updated to account for the regulatory changes
                resulting from the process established in this final rule, it could
                lead to confusion for regulated entities. A few commenters asked for
                clarification on whether the Department is considered to have Reviewed
                a regulation if the Department issues a guidance document on that
                particular regulation.
                 Response: The Department may not issue any guidance document that
                establishes a legal obligation that is not reflected in a duly enacted
                statute or in a regulation lawfully promulgated under a statute. The
                Department may not use any guidance document for purposes of requiring
                a person or entity outside the Department to take any action, or
                refrain from taking any action, beyond what is required by the terms of
                an applicable statute or regulation.\128\ Therefore, any guidance
                document based on an expired regulation has no effect. If a guidance
                document addresses expired regulations as well as regulations still in
                effect, the Department would seek to expeditiously revise the guidance
                document.
                ---------------------------------------------------------------------------
                 \128\ Department of Health and Human Services Good Guidance
                Practices, 85 FR 78785 (Dec. 7, 2020).
                ---------------------------------------------------------------------------
                 The Department is not considered to have Reviewed a Section simply
                because the Department issues a guidance document concerning that
                particular Section. The Department is only considered to have Reviewed
                a Section if, with respect to the Section, the Department has followed
                the procedures specified in section [XX](f) of this final rule. The
                Department must publish the results of the Review, including the full
                underlying analyses and data used to support the results (subject to
                any applicable privilege, protections for confidential business
                information, or explicit legal prohibition on disclosure), in the
                Federal Register.
                 Comment: A few commenters asked how other enforcement agencies,
                such as the Office of the Inspector General or the Department of
                Justice, and federal healthcare program contractors, would be affected
                by the proposed rule. Commenters stated that a lack of coordination
                between agencies and other entities with equities in an expired
                regulation could lead to different and possibly contrary conclusions
                about how to proceed. These commenters also stated that this could lead
                to conflicting requirements, resulting in different rules in different
                jurisdictions. Commenters asked the Department to clarify how corporate
                compliance programs should advise their organizations if a regulation
                expires.
                 Response: This final rule applies to the HHS Office of Inspector
                General (OIG), which is a component of HHS, although certain
                regulations for which OIG has enforcement responsibility are exempt,
                such as 42 CFR 1001.952. For regulations that were issued in
                coordination with another Agency, that function in concert with another
                Agency's regulations, or that have a specific, direct impact on
                regulations issued by another Federal agency, the Department shall
                consult with that other Agency when undertaking the Assessment or
                Review, and consider the other Agency's views when considering the
                factors described in section [XX](d). In addition, when Assessing or
                Reviewing regulations that require review and approval by the Attorney
                General under Exec. Order No. 12250 of
                [[Page 5713]]
                Nov. 2, 1980, 45 FR 72995 (Nov. 4, 1980), the Department will consult
                with the Department of Justice (DOJ) and provide a draft of the
                findings to DOJ well in advance of the Assessment or Review deadline so
                DOJ can review and approve prior to the publication of the findings. If
                an HHS regulation is amended, rescinded, or expires, no other
                governmental body may take a different view of the regulation's legal
                effect.
                 Regarding how corporate compliance programs should advise their
                organizations if a regulation expires, an HHS regulation that expires
                no longer has legal effect and cannot be enforced by any governmental
                body against a regulated entity.
                 Comment: One commenter stated that HHS observes that the proposed
                rule's review requirements ``do not impose new burdens . . . if
                incomplete compliance [with the Regulatory Flexibility Act] is not
                accounted for in the regulatory baseline.'' \129\ But HHS's entire
                rationale for the proposed pule, according to the commenter, is that
                incomplete compliance with existing review requirements is and will
                continue to be a problem under the regulatory baseline (i.e., absent
                the proposed rule).
                ---------------------------------------------------------------------------
                 \129\ 85 FR 70112.
                ---------------------------------------------------------------------------
                 Response: HHS maintains that the proposed rule, as well as this
                final rule, does not impose new burdens if incomplete compliance with
                the RFA is not accounted for in the regulatory baseline. HHS recognizes
                that, after implementation of this final rule, the Department's
                Assessments and Reviews will likely result in an additional resource
                expenditure beyond what would occur absent promulgation of this final
                rule. This was analyzed in the Regulatory Impact Analysis of the
                proposed rule and in more detail (largely due to comments received) in
                the Regulatory Impact Analysis of this final rule. It is worth noting,
                though, that the burdens resulting from this final rule are burdens
                that Congress already intended for the Department to bear.
                 Comment: A few commenters stated that the Department does not cite
                any reason why a regulatory review should be triggered by the age of a
                regulation or why ten years should be the trigger. Some commenters
                stated that a regulatory review could also be based on the subject
                matter of the regulation, its economic impact, or the number of people
                it affects. Other commenters pointed out that the Department also could
                have used a different time period other than ten years to conduct its
                reviews. Commenters point to the Department's citation to a number of
                foreign and sub-national entities that mandate the reviews of
                regulations after five or seven years. These commenters stated that
                since there are other options for the frequency of regulatory review,
                the proposal to have such rules automatically expire after ten years is
                arbitrary and capricious.
                 Response: HHS respectfully disagrees. The proposed rule explained
                why the Department chose ten years:
                 The Department proposes to perform the Assessment and (if
                required) the Review on each Regulation every ten years. Some states
                provide that, unless readopted or re-reviewed, their regulations
                expire in seven years,\130\ while at least one state uses a ten-year
                time period.\131\ The Department proposes to perform the Assessment
                and (if required) the Review every ten years, because ten years is
                the period listed in 5 U.S.C. 610. The Department has many
                Regulations, some of which are complex, so having to perform the
                Assessment and Review more than once every ten years could unduly
                burden the Department and increase the likelihood that a Regulation
                inadvertently expires because it is not Assessed or Reviewed.\132\
                ---------------------------------------------------------------------------
                 \130\ See, e.g., N.J. Admin. Code Sec. 1:30-6.4 (2020)
                (regulations expire every seven years unless readopted, subject to
                certain exceptions); Ind. Code 4-22-2.5-2 (imposing seven-year
                expiration date on regulations unless readopted).
                 \131\ N.C. Gen. Stat. 150B-21.3A.
                 \132\ 85 FR at 70106.
                 This rationale still holds. In this final rule, the Department
                decides to Review rules that have a SEISNOSE, because those are the
                rules that the RFA directed HHS to review.
                 Comment: A few commenters stated that the proposed rule interferes
                with the RFA's procedure for regulatory review. 5 U.S.C. 610-611. These
                commenters note that those sections require agencies to publish plans
                for regulatory review, provide a schedule for revision that varies by
                agency, give agency heads the right to delay review for one-year
                periods, up to a maximum of five years, identify multiple factors that
                must be considered in reviewing each rule, prescribe the terms of
                public notice via the Federal Register, and specify judicial appeal
                procedures and criteria, including standing rights and remedies. These
                commenters also stated that the Department's proposed rule would scrap
                that process and replace it with a default of across-the-board
                regulatory repeal in case of inaction, without recourse, using a
                completely different system of judicial review premised on the
                underlying APA, rather than the RFA. Commenters stated that this would
                be a usurpation of Congress's role, and would raise constitutional
                questions involving balance of power between the branches. According to
                commenters, the Department must address this issue or else promulgating
                this final rule would be arbitrary and capricious.
                 Response: HHS respectfully disagrees. This final rule is consistent
                with the RFA's requirement to publish a plan for periodic review--it is
                such a plan, and the RFA does not prohibit the Department from
                including expiration dates in its regulations. The Review process
                considers the five factors enumerated in the RFA. See 5 U.S.C. 610(b).
                This final rule requires publication in the Federal Register of the
                results of Assessments and Reviews under section [XX](f). This final
                rule does not supplant or purport to foreclose any available judicial
                review under 5 U.S.C. 611. And with respect to section 610 compliance,
                the RFA's judicial-review provisions expressly cross-reference the
                broader APA judicial-review provisions. See 5 U.S.C. 611(a)(1) (``For
                any rule subject to this chapter, a small entity that is adversely
                affected or aggrieved by final agency action is entitled to judicial
                review of agency compliance with the requirements of sections 601, 604,
                605(b), 608(b), and 610 in accordance with chapter 7.'') (emphasis
                added). Because this rule is consistent with the RFA, it does not usurp
                Congress's role or raise constitutional separation-of-power concerns.
                To the contrary, it implements Congressional intent for periodic review
                of regulations. Section II.F of this final rule further addresses the
                commenters' concerns in discussing how the Department will
                operationalize this final rule.
                 Comment: Several commenters stated that the proposed rule violates
                the RFA's intent as expressed by Congress. In passing the RFA, Congress
                expressly made the following finding: ``the practice of treating all
                regulated businesses, organizations, and governmental jurisdictions as
                equivalent may lead to inefficient use of regulatory agency resources,
                enforcement problems and, in some cases, to actions inconsistent with
                the legislative intent of health, safety, environmental and economic
                welfare legislation.'' \133\ These commenters stated that the proposed
                rule departs from the Congressional intent in passing the RFA because
                the proposed rule would subject every regulation to mandatory review as
                well as repeal by default. In this way, the proposed rule ``treats all
                regulated businesses, organizations, and governmental jurisdictions as
                equivalent'' by terminating all
                [[Page 5714]]
                regulations, without considering the unique set of stakeholders
                affected by each regulation.
                ---------------------------------------------------------------------------
                 \133\ Public Law 96-354, 94 Stat. 1164, 1164 (1980) (as amended
                1996).
                ---------------------------------------------------------------------------
                 Response: HHS respectfully disagrees with these comments because
                these commenters fundamentally misunderstand the operation of this
                final rule, as well as the Congressional finding they quote. This final
                rule does not repeal regulations by default. As explained in this final
                rule, the Department intends to timely complete the necessary
                Assessments and Reviews and has built in safeguards to mitigate the
                risk of inadvertent expiration. Under this final rule, the Department
                must Assess which of its rule makings have a significant economic
                impact upon a substantial number of small entities, and then perform
                the more robust Reviews on those rule makings. Therefore, the
                Department is paying special attention to those regulations which have
                a significant economic impact upon a substantial number of small
                entities. As explained in the proposed rule, the Department cannot know
                which regulations currently have a SEISNOSE without Assessing its
                regulations.\134\ This process is consistent with the RFA, which
                instructs agencies to review ``the rules issued by the agency which
                have or will have a significant economic impact upon a substantial
                number of small entities.''
                ---------------------------------------------------------------------------
                 \134\ See 85 FR 70107.
                ---------------------------------------------------------------------------
                 Reviews consider the five factors expressly included within the
                RFA, as well as an additional factor that is indisputably beneficial
                and appropriate: ``Whether the rulemaking complies with applicable
                law.'' See Section [XX](d). Subjecting regulations with a SEISNOSE to
                Review does not ``treat all regulated businesses, organizations, and
                governmental jurisdictions as equivalent'' because the findings of the
                Review will be tailored to the regulation.\135\
                ---------------------------------------------------------------------------
                 \135\ Under the commenters' argument, the fact that the RFA sets
                forth five factors to be considered (see 5 U.S.C. 610(b)) would also
                supposedly be inconsistent with Congressional intent.
                ---------------------------------------------------------------------------
                 The commenters also quote the language from the Congressional
                findings and declaration of purpose out of context. Congress was
                clearly focused on agencies ignoring the distinction between ``large
                scale entities'' and small entities.\136\ Given that this rule closely
                tracks the RFA's goal of minimizing undue burden on small entities, it
                aligns with the Congressional intent behind the RFA.
                ---------------------------------------------------------------------------
                 \136\ See Public Law 96-354, 94 Stat. 1164, 1164 (1980) (as
                amended 1996), Sec. 2(a)(2) (``laws and regulations designed for
                application to large scale entities have been applied uniformly to
                small businesses, small organizations, and small governmental
                jurisdictions even though the problems that gave rise to government
                action may not have been caused by those smaller entities''); Sec.
                2(b) (``It is the purpose of this Act to establish as a principle of
                regulatory issuance that agencies shall endeavor, consistent with
                the objectives of the rule and of applicable statutes, to fit
                regulatory and informational requirements to the scale of the
                businesses, organizations, and governmental jurisdictions subject to
                regulation.'').
                ---------------------------------------------------------------------------
                 Comment: A commenter stated that automatic expiration of Department
                regulations could frustrate the RFA's purpose by inappropriately
                sunsetting rules that increase economic benefits for small entities.
                This commenter stated that the proposed rule does not sufficiently
                address this concern. This commenter also stated that the proposed rule
                undermines congressional intent because the proposed rule does not
                consider that the Department may be impeding its ability to conduct
                reviews under the RFA by instituting added procedural requirements and
                broadly applicable regulatory sunsets. This commenter further stated
                that expiration dates are particularly contrary to effectuating RFA
                compliance because the Department will need to prioritize assessing
                rules without any impact on small entities simply due to their imminent
                expiration, rather than using Department resources efficiently to focus
                on rules requiring the Department's review under the RFA.
                 Response: The Department respectfully disagrees. The RFA calls on
                the Department to periodically review regulations that have a
                significant economic impact upon a substantial number of small
                entities. This final rule intends to increase the number of such
                reviews that occur, and directs the Department to review using the
                criteria specified in 5 U.S.C. 610(b) (plus whether the rule making
                complies with applicable law). As for Assessing regulations not
                previously determined to have a SEISNOSE, implicit in 5 U.S.C. 610 is
                the requirement to determine which regulations have a SEISNOSE.\137\
                Without performing the Assessment, the Department may not know which
                regulations have or will have a significant economic impact upon a
                substantial number of small entities. Due to changed circumstances, a
                regulation that did not have such an impact at the time it was
                promulgated may now have such an impact.\138\ 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. The regulatory impact analysis addresses this in more detail.
                ---------------------------------------------------------------------------
                 \137\ 85 FR 70112.
                 \138\ 85 FR 70107.
                ---------------------------------------------------------------------------
                 Comment: A few commenters stated that beyond simply cutting
                regulatory burdens, the scheduled regulatory review of existing HHS
                regulations will afford HHS the opportunity to keep regulations up to
                date with modern trends. These commenters noted that not only will this
                rule establish an opportunity for the Department to terminate obsolete
                regulations that are no longer fit for purpose or that are judged to be
                ineffective, but it will also give HHS and the public a reliable
                framework and a set of tools to continually keep regulations up to date
                with evolving circumstances.
                 Response: The Department agrees with these comments and emphasizes
                that the benefits of retrospective review--some of which are cited by
                these commenters--are substantial. As the proposed rule noted,
                Professor Cass Sunstein, who served as OIRA Administrator from 2009 to
                2012, has observed that ``the requirement of retrospective analysis,''
                if ``firmly institutionalized,'' ``would count as the most important
                structural change in regulatory policy since the original requirement
                of prospective analysis during the Reagan Administration.'' \139\
                ---------------------------------------------------------------------------
                 \139\ Cass R. Sunstein, The Regulatory Lookback, 94 B.U. L. Rev.
                579, 584 (2014).
                ---------------------------------------------------------------------------
                 Comment: A few commenters stated that regulatory review does not
                create as much benefit to regulated entities as the proposed rule
                suggests, because many of the costs of regulatory compliance have
                already been factored into the cost of doing business, and are
                essentially evanescent over time.
                 Response: While some costs of regulatory compliance may have been
                factored into the cost of doing business, this comment overlooks many
                of the benefits of retrospective review. For example, economic,
                technological, or legal changes can make a regulation obsolete over
                time. Retrospective review is widely acknowledged to be beneficial by
                scholars across the ideological spectrum, many of whom are cited in the
                proposed and this final rule.
                 Comment: A commenter asked for greater detail on the Assessment and
                Review process, especially planning of what is to be included and
                excluded in the retrospective review process. The commenter also asked
                for greater explanation of how the Department will provide notification
                of what rules have been Assessed. The commenter also asked what would
                happen if a part of a rule was reviewed but not other parts of it.
                [[Page 5715]]
                 Response: Section II.F of this final rule's preamble provides
                greater detail on the Assessment and Review process and the
                Department's planning for Assessments and Reviews. Examples of Section
                610 reviews conducted by the EPA are instructive on how the Department
                anticipates the five factors set forth in 5 U.S.C. 610(b) will be
                analyzed.\140\ The results of all Assessments and Reviews conducted in
                a calendar year will be published in a single document in the Federal
                Register during that calendar year. The Department also intends to
                place the results of an Assessment or Review in the docket for the rule
                on Regulations.gov. Lastly, this final rule defines ``Assess'' as a
                determination as to whether the ``Sections issued as part of the same
                rulemaking (and any amendments or additions that may have been added
                thereafter)'' currently have a significant economic impact upon a
                substantial number of small entities. This final rule defines
                ``Review'' as a process the purpose of which is to determine whether
                ``Sections that were issued as part of the same rulemaking (and any
                amendments or additions that may have been issued thereafter)'' should
                be continued without change, amended, or rescinded. Thus, while
                Sections are what expire if they are not timely Assessed or Reviewed,
                the Department should be Assessing or Reviewing all Sections that were
                part of the same rulemaking (and any amendments or additions that may
                have been issued thereafter), not just some of them.
                ---------------------------------------------------------------------------
                 \140\ See Results of EPA's Section 610 Review of the Final Rule
                for Control of Emissions of Air Pollution from Nonroad Diesel
                Engines and Fuel, EPA Off. of Transp. & Quality (Sept. 2014),
                https://www.regulations.gov/document?D=EPA-HQ-OAR-2013-0642-0003;
                Regulatory Flexibility Act Section 610 Review of the National
                Pollutant Discharge Elimination System (NPDES) Permit Regulation and
                Effluent Limitation Guidelines and Standards for Concentrated Animal
                Feeding Operations (CAFOs), EPA Off. of Water (June 3, 2014),
                https://www.regulations.gov/document?D=EPA-HQ-OW-2012-0813-0216;
                Results of EPA's Section 610 Review of the Final Rule for Lead;
                Renovation, Repair, and Painting Program, EPA Off. of Pollution
                Prevention and Toxics (Apr. (April 2018), https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0126-0019.
                ---------------------------------------------------------------------------
                 Comment: One commenter stated that it previously advocated for the
                review and modernization of some of the Department's regulations
                covering Medicare health and safety standards. For example, according
                to the commenter, the Medicare Conditions of Participation regulations
                for psychiatric hospitals do not align their requirements with modern
                psychiatric care. However, the commenter stated that no substantive
                revisions to the provisions have occurred since the requirements for
                psychiatric hospitals were first implemented, meaning that a
                comprehensive review of these regulations has not occurred for at least
                40 years, when psychiatric care was delivered much differently. This
                commenter stated that this is a clear example of why regular regulatory
                reviews are necessary.
                 Response: The Department thanks the commenter for identifying these
                regulations. The Department intends to timely Assess and (if necessary)
                Review these regulations. If the Assessments and Reviews suggest these
                regulations should be amended or rescinded, the Department will
                commence rulemaking to amend or rescind them.
                 Comment: A few commenters applauded the Department for continuing
                the bipartisan work on regulatory review to ensure federal agencies are
                continually held accountable to taxpayers and that regulations remain
                relevant and updated to innovation and changes in market conditions.
                The commenters also asked when the planning and drafting of the
                proposed rule began, any recent regulatory actions that would
                demonstrate the effects that regulatory reviews, suspensions, or
                updates can have on the health care industry, or the economy more
                broadly, and a list of Department regulations suspended during the
                pandemic.
                 Response: The Department thanks the commenters for the first part
                of this comment. Second, for a non-exhaustive list of 382 enforcement
                discretion announcements, waivers or changes to regulations, agency
                guidance materials, or compliance obligations made to respond to the
                COVID-19 pandemic and its impact on the healthcare industry, see
                Regulatory Relief to Support Economic Recovery; Request for Information
                (RFI), 85 FR 75720 (Nov. 25, 2020) at Attachment A. The planning and
                drafting of the proposed rule is subject to the deliberative process
                privilege, but evolved out of the 2019 regulatory streamlining analysis
                discussed in the proposed rule.
                Technical Legal Comments
                 Comment: A large number of commenters stated that the proposed rule
                would violate the Administrative Procedure Act (APA), because it would
                allow the Department to revise or rescind thousands of regulations at
                one time instead of conducting notice and comment rulemaking on each
                existing individual rule it chooses to repeal. Some of these commenters
                also mentioned that the APA requires agencies to use substantially the
                same process to repeal a rule as they used to promulgate a rule, so a
                process that allows for automatic expiration of a rule would not meet
                this statutory requirement. A commenter stated that ``Revocation
                constitutes a reversal of the agency's former views as to the proper
                course'' and ``[w]hile the agency is entitled to change its view on [a
                matter], it is obligated to explain its reasons for doing so. . . .
                [A]n agency changing its course by rescinding a rule is obligated to
                supply a reasoned analysis for the change'' and ``[g]enerally, one
                aspect of that explanation would be a justification for rescinding the
                regulation . . .'' (quoting Motor Vehicles Mfrs. Ass'n of U.S., Inc. v.
                State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 41, 42, 52, 56 (1983)).
                Commenters stated that this rule would be arbitrary and capricious on
                these grounds. One commenter stated that if the Department does not
                perform an affirmative action to prevent expiration of a regulation,
                the Department would fail to articulate a satisfactory explanation for
                its expiration, making the agency action arbitrary and capricious.
                 Response: This final rule complies with the APA. The APA generally
                requires, with certain exceptions, notice and comment prior to
                finalizing a ``rule making,'' 5 U.S.C. 553, which is defined as
                ``formulating, amending, or repealing a rule.'' 551(5). See Motor
                Vehicles Mfrs. Ass'n of U.S. v. State Farm Mut. Auto. Ins. Co., 463
                U.S. 29, 41 (1983) (``We believe that the recession or modification of
                an [agency rule] is subject to the same test.''). The APA has already
                ``established the maximum procedural requirements which Congress was
                willing to have the courts impose upon agencies in conducting
                rulemaking procedures.'' Vt. Yankee Nuclear Power Corp. v. Nat. Res.
                Def. Council, Inc., 435 U.S. 519, 524 (1978). Neither courts nor
                regulated entities may ``impose upon [an] agency its own notion of
                which procedures are `best' or most likely to further some vague,
                undefined public good.'' Id. at 549.
                 The Department agrees with commenters who stated the APA generally
                requires agencies to use substantially the same process to amend or
                repeal a rule as they used to promulgate a rule. The Department is
                complying with this requirement. See Clean Air Council v. Pruitt, 862
                F.3d 1, 9 (2017) (an agency can amend or revoke a legislative rule
                through notice-and-comment rulemaking). In this rule making, the
                Department has gone through notice-and-comment rule making to amend its
                regulations by establishing conditions under which the regulations will
                either be Assessed and/
                [[Page 5716]]
                or Reviewed or expire. This is permissible. The Department is going
                through notice-and-comment rule making to amend its regulations to
                apply expiration dates unless certain conditions are satisfied.
                Agencies already promulgate regulations that expire upon the
                satisfaction of a future event or non-event.\141\ Nothing in the APA
                forecloses agencies from including conditional expirations dates in
                regulations. It would call into question many rules--and be extremely
                disruptive--if courts held that conditional expiration dates violate
                the APA.
                ---------------------------------------------------------------------------
                 \141\ See, e.g., Control of Communicable Diseases; Foreign
                Quarantine 85 FR 7874, 7874 (Feb. 12, 2020) (providing that, unless
                extended, interim final rule ``will cease to be in effect on the
                earlier of (1) the date that is two incubation periods after the
                last known case of 2019-nCoV, or (2) when the Secretary determines
                there is no longer a need for this interim final rule''); Medicare
                and Medicaid Programs, Clinical Laboratory Improvement Amendments
                (CLIA), and Patient Protection and Affordable Care Act; Additional
                Policy and Regulatory Revisions in Response to the COVID-19 Public
                Health Emergency, 85 FR 54820, 54820 (Sept. 2, 2020) (providing that
                an interim final rule applies ``for the duration of the [public
                health emergency] for COVID-19''); U.S. Dep't of Transp., Final
                Regulatory Impact Analysis: Amendment to Federal Motor Vehicle
                Safety Standard 208 Passenger Car Front Seat Occupant Protection, at
                XII-35 (July 11, 1984), http://www-nrd.nhtsa.dot.gov/Pubs/806572.pdf
                (explaining that ``[i]f mandatory use laws are passed that will
                cover 67 percent of the population effective September 1, 1989, the
                rule will be rescinded'').
                ---------------------------------------------------------------------------
                 The Department also rejects the argument that it cannot revise many
                regulations in one rule making, but instead must conduct notice-and-
                comment rule making on each individual regulation it seeks to amend or
                rescind. The APA does not include such a requirement. When 5 U.S.C.
                551(5) defines ``rule making'' as an ``agency process for formulating,
                amending, or repealing a rule'' (emphasis added), that includes
                formulating, amending, or repealing ``rules.'' See 1 U.S.C. 1 (``In
                determining the meaning of any Act of Congress, unless the context
                indicates otherwise--words importing the singular include and apply to
                several persons, parties, or things''). Agencies can--and often do--
                issue one rule that applies to many other agency rules, rather than
                amending or rescinding each affected regulation individually. To take
                one example, in 2008 the Department revised the definition of
                ``entity'' at 42 CFR 411.351. See 73 FR 48434, 48751 (Aug. 19, 2008).
                The revised definition had the effect of changing the meaning of
                ``entity'' each time it was used in 42 CFR part 411, subpart J. It
                would be burdensome to specify the meaning of ``entity'' each time it
                appears in subpart J, so the Department issued one definition that
                broadly applied to all sections of subpart J. There are many other
                examples where an Agency issues a regulation that applies to, amends,
                rescinds, or supersedes many other regulations.\142\ This avoids an
                unnecessarily cumbersome process. A court ruling that Agencies must
                amend each individual regulation would call into question large numbers
                of Agency regulations and impose substantial burdens on agencies (and
                the Office of the Federal Register, which would be required to print
                the same text over and over) when promulgating future regulations. In
                addition, the Department will consider each individual regulation when
                conducting Assessments and (if needed) Reviews.
                ---------------------------------------------------------------------------
                 \142\ See, e.g., 21 CFR 1.1(b) (``the definitions and
                interpretations of terms contained in sections 201 and 900 of the
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 and 387) shall
                be applicable also to such terms when used in regulations
                promulgated under that act'').''); 7 CFR 786.113 (``Notwithstanding
                any other regulation, interest will be due from the date of the
                disbursement to the producer or other recipient of the funds''); 40
                CFR 455.21 (``Notwithstanding any other regulation, process
                wastewater flow for the purposes of this subpart does not include
                wastewaters from the production of intermediate chemicals''); 7 CFR
                3430.1 (``In cases where regulations of this part conflict with
                existing regulations of NIFA in Title 7 (i.e., 7 CFR parts 3400
                through 3499) of the Code of Federal Regulations, regulations of
                this part shall supersede''); 45 CFR 611.12 (``All regulations . . .
                heretofore issued by any officer of the Foundation which impose
                requirements designed to prohibit any discrimination against
                individuals on the ground of race, color, or national origin under
                any program to which this part applies, and which authorize the
                suspension or termination of or refusal to grant or to continue
                Federal financial assistance to any applicant for or recipient of
                such assistance for failure to comply with such requirements, are
                hereby superseded to the extent that such discrimination is
                prohibited by this part,'' with certain exceptions).
                 .
                ---------------------------------------------------------------------------
                 Moreover, in this rule making the Department considered each
                individual Department regulation, and, as discussed further, decided to
                exempt certain regulations from this final rule. The Department
                concluded that the benefits of retrospective review, and need to more
                strongly incentivize it, justified applying this final rule to the
                Department's remaining regulations. In this rule making, the Department
                is considering the important factors. It issues this final rule
                because, for the reasons described herein, the Department believes the
                benefits of retrospective review, and the need to strongly incentivize
                it, are so great that the risk of a regulation inadvertently expiring
                is justified by the benefit of institutionalizing retrospective review
                in this manner. Forty years of experience since the RFA's enactment;
                the decades since relevant Executive Orders were enacted; and other
                Federal government efforts to spur the Department to conduct more
                retrospective reviews indicate that, absent such a pushing mechanism,
                the Department will not conduct as many retrospective reviews as
                desired. Indeed, this final rule, rather than being a revocation of
                prior regulations, will enhance the fulfillment of the existing
                policies that led to the Department's regulations subject to this final
                rule.
                 Comment: Many commenters stated that the proposed rule could create
                legal uncertainty regarding the validity and enforceability of
                regulations that the Department, after conducting a Review, determines
                should be amended or rescinded. Commenters stated this could have
                negative effects on the HHS programs, the healthcare industry, and
                states which administer Medicaid and CHIP. Some of these commenters
                stated that HHS admits that enforcing a Regulation deemed to require
                amendment or rescission in some cases could raise concerns about
                whether such enforcement is arbitrary and capricious. Continuing to
                enforce the regulation (or portions thereof) could arguably run counter
                to the evidence before the agency. However, these commenters stated
                that, HHS provides no insight or explanation on how it would address
                this conundrum.
                 Response: The Department respectfully disagrees. The commenters'
                concerns only apply where the Department has announced, after Review,
                that a regulation should be amended or rescinded. Where that is the
                case, the announced results will suggest what portions of the
                regulation may need revision and the Department anticipates that
                commenters will generally be able to participate in subsequent rule
                making regarding amending or rescinding the regulation. The basis for
                amendment or rescission will suggest the extent to which continued
                enforcement in the interim is appropriate. That is why the proposed
                rule states the Department would exercise enforcement discretion ``on a
                case-by-case basis as appropriate.'' \143\ Consistent with Department
                practice, the Department would announce if it is exercising enforcement
                discretion to not enforce a regulation.
                ---------------------------------------------------------------------------
                 \143\ 85 FR 70108.
                ---------------------------------------------------------------------------
                 Comment: Several commenters stated that if Congress's intent was to
                effectuate results similar to those in the proposed rule, it could have
                included sunset provisions in its statutes. By not including sunsets in
                its statutes, Congress must not have perceived a need for
                Congressionally-directed
                [[Page 5717]]
                rulemaking to expire in the foreseeable future, or at least not
                automatically.
                 Response: HHS disagrees that Congress's choice to not include
                automatic sunset provisions in its statutes undercuts or forecloses the
                proposed rule. The RFA requires the Department to develop ``a plan for
                the periodic review of the rules issued by the agency which have or
                will have a'' SEISNOSE, but leaves the details of said plan to the
                Department. 5 U.S.C. 610(a). The RFA demonstrates Congress's intent
                that agencies conduct retrospective review, and the Department has
                determined, for the reasons explained in the proposed rule, that sunset
                provisions are a practical and effective way to ensure that
                Congressional intent is honored. The commenters' position suggests it
                is improper to take steps to effectuate Congressional intent if
                Congress itself has not expressly legislated such steps--but, of
                course, agencies frequently fill in the details of a statutory regime
                implemented by Congress.
                 Comment: One commenter stated that the proposed rule is misleading,
                which thwarts public comment and violates the APA. This commenter
                stated that it was misleading and irrational for HHS to suggest that it
                is hypothetical whether any regulation would sunset under the rule,
                because every regulation would sunset unless a timely Assessment or
                Review occurs. This commenter suggested that the rule's description is
                inadequate to meet the notice standard required by the APA. This
                commenter reasoned that the Department's explanation of the proposed
                rule and its reasoning did not provide the public with a meaningful
                opportunity to participate in rulemaking through the submission of
                comments, which violates the notice and comment requirement of the APA.
                5 U.S.C. 553.
                 Response: HHS respectfully disagrees. ``The APA requires that the
                notice of proposed rulemaking contain `reference to the legal authority
                under which the rule is proposed' and `either the terms or substance of
                the proposed rule or a description of the subjects and issues
                involved.' '' Little Sisters of the Poor Saints Peter and Paul Home v.
                Pa., 140 S. Ct. 2367, 2384 (2020) (quoting 5 U.S.C. 553(b)(2)-(3)). The
                notice of proposed rulemaking, which spanned 29 pages of the Federal
                Register, did just that. The adequacy of the notice is demonstrated by
                the fact that the agency received 532 comments--both critical and in
                support of the proposed rule--that raised general issues as well as
                commented on specific provisions of the proposed rule. The volume of
                comments also demonstrates that the public had ample, meaningful
                opportunity to participate in this rulemaking. There is nothing
                misleading in the Department's statement that it intends to timely
                Assess and (where required) Review its Sections. The proposed rule and
                this final rule adequately explain the basis for this final rule.
                 Comment: One commenter stated that the proposed rule is arbitrary
                and capricious because the stated rationale of incentivizing
                retrospective regulatory review is implausible. This commenter stated
                that it is wrong to think that the Department is incentivized to Assess
                or Review its regulations, because the Department may want its
                regulations to expire. The commenter said that the penalty for failure
                to review regulations actually falls on the regulated industry, not the
                Department. The commenter stated that HHS unlawfully ignored the
                predictable effects of the proposed rule on third parties.
                 Response: HHS respectfully disagrees. The proposed rule amply
                explained the benefits of retrospective review. It also explained why
                sunset deadlines were necessary to incentivize retrospective review
                (including, for example, the Department's experience with under-
                utilization of retrospective review). This rationale is not implausible
                because of the speculative possibility that the Department will
                intentionally forego Assessments and Reviews. If the Department wanted
                its regulations to expire, it would have conducted rulemakings to
                rescind its regulations. The proposed rule and this final rule
                demonstrate the Department's commitment to timely Assess and (where
                necessary) Review its regulations. For example, the proposed rule and
                final rule include (among other things) a clear-eyed analysis of the
                resources and staff time required to conduct Assessments and Reviews,
                and provide a mechanism for the public to request the Department to
                conduct Assessments and Reviews on certain regulations.
                 Comment: A few commenters stated that the proposed regulatory
                review process is arbitrary and capricious, because it elevates the
                need to undertake RFA reviews above any other purpose served by the
                Department's regulations, which commenters state is disproportionate to
                the problem at hand. These commenters state that since HHS estimates
                that only 11% of its regulations have a SEISNOSE and would be subject
                to the RFA, it is arbitrary and capricious to subject the other 89% of
                regulations to possible rescission.
                 Response: HHS respectfully disagrees. As explained in the proposed
                rule and this final rule's preamble, there is a need for widespread
                retrospective regulatory review. It is nearly impossible to see how a
                satisfyingly comprehensive review could occur without a sunset
                mechanism. The Department recognizes that in many cases the Department
                had strong reasons for issuing its regulations. Those regulations were
                motivated by important policy goals that the Department wishes to
                achieve. This final rule will further these goals. The literature and
                the Department's experience suggest that large numbers of regulations
                are having impacts that, over time, differ from what was estimated at
                the time the regulations were promulgated. Therefore, the Department
                needs to conduct periodic reviews of its regulations to determine
                whether the policy goals behind the regulations are in fact being
                effected (and if amending those regulations could more effectively
                further those goals). Therefore, this final rule is in fact an effort
                to enhance both (1) the fulfillment of the existing policies that led
                to the Department's regulations and (2) the Department's longstanding
                desire to comply with the RFA and periodically review its regulations.
                 As for conducting Assessments on many regulations, and not just
                Reviewing those regulations previously determined to have a SEISNOSE,
                the proposed rule explained that ``[w]ithout performing the Assessment,
                the Department may not know which regulations have or will have a
                significant economic impact upon a substantial number of small
                entities. Due to changed circumstances, a regulation that did not have
                such an impact at the time it was promulgated may now have such an
                impact.'' \144\
                ---------------------------------------------------------------------------
                 \144\ 85 FR 70107.
                ---------------------------------------------------------------------------
                 Comment: One commenter stated that the Department may not finalize
                the proposed rule without conducting a review under the National
                Environmental Policy Act (NEPA) or considering how the proposed rule is
                consistent with Executive Orders 13045 or 12898.
                 This commenter stated that HHS violated its obligations under NEPA
                because commenters believe the rule is a major federal action.
                According to the commenter, the proposed rule stated that it ``will not
                have a significant impact on the environment'' without providing
                additional explanation.\145\ The commenter stated that the FDA's own
                NEPA regulations require it to conduct at least an environmental
                assessment before promulgating certain
                [[Page 5718]]
                regulations, and FDA cannot rescind those regulations without
                conducting NEPA review. See 21 CFR 25.20.
                ---------------------------------------------------------------------------
                 \145\ 85 FR 70118.
                ---------------------------------------------------------------------------
                 This commenter also stated that the proposed rule does not
                adequately consider Executive Orders 13045 or 12898. Executive Order
                13045 imposes requirements on agencies to protect children from
                environmental health risks and safety risks.\146\ The commenter stated
                that because the Department did not mention Executive Order 13045 in
                its proposed rule, it must have failed to consider it. Executive Order
                12898 directs federal agencies to make environmental justice part of
                their mission, and to identify and address the disproportionate
                environmental and health effects of their activities.\147\ This
                commenter expressed that HHS did not consider whether the proposed
                sunset rule will cause ``disproportionately high and adverse human
                health or environmental effects . . . on minority populations and low-
                income populations'' \148\ even though the commenter believes there is
                every reason to think that the sunset rule will cause such adverse
                effects.
                ---------------------------------------------------------------------------
                 \146\ Exec. Order No. 13045 of Apr. 21, 1997, 62 FR 19885 (Apr.
                23, 1997) (E.O. 13045).
                 \147\ Exec. Order No. 12898 of Feb. 11, 1994, 59 FR 7629 (Feb.
                16, 1994) (E.O. 12898).
                 \148\ Id.
                ---------------------------------------------------------------------------
                 Response: HHS respectfully disagrees that further analysis under
                NEPA, E.O. 12898 (``Federal Actions To Address Environmental Justice in
                Minority Populations and Low-Income Populations''), and/or E.O. 13045
                (``Protection of Children From Environmental Health Risks and Safety
                Risks''), is required. The commenter's position is based on a
                fundamental misunderstanding of how the final rule functions. As
                explained in the notice of proposed rulemaking, this rule does not in
                and of itself rescind any regulations; it provides that certain
                regulations will expire if not Assessed and (if required) Reviewed by
                certain dates.
                 Thus, there is no basis to say that this final rule itself
                ``significantly affect[s] the quality of the human environment,'' 42
                U.S.C. 4332(C); may cause ``disproportionately high and adverse human
                health or environmental effects . . . on minority populations and low-
                income populations,'' E.O. 12898, Sec. 1-101; or ``concern[s] an
                environmental health risk or safety risk that an agency has reason to
                believe may disproportionately affect children,'' E.O. 13045 Sec. 2-
                202(b).\149\
                ---------------------------------------------------------------------------
                 \149\ See also 85 FR 70118 (``HHS has determined that the
                proposed rule will not have a significant impact on the
                environment.'').
                ---------------------------------------------------------------------------
                 The commenter says an environmental assessment may be necessary,
                including consideration of alternatives as required by section
                102(2)(E) of NEPA, 40 CFR 1501.5(c)(2), if it is unclear whether the
                rule will significantly affect the environment. But it is clear that
                this rule alone does not have a significant environmental impact. Any
                rescissions or amendments pursuant to Assessments and Reviews will be
                effected through notice-and-comment rulemaking independent of this rule
                and include any required environmental (and other) analyses. In any
                event, the Department adequately explained the alternatives it
                considered in its proposed rule,\150\ as well as in the regulatory
                impact analysis for this final rule.
                ---------------------------------------------------------------------------
                 \150\ See 85 FR 70116-17.
                ---------------------------------------------------------------------------
                 Comment: A few commenters stated that HHS mistakenly exempts the
                proposed rule from the regulatory review process it creates. The
                proposed rule states that it ``cannot, absent other actions, directly
                impose on the public costs that exceed benefits . . . [o]nly the
                failure to perform an Assessment or Review in the future could
                theoretically impose on the public costs that exceed benefits.'' \151\
                These commenters stated that it was a mistake for HHS to assume that
                the proposed rule will not ``directly impose on the public costs that
                exceed benefits'' because costs would be imposed on the public unless
                Assessment or Review of Regulations take place. These commenters took
                the position that the Department's regulations would expire by default,
                and that expiration would impose a cost that would exceed benefits.
                ---------------------------------------------------------------------------
                 \151\ 85 FR 70109.
                ---------------------------------------------------------------------------
                 Response: HHS respectfully disagrees. This final rule would not
                become obsolete due to economic, technological, or legal changes the
                way that many other rules can. For the reasons discussed herein, the
                Department believes the process set forth in this final rule will
                enable the Department to Assess and (where required) Review its
                regulations. It is a mistake, and bereft of evidence, to assume that
                the Department's regulations would expire by default.
                 Comment: Several commenters stated that the Department did not
                adequately explain its reasoning for the proposed rule. Some of these
                commenters stated that HHS did not acknowledge the facts and
                circumstances that motivated the initial promulgation of its
                regulations, nor did HHS discuss in the proposed rule the serious
                reliance interests that have been created by some of these regulations.
                Commenters asserted that the Department claims that it ``is considering
                the important factors''--without articulating what those factors are--
                and asserts that it ``believes the benefits of retrospective review,
                and the need to strongly incentivize it, are so great that the risk of
                a Regulation inadvertently expiring is outweighed by the benefit of
                institutionalizing retrospective review in this manner.'' \152\ A few
                commenters asked HHS to identify the regulations that are vulnerable to
                rescission under the rule, and to describe the nature and magnitude of
                the harm that might result from their expiration.
                ---------------------------------------------------------------------------
                 \152\ 85 FR 70106.
                ---------------------------------------------------------------------------
                 Response: The Department believes the proposed rule adequately
                explained the facts and circumstances that motivated issuing the
                proposed rule, and adequately showed that the Department considered the
                relevant factors. The same is true for the preamble to this final rule,
                which provides additional explanation for why the Department is issuing
                this final rule and the factors it considered. The Department
                recognizes that in many cases the Department had strong reasons for
                issuing its regulations. Examples of such motivations might include
                enhancing food safety,\153\ increasing access to health insurance,\154\
                or increasing the incentive for Temporary Assistance for Needy Families
                recipients to work.\155\ These are all important policy goals that the
                Department wishes to achieve. This final rule is intended to further
                these goals, as well as the other goals motivating the Department's
                regulations. The literature and the Department's experience suggest
                that large numbers of regulations are having impacts that, over time,
                differ from what was estimated at the time the regulations were
                promulgated. Therefore, the Department needs to conduct periodic
                reviews of its regulations to determine whether the policy goals behind
                the regulations are in fact being effected (and if amending those
                regulations could more effectively further those goals). Outside of the
                exempted regulations, no particular regulations are more ``vulnerable
                to rescission'' than others under this final rule. This final rule is
                agnostic as to all Department regulations. They must all be Assessed
                and, if they have a SEISNOSE, Reviewed using the criteria specified in
                section [XX](d).
                ---------------------------------------------------------------------------
                 \153\ E.g., 21 CFR part 112.
                 \154\ E.g., 45 CFR part 147.
                 \155\ 45 CFR part 261.
                ---------------------------------------------------------------------------
                [[Page 5719]]
                Comments on the Statutory Authority for This Final Rule
                 Comment: Several commenters stated that the Department does not
                have the authority to propose automatic expiration of its regulations.
                Some commenters stated that HHS fails to explain how Congress's grants
                of authority to the Department to ``promulgate,'' 21 U.S.C. 371(a), to
                ``make and publish,'' 42 U.S.C. 1302(a), or to ``prescribe,'' 42 U.S.C.
                1395hh(a), regulations also give it the authority to rescind those
                regulations, with that rescission subject to future reversal at the
                Department's discretion. Other commenters stated that the proposed rule
                not only falls outside these grants of rulemaking authority, but
                squarely contradicts Congress's instructions that HHS ``shall''
                promulgate certain regulations. E.g., 21 U.S.C. 371, 42 U.S.C.
                1395hh(a). Some commenters cited to section 1102 of the Social Security
                Act, which directs the Secretary of HHS to issue regulations ``not
                inconsistent with this Act'' to implement the Medicaid and CHIP
                programs but does not provide specific statutory authority for the
                Secretary to write automatic expiration dates into regulations.
                 Response: The Department respectfully disagrees. As explained in
                the proposed rule, the statutory authorities supporting this rule
                making are the statutory authorities for the Department's existing
                regulations.\156\ Moreover, the Department believes that the relevant
                portions of the proposed rule, as finalized herein, are fully
                consistent with 42 U.S.C. 1302(a). Indeed, it specifically cited this
                provision as one source of statutory authority for promulgating the
                proposed rule (85 FR at 70103), and does so in this final rule. The
                commenters' position is incorrect for multiple reasons. First, the
                commenters' assertion seems to suggest that any action by the
                Department to repeal or amend Medicaid or CHIP regulations, by the mere
                act of amendment or rescission, is ``inconsistent'' with those
                programs. That position is untenable.\157\ In fact, this final rule is
                the promulgation of a regulation that will contribute to ``the
                efficient administration of '' the Department's functions under the
                Social Security Act, because the Reviews called for by this final rule
                will take into account both the continued need for particular
                regulations, as well as whether the burden of those regulations on
                small entities can be minimized (among several other factors that will
                enhance efficiency, such as the complexity of the Regulation or whether
                it is duplicative). For the same reasons, this final rule is the
                promulgation of a regulation for ``the efficient enforcement'' of the
                Federal Food Drug, and Cosmetic Act and necessary to carry out the
                administration of the Medicare program. See 21 U.S.C. 371(a); 42 U.S.C.
                1395hh(a)(1). This final rule will enhance the fulfillment of the
                policies that motivated the regulations issued pursuant to 42 U.S.C.
                1302, 42 U.S.C. 1395hh, and 21 U.S.C. 371.
                ---------------------------------------------------------------------------
                 \156\ 85 FR 70103.
                 \157\ See, e.g., Medicare and Medicaid Programs; Regulatory
                Provisions To Promote Program Efficiency, Transparency, and Burden
                Reduction; Part II, 79 FR 27106, 27153 (May 12, 2014) (citing 42
                U.S.C. 1302 as statutory authority for the removal of certain
                regulatory text); Medicare Program; Amendment to Payment Policies
                Under the Physician Fee Schedule and Other Revisions to Part B for
                CY 2011 76 FR 1366, 1367 (Jan. 10, 2011) (relying on 42 U.S.C. 1302
                and 42 U.S.C. 1395hh, among other statutory provisions, to amend or
                remove regulatory text); Color Additives; D&C Green No. 6; Uniform
                Specifications, 51 FR 37908, 37909 (Oct. 27, 1986) (citing 21 U.S.C.
                371 as statutory authority for amending and removing regulatory
                text).
                ---------------------------------------------------------------------------
                 Comment: Several commenters stated that the proposed rule exceeds
                the statutory authority of the RFA, because the RFA only affects
                regulations that ``have a significant economic impact upon a
                substantial number of small entities.'' 5 U.S.C. 602, 604, 605.
                However, according to the commenters, the proposed rule does not limit
                its reach to those regulations covered by the RFA because it adds
                expiration dates to all HHS regulations, not just those that ``have a
                significant economic impact upon a substantial number of small
                entities.'' \158\ These commenters added that the RFA also does not
                mandate the automatic expiration of regulations that have not undergone
                agency review.
                ---------------------------------------------------------------------------
                 \158\ See 85 FR 70123; id. at 70104-05 (defining ``Regulations''
                as ``a section of the Code of Federal Regulations'').
                ---------------------------------------------------------------------------
                 Response: The primary statutory authorities for this final rule are
                the statutory authorities for the Department's existing regulations.
                The Department also notes, though, that the text of 5 U.S.C. 610
                indicates Congress believed agencies have the authority to periodically
                review at least those regulations that have a significant economic
                impact upon a substantial number of small entities (and that agencies
                have the authority to assess which of their regulations have such an
                impact). See 5 U.S.C. 610(a)-(b). The commenters are correct that the
                RFA does not mandate the automatic expiration of rules; however, the
                RFA also does not foreclose this final rule's approach. As explained
                throughout the proposed rule and in this final rule, decades of
                experience, empirical evidence, and scholarly commentary all support
                the Department's view that this final rule will enhance compliance with
                the RFA's directive to periodically review regulations with a SEISNOSE.
                 Comment: A few commenters stated that the proposed rule does not
                cite the RFA (5 U.S.C. 610) as a source of its statutory authority.
                These commenters stated that they believe the Department omitted the
                RFA it its list of statutory authority because the rule is contrary to
                the statute.
                 Response: The proposed rule cited 5 U.S.C. 610 as one of the
                statutory bases for the proposed rule.\159\ The statutory bases for
                this rulemaking also include the existing statutory authorities for the
                Department's regulations. This final rule is consistent with the RFA,
                because it sets forth a plan for the periodic review of the regulations
                issued by the Department which have or will have a significant economic
                impact upon a substantial number of small entities. See 5 U.S.C.
                610(a). Moreover, this final rule requires such review to consider the
                factors set forth in 5 U.S.C. 610(b). The text of 5 U.S.C. 610
                indicates Congress believed agencies have the authority to periodically
                review at least those regulations that have a significant economic
                impact upon a substantial number of small entities (and that agencies
                have the authority to assess which of their regulations have such an
                impact). See 5 U.S.C. 610(a)-(b).
                ---------------------------------------------------------------------------
                 \159\ See 85 FR 70119, 70120, 70121, 70123.
                ---------------------------------------------------------------------------
                Specific Provisions of the Proposed Rule and Final Rule
                Section [XX](a)
                 In the proposed rule, HHS proposed to add Section [XX](a), which
                provided that the proposed rule would apply to and amend all
                Regulations issued by the Secretary or his delegates or sub-delegates
                in this title. HHS received no comments specific to Section [XX](a).
                However, in this final rule HHS replaces ``this title'' with ``this
                chapter,'' and amends the relevant chapters of Titles 21, 42, and 45,
                rather than amending all regulations that were issued by the Secretary
                (or his delegates or sub-delegates) in the titles. HHS makes this
                change to increase clarity and precision. For example, certain chapters
                in Title 21 contain Drug Enforcement Administration, not HHS or FDA
                regulations. Although the proposed rule's use of the language
                ``Regulations issued by the Secretary or his delegates or sub-delegates
                in this title'' addressed this by limiting the scope of the
                [[Page 5720]]
                proposed rule to regulations issued by the HHS Secretary or his
                delegates or sub-delegates, HHS in this final rule amends the chapters
                belonging to HHS, rather than the entirety of the titles. This is not a
                substantive change and does not cause the application of the final rule
                or the rights and obligations it creates to differ from the proposed
                rule.\160\
                ---------------------------------------------------------------------------
                 \160\ In addition, whereas the proposed rule added certain
                regulatory text to Title 45, Part 6, this final rule adds the text
                to Title 45, Part 8. This is not a substantive change. Since the
                Department anticipates that, for good governance and streamlining
                reasons, Part 6 soon may soon be subsumed into Part 5, the
                Department in this final rule adds the relevant text to Part 8.
                ---------------------------------------------------------------------------
                 Similarly, HHS clarifies that it is amending its other regulations
                through the provisions in this final rule by generally applying an
                expiration date to those regulations, if certain conditions are not
                met, rather than asking the Office of the Federal Register to literally
                amend each other regulation, which would be unnecessarily burdensome
                and resource intensive. Accordingly, this final rule states that it
                applies to and ``shall be deemed to amend'' all regulations issued by
                the Secretary or his delegates or sub-delegates in the applicable
                chapters. This is not a substantive change and does not affect the
                application of the final rule or the rights and obligations it creates.
                 HHS received no comments specific to section [XX](a) of the
                proposed rule.
                 Accordingly, HHS finalizes section [XX](a) to read, ``[t]his
                section applies to and shall be deemed to amend all regulations issued
                by the Secretary or his delegates or sub-delegates in this chapter.''
                Section [XX](b)
                 HHS proposed to add section [XX](b), which defined several terms
                used in the proposed rule.
                i. Section [XX](b)(1)
                 HHS proposed to define ``Assess'' as ``a determination by the
                Department, in consultation with other Federal agencies as appropriate,
                as to whether the Regulations issued as part of the same rulemaking
                (and any amendments or additions that may have been added thereafter)
                currently have a significant economic impact upon a substantial number
                of small entities.''
                 5 U.S.C. 610 directs agencies to have plans to periodically review
                those regulations that have or will have a significant economic impact
                upon a substantial number of small entities. Accordingly, in order to
                determine which regulations to periodically review using 5 U.S.C. 610's
                criteria, the Department must first determine which rules have a
                significant economic impact upon a substantial number of small
                entities. When promulgating regulations, the Department is required to
                determine whether a rule will have a significant economic impact on a
                substantial number of small entities. See 5 U.S.C. 605(b).\161\ The
                Assessment refers to an essentially identical determination. In making
                the Assessment, the Department can look to the determination of the
                regulation's impact on small entities made at the time of promulgation,
                as well as experience since promulgation.
                ---------------------------------------------------------------------------
                 \161\ 5 U.S.C. 605(b) refers to rules that have a ``significant
                economic impact on a substantial number of small entities,'' whereas
                5 U.S.C. 610 refers to rules that have ``significant economic impact
                upon a substantial number of small entities.'' This does not appear
                to be a material difference.
                ---------------------------------------------------------------------------
                Comments on Section [XX](b)(1)
                 HHS received the following comment on the proposed definition of
                ``Assess.''
                 Comment: A few commenters stated that HHS should clarify that
                periodic Assessments must look to the determination of the regulation's
                impact on small entities made at the time of promulgations, as well as
                experience since promulgation.\162\ These commenters stated that HHS
                should clarify that any Assessment that only contemplates the former
                and ignores the latter will be deficient.
                ---------------------------------------------------------------------------
                 \162\ See A Guide for Government Agencies: How To Comply With
                The Regulatory Flexibility Act, U.S. SBA Off. of Advoc., at 80-81
                (2017), https://cdn.advocacy.sba.gov/wp-content/uploads/2019/06/21110349/How-to-Comply-with-the-RFA.pdf, (``If Congress meant to
                limit periodic reviews, it would have simply required agencies to
                review rules that originally had a significant impact, rather than
                rules that now have a significant impact.'').
                ---------------------------------------------------------------------------
                 Response: Assessments must analyze the regulation's impact on small
                entities at the time the regulation is being Assessed. The Department
                believes this is clear from the text of the proposed rule, which
                defined ``Assess'' as ``a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Regulations issued as part of the same rulemaking (and any
                amendments or additions that may have been added thereafter) currently
                have a significant economic impact upon a substantial number of small
                entities'' (emphasis added). Accordingly, the Department adopts in this
                final rule the definition of ``Assess'' from the proposed rule, except
                that the term ``Regulations'' in the proposed rule is changed to
                ``Sections'' in this final rule. The determination made at the time of
                promulgation about whether a rulemaking had a SEISNOSE may be a useful
                data point in assessing the regulation's current impact on small
                entities.
                 Accordingly, HHS is finalizing the definition of ``Assess'' as
                proposed, with the technical amendment just mentioned.
                ii. Section [XX](b)(2)
                 HHS proposed to define ``Review'' as a process conducted by the
                Department, in consultation with other Federal agencies as appropriate,
                the purpose of which shall be to determine whether the Regulations that
                were issued as part of the same rulemaking (and any amendments or
                additions that may have been issued thereafter) should be continued
                without change, or should be amended or rescinded, consistent with the
                stated objectives of applicable statutes, to minimize any significant
                economic impact of the Regulations upon a substantial number of small
                entities.
                 HHS received no comments specific to the proposed definition of
                ``Review.''
                 Accordingly, HHS is finalizing the definition of ``Review'' as
                proposed, except that it replaces the term ``Regulations'' with
                ``Sections,'' to conform this provision to the rest of this final rule.
                iii. Section [XX](b)(3)
                 HHS proposed to define ``Regulation'' as ``a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Regulation, and 42
                CFR 2.14 is another Regulation.'' This definition was proposed to make
                clear that a section of the CFR, as opposed to a part, subpart, or
                paragraph within a section, is the unit that must be Assessed and (if
                required) Reviewed, or will otherwise expire. Defining ``Regulation''
                in this objective way makes it easier for the Department and the public
                to know what exactly has to be Assessed or Reviewed by the dates listed
                in the proposed rule. Had the Department used the Administrative
                Procedure Act's (APA's) definition of ``rule,'' \163\ it could be
                unclear in certain circumstances what precisely needed to be reviewed.
                ---------------------------------------------------------------------------
                 \163\ 5 U.S.C. 551(4) (providing that `` `rule' means the whole
                or a part of an agency statement of general or particular
                applicability and future effect designed to implement, interpret, or
                prescribe law or policy or describing the organization, procedure,
                or practice requirements of an agency and includes the approval or
                prescription for the future of rates, wages, corporate or financial
                structures or reorganizations thereof, prices, facilities,
                appliances, services or allowances therefor or of valuations, costs,
                or accounting, or practices bearing on any of the foregoing'').
                ---------------------------------------------------------------------------
                 In the final rule, HHS changes the term ``Regulation'' to
                ``Section'' for the reasons previously discussed.
                [[Page 5721]]
                Comments on Section [XX](b)(3)
                 HHS received the following comments on the proposed definition of
                ``Regulation.''
                 Comment: A few commenters stated that HHS arbitrarily chose to
                reject the APA's definition of ``Regulation'' and adopted its own
                definition of ``Regulation'' for the purposes of this rule, defining
                regulation as ``a section of the Code of Federal Regulations.'' Some
                commenters stated that using a different definition in this rule from
                the definition in the APA (and incorporated in Executive Order 12866
                and Executive Order 13771) is confusing. Commenters stated that the
                Department's explanation that it used a special definition of
                ``Regulation'' to avoid confusion that could be created by using the
                APA's definition was insufficient and lacked statutory basis.
                 Response: To avoid any confusion, HHS uses ``Section,'' rather than
                ``Regulation,'' in this final rule to refer to a section of the Code of
                Federal Regulations. It is crucial to the proper function of this final
                rule that the Department and public clearly understand the scope and
                timing of the Assessment and Review process. Such understanding is made
                easier with a bright-line definition of the agency issuances that are
                subject to Assessment and Review. The Department's use of ``Section''
                endeavors to provide such clarity by using a readily available and
                well-established system of organization, the Code of Federal
                Regulations. It is clear when a section of the Code of Federal
                Regulations was first promulgated.
                 The use of ``Section,'' rather than ``Regulation,'' in this final
                rule is not a substantive change from the proposed rule. Rather, it is
                an attempt to bring additional clarity by using ``Section'' to refer to
                a section of the Code of Federal Regulations, rather than using the
                term ``Regulation.''
                 Comment: One commenter expressed concern over the proposed rule's
                definition of ``Regulation,'' stating that the definition is too
                narrow. This commenter stated that under the proposed rule, each
                Regulation would be Assessed or Reviewed without the context of the
                preamble language that was included in the rulemaking.
                 Response: HHS respectfully disagrees. ``Assessment'' and ``Review''
                are defined in this final rule as determinations with respect to
                ``Sections that were issued as part of the same rulemaking (and any
                amendments or additions that may have been issued thereafter).'' In the
                proposed rule, ``Regulation'' was defined as a section of the Code of
                Federal Regulations so the Department and public can know what units
                would expire absent Assessment or (if needed) Review. But the text of
                the final rule makes clear that a single Assessment or Review should be
                performed on all Sections that were issued as part of the same
                rulemaking (and any amendments or additions that may have been issued
                thereafter). The Department disagrees with the commenters who stated
                that, under the proposed rule, each Regulation would be Assessed or
                Reviewed without the context of the preamble language that was included
                in the rulemaking. Under this final rule, the Department may consider
                this information when conducting Assessments and Reviews.
                 Accordingly, HHS is finalizing the definition proposed, except that
                it defines the term ``Section'' rather than ``Regulation.''
                iv. Section [XX](b)(4)
                 HHS proposed to define ``Year of the Regulation's Promulgation'' to
                mean the calendar year the Regulation first became effective,
                irrespective of whether it was subsequently amended. The purpose of
                this proposed definition was to provide clarity to the Department and
                the public. If a regulation were amended, questions could arise whether
                the clock for re-reviewing the rule making in which the regulation was
                first promulgated begins on the date the rule making was first
                promulgated; the date it was last amended; or whether the clock for
                reviewing the amended portion begins on a different date than the
                portion that was initially enacted. The proposed definition is more
                clear for the Department and the public, because this definition, in
                conjunction with section [XX](c) of the proposed rule, makes clear that
                the clock starts for the retrospective review of a regulation on the
                date that the rule making from which the regulation originates was
                first promulgated, even if it is subsequently amended.
                 If, for example, the Department issues a regulation as a part of a
                rule making and amends it nine years later, the Department may wish to
                conduct the regulatory review of the entire rule making at the time of
                amendment of a specific regulation initially promulgated in that rule
                making, particularly since the Department is presumably already
                performing a regulatory impact analysis with regard to the amendment.
                Since the Department is already conducting a regulatory impact
                analysis, performing the regulatory review at that time may save
                Department resources and spare the Department from having to perform
                the Review on the regulation the next year. In fact, any time the
                Department amends a regulation, it could perform the regulatory review
                at that time, thereby conserving Department resources.
                 HHS received no comments specific to the proposed definition of
                ``Year of the Regulation's Promulgation.''
                 Accordingly, HHS is finalizing the definition of ``Year of the
                Regulation's Promulgation'' as proposed, except that it changes the
                term ``Regulation'' to ``Section.''
                v. Section [XX](b)(5)
                 HHS proposed to define ``[s]ignificant economic impact upon a
                substantial number of small entities'' as having the meaning ascribed
                to that term in the Regulatory Flexibility Act, Public Law 96-354, 94
                Stat. 1164 (Sept. 19, 1980) (as amended 1996).
                 HHS received the following comments on the proposed definition of
                ``Significant economic impact upon a substantial number of small
                entities.''
                 Comment: A few commenters stated that neither the proposed rule,
                nor the RFA gives a clear definition of ``significant impact'' or of
                ``small entity,'' and asked that HHS clarify the definition of these
                terms in the final rule.
                 Response: HHS declines to add definitions of these terms within
                this final rule. ``Significant economic impact'' and ``small entity''
                are terms within the RFA, which has been in existence for over forty
                years. These terms have been applied by the Department and other
                agencies since the RFA's enactment. Definitions pertinent to ``small
                entity'' appear at 5 U.S.C. 601. As explained in the proposed rule, the
                Department has considered a rule to have a significant impact on a
                substantial number of small entities if it has at least a three percent
                impact on revenue on at least five percent of small entities.\164\
                ---------------------------------------------------------------------------
                 \164\ See 85 FR at 70117.
                ---------------------------------------------------------------------------
                 Comment: One commenter stated that the citation in the definition
                of ``Significant economic impact upon a substantial number of small
                entities'' found at 21 CFR 6.1(b)(5), 42 CFR 1.1(b)(5), 42 CFR
                404.1(b)(5), and 45 CFR 6.1(b)(5) was incorrect. The proposed rule
                cited the Regulatory Flexibility Act, Public Law 96-354, 94 Stat. 1164
                (Sept. 19, 1980) (as amended 1996). This commenter stated that because
                the definition in the RFA appears in section 610 of title 5 of the U.S.
                Code, the correct citation is to the code. This commenter also stated
                that the definition of ``Significant economic impact upon a substantial
                number of
                [[Page 5722]]
                small entities'' shall be defined to have the meaning ``of'' that term
                in 5 U.S.C. 610, rather than the meaning ``ascribed to'' that term in 5
                U.S.C. 610.
                 Response: HHS appreciates the comments and agrees that citation to
                the Code is proper. This final rule incorporates this suggestion, and
                replaces the citation in the proposed rule with ``5 U.S.C. 610.'' It
                also incorporates the comment to use ``of'' instead of ``ascribed to.''
                This revised definition may provide increased clarity.
                 Accordingly, in this final rule HHS is finalizing the definition of
                ``[s]ignificant economic impact upon a substantial number of small
                entities'' to provide that this term shall have the meaning of that
                term in section 610 of title 5 of the United States Code.
                Section [XX](c)
                i. Section [XX](c)(1)-(2)
                 In the proposed rule, HHS proposed that unless a Regulation
                contains an earlier expiration date or is rescinded earlier, all
                Regulations issued by the Secretary or his delegates or sub-delegates
                in this title shall expire at the end of either (1) two calendar years
                after the year that this 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 Review of the Regulation is required pursuant to paragraph (d))
                Reviewed the Regulation, whichever is latest. The last year in which
                the Department Assessed and (if Review of the Regulation is required)
                Reviewed the Regulation shall be the year during which the findings of
                the Assessment and, if required, the Review of the Regulation are
                published in the Federal Register pursuant to paragraph (f) of this
                section.
                 In other words, under the proposed rule the Department must Review
                all its regulations (subject to the exceptions listed below) that have
                a significant economic impact upon a substantial number of small
                entities every ten years, or such regulations shall expire. To
                determine which regulations have a significant economic impact upon a
                substantial number of small entities, the proposed rule stated that the
                Department must Assess all its regulations (subject to the exceptions
                listed below) every ten years, or such regulations shall expire if not
                Assessed. The Department believes all of its regulations (subject to
                the exceptions) should be Assessed and, if they have a significant
                economic impact upon a substantial number of small entities, Reviewed.
                The proposed rule stated that Assessments and Reviews should not be
                performed only on those regulations issued after the proposed rule goes
                into effect. After all, it is likely that some regulations promulgated
                decades ago may have become outdated.\165\
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                 \165\ See, e.g., Office of Mgmt. & Budget, Validating Regulatory
                Analysis: 2005 Report to Congress on the Costs and Benefits of
                Federal Regulations and Unfunded Mandates on State, Local, and
                Tribal Entities, at 46-47 (2005), http://perma.cc/R8LX-BQMJ; Cynthia
                Morgan & Nathalie B. Simon, National primary drinking water
                regulation for arsenic: A retrospective assessment of costs, 5 J.
                Benefit Cost Anal. no. 2, 2014, at 259-84, https://www.cambridge.org/core/services/aop-cambridge-core/content/view/A7B29CE98E650B424E92FF292A8FFC89/S2194588800000774a.pdf/national_primary_drinking_water_regulation_for_arsenic_a_retrospective_assessment_of_costs.pdf.
                ---------------------------------------------------------------------------
                 Section [XX](c) of the proposed rule made clear that Department
                regulations (subject to the exceptions listed below) shall expire if
                their Assessment and (if required) Review are not timely performed.
                Both 5 U.S.C. 610 and executive orders by multiple presidents over
                several decades direct the Department to devise plans to periodically
                review many of its regulations.\166\ Although the Department
                retrospectively reviewed a very limited number of its regulations,
                observers have over the decades noted that the Department has not
                always performed retrospective review to a satisfactory extent, and
                many of its regulations have not been reviewed. Therefore, the
                Department concluded in the proposed rule that it was appropriate to
                impose on itself a stronger incentive to ensure it complies with the
                purposes animating the RFA and the executive orders, as well as to
                ensure its regulations are not unduly burdening the public. As a CRS
                report put it, ``[w]ithout some type of enforcement of the review
                requirement, agencies are unlikely to conduct many more reviews than
                have occurred pursuant to Section 610.'' \167\ This is one reason why
                analyses have found that sunset provisions are an effective way to
                improve governance and reduce undue regulatory burdens.\168\ States
                have imposed similar expiration dates for many of their regulations
                unless they are reviewed or readopted.
                ---------------------------------------------------------------------------
                 \166\ The RFA and the Executive Orders direct agencies to review
                overlapping, but not identical, sets of regulations. The RFA directs
                agencies to have plans to review regulations that have a
                ``significant economic impact upon a substantial number of small
                entities.'' 5 U.S.C. 610. By contrast, Executive Order 12866
                directed agencies to submit to OIRA programs to periodically review
                ``significant regulations.'' Exec. Order 12866, Sec. 5(a).
                ``Significant regulations'' are not necessarily those that have a
                ``significant economic impact upon a substantial number of small
                entities.'' Id. at Sec. 3(f) (defining ``significant regulatory
                action'' as any regulatory action that is likely to result in a rule
                that may: (1) Have an annual effect on the economy of $100 million
                or more or adversely affect in a material way the economy, a sector
                of the economy, productivity, competition, jobs, the environment,
                public health or safety, or State, local, or tribal governments or
                communities; (2) Create a serious inconsistency or otherwise
                interfere with an action taken or planned by another agency; (3)
                Materially alter the budgetary impact of entitlements, grants, user
                fees, or loan programs or the rights and obligations of recipients
                thereof; or (4) Raise novel legal or policy issues arising out of
                legal mandates, the President's priorities, or the principles set
                forth in this Executive order.''). Executive Order 13563 also
                directed agencies to review ``significant regulations.'' Exec. Order
                13563, Sec. 6. The Department has proposed to Review those
                regulations that satisfy the RFA criteria, since those are the
                regulations that Congress directed agencies to have plans to review.
                The Department requested comment on whether additional regulations,
                such as significant regulations, should also be Reviewed.
                 \167\ Curtis W. Copeland, Cong. Rsch. Serv., RL32801,
                Reexamining Rules: Section 610 of the Regulatory Flexibility Act 11
                (2008); see also Yoon-Ho Alex Lee, An Options Approach to Agency
                Rulemaking, 65 Admin. L. Rev. 881, 895-96 (2013) (setting forth
                possible reasons why agencies, even when they have adequate
                resources, may be reluctant to perform retrospective reviews).
                 \168\ Russell S. Sobel & John A. Dove, State Regulatory Review:
                A 50 State Analysis of Effectiveness 36 (Mercatus Ctr., Working
                Paper No. 12-18, 2012), https://www.mercatus.org/system/files/State-Regulatory-Review-50-State-Analysis-Effectiveness.pdf;);
                Occupational Licensing: A Framework for Policymakers, The White
                House, at 48-50 (July 2015), https://obamawhitehouse.archives.gov/sites/default/files/docs/licensing_report_final_nonembargo.pdf.
                ---------------------------------------------------------------------------
                 It complies with the APA to amend regulations to specify dates by
                which regulations expire unless the Assessment and/or Review is timely
                performed. An agency can, through notice-and-comment rulemaking, amend
                its regulations to provide that they expire at a future date.\169\ An
                agency can also provide that its regulations expire upon the occurrence
                of a condition.\170\ That is what the Department proposed
                [[Page 5723]]
                in the proposed rule. To be sure, an agency generally must ``articulate
                a satisfactory explanation'' for its action, ``including a rational
                connection between the facts found and the choice made,'' and cannot
                ``entirely fail[] to consider an important aspect of the problem.''
                \171\ The Department anticipates that if a regulation expires because
                the Department does not timely complete its regulatory review, a
                litigant might object to the expiration on the grounds that the
                Department by definition did not ``articulate a satisfactory
                explanation'' or ``failed to consider an important factor,'' because in
                not performing an Assessment or Review, the Department failed to
                consider any factors. The Department rejects such arguments. In this
                rulemaking, the Department is considering the important factors. For
                the reasons described in the proposed rule and in this final rule, the
                Department believes the benefits of retrospective review, and the need
                to strongly incentivize it, are so great that the risk of a regulation
                inadvertently expiring is justified by the benefit of
                institutionalizing retrospective review in this manner. Forty years of
                experience since the RFA's enactment; the decades since relevant
                Executive Orders were enacted; and other Federal government efforts to
                spur the Department to conduct more retrospective reviews indicate
                that, absent such a forcing mechanism, the Department will not conduct
                as many retrospective reviews as desired.
                ---------------------------------------------------------------------------
                 \169\ See, e.g., Amendment to the Interim Final Regulation for
                Mental Health Parity, 70 FR 42276, 42277 (July 22, 2005) (amending
                interim final rule, to provide that ``the requirements of the MHPA
                interim final regulation apply to group health plans and health
                insurance issuers offering health insurance coverage in connection
                with a group health plan during the period commencing August 22,
                2005 through December 31, 2005. Under the extended sunset date, MHPA
                requirements do not apply to benefits for services furnished after
                December 31, 2005.''); see generally Clean Air Council, 862 F.3d at
                9 (an agency can amend or revoke a legislative rule through notice-
                and-comment rulemaking).
                 \170\ See, e.g., Control of Communicable Diseases; Foreign
                Quarantine 85 FR 7874, 7874 (Feb. 12, 2020 (providing that, unless
                extended, interim final rule ``will cease to be in effect on the
                earlier of (1) the date that is two incubation periods after the
                last known case of 2019-nCoV, or (2) when the Secretary determines
                there is no longer a need for this interim final rule''); Medicare
                and Medicaid Programs, Clinical Laboratory Improvement Amendments
                (CLIA), and Patient Protection and Affordable Care Act; Additional
                Policy and Regulatory Revisions in Response to the COVID-19 Public
                Health Emergency, 85 FR 54820, 54820 (Sept. 2, 2020) (providing that
                an interim final rule applies ``for the duration of the [public
                health emergency] for COVID-19'').
                 \171\ Little Sisters of the Poor Saints Peter and Paul Home v.
                Pa., 140 S. Ct. 2367, 2383-84 (2020) (quoting Motor Vehicle Mfrs.
                Assn. of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29,
                43 (1983)).
                ---------------------------------------------------------------------------
                 The Department will mitigate this risk by setting up two web pages
                on the Department's website by the date this final rule is published;
                one that lists the dates of promulgation of all of its rulemakings, and
                a second that lists the rulemakings that contain regulations (called
                ``Sections'' in this final rule) that the Department has decided to
                Assess or Review. The Department will regularly update the web page
                listing the rulemakings containing Sections that it has decided to
                Assess or Review with all additional rulemakings containing Sections
                that it begins to Assess or Review. The Department will also create a
                docket on Regulations.gov, to which the public may direct any comments
                requesting that the Department begin the Assessment or Review of
                regulations. This requirement is described in more detail in the
                discussion of section [XX](h).
                 Therefore, in this rulemaking process, which amends Department
                regulations through the notice-and-comment process, the Department is
                considering the important factors. In addition, the Department intends
                to create on its website a dashboard that shows its progress on its
                Assessments and Reviews, including when it commenced those Assessments
                and Reviews, its progress, and when it expects them to be completed.
                The Department also intends to create a dashboard showing its progress
                on conducting Assessments and Reviews. See Section II.F. for more
                detail on the dashboard.
                 The Department proposed to perform the Assessment and (if required)
                the Review on each regulation every ten years. Some states provide
                that, unless readopted or re-reviewed, their regulations expire in
                seven years,\172\ while at least one state uses a ten-year time
                period.\173\ The Department proposed to perform the Assessment and (if
                required) the Review every ten years, because ten years is the period
                listed in 5 U.S.C. 610.
                ---------------------------------------------------------------------------
                 \172\ See, e.g., N.J. Admin. Code Sec. 1:30-6.4 (2020)
                (regulations expire every seven years unless readopted, subject to
                certain exceptions); Ind. Code 4-22-2.5-2 (2020) (imposing seven-
                year expiration date on regulations unless readopted).
                 \173\ N.C. Gen. Stat. 150B-21.3A (2020).
                ---------------------------------------------------------------------------
                 The proposed rule provided that regulations promulgated more than
                ten years ago will expire at the end of two calendar years from the
                date the proposed rule, if finalized, became effective, unless an
                Assessment and (if required) the Review is performed on them. In the
                proposed rule, the Department requested public comment on whether two
                years is an appropriate time period to Assess and (if required) Review
                Regulations promulgated more than ten years ago.
                 The Department has decided that all of its regulations (subject to
                the exceptions listed below) should be periodically Assessed to
                determine whether they have a significant economic impact upon a
                substantial number of small entities. Without performing the
                Assessment, the Department may not know which regulations have or will
                have a significant economic impact upon a substantial number of small
                entities. Due to changed circumstances, a regulation that did not have
                such an impact at the time it was promulgated may now have such an
                impact. The Department is also aware of literature suggesting that
                agencies have not been consistent in deciding which rules have a
                significant economic impact on a substantial number of small entities,
                or have avoided such a finding in order to avoid complying with the
                RFA's requirements.\174\ By Assessing all of its regulations (subject
                to the exceptions described herein) and publishing the results of the
                Assessments, the Department can avoid concern that the Department is
                failing to Assess or Review regulations that have a significant
                economic impact upon a substantial number of small entities.
                ---------------------------------------------------------------------------
                 \174\ See, e.g., Connor Raso, Agency Avoidance of Rulemaking
                Procedures, 67 Admin. L. Rev. 65, 93-95, 99-101 (2015); Michael R.
                See, Willful Blindness: Federal Agencies' Failure to Comply with the
                Regulatory Flexibility Act's Periodic Review Requirement--And
                Current Proposals to Reinvigorate the Act, 33 Fordham Urb. L. J.
                1199, 1222-25 (2006).
                ---------------------------------------------------------------------------
                 The Department should in many cases perform a single Assessment
                (and, where required, a single Review) that considers all regulations
                issued as part of the same rulemaking. That would generally make sense
                from an economic perspective, for the same reasons that the Department
                in many cases does a single regulatory impact analysis on all
                regulations that are issued as part of the same rulemaking. That is why
                the proposed rule and this final rule define ``Assess'' and ``Review''
                as determinations regarding ``Regulations issued as part of the same
                rulemaking (and any amendments or additions that may have been added
                thereafter)'' (except that the term ``Regulations'' is replaced with
                ``Sections'' in this final rule). Indeed, 5 U.S.C. 605(c) provides that
                ``[i]n order to avoid duplicative action, an agency may consider a
                series of closely related rules as one rule for the purposes of
                sections 602, 603, 604 and 610 of this title.'' Thus, if a series of
                regulations were issued as part of the same rulemaking and one of those
                regulations was subsequently amended, the Department would in many
                cases take the view that the series of regulations could be Assessed or
                Reviewed together for purposes of this final rule.
                 The same is true for the converse. Consider, for example, the 2015
                rulemaking Preventive Controls for Human Food that established 21 CFR
                part 117 and also amended or revised individual regulations in Parts 1,
                106, 110, 114, 120, 123, 129, 179, and 211 that were originally issued
                before 2015.\175\ If the Department so chose, when the deadline
                approaches for Assessing and (if required) Reviewing the amended
                regulations in 21 CFR part
                [[Page 5724]]
                106, the Department could, as part of the same Assessment or Review,
                also assess or review the other regulations that were amended in this
                rulemaking.
                ---------------------------------------------------------------------------
                 \175\ Current Good Manufacturing Practice, Hazard Analysis, and
                Risk-Based Preventive Controls for Human Food, 80 FR 55,907 (Sept.
                17, 2015). https://www.federalregister.gov/documents/2015/09/17/2015-21920/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human.
                ---------------------------------------------------------------------------
                 For regulations that were issued in coordination with another
                Agency, that function in concert with another Agency's regulations, or
                that have a specific, direct impact on regulations issued by another
                Federal agency, the proposed rule proposed that the Department would
                consult with that other Agency when undertaking the Assessment or
                Review, and consider the other Agency's views when considering the
                factors described in section [XX](d). An example of regulations that
                have a specific, direct impact on regulations issued by another Federal
                agency are the Department's ACA regulations concerning the operation of
                Exchanges that affect eligibility for the advance premium tax credit.
                Such regulations have a specific, direct impact on Department of the
                Treasury regulations.\176\
                ---------------------------------------------------------------------------
                 \176\ See, e.g., 45 CFR 155.340 (regarding administration of
                advance payments of the premium tax credit and cost-sharing
                reductions and requiring the Exchange to comply with Treasury
                regulations).
                ---------------------------------------------------------------------------
                 The Department's understanding is that the decisions based upon
                Reviews, including the amendment, repeal, or continuance of regulations
                without change, will constitute final agency action. First, the
                decisions will mark the consummation of the agency's decisionmaking
                process with respect to whether a regulation satisfies the criteria
                described in section [XX](d). Second, the decisions constitute action
                by which rights or obligations have been determined, or from which
                legal consequences will flow. This is because if the Review is not
                performed, the regulation would expire.\177\ Therefore, because the
                decisions based upon Reviews constitute final agency action, they must
                be performed in such a manner that they would withstand judicial review
                under the arbitrary and capricious standard.\178\
                ---------------------------------------------------------------------------
                 \177\ See U.S. Army Corps of Engineers v. Hawkes Co., Inc., 136
                S. Ct. 1807, 1813 (2016) (to have final agency action, ``First, the
                action must mark the consummation of the agency's decisionmaking
                process--it must not be of a merely tentative or interlocutory
                nature. And second, the action must be one by which rights or
                obligations have been determined, or from which legal consequences
                will flow'' (quoting Bennett v. Spear, 520 U.S. 154, 177-78 (1997)).
                 \178\ See 5 U.S.C. 704 (final agency action is reviewable); 5
                U.S.C. 706 (a reviewing court shall hold unlawful and set aside
                agency action, findings, and conclusions found to be arbitrary,
                capricious, an abuse of discretion, or otherwise not in accordance
                with law).
                ---------------------------------------------------------------------------
                 Similarly, if an Assessment concludes that a regulation does not
                have a significant economic impact upon a substantial number of small
                entities, that would mark the consummation of the Department's
                decisionmaking process with respect to whether a Review must be
                performed on the regulation. Such an Assessment's findings would also
                constitute action by which rights or obligations have been determined,
                or from which legal consequences will flow, because if the Assessment
                is not performed, the regulation would expire. Therefore, Assessments
                must also be performed in such a manner that they would withstand
                judicial review under the arbitrary and capricious standard.
                 The Department proposed to perform the Assessment and (if required)
                the Review on each Regulation every ten years. Some states provide
                that, unless readopted or re-reviewed, their regulations expire in
                seven years,\179\ while at least one state uses a ten-year time
                period.\180\ The Department proposed to perform the Assessment and (if
                required) the Review every ten years, because ten years is the period
                listed in 5 U.S.C. 610. The Department has many regulations, some of
                which are complex, so having to perform the Assessment and Review more
                than once every ten years could unduly burden the Department and
                increase the likelihood that a Regulation inadvertently expires because
                it is not Assessed or Reviewed.
                ---------------------------------------------------------------------------
                 \179\ 85 FR 70,105.
                 \180\ Id.
                ---------------------------------------------------------------------------
                Comments and Responses Regarding Section [XX](c)
                 HHS received the following comments on Section [XX](c) of the
                proposed rule.
                 Comment: Several commenters asked the Department to extend, from
                two years to five years, the timeframe for Assessment or Review of
                regulations that are over ten years old.
                 Response: The Department considered this comment, and has decided
                to make this change. Under this final rule, regulations that are more
                than ten years old when this final rule becomes effective shall expire
                if not Assessed and (if needed) Reviewed within five calendar years of
                the year that this final rule becomes effective. This will spread out
                the initial burden on the Department and provide the opportunity for
                more robust Assessments and Reviews. It also reduces any harm to
                reliance interests, since the public will now be on notice further in
                advance of the initial Assessment and Review deadlines.
                 Comment: Several commenters stated that the final rule should
                provide the Secretary with the authority to make one-time, case-by-case
                exceptions to the automatic expiration of a rule.
                 Response: HHS appreciates this comment and has decided to include
                within this final rule a provision that allows the Secretary--on a non-
                delegable basis--to extend on a one-time, case-by-case basis the
                automatic expiration date of a Section by one year. The Department
                shall promptly publish in the Federal Register any such determination
                by the Secretary to extend the expiration date.
                 Comment: A large number of commenters stated that the process
                established in the proposed rule could result in important regulations
                slipping through the cracks and expiring, which could have implications
                for other rules. These commenters stated that the Assessment and Review
                process established in the proposed rule would be complicated and time-
                consuming to put into practice, which could result in the automatic
                expiration of some regulations. A large number of commenters
                specifically mentioned regulations at 42 CFR 435.603, on which multiple
                insurance affordability programs, including Medicaid and CHIP, rely to
                determine financial eligibility using Modified Adjusted Gross Income
                (MAGI) methodologies. According to the commenters, the expiration of
                that regulation would allow programs to redefine MAGI household and
                income counting rules, with no standards, consistency, or
                accountability, which commenters fear could wreak havoc in HHS
                programs. Another commenter stated that if some critical regulations,
                such as the Medicare health and safety standards which provide a
                baseline for patient safety sunset, this could threaten patient safety.
                A large number of commenters suggested that safeguards be put in place
                to ensure that regulations that are critical to the operation of safety
                net providers do not simply expire because an Assessment or Review was
                not completed in time.
                 Response: HHS appreciates the theoretical possibility raised by
                these commenters that important regulations (such as MAGI methodologies
                or Medicare health and safety standards) could expire inadvertently.
                But as explained throughout the proposed rule and in this final rule,
                the Department intends to timely complete the required Assessments and
                Reviews. As noted in the proposed rule, as an additional safeguard, in
                the unlikely event it appears HHS has overlooked an impending deadline,
                interested members of the public can raise the need to Assess or Review
                specific regulation through public comment. As
                [[Page 5725]]
                an additional safeguard, the Department adds in this final rule that
                if, prior to the expiration of a Section, the Secretary makes a written
                determination that the public interest requires continuation of the
                Section in force beyond the date on which the Section would otherwise
                expire under this final rule, the Secretary may continue the Section in
                force one time for a period stated in the determination, which period
                shall not exceed one year.
                 Comment: Several commenters expressed concern about the precedent
                created by an automatic expiration date, which they believe could allow
                future administrations to reject regulations by simply letting them
                lapse. These commenters stated that this scenario would allow the
                Department to bypass the regulatory process and deprive the American
                people of the opportunity for comment and input.
                 Response: HHS respectfully disagrees that this is a significant
                enough risk to outweigh the tremendous benefits from retrospective
                review. The commenters' concerns assume a lack of good faith by future
                administrations. There would also likely be a tremendous public outcry
                if many beneficial regulations were permitted to expire.
                 This final rule does not bypass the regulatory process or deprive
                the American people of the opportunity for comment and input. In this
                rulemaking, the Department is going through the APA's ordinary notice-
                and-comment process. This final rule reflects that the Department
                accepted and considered over 500 public comments on the proposed rule.
                The Department also held a public hearing on the proposed rule and
                considered the comments made there in promulgating this final rule. In
                addition, this final rule institutionalizes an ongoing opportunity for
                public comment during this regulatory review process.
                 Comment: Several commenters stated that public harm could result
                from removing regulations that protect the public health and consumers.
                A few commenters suggested that the Assessments and Reviews conducted
                by the Department should specifically consider consumer protection.
                 Response: For the reasons explained in the preamble and regulatory
                impact analysis for this final rule, this final rule implements a
                process by which the Department will Assess and Review its regulations.
                HHS intends to undertake a careful Assessment, and (if necessary)
                Review of each regulation subject to this final rule to determine if
                the regulation should be continued without change, amended, or
                rescinded. HHS has no intention to rescind regulations that
                appropriately protect the public health or consumers. Reviews will
                consider the factors described in 5 U.S.C. 610(b) (as well as whether
                the regulation complies with applicable law). These are the factors
                that Congress directed the Department to consider when periodically
                reviewing regulations that have a SEISNOSE. Considerations with respect
                to consumer protection will often be subsumed in this analysis.
                 Comment: A few commenters suggested that instead of the proposed
                timeframe for review, the Department should instead Review regulations
                on a rolling basis but not less than 10 years from the date of first
                promulgation or substantial amendment.
                 Response: HHS respectfully disagrees. Clear and specific deadlines
                are needed to ensure the efficacy of this rule and to secure robust
                retrospective review of agency regulations. Moreover, the commenters'
                suggestion that review occur no less than 10 years from the date of
                promulgation or substantial amendment is, in the Department's view, an
                undue time lapse. It threatens to leave long outdated and burdensome
                regulations in place for too long.
                 Comment: One commenter stated that the proposed timeline for
                reviewing regulations is inconsistent with the proposed rule's goal of
                reviewing regulations based on the likelihood of their obsolescence.
                This commenter stated that the proposed rule assumes that the passage
                of time increases the likelihood of regulatory obsolescence, but the
                proposed rule defines a Regulation's age based on the date on which it
                was originally promulgated, regardless of subsequent amendments.
                Therefore, some regulations that have been subsequently amended could
                reach their time for review earlier than regulations that were
                promulgated and never amended. For example, a Medicaid regulation first
                adopted in 1968 but revised repeatedly and as recently as 2020 would
                need to be Assessed, possibly Reviewed, and possibly revised again even
                though it was just amended.
                 This commenter said this timing is also incongruent with specific
                provisions in the RFA. The RFA defines a ``rule'' to include ``any rule
                for which the agency publishes a general notice of proposed rulemaking
                pursuant to section 553(b),'' which explicitly includes regulatory
                amendments. See 5 U.S.C. 553(b) and 551(5). The commenter stated that
                this statutory provision requires the proposed rule's ``clock'' for 10-
                year review to be reset based on the most recent regulatory amendment
                that went through APA notice and comment procedures.
                 Response: HHS respectfully disagrees. As an initial matter, 5
                U.S.C. 610 refers to review ``within'' ten years; it does not foreclose
                reviewing regulations sooner. Second, this rule seeks to balance the
                desire to review older regulations first, while also specifying clear,
                easily-ascertainable deadlines for Assessments and Reviews. It would be
                harder for the Department and the public to determine the Assessment
                and Review deadlines if the deadlines changed each time a regulation
                were amended. Providing that the ``clock'' begins to run from the year
                a Section was first promulgated is a reasonable way to balance these
                considerations. Tying deadlines to the amendments of Sections threatens
                to make the rule completely unwieldy--leaving an open question of when
                certain parts of a rule are up for Assessment and Review.
                 Also, as explained in the proposed rule, if the Department is
                amending a regulation close in time to its ten-year Assessment or
                Review date, then the Department can conduct Assessment and Review
                alongside the amendment, thereby restarting the ten-year clock if it
                publishes the findings in the Federal Register in the manner specified
                in this final rule.\181\
                ---------------------------------------------------------------------------
                 \181\ 85 FR 70105.
                ---------------------------------------------------------------------------
                Amendments to Section [XX](c)
                 After considering the public comments on the two year time period
                to Assess and (if required) Review regulations that are more than ten
                years old, the Department has decided to extend this time period to
                five calendar years after the year that this section first becomes
                effective. Furthermore, in this final rule the Department amends
                section [XX](c) to read ``this chapter,'' rather than ``this title,''
                as was used in the proposed rule. The Department makes this change to
                conform to the fact that this final rule amends certain chapters,
                rather than entire titles. The Department finalizes sections [XX]
                (c)(1)-(2) as amended.
                ii. Section [XX](c)(3)
                 After considering the public comments received on the proposed
                rule, the Department decided to add a new Section [XX](c)(3) to this
                final rule.
                 Section [XX](c)(3) states that if, prior to the expiration of a
                Section under paragraph (c)(1) of this section, the Secretary makes a
                written determination that the public interest requires continuation of
                the Section in force beyond the date on which the Section would
                otherwise expire under paragraph (c)(1), the Secretary may continue the
                Section in force one time
                [[Page 5726]]
                for a period stated in the determination, which shall not exceed one
                calendar year. This final rule requires the Department to promptly
                publish any such written determination in the Federal Register. The
                authority of the Secretary to make this written determination is not
                delegable and may be exercised only by the Secretary or, when the
                office of the Secretary is vacant or the Secretary has become unable to
                perform the functions and duties of the office of the Secretary, by the
                individual acting as Secretary in accordance with the law. This
                provision, like other provisions of this final rule, is severable.
                 The Department adds this provision so that, if a pandemic,
                emergency, or other development arises that prevents the Department
                from timely Assessing or Reviewing certain Sections and the public
                interest requires their continuation, the Department can have
                additional time to Assess and (if needed) Review those Sections.
                A. Section [XX](d)
                 HHS proposed in Section [XX](d) of the proposed rule that the
                Department would be required to Review those Regulations that the
                Department Assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing Regulations to
                minimize any significant economic impact of the Regulation on a
                substantial number of small entities in a manner consistent with the
                stated objectives of applicable statutes, the proposed rule stated that
                the Department's Review shall consider (1) the continued need for the
                Regulation, consideration of which shall include but not be limited to
                the extent to which the Regulation defines terms or sets standards used
                in or otherwise applicable to other Federal rules; (2) the nature of
                complaints or comments received concerning the Regulation from the
                public; (3) the complexity of the Regulation; (4) the extent to which
                the Regulation overlaps, duplicates or conflicts with other Federal
                rules, and, to the extent feasible, with State and local governmental
                rules; (5) the degree to which technology, economic conditions, or
                other factors have changed in the area affected by the regulation since
                the Regulation was promulgated or the last time the Regulation was
                Reviewed by the Department; (6) whether the Regulation complies with
                applicable law; and (7) other considerations as required by relevant
                executive orders and laws.
                 This largely mirrors the review described in 5 U.S.C. 610. It is
                also consistent with ACUS' recommendation that agencies ``consider
                whether the [existing] regulations are accomplishing their intended
                purpose or whether they might, to the extent permitted by law, be
                modified, strengthened or eliminated in order to achieve statutory
                goals more faithfully, minimize compliance burdens on regulated
                entities, or more effectively confer regulatory benefits.'' \182\ Prior
                to finalization, OIRA may review Reviews, including to coordinate
                inter-agency participation in the Review process where there are
                significant inter-agency equities or as otherwise appropriate.\183\ For
                example, when Assessing or Reviewing regulations that require Executive
                Order 12250 review and approval by the Attorney General, the Department
                will consult with the Department of Justice (DOJ) and provide a draft
                of the findings to DOJ well in advance of the Assessment or Review
                deadline, so that DOJ can review and approve prior to the publication
                of the findings. It may be appropriate for OIRA to coordinate this
                process.
                ---------------------------------------------------------------------------
                 \182\ Administrative Conference of the United States,
                Recommendation 2014-5, 79 Fed. App'x--Recommendations of the
                Administrative Conference of the United States, 79 FR 75114, 75117
                (Dec. 17, 2014).
                 \183\ OIRA may also coordinate inter-agency participation in the
                Assessment process where there are significant inter-agency equities
                or as otherwise appropriate.
                ---------------------------------------------------------------------------
                 Proposed section [XX](d) of the proposed rule provided that the
                Department shall consider the continued need for the Regulation,
                ``consideration of which shall include but not be limited to the extent
                to which the Regulation defines terms or sets standards used in or
                otherwise applicable to other Federal rules.'' The quoted phrase is not
                found in 5 U.S.C. 610, but the Department included it in the proposed
                rule to clarify that determining the continued need for a regulation
                includes determining the extent to which it defines terms or sets
                standards used in or otherwise applicable to other Federal rules.
                However, this was not meant to be the only factor the Department should
                consider when determining the continued need for a regulation. Under
                the proposed rule, the Department shall consider any factors that, for
                a particular regulation, are relevant to determining whether there is a
                continued need for the regulation.
                 In addition to this phrase, two factors listed in section [XX](d)
                of the proposed rule were not found in 5 U.S.C. 610. The first is that
                section [XX](d) of the proposed rule stated that the Review should take
                into account ``whether the Regulation complies with applicable law.''
                Since applicable law may have changed since a regulation was
                promulgated, the Department wants to ensure that its regulations are
                regularly reviewed to ensure that they comply with applicable law.
                 Second, section [XX](d) of the proposed rule stated that the Review
                should take into account ``other considerations as required by relevant
                executive orders and laws.'' The proposed rule stated that to the
                extent Executive Orders or laws enacted since the RFA require the
                Department to consider additional factors when performing retrospective
                review of particular regulations, the Department wishes to comply with
                those Executive Orders and laws. A recent Department of Transportation
                rule similarly required that agency, when periodically reviewing its
                regulations, to consider ``[o]ther considerations as required by
                relevant executive orders and laws.'' See 49 CFR 5.13(d)(2)(vi). Upon
                further consideration, the Department has decided not to finalize this
                seventh factor. First, this factor is not included in the RFA.\184\
                Second, this factor is potentially unclear and could be open to
                multiple interpretations. Third, this final rule already requires the
                Department to consider whether the rulemaking complies with applicable
                law. Thus, the seventh factor is not only susceptible to multiple
                interpretations, but seems largely (if not entirely) subsumed by other
                factors in this final rule.
                ---------------------------------------------------------------------------
                 \184\ The RFA also does not include ``whether the Regulation
                complies with applicable law'' as a factor. But it seems
                uncontroversial to require the Department to consider whether its
                regulations comply with applicable law, and this phrase has a clear
                meaning.
                ---------------------------------------------------------------------------
                 The Department anticipates that the Reviews would be similar to the
                section 610 analyses currently performed by agencies. The Reviews would
                benefit from real-world data and information gathered since the
                regulations were promulgated to potentially discern the impact of the
                regulation on small entities and on society more generally.
                 Section [XX](d) of the proposed rule requires that only regulations
                that have a significant economic impact upon a substantial number of
                small entities be Reviewed, because those are the regulations that 5
                U.S.C. 610 requires agencies have a plan to periodically review.
                Comments on Section [XX](d)
                 HHS received the following comments on Section [XX](d) of the
                proposed rule.
                 Comment: Several commenters suggested that HHS consult with trade
                [[Page 5727]]
                groups and other specialty societies to consider the policy
                recommendations of providers and others in the healthcare industry to
                understand the implications of modifying or rescinding existing
                regulations. Some of these commenters brought up certain regulations
                for which they care deeply and would like to see rescinded or
                maintained.
                 Response: HHS appreciates these comments and wishes for the public
                to have the opportunity to provide meaningful feedback on regulatory
                changes that the Department may consider as it conducts its Assessments
                and Reviews. To achieve that goal, the proposed rule, as finalized,
                includes a process of soliciting robust public comments and feedback,
                which HHS will consider and incorporate into its Assessment and Review
                decisions. As stated in [XX](d)(2), ``[t]he nature of complaints or
                comments received concerning the Regulation from the public'' is one of
                the factors that the Department is required to consider under this rule
                when it conducts its Assessments and Reviews. HHS is committed to
                ensuring that the public has ample opportunity to opine on its
                regulations, and looks forward to thoughtfully considering public
                comments during the regulatory review process resulting from this final
                rule.
                 Comment: A few commenters stated that the Department's process for
                reviewing regulations that have a SEISNOSE was unclear from the
                proposed rule. These commenters asked that the Department provide at
                least one example of how factors would be considered and how HHS would
                conduct its decision-making process.
                 Response: Based in part on these comments, in this final rule the
                Department removes the final factor specified in the proposed rule
                (``other considerations as required by relevant executive orders and
                laws''). The Department does so because this factor's meaning could be
                unclear, it is not in the RFA, and it adds little beyond what is
                already more clearly stated in other factors, such as whether the
                rulemaking complies with applicable law. Beyond removing this factor,
                HHS respectfully declines to provide additional clarity within this
                final rule as to the exact contours of the Review process. As explained
                in the proposed rule, the Review takes into account factors that
                already exist under 5 U.S.C. 610(b), along with a consideration of
                whether the rulemaking complies with applicable law, a factor whose
                meaning is clear and uncontroversial. It is anticipated that the Review
                process will track the Department's and other agencies' past practice
                with respect to Section 610 analyses. In particular, examples of
                Section 610 reviews conducted by the EPA are instructive on how the
                Department anticipates the five factors set forth in 5 U.S.C. 610(b)
                will be analyzed.\185\ The Review decision-making process will be
                implemented in a manner appropriate for the regulation in question,
                including but not limited to input from subject-matter experts within
                the Department and the public.
                ---------------------------------------------------------------------------
                 \185\ See Results of EPA's Section 610 Review of the Final Rule
                for Control of Emissions of Air Pollution from Nonroad Diesel
                Engines and Fuel, EPA Off. of Transp. & Quality (Sept. 2014),
                https://www.regulations.gov/document?D=EPA-HQ-OAR-2013-0642-0003;
                Regulatory Flexibility Act Section 610 Review of the National
                Pollutant Discharge Elimination System (NPDES) Permit Regulation and
                Effluent Limitation Guidelines and Standards for Concentrated Animal
                Feeding Operations (CAFOs), EPA Off. of Water (June 3, 2014),
                https://www.regulations.gov/document?D=EPA-HQ-OW-2012-0813-0216;
                Results of EPA's Section 610 Review of the Final Rule for Lead;
                Renovation, Repair, and Painting Program, EPA Off. of Pollution
                Prevention and Toxics (Apr. (April 2018), https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0126-0019.
                ---------------------------------------------------------------------------
                 Comment: A few commenters asked for clarification regarding the
                Department's decision-making process as to whether a regulation would
                be identified as requiring a rescission or amendment based on the
                factors provided. For example, if HHS were to identify overlap or
                duplication between a regulation under Review and other Federal
                regulations, how would HHS assess the factors to make a decision to
                rescind or amend? These commenters also asked for clarification on how
                the Department would determine that a regulation is duplicative.
                 Response: The factors specified in the final rule will be balanced,
                and a determination as to whether to amend or rescind a Section will be
                made on a case-by-case basis. No one factor by itself is dispositive
                (unless the Section does not comply with applicable law). The balancing
                of a series of considerations, sometimes complex and wide-ranging, is
                inherent in the Department's policy-making functions, even beyond the
                context of the Review process set out in this final rule. In the prior
                comment, the Department provided examples of how the Reviews will
                consider the relevant factors. The concept of regulatory duplication,
                which has been in the RFA, 5 U.S.C. 610(b)(4) for over forty years, is
                largely self-explanatory. A regulation may be considered duplicative,
                if, for instance, it serves the same function or overlaps with another
                regulation.\186\ Amending or rescinding duplicative regulations can
                reduce complexity and regulatory burden.
                ---------------------------------------------------------------------------
                 \186\ Duplicative, Black's Law Dictionary (11th ed. 2019)
                (defining ``duplicative'' as ``Having or characterized by having
                overlapping content, intentions, or effect'').
                ---------------------------------------------------------------------------
                 Comment: Some commenters asked HHS to clarify how it would consider
                public comments about a regulation, and whether there would be
                numerical or content benchmarks that HHS would use to guide its
                decision-making regarding the public feedback it receives.
                 Response: The Department will create dockets on Regulations.gov for
                its Assessments and Reviews, and the public may submit comments to
                those dockets in the same manner as it can submit comments on notices
                of proposed rulemaking. The Department's Reviews will be holistic and
                consider the five factors specified in 5 U.S.C. 610(b), as well as
                compliance with applicable law. No one factor by itself is dispositive
                (unless the Section does not comply with applicable law). The weight
                that the Department gives to comments will be a case-by-case
                determination. For example, fifty complaints about a major rule that
                also had 500 supportive comments might not counsel in favor of amending
                or rescinding the rule. But fifty complaints about a rule that had no
                comments supporting it might weigh in favor of amendment or rescission,
                particularly if the other section 610 factors do not counsel strongly
                in favor of continuing the regulation without change. The public-
                comment process, and how much weight to give to various comments, is
                familiar to the Department and the public from the many instances of
                public comment on Department policymaking actions. A similar standard
                will be applied here.
                 Accordingly, the Department finalizes section [XX](d) of the
                proposed rule as proposed, except that it removes (d)(7), which
                proposed that Reviews consider ``[o]ther considerations as required by
                relevant executive orders and laws.'' Moreover, in the finalized
                section [XX](d), the Department replaces the term ``Regulation'' with
                ``rulemaking.'' This is in response to comments previously discussed
                expressing concerning about potential ambiguity caused by the use of
                the term ``Regulation.'' This change is also made to conform section
                [XX](d) to the fact that ``Reviews'' are defined as determinations as
                to ``whether Sections \187\ that were issued as part of the same
                rulemaking (and any amendments or additions that may have been issued
                thereafter)'' should be continued without change, amended, or
                rescinded. Reviews are therefore not of individuals sections but of the
                sections
                [[Page 5728]]
                issued as part of the same rulemaking. Thus, this revision to section
                [XX](d) is made for clarity but is not a substantive change from the
                proposed rule.
                ---------------------------------------------------------------------------
                 \187\ ``Regulations'' in the proposed rule.
                ---------------------------------------------------------------------------
                Section [XX](e)
                 In the proposed rule, HHS proposed that if the Review concludes
                that a Regulation should be amended or rescinded, the Department shall
                have two years from the date that the findings of the Review are
                published in the Federal Register pursuant to paragraph (f) to amend or
                rescind the Regulation. The proposed rule further stated that if the
                Secretary determines that completion of the amendment or rescission is
                not feasible by the established date, he shall so certify in a
                statement published in the Federal Register and may extend the
                completion date by one year at a time for a total of not more than five
                years.
                 The Department included this provision in the proposed rule
                because, if the Review concludes that a Regulation should be amended or
                rescinded, the Regulation should in fact be amended or rescinded. The
                Department believes that two years will generally be an adequate amount
                of time to amend or rescind a Regulation, since the Department will
                have already conducted a Review of the Regulation. In circumstances
                where amendment is not feasible within that time period, the proposed
                rule stated that the Secretary could so certify in a statement
                published in the Federal Register and extend the completion date by one
                year at a time for a total of not more than five years.
                 As stated in the proposed rule, when the Review determines that a
                regulation should be amended or rescinded, the Department would, on a
                case-by-case basis as appropriate, use enforcement discretion to not
                enforce the regulation or a portion of the regulation until it is
                amended or rescinded. This is because in many cases the Department
                would not want to enforce regulations (or portions of regulations) that
                it determines should be amended or rescinded. The Department noted that
                enforcing a regulation deemed to require amendment or rescission in
                some cases raises concerns about whether such enforcement is arbitrary
                and capricious. Continuing to enforce the regulation (or portions
                thereof) would arguably ``run[ ] counter to the evidence before the
                agency.'' \188\
                ---------------------------------------------------------------------------
                 \188\ Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut.
                Auto. Ins. Co., 463 U.S. 29, 43 (1983).
                ---------------------------------------------------------------------------
                Comments on Section [XX](e)
                 HHS received the following comments on Section [XX](e) of the
                proposed rule.
                 Comment: Some commenters stated that the Department should limit
                the length of time for amending or rescinding a Regulation from two
                years with three one-year extensions for a total of not more than five
                years to two years with the possibility to extend for one year (for a
                total of not more than three years). One commenter also stated that the
                current text is ambiguous as to whether it is a maximum of five years
                (two years plus three one-year extensions) or a maximum of seven years
                (two years plus five one-year extensions).
                 Response: HHS appreciates these comments and, in this final rule,
                modifies the rule's text to clarify that, if a Review concludes that a
                Section should be amended or rescinded, the maximum time for amending
                or rescinding the Section (including all possible extensions) is five
                years. That is, there is a two-year period to amend or rescind, which
                can be extended no more than three times for one year each time.
                 The Department believes the two-year default period is appropriate
                and declines to further limit the number of possible extensions. If the
                Department concludes that a regulation should be amended or rescinded,
                it does not want to unduly delay doing so. The Department believes that
                two years will generally be an adequate amount of time to amend or
                rescind such regulations, since the Department has already Reviewed
                them. However, given the complexity of some Department regulations and
                competing priorities, in some circumstances it may not be feasible to
                amend or rescind a regulation within two years. In circumstances where
                amendment or rescission is not feasible within that time period, the
                Secretary can so certify in a statement published in the Federal
                Register and extend the completion date by one year at a time no more
                than three times, for a total of not more than five years (inclusive of
                the initial two-year period).
                 Accordingly, after considering the public comments, the Department
                chose to clarify the language in section [XX](e) of the proposed rule
                with respect to the time period for extension of the completion of an
                amendment or rescission. Where the proposed rule stated that the
                Secretary ``may extend the completion date by one year at a time for a
                total of not more than five years,'' the final rule clarifies that the
                Secretary ``may extend the completion date by one year at a time, no
                more than three times, for a total of not more than five years
                (inclusive of the initial two-year period)'' (emphasis added). This
                change does not alter the time period for extending the completion date
                of an amendment or rescission, but HHS believes that this language
                clarifies the length of time that the completion may be extended. The
                Department finalizes Section [XX](e) of the proposed rule, with this
                clarifying language.
                Section [XX](f)
                 Section [XX](f) of the proposed rule provided that the results of
                all Assessments and Reviews conducted in a calendar year, including the
                full underlying analyses and data used to support the results (subject
                to any applicable privilege, protections for confidential business
                information, or explicit legal prohibition on disclosure), shall be
                published in a single document in the Federal Register during that
                calendar year. The proposed rule stated that the document shall be
                organized in a manner that enables both the Department and the public
                to readily determine which Assessments and Reviews were conducted
                during that calendar year. It further proposed that the document shall
                also specify the year by which the next Assessment (and, if required,
                the next Review) of the Regulation shall be completed.
                 The Department included this requirement in the proposed rule so
                that both the Department and the public could readily know which
                Regulations were Assessed and Reviewed each year. If Assessments and
                Reviews were published in disparate places throughout the year, it
                could become extraordinarily difficult for both the Department and the
                public to know which Regulations were Assessed and Reviewed each year.
                Section [XX](f) was proposed to enable both the Department and the
                public to look in one place to know which Assessments and Reviews were
                conducted each calendar year, and know the findings of those
                Assessments and Reviews.
                 The proposed rule stated that when publishing the findings of an
                Assessment or Review, the Department should include the full underlying
                analyses and data used to support the results, subject to any
                applicable privilege, protections for confidential business
                information, or explicit prohibition on disclosure. This will increase
                transparency and permit the public to see how the Department reached
                its conclusion. By requiring publication of the Reviews and the
                underlying analyses and data, the Department also incorporated ACUS'
                [[Page 5729]]
                suggestion that ``[a]gencies should disclose relevant data concerning
                their retrospective analyses'' so as to ``allow private parties to
                recreate the agency's work and to run additional analyses concerning
                existing rules' effectiveness.'' \189\ The Department does not believe
                that the deliberative process privilege would generally bar disclosing
                the final underlying analyses and data referred to in section
                [XX](f).\190\
                ---------------------------------------------------------------------------
                 \189\ 79 FR 75114, 75117 (Dec. 17, 2014); see also Exec. Order
                13563, Sec. 6(a) (Jan. 18, 2011) (``retrospective analyses,
                including supporting data, should be released online whenever
                possible''). Although this final rule incorporates several ACUS'
                recommendations, it does not incorporate all of them. This final
                rule does not set forth a prioritization scheme, although the
                Department intends to subsequently set forth a schedule for
                conducting Assessments and Reviews.
                 \190\ See, e.g., Coastal States Gas Corp. v. Dep't of Energy,
                617 F.2d 854, 866 (D.C. Cir. 1980) (``[E]ven if the document is
                predecisional at the time it is prepared, it can lose that status if
                it is adopted, formally or informally, as the agency position on an
                issue or is used by the agency in its dealings with the public.'').
                ---------------------------------------------------------------------------
                 Section [XX](f) of the proposed rule also provides that the
                document published in the Federal Register shall specify the year by
                which the next Assessment (and, if required, the next Review) of the
                Regulation shall be completed. This can be particularly helpful if the
                Department conducts an Assessment or Review of a Regulation prior to
                the deadline year.
                Comments on Section [XX](f)
                 HHS received the following comments on Section [XX](f) of the
                proposed rule.
                 Comment: A few commenters suggested that the results of each
                Assessment and Review should be published separately in the Federal
                Register as they are completed, with a title clearly identifying the
                affected regulation and the Department's responses to the public
                comments received.
                 Response: HHS respectfully disagrees that the results should be
                published on a rolling basis. Announcing the results of all Assessments
                and Reviews within a single document makes it easier for the public
                (and the Department) to determine (1) which Sections were Assessed and
                Reviewed, (2) the dates by which they were Assessed and Reviewed, and
                (3) when they next need to be Assessed and (if needed) Reviewed.
                Interested parties need only refer to a single source of information
                for a given year. Publishing all Assessments and Reviews for a given
                year in a single document also reduces the risk that a Section will
                inadvertently expire.
                 The commenters' concerns about the Reviews including the
                Department's responses to public comments was already addressed in the
                proposed rule. Section [XX](d) of the proposed rule directed the agency
                to consider, as part of Reviews, ``the nature of complaints or comments
                received concerning the Regulation from the public.'' And the document
                published in the Federal Register shall include the ``full underlying
                analyses and data used to support the results (subject to any
                applicable privilege, protections for confidential business
                information, or explicit legal prohibition on disclosure.'' Section
                [XX](d)'s requirement to consider the nature of complaints or comments
                only applies to Reviews, not Assessments. Assessments are preliminary
                determinations that only focus on whether a rule making has a SEISNOSE,
                and do not require as extensive an analysis as Reviews. If the
                Department receives comments during the Assessment process, it would
                endeavor to take them into account in determining whether a rule making
                has a SEISNOSE. Moreover, as the proposed rule proposed,\191\ the
                document published in the Federal Register will be organized in a
                manner that enables both the Department and the public to readily
                determine which Assessments and Reviews were conducted during each
                calendar year.
                ---------------------------------------------------------------------------
                 \191\ See, e.g., 85 FR 70121.
                ---------------------------------------------------------------------------
                 Comment: Some commenters stated that the Department should commit
                to publishing results of Reviews as they are completed, or on no less
                than a monthly basis, so that the interested public can truly
                contemplate each regulation now in question.
                 Response: The Department intends to publish the results of the
                Assessments and Reviews in the dockets for the applicable regulations.
                However, as compared to publishing Assessments and Reviews in the
                Federal Register on a rolling basis, announcing the results of all
                Assessments and Reviews within a single document makes it easier for
                the public (and the Department) to determine (1) which Sections were
                Assessed and Reviewed, (2) the dates by which they were Assessed and
                Reviewed, and (3) when they next need to be Assessed and (if needed)
                Reviewed. Interested parties need only refer to a single source of
                information for a given year. Publishing all Assessments and Reviews
                for a given year in a single document also reduces the risk that a
                Section will inadvertently expire. The Department will announce on a
                periodic basis when it has commenced the process of performing an
                Assessment or Review.
                 Comment: A few commenters asked what role the Office of Information
                and Regulatory Affairs (OIRA) within the Office of Management and
                Budget (OMB) would have in reviewing the reports, and any proposed
                revisions to standing regulations.
                 Response: As noted in the proposed rule, ``Prior to finalization,
                OIRA may review Reviews, including to coordinate inter-agency
                participation in the Review process where there are significant inter-
                agency equities or as otherwise appropriate.'' \192\
                ---------------------------------------------------------------------------
                 \192\ 85 FR 70108.
                ---------------------------------------------------------------------------
                 Accordingly, after considering the public comments, HHS finalizes
                section [XX](f) as proposed.
                Section [XX](g)
                 HHS proposed in Section [XX](g) of the proposed rule that paragraph
                (c) of the proposed rule would not apply to Regulations that are
                prescribed by Federal law, such that the Department exercises no
                discretion as to whether to promulgate the Regulation and as to what is
                prescribed by the Regulation. For such Regulations that are adopted
                after the effective date of this section, the proposed rule stated that
                the Federal law described shall be cited in the notice of adoption.
                Section [XX](g) of the proposed rule also provided that paragraph (c)
                of the proposed rule would not apply to (1) Regulations whose
                expiration pursuant to this section would violate any other Federal
                law; (2) this section; (3) Regulations that involve a military or
                foreign affairs function of the United States; (4) Regulations
                addressed solely to internal agency management or personnel matters;
                (5) Regulations related solely to Federal Government procurement; and
                (6) Regulations that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 Section[XX](g)(1) of the proposed rule excepted Regulations that
                are prescribed by Federal law, such that the Department exercises no
                discretion as to whether to promulgate the Regulation and as to what is
                prescribed by the Regulation. This is only the case in rare
                circumstances. Because the Department lacks discretion over what is
                contained in these Regulations and cannot rescind them, they are
                exempted from section [XX](c). For such Regulations that are
                promulgated after the effective date of this final rule, the Department
                shall describe in the Regulation's notice of adoption the Federal law
                that results in
                [[Page 5730]]
                the Department having no discretion as to whether to promulgate the
                Regulation and what is prescribed by the Regulation. The proposed rule
                included this requirement so the public has notice that such
                Regulations are exempt from section [XX](c).
                 Section [XX](g) of the proposed rule likewise also exempted from
                section [XX](c) any Regulation whose expiration pursuant to this
                section would violate any other Federal law. The exceptions listed in
                sections [XX](g)(1) and [XX](g)(2) of the proposed rule are not
                satisfied simply because the statutory authority for the regulation
                provides that the Secretary ``shall'' prescribe regulations. For
                example, section 804(b) of the Federal Food Drug & Cosmetic Act, 21
                U.S.C. 384(b), provides that the ``Secretary, after consultation with
                the United States Trade Representative and the Commissioner of U.S.
                Customs and Border Protection, shall promulgate regulations permitting
                pharmacists and wholesalers to import prescription drugs from Canada
                into the United States'' (emphasis added). However, although the
                statute was enacted in 2003, as of January 1, 2020 the Department had
                not issued any regulations implementing it, indicating the Department's
                view that section 804(b) did not require the Department to issue
                regulations. Similarly, Section 1102 of the Social Security Act, 42
                U.S.C. 1302, provides that the Secretary ``shall make and publish such
                rules and regulations, not inconsistent with this Act, as may be
                necessary to the efficient administration of the functions with which
                [he] is charged under this Act'' (emphasis added). But the Department
                does not believe every regulation promulgated pursuant to section 1102
                is required to have been issued, or that it would violate Federal law
                to rescind such regulations.
                 Section [XX](g) of the proposed rule also exempted the proposed
                rule from section [XX](c). Assuming that no rules expire due to lack of
                Assessment or Review, the proposed rule stated that this rule cannot,
                absent other actions, directly impose on the public costs that exceed
                benefits, since the proposed rule merely would require the Department
                to periodically Assess and, in some cases, Review its Regulations. Only
                the failure to perform an Assessment or Review in the future could
                theoretically impose on the public costs that exceed benefits (assuming
                expired Regulations were on balance benefiting the public). The
                proposed rule stated that it would improve the Department's regulations
                by requiring the Department to evaluate the impact of its regulations
                and amend or rescind those regulations with a significant economic
                impact upon a substantial number of small entities that the Department
                determines should be amended or rescinded. Therefore, the rationale for
                periodic review would not apply to the proposed rule to the extent it
                applies to other Department regulations. The Department realizes that
                certain members of the regulated community might rely on particular
                regulations, but the Department proposed that it would take that into
                account when performing Assessments and Reviews. The Department
                proposed that it would only determine that a regulation should be
                amended or rescinded if the regulation's burdens outweigh these
                reliance interests and the other benefits of the regulation or if other
                factors, such as a change in law, might compel amendment or rescission.
                The Department stated in the proposed rule that it does not intend to
                avoid Assessing or, if required, Reviewing any regulation and does not
                anticipate that an important regulation would expire due to failure to
                Assess or Review it. Accordingly, the Department proposed to exempt the
                proposed rule from Section [XX](c).
                 The Department also proposed in Section [XX](g) of the proposed
                rule to exempt Regulations that involve a military or foreign affairs
                function of the United States. For purposes of the proposed rule (as
                well as in this final rule), ``a military or foreign affairs function
                of the United States'' has the same meaning as that phrase has under 5
                U.S.C. 553(a). Regulations that involve a military or foreign affairs
                function of the United States were exempted from the proposed rule for
                the same reasons that Congress exempted them from the requirements of 5
                U.S.C. 553.
                 Section [XX](g) of the proposed rule also exempted Regulations
                addressed solely to internal agency management or personnel matters and
                Regulations related solely to Federal Government procurement. Because
                such Regulations do not directly impact the public, the rationale for
                retrospective review is weaker with respect to these Regulations.
                 The portion of the proposed rule applying to Title 42 also exempted
                42 CFR 1001.952 from expiration. 42 CFR 1001.952 provides a safe harbor
                for various payment and business practices that, although they
                potentially implicate the Federal anti-kickback statute, are not
                treated as offenses under the statute. The Department proposed to
                exempt this regulation because it was concerned that certain otherwise
                permissible behavior could become criminal simply because the
                Department did not Review this Regulation. The portion of the proposed
                rule applying to Title 42 also exempted 42 CFR part 73. 42 U.S.C. 262a
                provides that, with respect to Part 73, the ``Secretary shall review
                and republish [a list of certain biological agents and toxins]
                biennially, or more often as needed, and shall by regulation revise the
                list as necessary in accordance with such paragraph.'' Since those
                regulations are already being reviewed biennially, there was no need
                for the proposed rule to apply to 42 CFR part 73. Similarly, the
                portion of the proposed rule applying to Title 42 also exempted the
                annual Medicare Part A and Part B payment methodology update rules.
                Since these rules are amended annually, it does not make sense to
                Review them every ten years. Lastly, the portion of the proposed
                applying to Title 42 also exempted 42 CFR 100.3, since the statutory
                basis for this regulation provides that it cannot be amended unless (1)
                a proposed regulation is provided to the Advisory Committee on
                Childhood Vaccines (ACCV) and the ACCV is provided at least 90 days to
                make recommendations and comments, and (2) there is subsequently a 180-
                day public comment period. See 42 U.S.C. 300aa-14(c). For these
                reasons, these regulations are also exempted from this final rule.
                 Section [XX](g) of the proposed rule also exempted any Regulations
                that were issued jointly with other Federal agencies, or that were
                issued in consultation with other agencies because of a legal
                requirement to consult with that other agency. This is because the
                Department cannot on its own rescind or amend a Regulation issued
                jointly with another Federal agency. An example of regulations issued
                with other agencies because of a legal requirement to consult with
                those other agencies are the regulations issued jointly by the
                Department and the Departments of Labor and the Treasury in accordance
                with section 104 of the Health Insurance Portability and Accountability
                Act (HIPAA). This provision directs the Secretaries of HHS, Labor and
                the Treasury to ensure that regulations issued pursuant to provisions
                where the Secretaries share interpretive jurisdiction (which includes
                many of the provisions in Title XXVII of the Public Health Service
                (PHS) Act) are administered to have the same effect at all times.\193\
                An example of jointly-issued regulations are regulations governing
                State innovation waivers under section 1332 of the
                [[Page 5731]]
                Patient Protection and the Affordable Care Act.\194\
                ---------------------------------------------------------------------------
                 \193\ See Health Insurance Portability and Accountability Act of
                1996, Public Law 104-191, 110 Stat. 1936 (1996).
                 \194\ See, e.g., 77 FR 11700 (Feb. 27, 2012).
                ---------------------------------------------------------------------------
                 The Department retains these exemptions for the reasons discussed
                in the proposed rule. For the reasons discussed below, this final rule
                also exempts certain other regulations from this final rule.
                Comments on Section [XX](g)
                 HHS received the following comments on Section [XX](g) of the
                proposed rule.
                 Comment: Several commenters asked for further clarity on the
                proposed exemptions from the proposed rule. These commenters stated
                that it is unclear how the public would know which regulations are
                eligible for an exemption under the proposed rule. They suggested that
                the Department may be interpreting ``Regulations that are prescribed by
                Federal law, such that the Department exercises no discretion as to
                whether to promulgate the Regulation and as to what is prescribed in
                the Regulation'' very narrowly, because the proposed rule stated that
                it is ``rare'' that the Department has ``no discretion as to whether to
                promulgate [a] regulation and what is prescribed by the regulation.''
                \195\ These commenters stated that the examples given in the proposed
                rule were insufficient and open to interpretation, and members of the
                public should not be expected to be able to conduct their own statutory
                analysis. Some commenters specifically asked for at least one example
                of a regulation that would be exempted under this rule. Commenters also
                asked for examples of regulations that ``were issued in consultation
                with other agencies because of a legal requirement to consult with that
                other agency.''
                ---------------------------------------------------------------------------
                 \195\ 85 FR 70109.
                ---------------------------------------------------------------------------
                 Response: The Department thanks these commenters for their
                comments. Regulations that ``involve a military or foreign affairs
                function of the United States'' are regulations that would satisfy that
                standard under 5 U.S.C. 553(a)(1). ``Regulations addressed solely to
                internal agency management or personnel matters'' refers to regulations
                that would satisfy the ``matter relating to agency management or
                personnel'' standard under 5 U.S.C. 553(a)(2).\196\
                ---------------------------------------------------------------------------
                 \196\ See, e.g., regulations amended in Update of Organizational
                References, 50 FR 8993 (Mar. 6, 1985) (``Because these amendments
                related to internal agency management and personnel and because the
                amendments are not substantive, the rule is exempt from the notice
                and comment and delayed effective date requirements of section
                553(b) and (d)(3) of the Administrative Procedure Act'').
                ---------------------------------------------------------------------------
                 An example of regulations issued with other agencies because of a
                legal requirement to consult with those other agencies are the
                regulations issued jointly by the Department and the Departments of
                Labor and the Treasury in accordance with section 104 of HIPAA. This
                provision directs the Secretaries of HHS, Labor and the Treasury to
                ensure that regulations issued pursuant to provisions where the
                Secretaries share interpretive jurisdiction (which includes many of the
                provisions in Title XXVII of the PHS Act) are administered to have the
                same effect at all times.\197\ Such regulations constitute a small
                percentage of the Department's overall number of regulations (although
                they may have an outsize impact), and the Department is not aware of
                many regulations outside those promulgated pursuant to the relevant
                HIPAA provisions that would satisfy this exception. Regulations that
                are prescribed by Federal law, such that the Department exercises no
                discretion as to whether to promulgate the regulation and as to what is
                prescribed in the regulation is also a very small category.
                ---------------------------------------------------------------------------
                 \197\ See Health Insurance Portability and Accountability Act of
                1996, Public Law 104-191, 110 Stat. 1936 (1996). See also 85 FR
                70110.
                ---------------------------------------------------------------------------
                 Comment: A few commenters stated that it was disingenuous for HHS
                to specifically decide to exempt this rule from the assessment and
                review process. These commenters stated that this decision is at best
                disingenuous or at worst an attempt to permanently impose a rigid
                review structure.
                 Response: HHS respectfully disagrees. This final rule does not
                permanently impose a rigid review structure, because this rule can be
                amended or rescinded under the APA. As explained in the notice of
                proposed rulemaking, the nature of this rule means that ``the rationale
                for periodic review does not apply to this proposed rule to the extent
                it applies to other Department regulations.'' \198\ This final rule
                would not become obsolete due to economic, technological, or legal
                changes the way that many other rules can.
                ---------------------------------------------------------------------------
                 \198\ 85 FR at 70109.
                ---------------------------------------------------------------------------
                 Comment: Several commenters stated that they do not want the annual
                Notice of Benefits and Payment Parameters (NBPP) rule to be subject to
                this rule.
                 Response: The Department agrees and has decided to exempt the
                annual Notice of Benefit and Payment Parameters update rules. Just as
                the proposed rule exempted the annual Medicare payment rules, this
                final rule need not apply to NBPP rules that are already reviewed and
                updated annually. The 2021 NBPP annual rules can be found at 85 FR
                29164 (May 14, 2020). These and the equivalents for other years are
                exempt from this final rule.
                Final Section [XX](g)
                 Based in part on comments, the Department has decided in the
                portion of the final rule applying to Title 21, Chapter I to also
                exempt the following provisions from this final rule:
                 21 CFR parts 131, 133, 135-137, 139, 145, 146, 150, 152,
                155, 156, 158, 160, 161, 163-166, 168, 169.
                 21 CFR parts 331-333, 335-336, 338, 340-341, 343-344, 346-
                350, 352, 355, 357, 358.
                 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 878,
                880, 882, 884, 886, 888, 890, 892, 895, 898.
                 Based in part on comments, the Department decided in the portion of
                the file rule applying to Title 45, Subchapter A, to also exempt the
                annual Notice of Benefit and Payment Parameters update rules.
                 The first three bullets encompass FDA's food standard, device-
                specific, and over-the-counter drug regulations that specify
                characteristics of certain foods, devices, and over-the-counter drugs.
                These are regulations that specify the characteristics of particular
                foods, devices, and over-the-counter drugs. Many of the device
                regulations are already required to be reviewed in some way every five
                years.\199\ Similarly, FDA is already undergoing a process to establish
                a set of general principles for food standards for FDA to use when
                considering whether to establish, revise, or eliminate a food
                standard.\200\ Thus, there is less need to review these regulations
                every ten years, since these are being reviewed, or new processes for
                reviewing these regulations are being established. In addition, the
                exempt food standard, device, and OTC drug regulations simply create
                product identities.
                ---------------------------------------------------------------------------
                 \199\ See, e.g., 21 U.S.C. 360(l) (providing that ``at least
                once every 5 years thereafter, as the Secretary determines
                appropriate, the Secretary shall identify, through publication in
                the Federal Register, any type of class I device that the Secretary
                determines no longer requires a report under subsection (k) to
                provide reasonable assurance of safety and effectiveness''; 21
                U.S.C.(m) (providing that the Secretary, ``at least once every 5
                years thereafter, as the Secretary determines appropriate [ ]
                publish in the Federal Register a notice that contains a list of
                each type of class II device that the Secretary determines no longer
                requires a report under subsection (k) to provide reasonable
                assurance of safety and effectiveness'').
                 \200\ See https://www.federalregister.gov/documents/2020/04/20/2020-08182/food-standards-general-principles-and-food-standards-modernization-extension-of-comment-period.
                ---------------------------------------------------------------------------
                 As explained supra, the annual Notice of Benefit and Payment
                Parameters update rules are also now being exempt because those are
                already updated
                [[Page 5732]]
                annually. Thus, there is no need to Assess or Review them every ten
                years.
                 In addition, whereas the proposed rule exempted in Title 42 the
                ``annual Medicare Part A and Part B payment methodology update rules,''
                this final rule exempts the ``annual Medicare payment update rules.''
                All annual Medicare payment update rules are revised annually, so there
                is no need to require Assessment or Review of them every ten years.
                 Other than adding or revising these exemptions and changing the
                term ``Regulation'' to ``Section,'' the Department finalizes Section
                [XX](g) as proposed.
                Section [XX](h)
                 HHS proposed in Section [XX](h) of the proposed rule that when the
                Department commences the process of performing an Assessment or Review,
                it shall state on a Department-managed website the Regulation(s) whose
                Assessment or Review it is commencing. As proposed, the public would be
                able to submit comments regarding these Regulation(s) in the manner
                specified on this website. HHS proposed that members of the public
                could also submit comments in the manner specified on the website
                requesting that the Department begin the Assessment or Review of a
                Regulation, particularly if they are concerned that the deadline is
                nearing and the Department has not stated that it has commenced the
                Assessment or Review.
                 The Department included this provision in the proposed rule so
                that, when the Department is Assessing or Reviewing a regulation, the
                public can submit comments for the Department's consideration. The
                Department stated in the proposed rule that it believes this will
                maximize transparency, public participation, and the Department's
                knowledge of the real-world impacts of its regulations.
                 The Department also proposed in this provision to allow the public
                to submit comments on the Department website requesting that the
                Department begin the Assessment or Review of a regulation. The
                Department stated that it considered the risk that a regulation could
                expire because the Department inadvertently did not Assess or Review
                it. The Department proposed to mitigate this risk by allowing members
                of the public to submit comments requesting that the Department
                commence the Assessment or Review of a regulation. If a person is
                concerned that the Department has not announced the Assessment or
                Review of a Regulation and the deadline is nearing, the person can
                request that the Department to conduct the Assessment or Review.
                 The Department stated in the proposed rule that it intends to
                timely Assess and, where required, Review all its regulations. The
                Department noted, however, that if it has not announced that it is
                Assessing or Reviewing a Regulation, and the deadline is nearing, those
                who rely on the regulation are on notice that it might expire, just as
                the public is on notice that a regulation might be rescinded when an
                agency issues a notice of proposed rulemaking to rescind the
                Regulation.
                Comments on Section [XX](h)
                 HHS received the following comments on section [XX](h) of the
                proposed rule.
                 Comment: Several commenters questioned the adequacy of the proposed
                process for soliciting comments on the regulations that are reaching
                their time for Assessment or Review. Some of these commenters stated
                that the public should be given ample notice of upcoming Assessments
                and Reviews, and a clear and adequate timeframe for providing comments.
                Other commenters expressed concern about the process of posting
                information regarding Assessments and Reviews to a Department-managed
                website. Some commenters stated that instead of providing notice of
                Assessments and Reviews and instructions on how to submit public
                comments exclusively on a Department-managed website, the Department
                should also put this information on the Federal Register.
                 Several commenters stated that members of the public should not be
                responsible for monitoring an HHS website to see if Assessment or
                Review of a particular regulation is commencing. Some commenters cited
                the added expense on the regulated industry that would be created if an
                additional review process is created by this rule, which would
                disproportionately fall on small businesses. One commenter even
                suggested this was a purposeful decision by the Department to create a
                system that favors well-funded special interests that can afford
                lawyers and lobbyists to advocate for their favored policies.
                Commenters stated that although HHS proposes to create a website to
                enable the public to comment and request a review when the deadline for
                assessing a rule is approaching, this website would not be governed by
                APA rules and the Department would not be required to meaningfully
                respond to those comments. Commenters stated that, as a result, rules
                that govern the administration of Medicaid and CHIP and affect access
                to care for millions of beneficiaries could automatically expire
                without public comment.
                 A potential solution suggested by one commenter is that the
                Department could include in the final rule a requirement that it
                include a notice of all regulations scheduled for review during the
                next 12 months in its semi-annual regulatory agendas published in the
                Federal Register. This commenter also suggested that HHS publish semi-
                annually in the Federal Register a list of regulations that are
                scheduled to expire in the next 12 months if they are not Assessed and
                Reviewed.
                 Other commenters requested clarification on how HHS will treat the
                comments it receives. For example, some commenters asked whether the
                comments would be included as a part of the public record. Other
                commenters mentioned that the proposed rule does not clarify whether
                HHS will be required to respond to all comments made by the public.
                These commenters asked the Department to ensure that it publicly
                display the comments it receives.
                 Response: The Department appreciates these comments and seeks to
                minimize costs for the public. Accordingly, this final rule makes some
                revisions in response to these comments. Under this final rule, when
                the Department commences the process of performing an Assessment or
                Review, it shall state on a Department-managed website the Section(s)
                whose assessment or Review it is commencing. It shall also announce
                once a month in the Federal Register those new Assessments or Reviews
                that it has commenced in the last month. The Department will create a
                docket on Regulations.gov for each Assessment or Review that the
                Department is conducting. These docket numbers will be referenced in
                the Federal Register announcements. The public will be able to submit
                comments to the dockets of each rule making being Assessed or Reviewed.
                Each docket shall specify the date by which comments must be received.
                There shall also be a general docket on Regulations.gov where the
                public can submit comments requesting that the Department Assess or
                Review a regulation. These changes address the concern about putting
                the information on a Department website, rather than in the Federal
                Register. The Department anticipates that the process will be similar
                to that currently used by the EPA.\201\ The Department also intends to
                [[Page 5733]]
                publish the results of the Assessments and Reviews in the dockets for
                the applicable regulations.
                ---------------------------------------------------------------------------
                 \201\ See, e.g., Regulatory Flexibility Act Section 610 Review
                of the Testing and Labeling Regulations Pertaining to Product
                Certification of Children's Products, Including Reliance on
                Component Part Testing, 85 FR 52078 (Aug. 24, 2020).
                ---------------------------------------------------------------------------
                 Separately, in conjunction with this final rule, the Department is
                placing at https://www.hhs.gov/regulations/federal-registry/index.html
                a list of Department rule makings, the year they were initially
                promulgated, the last year the rule making was amended, and the Federal
                Register citation from the time the rule making was last amended. This
                list was generated with artificial intelligence and the Department
                believes it is accurate, but it is conceivable that some Department
                regulations are not included. This list includes all Department
                regulations, including those that may be exempt from this final rule.
                The Department believes it would be informative to the public to
                provide a list of all Department regulations, as well as their Federal
                Register citations and promulgation dates. The Department intends to
                update this list annually with newly-issued regulations. The schedule
                for Assessment and Review is discussed in Section II.F.
                 HHS disagrees that this final rule is for the benefit of well-
                financed special interests. As the Department observed in the proposed
                rule, empirical evidence confirms that, due to the inherent advantage
                from economies of scale, large, well-capitalized entities are better
                positioned to absorb compliance costs than small entities.\202\ By
                announcing Assessments and Reviews on Regulations.gov, and putting the
                dockets for Assessments and Reviews on Regulations.gov, this final rule
                reduces the costs associated with having to monitor two separate
                websites. The regulatory impact analysis for this final rule addresses
                the estimated impacts for this final rule, including monitoring and
                comment costs.
                ---------------------------------------------------------------------------
                 \202\ 85 FR 70118 & n.145.
                ---------------------------------------------------------------------------
                 Comment: A few commenters suggested that instead of the process set
                forth in the proposed rule, HHS should provide a means of soliciting
                public comment at least every ten years on the Department's existing
                rules, which the Department would then be required to consider.
                 Response: The Department is incorporating aspects of this
                suggestion. This final rule makes the nature of complaints or comments
                on a regulation one of the factors to be considered when performing
                Reviews. But the commenters' suggestion by itself would not be adequate
                to address the problem. The Department's rules have always been open
                for public comment under 5 U.S.C. 553(e), yet only limited
                retrospective review has taken place, contrary to Congressional intent.
                The suggestion that the Department take a passive role in retrospective
                review is inconsistent with the RFA, which intends for HHS to engage in
                this analysis on its own initiative.
                 Comment: Several commenters stated that, according to the process
                set forth in the proposed rule, it would be difficult, if not
                impossible, for the public to accurately determine whether a regulation
                is subject to an Assessment, and if so, the deadline for informing the
                agency and commenting. These commenters surmise that there could be
                scenarios where a regulation was not Assessed, but it is unclear
                whether it has expired or was exempt from the regulatory review process
                and is still in place. This could leave regulated entities subject to
                the regulation without guidance on what is expected of them, or could
                result in regulations being inadvertently removed with negative impacts
                on beneficiaries, consumers, and the public in general.
                 Response: The Department respectfully disagrees. Again, as stated
                above, the Department intends to timely Assess and (if needed) Review
                its regulations. This final rule provides that un-Reviewed and un-
                Assessed Sections expire based on the time elapsed since the Year of
                the Section's promulgation. To aid the public, in conjunction with this
                final rule the Department is placing at https://www.hhs.gov/regulations/federal-registry/index.html a list of Department rule
                makings, the year they were initially promulgated, the last year the
                rule making was amended, and the Federal Register citation from the
                time the rule making was last amended. This list was generated with
                artificial intelligence and the Department believes it is accurate, but
                it is conceivable that some Department regulations are not included.
                This list is meant to be an aid to the public and the Department, but
                the Federal Register and Code of Federal Regulations are what have
                legal force and determine the dates of promulgation. Moreover, a
                regulated entity can use the Federal Register and Code of Federal
                Regulations to determine the year in which a Section was promulgated.
                From there, the regulated entity can determine the year by which a
                Section must be Assessed and (if needed) Reviewed. The regulated entity
                can consult the Federal Register document containing the findings of
                the Department's Assessments and Reviews from that year to determine if
                the Section was timely Assessed and (if needed) Reviewed. This is less
                burdensome than many legal research activities that regulated entities
                need to do to determine whether they are in compliance with the law.
                Regulated entities frequently must determine whether a particular
                statute or regulation is still in effect, has been amended, or whether
                there is a proposed change to the statute or regulation before Congress
                or in front of an agency.
                 Comment: Several commenters had comments related to APA petitions.
                A commenter stated that the APA also includes a process for the public
                to petition for retrospective review of existing rules. See 5 U.S.C.
                553(e). Other commenters noted the APA does not specify the process for
                receiving petitions. As a result, according to the commenters, how
                petitions are received and treated varies across--and even within--
                agencies. These commenters stated that to date, HHS has not adopted any
                particular regulations concerning the form that petitions under section
                553(e) must take. Nor has HHS adopted recommendations by the
                Administrative Conference of the United States for receiving,
                processing, and responding to petitions. A few commenters noted that
                they had submitted petitions but no action had been taken to date on
                their request. For example, one commenter stated that it filed citizen
                petitions in August 2016 and February 2017 asking the agency to remove
                outdated recordkeeping requirements. Another commenter stated that in
                February 2018 it commented to the Food and Drug Administration Center
                for Veterinary Medicine (CVM) on regulations that the commenter claimed
                are outdated or needing improvement.
                 Response: The Department respectfully disagrees with the
                commenters' suggestion that the petition mechanism in 5 U.S.C. 553(e)
                somehow undercuts or forecloses this final rule. Indeed, the
                substantive point of these comments--that the agency should
                retrospectively review its rules to determine whether amendment or
                rescission is necessary, especially where pressed to do so by the
                public--is fully consistent with this final rule. The commenters who
                stated they petitioned the Department to amend or rescind regulations,
                yet the Department took no action, further supports why this final rule
                is needed (although the Department takes no position in this final rule
                on whether any particular commenters' petition had merit).\203\ The
                comments
                [[Page 5734]]
                suggest the Department is not examining its existing regulations as
                often as is desired. Moreover, 5 U.S.C. 553(e)'s petition process does
                not make this final rule unnecessary, because there is reason to
                believe that even some rules that have not been the subject of any
                petitions would benefit from amendment or rescission.\204\ The
                literature and the Department's experience suggest that large numbers
                of regulations are having impacts that, over time, differ from what was
                estimated at the time of promulgation.
                ---------------------------------------------------------------------------
                 \203\ See also Maeve P. Carey, Cong. Rsch. Serv., R46190,
                Petitions for Rulemaking: An Overview 1 (2020) (describing Sec.
                553(e) as ``arguably underused''); ACUS, ``Adoption of
                Recommendations,'' 79 FR 75114, 75117-18 (describing long-standing
                problems in agencies' handling of Sec. 553(e) petitions).
                 \204\ See Section II, supra.
                ---------------------------------------------------------------------------
                 Some HHS components have regulations governing petitions.\205\ But
                whether the Department should have additional or different petition
                procedures is outside the scope of this final rule, which, like 5
                U.S.C. 610, operates independently of 5 U.S.C. 553(e)'s petition
                process.
                ---------------------------------------------------------------------------
                 \205\ See, e.g., 21 CFR 10.20, 10.30, 10.33.
                ---------------------------------------------------------------------------
                 Comment: Some commenters stated that it was arbitrary for HHS to
                not meaningfully consider other ``strong incentives'' to revisit its
                own rules besides the process it proposes. For example, commenters
                suggested that HHS could have explored creating a petition process
                whereby parties could request review of certain rules, or could have
                convened a Federal Advisory Committee to advise the Department on which
                rules merit review. In both these scenarios, HHS could incentivize
                itself to act by giving parties a right of judicial review if the
                Department failed to respond to a petition or a Committee
                recommendation.
                 Response: HHS respectfully disagrees. The APA itself already
                affords a process for petitioning for review of rules. 5 U.S.C. 553(e)
                (``Each agency shall give an interested person the right to petition
                for the issuance, amendment, or repeal of a rule.''). And denials of
                such petitions may be subject to the APA's judicial review
                procedures.\206\ Notwithstanding the existence of section 553(e),
                comprehensive retrospective review of agency rules has not taken hold.
                The literature suggests large numbers of Department regulations are
                having impacts that differ from their estimated impacts. It is unlikely
                that a Federal Advisory Committee could undertake the scale of review
                needed to comprehensively advise on which regulations merit review.
                ---------------------------------------------------------------------------
                 \206\ See, e.g., Am. Horse Protection Assoc. v. Lyng, 812 F.2d 1
                (D.C. Cir. 1987). Case law also suggests that an agency's failure to
                respond may also be subject to judicial redress. See Jason A.
                Schwartz and Richard L. Revesz, ``Petitions for Rulemaking--Final
                Report to the Administrative Conference of the United States'' at 13
                & n.55, 28-29 (Nov. 5, 2014).
                ---------------------------------------------------------------------------
                 Comment: Some commenters stated that the Department should provide
                clear notice to the public of when a Regulation may be about to expire,
                and provide actual notice of rescissions.
                 Response: The Department reiterates its previous response to a
                similar comment. The Department intends to timely Assess and, where
                required, Review all its regulations. However, if the Department has
                not announced that it is Assessing or Reviewing a regulation, and the
                deadline is nearing, the public is on notice that it might expire, just
                as the public is on notice that a regulation might be rescinded when an
                agency issues a notice of proposed rulemaking to rescind the
                regulation.\207\ Moreover, section [XX](f) requires that the
                Department, in announcing the results of Assessments and Reviews,
                ``shall also specify the year by which the next assessment (and, if
                required, the next review) of the Section shall be completed.''
                ---------------------------------------------------------------------------
                 \207\ 85 FR 70110.
                ---------------------------------------------------------------------------
                 The Department plans to periodically announce in the Federal
                Register regulations that have expired, and have the Code of Federal
                Regulations revised accordingly.
                Final Section [XX](h)
                 Accordingly, based on public comments, HHS finalizes section
                [XX](h) to provide that when the Department commences the process of
                performing an Assessment or Review, it shall state on a Department-
                managed website the Section(s) whose Assessment or Review it is
                commencing. It shall also announce once a month in the Federal Register
                those new Assessments or Reviews that it has commenced in the last
                month. The Department will create a docket on Regulations.gov for each
                Assessment or Review that the Department is conducting. The public will
                be able to submit comments to the dockets of each rule making being
                Assessed or Reviewed. Each docket shall specify the date by which
                comments must be received. There shall also be a general docket on
                Regulations.gov where the public can submit comments requesting that
                the Department assess or review a Section.
                Section [XX](i)
                 Lastly, the proposed rule included a severability clause. The
                Department stated in the proposed rule that it believes the proposed
                rule fully complies with applicable law, but does not wish to see the
                entire proposed rule vacated in the event that a portion of it is
                vacated. For example, the Department does not wish to see the entire
                final rule vacated because one of the exceptions listed in section
                [XX](g) is invalidated. However, the Department requested comment in
                the proposed rule on whether the amendments to add expiration dates
                should be severable from other portions of the proposed rule, including
                the requirements to perform Assessments and Reviews. The Department
                stated that it was requesting comments on this because it is not clear
                that the proposed rule could properly function without the expiration
                dates.
                 HHS received no comments specific to Section [XX](i) of the
                proposed rule.
                 Accordingly, for the reasons stated in the proposed rule, HHS
                finalizes the provisions of Section [XX](i) as proposed.
                Additional Comments on Particular Regulations
                 Comment: Commenters identified certain regulations that they would
                not want to expire under the proposed rule. These regulations include,
                but are not limited to:
                 Regulations implementing Medicare, Medicaid, CHIP, and
                other large programs that HHS administers.
                 Regulations implementing the Affordable Care Act (ACA).
                 Regulations that operate Temporary Assistance for Needy
                Families (TANF) program, the Child Care and Development Fund (CCDF)
                program, Head Start and Early Head Start Programs, and the Family
                Violence Prevention and Services (FVPSA) Program.
                 FDA Regulations at 21 CFR Chapter 1.
                 Provisions at 42 CFR 435.603 which determine financial
                eligibility using the Modified Adjusted Gross Income (MAGI)
                methodologies.
                 Regulations implementing Income and Eligibility
                Verification requirements at 42 CFR 435.940-435.965.
                 42 CFR 435.907, related to Medicaid application
                requirements.
                 Medicaid cost-sharing regulations.
                 Regulations governing Medicaid waivers, including Section
                1115 and Section 1332 waivers and Home & Community-Based Services
                (HCBS) waivers.
                 Fair Hearings for Applicants and Beneficiaries
                requirements in 42 CFR 431 Subpart E.
                 Confidentiality regulations in 42 CFR part 431 Subpart F.
                 Regulations relating to comparability or services for
                groups of
                [[Page 5735]]
                beneficiaries and sufficiency of amount, duration, and scope of
                Medicaid services, found at 42 CFR 440.230-440.250.
                 The Medicaid balanced billing regulation at 42 CFR 447.15.
                 Regulations that shape children's access to care in a wide
                range of areas, including but not limited to: 42 CFR 438.1-438.930--
                Medicaid Managed Care; 42 CFR 447.56--Limitations on premiums and cost
                sharing; 42 CFR 447.203--Documentation of access to care and service
                payment rates; 42 CFR 447.204--Medicaid provider participation and
                public process to inform access to care; 42 CFR 447.400--Payments for
                Primary Care Services Furnished by Physicians; 42 CFR 410.78--
                Telehealth services; 45 CFR 156.10-156.1256--Health Insurance Issuer
                Standards Under the Affordable Care Act, Including Standards Related to
                Exchanges.
                 Regulations concerning infant formula, including: 21 CFR
                101: Food Labeling; 21 CFR 105.65: Infant Foods; 21 CFR 106: Infant
                Formula Requirements Pertaining to Current Good Manufacturing Practice,
                Quality Control; Procedures, Quality Factors, Records and Reports, and
                Notifications; 21 CFR 107: Infant Formula; and 21 CFR 312:
                Investigational New Drug Application.
                 Regulations implementing the Vaccines for Children Program
                at 42 CFR 441.600-441.615 and Grants for Childhood Immunization
                Programs at 42 CFR 51b.201-51b.206.
                 Regulations implementing title IV-E programs that HHS
                administers, which provide funds for States and Tribes to provide
                foster care, transitional independent living programs for children,
                guardianship assistance, and adoption assistance for children with
                special needs at 45 CFR part 1356.
                 Regulations that pertain to maternal and child health
                project grants administered by the Health Resources and Services
                Administration's Maternal and Child Health Bureau at 42 CFR 51a.1-42
                CFR 51a.8.
                 Medicaid regulations that outline the mandatory and
                optional benefits that States commonly use to finance home visiting
                services, such as: Extended pregnancy services (42 CFR 440.210, 42 CFR
                440.220); Targeted case management (42 CFR 440.169(b)); Medical or
                other remedial care by licensed practitioners (42 CFR 440.60); Early
                and Periodic Screening, Diagnostic and Treatment (42 CFR 440.40(b));
                Medicaid Administrative Claiming (42 CFR 433.15); and Managed care (42
                CFR part 438).
                 Regulations in 45 CFR Subchapter B that require insurance
                coverage of essential health benefits (EHBs) such as preventive health
                services, prohibit preexisting condition exclusions, and establish fair
                practices in setting health insurance premiums and mental health
                parity, among other protections.
                 Regulations in 42 CFR part 441, which sets forth State
                Medicaid plan requirements and Federal Financial Participation for
                specific services. Commenters specifically mentioned Early and Periodic
                Screening, Diagnosis, and Treatment (EPSDT) regulations found
                throughout Part 441, which provide essential comprehensive and
                preventive services to children who are covered by Medicaid.
                 Regulations that protect nursing home patients by
                requiring reasonable promptness for medical assistance fair hearing
                obligations (42 CFR 435.930(a), 42 CFR 431.10(c)(3); 435.1200(b).
                 Regulations found in 42 CFR part 483 protecting long term
                care facility residents, and specifically Subpart G, which protects
                children in psychiatric residential treatment facilities (PRTFs) from
                restraint and seclusion used as a means of ``coercion, discipline,
                convenience or retaliation.''
                 Regulations found in 42 CFR part 460, implementing
                Programs of All-Inclusive Care for the Elderly (PACE).
                 Regulations implementing the Medicare Low Income Subsidy
                program under 42 CFR part 423.
                 Regulations at 42 CFR part 438 which implement Medicaid
                Managed Care.
                 Regulations related to food ingredients, including color
                additives (21 CFR parts 70-82), Generally Recognized as Safe (GRAS)
                regulations, and procedural regulations governing the agency's
                premarket review functions, among others.
                 Regulations implementing the Food Safety Modernization Act
                (FSMA), Good Manufacturing Practices (GMPs), low acid canned foods/
                acidified foods (LACF/AF), Hazard Analysis and Critical Control Point
                (HACCP) regulations for juice and seafood, Dietary Supplement GMPs,
                import/export requirements, and infant formula, among others).
                 Nutrition labeling regulations.
                 Regulations implementing Food Standards of Identity and
                Quality (e.g., dairy standards, bottled water (21 CFR 165.110), cacao
                products, and other food categories).
                 Regulations implementing the Family Smoking Prevention and
                Tobacco Control Act (the ``TCA'').
                 Regulations governing the Indian health system, the Indian
                Health Service's (IHS) Tribal Self-Governance program, and Indian
                specific provisions in the Medicaid, Medicare CHIP and Marketplace
                regulations.
                 Regulations implementing the Indian Child Welfare Act,
                which impacts all Indian Health Service regulations (42 CFR parts 136
                and 136a) and the Department's Tribal Self-Governance regulations (42
                CFR part 137).
                 Regulations implementing the Mental Health Parity and
                Addiction Equity Act (MHPAEA), which requires that mental health and
                substance use disorder coverage be comparable to general medical
                coverage.
                 Regulations that implement programs authorized by the
                Developmental Disabilities Assistance and Bill of Rights Act that help
                ensure people with intellectual or developmental disabilities and their
                families have access to needed community services and individualized
                supports, and other programs that are important to people with
                disabilities, such as the Independent Living programs and critical
                safety net programs such as Medicaid.
                 42 CFR 457.520, relating to cost sharing for well-baby and
                well-child care services.
                 Regulations in 42 CFR part 407 relating to Hospital
                Insurance Entitlement and Supplementary Medical Insurance Enrollment
                and Entitlement, Part B enrollment including so-called state buy-in
                plans would harm seniors, and retroactive liability for Part B premiums
                when a beneficiary loses eligibility for a buy-in plan.
                 Provisions found at 45 CFR 146.136 that apply the federal
                law requiring parity between private health insurance coverage for
                physical ailments and for mental illness and substance use disorders
                would be at risk.
                 Regulations that implement the Title X Family Planning
                Program.
                 Regulations guiding the practice of social work.
                 Regulations implementing the Health Insurance Portability
                and Accountability Act of 1996 (HIPAA), found in 45 CFR parts 160, 162,
                and 164, particularly 45 CFR 164.502, which clarifies and strengthens
                privacy protections people with HIV.
                 Preadmission Screening and Resident Review (PASRR)
                regulations found at 483.100 through 483.138.
                 Regulations protecting the confidentiality of Substance
                Use Disorder (SUD) patient records, found at 42 CFR part 2.
                 Regulations that prohibit insurance plans and issuers from
                imposing
                [[Page 5736]]
                financial requirements or treatment limitations on mental health and
                SUD benefits that are more restrictive than those that apply to
                medical/surgical benefits.
                 Office of Human Research Protections (OHRP) regulations in
                45 CFR part 46, and FDA regulations at 21 CFR part 50, which protect
                human research subjects.
                 Regulations in 45 CFR part 96, which govern block grants.
                 42 CFR 489.24, related to the special responsibilities of
                Medicare hospitals in emergency cases.
                 Regulations concerning Section 1557 of the Affordable Care
                Act, which prevents discrimination on the basis of race, sex, sexual
                orientation, and gender identity in healthcare settings.
                 Regulations implementing the Ryan White Program
                 Regulations governing Medicare's Six Protected Classes.
                 Regulations related to the Congregate and Home-Delivered
                Nutrition Programs.
                 Regulations related to over-the-counter medicine products.
                 Regulations at 42 CFR 425.612 identify the circumstances
                under which specific payment regulations are waived under the
                accountable care organization (ACO) program.
                 Regulations related to non-emergency medical
                transportation (NEMT).
                 Regulations affecting the domestic and global seafood
                industry.
                 Regulations affecting the pet food industry.
                 Regulations implementing the Medicare Modernization Act,
                such as 42 CFR 422.2268, which establishes standards for marketing by
                MA plans.
                 Regulations requiring CMS programs to include an
                extraordinary circumstances exception (ECE) policy for natural
                disasters and other circumstances (see 42 CFR 412.140(c)(2) for the
                inpatient quality reporting (IQR) program and 42 CFR 412.160(c)(1)-(4)
                for the value-based purchasing program).
                 Regulations at 42 CFR 441.62, which require, according to
                the commenters, that states assure transportation for periodic
                screening and treatment for Medicaid eligible children, and regulations
                at 42 CFR 440.170(a), which provide the definition for what constitutes
                transportation, e.g., ambulance, taxicab, common carrier or other
                appropriate means, as well as meals and lodging for both the child and
                necessary attendant.
                 42 CFR 440.230(b)-(d), which requires that services be
                ``sufficient in amount, duration, and scope to reasonably achieve their
                purpose,'' directs states not to ``arbitrarily deny or reduce the
                amount, duration, or scope of such services to an otherwise eligible
                individual solely because of the diagnosis, type of illness, or
                condition,'' and permits states to place appropriate limits on a
                service based on such criteria as ``medical necessity'' or on
                utilization review criteria.
                 42 CFR 435.831, which establishes the standards for
                determining eligibility for the ``medically needy''--an optional
                category that may enable aged, blind and disabled persons in certain
                states who have ``excess income'' above the Medicaid limits to qualify
                for Medicaid, if they incur certain medical expenses.
                 42 CFR 415.174 Exception: Evaluation and management
                services furnished in certain centers.
                 42 CFR 457.496--Parity in mental health and substance use
                disorder benefits.
                 42 CFR 457.410--Health benefits coverage options.
                 What commenters characterized as many highly important and
                sensitive Medicare provisions in Title 42, CFR parts 400-499 that
                directly impact beneficiaries and health care providers. Some of these
                provisions include beneficiary and provider appeal rights (Part 405);
                Part A eligibility and entitlement provisions (Part 406); Part B
                enrollment and entitlement provisions (Part 407); provisions that
                outline the scope of Part A Benefits, including hospital and skilled
                nursing facility coverage (Part 409); Medicare Advantage coverage rules
                and enrollee protections (Part 422); and, Part D prescription drug
                parameters (Part 423).
                 Response: The Department thanks the commenters for identifying
                these regulations. The Department intends to timely Assess and (if
                necessary) Review these regulations.
                 Comment: Commenters identified certain regulations for which they
                would like the Department to prioritize amendment through its proposed
                retrospective regulatory review process. These regulations include, but
                are not limited to:
                 Regulations mandated for review by the 21st Century Cures
                Act, Public Law 114-255, sec. 2034, 130 Stat. 1033 (2016). Section 2034
                of that Act requires the Secretary to lead a review by research funding
                agencies of all regulations and policies related to the disclosure and
                reporting of financial conflicts of interest to reduce administrative
                burden on federally funded researchers. It also calls for the Secretary
                to harmonize the differences between the Basic HHS Policy for the
                Protection of Human Research Subjects (45 CFR part 46, subpart A) and
                the FDA regulations for the protection of human subjects (21 CFR parts
                50 and 56). Commenters stated that these regulations are well overdue
                for assessment and review.
                 Regulations covering access to skilled therapy services,
                which commenters say must be updated to reflect the national settlement
                in the Jimmo v. Sebelius litigation to codify the fact that skilled
                services are covered for Medicare beneficiaries not just to improve
                function, but to maintain or prevent deterioration in function.
                 The dockets established by FDA's Center for Food Safety
                and Applied Nutrition and Center for Veterinary Medicine on Sept. 8,
                2017,\208\ in which the Centers requested comments and information to
                assist in identifying existing regulations and related paperwork
                requirements that could be modified, repealed or replaced, consistent
                with the law, to achieve meaningful burden reduction while allowing FDA
                to achieve its public health mission and fulfill statutory obligations
                are examples of incomplete regulatory review initiatives.\209\
                Commenters stated that despite submitting extensive comments that
                detailed numerous regulations that they believe could be modified,
                repealed or replaced, the agency did not take any further action.
                ---------------------------------------------------------------------------
                 \208\ E.g., Nonrulemaking Docket FDA-2017-N-5093: Review of
                Existing General Regulatory and Information Collection Requirements
                of the Food and Drug Administration, https://beta.regulations.gov/docket/FDA-2017-N-5093.
                 \209\ See Review of Existing General Regulatory and Information
                Collection Requirements of the Food and Drug Administration, 82 FR
                42506 (Sept. 8, 2017); FDA-2017-N-5093, https://beta.regulations.gov/docket/FDA-2017-N-5093.
                ---------------------------------------------------------------------------
                 Response: The Department thanks the commenters for identifying
                these regulations. The Department intends to timely Assess and (if
                necessary) Review these regulations. If the Assessments and Reviews
                suggest these regulations should be amended or rescinded, the
                Department will commence rulemaking to amend or rescind them.
                 Comment: Commenters identified certain regulations that they would
                want amended or rescinded. These regulations include, but are not
                limited to:
                 What the commenters characterized as unnecessary burdens
                in post-acute care (PAC) regulations.
                 What the commenters characterized as the outdated and
                inappropriate ``in the home'' requirement for coverage of durable
                medical equipment (DME), which commenters believe significantly limits
                the mobility devices available to beneficiaries with mobility
                disabilities.
                [[Page 5737]]
                 Response: The Department thanks the commenters for identifying
                these regulations. The Department intends to timely Assess and (if
                necessary) Review these regulations. If the Assessments and Reviews
                suggest these regulations should be amended or rescinded, the
                Department will commence rulemaking to amend or rescind them.
                 Comment: Some commenters provided feedback on what baseline the
                Department could use when conducting an analysis of an existing
                regulation. Commenters suggested that HHS could simply conduct an ex
                ante analysis of how the regulation is likely to perform going forward
                compared with the baseline scenario of what would happen if the
                regulation were allowed to expire. The benefits of this approach,
                according to the commenters, are that HHS already produces ex ante
                analyses (so this approach would not be departing from present
                practices), the analysis could still include a backward-looking
                component to the extent that data on past performance could be used to
                forecast the regulation's future performance, and the regulation's
                future performance is what should ultimately determine whether the
                regulation should continue as-is or be amended or rescinded. Another
                option, according to commenters, is that the Department could perform a
                retrospective cost-benefit analysis that looks at how the regulation
                performed relative to the baseline of what would have happened in the
                absence of the regulation, or relative to the regulation as it stood
                before it was last significantly amended.
                 Response: The Department appreciates this comment. The comments
                suggest different approaches may make sense for different regulations.
                Accordingly, the Department declines to adopt in this final rule a
                single method for conducting retrospective reviews. Reviews must be
                conducted in a manner that is not arbitrary and capricious under the
                APA, so that will provide a minimum level of rigor that all Reviews
                will have to meet, though different methodologies may be appropriate in
                different cases. The Department intends to take into account these
                comments when conducting Reviews pursuant to this final rule.
                V. Regulatory Impact Analysis (Executive Orders 12866, 13563, 13771)
                A. Executive Order 12866 Determination
                 Executive Order 12866 directs agencies to assess the costs and
                benefits of available regulatory alternatives and, if regulation is
                necessary and not prohibited by statute, to select regulatory
                approaches that maximize net benefits. Section 3(f) of Executive Order
                12866 defines a ``significant regulatory action'' as an action that is
                likely to result in a regulation (1) having an annual effect on the
                economy of $100 million or more in any one year, or adversely and
                materially affecting a sector of the economy, productivity,
                competition, jobs, the environment, public health or safety, or State,
                local, or tribal governments or communities (also referred to as
                ``economically significant''). OMB has designated this rule as
                economically significant for the purposes of Executive Order 12866.
                This regulatory impact analysis fulfills analytical obligations under
                section 3(f) of Executive Order 12866 for economically significant
                rulemakings.\210\
                ---------------------------------------------------------------------------
                 \210\ This analysis was informed by public comments and also by
                work of Dr. James Broughel.
                ---------------------------------------------------------------------------
                B. Need for Regulation
                 The first principle of regulation, according to Executive Order
                12866, is that ``Each agency shall identify the problem that it intends
                to address (including, where applicable, the failures of private
                markets or public institutions that warrant new agency action) as well
                as assess the significance of that problem.'' The regulation being
                finalized by the Department addresses lax compliance with periodic
                review requirements under the Regulatory Flexibility Act (RFA) of 1980
                and the need to periodically review existing regulations to determine
                if they are having their intended impacts. Section 610 of the RFA calls
                upon the Department to have a plan to conduct periodic reviews of its
                regulations that have or will have a significant economic impact upon a
                substantial number of small entities (SEISNOSE). The RFA directs
                agencies to consider the following factors as part of those reviews:
                (1) The continued need for the rule; (2) the nature of complaints or
                comments received concerning the rule from the public; (3) the
                complexity of the rule; (4) the extent to which the rule overlaps,
                duplicates or conflicts with other rules; and (5) the length of time
                since the rule has been evaluated or the degree to which technology,
                economic conditions, or other factors have changed in the area affected
                by the rule.
                 A review of department semi-annual agenda reports over the last ten
                years, as well as a review of specific rules identified in those
                agendas as completed rulemakings resulting from section 610 reviews,
                indicated three completed final rulemakings that emanated from section
                610 reviews since 2011.\211\ (These rules are presented in table 1
                below). To put this in context, the Department estimates it has roughly
                18,000 regulations under its purview and that five regulations on
                average are part of the same rulemaking. Further, (as discussed in more
                detail below) the Department estimates approximately 11% of its
                regulations have a SEISNOSE, which suggests that approximately 396
                Department rulemakings have a SEISNOSE. The three rules in table 1
                amend approximately 130 sections of the CFR. (If an average rulemaking
                contains five sections, 130 sections correspond to the number of
                sections on average in approximately 26 rulemakings.) Given that
                Section 610 of the RFA sets a 10-year schedule for review of
                rulemakings, one might expect that roughly ten percent of regulations
                with a SEISNOSE would be reviewed each year, which would be
                approximately 40 rulemakings every year.\212\ Moreover, many of these
                regulations should likely be updated to reflect evolving circumstances.
                However, this does not appear to be occurring.\213\
                ---------------------------------------------------------------------------
                 \211\ Note that some rules labeled as 610 reviews in Department
                semi-annual agendas were not, in actuality, a result of section 610
                reviews.
                 \212\ There are roughly 3,600 rulemakings (18,000 divided by 5).
                11% of this figure is 396. Ten percent of 396 is roughly 40.
                 \213\ A review of Department semiannual regulatory agendas
                issued between June of 2016 and August of 2020 confirms the three
                rules listed in table 1 are the only three final rulemakings to be
                completed in the last five years that are also associated with
                section 610 reviews. One rule, 0938-AT23, was merged with another
                rule, 0938-AS21. See Dept. Health & Human Servs., Semiannual
                Regulatory Agenda, 81 FR 37,294 (Jun. 9, 2016); 81 FR 94742 (Dec.
                23, 2016); 82 FR 40278 (Aug. 24, 2017); 83 FR 27126 (Jun. 11, 2018);
                83 FR 58020 (Nov. 16, 2018); 84 FR 29624 (Jun. 24, 2019); 84 FR
                71130 (Dec. 26, 2019); and 85 FR 52704 (Aug. 26, 2020).
                [[Page 5738]]
                 Table 1--Final Actions as a Result of Section 610 Reviews Since 2011
                ----------------------------------------------------------------------------------------------------------------
                 Regulatory changes made
                 Name of rulemaking CFR citation and Year as a result of Section
                 RIN 610 reviews
                ----------------------------------------------------------------------------------------------------------------
                Medicare and Medicaid Programs; 42 CFR Parts 403, 2019 (Final Rule)............. Reformed Medicare
                 Regulatory Provisions To Promote 416, 418, 441, regulations that were
                 Program Efficiency, 460, 482, 483, identified as
                 Transparency, and Burden 484, 485, 486, unnecessary, obsolete,
                 Reduction; Fire Safety 488, 491, and 494. or excessively
                 Requirements for Certain RIN 0938-AT23...... burdensome on health
                 Dialysis Facilities; Hospital care providers and
                 and Critical Access Hospital suppliers, and
                 (CAH) Changes To Promote increased the ability
                 Innovation, Flexibility, and of health care
                 Improvement in Patient Care. professionals to devote
                 resources to improving
                 patient care by
                 eliminating or reducing
                 requirements that
                 impede quality patient
                 care or that divert
                 resources away from
                 furnishing high quality
                 patient care. Updated
                 fire safety standards
                 for Medicare and
                 Medicaid participating
                 End-Stage Renal Disease
                 (ESRD) facilities by
                 adopting the 2012
                 edition of the Life
                 Safety Code and the
                 2012 edition of the
                 Health Care Facilities
                 Code, and updated the
                 requirements that
                 hospitals and Critical
                 Access Hospitals must
                 meet to participate in
                 the Medicare and
                 Medicaid programs.
                 Requirements were
                 intended to conform to
                 current standards of
                 practice and support
                 improvements in quality
                 of care, reduce
                 barriers to care, and
                 reduce some issues that
                 may exacerbate
                 workforce shortage
                 concerns.
                Medicare and Medicaid Programs; 42 CFR Parts 409, 2017 (Final Rule)............. Revised the conditions
                 Conditions of Participation for 410, 418, 440, of participation that
                 Home Health Agencies. 484, 485 and 488. home health agencies
                 RIN 0938-AG81...... (HHAs) must meet in
                 order to participate in
                 the Medicare and
                 Medicaid programs. The
                 new requirements focus
                 on the care delivered
                 to patients by HHAs,
                 reflect an
                 interdisciplinary view
                 of patient care, allow
                 HHAs greater
                 flexibility in meeting
                 quality care standards,
                 and eliminate
                 unnecessary procedural
                 requirements.
                Medicare and Medicaid Programs; 42 CFR Parts 405, 2016 (Final Rule)............. Revised the requirements
                 Reform of Requirements for Long- 431, 447, 482, that Long-Term Care
                 Term Care Facilities. 483, 485, 488, and facilities must meet to
                 489. participate in the
                 RIN 0938-AR61...... Medicare and Medicaid
                 programs. These changes
                 are necessary to
                 reflect the substantial
                 advances that have been
                 made over the past
                 several years in the
                 theory and practice of
                 service delivery and
                 safety.
                ----------------------------------------------------------------------------------------------------------------
                 The Department's limited success in performing retrospective
                regulatory review is further supported by a regulatory reform project
                the Department piloted, which utilized AI-driven data analysis.
                Machine-learning algorithms identified over 1,200 CFR section citations
                that merited consideration for reform and 159 CFR sections that could
                benefit from regulatory streamlining based on their similarities to
                other sections.\214\ That project uncovered that 85% of Department
                regulations created before 1990 have not been edited, and that the
                Department has nearly 300 broken citation references in the CFR (i.e.,
                CFR sections that reference other CFR sections that no longer
                exist).\215\ These findings are consistent with a 2018 study by the
                same consulting firm that estimated that 68 percent of federal
                regulations have never been updated.\216\ These findings suggest
                regulations are not being updated to reflect evolving economic
                conditions and technology, even though this is a goal of the RFA.
                ---------------------------------------------------------------------------
                 \214\ Regulatory Streamlining & Analysis, at 11 (Mar. 2019).
                 \215\ Id.
                 \216\ William D. Eggers & Mike Turley, The Future of Regulation:
                Principles for Regulating Emerging Technologies, Deloitte Ctr. for
                Gov't Insights (2018), https://www2.deloitte.com/content/dam/Deloitte/lu/Documents/risk/lu-future-of-regulation.pdf.
                ---------------------------------------------------------------------------
                 Machine-learning tools also demonstrate the complexity of
                Department rules--and reducing complexity is another goal of the RFA.
                See, e.g., 5 U.S.C. 610(b)(3). Data from the Mercatus Center show that
                the Department's regulations in 2019 received a Shannon entropy score
                of 8.2. Shannon Entropy is a measure of complexity based on the amount
                of information contained in text. It can be thought of as measuring the
                number of new ideas that are introduced in a document, or,
                alternatively, how much computational effort would be required to
                understand a document. To put the Shannon entropy score into context, a
                typical Shakespeare play receives a Shannon entropy score of 8.0. The
                complexity of Department regulations is not entirely surprising given
                that regulations often involve science, engineering, or other highly
                technical material. However, having regulations that are more complex
                than a typical Shakespeare play would seem to be at odds with various
                directives that fall on the Department for regulations to be simple,
                easy to understand, and written in plain language.\217\
                ---------------------------------------------------------------------------
                 \217\ See, e.g., Exec. Order No. 12866; Exec. Order 13563, sec.
                1; and various presidential memoranda and guidance on plain
                language.
                 Table 2--2019 Shannon Entropy Score for HHS Regulations
                ------------------------------------------------------------------------
                 Shannon
                 Department entropy
                 score
                ------------------------------------------------------------------------
                Department of Health and Human Services.................... 8.2
                ------------------------------------------------------------------------
                Source: Quantgov.org.
                 Without a consistent process for periodically reviewing
                regulations, there is no guarantee that regulations will be
                [[Page 5739]]
                reviewed and revised to align with technological, economic, and other
                developments. Section 5 of Executive Order 12866 requires agencies to
                submit to the Office of Information and Regulatory Affairs (OIRA) a
                plan to periodically review their existing significant regulations to
                determine whether any such regulations should be modified or eliminated
                so as to make the agency's regulatory program more effective in
                achieving regulatory objectives, less burdensome, or in greater
                alignment with the President's priorities and principles. Section 6 of
                Executive Order 13563 similarly requires agencies to submit to OIRA a
                plan to periodically review their existing significant regulations to
                determine whether any such regulations should be modified, streamlined,
                expanded, or repealed so as to make the agency's regulatory program
                more effective or less burdensome in achieving regulatory objectives.
                 However, existing executive orders have not institutionalized a
                process for retrospective review and periodic updating of regulations,
                as evidenced by the fact that relatively few Department regulations are
                updated. Furthermore, every president since Jimmy Carter, including all
                those elected after enactment of 5 U.S.C. 610, has ordered some form of
                retrospective review of regulations,\218\ with mixed effects. This
                suggests that stronger incentives and forcing mechanisms are needed to
                ensure retrospective review occurs to an appropriate extent.
                ---------------------------------------------------------------------------
                 \218\ See Exec. Order No. 12044 of Mar. 23, 1978, 43 FR 12661
                (Mar. 24, 1978) (President Carter) (revoked by Exec. Order No. 12291
                of Feb. 17, 1981, 46 FR 13193 (Feb. 19, 1981) (President Reagan));
                Memorandum on Reducing the Burden of Government Regulation (Jan. 28,
                1992) (President H.W. Bush); Exec. Order No. 12866 of Sept. 30,
                1993, 58 FR 190 (Oct. 4, 1993) (President Clinton); Exec. Order No.
                13563 of Jan. 18, 2011, 76 FR 3821 (Jan. 21, 2011) (President
                Obama); Exec. Order No. 13771 of Jan. 30, 2017, 82 FR 9339 (Feb. 3,
                2017) (President Trump).
                ---------------------------------------------------------------------------
                 Some commenters suggested that a review of existing regulations
                does not make sense during a pandemic, but this misses the broader
                point that the Department has waived, suspended, or exercised
                enforcement discretion not to enforce many regulations in order to
                respond to the pandemic.\219\ Had the Department not done so, this may
                have hampered the Department's ability to respond nimbly, flexibly and
                quickly to the emergency.\220\ For example, the Department has issued
                waivers or exemptions, or exercised enforcement discretion with respect
                to, certain Medicare, Medicaid, CHIP, and HIPAA restrictions, including
                waivers to increase hospital capacity, ease restrictions on services
                rendered by medical residents, and allow patients to seek more services
                via telehealth. Meanwhile, other regulations that may have facilitated
                pandemic response have remained in place.
                ---------------------------------------------------------------------------
                 \219\ See Regulatory Relief to Support Economic Recovery;
                Request for Information (RFI), 85 FR 75720, at Attachment A (Nov.
                25, 2020).
                 \220\ See, for example, Alec Stapp, ``Timeline: The
                Regulations--and Regulators--That Delayed Coronavirus Testing,'' The
                Dispatch (March 20, 2020).
                ---------------------------------------------------------------------------
                 The Department's position is that retrospective review would
                require some change from the status quo, and unless there is a strong
                incentive to change, continuing business as usual is the path of least
                resistance.\221\ Thus, the status quo is maintained. Moreover,
                rescinding a regulation that has already been promulgated is likely to
                meet greater resistance than resistance to foregoing promulgating a
                regulation not yet enacted. This reflects a phenomenon known as loss
                aversion.\222\
                ---------------------------------------------------------------------------
                 \221\ See also Yoon-Ho Alex Lee, An Options Approach to Agency
                Rulemaking, 65 Admin. L. Rev. 881, 895-96 (2013) (positing reasons
                why agencies may be reluctant to perform retrospective reviews).
                 \222\ Daniel Kahneman et al., Anomalies: The Endowment Effect,
                Loss Aversion, and Status Quo Bias, 5 J. Econ. Persp. 193 (1991).
                ---------------------------------------------------------------------------
                 The Department's determination is that this final rule will address
                these issues by changing the choice architecture facing the Department
                by enacting a new default rule when the Department fails to conduct
                retrospective reviews. Sunset provisions change the default from rules
                staying on the books indefinitely to rules being eliminated after some
                predetermined amount of time unless evidence is presented for why rules
                should continue. When a default rule is changed, the choice
                architecture confronting decision makers is altered and can spur
                changes in behavior. A consistent finding in the literature on
                behavioral anomalies is that choice architecture and default rules have
                an important influence on decision making.\223\ Changes in the
                Department's choice architecture can ultimately result in changes in
                public wellbeing.
                ---------------------------------------------------------------------------
                 \223\ Richard H. Thaler et al., Choice Architecture, in The
                Behavioral Foundations of Public Policy 428, (Eldar Shafir ed.,
                2012).
                ---------------------------------------------------------------------------
                 To conclude, this final rule is intended to address a failure to
                periodically review regulations as often as desired in line with the
                RFA and other directives for retrospective review. The Department
                believes that this final rule, by changing the default for regulations
                from continued existence to expiration unless periodic review is
                conducted, will result in more widespread retrospective review of
                regulations. Requiring the expiration of rules that have not been
                assessed or reviewed in accordance with section 610 of the RFA should
                result in more regulations being updated to reflect evolving
                circumstances.
                C. Alternatives Considered
                 The Department considered several alternatives to the proposed
                regulation. First, it considered not issuing this final rule. However,
                the RFA and certain Executive Orders direct the Department to
                periodically review certain Department regulations. Moreover, the
                literature and the Department's experience suggest that large numbers
                of regulations are having estimated impacts that, over time, differ
                from what was estimated at the time the regulations were promulgated,
                so many regulations should be periodically reviewed.\224\ The
                Department's experience over the last forty years is that, absent a
                strong incentive such as the potential expiration of a regulation, the
                Department will not review an adequate number of its regulations.
                ---------------------------------------------------------------------------
                 \224\ Office of Mgmt. & Budget, Validating Regulatory Analysis:
                2005 Report to Congress on the Costs and Benefits of Federal
                Regulations and Unfunded Mandates on State, Local, and Tribal
                Entities, at 46-47 (2005), http://perma.cc/R8LX-BQMJ (collecting
                studies comparing ex ante and ex post analyses of regulations' costs
                and benefits, including examples where cost and benefit estimates
                were off by more than a factor of ten); Winston Harrington, Grading
                Estimates of the Benefits and Costs of Federal Regulation 33 (Res.
                for the Future, Discussion Paper 06-39, 2006), http://papers.ssrn.com/sol3/papers.cfm?abstract_id=937357.; Richard
                Morgenstern, Retrospective Analysis of U.S. Federal Environmental
                Regulation, J. of Benefit Cost Anal. 9 no. 2, 2018, at 285.
                ---------------------------------------------------------------------------
                 Next, the Department considered seeking to perform the reviews
                called for by the RFA without implementing a new forcing mechanism.
                Given past experience, however, it seems unrealistic to assume this
                would bring about meaningful change. First, the fact that these reviews
                are not already occurring is evidence they are unlikely to occur in the
                future. Second, as discussed above, there is a strong bias towards the
                status quo in governmental action, and this may stand in the way of
                behavior changes. Third, the literature suggests that enforcement
                mechanisms are needed to spur more periodic reviews, and specifically
                that sunset provisions are a useful enforcement mechanism.\225\
                Moreover,
                [[Page 5740]]
                even if the Department conducted the reviews called for by the RFA
                absent a new forcing mechanism, there might be benefits to this final
                rule, albeit ones that are hard to quantify. For example, this final
                rule could guard against a decrease in the frequency of Department
                retrospective reviews in future years.
                ---------------------------------------------------------------------------
                 \225\ Curtis W. Copeland, Cong. Rsch. Serv., RL32801,
                Reexamining Rules: Section 610 of the Regulatory Flexibility Act
                (2008); Michael Greenstone, Toward a Culture of Persistent
                Regulatory Experimentation and Evaluation, in New Perspectives on
                Regulation 111, 113 (David Moss & John Cisternino eds., 2009);
                Australian Gov't Att'y Gen.'s Dep't, Guide to Managing the
                Sunsetting of Legislative Instruments, at 3 (July 2020), https://www.ag.gov.au/sites/default/files/2020-07/Guide%20to%20Managing%20Sunsetting%20of%20Legislative%20Instruments.pdf.
                ---------------------------------------------------------------------------
                 Another alternative the Department considered is conducting in-
                depth Reviews of all of its Regulations (absent those that are exempt
                from this rulemaking), not just those designated as having a SEISNOSE.
                The Department sees value in conducting such widespread Reviews.
                However, the Department has opted not to require a complete Review of
                all Department regulations at the present time, although it leaves open
                the option to require such Reviews in the future.
                 The Department also considered conducting Reviews of significant
                regulations, as that term is defined in Executive Order 12866. The
                Department is choosing to Review those regulations that have a
                SEISNOSE, in order to maintain a close connection between this final
                rule and the RFA. The Department sought comment on whether to Review
                additional regulations, such as those that are significant under
                Executive Order 12866. Given limited responses to this request, the
                Department will not Review other regulations at this time beyond those
                designated as having a SEISNOSE. However, the Department leaves open
                the possibility to conduct Reviews of other regulations in the future.
                 The Department considered only Reviewing those regulations that, at
                the time of promulgation, the Department determined had a SEISNOSE.
                However, such determinations were not made for regulations that were
                promulgated prior to the passage of the RFA,\226\ and some post-RFA
                regulations that did not have such a SEISNOSE at the time of
                promulgation might have such a SEISNOSE today. One commenter suggested
                that an alternative to the proposed rule would be to attach sunset
                dates only prospectively for regulations finalized after the effective
                date of this rule. The same commenter suggested requiring retrospective
                reviews only for those regulations specifically identified by
                stakeholders as problematic. But as a general matter, the Department
                believes that older regulations are more likely to be obsolete. As a
                result, the Department believes that this final rule should apply to
                them. Moreover, only reviewing regulations identified by stakeholders
                is unlikely to suffice. Regulations are known to create entry barriers
                into industries and these barriers often affect small businesses
                disproportionally.\227\ Therefore, the Department believes stakeholder
                input cannot be the only source of information to spur reviews.
                Concentrated interest groups will lobby to protect regulations that
                have been specifically constructed for their benefit. Meanwhile,
                consumers, small businesses, and the public more generally often
                experience dispersed costs that are not taken into account by these
                stakeholders. The work of political scientist Mancur Olson explains why
                these groups that comprise broader society, because they are larger,
                face collective action problems and often find it costly to organize
                and lobby on behalf of their own interests.\228\ Meanwhile, more
                narrow, concentrated interests find it relatively easier to organize
                and lobby for their own interests. Thus, stakeholders may not identify
                to the Department many regulations that are unduly burdensome to the
                public at large.\229\
                ---------------------------------------------------------------------------
                 \226\ The Department estimates that 16% of its regulations that
                are more than ten years old were promulgated prior to 1980, when
                Congress passed the RFA.
                 \227\ See, e.g., Regulatory Reform: Hearings on S. 104, S. 262,
                S. 755, S. 1291 Before the Subcomm. on Admin. Practice & Procedure
                of the Comm. on the Judiciary, 96th Cong. 3-4 (1979) (statement of
                Peter J. Petkas, Director, The Regulatory Council) (describing the
                disproportionate impact on small businesses and uncertainty about
                benefits resulting from burdensome regulations); 142 Cong. Rec.
                S1637 (daily ed. Mar. 7, 1996) (statement of Sen. Bond) (``The SBA
                chief counsel for advocacy released a report that said that small
                businesses bear a disproportionate share of the regulatory
                burden.''); Nicole V. Crain & W. Mark Crain, The Impact of
                Regulatory Costs on Small Firms, (U.S. Small Bus. Admin., Office of
                Advocacy, Washington, DC), at 55, 57 (2010) (finding that
                ``regulations cost small firms an estimated $10,585 per employee.
                Regulations cost medium-sized firms $7,454 per employee, and large
                firms $7,755 per employee,'' and that in the health care sector, the
                cost per employee is 45 percent higher in small firms than in
                medium-sized firms, and 28 percent higher in small firms than in
                large firms).
                 \228\ Mancur Olson, The Logic of Collective Action (Harv. U.
                Press 1971).
                 \229\ The Department welcomes comments from all members of the
                public on (1) regulations being Assessed or Reviewed pursuant to
                this final and (2) future notices of proposed rulemaking. The
                Department will consider comments received from all members of the
                public. We merely make this observation to explain why relying
                solely on stakeholders may not enable the Department to identify
                certain regulations that should be amended or rescinded.
                ---------------------------------------------------------------------------
                 The Department is also aware of literature suggesting that agencies
                have not been consistent in deciding which rules have a SEISNOSE or
                have avoided such a finding in order to avoid the RFA's
                requirements.\230\ Moreover, 5 U.S.C. 610 presupposes the agency will
                make a determination about which regulations have or will have a
                SEISNOSE. This suggests there is good reason to Assess most of the
                Department's regulations. For these reasons, the Department has chosen
                to Assess all of its Regulations (subject to the exceptions listed
                herein) to determine which have a SEISNOSE and to Review those
                Regulations that have a SEISNOSE using the criteria listed in 5 U.S.C.
                610 (as well as whether they comply with applicable law).
                ---------------------------------------------------------------------------
                 \230\ See, e.g., Connor Raso, Agency Avoidance of Rulemaking
                Procedures, 67 Admin. L. Rev. 65, 93-95, 99-101 (2015); Michael R.
                See, Willful Blindness: Federal Agencies' Failure to Comply with the
                Regulatory Flexibility Act's Periodic Review Requirement--And
                Current Proposals to Reinvigorate the Act, 33 Fordham Urb. L. J.
                1199, 1222-25 (2006).
                ---------------------------------------------------------------------------
                 Finally, some commenters suggested that the Department include a
                provision granting the Secretary the authority to extend the expiration
                date in certain circumstances. Other commenters suggested that the
                proposed rule's two-year Assessment and Review period affecting some of
                the Department's older regulations was too short. In response, the
                Department has made several modifications to the final rule from its
                proposed form. First, regulations older than ten years will expire
                after five years, as opposed to expiring after two years, if these
                Regulations are not Assessed and (when necessary) Reviewed. Second,
                this final rule grants the Secretary a one-time option to push back
                this expiration date by one year for a given Regulation. Both of these
                modifications have the effect of lowering some costs of this final rule
                as compared to the proposed rule, because these changes lengthen the
                expected Assessment and Review period, pushing some costs into the
                future. This reduces the present value of these costs.
                D. Cost Analysis
                 5 U.S.C. 610 already directs the Department to undertake periodic
                reviews of its regulations. Nevertheless, because the Department
                believes this final rule will stimulate a behavior change at the
                Department and among the public, the regulation has some costs
                associated with it. Therefore, the Department performed the following
                analysis to estimate the costs and burdens to the Department and the
                public from (1) Assessing which Department regulations have a SEISNOSE,
                and (2) Reviewing those regulations.
                 The Department has roughly 18,000 regulations, the vast majority of
                which it believes would need to be Assessed.\231\ Roughly 12,400 of
                these
                [[Page 5741]]
                regulations are over ten years old, and roughly 17,200 are more than
                five years old.\232\ The vast majority of these would need to be
                Assessed within five years of this final rule's effective date (or six
                years if the optional extension is exercised by the Secretary). The
                Department estimates that roughly five regulations on average are part
                of the same rulemaking due to the number of unique Federal Register
                citations associated with its regulations. This would suggest the
                Department would have to perform roughly 3,440 Assessments in the first
                five years (or six for certain of these regulations if the extension is
                exercised by the Secretary, and 3,600 Assessments in total.
                ---------------------------------------------------------------------------
                 \231\ See Enhancing Regulatory Reform Through Advanced Machine
                Learning Findings (internal HHS slide) (the sum of the numbers
                listed in the table under the column denoted ``#'' is 17,890
                Department regulations).
                 \232\ See id. (adding the figures listed in the ``#'' columns
                for the 1950s, 1960s, 1970s, 1980s, 1990s, and 2000s yields 12,383
                regulations. 17,200 regulations are estimated to have been issued by
                the end of 2016).
                ---------------------------------------------------------------------------
                 However, some of these rulemakings are exempt from this final rule.
                The Department estimates that approximately 66 parts of the CFR that
                the Department actively updates contain the vast majority of the
                regulations that are exempt from this final rule. According to analysis
                from the Mercatus Center, however, the Department has approximately
                8,574 active parts of the CFR.\233\ 66 parts are therefore less than 1%
                of the Department's active parts. As a result, the Department does not
                believe the exemptions will significantly alter the costs of this final
                rule.\234\
                ---------------------------------------------------------------------------
                 \233\ These data are available at Quantgov.org.
                 \234\ The exempt parts may on average have more Sections than
                other parts. But even still, it seems unlikely the exemptions would
                significantly alter the costs of this final rule. If the Department
                were incorrect about this assumption, costs from this final rule
                would likely be lower than estimated herein. Similarly, the
                Department does not have enough information at present to determine
                whether the CFR sections that could potentially benefit from
                regulatory streamlining based on their similarities to, overlap
                with, or duplicativeness of other Sections will lead to a reduction
                in Department costs of Assessments and Reviews, due to duplication
                of work. The initial Assessment of all non-exempt regulations would
                determine whether this is the case.
                ---------------------------------------------------------------------------
                 To help estimate the impact of this final rule, the Department
                conducted a limited randomized sampling \235\ of its regulations and
                assessed whether the sampled regulations would be exempt from this
                final rule and whether, at the time of issuance, the regulations were:
                Economically significant; found to have a SEISNOSE; or subject to the
                Unfunded Mandates Reform Act (UMRA) of 1995. This information is
                included in table 3. Also included in table 3 is the estimated impact
                of the regulations when they were first promulgated.
                ---------------------------------------------------------------------------
                 \235\ With the aid of a random number generator, the Department
                selected Department regulations in each of its three main titles
                (21, 42, and 45) of the Code of Federal Regulations. The random
                number generator was used to identify the relevant part of each
                title of the CFR to assess.
                 Table 3--Sampled Department Regulations
                --------------------------------------------------------------------------------------------------------------------------------------------------------
                 Impact
                 Title Rulemaking Citation Exempt from this Economically SEISNOSE? Subject to estimates at
                 Final Rule? significant? UMRA? issuance
                --------------------------------------------------------------------------------------------------------------------------------------------------------
                21........................... Toll-Free Number 73 FR 63886..... No.............. No.............. No............. No............. ``[O]ne-time
                 for Reporting costs will
                 Adverse Events range from
                 on Labeling for approximately
                 Human Drug $38.0 million
                 Products. to $49.6
                 million and
                 annual costs
                 will range
                 from $12.4
                 million to
                 $46.3
                 million.'' 236
                21........................... Unique Device 78 FR 58786..... No.............. Yes............. Yes............ Yes............ ``Over 10
                 Identification years, the
                 System. estimated
                 present value
                 of the total
                 domestic costs
                 is $642.2
                 million using
                 a 7 percent
                 discount rate
                 and $737.7
                 million using
                 a 3 percent
                 rate, and the
                 annualized
                 costs are
                 $85.7 million
                 using a 7
                 percent
                 discount rate
                 and $84.1
                 million using
                 a 3 percent
                 discount
                 rate.'' 237
                21........................... Requirements for 81 FR 60170..... No.............. No.............. No............. No............. ``We estimate
                 Foreign and one-time total
                 Domestic costs of $59.7
                 Establishment million and
                 Registration recurring
                 And Listing for costs of $0.5
                 Human Drugs, million. These
                 Including Drugs costs
                 That Are represent
                 Regulated Under total
                 a Biologics annualized
                 License costs of $9
                 Application, million when
                 and Animal calculated at
                 Drugs. a 7-percent
                 discount rate
                 over 10 years,
                 and $7.5
                 million when
                 calculated
                 using a 3-
                 percent
                 discount rate.
                 The largest
                 cost elements
                 will be for
                 registrants
                 reading and
                 understanding
                 the final rule
                 and making
                 changes to
                 their standard
                 operating
                 procedures.''2
                 38
                21........................... Human Tissue 62 FR 40429..... No.............. No.............. No............. No............. FDA confirmed
                 Intended for ``that the
                 Transplantation. only economic
                 impact of the
                 rule would be
                 related to
                 recordkeeping
                 burdens'' that
                 already
                 existed.239
                42........................... Medicare 70 FR 57368..... No.............. Yes............. No............. No............. ``The Congress
                 Program; Health provided
                 Care $142,000,000
                 Infrastructure for the loan
                 Improvement program
                 Program; effective July
                 Selection 1, 2004
                 Criteria of through
                 Loan Program September 30,
                 for Qualifying 2008, and not
                 Hospitals more than
                 Engaged in $2,000,000 may
                 Cancer-Related be used for
                 Health Care. the
                 administration
                 of the loan
                 program for
                 each of the
                 fiscal years
                 (that is, 2004
                 through
                 2008).''240
                [[Page 5742]]
                
                42........................... Organ 63 FR 16296..... No.............. Yes............. No............. No............. Although
                 Procurement and incremental
                 Transplantation effects
                 Network. attributable
                 to the rule
                 were not
                 estimated,
                 impact
                 categories
                 would have
                 included life-
                 years saved by
                 non-renal
                 organ
                 transplants,
                 quality of
                 life
                 improvements
                 for kidney
                 recipients,
                 and the
                 admittedly
                 expensive
                 costs of
                 transplantatio
                 n.241
                42........................... Medicare 53 FR 47199..... No.............. No.............. No............. N/A (rule N/A: ``We have
                 Program; issued prior determined
                 Hospital to UMRA being that a
                 Insurance enacted). regulatory
                 Entitlement and impact
                 Supplementary analysis is
                 Medical not required
                 Insurance for these
                 Enrollment and rules because
                 Entitlement. they would not
                 have an annual
                 impact of $100
                 million or
                 more.''242
                45........................... Cooperation in 56 FR 8926...... No.............. No.............. No............. N/A (rule ``[T]he cost of
                 Identifying and issued prior implementation
                 Providing to UMRA being is expected to
                 Information To enacted). be
                 Assist States insignificant.
                 in Pursuing ''243
                 Third Party
                 Health Coverage.
                45........................... Responsibility 76 FR 53256..... No.............. No.............. No............. No............. Estimated
                 of Applicants annual cost of
                 for Promoting $23,236,238.24
                 Objectivity in 4
                 Research for
                 which Public
                 Health Service
                 Funding is
                 Sought and
                 Responsible
                 Prospective
                 Contractors.
                45........................... Rate Increase 76 FR 29964..... No.............. No.............. No............. No............. ``CMS estimates
                 Disclosure and that issuers
                 Review. will incur
                 approximately
                 $10 million to
                 $15 million in
                 one-time
                 administrative
                 costs, and
                 $0.6 million
                 to $5.5
                 million in
                 annual ongoing
                 administrative
                 costs related
                 to complying
                 with the
                 requirements
                 of this final
                 rule from 2011
                 through 2013.
                 In addition,
                 States will
                 incur very
                 small
                 additional
                 costs for
                 reporting the
                 results of
                 their reviews
                 to the Federal
                 government,
                 and the
                 Federal
                 government
                 will incur
                 approximately
                 $0.7 million
                 to $5.9
                 million in
                 annual costs
                 to conduct
                 reviews of
                 justifications
                 filed by
                 issuers in
                 States that do
                 not perform
                 effective
                 reviews.''
                 \245\
                --------------------------------------------------------------------------------------------------------------------------------------------------------
                 None of the sampled regulations would be exempt from this final
                rule, meaning all sampled rules would need to be Assessed. This is
                consistent with the assumption that few enough regulations would be
                exempt from this final rule to significantly affect the cost estimates
                presented here. At the time the ten sampled regulations were
                promulgated, the Department believed that one of the ten had a
                SEISNOSE. If the Assessments' findings mirror the findings from the
                time of issuance, one of the ten sampled regulations would need to be
                Reviewed. Similarly, an academic study found 11.1% of Department final
                rules issued in 1993 had a SEISNOSE.\246\ A more recent study found
                that 92% of agency rules were found to not be subject to the RFA,
                suggesting agencies believe roughly 8% of their regulations have a
                SEISNOSE.\247\
                ---------------------------------------------------------------------------
                 \236\ Toll-Free Number for Reporting Adverse Events on Labeling
                for Human Drug Products, 73 FR 63,886, 63,892 (Oct. 28, 2008).
                 \237\ Unique Device Identification System, 78 FR 58786, 58811
                (Sept. 24, 2013).
                 \238\ Requirements for Foreign and Domestic Establishment
                Registration And Listing for Human Drugs, Including Drugs That Are
                Regulated Under a Biologics License Application, and Animal Drugs,
                81 FR 60170, 60171 (Aug. 31, 2016).
                 \239\ Human Tissue Intended for Transplantation, 62 FR 40429,
                40442 (Jul. 29, 1997).
                 \240\ Medicare Program; Health Care Infrastructure Improvement
                Program; Selection Criteria of Loan Program for Qualifying Hospitals
                Engaged in Cancer-Related Health Care, 70 FR 57368, 57372 (Sept. 30,
                2005).
                 \241\ Organ Procurement and Transplantation Network, 63 FR
                16296, 16321-29 (Apr. 2, 1998).
                 \242\ Medicare Program; Hospital Insurance Entitlement and
                Supplementary Medical Insurance Enrollment and Entitlement, 53 FR
                47199, 47201 (Nov. 22, 1988).
                 \243\ Cooperation in Identifying and Providing Information To
                Assist States in Pursuing Third Party Health Coverage, 56 FR 8926,
                8929 (Mar. 4, 1991).
                 \244\ Responsibility of Applicants for Promoting Objectivity in
                Research for which Public Health Service Funding is Sought and
                Responsible Prospective Contractors, 76 FR 53256, 53280 (Aug. 25,
                2011).
                 \245\ Rate Increase Disclosure and Review, 76 FR 29964, 29978
                (May 23, 2011).
                 \246\ Michael R. See, Willful Blindness: Federal Agencies'
                Failure to Comply with the Regulatory Flexibility Act's Periodic
                Review Requirement--And Current Proposals to Reinvigorate the Act,
                33 Fordham Urb. L. J. 1199, 1217 (2006).
                 \247\ Connor Raso, Agency Avoidance of Rulemaking Procedures, 67
                Admin. L. Rev. 65, 69 (2015).
                ---------------------------------------------------------------------------
                 Assuming the Department has roughly 3,600 total rulemakings that
                are subject to this final rule; 3,440 of these are more than five years
                old (i.e. would be ten years old by the end of 2026); and that roughly
                11% \248\ have a SEISNOSE, then the Department might have to perform
                roughly 396 Reviews in total, of which 378 would have to be completed
                in the five years after this rule is finalized. However, some of these
                rulemakings might be reviewed as part of section 610 reviews even in
                absence of this final rule (i.e., in the baseline scenario). As noted
                above, the Department estimates that the three completed rulemakings
                emanating from section 610 reviews over the last decade amend
                approximately 130 sections of the CFR.
                [[Page 5743]]
                If the decade following implementation of this final rule is similar to
                the previous decade, then the Department can expect to review and amend
                130 sections of the CFR, which is equivalent to 26 average rulemakings
                if 5 regulations correspond with one rulemaking on average. These 26
                rulemakings are assumed to be what would be Reviewed in the baseline
                scenario. Therefore, the Department expects to conduct 370 Reviews in
                total, of which 353 would have to be completed in the five years after
                this rule is finalized.\249\
                ---------------------------------------------------------------------------
                 \248\ The Department chooses 11%, rather than 8% or 10%, because
                the study that found 11.1% of Department regulations had a
                significant economic impact upon a substantial number of small
                entities was focused solely on the Department's regulations.
                 \249\ Since approximately 95 percent of Department rules were
                finalized before 2016, this analysis assumes 25 Reviews in the
                baseline scenario would occur in the first five years following
                implementation of this final rule, and one Review would occur in the
                subsequent five years.
                ---------------------------------------------------------------------------
                 Of the 353 rulemakings subject to Reviews in the first five years
                (or six years if the Secretary exercises the one-year extension
                authority), the Department estimates roughly 44 rulemakings were
                promulgated prior to the requirement for prospective regulatory
                flexibility analyses. Those 44 Reviews will require more Department
                resources than the estimated 309 Reviews of rulemakings promulgated
                after the prospective analysis requirement went into effect.
                 Therefore, as a result of this final rule, the Department expects
                to have to conduct 370 Reviews in total. These include approximately 44
                rulemakings that were promulgated prior to the requirement for
                prospective regulatory flexibility analyses, and 326 Reviews of
                rulemakings promulgated after the prospective analysis requirement went
                into effect. Of these 326, the Department assumes most Reviews will
                occur earlier in the coming ten years such that 309 Reviews are
                conducted in the first five calendar years following implementation of
                this final rule and 17 of the Reviews occur in the second five calendar
                years. This is consistent with the fact that the vast majority, roughly
                95 percent, of Department regulations are older than five years (and
                therefore will be more than ten years old by the end of 2026).
                1. Costs Related to Section 610 Reviews of Regulations More Than Five
                Years Old
                 The majority of the Reviews conducted in response to this
                regulation will have to be conducted in the first five calendar years
                following implementation of this regulation, because the vast majority
                of the Department's regulations were finalized before the end of 2016.
                A full initial Regulatory Flexibility Act (RFA) analysis requires 250
                to 500 hours to complete because federal agencies must analyze the
                impact of their regulatory actions on small entities (small businesses,
                small non-profit organizations and small jurisdictions of government)
                and, where the regulatory impact is likely to be ``significant'' and
                affecting a ``substantial number'' of these small entities, seek less
                burdensome alternatives for them. This involves defining the market and
                determining costs for each small entity. The section 610 review is a
                more streamlined analysis because the regulatory flexibility analysis
                is the starting point. The section 610 review focuses on five areas of
                analysis: (1) Whether there is a continued need for the rule, (2) the
                number and nature of complaints, (3) the complexity of the regulation,
                (4) whether there is duplication, and (5) the degree to which
                technology, economic conditions, or other factors have changed in the
                area affected by the rule, as well as whether the Regulation complies
                with applicable law. As such, the Department estimates that a Review
                will require significantly less time than a full RFA analysis.
                 The Department recognizes that some regulations were promulgated
                prior to when the requirement for prospective regulatory analysis went
                into effect, and that a section 610 review of such rulemakings may be
                more time intensive. The Department estimates 309 rulemakings from 2016
                or earlier will be subject to section 610 review where some prospective
                analysis has been performed, in which case such reviews will take 40 to
                100 hours. The Department estimates it will undertake section 610
                reviews of 44 rules for which no prospective regulatory analysis was
                performed. The Department assumes that between 250 to 500 hours may be
                required for these reviews, even though the section 610 review is more
                circumscribed than a full regulatory flexibility analysis and will
                therefore generally take less time to perform. The Department also
                notes that there could be costs associated with publishing the notices
                of Assessments and Reviews to the Department's website and the Federal
                Register for public comment, but that such costs will be minimal and
                would not require the hiring of additional personnel.
                 Therefore, the Department estimates that a total of between 23,360
                and 52,900 hours will be spent on Reviews outside the Assessment
                process during the first five years (the number of hours may ultimately
                be slightly less if the Secretary exercises the optional one-year
                extension with respect to some regulations), which will clear the
                backlog of section 610 reviews for regulations at least five years old.
                The Department assumes 40 to 100 hours per Review for the estimated 309
                Reviews for which an initial prospective analysis was performed. The
                Department assumes 250 to 500 hours per Review for the estimated 44
                Reviews where no such initial prospective analysis was performed.
                 The Department estimates that the fully-loaded cost per hour to the
                Department to employ a person to conduct a Review or Assessment is
                $244.98 per hour (referred to as ``LaborCost'').\250\ Assuming the
                23,360 to 52,900 estimated hours are spread evenly across the first
                five years following implementation of this final rule, and assuming a
                7 percent discount rate, the present value of these costs ranges from
                $4.7 to $10.6 million in total. Without discounting, this is equal to
                20.1 to 45.6 full-time equivalents (FTEs) working at LaborCost to
                initiate and conduct Reviews of regulations in the first 5 years.
                ---------------------------------------------------------------------------
                 \250\ Here, the Department uses the reported ``FY 2021 average
                fully supported cost to [FDA of] $284,174 per FTE,'' divided by
                1,160 ``Net Supported Direct FDA Work Hours Available for
                Assignments'' per year to arrive at $244.98 per hour. Food Safety
                Modernization Act Domestic and Foreign Facility Reinspection,
                Recall, and Importer Reinspection Fee Rates for Fiscal Year 2021, 85
                FR 46669, 46670 (Aug. 3, 2020).
                ---------------------------------------------------------------------------
                2. Costs Related to Rulemakings That ``Age In'' To Section 610 Review
                 The Department estimates 17 rulemakings would ``age in'' \251\ to
                the section 610 review requirement during years six through ten after
                this rule is finalized. The Department estimates it will require
                between 680 to 1,700 hours to Review these rules, because the
                Department assumes those 17 Reviews would take between 40 to 100 hours
                per Review, as each of those rulemakings were promulgated after
                prospective regulatory analysis was required. Assuming hours reviewing
                these rulemakings are spread equally across years six through ten, the
                Department estimates the present value of the cost of Reviewing 17
                rulemakings in years six through ten to be between $0.1 million and
                $0.3 million at a seven percent discount rate. Without discounting,
                this represents 0.6 to 1.5 FTEs working at LaborCost to conduct 17
                Reviews of rules that age into the Review requirement during the decade
                following implementation of this regulation.
                ---------------------------------------------------------------------------
                 \251\ ``Age in,'' meaning that the rules become ten years old
                during years six through ten.
                ---------------------------------------------------------------------------
                [[Page 5744]]
                3. Costs Related to Assessments
                 In addition to conducting Reviews of rulemakings that have a
                SEISNOSE, the Department will allocate resources towards conducting
                Assessments of its rulemakings to determine whether a Review is
                required. At the time of promulgation, regulations are evaluated as to
                whether they had a SEISNOSE under the RFA. However, some regulations
                were promulgated prior to the RFA, while others were certified exempt
                from having to produce a regulatory flexibility analysis because they
                were certified as not having a SEISNOSE. This final rule will require
                the Department to make a determination as to whether covered
                rulemakings currently have a SEISNOSE and, if so, to Review those
                regulations. Because circumstances could change over time, the
                designation that a regulation has a SEISNOSE is likely to change for
                some rules. As a result, this final rule requires the Department to
                timely Assess all of its regulations (subject to the exceptions in this
                final rule) to determine whether they have a SEISNOSE, otherwise the
                regulations would expire. As discussed above, some rulemakings may
                overlap with or be duplicative of one another, reducing the number of
                Reviews that will be eventually required. However, the Department
                believes an initial Assessment of all rulemakings (subject to this
                final rule's exceptions) will likely be required first to determine the
                extent of such overlap or duplication.
                 The Department believes each Assessment will require between three
                and 10 hours to perform. The Department estimates that it will have to
                conduct roughly 3,062 Assessments in the first five years after this
                rule is finalized, and an additional 142 Assessments in the subsequent
                five years, for a total of 3,204 Assessments across ten years.\252\
                ---------------------------------------------------------------------------
                 \252\ 3,062 is 3,440 total Department rulemakings older than
                2016, minus 25 rulemakings Reviewed in the baseline scenario, minus
                the 353 rulemakings Reviewed in the first five years. 142 is 160
                rulemakings affected by this final rule in the second five years,
                minus one rulemaking Reviewed in the baseline scenario, minus the 17
                rulemakings expected to be Reviewed in the second five years.
                ---------------------------------------------------------------------------
                 As such, the Department believes 9,186 to 30,620 hours will be
                spent on Assessments in the first five years. The Department believes
                426 to 1,420 hours will be spent on Assessments in the following five
                years. Assuming these hours are spread evenly across their respective
                ranges of years, the present value of costs associated with these
                Assessments ranges from $1.9 to $6.4 million at a 7 percent discount
                rate. Without discounting, this represents 8.3 to 27.6 FTEs working on
                a total of 3,204 Assessments over ten years. If, as seems plausible,
                Assessments of regulations more than ten years old will
                disproportionately occur in the latter half of the 2021-2026 time
                period, the present value of the cost of Assessments will be slightly
                less than estimated herein.
                4. Costs Related to Review of Additional Rulemakings Found To Have a
                SEISNOSE
                 Depending on the outcome of the Assessments, the Department may
                have to Review additional rulemakings. The Department estimates roughly
                5% of Assessments of Regulations not initially found to have a SEISNOSE
                will conclude that a Review is required. The Department believes this
                is a reasonable estimate because the 5% rate is roughly half of the
                percentage of all Department regulations that the Department currently
                believes have a SEISNOSE. Accordingly, the Department estimates 153
                Reviews will be required in the first five years,\253\ and seven
                Reviews will be required in the subsequent five years,\254\ for a total
                of 160 additional Reviews. The Department estimates the 153 Reviews
                will require 6,120 to 15,300 hours,\255\ and that the seven Reviews
                will require 280 to 700 hours in the subsequent five years.
                ---------------------------------------------------------------------------
                 \253\ 5% of 3,062 is 153.
                 \254\ 5% of 142 is 7.
                 \255\ Each review will take 40-100 hours.
                ---------------------------------------------------------------------------
                 Assuming these hours are spread evenly across the corresponding
                time frames, multiplying these hour estimates by LaborCost and
                discounting at a seven percent discount rate yields an estimated $1.3
                to $3.2 million over ten years, which corresponds with 5.5 to 13.8 FTEs
                for additional post-Assessment Reviews over ten years (without
                discounting). If, as seems plausible, Reviews of regulations in this
                category will not be spread evenly across the corresponding time frames
                but will disproportionately occur in the latter half of the time
                frames, the present value of the cost of these Reviews will be slightly
                less than estimated herein.
                5. Monitoring Costs
                 Some commenters argued that the proposed rule's regulatory impact
                analysis underestimated the costs of this rulemaking, because it did
                not consider the costs to the regulated community of: Monitoring which
                regulations may expire; commenting either during the Assessment and
                Review process or to request that the Department conduct an Assessment
                or Review; and, when necessary, writing and submitting comments on
                regulations amended as a result of retrospective reviews conducted
                pursuant to this final rule.
                 The Department believes the cost of monitoring Assessments will be
                relatively trivial. This final rule requires the Department to announce
                on its website, as well as on Regulations.gov, when it has commenced
                Reviews and Assessments. Making the announcement on Regulations.gov (as
                opposed to only on the Department's website, as proposed) will reduce
                the monitoring costs raised by the commenters, because the regulated
                community already monitors Regulations.gov.
                 Moreover, in conjunction with this final rule, the Department is
                placing at https://www.hhs.gov/regulations/federal-registry/index.html
                a list of Department regulations, the year they were initially
                promulgated, the last year the rule was amended, and the Federal
                Register citation from the time the rule was initially promulgated.
                This list was generated with artificial intelligence and the Department
                believes it is accurate, but it is conceivable that some Department
                regulations are not included. This list can be used to easily create a
                schedule of expiration dates, so that the monitoring public does not
                need to identify these dates itself. Announcements of this kind conform
                to Organisation for Economic Co-operation and Development guidelines
                that recommended creating a predetermined schedule for when regulations
                are due for assessment and review.\256\ This type of ``programmed
                review'' would give both the Department and the public ample time to
                prepare for the Review and to submit comments as needed. It would also
                reduce the time and effort required of the public to track those
                regulations that are set to expire or be revised. As such, the
                monitoring public should not bear any significant expense keeping track
                of when regulations are set to expire or reminding the Department of
                when regulations are set to expire. Additionally, monitoring costs
                associated with Assessments are likely to not be significant because
                Assessments are unlikely to result in amendments of regulations, absent
                a subsequent Review also occurring. This final rule only mandates
                amendment or rescission of certain regulations that have been Reviewed.
                ---------------------------------------------------------------------------
                 \256\ Organisation for Economic Co-operation and Development,
                ``Reviewing the Stock of Regulation'' (2020).
                ---------------------------------------------------------------------------
                 In addition, the Department intends to create on its website a
                dashboard that shows its progress on its Assessments and Reviews,
                including when it commenced those Assessments and Reviews, its
                progress, and when it
                [[Page 5745]]
                expects them to be completed. If they so choose, the public can view
                this dashboard to see the Department's progress on its Assessments and
                Reviews of particular regulations. The dashboard will also help to keep
                the Department on track to timely complete Assessments and Reviews.
                 Based on the experience of North Carolina,\257\ the Department
                estimates that approximately 10 percent of Reviewed rulemakings will be
                rescinded and 30 percent of Reviewed rulemakings will be amended in
                some way. Since 530 rulemakings are expected to be Reviewed in
                total,\258\ this suggests 53 regulations will be rescinded and 159 will
                be updated.
                ---------------------------------------------------------------------------
                 \257\ Jon Sanders, Rule removal under periodic review has slowed
                down, but a new law tightens the process, The John Locke Found.: The
                Locker Room (July 22, 2019), https://lockerroom.johnlocke.org/2019/07/22/rule-removal-under-periodic-review-has-slowed-down-but-a-new-law-tightens-the-process/.
                 \258\ This is 370 Reviews from rules that were initially
                identified as having a SEISNOSE plus the 160 Reviews from
                Assessments determining that additional rulemakings have a SEISNOSE.
                ---------------------------------------------------------------------------
                 To estimate how much interest these expiring and amended
                regulations are likely to generate, the Department notes that it
                received 486 comments on the proposed rule as of the close of the 30-
                day public comment period. A typical commenter is likely to be someone
                with a legal background. According to the Bureau of Labor
                Statistics,\259\ the mean hourly wage of a lawyer is $71.60 (2020$).
                Assuming base salary constitutes one half of fully-loaded wages,\260\
                this suggests the fully loaded cost per hour of writing comments is
                $143.20.
                ---------------------------------------------------------------------------
                 \259\ See Bureau of Labor Statistics, Occupational Employment
                Statistics, 23-1011 Lawyers. https://www.bls.gov/oes/current/oes231011.htm.
                 \260\ This assumption is in line with Department guidelines on
                regulatory analysis. See U.S. Dep't of Health & Hum. Servs.,
                Guidelines for Regulatory Impact Analysis, at 28 (2016).
                ---------------------------------------------------------------------------
                 If a typical comment takes 5 to 15 hours to write, and if the 486
                comments the Department received on the proposed rule is a good proxy
                for the interest the Department will receive on the 159 rulemakings
                expected to be amended as a result of this final rule over the next
                decade, then the total (undiscounted) monitoring cost related to
                writing comments on those 159 regulations is $55.3 to $166.0
                million.\261\ However, rulemakings are not likely to all be amended at
                the same time. Further, if the Secretary determines that completion of
                an amendment or a rescission is not feasible by the required date, he
                or she can certify this in a statement published in the Federal
                Register and may extend the completion date by one year at a time, no
                more than three times.
                ---------------------------------------------------------------------------
                 \261\ This is 159 rulemakings x 486 commenters x $143.20 per
                hour x 5 to 15 hours per comment.
                ---------------------------------------------------------------------------
                 Assuming the Secretary does not extend the completion date (this
                assumption is relaxed in the sensitivity analysis below), the
                Department expects 152 of the amended rulemakings will be Reviewed in
                the first five years and seven regulations Reviewed in the second five
                years. Assuming monitoring costs are spread equally across these
                timeframes (with the understanding that this may overestimate costs
                somewhat since rulemakings are likely to be amended after they are
                Reviewed, which would push amendment to the later end of the timeframe)
                the present value of these monitoring costs ranges from $44.8 to $134.3
                million at a seven percent discount rate.
                 The Department expects it will receive less interest in regulations
                that are rescinded after being Reviewed, given that many regulations
                that are sunset in states often face little resistance from the public,
                perhaps because their rescission is uncontroversial. For example, the
                state of Idaho underwent a sunset review process for its entire
                regulatory code in 2019. As a result of the review, 19 percent of rule
                chapters, 10 percent of pages, and more than 19,000 regulatory
                restrictions were rescinded when the code was rewritten in the summer
                of 2019.\262\ This occurred with little controversy, suggesting many
                regulations that were rescinded were obviously outdated or
                counterproductive, such that their removal was uncontroversial.\263\
                ---------------------------------------------------------------------------
                 \262\ Office of Gov. Brad Little, Idaho's Historic Regulatory
                Cuts (July 2019).
                 \263\ The fact that there seemed to be little controversy
                surrounding rescinded rules may imply some of those rescissions were
                fairly trivial in some cases. While data on the extent to which
                rescissions were trivial or nontrivial are unavailable, news stories
                provide some basis for this belief. Note that rescinded rules being
                relatively trivial is not evidence that amended rules were trivial.
                See, e.g., Editorial, Idaho Quits Worrying About Snails, Wall St.
                J., June 28, 2019, https://www.wsj.com/articles/idaho-quits-worrying-about-snails-11561763217.
                ---------------------------------------------------------------------------
                 The North Carolina experience, which has been ongoing for several
                years, may be a better representation of what the Department can expect
                from its reviews, since the circumstances in Idaho were somewhat
                unique. Nonetheless, the 10 percent of reviewed rules being rescinded
                in North Carolina is comparable to the 10 percent of pages of rules
                repealed during Idaho's mid-2019 review. The Department assumes
                rescinded regulations will receive half as many comments as amended
                regulations. In that case, 53 rescinded regulations, of which 51 are
                expected in the first five years, should generate costs of $7.5 to
                $22.4 million (discounted at a 7 percent discount rate, assuming
                rescinded regulations are spread across corresponding timeframes in a
                manner consistent with the amended regulations described above). Thus,
                the total cost of monitoring is likely to range from $52.2 to $156.7
                million (at a seven percent discount rate).
                6. Total Estimated Costs From Implementing This Rulemaking
                 The Department estimates a total cost of between $60.2 to $199.3
                million over ten years in order to do the following: (a) Conduct
                section 610 Reviews for Department rulemakings from 2016 or earlier in
                years 1 to 5, (b) conduct section 610 Reviews of rulemakings that ``age
                in'' to section 610 review in years 6 to 10, (c) conduct Assessments of
                rulemakings in years 1 to 10, and (d) conduct section 610 Reviews of
                rulemakings deemed to be subject to Review following an Assessment in
                years 1 to 10. The total number of Department employees required to
                conduct these activities is estimated to be 34.5 to 88.5 FTEs over ten
                years. The Department has also estimated the cost of increased
                monitoring falling on regulated entities. Results are presented in
                table 4 below, which also includes cost estimates discounted at a 3
                percent discount rate for sensitivity purposes.\264\
                ---------------------------------------------------------------------------
                 \264\ The Office of Management and Budget recommends a 7 percent
                base-case default discount rate be used in regulatory impact
                analysis. OMB also recommends a 3 percent consumption rate of
                interest be used as an alternative. See Office of Mgmt. & Budget,
                Circular A-4, Regulatory Analysis (Sept. 17, 2003).
                 Table 4--Present Value of Estimated Cost of Assessing and Reviewing Department Regulations Over Ten Years
                 (Millions of 2020$), at 3 and 7 Percent Discount Rates
                ----------------------------------------------------------------------------------------------------------------
                 Type of cost Cost (7%) Cost (3%) FTEs
                ----------------------------------------------------------------------------------------------------------------
                Department Costs:
                [[Page 5746]]
                
                 A. Costs Related to Section 610 $4.7 to $10.6 million.. $5.2 to $11.9.......... 20.1 to 45.6.
                 Reviews of Regulations More Than
                 Five Years Old.
                 B. Costs Related to Rulemakings $0.1 to $0.3........... $0.2 to $0.4........... 0.6 to 1.5.
                 That ``Age In'' to Section 610
                 Review.
                 C. Costs Related to Assessments.. $1.9 to $6.4........... $2.1 to $7.1........... 8.3 to 27.6.
                 D. Costs Related to Review of $1.3 to $3.2........... $1.4 to $3.6........... 5.5 to 13.8.
                 Additional Rulemakings Found to
                 Have a SEISNOSE.
                Private Costs:
                 E. Cost to Monitoring Public..... $52.2 to $156.7........ $58.8 to $176.3........ N/A.
                 --------------------------------------------------------------------------
                 Total........................ $60.2 to $177.2........ $67.7 to $199.3........ 34.5 to 88.5.
                ----------------------------------------------------------------------------------------------------------------
                 These figures can also be presented on an annualized basis,
                calculations of which are presented in table 5 below. Annualized costs
                are estimated to range from $7.9 million to $25.2 million per year over
                the decade following implementation of this final rule.
                 Table 5--Accounting Statement: Annualized Costs of Final Rules
                ----------------------------------------------------------------------------------------------------------------
                 Discount rate Annualized, millions of 2020$ per
                 Present value (millions of 2020$) (percent) Time horizon year
                ----------------------------------------------------------------------------------------------------------------
                $60.2 to $177.2.......................... 7 2021-2030 $8.6 to $25.2.
                $67.7 to $199.3.......................... 3 2021-2030 $7.9 to $23.4.
                ----------------------------------------------------------------------------------------------------------------
                7. Sensitivity Analysis
                 One commenter noted that conducting a retrospective analysis can be
                as time-consuming and expensive as a prospective regulatory analysis,
                suggesting the Department's estimates of the time and expense of
                Reviews may be understated. The Department believes that on average
                Reviews of rulemakings implemented after the RFA are likely to be less
                time consuming than those implemented before. Moreover, 250 to 500
                hours is the amount of time estimated to produce a full initial RFA
                analysis, which requires more time than a section 610 review, even one
                where no RFA analysis was conducted when the rulemaking was
                promulgated. Nevertheless, for the sake of testing the sensitivity of
                the cost estimates for Reviews, the Department calculates the costs of
                Reviews assuming all Reviews take 250 to 500 hours, rather than the
                assumption of 40 to 100 hours for post-RFA regulations made above. In
                this case, the present value of the total cost of Reviews (A, B and D
                in table 4) would rise to $26.5 to $53.0 million from $6.1 to $14.1
                million (at a seven percent discount rate), and would rise to $29.7 to
                $59.4 million from $6.8 to $15.8 million (at a three percent discount
                rate).
                 However, there are also reasons to believe the costs estimated in
                table 4 are overestimated. First, this final rule permits the Secretary
                to extend by up to one year the expiration date for particular
                regulations. Having this option might have the effect of pushing back
                the time horizon for certain Reviews and Assessments by one year. This
                would suggest the costs presented in table 4 above are overestimated to
                the extent that the present value of these costs will fall as some
                costs are pushed into the future. Assuming all costs are pushed back by
                one year, discounting the total costs by one additional year at a seven
                percent discount rate yields a present value of total costs in the
                range of $56.3 million to $165.6 million, and at a three percent rate
                yields a present value of total costs in the range of $65.7 to $193.5
                million. These potential reduced costs are one reason the Department
                has decided to modify the final rule from its proposed form.
                 Similarly, the costs of monitoring might be pushed into the future
                if the Secretary exercises his or her right to extend the completion
                date by one year at a time, up to three times, with respect to
                amendment or rescission of regulations after Review. Assuming amended
                or rescinded regulations are pushed back three years in the future, the
                present value of monitoring costs would fall to $42.6 to $127.9 million
                at a seven percent discount rate and to $53.8 to $161.3 million at a
                three percent discount rate. If, as some commenters stated, this final
                rule resulted in the Department issuing fewer new notices of proposed
                rulemaking, the reduction in commenting costs from the reduction in new
                notices of proposed rulemaking would cause the monitoring costs from
                this final rule to drop.
                8. Other Possible Costs
                 Some commenters noted that there might be other sources of cost
                associated with this rulemaking other than those cited in the
                regulatory impact analysis accompanying the proposed rule. Some of
                these costs have been accounted for above, such as the cost of
                monitoring or the potential for Reviews to take longer than estimated
                in the proposed rule. Other commenters cited increased uncertainty to
                businesses and members of the regulated community as a possible cost
                due to the increased chance that rules may expire in the future. The
                Department does not believe uncertainty among the regulated community
                will add significantly to the costs of this rulemaking for the
                following reasons. The Department's sporadic use of periodic
                retrospective review--notwithstanding the RFA and Executive Orders--
                itself leads to ``uncertainty'' about how robustly the Department
                implements directives that make for good policy.\265\ To the extent
                that the Department can maintain compliance with its obligations, this
                should build trust in the Department
                [[Page 5747]]
                and reduce uncertainty (offsetting some or all of the uncertainty
                discussed by the commenters, if such uncertainty exists). Further, as
                noted above, the Department plans to release information about the
                18,000 regulations under its authority and when they were adopted, such
                that any uncertainty surrounding the expiration dates of the
                Department's various rulemakings will be reduced substantially, if not
                entirely. Additional measures to mitigate private costs are discussed
                in the ``Operationalization of This Final Rule'' section of this final
                rule.
                ---------------------------------------------------------------------------
                 \265\ To the extent this uncertainty has been lessened because
                the public has seen how the Department has implemented these
                directives over the course of many years, the same can be said for
                this final rule once it has been implemented for several years.
                ---------------------------------------------------------------------------
                 Second, the Department notes that many states have sunset
                provisions that are a routine part of their regulatory processes. New
                Jersey, Indiana, and North Carolina have sunset provisions for their
                regulations. Missouri has a sunset provision for regulations, which is
                tied to a periodic review requirement.\266\ Colorado, California, and
                Texas have sunset review processes for entire boards, commissions, and
                agencies. Some states have an annual sunset review process for their
                entire administrative code.\267\ Although the sunset clause is rarely
                exercised, there nevertheless is always the possibility the entire
                regulatory code will expire in these states in any particular year. In
                fact, two states (Idaho and Rhode Island) replaced their regulatory
                codes in recent years as part of sunset processes, and these
                experiences seemed to work relatively seamlessly.\268\
                ---------------------------------------------------------------------------
                 \266\ Missouri Revised Statutes, Title XXXVI Sec. 536.175.5.
                 \267\ Utah Code Ann. Sec. 63G-3-502(2) (2020); Idaho Code Ann.
                Sec. 67-5292 (2020).
                 \268\ James Broughel, The Mighty Waves of Regulatory Reform:
                Regulatory Budgets and the Future of Cost-Benefit Analysis, 3 Bus.
                Entrepreneurship & Tax L. Rev. 206, at 216 (2019).
                ---------------------------------------------------------------------------
                 Similarly, many major federal laws have sunset clauses attached to
                them. Notable among these are the Patriot Act, enacted in the aftermath
                of the 9/11 terrorist attack, and tax laws passed as part of the budget
                reconciliation process under the Byrd Rule in the U.S. Senate. Federal
                agencies like the Food and Drug Administration within the Department
                periodically go through a reauthorization process, not unlike a sunset
                review.\269\ Sunset provisions are also routinely used in other
                countries, notably in Australia, Canada and the United Kingdom. A
                recent OECD report noted that just under half of OECD member countries
                have some form of sunsetting arrangements in place.\270\ In Australia,
                since the passage of the Legislation Act of 2003,\271\ all regulations
                (known as legislative instruments), with some exceptions, automatically
                expire 10 years after enactment unless parliament acts to extend the
                period or a replacement instrument is adopted.\272\ The Australian
                Federal Register of Legislation (the equivalent of the Federal Register
                in the United States) maintains the sunset dates for qualifying
                legislation and provides notice about legislative instruments set to
                expire soon.\273\ The Department also plans to provide advance notice
                of expiration dates, and will provide updates on its progress
                conducting its regulatory reviews.
                ---------------------------------------------------------------------------
                 \269\ See FDA Reauthorization Act of 2017, Public Law 115-52
                (Aug. 18, 2017).
                 \270\ OECD, Reviewing the Stock of Regulation, at 25 (2020).
                 \271\ Legislation Act 2003 (Cth) (Austl.)
                 \272\ Australian Gov't Att'y Gen.'s Dep't, Guide to Managing the
                Sunsetting of Legislative Instruments, at 6 (July 2020), https://www.ag.gov.au/sites/default/files/2020-07/Guide%20to%20Managing%20Sunsetting%20of%20Legislative%20Instruments.pdf.
                 \273\ ``Federal Register of Legislation,'' Australian
                Government, accessed November 30, 2020, https://www.legislation.gov.au/Browse/Results/BySunsetDate/LegislativeInstruments/SunsettingSoon/2022/0/0/.
                ---------------------------------------------------------------------------
                 The Australian government also notes that sunset provisions are a
                useful way to spur periodic review of regulations, stating in a report
                that ``Sunsetting provides an opportunity for agencies to review and
                streamline legislative instruments. It is an important mechanism for
                reducing red tape, delivering clearer laws and aligning existing
                legislation with current government policy.'' \274\
                ---------------------------------------------------------------------------
                 \274\ Id. at 3.
                ---------------------------------------------------------------------------
                 The Republic of Korea (ROK) enacted regulatory sunset legislation
                in the late 1990s and formed a Regulatory Reform Committee (RRC) to
                review newly-introduced regulations and to improve the quality of
                existing regulations.\275\ According to a report from the OECD, ``The
                overall aim of the sunset clause is to periodically review regulations
                in order to determine whether it will be retained or abolished.'' \276\
                In 2009, ROK broadened the scope of its regulatory sunset process by
                tying in requirements for retrospective analysis.\277\ About 20 percent
                of existing regulations are reviewed every three to five years and
                rescinded if found to ``not serve the originally intended purpose.''
                \278\ Moreover, according to the OECD, ``[i]n 2014, the RRC set goals
                to reduce the economic regulations by 10% . . . As a result, 995 out of
                9,876 economic regulations were improved, which amounts to 10.1% of the
                total.'' \279\
                ---------------------------------------------------------------------------
                 \275\ OECD, Regulatory Policy in Korea: Towards Better
                Regulation (2017).
                 \276\ Id. at 20.
                 \277\ Id.at 71.
                 \278\ Id. at 41.
                 \279\ Id. at 84.
                ---------------------------------------------------------------------------
                 These jurisdictions' sunset provisions do not all work identically
                to this final rule. However, in some ways this final rule is more lax
                than these other jurisdictions' sunset provisions, because the
                requirements to extend expiration dates are more modest compared to
                some other jurisdictions. For example, conducting an Assessment, and
                when necessary, a Review, is a relatively easy way to extend an
                expiration date compared to having to initiate an entirely new
                rulemaking. If the sunset reviews in these other jurisdictions do not
                create tremendous uncertainty, it stands to reason that neither will
                this final rule.
                 Some commenters expressed concern that regulations might
                accidentally expire due to the Department not timely conducting an
                Assessment or Review. The Department intends to review all regulations
                subject to this final rule, and that any regulations that are
                eliminated will be formally rescinded following the Review process.
                This is consistent with the experiences of other jurisdictions with
                sunset provisions, where rules (or boards or commissions) are first
                subjected to a review process before they are reauthorized or
                rescinded. As an example, Idaho recently conducted a sunset review of
                its entire regulatory code. While a significant number of rule chapters
                were eliminated as part of that effort, those chapters were rescinded
                as part of a deliberate review process.
                 New Jersey is a state that attaches a 7-year sunset provision to
                regulations. According to the Office of Administrative Law in the
                state, it is a relatively rare phenomenon that rules expire due to
                administrative error.\280\ Similarly, accidental expiration of rules
                appears to be uncommon in Missouri, a state that connects a sunset
                provision to a periodic review requirement, much like this final
                rule.\281\
                ---------------------------------------------------------------------------
                 \280\ Personal communication with an official from the New
                Jersey Office of Administrative Law (Dec. 9, 2020).
                 \281\ Personal communication with an official from the Missouri
                Office of the Attorney General (Dec. 31, 2020).
                ---------------------------------------------------------------------------
                 Data from North Carolina's sunset review process can be informative
                about the extent to which rules are likely to be rescinded, modified,
                or kept without change as part of a sunset review. A North Carolina
                public policy organization found that 19,361 rules were reviewed as
                part of that state's sunset review process in recent years.\282\
                [[Page 5748]]
                Of these, 5,542 were sent back through the rule adoption process
                (28.6%), presumably to be updated, and 11,811 rules were automatically
                re-upped with no change (61.0%). About 10 percent of regulations
                reviewed under the recent sunset review process were rescinded,\283\
                and this occurred under the supervision of the state Rules Review
                Commission that was overseeing the process.
                ---------------------------------------------------------------------------
                 \282\ Jon Sanders, Rule removal under periodic review has slowed
                down, but a new law tightens the process, The John Locke Found.: The
                Locker Room (July 22, 2019), https://lockerroom.johnlocke.org/2019/07/22/rule-removal-under-periodic-review-has-slowed-down-but-a-new-law-tightens-the-process/.
                 \283\ Jon Sanders, Rule removal under periodic review has slowed
                down, but a new law tightens the process, The John Locke Found.: The
                Locker Room (July 22, 2019), https://lockerroom.johnlocke.org/2019/07/22/rule-removal-under-periodic-review-has-slowed-down-but-a-new-law-tightens-the-process/.
                ---------------------------------------------------------------------------
                 These numbers reinforce that there is little empirical basis to
                support fears that thousands of regulations might accidentally expire
                as a result of the Department's final regulation. The experiences in
                Idaho, New Jersey, Missouri and North Carolina demonstrate that sunset
                reviews tend to be orderly processes. Even in states like Idaho and
                Rhode Island, where significant portions of their regulatory codes were
                eliminated in recent years, these processes took place in an orderly
                fashion under the supervision of the state budget offices in those
                states.
                 Moreover, the Department has built in safeguards to prevent
                inadvertent expiration of regulations, such as seeking comment on the
                proposed rule regarding regulations that are important to Assess and
                Review, and enabling the public to submit comments requesting that the
                Department commence an Assessment or Review. Most importantly, the
                Department plans to release a list of when all of the regulations under
                its authority were created and last modified. This can be used to
                easily determine the expiration date of all regulations under its
                authority, which will significantly lower the chance any regulation
                might expire accidentally. The fact that a schedule of the Department's
                rules, along with their corresponding creation and modification dates,
                will be made public by the Department means the public will also be
                aware of which rules are scheduled to expire and when, thereby
                providing an additional safeguard against accidental expirations.
                Additionally, the timeline for initial reviews of older regulations has
                also been extended to five years in this final rule, with the option of
                a one-year extension, which should give the Department ample time to
                conduct Assessments and Reviews and should result in few, if any,
                accidental expirations.
                 One might worry that periodic reviews may distract from other
                potentially beneficial rulemakings, which could impose a cost that the
                Department has not fully considered in the proposed rule. However,
                there is some indication that when regulators are undergoing
                retrospective review efforts, if a rulemaking is an urgent priority to
                them, they often find ways to justify it as part of their reviews, even
                if the rulemaking would have occurred absent the review.\284\ In other
                words, regulators maintain some flexibility to enact necessary new
                regulations by folding them into retrospective reviews, including the
                amendment and rescission process, alleviating some of the concern
                raised by the commenters. To the extent that any new rulemaking is
                displaced as a result of reviews required by the current regulation, it
                is likely to be the case that relatively lower priority rulemakings are
                displaced first (as presumably the Department will first implement high
                priority regulations before moving on to lower priority regulations).
                ---------------------------------------------------------------------------
                 \284\ Randall Lutter, Regulatory Policy: What Role for
                Retrospective Analysis and Review?, 4 J. Benefit-Cost Analysis 17
                (2013).
                ---------------------------------------------------------------------------
                 Unfortunately, it is unknown with certainty whether Department
                rules impose benefits in excess of costs on average. The vast majority
                of Department rules do not have cost-benefit reports associated with
                them. Even for those that do, there are large uncertainties, and the
                literature suggests that many regulations are having estimated impacts
                that, over time, differ from what was estimated at the time the
                regulations were promulgated.\285\ This suggests that if a regulation
                did expire accidentally, this could be a cost or a benefit of this
                final rule, depending on the circumstances, since it is unknown whether
                the net benefits of the preponderance of Department rules are positive
                or negative. Regulations that are rescinded through sunset procedures
                are sometimes obviously problematic, such that their removal is
                uncontroversial. And if a regulation accidentally expired, it could
                very well be because neither the Department nor interested members of
                the public saw a discernible benefit from the regulation. Regulations
                with discernible benefits are unlikely to go under the radar.
                ---------------------------------------------------------------------------
                 \285\ Office of Mgmt. & Budget, Validating Regulatory Analysis:
                2005 Report to Congress on the Costs and Benefits of Federal
                Regulations and Unfunded Mandates on State, Local, and Tribal
                Entities, at 46-47 (2005) http://perma.cc/R8LX-BQMJ (collecting
                studies comparing ex ante and ex post analyses of regulations' costs
                and benefits, including examples where cost and benefit estimates
                were off by more than a factor of ten); Winston Harrington, Grading
                Estimates of the Benefits and Costs of Federal Regulation, at 33
                (Resources for the Future, Discussion Paper No. 06-39, 2006), http://papers.ssrn.com/sol3/papers.cfm?abstract_id=937357.; Richard
                Morgenstern, Retrospective Analysis of U.S. Federal Environmental
                Regulation, 9 J. Benefit-Cost Analysis 285, at 294 (2018).
                ---------------------------------------------------------------------------
                 A related concern in comments is that Assessments and Reviews will
                take Department time and resources away from responding to the COVID-19
                pandemic. Under this final rule, no Assessments or Reviews need to be
                completed until the end of 2026, well after the COVID-19 pandemic is
                likely to have subsided. Hence it is unlikely that this final rule will
                hamper the response to the pandemic.
                 The Department recognizes that this final rule requires the
                Department to undertake certain tasks. But given the importance of
                retrospective review, the Department believes that review should be a
                priority and it is willing to commit the necessary resources towards
                performing Assessments and Reviews.\286\
                ---------------------------------------------------------------------------
                 \286\ See also In re Barr Labs., Inc., 930 F.2d 72, 76 (D.C.
                Cir. 1991) (courts ``have no basis for reordering agency priorities.
                The agency is in a unique--and authoritative--position to view its
                projects as a whole, estimate the prospects for each, and allocate
                its resources in the optimal way.'').
                ---------------------------------------------------------------------------
                 The expertise of Department analysts may also be best leveraged
                through Assessments and Reviews that could facilitate the Department's
                response to future pandemics or emergencies. As noted earlier, the
                Department waived or exercised enforcement discretion with respect to
                many regulations as part of its response to the pandemic. A review of
                those regulations is entirely appropriate to determine whether those
                regulations are undermining Department goals. Additionally, the COVID-
                19 pandemic has raised serious questions about whether certain
                Department regulations are protecting public health or otherwise
                achieving their objectives. In fact, it is possible that in the coming
                years even absent this final rule the Department would find it
                necessary to conduct in-depth reviews of Department regulations given
                the need to suspend, waive, or exercise enforcement discretion with
                respect to certain regulations during the COVID-19 pandemic. If such
                reviews would have taken place even absent this final rule, the cost of
                this final rule could be significantly lower than estimated (since
                those costs would be built into the baseline scenario).
                 Some commenters cited a report that stated ``sunset requirements
                produce perfunctory reviews and waste
                [[Page 5749]]
                resources.'' \287\ Indeed, the same report was cited in the preamble of
                the proposed version of this rule. However, as noted in the proposed
                rule's preamble, this statement from the report does not appear to be
                supported by the evidence. For example, the report noted that some
                states have repealed their sunset provisions, highlighting that ``North
                Carolina was first to repeal its sunset law, and many other states
                quickly followed suit,'' and concluded that ``sunset provisions quickly
                proved to be an expensive, cumbersome, and disappointing method for
                enhancing legislative control.'' \288\ However, North Carolina
                reenacted a sunset process for regulations in 2013 \289\ (after the
                report in question was published). Moreover, not every jurisdiction
                uses sunset provisions as a mechanism for enhancing legislative
                control. As already noted, the purpose of sunset provisions is often to
                spur retrospective review and analysis of regulation or legislation,
                not necessarily to empower the legislative branch of government. Nor is
                it the Department's intention with this final rule to enhance
                legislative control, but instead to encourage more retrospective review
                and improve outcomes resulting from the Department's regulations.
                ---------------------------------------------------------------------------
                 \287\ Jason A. Schwartz, 52 Experiments with Regulatory Review,
                Inst. for Pol'y Integrity, at 24 (Nov. 2010), https://policyintegrity.org/files/publications/52_Experiments_with_Regulatory_Review.pdf.
                 \288\ Id. at 33.
                 \289\ Regulatory Reform Act of 2013, H.B. 74, 2013 Gen. Assemb.,
                2013 Sess. (N.C. 2013).
                ---------------------------------------------------------------------------
                 Sunset provisions are set up in institutionally diverse ways across
                diverse jurisdictions. Different jurisdictions set different expiration
                time horizons on rules and grant authority to different governing
                bodies to decide whether regulations should be extended or not. New
                Jersey and Indiana grant the authority to renew regulations to the
                regulating agency, not the legislature (similar to this final rule).
                Meanwhile, Idaho and Tennessee task the legislature with renewing
                regulations.
                 While legal scholars have sometimes argued that sunset provisions
                have a useful role to play in strengthening legislative control,\290\
                sunset provisions' benefits in terms of improving the impacts of
                regulations are equally if not more important than these legislative
                oversight or separation of powers issues. It may be the case that
                sometimes legislators do not want or do not have time to devote to in-
                depth reviews of large numbers of regulations, which is perhaps why
                sunset reviews that engage the legislature have sometimes turned into
                pro forma exercises.\291\ In other words, it seems likely that the
                criticisms of sunset provisions that have appeared sporadically in the
                academic literature may relate to whether sunsets spur legislative
                engagement in rulemaking, rather than whether they are useful in terms
                of spurring retrospective review (where there seems to be less
                controversy).
                ---------------------------------------------------------------------------
                 \290\ Jonathan H. Adler & Christopher Walker, Delegation and
                Time, 105 Iowa L. Rev. 1931 (2020).
                 \291\ Robert W. Hahn, State and Federal Regulatory Reform: A
                Comparative Analysis, 29 The J. Legal Stud. 873 (2000).
                ---------------------------------------------------------------------------
                 To conclude, the Department acknowledges that some categories of
                costs have not been quantified here. While other categories of costs do
                exist than those calculated in table 4, they may be subject to greater
                uncertainty, be more challenging to estimate, or be relatively minor
                such that their estimation would not substantially alter the
                conclusions of this cost analysis.
                 As is common practice, this regulatory impact analysis has not
                sought to quantify the benefits of this final rule, but the Department
                believes they will be substantial.
                E. Summary of Regulatory Impact Analysis
                 A forcing mechanism will help ensure robust compliance with the
                Department's statutory obligations, which will strengthen the rule of
                law in the United States. Given how much of federal spending is driven
                by Department spending, regulatory reviews may also constitute a way to
                cut the federal budget deficit. If the Department is not able to review
                its own regulations in a timely manner, it is not clear how any member
                of the public can be expected to comply with all of the regulations the
                Department has written for them (plus all of the regulations issued by
                other federal, state, and local agencies). Fortunately, the Department
                intends to timely Assess and (where needed) Review those regulations
                not exempt from this final rule. Even if for some reason the Department
                cannot, it has provided itself an opportunity to delay the expiration
                date where the public interest requires so doing.
                Regulatory Flexibility Act
                 The Department has examined the economic implications of this final
                rule as required by the RFA (5 U.S.C. 601-612). The RFA generally
                requires that when an agency issues a proposed rule, or a final rule
                pursuant to section 553(b) of the APA or another law, the agency must
                prepare a regulatory flexibility analysis that meets the requirements
                of the RFA and publish such analysis in the Federal Register. 5 U.S.C.
                603, 604. Specifically, the RFA normally requires agencies to describe
                the impact of a rulemaking on small entities by providing a regulatory
                impact analysis. Such analysis must address the consideration of
                regulatory options that would lessen the economic effect of the rule on
                small entities. The RFA defines a ``small entity'' as (1) a proprietary
                firm meeting the size standards of the Small Business Administration
                (SBA); (2) a nonprofit organization that is not dominant in its field;
                or (3) a small government jurisdiction with a population of less than
                50,000. 5 U.S.C. 601(3)-(6). Except for such small government
                jurisdictions, neither State nor local governments are ``small
                entities.'' Similarly, for purposes of the RFA, individual persons are
                not small entities. The requirement to conduct a regulatory impact
                analysis does not apply if the head of the agency ``certifies that the
                rule will not, if promulgated, have a significant economic impact on a
                substantial number of small entities.'' 5 U.S.C. 605(b). The agency
                must, however, publish the certification in the Federal Register at the
                time of publication of the rule, ``along with a statement providing the
                factual basis for such certification.'' Id. If the agency head has not
                waived the requirements for a regulatory flexibility analysis in
                accordance with the RFA's waiver provision, and no other RFA exception
                applies, the agency must prepare the regulatory flexibility analysis
                and publish it in the Federal Register at the time of promulgation or,
                if the rule is promulgated in response to an emergency that makes
                timely compliance impracticable, within 180 days of publication of the
                final rule. 5 U.S.C. 604(a), 608(b).
                 The Department considers a rule to have a significant impact on a
                substantial number of small entities if it has at least a three percent
                impact on revenue on at least five percent of small entities.
                Department regulations impact at least NAICS industry sectors 11, 31-
                33, 42, 44-45, 48-49, 52, 54, 62, 81, and 92.
                 The Regulatory Impact Analysis in the prior section also satisfies
                the Department's obligation to conduct a regulatory flexibility
                analysis under section 604. For the reasons described in this final
                rule, this final rule will benefit small entities.
                Congressional Review Act
                 The Congressional Review Act (CRA) defines a ``major rule'' as
                ``any rule that the Administrator of the Office of Information and
                Regulatory Affairs
                [[Page 5750]]
                (OIRA) of the Office of Management and Budget finds has resulted in or
                is likely to result in--(A) an annual effect on the economy of
                $100,000,000 or more; (B) a major increase in costs or prices for
                consumers, individual industries, Federal, State, or local government
                agencies, or geographic regions; or (C) significant adverse effects on
                competition, employment, investment, productivity, innovation, or on
                the ability of United States-based enterprises to compete with foreign-
                based enterprises in domestic and export markets.'' 5 U.S.C. 804(2).
                Based on the analysis of this final rule under Executive Order 12866,
                this rule is expected to be a major rule for purposes of the CRA. The
                Department will comply with the CRA's requirements to inform Congress.
                Unfunded Mandates Reform Act
                 Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded
                Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a
                budgetary impact statement before promulgating a rule that includes any
                Federal mandate that may result in the expenditure by State, local, and
                tribal governments, in the aggregate, or by the private sector, of $100
                million in 1995 dollars, updated annually for inflation. Currently,
                that threshold is approximately $156 million. If a budgetary impact
                statement is required, section 205 of the Unfunded Mandates Act also
                requires covered agencies to identify and consider a reasonable number
                of regulatory alternatives before promulgating a rule.
                National Environmental Policy Act (NEPA)
                 HHS has determined that the proposed rule will not have a
                significant impact on the environment.
                Executive Order 12988: Civil Justice Reform
                 HHS has reviewed this rule under Executive Order 12988 on Civil
                Justice Reform and has determined that this final rule complies with
                this Executive Order.
                Executive Order 13132: Federalism
                 Executive Order 13132 establishes certain requirements that an
                agency must meet when it promulgates a rule that imposes substantial
                direct costs on State and local governments or has federalism
                implications. The Department has determined that this final rule does
                not impose substantial direct costs on State and local governments or
                have federalism implications as defined in Executive Order 13132. The
                final rule requires the Department to periodically review certain of
                its regulations, and provides that if the regulations are not reviewed
                by a certain date, they will expire. Any rescission of a regulation
                would only occur because of acts independent of this final rule--either
                the findings of a Review determining a regulation should be amended, or
                a failure to perform an Assessment or Review. Thus, this final rule
                would impose no substantial direct costs on State and local
                governments.
                 The Department notes, though, that this final rule might indirectly
                have beneficial federalism implications. Among other things, the
                Reviews called for by this final rule require the Department to
                determine if certain Department regulations overlap, duplicate or
                conflict with State and local government rules and, if so, to consider
                that when determining whether to amend or rescind the regulations. If a
                Review conducted pursuant to this final rule were to find that a
                Department regulation should be amended or rescinded, the Department
                would comply with Executive Order 13132 in amending or rescinding the
                regulation.
                Plain Writing Act of 2010
                 Under the Plain Writing Act of 2010 (Pub. L. 111-274, October 13,
                2010), executive departments and agencies are required to use plain
                language in documents that explain to the public how to comply with a
                requirement the federal government administers or enforces. The
                Department has attempted to use plain language in promulgating this
                proposed rule, consistent with the Federal Plain Writing Act
                guidelines.
                Assessment of Federal Regulation and Policies on Families
                 Section 654 of the Treasury and General Government Appropriations
                Act of 1999, Public Law 105-277, sec. 654, 112 Stat. 2681 (1998)
                requires Federal departments and agencies to determine whether a policy
                or regulation could affect family well-being. Section 601 (note)
                required agencies to assess whether a regulatory action (1) impacted
                the stability or safety of the family, particularly in terms of marital
                commitment; (2) impacted the authority of parents in the education,
                nurturing, and supervision of their children; (3) helped the family
                perform its functions; (4) affected disposable income or poverty of
                families and children; (5) was justified if it financially impacted
                families; (6) was carried out by State or local government or by the
                family; and (7) established a policy concerning the relationship
                between the behavior and personal responsibility of youth and the norms
                of society.
                 This final rule would apply to and amend certain Department
                regulations to add dates by which they would expire unless the
                Department periodically reviews the regulations using certain criteria.
                Standing alone, absent the failure to perform an Assessment or Review,
                this final rule would have no direct impact, other than resulting in
                the Department amending or rescinding Regulations that it determines do
                not satisfy the Review criteria.
                 If the family well-being determination requirement were still in
                force, for the reasons described in this final rule's Regulatory Impact
                Analysis, the Department concludes that the benefits to the public,
                including families, that flow from periodic Assessments and Reviews of
                Regulations far outweigh any potential adverse impact on family well-
                being that might result from a regulation expiring because the
                Department did not Assess or Review it. The Department believes that
                impacted families benefit greatly when a regulatory body considers the
                real-world impacts of its regulations, and whether changes in
                technology, the economy, or the legal landscape counsel in favor of
                amending or rescinding regulations. It is conceivable that a regulation
                affecting the disposable income or poverty of families or children
                could expire. It is also possible that the expiration of a regulation
                that the Department does not Review could have beneficial impacts on
                family well-being. If, pursuant to this final rule, the Department
                amends or rescinds a regulation, it would conduct any required
                assessment of the policy on families at the time of such rulemaking.
                Paperwork Reduction Act of 1995
                 In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
                3506; 5 CFR 1320 Appendix A.1), HHS has reviewed this final rule and
                has determined that there are no new collections of information
                contained therein.
                List of Subjects
                21 CFR Part 6
                 Administrative practice and procedure.
                42 CFR Part 1
                 Administrative practice and procedure.
                42 CFR Part 404
                 Administrative practice and procedure.
                [[Page 5751]]
                42 CFR Part 1000
                 Administrative practice and procedure.
                45 CFR Part 8
                 Administrative practice and procedure.
                45 CFR Part 200
                 Administrative practice and procedure.
                45 CFR Part 300
                 Administrative practice and procedure.
                45 CFR Part 403
                 Administrative practice and procedure.
                45 CFR Part 1010
                 Administrative practice and procedure.
                45 CFR Part 1390
                 Administrative practice and procedure.
                 For the reasons set forth in the preamble, the Department amends 21
                CFR, chapter I, 42 CFR chapters I, IV, and V; 45 CFR subtitle A; and 45
                CFR subtitle B, chapters II, III, IV, X, and XIII, as follows:
                Title 21--Food and Drugs
                CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                SERVICES
                0
                1. Add part 6 to read as follows:
                PART 6--REVIEW OF REGULATIONS
                Sec.
                6.1 Retrospective Review of Existing Regulations.
                6.2 through 6.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 610; 15 U.S.C. 402; 15 U.S.C.
                409; 15 U.S.C. 1261-1276; 15 U.S.C. 1333; 15 U.S.C. 1451-1461; 15
                U.S.C. 4402; 18 U.S.C. 1905; 19 U.S.C. 1490-1491; 19 U.S.C. 2531-
                2582; 21 U.S.C. 41-50; 21 U.S.C. 141-149; 21 U.S.C. 301 et seq.; 21
                U.S.C. 355 note; 21 U.S.C. 301-397; 21 U.S.C. 467f; 21 U.S.C. 679;
                21 U.S.C. 821; 21 U.S.C. 1034; 21 U.S.C. 1401-1403; 28 U.S.C. 2112;
                35 U.S.C. 156; 42 U.S.C. 201-262; 42 U.S.C. 263a; 42 U.S.C. 263b-
                263n; 42 U.S.C. 264; 42 U.S.C. 265; 42 U.S.C. 271; 42 U.S.C. 300aa-
                28; 42 U.S.C. 300u-300u-5; 42 U.S.C. 4321; 42 U.S.C. 4332, 42 U.S.C.
                7671 et seq.; Sec. 121, Pub. L. 105-115, 111 Stat. 2296; Pub. L.
                107-109; Pub. L. 107-188, 116 Stat. 594, 668-69; Pub. L. 108-155;
                Secs. 201 and 202, Pub. L. 111-31, 123 Stat. 1776; Secs. 901(b) and
                906(d), Pub. L. 111-31; Pub. L. 111-353, 124 Stat. 3885, 3889; Pub.
                L. 113-54.
                Sec. 6.1 Retrospective Review of Existing Regulations.
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this chapter.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if required) the
                review of a Section are published in the Federal Register pursuant to
                paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination, which shall not exceed
                one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was promulgated or the last time the rulemaking was reviewed
                by the Department; and
                 (6) Whether the rulemaking complies with applicable law.
                 (e) If the review concludes the Section should be amended or
                rescinded, the Department shall have two years from the date that the
                findings of the review are published in the Federal Register pursuant
                to paragraph (f) of this section to amend or rescind the Section. If
                the Secretary determines that completion of the amendment or rescission
                is not
                [[Page 5752]]
                feasible by the established date, he shall so certify in a statement
                published in the Federal Register and may extend the completion date by
                one year at a time, no more than three times, for a total of not more
                than five years (inclusive of the initial two-year period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (8) 21 CFR parts 131, 133, 135-137, 139, 145, 146, 150, 152, 155,
                156, 158, 160, 161, 163-166, 168, and 169.
                 (9) 21 CFR parts 331-333, 335-336, 338, 340-341, 343-344, 346-350,
                352, 355, 357, and 358.
                 (10) 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880,
                882, 884, 886, 888, 890, 892, 895, and 898.
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting. The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by which comments must be
                received. There shall also be a general docket on Regulations.gov where
                the public can submit comments requesting that the Department assess or
                review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                Sec. Sec. 6.2 through 6.5 [Reserved].
                Title 42--Public Health
                CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
                SERVICES
                0
                2. Add part 1 to read as follows:
                PART 1--REVIEW OF REGULATIONS
                Sec.
                1.1 Retrospective Review of Existing Regulations
                1.2 through 1.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 610, 8 U.S.C. 1182, 8 U.S.C.
                1222, 29 U.S.C. 670(a), 30 U.S.C. 957, 31 U.S.C. 9701, 42 U.S.C.
                216, 42 U.S.C. 241, 42 U.S.C. 300a-4, 42 U.S.C. 10801, 42 U.S.C.
                1302, 42 U.S.C. 1395hh, 42 U.S.C. 702(a), 42 U.S.C. 702(b)(1)(A), 42
                U.S.C. 706(a)(3), 42 U.S.C. 243, 42 U.S.C. 247b, 247c, 42 U.S.C.
                247d-6e, 31 U.S.C. 1243 note, 42 U.S.C. 252, 42 U.S.C. 254c, 42
                U.S.C. 262a, 42 U.S.C. 256b, 42 U.S.C. 263, 42 U.S.C. 263a, 42
                U.S.C. 264-271, 42 U.S.C. 273-274d; 42 U.S.C. 274e; 42 U.S.C.
                290aa(m), 42 U.S.C. 284g, 42 U.S.C. 285a-6(c)(1)(E), 42 U.S.C. 285a-
                7(c)(1)(G), 42 U.S.C. 285b-4, 42 U.S.C. 285c-5, 42 U.S.C. 285c-8, 42
                U.S.C. 285d-6, 42 U.S.C. 285e-2, 42 U.S.C. 285e-3, 42 U.S.C. 285e-
                10a, 42 U.S.C. 285f-1, 42 U.S.C. 285g-5, 42 U.S.C. 285g-7, 42 U.S.C.
                285g-9, 42 U.S.C. 285m-3, 42 U.S.C. 285o-2, 42 U.S.C. 286a-
                7(c)(1)(G), 42 U.S.C. 287c-32(c), 42 U.S.C. 288, 42 U.S.C. 289a, 42
                U.S.C. 289b, 42 U.S.C. 290aa, et seq., 42 U.S.C. 290aa(d), 42 U.S.C.
                290aa(m), 42 U.S.C. 290cc-21, et seq., 42 U.S.C. 290dd-2, 42 U.S.C.
                290kk, et seq., 42 U.S.C. 300 through 300a-6, 42 U.S.C. 300cc-16, 42
                U.S.C. 300mm-300mm-61, 42 U.S.C. 300x-21, et seq, 42 U.S.C. 7384n,
                42 U.S.C. 7384q, 42 U.S.C. 6939a.
                Sec. 1.1 Retrospective Review of Existing Regulations.
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this chapter.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if
                [[Page 5753]]
                required) the review of a Section are published in the Federal Register
                pursuant to paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination, which shall not exceed
                one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was promulgated or the last time the rulemaking was reviewed
                by the Department; and
                 (6) Whether the rulemaking complies with applicable law.
                 (e) If the review concludes the Section should be amended or
                rescinded, the Department shall have two years from the date that the
                findings of the review are published in the Federal Register pursuant
                to paragraph (f) of this section to amend or rescind the Section. If
                the Secretary determines that completion of the amendment or rescission
                is not feasible by the established date, he shall so certify in a
                statement published in the Federal Register and may extend the
                completion date by one year at a time, no more than three times, for a
                total of not more than five years (inclusive of the initial two-year
                period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (8) 42 CFR part 73.
                 (9) 42 CFR 100.3.
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting. The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by which comments must be
                received. There shall also be a general docket on Regulations.gov where
                the public can submit comments requesting that the Department assess or
                review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                Sec. Sec. 1.2 through 1.5 [Reserved]
                CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF
                HEALTH AND HUMAN SERVICES
                0
                3. Add part 404 to subchapter A to read as follows:
                PART 404--REVIEW OF REGULATIONS
                Sec.
                404.1 Retrospective Review of Existing Regulations
                404.2 through 404.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 610; 31 U.S.C. 9701; 42 U.S.C.
                263a; 42 U.S.C. 273; 42 U.S.C. 300e; 42 U.S.C. 300e-5; 42 U.S.C.
                300e-9; 42 U.S.C. 405(a), 42 U.S.C. 1302; 42 U.S.C. 1306; 42 U.S.C.
                1315a; 42 U.S.C. 1320a-7; 42 U.S.C. 1320a-7j; 42 U.S.C. 1320b-8; 42
                U.S.C. 1320b-12; 42 U.S.C. 1395; 42 U.S.C. 1395aa(m); 42 U.S.C.
                1395cc; 42 U.S.C. 1395d(d); 42 U.S.C. 1395ddd; 42 U.S.C. 1395eee(f);
                42 U.S.C. 1395f(b); 42 U.S.C. 1395ff; 42 U.S.C. 1395g; 42 U.S.C.
                1395hh; 42 U.S.C. 1395i; 42 U.S.C. 1395i-3; 42 U.S.C. 1395l(a), (i),
                (n), and (t); 42 U.S.C. 1395jjj; 42 U.S.C. 1395kk; 42 U.S.C. 1395m;
                42 U.S.C. 1395nn; 42 U.S.C. 1395rr; 42 U.S.C. 1395rr(b)(l); 42
                U.S.C. 1395tt; 42 U.S.C. 1395w-5; 42 U.S.C. 1395w-101 through 1395w-
                152; 42 U.S.C. 1395ww; 42 U.S.C. 1395ww(k); 42 U.S.C. 1395x;
                1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16));
                42 U.S.C. 1395x(v); 42 U.S.C. 1395y(a); 42 U.S.C. 1396r; 42 U.S.C.
                1396r-8; 42 U.S.C. 1396u-4(f); 44 U.S.C. Chapter 35; Section 1331 of
                the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-
                [[Page 5754]]
                148, 124 Stat. 119), as amended by the Health Care and Education
                Reconciliation Act of 2010 (Pub. L. 111-152, 124 Stat 1029); Pub. L.
                112-202 amendments to 42 U.S.C. 263a; sec. 105, Pub. L. 114-10, 129
                Stat. 87.
                Sec. 404.1 Retrospective Review of Existing Regulations.
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this chapter.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if required) the
                review of a Section are published in the Federal Register pursuant to
                paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination, which shall not exceed
                one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was promulgated or the last time the rulemaking was reviewed
                by the Department; and
                 (6) Whether the rulemaking complies with applicable law.
                 (e) If the review concludes the Section should be amended or
                rescinded, the Department shall have two years from the date that the
                findings of the review are published in the Federal Register pursuant
                to paragraph (f) of this section to amend or rescind the Section. If
                the Secretary determines that completion of the amendment or rescission
                is not feasible by the established date, he shall so certify in a
                statement published in the Federal Register and may extend the
                completion date by one year at a time, no more than three times, for a
                total of not more than five years (inclusive of the initial two-year
                period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (8) The annual Medicare payment update rules.
                [[Page 5755]]
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting. The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by which comments must be
                received. There shall also be a general docket on Regulations.gov where
                the public can submit comments requesting that the Department assess or
                review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                Sec. Sec. 404.2 through 404.5 [Reserved]
                CHAPTER V--OFFICE OF INSPECTOR GENERAL--HEALTH CARE, DEPARTMENT OF
                HEALTH AND HUMAN SERVICES
                0
                4. Add subpart A to part 1000 to read as follows:
                PART 1000--Introduction, General Definitions
                Subpart A--Review of regulations
                Sec.
                1000.1 Retrospective Review of Existing Regulations
                1000.2 through 1000.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 610; 31 U.S.C. 6101 note; 42
                U.S.C. 262a; 42 U.S.C. 405(a); 42 U.S.C. 405(b); 42 U.S.C. 405(d);
                42 U.S.C. 405(e); 42 U.S.C. 1302; 42 U.S.C.1320; 42 U.S.C. 1320a-
                7d(b); 1320b-10; 42 U.S.C. 1320c-5; 42 U.S.C. 1395cc(b)(2)(D), (E),
                and (F); 42 U.S.C. 1395cc(j); 42 U.S.C. 1395dd(d)(1); 42 U.S.C.
                1395hh; 42 U.S.C. 1395mm; 42 U.S.C. 1395nn(g); 42 U.S.C. 1395ss(d);
                42 U.S.C. 1395u(j); 42 U.S.C. 1395u(k); 42 U.S.C. 1395w-104(e)(6);
                42 U.S.C. 1395w-141(i)(3); 42 U.S.C. 1395y(d); 42 U.S.C. 1395y(e);
                42 U.S.C. 1396(a)(4)(A); 42 U.S.C. 1396a(p); 42 U.S.C. 1396a(a)(39);
                42 U.S.C. 1396a(a)(41); 42 U.S.C. 1396a(a)(61); 42 U.S.C.
                1396b(a)(6); 42 U.S.C. 1396b(b)(3); 42 U.S.C. 1396b(i)(2); 42 U.S.C.
                1396b(m); 42 U.S.C. 1396b(q); 42 U.S.C. 1842(j)(1)(D)(iv); 42 U.S.C.
                1842(k)(1); 42 U.S.C. 11131(c); 42 U.S.C. 11137(b)(2).
                Sec. 1000.1 Retrospective Review of Existing Regulations.
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this chapter.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if required) the
                review of a Section are published in the Federal Register pursuant to
                paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination, which shall not exceed
                one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was promulgated or the last time the rulemaking was reviewed
                by the Department; and
                 (6) Whether the rulemaking complies with applicable law.
                 (e) If the review concludes the Section should be amended or
                rescinded, the
                [[Page 5756]]
                Department shall have two years from the date that the findings of the
                review are published in the Federal Register pursuant to paragraph (f)
                of this section to amend or rescind the Section. If the Secretary
                determines that completion of the amendment or rescission is not
                feasible by the established date, he shall so certify in a statement
                published in the Federal Register and may extend the completion date by
                one year at a time, no more than three times, for a total of not more
                than five years (inclusive of the initial two-year period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (8) 42 CFR 1001.952.
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting. The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by which comments must be
                received. There shall also be a general docket on Regulations.gov where
                the public can submit comments requesting that the Department assess or
                review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                Sec. Sec. 1000.2 through 1000.5 [Reserved]
                Title 45--Public Welfare
                Subtitle A--Department of Health and Human Services
                0
                5. Add part 8 to read as follows:
                PART 8--REVIEW OF REGULATIONS
                Sec.
                8.1 Retrospective Review of Existing Regulations
                8.2 through 8.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 504(c)(1); 5 U.S.C. 552; 5
                U.S.C. 552a; 5 U.S.C. 553; 5 U.S.C. 5514; 5 U.S.C. 7301; 8 U.S.C.
                1182(e)); 8 U.S.C. 1182(j)(2)(A); 18 U.S.C. 207(j); 18 U.S.C. 1905;
                20 U.S.C. 91; 20 U.S.C. 1405; 20 U.S.C. 1681 et seq.; 20 U.S.C. 1681
                through 1688; 21 U.S.C. 1174; 22 U.S.C. 2151b(f) (e.g., Pub. L. 116-
                6, Div. F, sec. 7018); 22 U.S.C. 2451 et seq.; 22 U.S.C. 7631(d); 22
                U.S.C. 7631(f); 26 U.S.C. 36B; 26 U.S.C. 5000A(d)(2); 28 U.S.C.
                2672; 29 U.S.C. 669(a)(5); 29 U.S.C. 794; 31 U.S.C. 1243 note; 31
                U.S.C. 1352; 31 U.S.C. 3711(d); 31 U.S.C. 3720A; 31 U.S.C. 3720D; 31
                U.S.C. 3721; 31 U.S.C. 3801-3812; 31 U.S.C. 6506; 31 U.S.C. 7501-
                7507; 31 U.S.C. 9701; 40 U.S.C. 121(c); 40 U.S.C. 318-318d; 40
                U.S.C. 484; 40 U.S.C. 484(k); 40 U.S.C. 486; 42 U.S.C. 216; 42
                U.S.C. 216(b); 42 U.S.C. 238n; 42 U.S.C. 263a(f)(1)(E); 42 U.S.C.
                280g-1(d); 42 U.S.C. 289(a); 42 U.S.C. 289b-1; 42 U.S.C. 290bb-
                36(f); 42 U.S.C. 290dd-2; 42 U.S.C. 299c-4; 42 U.S.C. 300a-7; 42
                U.S.C. 300aa-11; 42 U.S.C. 300gg through 300gg-63; 42 U.S.C. 300gg-1
                through 300gg-5; 42 U.S.C. 300gg-11 through 300gg-23; 42 U.S.C.
                300gg-18; 42 U.S.C. 300gg-91; 42 U.S.C. 300gg-92; 42 U.S.C. 300gg-
                94; 42 U.S.C. 300jj-11; 42 U.S.C 300jj-14; 42 U.S.C. 300jj-52; 42
                U.S.C. 300w et seq.; 42 U.S.C. 300x et seq.; 42 U.S.C. 300y et seq.;
                42 U.S.C. 618; 42 U.S.C. 622(b); 42 U.S.C. 629b(a); 42 U.S.C.
                652(a); 42 U.S.C. 652(d); 42 U.S.C. 654A; 42 U.S.C. 671(a); 42
                U.S.C. 701 et seq.; 42 U.S.C. 1302; 42 U.S.C. 1302(a); 42 U.S.C.
                1306(c); 42 U.S.C. 1310; 42 U.S.C. 1315; 42 U.S.C. 1315a; 42 U.S.C.
                1320a-1; 42 U.S.C. 1320a-7e; 42 U.S.C. 1320c-11; 42 U.S.C.
                1395cc(f); 42 U.S.C. 1320d-2 (note); 42 U.S.C. 1320d-1320d-9; 42
                U.S.C. 1395i-3; 42 U.S.C. 1395i-5; 42 U.S.C. 1395w-22(j)(3)(B); 42
                U.S.C. 1395w-26; 42 U.S.C. 1395w-27; 42 U.S.C. 1395x; 42 U.S.C.
                1396a; 42 U.S.C. 1396a(a); 42 U.S.C. 1396a(w)(3); 42 U.S.C. 1396f;
                42 U.S.C. 1396r; 42 U.S.C. 1396r-2; 42 U.S.C. 1396s(c)(2)(B)(ii); 42
                U.S.C. 1396u-2(b)(3)(B); 42 U.S.C. 1397 et seq.; 42 U.S.C. 1397j-
                1(b); 42 U.S.C. 2000d et seq.; 42 U.S.C. 2000d-1; 42 U.S.C. 2942; 42
                U.S.C. 3334; 42 U.S.C. 3505; 42 U.S.C. 3535(d); 42 U.S.C. 5106i(a);
                42 U.S.C. 6101 et seq.; 42 U.S.C. 8621 et seq.; 42 U.S.C. 9858; 42
                U.S.C. 9901 et seq.; 42 U.S.C. 11101-11152; 42 U.S.C. 11411; 42
                U.S.C. 14406; 42 U.S.C. 18021-18024; 42 U.S.C. 18031-18033; 42
                U.S.C. 18041(a); 42 U.S.C. 18041-18042; 42 U.S.C. 18044; 42 U.S.C.
                18051; 42 U.S.C. 18054; 42 U.S.C. 18061 through 18063; 42 U.S.C.
                18071; 42 U.S.C. 18081-18083; 42 U.S.C. 18113; 42 U.S.C. 18116; 48
                U.S.C. 1469a; 50 U.S.C. App. 2061-2171; 27 Stat. 395; Sec. 1(a), 80
                Stat. 306; secs. 1, 5, 6, and 7 of Reorganization Plan No. 1 of
                1953, 18 FR 2053, 67 Stat. 631 and authorities cited in the
                Appendix; Sec. 203, 63 Stat. 385; Section 213, Uniform Relocation
                Assistance and Real Property Acquisition Policies Act of 1970, Pub.
                L. 91-646, 84 Stat. 1894 (42 U.S.C. 4633) as amended by the Surface
                Transportation and Uniform Relocation Assistance Act of 1987, Title
                IV of Pub. L. 100-17, 101 Stat. 246-256 (42 U.S.C. 4601 note); Sec.
                223, 58 Stat. 683, as amended by 81 Stat. 539: 42 U.S.C. 217b; Sec.
                602, 78 Stat. 252; Sec. 501 of Pub. L. 100-77, 101 Stat. 509-10, 42
                U.S.C 11411; Pub. L. 100-259, 102 Stat. 28 (Mar. 22, 1988); 5 U.S.C.
                301, Pub. L. 100-259, 102 Stat. 28 (Mar. 22 1988); Public Law 101-
                410, Sec. 701 of Public Law 114-74, 31 U.S.C. 3801-3812; Section
                5301 of Pub. L. 100-690, the Anti-Drug Abuse Act of 1988, 102 Stat.
                4310, 21 U.S.C. 853a; secs. 13400-13424, Pub. L. 111-5, 123 Stat.
                258-279; Sec. 1101 of the Patient Protection and Affordable Care Act
                (Pub. L. 111-148); Section 1103 of the Patient Protection and
                Affordable Care Act (Pub. L. 111-148); secs. 1104 and 10109 of Pub.
                L. 111-148, 124 Stat. 146-154 and 915-917; Title I of the Affordable
                Care Act, Sections 1311, 1312, 1411, 1412, Pub. L. 111-148, 124
                Stat. 119; Medicare Advantage (e.g., Pub. L. 115-245, Div. B, sec.
                209); the Weldon Amendment (e.g., Pub. L. 115-245, Div. B, sec.
                507(d)); 5 U.S.C. 610.
                Sec. 8.1 Retrospective Review of Existing Regulations.
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this subtitle.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                [[Page 5757]]
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if required) the
                review of a Section are published in the Federal Register pursuant to
                paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination, which shall not exceed
                one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was promulgated or the last time the rulemaking was reviewed
                by the Department; and
                 (6) Whether the rulemaking complies with applicable law.
                 (e) If the review concludes the Section should be amended or
                rescinded, the Department shall have two years from the date that the
                findings of the review are published in the Federal Register pursuant
                to paragraph (f) of this section to amend or rescind the Section. If
                the Secretary determines that completion of the amendment or rescission
                is not feasible by the established date, he shall so certify in a
                statement published in the Federal Register and may extend the
                completion date by one year at a time, no more than three times, for a
                total of not more than five years (inclusive of the initial two-year
                period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (8) The annual Notice of Benefit and Payment Parameters update
                rules.
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting. The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by
                [[Page 5758]]
                which comments must be received. There shall also be a general docket
                on Regulations.gov where the public can submit comments requesting that
                the Department assess or review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                Sec. 8.2 through 8.5 [Reserved]
                Subtitle B--Regulations Relating to Public Welfare
                CHAPTER II--OFFICE OF FAMILY ASSISTANCE (ASSISTANCE PROGRAMS),
                ADMINISTRATION FOR CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND
                HUMAN SERVICES
                0
                6. Add part 200 to read as follows:
                PART 200--REVIEW OF REGULATIONS
                Sec.
                200.1 Retrospective Review of Existing Regulations
                200.2 through 200.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 610; 24 U.S.C. 321-329; 31
                U.S.C. 7501 et seq.; 42 U.S.C. 301; 42 U.S.C. 303; 42 U.S.C. 601; 42
                U.S.C. 601 note; 42 U.S.C. 602; 42 U.S.C. 602 (note); 42 U.S.C.
                602(a)(44); 42 U.S.C. 603; 42 U.S.C. 603(a)(4); 42 U.S.C. 604; 42
                U.S.C. 605; 42 U.S.C. 606; 42 U.S.C. 607; 42 U.S.C. 608; 42 U.S.C.
                609; 42 U.S.C. 610; 42 U.S.C. 611; 42 U.S.C. 612; 42 U.S.C. 613; 42
                U.S.C. 613(i); 42 U.S.C. 616; 42 U.S.C. 619; 42 U.S.C. 654; 42
                U.S.C. 862a; 42 U.S.C. 1202; 42 U.S.C. 1203; 42 U.S.C. 1301; 42
                U.S.C. 1302; 42 U.S.C. 1306(a); 42 U.S.C. 1308; 42 U.S.C. 1313; 42
                U.S.C. 1316; 1320b-7: 42 U.S.C. 1973gg-5; 42 U.S.C. 1337; 42 U.S.C.
                1352; 42 U.S.C. 1353; 42 U.S.C. 1382 (note); 42 U.S.C. 1383 (note);
                sections 1, 5, 6, and 7 of Reorganization Plan No. 1 of 1953, 67
                Stat. 631; Secs. 1-11, 74 Stat. 308-310; Sec. 302, 75 Stat. 142,
                sec. 1102, 49 Stat. 647; sec. 6 of Pub. L. 94-114, 89 Stat. 579;
                Pub. L. No. 97-248, 96 Stat. 324, and Pub. L. No. 99-603, 100 Stat.
                3359; sec. 4 of Pub. L. 97-458, 96 Stat. 2513; sec. 2 of Pub. L. 98-
                64, 97 Stat. 365; sec. 1883 of Pub. L. 99-514, 100 Stat. 2916; sec.
                15 of Pub. L. 100-241, 101 Stat. 1812; sec. 105(f) of Pub. L. 100-
                383, 102 Stat. 908; sec. 206(d) of Pub. L. 100-383, 102 Stat. 914;
                sec. 105(i) of Pub. L. 100-707, 102 Stat. 4693; sec. 1(a) of Pub. L.
                101-201, 103 Stat. 1795; sec. 10405 of Pub. L. 101-239, 103 Stat.
                2489; sec. 501(c) of Pub. L. 101-392, 104 Stat. 831; sec. 6(h)(2) of
                Pub. L. 101-426, 104 Stat. 925; and sec. 471(a) of Pub. L. 102-325,
                106 Stat. 606; Sec. 7102, Pub. L. 109-171, 120 Stat. 135; Public Law
                111-5; Sec. 4004, Pub. L. 112-96, 126 Stat. 197; 49 Stat. 647.
                Sec. 200.1 Retrospective Review of Existing Regulations.
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this chapter.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if required) the
                review of a Section are published in the Federal Register pursuant to
                paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination, which shall not exceed
                one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was promulgated or the last time the rulemaking was reviewed
                by the Department; and
                 (6) Whether the rulemaking complies with applicable law.
                [[Page 5759]]
                 (e) If the review concludes the Section should be amended or
                rescinded, the Department shall have two years from the date that the
                findings of the review are published in the Federal Register pursuant
                to paragraph (f) of this section to amend or rescind the Section. If
                the Secretary determines that completion of the amendment or rescission
                is not feasible by the established date, he shall so certify in a
                statement published in the Federal Register and may extend the
                completion date by one year at a time, no more than three times, for a
                total of not more than five years (inclusive of the initial two-year
                period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting.The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by which comments must be
                received. There shall also be a general docket on Regulations.gov where
                the public can submit comments requesting that the Department assess or
                review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                Sec. 200.2 through 200.5 [Reserved]
                CHAPTER III--OFFICE OF CHILD SUPPORT ENFORCEMENT (CHILD SUPPORT
                ENFORCEMENT PROGRAM), ADMINISTRATION FOR CHILDREN AND FAMILIES,
                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                0
                7. Add part 300 to read as follows:
                PART 300--REVIEW OF REGULATIONS
                Sec.
                300.1 Retrospective Review of Existing Regulations
                300.2 through 300.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 610; 25 U.S.C. 1603(12); 25
                U.S.C. 1621e; 42 U.S.C. 609(a)(8); 42 U.S.C. 651 through 658; 42
                U.S.C. 652(a)(4) and (g); 42 U.S.C. 654(15)(A); 42 U.S.C. 655(f); 42
                U.S.C. 658a; 42 U.S.C. 659a; 42 U.S.C. 660; 42 U.S.C. 663; 42 U.S.C.
                664; 42 U.S.C. 666 through 669A; 42 U.S.C. 1301; 42 U.S.C. 1302; 42
                U.S.C. 1396a(a)(25); 42 U.S.C. 1396b(d)(2); 42 U.S.C. 1396b(o); 42
                U.S.C. 1396b(p); 42 U.S.C. 1396(k).
                Sec. 300.1 Retrospective Review of Existing Regulations.
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this chapter.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if required) the
                review of a Section are published in the Federal Register pursuant to
                paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination,
                [[Page 5760]]
                which shall not exceed one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was promulgated or the last time the rulemaking was reviewed
                by the Department; and
                 (6) Whether the rulemaking complies with applicable law.
                 (e) If the review concludes the Section should be amended or
                rescinded, the Department shall have two years from the date that the
                findings of the review are published in the Federal Register pursuant
                to paragraph (f) of this section to amend or rescind the Section. If
                the Secretary determines that completion of the amendment or rescission
                is not feasible by the established date, he shall so certify in a
                statement published in the Federal Register and may extend the
                completion date by one year at a time, no more than three times, for a
                total of not more than five years (inclusive of the initial two-year
                period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting. The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by which comments must be
                received. There shall also be a general docket on Regulations.gov where
                the public can submit comments requesting that the Department assess or
                review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                Sec. 300.2 through 300.5 [Reserved]
                CHAPTER IV--OFFICE OF REFUGEE RESETTLEMENT, ADMINISTRATION FOR
                CHILDREN AND FAMILIES DEPARTMENT OF HEALTH AND HUMAN SERVICES
                0
                8. Add part 403 to read as follows:
                PART 403--REVIEW OF REGULATIONS
                Sec.
                403.1 Retrospective Review of Existing Regulations
                403.2 through 403.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 610; 6 U.S.C. 279; 8 U.S.C.
                1103(a)(3); 8 U.S.C. 1232; 8 U.S.C. 1255a note; 8 U.S.C. 1522 note;
                8 U.S.C. 1522(a)(9); 42 U.S.C. 15607(d).
                Sec. 403.1 Retrospective Review of Existing Regulations.
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this chapter.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                [[Page 5761]]
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if required) the
                review of a Section are published in the Federal Register pursuant to
                paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination, which shall not exceed
                one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was promulgated or the last time the rulemaking was reviewed
                by the Department; and
                 (6) Whether the rulemaking complies with applicable law.
                 (e) If the review concludes the Section should be amended or
                rescinded, the Department shall have two years from the date that the
                findings of the review are published in the Federal Register pursuant
                to paragraph (f) of this section to amend or rescind the Section. If
                the Secretary determines that completion of the amendment or rescission
                is not feasible by the established date, he shall so certify in a
                statement published in the Federal Register and may extend the
                completion date by one year at a time, no more than three times, for a
                total of not more than five years (inclusive of the initial two-year
                period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting. The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by which comments must be
                received. There shall also be a general docket on Regulations.gov where
                the public can submit comments requesting that the Department assess or
                review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                [[Page 5762]]
                Sec. 403.2 through 403.5 [Reserved]
                CHAPTER X--OFFICE OF COMMUNITY SERVICES, ADMINISTRATION FOR
                CHILDREN AND FAMILIES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
                0
                9. Add part 1010 to read as follows:
                PART 1010--REVIEW OF REGULATIONS
                Sec.
                1010.1 Retrospective Review of Existing Regulations
                1010.2 through 1010.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 610; 42 U.S.C. 604 nt.; 42
                U.S.C. 9901 et seq.; 42 U.S.C. 11302 (101 Stat. 485); 42 U.S.C.
                11461-11464; 42 U.S.C. 11472 (101 Stat. 532-533).
                Sec. 1010.1 Retrospective Review of Existing Regulations
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this chapter.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if required) the
                review of a Section are published in the Federal Register pursuant to
                paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination, which shall not exceed
                one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was promulgated or the last time the rulemaking was reviewed
                by the Department; and
                 (6) Whether the rulemaking complies with applicable law.
                 (e) If the review concludes the Section should be amended or
                rescinded, the Department shall have two years from the date that the
                findings of the review are published in the Federal Register pursuant
                to paragraph (f) of this section to amend or rescind the Section. If
                the Secretary determines that completion of the amendment or rescission
                is not feasible by the established date, he shall so certify in a
                statement published in the Federal Register and may extend the
                completion date by one year at a time, no more than three times, for a
                total of not more than five years (inclusive of the initial two-year
                period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                [[Page 5763]]
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting. The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by which comments must be
                received. There shall also be a general docket on Regulations.gov where
                the public can submit comments requesting that the Department assess or
                review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                Sec. 1010.2 through 1010.5 [Reserved]
                CHAPTER XIII--ADMINISTRATION FOR CHILDREN AND FAMILIES, DEPARTMENT
                OF HEALTH AND HUMAN SERVICES
                0
                10. Add subchapter A to read as follows:
                SUBCHAPTER A--[include your preferred subchapter heading]
                PART 1300--REVIEW OF REGULATIONS
                Sec.
                1300.1 Retrospective Review of Existing Regulations.
                1300.2 through 1390.5 [Reserved]
                 Authority: 5 U.S.C. 301; 5 U.S.C. 610; 29 U.S.C. 709; 29 U.S.C.
                3343; 42 U.S.C. 620 et seq., 42 U.S.C. 670 et seq.; 42 U.S.C. 1302;
                42 U.S.C. 1395b-4; 42 U.S.C. 2991, et seq.; 42 U.S.C. 3001 et seq.;
                Title III of the Older Americans Act; 42 U.S.C. 3001; Title VI, Part
                A of the Older Americans Act; 42 U.S.C. 3001; Title VI Part B of the
                Older Americans Act; 42 U.S.C. 3515e; 42 U.S.C. 5701; 42 U.S.C. 9801
                et seq.; 42 U.S.C. 10401 et seq.; 42 U.S.C. 15001 et seq.
                Sec. 1300.1 Retrospective Review of Existing Regulations.
                 (a) This section applies to and shall be deemed to amend all
                regulations issued by the Secretary or his delegates or sub-delegates
                in this chapter.
                 (b) For purposes of this section,
                 (1) Assess shall refer to a determination by the Department, in
                consultation with other Federal agencies as appropriate, as to whether
                the Sections issued as part of the same rulemaking (and any amendments
                or additions that may have been added thereafter) currently have a
                significant economic impact upon a substantial number of small
                entities.
                 (2) Review shall refer to a process conducted by the Department, in
                consultation with other Federal agencies as appropriate, the purpose of
                which shall be to determine whether Sections that were issued as part
                of the same rulemaking (and any amendments or additions that may have
                been issued thereafter) should be continued without change, or should
                be amended or rescinded, consistent with the stated objectives of
                applicable statutes, to minimize any significant economic impact of the
                Sections upon a substantial number of small entities.
                 (3) Section (when capitalized) shall mean a section of the Code of
                Federal Regulations. For example, 42 CFR 2.13 is a Section, and 42 CFR
                2.14 is another Section (see 1 CFR 21.11).
                 (4) Year of the Section's promulgation shall mean the year the
                Section first became effective, irrespective of whether it was
                subsequently amended.
                 (5) Significant economic impact upon a substantial number of small
                entities shall have the meaning of that term in section 610 of title 5
                of the United States Code.
                 (c)(1) Unless a Section expires earlier or is rescinded, all
                Sections issued by the Secretary or his delegates or sub-delegates in
                this chapter shall expire at the end of:
                 (i) Five calendar years after the year that this section first
                becomes effective;
                 (ii) Ten calendar years after the year of the Section's
                promulgation; or
                 (iii) Ten calendar years after the last year in which the
                Department assessed and (if review of the Section is required pursuant
                to paragraph (d) of this section) reviewed the Section, whichever is
                latest.
                 (2) The last year in which the Department assessed and (if review
                of the Section is required) reviewed the Section shall be the year
                during which the findings of the assessment and (if required) the
                review of a Section are published in the Federal Register pursuant to
                paragraph (f) of this section.
                 (3)(i) If, prior to the expiration of a Section under paragraph
                (c)(1) of this section, the Secretary makes a written determination
                that the public interest requires continuation of the Section in force
                beyond the date on which the Section would otherwise expire under
                paragraph (c)(1), the Secretary may continue the Section in force one
                time for a period stated in the determination, which shall not exceed
                one calendar year.
                 (ii) The Department shall promptly publish in the Federal Register
                any written determination under paragraph (c)(3)(i) of this section.
                 (iii) The authority of the Secretary under paragraph (c)(3)(i) of
                this section is not delegable and may be exercised only by the
                Secretary or, when the office of the Secretary is vacant or the
                Secretary has become unable to perform the functions and duties of the
                office of the Secretary, by the individual acting as Secretary in
                accordance with the law.
                 (d) The Department is required to review those rulemakings (and any
                amendments or additions that may have been added thereafter) that the
                Department assesses have a significant economic impact upon a
                substantial number of small entities. In reviewing rulemakings to
                minimize any significant economic impact on a substantial number of
                small entities in a manner consistent with the stated objectives of
                applicable statutes, the Department's review shall consider the
                following factors:
                 (1) The continued need for the rulemaking, consideration of which
                shall include but not be limited to the extent to which the rulemaking
                defines terms or sets standards used in or otherwise applicable to
                other Federal rules;
                 (2) The nature of complaints or comments received concerning the
                rulemaking from the public;
                 (3) The complexity of the rulemaking;
                 (4) The extent to which the rulemaking overlaps, duplicates or
                conflicts with other Federal rules, and, to the extent feasible, with
                State and local governmental rules;
                 (5) The degree to which technology, economic conditions, or other
                factors have changed in the area affected by the rulemaking since the
                rulemaking was
                [[Page 5764]]
                promulgated or the last time the rulemaking was reviewed by the
                Department; and
                 (6) Whether the rulemaking complies with applicable law.
                 (e) If the review concludes the Section should be amended or
                rescinded, the Department shall have two years from the date that the
                findings of the review are published in the Federal Register pursuant
                to paragraph (f) of this section to amend or rescind the Section. If
                the Secretary determines that completion of the amendment or rescission
                is not feasible by the established date, he shall so certify in a
                statement published in the Federal Register and may extend the
                completion date by one year at a time, no more than three times, for a
                total of not more than five years (inclusive of the initial two-year
                period).
                 (f) The results of all assessments and reviews conducted in a
                calendar year, including the full underlying analyses and data used to
                support the results (subject to any applicable privilege, protections
                for confidential business information, or explicit legal prohibition on
                disclosure), shall be published in a single document in the Federal
                Register during that calendar year. The document shall be organized in
                a manner that enables both the Department and the public to readily
                determine which assessments and reviews were conducted during that
                calendar year. The document shall also specify the year by which the
                next assessment (and, if required, the next review) of the Section
                shall be completed.
                 (g) Paragraph (c) of this section shall not apply to:
                 (1) Sections that are prescribed by Federal law, such that the
                Department exercises no discretion as to whether to promulgate the
                Section and as to what is prescribed by the Section. For Sections
                described in this paragraph (g)(1) that are adopted after the effective
                date of this section, the Federal law described in this paragraph
                (g)(1) shall be cited in the notice of adoption.
                 (2) Sections whose expiration pursuant to this section would
                violate any other Federal law.
                 (3) This section.
                 (4) Sections that involve a military or foreign affairs function of
                the United States.
                 (5) Sections addressed solely to internal agency management or
                personnel matters.
                 (6) Sections related solely to Federal Government procurement.
                 (7) Sections that were issued jointly with other Federal agencies,
                or that were issued in consultation with other agencies because of a
                legal requirement to consult with that other agency.
                 (h) When the Department commences the process of performing an
                assessment or review, it shall state on a Department-managed website
                the Section(s) whose assessment or review it is commencing. It shall
                also announce once a month in the Federal Register those new
                assessments or reviews that it has commenced in the last month. The
                Department will create a docket on Regulations.gov for each assessment
                or review that the Department is conducting. The public will be able to
                submit comments to the dockets of each rulemaking being assessed or
                reviewed. Each docket shall specify the date by which comments must be
                received. There shall also be a general docket on Regulations.gov where
                the public can submit comments requesting that the Department assess or
                review a Section.
                 (i) Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give the maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                Sec. 1300.2 through 1300.5 [Reserved]
                 Dated: January 8, 2021.
                Alex M. Azar II,
                Secretary, Department of Health and Human Services.
                [FR Doc. 2021-00597 Filed 1-15-21; 8:45 am]
                BILLING CODE 4150-26-P