Securing Updated and Necessary Statutory Evaluations Timely
| Citation | 86 FR 5694 |
| Record Number | 2021-00597 |
| Published date | 19 January 2021 |
| Section | Rules and Regulations |
| Court | Centers For Medicare And Medicaid Services,Public Health Service,The Inspector General Office |
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.
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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\
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\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.
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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.
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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.
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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.
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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.
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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.
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\93\ As discussed below, HHS has roughly 18,000 regulations
total.
\94\ 85 FR 70102.
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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.
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\95\ See, e.g., Coronavirus waivers and flexibilities, CMS.gov,
https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.
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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).
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\96\ E.g., 21 CFR part 112.
\97\ E.g., 45 CFR part 147.
\98\ 45 CFR part 261.
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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\
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\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).
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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\
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\100\ See, e.g., 85 FR 70120.
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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.
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\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\
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\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:
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\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.
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\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'').
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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.
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\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).
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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\
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\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.
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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.
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\111\ See 85 FR 70096.
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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.
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\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).
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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\
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\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.
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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\
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\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.
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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.
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\118\ 85 FR at 70097.
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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\
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\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.
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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.
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\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.
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\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.
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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.
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\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.
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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.
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\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\
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\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.
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\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'').
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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.
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\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).
.
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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.
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[[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).
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\159\ See 85 FR 70119, 70120, 70121, 70123.
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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\
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\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.
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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.
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\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.
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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.
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\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.'').
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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.
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\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'').
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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\
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\164\ See 85 FR at 70117.
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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.
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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.
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\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.
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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.
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\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)).
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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.
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\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).
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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.
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\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).
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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.
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\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.
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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\
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\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).
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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\
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\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).
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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.
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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\
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\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.
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\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.
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\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.
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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.
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\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\
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\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\
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\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.
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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.
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\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).
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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.
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\202\ 85 FR 70118 & n.145.
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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.
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\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.
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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.
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\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.
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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\
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\210\ This analysis was informed by public comments and also by
work of Dr. James Broughel.
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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\
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\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\
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\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
