[Federal Register Volume 86, Number 207 (Friday, October 29, 2021)]
[Proposed Rules]
[Pages 59906-59931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23472]



[[Page 59906]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 6

Public Health Service

42 CFR Part 1

Centers for Medicare and Medicaid Services

42 CFR Part 404

Office of the Inspector General

42 CFR Part 1000

Office of the Secretary

45 CFR Part 8

Administration for Children and Families

45 CFR Parts 200, 300, 403, 1010, and 1300

[Docket No. HHS-OS-2020-0012]
RIN 0991-AC24


Securing Updated and Necessary Statutory Evaluations Timely; 
Proposal To Withdraw or Repeal

AGENCY: Department of Health and Human Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Department of Health and Human Services (HHS or 
Department) is proposing to withdraw or repeal a final rule entitled 
``Securing Updated and Necessary Statutory Evaluations Timely'' (SUNSET 
final rule) and published in the Federal Register of January 19, 2021. 
The SUNSET final rule was originally scheduled to take effect on March 
22, 2021. However, after a lawsuit was filed on March 9, 2021, seeking 
to overturn the SUNSET final rule, HHS issued an administrative delay 
of effective date that extended the effective date of the SUNSET final 
rule until March 22, 2022. HHS is now proposing to withdraw or repeal 
the SUNSET final rule.

DATES: Submit either electronic or written comments on the proposed 
rule by 11:59 p.m. on December 28, 2021.

ADDRESSES: You may submit comments through the Federal eRulemaking 
Portal: https://www.regulations.gov. Follow the ``Submit a comment'' 
instructions.
    Warning: Do not include any personally identifiable information 
(such as name, address, or other contact information) or confidential 
business information that you do not want publicly disclosed. All 
comments may be posted on the internet and can be retrieved by most 
internet search engines. No deletions, modifications, or redactions 
will be made to comments received.
    Inspection of Public Comments: All comments received before the 
close of the comment period will be available for viewing by the 
public, including personally identifiable or confidential business 
information that is included in a comment. You may wish to consider 
limiting the amount of personal information that you provide in any 
voluntary public comment submission you make. HHS may withhold 
information provided in comments from public viewing that it determines 
may impact the privacy of an individual or is offensive. For additional 
information, please read the Privacy Act notice that is available via 
the link in the footer of https://www.regulations.gov. Follow the 
search instructions on that website to view the public comments.

FOR FURTHER INFORMATION CONTACT: Daniel J. Barry, Acting General 
Counsel, 200 Independence Avenue SW, Washington, DC 20201; or by email 
at [email protected]; or by telephone at 1-877-696-6775.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Proposed Rule
    B. Summary of Major Provisions
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. History of the SUNSET Rulemaking
    B. The Department's Review
IV. Legal Authority
V. Explanation of Proposed Rule To Withdraw or Repeal the SUNSET 
Final Rule
    A. Implementation Burdens on the Department and Stakeholders
    B. Potential Harms From the Possible and Actual Expiration of 
Regulations
    C. RFA Considerations
    D. APA Considerations
    E. Vague and Confusing Provisions
VI. Preliminary Economic Analysis of Impacts
    A. Introduction, Summary, and Background
    B. Market Failure or Social Purpose of Regulatory Federal Action
    C. Purpose of Proposed Withdrawal or Repeal Rule
    D. Baseline Conditions
    E. Benefits of Proposed Withdrawal or Repeal Rule
    F. Costs of Proposed Withdrawal or Repeal Rule
    G. Analysis of Regulatory Alternatives to the Proposed 
Withdrawal or Repeal Rule
VII. Federalism
VIII. Consultation and Coordination With Indian Tribal Governments
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act
XI. References

I. Executive Summary

A. Purpose of the Proposed Rule

    HHS issued the SUNSET final rule on January 19, 2021. 86 FR 5694. 
The SUNSET final rule provides, among other things, that all 
regulations, subject to certain exceptions, issued by the Secretary of 
the Department of Health and Human Services (Secretary) or his 
delegates or sub-delegates shall expire at the end of (1) five calendar 
years after the year that the SUNSET final rule first becomes 
effective, (2) ten calendar years after the year of the regulation's 
promulgation, or (3) ten calendar years after the last year in which 
the Department ``Assessed'' and, if required, ``Reviewed'' the 
regulation, whichever is latest.\1\ The SUNSET final rule was scheduled 
to take effect on March 22, 2021. However, after a lawsuit seeking to 
overturn the SUNSET final rule was filed on March 9, 2021, HHS issued 
an administrative delay of effective date, effective as of March 19, 
2021, which postponed the effective date of the SUNSET final rule, 
pending judicial review, until March 22, 2022. 86 FR 15404 (Mar. 23, 
2021).
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    \1\ The terms ``Section,'' ``Assess,'' and ``Review'' were 
capitalized in the preamble to the final rule where those terms have 
the definitions ascribed to them in the text of the final rule. For 
ease of readability, these terms are not capitalized in the 
following discussion of this proposed rule unless directly quoting 
or paraphrasing the final rule.
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    After reconsideration of the comments submitted on the SUNSET 
proposed rule (85 FR 70096 (Nov. 4, 2020)), HHS is now issuing this 
notice of proposed rulemaking to withdraw or repeal the SUNSET final 
rule.

B. Summary of Major Provisions

    We are proposing to withdraw or repeal the SUNSET final rule in its 
entirety.

C. Legal Authority

    The primary statutory authorities supporting this proposed rule are 
the general rulemaking authorities for the various substantive areas 
under the Department's umbrella, as well as a general authorization for 
agencies to issue regulations regarding the administrative processes to 
be followed by that agency. These provisions include: 21 U.S.C. 371(a); 
42 U.S.C. 216; 42 U.S.C. 1302; 42 U.S.C. 1395hh; 42 U.S.C. 2003; and 5 
U.S.C. 301.

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D. Costs and Benefits

    This proposed regulatory action would reduce the time spent by the 
Department performing retrospective assessments and reviews of its 
regulations as required by the SUNSET final rule, and time spent by 
regulated entities and other stakeholders, including the general 
public, small and large businesses, non-governmental organizations, 
Tribes and state and local governments, on comments related to these 
assessments and reviews. We monetize the likely reductions in time 
spent by the Department and the general public as cost savings. Our 
primary estimate of these cost savings in 2020 dollars, annualized over 
10 years, using a 3% discount rate, totals $69.9 million. Using a 7% 
discount rate, we estimate $75.5 million in annualized cost savings. 
Table 1 reports these primary estimates alongside a range of estimates 
that capture uncertainty in the amount of time it will take the 
Department to perform each regulatory assessment and review, and 
uncertainty in the amount of time the public will spend on comments. 
The impact of the proposed withdrawal provisions is analyzed in the 
Preliminary Economic Analysis of Impacts for this proposed rule. We 
seek comment on these preliminary estimates and analysis.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

    As used in this preamble, the following terms and abbreviations 
have the meanings noted below.

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             Term                                Meaning
------------------------------------------------------------------------
ACA...........................  Affordable Care Act.
ACF...........................  Administration for Children and
                                 Families.
ACUS..........................  Administrative Conference of the United
                                 States.
APA...........................  Administrative Procedure Act.
CFR...........................  Code of Federal Regulations.
CHIP..........................  Children's Health Insurance Program.
CMS...........................  Centers for Medicare & Medicaid
                                 Services.
COVID-19......................  Coronavirus Disease 2019.
EO............................  Executive Order.
FD&C Act......................  Federal Food, Drug, and Cosmetic Act.
FDA...........................  Food and Drug Administration.
FSMA..........................  FDA Food Safety Modernization Act.
HHS or Department.............  U.S. Department of Health and Human
                                 Services.
IHS...........................  Indian Health Service.
OCR...........................  Office for Civil Rights.
OIRA..........................  Office of Information and Regulatory
                                 Affairs.
PDV...........................  Present Daily Value.
PHS Act.......................  Public Health Service Act.
RFA...........................  Regulatory Flexibility Act.
SAMSHA........................  Substance Abuse and Mental Health
                                 Services Administration.
SBA...........................  Small Business Administration.
SEISNOSE......................  Significant Economic Impact Upon a
                                 Substantial Number of Small Entities.
SECG..........................  Small Entity Compliance Guide.
SUNSET........................  Securing Updated and Necessary Statutory
                                 Evaluations Timely.
UA............................  Unified Agenda.
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III. Background

    The SUNSET final rule, if implemented, would significantly alter 
the operations of HHS with considerable repercussions for a diverse 
array of stakeholders. We note that the process to promulgate the rule 
was extremely unusual, if not unprecedented. The rule is expansive in 
scope and impact, faced considerable opposition from stakeholders (and 
very little support), and lacked a public health or welfare rationale 
for expediting rulemaking. In contrast to the Department's historical 
approach to rulemaking in these circumstances, HHS completed the 
rulemaking--from the publication of the proposal to publication of the 
final rule--in less than three months. Upon a thorough review of the 
rule, we find that, given the lack of a public health or welfare reason 
to expedite the rulemaking and other procedural shortcomings, the 
Department should now reconsider the commenters' significant objections 
to the proposal. Moreover, based on a reanalysis of the regulatory 
impact of the rule, we now believe that the rule rested on a flawed 
understanding of the resources required for this undertaking, which 
implicates the likelihood that HHS regulations would expire if the 
final rule were to go into effect. That in turn will require the 
Department to make resource allocation decisions which could impede the 
Department's routine operations and hamper its ability to carry out 
other key priorities and goals, particularly during an ongoing public 
health emergency. Now that we have reconsidered the public comments and 
the regulatory impact analysis, including a consideration of the 
impacts that are not quantified or monetized, we believe that the rule 
prioritized regulatory review over other Department operations to a 
degree that may negatively impact many stakeholders and the general 
public in a variety of ways. We disagree with that approach as a matter 
of policy and therefore are proposing to withdraw the rule in its 
entirety.

A. History of the SUNSET Rulemaking

1. Proposed Rule, Comment Period, and Final Rule
    On November 4, 2020, HHS published a notice of proposed rulemaking 
entitled ``Securing Updated and Necessary Statutory Evaluations 
Timely'' (SUNSET proposed rule). 85 FR 70096. Under the proposed rule, 
subject to certain exceptions, Department regulations would expire at 
the end of (1) two calendar years after the year that the SUNSET rule 
first became effective, (2) ten calendar years after the year of the 
regulation's promulgation, or (3) ten calendar years after the last 
year in which the Department ``Assessed'' and, if required, 
``Reviewed'' the regulation, whichever was latest. Thus, under the 
SUNSET proposed rule, unless HHS assessed and, if required, reviewed 
most of its regulations within a certain timeframe specified in the 
rule (for most existing regulations, within two years) and every ten 
years thereafter, the regulations would automatically expire.

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    The SUNSET proposed rule also provided that if a review led to a 
finding that a regulation should be amended or rescinded, the 
Department must amend or rescind the regulation within a specified 
timeframe (generally two years). In addition, the SUNSET proposed rule 
contained certain publication requirements, including that (1) the 
Department publish the results of all ``Assessments'' and ``Reviews,'' 
including the full underlying analyses and data used to support the 
results, in the Federal Register, and (2) the Department announce the 
commencement of an ``Assessment'' or ``Review'' of a particular 
regulation on the agency website, with an opportunity for public 
comment. The SUNSET proposed rule provided that comments to the 
proposed rule had to be submitted by December 4, 2020, except for 
comments on the portion of the rule amending 42 CFR parts 400-429 and 
parts 475-499 (Medicare program regulations), which were to be 
submitted by January 4, 2021.
    On November 16, 2020, HHS announced a public hearing, scheduled for 
November 23, 2020, to receive information and views on the proposed 
rule (Public Hearing). 85 FR 73007. Despite the short notice, over 
twenty interested parties provided oral comments at the Public Hearing. 
See Transcript, Public Hearing on the Securing Updated and Necessary 
Statutory Evaluations Timely Notice of Proposed Rulemaking (Nov. 23, 
2020) (available at https://www.regulations.gov/document/HHS-OS-2020-0012-0501) (Public Hearing Transcript). All of the commenters, which 
included industry/trade organizations, medical organizations, and 
public interest organizations,\2\ criticized the proposed rule in its 
substance, the rulemaking process, or both.
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    \2\ Commenters at the Public Hearing included: National Health 
Law Program, Center for Science in the Public Interest, Consumer 
Federation of America, Food & Water Watch and Food & Water Action, 
American Frozen Food Institute, American College of Obstetricians 
and Gynecologists, Lambda Legal, Center on Budget and Policy 
Priorities, American Lung Association, United Fresh Produce 
Association, Consumer Brands Association, Campaign for Tobacco-Free 
Kids, The National Confectioners Association, National Immigration 
Law Center, Prevent Blindness, American Feed Industry Association, 
Disability Rights New Mexico, Pet Food Institute, Public Citizen, 
American Medical Association, and Service Employees International 
Union.
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    In addition to the oral comments, a wide range of stakeholders 
submitted over 500 comments on the proposed rule. Almost all of the 
comments opposed the proposal. Comments opposing the rule were 
submitted by, for example, health care and medical organizations; 
Federally Qualified Health Centers and advocates for beneficiaries of 
Federal health care programs; State Attorneys General and other state 
government representatives; Tribal governments and Tribal 
organizations; large industry associations and trade associations; 
consumer and public interest groups; and interested individuals. Only a 
handful of commenters supported the rule, and two of those comments 
were submitted by an individual who, under an agreement with HHS, also 
provided a draft regulatory impact analysis for the SUNSET final rule. 
See 86 FR 5737 n.210. Other commenters supporting the rule included 
independent business advocacy organizations and a nonprofit legal 
organization.
    On December 18, 2020, the Office of Information and Regulatory 
Affairs (OIRA) in the White House Office of Management and Budget 
received the SUNSET final rule for review and clearance and posted on 
the OIRA dashboard for E.O. 12866 Regulatory review (Ref. 1). This 
preceded the January 4, 2021, conclusion of the comment period for the 
parts of the proposed rule relating to 42 CFR parts 400-429 and parts 
475-499.
    HHS issued the SUNSET final rule on January 19, 2021. 86 FR 5694. 
The final rule provides that all regulations issued by the Secretary or 
their delegates or sub-delegates in titles 21, 42, and 45 of the Code 
of Federal Regulations (CFR), subject to certain exceptions, shall 
expire at the end of (1) five calendar years after the year that the 
SUNSET final rule first becomes effective, (2) ten calendar years after 
the year of the regulation's promulgation, or (3) ten calendar years 
after the last year in which the Department ``Assessed'' and, if 
required, ``Reviewed'' the regulation, whichever is latest. Thus, the 
final rule contains the same basic expiration framework as the proposed 
rule, but extends the timeframe for assessment and any applicable 
review of most existing regulations from two calendar years to five 
calendar years. The final rule also provides for a one-time 
``continuation'' of a regulation that is subject to expiration if the 
Secretary makes a written determination that the public interest 
requires continuation. The continuation period, stated in the 
determination, is not to exceed one year. In addition, the final rule 
contains exemptions for a small set of HHS regulations applicable to 
the Food and Drug Administration (FDA), the Centers for Disease Control 
and Prevention (CDC), and the Centers for Medicare & Medicaid Services 
(CMS). The final rule maintains the timeframe for amendment or 
rescission of regulations, and includes a new Federal Register 
publication requirement in addition to the publication requirements 
proposed in the SUNSET proposed rule.\3\
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    \3\ The final rule also moved the location of some of the 
regulatory text from having a general provision covering an entire 
title to having a separate, duplicate provisions in different 
chapters of HHS regulations.
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2. Litigation and Delay of Effective Date
    On March 9, 2021, the County of Santa Clara and several other 
plaintiffs sued the Department seeking to overturn the SUNSET final 
rule under the Administrative Procedure Act (APA). Complaint, County of 
Santa Clara v. HHS, Case No. 5:21-cv-01655-BLF (N.D. Cal. Mar. 9, 2021) 
(Santa Clara) (Ref. 2).
    On March 18, 2021, the Acting Secretary of HHS signed, pursuant to 
5 U.S.C. 705 of the APA, an administrative delay of effective date 
(Administrative Delay Order), effective as of March 19, 2021, which 
extended the effective date of the SUNSET final rule until March 22, 
2022. 86 FR 15404.

B. The Department's Review

    The Department has reexamined the SUNSET final rule in light of the 
allegations in the Santa Clara complaint, the many comments submitted 
to the docket and raised at the Public Hearing, and changed policy 
views in the current Administration. This review has considered the 
processes followed in issuing the rule, its policy goals and 
objectives, the projected effects and analysis of impacts in its 
implementation, and the legal evaluation of and support for its 
provisions, including whether the rule is consistent with HHS statutory 
obligations and its mission to promote and protect the public health. 
It should be noted at the outset that HHS already conducts 
retrospective reviews, and the Department is open to feedback regarding 
how to improve these existing processes. The purpose of this review, 
however, has been to reconsider whether the new requirements imposed in 
the SUNSET final rule would achieve the goals of retrospective review 
in a manner that best serves the Department's public health and welfare 
mission. As described further below, based on our review, we now 
believe that the SUNSET final rule should be withdrawn in its entirety. 
However, we request comment on whether, consistent with the goals of 
retrospective review as well as other current policy priorities and 
considerations discussed in this proposed rule, the Department should

[[Page 59909]]

consider modifying, rather than withdrawing or repealing, the SUNSET 
final rule.
    Our current view is that, to be consistent with the Department's 
usual practices when engaging in rulemaking, the Department should have 
engaged in a more robust consideration of the comments, should have 
more thoroughly examined the factual and legal basis of the rule, and 
should have given greater weight to the potential harms to stakeholders 
and the public health. Our thinking is informed by a reevaluation of 
the factual premises and conclusions in the SUNSET final rule that are 
central to the Department's analysis of the rule's implications and 
effects. In particular, based on a reanalysis of the regulatory impact 
of the rule, we now believe that the rule likely rested on a flawed 
understanding of the resources required for this undertaking, which 
implicates the likelihood that HHS regulations would expire, and which 
in turn will require the Department to make resource allocation 
decisions which could impede the Department's ability to carry out 
other key priorities. That diversion of resources will likely impede 
efforts to adopt new rules to address national priorities and advance 
equity for all, including historically underserved and marginalized 
communities. It is therefore potentially inconsistent with the current 
Administration's policies that aim to empower agencies to use 
appropriate tools to achieve those ends. In this section, we summarize 
the key considerations, addressed in greater detail throughout the 
preamble, that have led us to change our view of the overall merit of 
the SUNSET final rule and to propose to withdraw the rule in its 
entirety.
    As an initial matter, based on our review, we have found that there 
were several procedural shortcuts taken in the rulemaking process which 
may have impeded full consideration of the commenters' significant 
objections to the proposal. The SUNSET final rule was issued on an 
unusually expedited timeline of less than three months for a rule of 
this significance, with potential impacts not just on small businesses 
but also the general public, larger businesses, Tribes, States, non-
governmental organizations, and other regulated entities and 
stakeholders across a wide range of industrial sectors. The SUNSET rule 
was also unusually expansive in scope, requiring review and possibly 
regulatory or deregulatory activity across a variety of distinct 
substantive statutes \4\ within the jurisdiction of a several operating 
divisions (e.g., CMS, FDA, CDC, Substance Abuse and Mental Health 
Services Administration (SAMSHA), the Office for Civil Rights (OCR), 
and the Administration for Children and Families (ACF)). Furthermore, 
it appears that the comments were not adequately considered (as 
evidenced by the summary mention in the preamble to the SUNSET final 
rule, as discussed further elsewhere in this preamble), and, contrary 
to policy, the Department did not consult with tribal governments.
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    \4\ See section IV below.
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    As for the substance, we note initially that the resources required 
to comply with the assessment and review requirements would be 
substantial. For each regulation covered by the SUNSET final rule, HHS 
agencies would need to: Collect data to conduct the relevant evaluation 
(which may require time for public notice and comment, and Office of 
Management and Budget (OMB) review and approval, under the Paperwork 
Reduction Act, 44 U.S.C. 3501 et seq., in addition to the time needed 
for data collection and analysis); engage subject matter experts and 
others to complete an assessment (and possibly a review); consult with 
state and local jurisdictions and Tribes; open and publicize public 
dockets for each assessment or review that the Department conducts; 
consider any comments to the public docket related to the evaluation; 
participate in interagency review; and publish the results of this 
process in the Federal Register, ``including the full underlying 
analyses and data used to support the results.'' 86 FR 5712. If 
warranted by the results of this process, HHS agencies would then need 
to complete a rulemaking to amend or rescind the regulation, which 
would require an additional investment of agencies' resources and 
public input. If the Department cannot complete this extensive process 
within the final rule's timeframes, the regulations would then 
automatically expire. In addition, after that lengthy process, the 
Department would likely then need to revise guidance documents 
associated with both expiring regulations and regulations still in 
effect.
    It appears that the SUNSET final rule made at least two errors in 
its justification for establishing this mandatory review process. 
First, based on the preliminary regulatory impact analysis for this 
proposed rule, it appears to have miscalculated the extent of the 
resources needed for this undertaking. In particular, we now believe 
that HHS underestimated the costs of complying with the rule at least 
by a factor of four. Second, and relatedly, it assumed that regulations 
would not simply expire. See, e.g., 86 FR 5710 (``HHS does not intend 
to allow a regulation to simply expire''); id. at 5712 (``the 
Department is committed to dedicating adequate resources to timely 
Assess and Review its regulations''); id. at 5714 (``the Department 
intends to timely complete the necessary Assessments and Reviews and 
has built in safeguards to mitigate the risk of inadvertent 
expiration''). Preventing the automatic expiration of regulations, 
however, would require prioritizing retrospective review above many 
other Department programs and missions. Based on our reconsideration 
and expert judgment, we no longer consider that resource prioritization 
to be in the best interests of the public health and well-being and 
therefore believe that this assumption--that no regulations would 
expire--was not well founded.
    Because we now believe that the SUNSET final rule underestimated 
the burden on the Department and its agencies imposed by the regulatory 
review required by the rule and dismissed the likelihood that rules 
would expire, it similarly did not adequately acknowledge the difficult 
resource allocations decisions that the Department would confront in 
implementing the rule. With its finite set of resources, the Department 
would be faced with a quandary of how best to triage the needs of its 
existing programs (as well as new public health priorities) and the new 
regulatory review process under the SUNSET final rule. On the one hand, 
given the large scale of resources that would be required to conduct 
the required reviews, compliance with these new review requirements 
would lead to the diversion of resources from existing and new priority 
programs to the detriment of the other programs. This diversion of 
resources would degrade HHS' capabilities to carry out mission-critical 
objectives such as protecting the health of Americans, strengthening 
their economic and social well-being, and fostering sound, sustained 
advances in the sciences. On the other hand, the automatic expiration 
of regulations could also undermine mission-critical objectives. The 
Department's ability to redirect resources may be further complicated 
by statutory directives regarding programs and their funding as well as 
difficulties in finding, hiring, training, and transferring personnel 
to ensure adequate familiarity and technical expertise to conduct the 
analyses. Our reanalysis of the rule's regulatory impact, and 
particularly the estimated hours per assessment and

[[Page 59910]]

review, indicates that such staffing measures likely would be needed in 
order to comply with the rule.
    It is not feasible at this time to determine with any specificity 
how the Department would make these difficult choices on when to divert 
resources from existing programs, to the extent permitted by statute 
and logistics, and when to let regulations expire without review. 
However, as described elsewhere in this proposed rule, we now predict, 
contrary to the statements in the SUNSET final rule, that it is very 
likely that some regulations will automatically expire without 
substantive review.
    This quandary has several implications. Both the potential for 
automatic expiration of rules, as well as the diversion of resources 
from existing regulatory programs, would create regulatory uncertainty, 
and that uncertainty could have several negative repercussions for 
stakeholders, including interference with planning, contracting, and 
product development. Further, the actual expiration of regulations 
could lead to confusion among stakeholders, undermine predictability 
and confidence in many sectors regulated by the Department, and could 
harm the public health in numerous ways, discussed in greater detail 
below.
    Commenters suggested that the legal analysis in the SUNSET final 
rule wrongly concluded that the final rule was consistent with the 
APA's requirements. As discussed further below (in section V.D), under 
the APA, HHS must consider the relevant factors and provide an adequate 
basis and explanation in the rulemaking record for its decision. 
Commenters asserted that the Department did not adequately consider the 
potential harms of each affected regulation automatically expiring, 
such as the facts and circumstances that would no longer be addressed 
upon automatic expiration of that regulation. In light of that absence, 
among other things, there may be a plausible argument that HHS's 
justification was inadequate under the APA.
    The SUNSET final rule is also based on policies that are contrary 
to several policy goals of the current Administration. The SUNSET final 
rule cited for support an Executive Order entitled ``Reducing 
Regulation and Controlling Regulatory Costs'' (E.O. 13771), which 
placed limits on agencies' ability to issue new regulations. 86 FR 5696 
(citing 82 FR 9339 (Jan. 30, 2017)). President Biden, on his first day 
in office, issued an Executive order entitled ``Revocation of Certain 
Executive Orders Concerning Federal Regulation,'' which revoked E.O. 
13771.\5\ 86 FR 7049 (Jan. 25, 2021) (E.O. 13992). As stated in E.O. 
13992, the current Administration's policy is to equip executive 
departments and agencies with flexibility to use available tools such 
as robust regulatory action to confront the urgent challenges facing 
the Nation, including the coronavirus disease 2019 (COVID-19) pandemic, 
economic recovery, racial justice, and climate change. Accordingly, 
E.O. 13992 revoked ``harmful policies and directives that threaten to 
frustrate the Federal Government's ability to confront these problems 
and empowers agencies to use appropriate regulatory tools to achieve 
these goals.'' Id.
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    \5\ The SUNSET final rule also cited ``Regulatory Relief To 
Support Economic Recovery,'' (May 19, 2020) (E.O. 13924), which was 
revoked in Executive Order 14018. 86 FR 11855 (Feb. 24, 2021).
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    Upon review, we now believe that the burdens imposed by the SUNSET 
final rule could undermine the Department's ability to fulfill its 
public health and human services missions, promote national priorities, 
and confront the challenges facing the nation--contrary to the policies 
expressed in E.O. 13992. Although the Department is committed to 
exploring ways to improve its processes for conducting retrospective 
reviews under the Regulatory Flexibility Act (RFA) and identify and 
retire obsolete rules, the approach in the SUNSET final rule appears to 
go beyond what is needed to meet those objectives, as noted by several 
commenters at the Public Hearing. See, e.g., Public Hearing Transcript, 
Comments by the Consumer Federation of America, American Frozen Food 
Institute, and Disability Rights New Mexico. In essence, the SUNSET 
final rule would likely have led to a sharply diminished role for the 
Department in providing Federal leadership in public health and human 
services, a position with which the current Administration 
fundamentally disagrees.
    Based on the many comments opposing the rule, the SUNSET final rule 
also appears to undercut the policy expressed on the first day of the 
current Administration in E.O. 13985 entitled ``Advancing Racial Equity 
and Support for Underserved Communities Through the Federal 
Government,'' which lays out the current Administration's policy for 
the Federal Government to ``pursue a comprehensive approach to 
advancing equity for all, including people of color and others who have 
been historically underserved, marginalized, and adversely affected by 
persistent poverty and inequality.'' 86 FR 7009 (Jan. 25, 2021). In 
addition, on January 26, 2021, the current Administration issued a 
``Memorandum on Tribal Consultation and Strengthening Nation-to-Nation 
Relationships,'' directing the heads of executive departments and 
agencies to make respect for Tribal sovereignty and self-governance, 
commitment to fulfilling Federal trust and treaty responsibilities to 
Tribal Nations, and regular, meaningful, and robust consultation with 
Tribal Nations cornerstones of Federal policy pertaining to American 
Indians and Alaska Natives. 86 FR 7491. The current administration also 
issued an E.O. titled ``Strengthening Medicaid and the Affordable Care 
Act,'' 86 FR 7793 (Feb. 2, 2021) (E.O. 14009), states that it is the 
policy of the Biden-Harris Administration for the Federal Government to 
protect and strengthen Medicaid and the ACA and to make high-quality 
healthcare accessible and affordable for every American. The E.O. 
directs HHS, among others, to examine its regulations, policies, and 
the like to ensure that they are consistent with the policy of 
providing high quality and accessible health care for all, and do not 
undermine protections for people with pre-existing conditions under the 
ACA, reduce coverage under or otherwise undermine Medicaid or the ACA, 
or undermine the Health Insurance Marketplace or the individual, small 
group, or large group markets for health insurance in the United 
States.
    If implemented, we now believe that the SUNSET final rule could 
negatively impact diverse groups of stakeholders, including 
historically underserved, marginalized, and adversely affected 
communities, and undermine the Department's public health mission. For 
example, as discussed in more detail below, numerous commenters 
expressed concern about the anticipated impacts on various populations 
including children, the elderly, the disabled, those living in poverty, 
and communities marginalized by racism and prejudice, who could lose 
eligibility for programs and services if the regulations underpinning 
the eligibility requirements were to expire. Public commenters, 
including Tribes and tribal representatives, assert that the SUNSET 
final rule would threaten the regulatory underpinnings of the Indian 
health system, completely disrupt the ability of that system's mission 
to provide care to tribal communities, undermine the delivery of HHS 
public health and social service programs for tribal members, and 
generate a level of uncertainty that is the antithesis of the goals of 
the HHS Tribal Consultation

[[Page 59911]]

Policy.\6\ Furthermore, HHS now acknowledges that the SUNSET final rule 
does not provide for advance notice of regulations that might 
automatically expire, which we believe conflicts with the Department's 
policy to engage in meaningful consultation with Tribal Nations.
---------------------------------------------------------------------------

    \6\ U.S. Department of Health and Human Services, HHS Tribal 
Consultation Policy (December 12, 2010) (available at https://www.hhs.gov/about/agencies/iea/tribal-affairs/consultation/index.html).
---------------------------------------------------------------------------

IV. Legal Authority

    The primary statutory authorities supporting this proposed rule are 
the general rulemaking authorities for the various substantive areas 
under the Department's umbrella, as well as a general provision 
authorizing agencies to issue regulations regarding the administrative 
processes to be followed by that agency. These include:
     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 215 of the Public Health Service Act (PHS Act), 42 
U.S.C. 216, which provides that ``The Surgeon General, with the 
approval of the Secretary, unless specifically otherwise provided, 
shall promulgate all other regulations necessary to the administration 
of the Service[ ];''
     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 [they are] 
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;''
     42 U.S.C. 2003, which provides that ``the Secretary of 
Health and Human Services is also authorized to make such other 
regulations as [they] deem desirable to carry out the provisions of 
this subchapter [transferring to the Indian Health Service (IHS) the 
authority to provide health care services to American Indians and 
Alaska Natives];'' 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.''
    Congress' grant of broad, discretionary rulemaking authority 
necessarily includes the authority not to promulgate--and therefore 
also to withdraw or repeal--a proposed or final rule. See Natural Res. 
Def. Council, Inc. v. SEC, 606 F.2d 1031, 1045 (D.C. Cir. 1979); see 
also 5 U.S.C. 551(5) (defining ``rule making'' to include formulating, 
amending, and repealing a rule).

V. Explanation of Proposed Rule To Withdraw or Repeal the SUNSET Final 
Rule

    The Department proposes to withdraw or repeal the SUNSET final rule 
based on the following concerns: (A) Implementation of the rule could 
create burdens on the Department and on stakeholders that would divert 
resources from pressing public health matters and thus harm the public; 
(B) both the possibility of automatic expiration of HHS regulations, 
and the actual expiration of HHS regulations, could harm the public; 
(C) the final rule may be harmful to small entities, inconsistent with 
Congress' intent in enacting the RFA, and unnecessary to achieve the 
RFA's objectives or to incentivize the Department to conduct reviews of 
regulations; and (D) ambiguity in the definitions and exceptions in the 
final rule may increase the burden of the regulation and the risk of 
regulations automatically expiring. In addition, questions were raised 
as to whether the final rule is consistent with the APA, which merit 
further consideration.

A. Implementation Burdens on the Department and Stakeholders

1. Burden on the Department
    The framework set forth in the SUNSET final rule would create a 
tremendous economic and workload burden on the Department, and would 
pursue the objective of regulatory review at great expense to the 
public and to the small business community it purports to benefit. As 
explained in more detail below, these harms are likely to be greater 
than any benefits of the retrospective review framework in the SUNSET 
rule. Although the SUNSET final rule acknowledged the submission of a 
large number of comments stating that the rule would burden the 
Department, divert its personnel resources, and adversely affect the 
Department's ability to administer programs, and issue and modify 
regulations, the final rule essentially concluded that these concerns 
were outweighed by its finding that ``widespread retrospective review 
is a worthwhile enterprise.'' 86 FR 5705. As previously discussed, that 
finding was predicated on what we now believe to be a flawed 
understanding of the regulatory impact of the rule. Our reanalysis of 
the burden of the SUNSET rule fundamentally alters any evaluation of 
the merits of the rule and gives new force to the comments concerning 
the burden. Also, as discussed, this Administration has different 
policy goals than the previous Administration, and these differences 
impact how these various issues, concerns, and goals are weighed. We 
now believe that the SUNSET final rule did not give sufficient 
consideration and weight to the large number of comments, discussed 
immediately below, raising concerns regarding the burdens on the 
Department's ability to effectively carry out its missions.
    Numerous commenters opposed the proposed rule out of concern that 
the burden and the diversion of resources to assessments and reviews 
would negatively impact public health activities. Several commenters 
referred to the burden imposed on the Department as ``undue,'' 
``unreasonable,'' ``unnecessary,'' ``onerous,'' and ``misguided.'' In 
response to these comments on the proposed rule, the SUNSET final rule 
attempted to minimize these concerns by extending the period for the 
automatic expiration of regulations from two to five years, and 
ultimately concluded that its retrospective review scheme is sensible 
``even if it takes some time away from issuing new regulations.'' 86 FR 
5705. We now believe that assertion rested on a flawed understanding of 
the resources required to implement the SUNSET final rule. The rule did 
not explain how HHS could devote numerous employees to full-time 
retrospective review without compromising the Department's and its sub-
agencies' many other crucial tasks, such as protecting the country from 
future pandemics or other public health emergencies. We now believe 
that the SUNSET final rule underestimated the rule's regulatory impact 
and failed to appreciate the scope of its effects on the Department, 
including that the rule could compromise some of the Department's most 
important initiatives.
    Commenters also emphasized particular apprehension about the impact 
of the rule on the Department's ability to address public health 
emergencies such as COVID-19 and the

[[Page 59912]]

opioid crisis. The SUNSET final rule ultimately concluded that the new 
retrospective review requirements would not hamper the response to the 
pandemic because by that time the COVID-19 Public Health Emergency ``is 
likely to have subsided.'' 86 FR 5748. However, as explained further 
below, many commenters expected that implementation of the rule--by 
diverting staff and resources--would create immediate disruption to 
programs essential to the COVID-19 response for patients, beneficiaries 
of HHS health programs, and the larger health system. Commenters also 
expected that these demands would continue to evolve during the 
remainder and aftermath of the current pandemic, and noted that the 
same problems could occur with other public health emergencies in the 
future. Bolstering the commenters predictions, the trajectory of the 
COVID-19 pandemic seems far less certain than when the SUNSET final 
rule was published.
    HHS has reconsidered these comments and now believes that the 
Department must continue to remain flexible and focused on the 
management and utilization of HHS resources to address COVID-19 and its 
impacts as well as future public health emergencies. The challenges of 
the continued current public health emergency suggest a risk of future 
harm because the SUNSET rule provides no good cause exception to avert 
the expiration of a regulation in the event of a pandemic, a public 
health emergency, or another declared national emergency. Although the 
final rule added a provision to permit the Secretary to extend the 
period for assessments and reviews, the extension can only be applied 
one time, for up to one year, per each section of regulation, and the 
extension can only be exercised through a determination published in 
the Federal Register. 86 FR 5725. Given the brief extension available 
for the assessment and review and the potential duration of an 
emergency (as evidenced by the current 18-month plus duration of the 
COVID-19 pandemic), the final rule was likely incorrect to conclude 
that this option would be sufficient to avoid the diversion of 
resources and the automatic expiration of regulations in the event of a 
pandemic, emergency, or other development that prevents the Department 
from timely assessing or reviewing certain sections. Id. at 5726.
    As noted in public comments, the SUNSET final rule imposes multiple 
types of burdens on the Department. First, the rule's assessment and 
review processes have substantial resource implications. Such processes 
require Department evaluations of regulations based on certain 
criteria, which would involve information collection and analysis 
(potentially including public notice and comment, and OMB review and 
approval, under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.), 
engagement with subject matter experts, and consultation with state and 
local jurisdictions and Tribes. In addition, the Department would need 
to solicit and consider public comment related to those evaluations, 
participate in interagency review, and publish results in the Federal 
Register, including the full underlying analyses and data used to 
support the results.\7\ Completing these steps for the thousands of 
regulations currently issued by the Department, and for future 
regulations, would be a colossal undertaking on any timeframe. But the 
SUNSET rule requires these processes on a compressed timeframe, meaning 
many assessments and reviews would need to occur simultaneously, 
thereby compounding the impact. Data collection may be infeasible under 
the timeframes required under the rule, which could compromise the 
quality and completeness of the work. As noted in the final rule, 
approximately 12,400 \8\ of the Department's estimated 18,000 sections 
in the CFR are over ten years old, and each of these are regulations 
that could automatically expire five years after the SUNSET final 
rule's effective date unless assessment and, as applicable, reviews are 
completed.\9\ For example, under the timeline and definitions provided 
in the final rule, over 7,000 sections of the CFR that were promulgated 
by the FDA are more than ten years old, or would become more than ten 
years old during the first five years the rule would be in effect, 
representing over 95 percent of this agency's current regulations. 
Although there are limited categorical exceptions and some specific 
regulations excepted from the rule, the enumerated exceptions are very 
limited and likely would not make a meaningful difference in the burden 
on the agency, including because HHS has yet to assess the 
applicability of these exceptions.\10\
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    \7\ These analyses and data would need to be reviewed in light 
of any applicable privilege, protections for confidential business 
information, or explicit legal prohibition on disclosure, thereby 
adding to the burden.
    \8\ 85 FR 5705.
    \9\ The SUNSET final rule defines ``Section'' as ``a section of 
the Code of Federal Regulations'' and provides the following 
example, 42 CFR 2.13 is a Section, and 42 CFR 2.14 is another 
Section (see 1 CFR 21.11). 86 FR 5751.
    \10\ In addition, based on a count from an HHS website that 
provides a listing of the rulemakings promulgated by HHS and 
includes the date that each regulation was first issued in title 21, 
title 42, and title 45 of the CFR, U.S. Department of Health and 
Human Services, List of HHS Rulemakings by Date of Promulgation 
(available at https://www.hhs.gov/regulations/federal-registry/index.html), over 3,000 sections of the CFR were promulgated by HHS 
before the enactment of the RFA in 1980, which required the 
rulemaking process to include an analysis of whether regulations 
have a significant economic impact upon a substantial number of 
small entities (SEISNOSE). Although the final rule acknowledges that 
additional resources would be needed to review regulations that 
predate the RFA, the rule does not reflect the additional work to 
assess these regulations to determine if a review is necessary. For 
older regulations enacted before the RFA that are not otherwise 
exempt from the rule, the assessment phase would not necessarily 
have analysis or information from the original rulemaking record to 
inform an assessment.
---------------------------------------------------------------------------

    Furthermore, this burden is recurring. As soon as the Department 
reviewed all the current rules, it would start having to review them 
again within a 10-year timeframe. And the expertise needed to conduct 
assessments and reviews and achieve the pace and scope set forth in the 
rule would require a reallocation of staff including subject matter 
experts, regulatory counsels, economists, and attorneys. This 
reallocation effort alone would entail a significant burden and would 
draw resources away from other public health and welfare activities.
    Second, if a review concludes that a regulation should be amended 
or rescinded, the rule requires the Department to amend or rescind the 
regulation within two years of the date that the review results are 
published. The development of regulations is a deliberative and 
resource-intensive process that requires consideration of a wide range 
of factors, including current relevant facts, statutory obligations, 
and public-health and -welfare goals. Requiring the Department not only 
to assess and review its regulations, but also to amend or rescind them 
(in applicable circumstances) on a specific timeframe, amplifies the 
burden on the Department.
    Third, as discussed further below, the SUNSET final rule contains 
ambiguities that would need to be clarified in order to operationalize 
the rule. This creates another hurdle to implementing the SUNSET final 
rule that is separate from the assessment, review, and rulemaking 
requirements. For example, under the rule, it is not clear when certain 
regulations would need to be assessed and whether the regulation falls 
within a categorical exception. The Department would need to develop 
processes and standard operating procedures to try to bring consistency 
and transparency to this process. While the Department expressed an 
intent to create a dashboard for monitoring assessments and reviews, 
the development,

[[Page 59913]]

monitoring, and updating of this dashboard would add to the burden on 
HHS. Collectively, these activities would likely delay the initiation 
of assessments and further strain the Department's ability to prevent 
regulations from automatically expiring.
    Fourth, the SUNSET rule imposes on HHS the task of determining 
where to redirect resources to support assessments and reviews and 
thereby preserve regulations. Multiple, complex considerations would 
likely be relevant to this effort, including public health and legal 
considerations. Furthermore, to the extent that any regulations would 
expire under the SUNSET final rule--which the Department now predicts 
would be likely--HHS would need to consider how to prioritize its 
assessment and review processes to manage that risk. Overall, the 
economic and workforce burdens imposed on the Department by the SUNSET 
final rule are significant.
    As noted above, commenters opposed to the rule expressed concern 
that the diversion of resources would disrupt public health activities 
and social service programs administered by specific HHS operating 
divisions. For example, commenters expressed concern that, in order to 
review or assess regulations within the rule's timeframe, FDA staff 
could be diverted from the review of medical product applications, food 
additive petitions, efforts to promote medical product innovation, 
competition, and access to medicine, and the regulation of the food and 
medicine supply for humans and animals. Commenters also described 
impacts on the administration of HHS social services programs, 
expressing concern that there will not be enough time and staff to 
efficiently review regulations and to serve citizens at the same time, 
including those who depend on safety net programs under the auspices of 
the ACF such as Head Start and the Low Income Home Energy Assistance 
Program. Multiple commenters who advocate for mental health issues also 
opposed the diversion of staff resources away from programmatic work 
that addresses inequities in access to health and mental health care.
    Commenters nationwide who represent state and county health 
departments, as well as legal and social service organizations who 
advocate for beneficiaries, individual beneficiaries themselves, and 
concerned citizens, expressed concern that the CMS would be hampered in 
the day-to-day administration of public health programs for millions 
enrolled in the Children's Health Insurance Program (CHIP), Medicaid, 
and Medicare. Some noted the burden of retrospective reviews could put 
a strain on the administration of the Affordable Care Act (ACA) and the 
development of new regulations and guidance to: Support health care 
coverage, innovation, and competition; enhance patient safety; and 
combat waste, fraud, and abuse. Commenters representing Federally 
Qualified Health Centers (FQHCs) expressed opposition to the rule 
because it would result in the diversion of resources from programs 
that support particular populations served by FQHCs such as Community 
Health Centers, Migrant Health Centers, Health Care for the Homeless, 
and Health Centers for Residents of Public Housing. Commenters 
representing or affiliated with American Indians and Alaska Natives 
described the potential impact of resource diversion from the 
administrative and operational activities of the IHS, which could 
diminish access to critical safety net programs for American Indians 
and Alaska Natives and decrease programmatic staff available to 
administer programs that provide critical protections for tribal youth. 
Some commenters also noted that the focus on the activities required by 
the SUNSET rule would impair the Department's ability to issue new 
regulations that would modernize the healthcare system, improve service 
delivery, and promote equity for all, including people of color and 
others who have been historically underserved, marginalized, and 
adversely affected by persistent poverty.
    Therefore, based on review of these comments and the Department's 
new cost estimates for the SUNSET rule, HHS now believes that the 
SUNSET final rule may have significantly underestimated the burden on 
the Department resources to comply with the rule and incorrectly 
evaluated the Department's ability to expend the necessary resources to 
prevent the automatic expiration of regulations. The Department also 
thinks it likely that these burdens would result in the diversion of 
significant resources from other HHS initiatives and priorities. The 
Department now believes that the harm and the costs resulting from this 
diversion are likely greater than any benefits of the retrospective 
review framework in the SUNSET rule. Department initiatives are each 
intended to further the health and well-being of Americans. Often, 
these respond to the most pressing issues of the day, which are diverse 
and range from foodborne illness to the opioid crisis to the COVID-19 
global pandemic to dealing with humanitarian crises, such as the care 
and custody of unaccompanied children at the border. Redirecting 
resources away from these types of initiatives in order to fully 
implement the SUNSET rule could mean neglecting the areas of greatest 
public health need, contrary to the Department's mission. As discussed 
above, many commenters identified examples of important programs 
threatened by the diversion of resources of SUNSET final rule, and the 
Department agrees with those examples. Ultimately, the Department no 
longer believes that the analysis of existing regulations, which may 
have little practical effect in many cases, should be elevated over 
HHS's other important regulatory initiatives.
2. Potential Burden on Stakeholders
    HHS has also reexamined the burden the SUNSET final rule places on 
stakeholders to prevent the automatic expiration of regulations and the 
final rule's estimation that ``the cost of monitoring Assessments will 
be relatively trivial.'' 86 FR 5744. The final rule describes 
``safeguards to mitigate the risk of inadvertent expiration,'' such as 
enabling the public to submit comments requesting that the Department 
commence an assessment or review, and making a dashboard that would be 
available on an HHS website that would enable stakeholders to monitor 
the status of assessment and reviews of regulatory sections that may 
expire. Id. at 5714. Various public commenters, however, opined that it 
is inappropriate and unfair to place such a heavy burden on the public. 
More than one commenter posited that the automatic expiration of 
regulations resulting from the Department's failure to complete 
assessments and reviews would constitute a penalty to the regulated, 
and not the regulators.
    Many commenters opposed to the rule expressed concern that the 
monitoring burden would be overwhelming, particularly for health care 
providers, public health advocates, caregivers, and beneficiaries, 
among other stakeholders, who would have to divert time and effort from 
providing direct health care. In addition, commenters representing a 
wide range of industry stakeholders anticipated a higher burden on 
small entities that would not have the personnel and resources to both 
monitor the status of thousands of regulations being assessed 
contemporaneously, and simultaneously provide comments about data and 
information that should be considered in an assessment or review. 
Similarly, commenters expressed concern that members of the

[[Page 59914]]

general public would not have the ability or awareness to participate 
in the process envisioned, so that the construct would favor well-
funded special interests who would have the resources to hire lawyers 
and lobbyists to advocate for their favored outcomes. Several 
commenters associated with trade associations and advocacy 
organizations described the immense effort that would be needed to 
engage organization membership and to research, draft, review, and 
submit consensus-driven comments with members and partner 
organizations. Some commenters noted that they expected the monitoring 
process to be chaotic as stakeholders seek the Department's 
prioritization of the assessment or review of regulations they are 
concerned might expire.
    The Department believes that any retrospective review process 
should not impose an undue burden on the public. Based on these 
comments and the Department's new cost estimates for the SUNSET rule, 
the Department now believes that the SUNSET final rule likely 
underestimated the burden on stakeholders to monitor and comment on 
potentially expiring regulations.

B. Potential Harm From the Possible and Actual Expiration of 
Regulations

1. Potential Harm From Uncertainty
    HHS has given further consideration to the harms to the public 
health from the regulatory uncertainty created by the SUNSET final 
rule. Because of the above-described substantial burdens imposed on the 
Department by the breadth and scope of the regulatory review process 
required by the SUNSET final rule, the Department now acknowledges 
that, despite statements in the final rule that HHS did not intend to 
allow any regulations to simply expire, see, e.g., 86 FR 5710, it is 
unrealistic to assume that no regulations would automatically expire as 
a result of the final rule. In fact, given the complicated resource 
allocation decisions discussed above, HHS is unable to forecast the 
number or identity of specific regulations that may expire without a 
completed review and assessment. It may therefore be difficult for 
stakeholders to know which regulations will remain in place because 
that will depend on whether the Department will actually be able, and 
will choose, to complete each regulation's assessment and/or review by 
the assessment or the review deadline. The potential automatic 
expiration of large swathes of rules, or even one complex rule, without 
a reasoned justification such as a change in the governing law or a 
change in circumstances, could create uncertainty and unpredictability 
regarding regulatory programs going forward.
    Several commenters supported the Department's efforts to explore 
ways to improve its processes for conducting retrospective reviews to 
reassess, update, and amend regulations. As discussed further in 
section V.3.C., HHS already exercises its authority to conduct 
retrospective reviews, and comments suggested improvements to achieve 
the goals of retrospective review productively and efficiently. 
However, as the comments explained, there is a stark difference, 
particularly from a planning standpoint, between thoughtful 
reconsideration of individual rules, with stakeholder participation and 
a reasoned justification, and automatic expiration of rules from lack 
of sufficient resources (by either or both stakeholders and the 
Department). Rather than the current baseline assumption that 
regulations will remain the same, absent a specific notice providing a 
basis for possible change, the new baseline would be uncertainty 
regarding the future validity of numerous regulations.
    Commenters explained that the uncertainty created by the potential 
automatic expiration of countless rules could have numerous 
repercussions for stakeholders and for the public health. Public 
commenters explained the importance of a relatively steady regulatory 
environment. For example, several commenters explained that rules that 
implement HHS policies and programs, such as Medicaid and CHIP, 
establish the national standards for Federal/State partnership 
programs, so that States in turn can design processes and run programs 
on a day-to-day basis based upon these standards. Predictable and 
reliable communication and guidelines facilitate effective 
implementation of these programs, so that providers can understand what 
their obligations are, and beneficiaries can understand what they are 
entitled to receive. Further, many participants in the health care 
ecosystem have structured their financial arrangements and business 
operations to satisfy the myriad conditions set forth in the current 
regulations. The uncertainty regarding the future of those regulations 
could upset the assurance of regulatory continuity underlying those 
arrangements and therefore disrupt planning and entering into longer-
term commitments. And, for programs that rely on Federal funding, 
commenters asserted that potentially expired regulations could impact 
the ability to apply for, or receive, funding sources governed by those 
rules, which in turn would disrupt longer-term planning.
    Commenters also contended that the increased unpredictability of 
the future of regulations under the SUNSET final rule would impede 
product development and innovation. Commenters asserted that 
uncertainty in regulation would be particularly harmful for drug 
development: Because new therapeutic products may require decades to 
develop and review, and because this process is expensive, drug 
sponsors rely on a predictable regulatory environment to plan their 
development programs. For instance, FDA has extensive regulations that 
address standards for clinical trials and premarket submissions, 
requests for orphan designation, patent term restoration, and 
exclusivity determinations. Although statutory provisions govern these 
programs, the statute does not specify in detail the substance or 
processes for these premarket submissions. As a result, the potential 
for expiration of the regulations, which clarify the application 
pathway and requirements, could curtail drug development, including 
progress on cancer therapies and therapies for those with unmet medical 
needs. Similarly, one commenter noted that the development of digital 
health care platforms typically takes 5 to 10 years, and the developers 
will need to understand the regulatory environment in which they will 
be developing their business. Another commenter asserted that 
investments are made in industrial biotechnology innovations based on 
the assumption that regulations will be in place for at least 10 years; 
consequently, some emerging industrial biotechnology companies will 
have difficulty finding investors in the face of regulatory 
uncertainty. Thus, as one commenter opined, ``[i]nstead of innovation, 
this rule could easily lead to stasis.''
    We question whether the SUNSET final rule adequately considered the 
potential costs of regulatory uncertainty created by the rule. The 
final rule states that it ``does not believe uncertainty among the 
regulated community will add significantly to the costs of this 
rulemaking'' because ``there is always a possibility that regulations 
could be amended or rescinded, even absent this rule.'' 86 FR 5709. HHS 
now believes the final rule's automatic expiration of regulations could 
instead be more haphazard and unpredictable, and therefore more 
disruptive, than the existing possibility of targeted changes to 
regulations based on a reasoned justification such as a change in the

[[Page 59915]]

governing law, technology, or other circumstances.
    The Department also notes that E.O. 13563, ``Improving Regulation 
and Regulatory Review,'' which the SUNSET final rule cited for support, 
includes among general principles of regulation that our regulatory 
system ``must promote predictability and reduce uncertainty.'' \11\ 
Upon reconsideration of the comments received, we now believe that, by 
introducing significant uncertainty about whether regulations will 
expire, the final rule may undermine these objectives.
---------------------------------------------------------------------------

    \11\ 76 FR 3821 (January 21, 2011).
---------------------------------------------------------------------------

2. Potential Harm From the Actual Expiration of Regulations
    After further consideration, HHS believes that, because the SUNSET 
rule failed to appropriately consider the likelihood that any 
regulations would expire, it likewise did not take into account the 
harm to stakeholders and the public health that could result from 
regulations expiring. The resources needed to prevent the automatic 
expiration of regulations are now estimated to be significantly higher 
than identified in the SUNSET final rule. Given statutory spending 
directives and other statutory obligations, it could be difficult, and 
in some cases prohibited, for the Department to redirect sufficient 
resources to prevent expiration of certain HHS regulations. Further, 
any attempt to divert the amount of resources necessary to prevent the 
expiration of regulations would degrade HHS' capabilities to carry out 
mission-critical objectives such as protecting the health of Americans, 
strengthening their economic and social well-being, and fostering 
sound, sustained advances in the sciences. As a result, these 
constraints make it likely that regulations could expire without 
review.
    This expiration is unlike the standard processes that agencies 
undertake to change rules. In general, it is more common for rules to 
be amended to account for a change in statutory authority or change in 
relevant circumstances; they are not simply rescinded in their entirety 
without a rule-specific justification or an opportunity for the public 
to comment on that justification, including identifying harms 
associated with the repeal.
    Because the final rule did not acknowledge the substantial risk of 
expiration of regulations, it did not examine the wide array of harmful 
effects that could arise in this situation including: Causing serious 
harm to millions of stakeholders who rely upon HHS programs, including 
underserved populations; upending established understandings across the 
public health spectrum as to how to comply with statutory requirements; 
and disrupting established industry standards that protect public 
health, create a level playing field for businesses, and boost consumer 
confidence.
    The breadth and complexity of some regulatory programs with 
interdependent regulatory provisions, and their integration into 
programs run by State and local authorities, could magnify the 
repercussions of many automatically expiring regulations. For example, 
as one commenter explained, Medicare is the largest payor in the U.S. 
health care system and the largest piece of a system comprised of 
thousands of interlocking moving parts; thus, the entire health care 
system is impacted by the Medicare program and therefore relies on 
Medicare regulations to function. The Medicare regulations were not 
contemporaneously enacted and therefore are subject to different 
potential expiration dates under the SUNSET final rule. If some 
individual Medicare regulations not subject to exceptions in the SUNSET 
final rule begin to expire, it could be difficult for regulated 
entities to disentangle the downstream effects to ascertain the 
remaining regulatory requirements. The expiration of these regulations 
also increases the potential for bad actors to try to exploit the lack 
of regulations, potentially resulting in increased fraud and abuse.
    Commenters explained that the confusion about what, if any, 
standards would govern in the event of a lapse in Federal regulations 
is likely to result in significantly increased regulatory complexity 
and implementation. Another commenter predicted that, if States will be 
directed to abandon expiring rules, and/or to suddenly implement new 
interpretations of statutory requirements in the event regulations 
automatically expire, they will be faced with enormous administrative 
costs such as computer system upgrades, staff training, amended 
services contracts, and public education on new requirements.
    Commenters provided numerous examples of harms to stakeholders and 
the public health that could arise from the actual expiration of 
regulations. States Attorneys General commented that States depend on 
HHS to administer trillions of dollars in Federal funding to support 
their healthcare systems and the health and safety of their residents, 
which would be disrupted by the expiration of regulations. Many 
commenters expressed particular concern about the anticipated impacts 
on various communities including children, the elderly, the disabled, 
those living in poverty, the LGBTQ community, patients living with HIV/
AIDS, tribal members, communities of color who are often more reliant 
upon HHS programming as a result of systemic racism, and people who 
live in rural areas who rely more heavily on federally funded HHS 
programs. According to the commenters, these individuals will suffer 
worse outcomes in terms of health and well-being if they were to lose 
eligibility for programs and services upon expiration of regulations. 
This loss in program coverage could in turn increase the economic costs 
to public assistance organizations, which would need to devote more 
time, energy, and resources to finding ways to assist individuals 
absent these protections from the Federal Government.
    For example, commenters asserted that implementation of Medicaid 
and the ACA depends heavily on regulations to clarify coverage 
requirements, program implementation, and the obligations of state 
programs serving people with low incomes. As discussed above, Federal 
regulations play an important role in HHS' partnership with States in 
implementing Medicaid, which, as one commenter described, has helped 
communities respond to economic downturns, natural disasters, 
epidemics, and public health emergencies since the program was enacted 
in 1965. Another commenter described the importance of detailed Federal 
regulations in implementing the accountable care organization program, 
which increases the quality of care for Medicare beneficiaries while 
reducing unnecessary costs, and that expiration of the governing 
regulations would interfere with those program goals. Another example 
included regulations that protect Medicare beneficiaries from 
misleading and high-pressure marketing tactics; expiration of those 
regulations could end compliance and enforcement actions against these 
bad actors. If the governing regulations were to expire, HHS programs 
and other programs reliant on HHS regulations might be free to operate 
without standards, consistency, or accountability, which could lead to 
real harm to, for example, the millions of children who rely on those 
programs. Similarly, advocates for HIV services commented that the 
SUNSET rule's potential to cause confusion over the validity and 
enforceability of Medicaid regulations

[[Page 59916]]

could lead to service and coverage delays, which, for people with HIV, 
can be detrimental, causing irreversible disease progression and 
prescription drug resistance. Commenters expressed concern regarding 
the expiration of other programs that support particular populations, 
which expiration could be devastating for the populations they 
serve.\12\
---------------------------------------------------------------------------

    \12\ Specific HHS programs identified to be at risk included: 
The Health Care Program; Low Income Energy Assistance Program; 
Temporary Assistance to Needy Families; Early and Periodic 
Screening, Diagnostic and Treatment; Indian Child Welfare Act; Child 
Care and Development Fund; the Administration for Community Living; 
Child Care and Development Grant; Head Start; Early Head Start; 
Maternal Infant and Early Childhood Home Visiting Program; National 
School Lunch Program; School Breakfast Program; Supplemental 
Nutrition Program for Women, Infants, and Children; Child and Adult 
Care Food Program; Summer Food Service Program; Community Mental 
Health Services Block Grant; Supplemental Nutrition Assistance 
Program; the Refugee Resettlement Program; and Medicaid Waiver 
programs including: The Children's Autism Home and 
Community[hyphen]Based Services Waiver Program; Adult Residential 
Waiver; Community Living Waiver; Adult Supports Waiver; Home and 
Community-Based Services Waiver for Persons with Traumatic Brain 
Injury; and the Frail Elder Home and Community-Based Services 
Waiver. More generally, commenters identified regulations protecting 
particular populations including those concerning Medicaid 
conditions of participation for nursing homes, substance use and 
addiction treatment and prevention programs, mental health services, 
access to childcare, foster care, adoption, and family violence 
services.
---------------------------------------------------------------------------

    Numerous tribes and tribal organizations commented that the Indian 
health system relies on a number of regulations that tribes have worked 
for decades on with the Department to promulgate on a government-to-
government basis. These include the regulations governing the IHS, 
Tribal Self-Governance, and Indian specific provisions in the Medicaid, 
Medicare, CHIP, and ACA Health Insurance Marketplace regulations. 
Commenters asserted that the SUNSET final rule would threaten the 
regulatory underpinnings of the Indian health system and completely 
disrupt the ability of that system's mission to provide care to tribal 
communities.
    Other commenters asserted that HHS regulations are essential to 
maintaining consumer confidence in the Nation's supply of consumer 
products, as well as a level playing field among industries. Some 
commenters noted that there are many rules setting industry standards 
that have remained untouched for years--not through neglect--but 
because they work as intended. For example, as described in several 
comments, the food industry relies on FDA regulations to provide 
clarity on statutory requirements, to maintain relationships of trust 
between all members of the supply chain, to protect public health by 
providing safe and nutritious food, and to support both domestic 
consumer and worldwide confidence in the safety of the U.S. food 
products. Under the FDA Food Safety Modernization Act (FSMA), FDA over 
the last decade has promulgated, with considerable stakeholder input, 
an extensive set of detailed regulations governing prevention of 
foodborne illness throughout the production and delivery in the global 
food supply. Industry members have devoted significant resources to 
develop food safety plans consistent with the new regulations and in 
many instances have made significant capital investments in equipment, 
personnel, and facilities. Expiration of the FSMA regulations (while 
FSMA's statutory obligations remain in effect) could create confusion 
and uncertainty with regard to what standards apply, particularly 
because the statute required rulemaking for implementation and 
interpretation of the food protection provisions. It also could create 
inefficiencies given the time and resources that have been invested by 
the industry in recent years to ensure the highest levels of 
compliance.
    In addition to food safety regulations, commenters identified other 
longstanding food regulations--involving nutrition and food labeling 
and food ingredients--that set essential standards for the food 
industry. A food manufacturing association asserted that, if food 
regulations are rescinded, consumers may become distrustful of the U.S. 
food supply and, as a result, individual States might feel the need to 
pass their own laws and regulations, meaning manufacturers would have 
to comply with a patchwork of potentially conflicting new rules. 
Compliance with a patchwork of State rules nationally can be costly to 
industry, and those costs may be passed to consumers or may put food 
companies out of business, reducing competition and consumer options. 
Additionally, another commenter asserted that any loss in confidence in 
the safety of U.S. pet food could result in lost sales and new 
requirements by foreign regulators seeking assurances that the pet 
foods they import from the U.S. are safe.
    Many other effective regulations, some of which are decades old, 
bring similar efficiencies to the industry by clarifying applicable 
statutory obligations. As a commenter explained, heavily regulated 
manufacturers benefit from regulatory certainty that provides clarity 
for manufacturers and fosters consumer confidence that the products are 
properly regulated. By contrast, if the regulations expire, 
disreputable companies will be tempted to cut corners to gain economic 
advantage over responsible companies, with the risk that consumers will 
be harmed and will lose confidence in the products. For example, as 
another commenter explained, color additive regulations, many of which 
are decades old, are fundamental to the industry's operation in the 
U.S., and provide confidence that color additives are safe in food, 
drugs, cosmetics, and medical devices. The expiration of those 
regulations could lead to significant confusion.
    Commenters also explained that FDA issues many regulations relating 
to food, drugs, devices, cosmetics, and tobacco products that are 
essential to protecting the public health. To list just a few 
additional examples, these regulations provide: Safety standards for 
the blood supply, access to investigational treatments, protection of 
clinical trial participants, protection from harmful tobacco products, 
and good manufacturing practices that are the linchpin of many product 
supply chains. The expiration of these regulations could mean that 
regulated entities would be unsure how to comply with long-standing 
statutory requirements and may no longer be compelled to comply with 
long-standing safety standards.
    Commenters also raised concerns that the SUNSET final rule could 
impede responses to public health emergencies. For example, the 
regulations established in 2006 to implement the Pandemic and All 
Hazards Preparedness Act took years to develop and have been essential 
to addressing the COVID-19 pandemic. The expiration of those rules 
could leave the Department unprepared to respond to future emergencies 
and result in unnecessary human suffering and loss of life.
    HHS now believes that commenters have raised credible concerns that 
the SUNSET final rule would likely result in actual expiration of 
regulations and that these expirations would adversely impact them. 
Although these comments were raised regarding the SUNSET proposed rule, 
the SUNSET final rule discounted their seriousness, and did not give 
them sufficient consideration and weight. See 86 FR 5709. As discussed 
in greater detail elsewhere in this preamble, we now believe that the 
rejection of these comments was in error because, given the resources 
demands that would be required by the SUNSET final rule, the likelihood 
that regulations would automatically expire is high. Moreover, the 
potential automatic expiration of regulations would be contrary to the 
Department's role as the

[[Page 59917]]

U.S. Government's principal agency for protecting the health of all 
Americans and providing essential human services, especially for those 
who are least able to help themselves.

C. RFA Considerations

1. Rule Requirements Beyond RFA Requirements
    The SUNSET final rule imposes requirements beyond the requirements 
of the RFA. These additional requirements may not be consistent with 
Congressional intent. The SUNSET final rule asserts that it 
``implements Congressional intent for periodic review of regulations'' 
and ``closely tracks the RFA's goal of minimizing undue burden on small 
entities'' 86 FR 5713-5714. Additionally, it asserts that, ``assuming 
full compliance with the RFA, th[e] rule does not impose any additional 
burden on the Department beyond what was already called for in the 
RFA'' because the RFA ``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.'' Id. at 5705. Many commenters disagreed with these 
assertions, and explained that the final rule would impose requirements 
beyond those set forth in the RFA. HHS remains committed to full 
compliance with the RFA, but, upon further consideration, HHS believes 
that the RFA does not require this final rule and finds the commenters' 
perspectives for repealing the rule worthy of further consideration.
    First, commenters assert that the final rule exceeds the RFA's 
express requirements by mandating that the Department conduct 
assessments of thousands of HHS regulations within certain timeframes. 
Section 610 of the RFA is focused on the retrospective review of rules 
identified with a Significant Economic Impact Upon a Substantial Number 
of Small Entities (SEISNOSE). Section 610 contemplates periodic review 
of a subset of ``rules issued by the agency which have or will have a 
[SEISNOSE]'' and imposes certain public notice and comment procedures 
for such reviews.\13\ Nothing in the express language of the statute 
requires the Department to conduct assessments of all HHS regulations 
in order to determine which regulations at time of reassessment have or 
will have a SEISNOSE. As one commenter noted, Congress ``does not[ ] . 
. . hide elephants in mouse holes.'' See Whitman v. Am. Trucking 
Ass'ns, 531 U.S. 457, 468 (2001). This principle suggests that it is 
unlikely that Congress intended to require widespread assessments of 
thousands of regulations via a requirement that the SUNSET final rule 
asserted was ``implicit'' in section 610. See 86 FR 5714. As explained 
below, commenters and the Small Business Administration (SBA) have 
identified numerous more targeted, efficient, and effective 
alternatives for identifying regulations that have or will have a 
SEISNOSE.\14\
---------------------------------------------------------------------------

    \13\ See 5 U.S.C. 610(c) (requiring agencies to ``publish in the 
Federal Register a list of the rules which have a [SEISNOSE], which 
are to be reviewed pursuant to this section during the succeeding 
twelve months'' and ``invite public comment upon the rule'').
    \14\ We also note that the RFA expressly includes a goal of 
avoidance of duplicative or unnecessary analyses. See 5 U.S.C. 605.
---------------------------------------------------------------------------

    Second, principles of statutory construction do not support a 
broader reading of section 610 to require agencies to simultaneously 
consider all regulations and to do so on a recurring basis to determine 
whether they have or will have a SEISNOSE. Had Congress intended to 
mandate this broader reading, it would have done so when it enacted the 
RFA or during any one of the numerous times it has amended the RFA 
since enactment.\15\ This principle holds particularly true for section 
610(a) of the RFA, given that the provision explicitly directed a one-
time simultaneous review of all SEISNOSE regulations that existed on 
the date of enactment. See, e.g., Salinas v. U.S. R.R. Retirement Bd., 
141 S. Ct. 691, 698 (2021) (quoting Russello v. United States, 464 U.S. 
16, 23 (1983) (``Where Congress includes particular language in one 
section of a statute but omits it in another section of the same Act, 
it is generally presumed that Congress acts intentionally and purposely 
in the disparate inclusion or exclusion.'').
---------------------------------------------------------------------------

    \15\ See Office of Advocacy, U.S. Small Bus. Admin., A Guide for 
Government Agencies: How to Comply with the Regulatory Flexibility 
Act 2-3 (Aug. 2017) (available at https://advocacy.sba.gov/2017/08/31/a-guide-for-government-agencies-how-to-comply-with-the-regulatory-flexibility-act/) (summarizing amendments enacted in 
1996, 2007, and 2010).
---------------------------------------------------------------------------

    Third, the SUNSET final rule's requirements for public notice and 
comment procedures--such as notifying the public on a Department-
managed website when it commences the process of performing an 
assessment, publishing a notice in the Federal Register within a month 
of commencement, and issuing a notice in the Federal Register to 
publish the results of all assessments--appear to extend beyond the 
RFA's notice and comment and other requirements for retrospective 
reviews. HHS agrees with commenters that section 610 requires notice 
and comment procedures for retrospective review, but it does not 
require notice and comment procedures to determine which regulations 
have or will have a SEISNOSE.\16\ Similarly, the RFA provides no basis 
for an expedited timeline as specified in the SUNSET final rule for the 
completion of reviews, which was noted by commenters. Section 610(a) of 
the RFA provides only that the reviews required under that section be 
conducted ``within ten years'' of specific dates.
---------------------------------------------------------------------------

    \16\ See 5 U.S.C. 610 (specifying factors agencies must consider 
in conducting reviews of rules that have or will have a SEISNOSE and 
requiring agencies to publish in the Federal Register plans for 
periodic reviews and a list of rules to be reviewed during the 
succeeding twelve months as well as invite public comment on rules 
to be reviewed); see also, e.g., id. 603(a) (requiring an initial 
regulatory flexibility analysis for proposed rules for which a 
notice of proposed rulemaking is required or published as well as 
public notice and comment and publication of the analysis); id. 
604(a)(2), (b) (requiring a final regulatory flexibility analysis 
for final rules for which a notice of proposed rulemaking was 
required or published and requiring the analysis to include the 
agency's consideration of public comments received and to be 
published in full or summary form in the Federal Register); id. 
605(b) (permitting an agency head to exempt a rule from the 
requirements of sections 603 and 604 by certifying that a rule will 
not have a SEISNOSE and requiring the agency to publish the 
certification in the Federal Register ``along with a statement 
providing the factual basis for such certification''); id. 608 
(requiring findings supporting a waiver or delay of completion of 
the requirements of sections 603 and 604 to be published in the 
Federal Register); id. 609(a) (with respect to rules that will have 
a SEISNOSE, requiring agency heads to ``assure that small entities 
have been given an opportunity to participate in the rulemaking for 
the rule through the reasonable use of techniques such as'' 
publication in certain sources and direct notification of interested 
small entities).
---------------------------------------------------------------------------

    Fourth, the automatic expiration of any rule issued by the 
Department simply because it was not timely assessed or, as applicable, 
reviewed, appears to be contrary to Congressional intent. Section 610 
neither provides for automatic expiration of rules with a SEISNOSE nor 
presumptively applies automatic expiration dates to regulations. 
Rather, section 610 contemplates informed rescission or revision of 
rules only if they have or will have a SEISNOSE and if the Department 
has determined, based on a multi-factor review, that such rules should 
be rescinded or revised to minimize any SEISNOSE. Additionally, we note 
that section 611(a) provides a remedy for agency noncompliance with the 
requirements of section 610: Judicial review of such noncompliance and 
relief deemed appropriate by the reviewing court.
    Fifth, the framework for regulations to automatically expire 
without any consideration of the statutory objectives the rule 
implements appears to be inconsistent with the RFA's intent to

[[Page 59918]]

balance the objectives of the RFA with the objectives of statutes 
critical to public health. The RFA's legislative history explicitly 
states that Congress did not intend for the RFA's requirements to 
``undermine . . . important [regulatory] achievements,'' specifically 
those in the area of public health. 126 Cong. Rec. 21,448, 21,451 
(August 6, 1980). The legislative history further states that Congress 
intended ``agencies to continue to enforce [substantive] laws in a 
fully effective fashion,'' id. at 21,451, and that ``environmental, 
health or safety catastrophes must never be made more likely because of 
flexible regulations.'' Id. at 21,455. Indeed, Congress expressed this 
intent in section 610 itself by providing that rescission of 
regulations should only occur if ``consistent with the stated 
objectives of applicable statutes.'' 5 U.S.C. 610(a).\17\
---------------------------------------------------------------------------

    \17\ The automatic expiration of rules without notice and 
comment appears to also be inconsistent with Congressional intent 
that the RFA's requirements ``not alter procedural requirements 
contained in other statutes applicable to the agency'' (126 Cong. 
Rec. 21,456).
---------------------------------------------------------------------------

    As described above, commenters argued that the monumental task of 
assessments would require diverting agency expertise and resources away 
from the Department's significant public health activities and would 
likely impair the Department's ability to respond to public health 
emergencies and administer critical public health programs. Commenters 
further argued that such results would undermine important public 
health statutory objectives and increase the likelihood of negative 
consequences for the public health. The RFA's legislative history 
explicitly addresses such concerns that the RFA ``might require 
agencies to significantly compromise the objectives of underlying 
statutes authorizing rulemaking,'' 126 Cong. Rec. 21,455, and, as noted 
above, emphasized that ``[i]t is not the intent of regulatory 
flexibility legislation to undermine . . . important [regulatory] 
achievements,'' id. at 21,451. Commenters also stated that the burden 
imposed on the Department by the final rule would impair the 
Department's ability to prevent the automatic expiration of regulations 
that would be imposed by the final rule, and, as discussed above, the 
actual expiration of regulations without any analysis would also 
undermine the objectives of those regulations' authorizing statutes 
contrary to Congressional intent.
    HHS notes that the economic and workforce burdens impairing the 
Department's ability to achieve important statutory objectives related 
to its mission would also be inconsistent with the RFA's intent to 
enhance administrative efficiency in the achievement of such 
objectives. The RFA's legislative history emphasizes that ``regulatory 
flexibility should be considered a means of improving administrative 
effectiveness in enforcing the regulatory statutes which the Congress 
has enacted rather than an additional bureaucratic burden.'' 126 Cong. 
Rec. 21,456. One commenter noted that requiring the Department to 
conduct analyses of thousands of rules within a compressed time period, 
in addition to the already complex existing tasks of the Department, is 
not efficient. Although the final rule asserts that it ``will 
contribute to `the efficient administration of' the Department's 
functions . . . 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,'' 86 FR at 5719, HHS now believes that the final rule 
could introduce greater inefficiencies if rules expire without any 
assessment or review of the need for the regulation or the impact of 
the regulation on small entities.
    In summary, this rule is not mandated by the RFA and may not be 
consistent with Congressional intent. As a matter of policy, we are 
therefore reconsidering the benefits of an additional rule that exceeds 
the requirements of the RFA.
2. Potential Harm to Small Entities Inconsistent With the RFA
    Commenters argued that the final rule will impose undue and 
disproportionate burdens on small entities that undermine the RFA's 
purpose of alleviating the regulatory burden on such entities. The RFA 
seeks to address the ``unnecessary and disproportionately burdensome 
demands . . . [of uniform regulatory requirements] upon small 
[entities] . . . with limited resources.'' 126 Cong. Rec. 21,449. After 
reconsidering the burden of the SUNSET final rule, the legislative 
history for the RFA, and the comments, it is now our view that 
implementation of the SUNSET final rule could harm small entities, 
contrary to Congressional intent in enacting the RFA. Below, we 
summarize the comments that discuss these issues in detail.
    Commenters expressed concerns that the sudden expiration of 
regulations and the threat of sudden expiration of regulations would 
disproportionately burden small entities by creating regulatory 
uncertainty and a confusing regulatory landscape that would be 
difficult for these entities to navigate. Commenters also noted that 
the sudden expiration of rules could result in reputational harm with 
customers whose confidence relies on compliance with regulatory 
standards, and other outcomes that would be particularly damaging to 
small entities. For example, as discussed above, the expiration of 
certain regulations could create instances where regulations expire but 
statutory requirements continue to be applicable, leaving it unclear to 
small businesses how the Department intends to implement the statutory 
requirements. As another example, if, as suggested in the preamble to 
the final rule (86 FR 5712), guidance documents based on expired 
regulations would cease to have effect, the expiration of regulations 
could leave stakeholders without needed information in relevant 
guidance, including Small Entity Compliance Guides (SECG).
    Although several commenters representing small business industry 
associations expressed support for the final rule based on the 
assumption that the assessments and reviews would lead to deregulatory 
actions that could benefit small businesses, the vast majority of 
commenters disagreed with that assumption and opposed the rule. These 
commenters expressed the concern that small entities who rely on 
regulations to level the playing field would suddenly lose the clarity 
provided by such regulations and associated guidance for industry, 
which would create confusion, costs, and vulnerability for small 
entities. Commenters noted that most small businesses would generally 
lack resources to monitor, understand, anticipate, and adapt to changes 
in the regulatory landscape caused by the automatic expiration 
framework. Congress's findings in the RFA's legislative history 
substantiate this concern, as Congress explicitly found that small 
entities often have limited access to regulatory expertise and capital 
as compared to larger businesses. See 126 Cong. Rec. 21,453.
    Moreover, commenters also expressed concerns that the final rule's 
requirements and timelines would undermine small entities' ability to 
participate in assessments and reviews, which HHS notes is inconsistent 
with the RFA's intent to ``give small businesses a greater opportunity 
to participate in shaping rules which would affect them.'' 126 Cong. 
Rec. 21,451. Commenters explained that the frenetic pace and scope of 
simultaneous assessment of rules would impair small entities' ability 
to effectively engage in the final rule's assessment and review process 
and for HHS to identify and

[[Page 59919]]

meaningfully address data and information related to impacts on these 
entities.
    Although the final rule suggests that regulatory uncertainty 
created by the final rule would be offset by increases in trust in the 
Department's RFA compliance, and greater transparency about when 
regulations were adopted, HHS has reason to doubt that assertion. 
First, this assertion may not have taken into account the high burden 
on the public, including small businesses, to calculate and track the 
expiration of regulations, or to participate in the assessment and 
review processes. Second, HHS no longer finds it appropriate to rely on 
conclusions regarding ``sunset reviews'' in other jurisdictions, 
including foreign governments and U.S. State legislatures, given the 
final rule's acknowledgement that ``[t]hese jurisdictions' sunset 
provisions do not all work identically to this final rule.'' 86 FR 
5747. Commenters pointed out that the experience of foreign governments 
with sunset provisions would not be applicable to HHS, because these 
governments are not bound by the requirements of the APA. Other 
entities also may not have the same resource constraints as HHS, for 
example, with respect to earmarked funds. Finally, as explained at 
length throughout this preamble, HHS is no longer confident that, by 
giving industry five years until any regulations expire, the SUNSET 
final rule would mitigate the negative effects of expiration. We 
welcome comments regarding the experience of state and foreign 
governments with these laws.
    Overall, the Department's current assessment that implementation of 
the SUNSET final rule has the potential to harm small entities, 
contrary to Congressional intent in enacting the RFA, suggests that 
there are no clear beneficiaries of this rule. These conclusions call 
into question the fundamental basis and justification for the SUNSET 
rule.
3. The Final Rule Is Unnecessary
    Consistent with our assessment, discussed above, that the SUNSET 
final rule's impact exceeds the requirements of the RFA and could 
impose additional burdens on small entities, HHS now seriously 
questions the conclusion in the SUNSET final rule that simultaneous 
Department-wide assessments of thousands of regulations is an efficient 
way to achieve the RFA's objectives. Instead, HHS now believes more 
targeted alternatives suggested by commenters merit further 
consideration.
    As commenters noted, there are more efficient and effective ways to 
identify rules that have or will have a SEISNOSE and require review. 
For example, the Department may request information or use other 
processes to seek input from small entities and the public to identify 
such rules in a more targeted way, and the public may use already-
existing petition processes to ask HHS to issue, amend, or repeal a 
rule. Conducting the assessments required by the rule could amount to 
searching for a needle in a haystack, and would not provide an 
effective means for stakeholders to provide input or for HHS to 
consider and evaluate such input and other relevant information. As 
commenters who expressed support for retrospective review also noted, 
the quality of reviews is more important than quantity, and the final 
rule's framework would strain the Department without improving the 
quality of reviews.
    Alternatives that employ a more targeted approach to identifying 
rules for review under section 610 of the RFA, which are less 
burdensome on the Department and stakeholders and incorporate 
meaningful participation by stakeholders, are consistent with guidance 
issued by the SBA's Office of Advocacy. That guidance explicitly 
recognizes that ``[b]ecause of the breadth and volume of federal 
regulations, a review of all existing rules on a particular industry 
group can be an onerous task for a federal agency.'' \18\ Additionally, 
the guidance states that ``[i]nsights about an existing regulation 
received from regulated entities and other interested parties should be 
a key component of a retrospective rule review,'' and that ``[b]y 
making the review process transparent and accessible, agencies are more 
likely to identify improvements that will benefit all parties at the 
conclusion of the review.'' \19\
---------------------------------------------------------------------------

    \18\ Office of Advocacy, U.S. Small Business Administration A 
Guide for Government Agencies: How to Comply with the Regulatory 
Flexibility Act. (Aug. 2017), p. 40.
    \19\ Id. at 83.
---------------------------------------------------------------------------

    A commenter noted that such alternatives are also consistent with 
the recommendations for best practices for retrospective review 
published by the Administrative Conference of the United States (ACUS), 
which is cited in the final rule,\20\ whereas the automatic expiration 
framework is not. HHS now agrees that the targeted alternatives 
proposed by commenters are generally consistent with ACUS's 
recommendations, including the recommendation to prioritize 
retrospective reviews ``[i]n light of resource constraints and 
competing priorities.'' \21\ Although the final rule asserts that 
certain of its provisions are consistent with ACUS recommendations, 
see, e.g., 86 FR 5726, the commenter further asserted that the 
automatic expiration framework is inconsistent with those 
recommendations, which do not endorse or reference sunset periods \22\ 
and do recommend that retrospective review processes require 
consideration of and be tailored to the specific rule being 
reviewed.\23\ ACUS issued new recommendations for periodic 
retrospective review in June 2021.\24\ In the preamble to the 
recommendations, ACUS discusses the tradeoffs of periodic retrospective 
review, including the costs and time associated with collecting and 
analyzing data and the uncertainty created by the review process, and 
advises agencies to ``tailor their periodic retrospective review plans 
carefully to account for these drawbacks.'' \25\ The consultant 
research report to ACUS on this topic specifically addresses the SUNSET 
final rule and notes:
---------------------------------------------------------------------------

    \20\ See Admin. Conf. of the U.S., Recommendation 2014-5, 
Retrospective Review of Agency
    Rules (2014) (available at https://www.acus.gov/sites/default/files/documents/Recommendation%25202014-5%2520%2528Retrospective%2520Review%2529_1.pdf).
    \21\ Id.
    \22\ See generally id. The commenter noted that the concept of 
sunset periods is mentioned only in passing in a report prepared in 
connection with the recommendations. See Joseph E. Aldy, Learning 
from Experience: An Assessment of the Retrospective Reviews of 
Agency Rules and the Evidence for Improving the Design and 
Implementation of Regulatory Policy 62, 65 (2014), (available at 
https://www.acus.gov/sites/default/files/documents/Aldy%2520Retro%2520Review%2520Draft%252011-17-2014.pdf).
    \23\ See ACUS Recommendations, supra n. 18, at 7.
    \24\ See Admin. Conf of the U.S., Recommendation 2021-2, 
Periodic Retrospective Review (2021), available at https://www.acus.gov/sites/default/files/documents/Redline%20-%20Periodic%20Retrospective%20Review%20-%20Final.pdf.
    \25\ Id. at 3.

    While recognizing the objective to promote retrospective reviews 
that may be needed, a strict sunset date is an especially strong, 
perhaps overly strong, incentive for periodic review. It raises 
questions under US administrative law regarding whether and how an 
agency can set an expiration date for thousands of its rules through 
a single new rule, without going through notice and comment 
rulemaking to rescind each rule or cluster of rules separately. 
Sunsetting rules may pose high social instability costs, as 
discussed above, if numerous rules on which stakeholders rely 
suddenly expire, potentially outweighing the benefits of the agency 
undertaking periodic reviews of some of these rules. Moreover, there 
does not seem to be a strong analytic basis presented for the

[[Page 59920]]

periodicity (5 or 10 years) required in the HHS sunset review 
rule.\26\
---------------------------------------------------------------------------

    \26\ Lori S. Bennear and Jonathan B. Wiener, Periodic Review of 
Agency Regulation (June 7, 2021) at 37-38 (report to the Admin. 
Conf. of the U.S.), available at https://www.acus.gov/report/periodic-retrospective-review-report-final (footnotes omitted).

    HHS agrees that the more targeted alternatives suggested by 
commenters are likely to achieve the goals of retrospective review more 
efficiently. We are now reconsidering the SUNSET final rule's apparent 
position that a burdensome and widespread assessment is necessary to 
identify regulations that have or will have a SEISNOSE. For example, 
the final rule primarily emphasizes what it perceives as the general 
benefits of ``widespread review'' with little explanation of the 
specific benefits of widespread assessment. See, e.g., 86 FR 5698 
(concluding that ``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'').\27\ Additionally, the final rule concludes that 
``stakeholder input cannot be the only source of information to spur 
reviews'' because such input would not reflect the ``dispersed costs'' 
that ``consumers, small businesses, and the public'' experience, given 
that those groups ``often find it costly to organize and lobby on 
behalf of their own interests'' and ``[c]oncentrated interests'' that 
``find it relatively easier'' to do so would not take such costs into 
account. Id. at 5740. However, HHS now doubts this conclusion because, 
as explained above, HHS received numerous comments to the SUNSET 
proposed rule from a diverse array of consumers, small businesses, and 
the public asserting the undue burdens and costs that rule would 
impose.
---------------------------------------------------------------------------

    \27\ Commenters noted that any benefits derived from assessing 
thousands of regulations to determine their potential impact on 
small entities cannot reasonably be deemed to outweigh the benefit 
of more targeted alternatives that preserve HHS' ability to 
accomplish activities that protect and promote the public health.
---------------------------------------------------------------------------

    As stated earlier, while the Department can explore ways to improve 
its processes, HHS does have a meaningful track record of retrospective 
regulatory review. As required by section 610 of the RFA, the 
Department conducts periodic reviews of regulations with impacts on 
small entities and provides notification of these reviews in the annual 
Unified Agenda of Regulatory and Deregulatory Actions. Among HHS's 
other recent retrospective review efforts are the Department's 2011 
Plan for Retrospective Review of Existing Rules, an initiative 
developed in accordance with E.O. 13563 and E.O. 13610, Identifying and 
Reducing Regulatory Burdens. The Department used this plan from Fiscal 
Year 2012 through Fiscal Year 2016 as a framework for its retrospective 
review of existing significant regulations to identify those rules that 
can be potentially eliminated as obsolete, unnecessary, burdensome, or 
counterproductive or that can be modified to be more effective, 
efficient, flexible, and streamlined. A number of commenters also 
specifically referenced a 2015 CMS initiative to modernize Medicaid 
Managed Care regulations for Medicaid and CHIP beneficiaries. We also 
note that the CMS Office of Burden Reduction and Health Informatics 
works, among other things, to eliminate overly burdensome and 
unnecessary regulations. More recently, in response to E.O. 13771, 
Enforcing the Regulatory Reform Agenda, HHS established a Regulatory 
Reform Task Force that oversaw an effort to evaluate existing 
regulations and make recommendations to the Secretary regarding their 
repeal, replacement, or modification, consistent with applicable law. 
HHS published summary reports of these reviews for Fiscal Years 2018-
2020 on the HHS website (available at https://www.hhs.gov/about/budget/fy2021/performance/regulatory-reform/index.html). These efforts 
demonstrate the Department's ongoing commitment to retrospective 
review, which could be upended rather than strengthened by the SUNSET 
final rule.
    The SUNSET final rule asserts that the threat of regulations 
expiring is necessary because ``it is nearly impossible to see how a 
satisfying comprehensive review could occur without a sunset 
provision,'' 86 FR 5702, and concludes that the Department ``needs to 
impose a strong incentive on itself to perform retrospective review.'' 
Id. at 5697. HHS now believes that there are numerous regulatory 
efforts that take place within agencies that routinely involve the 
review of regulations. Agencies are often requested to provide 
technical assistance to Congress on proposed legislation which quite 
often requires, among other considerations, an assessment of the 
proposal's impact on current regulations. FDA also reviews regulations 
in the course of responding to certain citizen petitions submitted 
under 21 CFR 10.30, requesting changes in FDA regulations.
    It is also common for new HHS regulations to amend, revise or 
modify sections of regulations in order to update, replace, or rescind 
requirements, or to add new definitions or clarifications, which 
inherently entail review of these sections. For example, the 
regulations FDA issued to implement FSMA \28\ included both the 
addition of new sections of regulation and revisions and modifications 
to existing sections. Additionally, regulation provisions are reviewed 
to determine if guidance documents are needed to provide 
recommendations for complying with the regulation. This is particularly 
important when the regulation is necessarily general or broad to 
accommodate scientific and other innovation changes, and guidance is 
helpful to consider applicability of the regulatory provisions.
---------------------------------------------------------------------------

    \28\ See FSMA Rules & Guidance for Industry (available at 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#Rules (accessed May 11, 2021)).
---------------------------------------------------------------------------

    Upon reconsideration, as a matter of policy, HHS now seriously 
questions whether automatic expiration is an effective or necessary 
means to incentivize regulatory review. Commenters expressed concern 
that the automatic expiration of regulations would in fact create a 
strong incentive, under certain circumstances, to not conduct reviews 
and thus, allow the Department to effectively rescind such regulations 
without any justification, explanation, or the notice and comment 
procedures generally required for rescinding a rule. The Department is 
concerned that the SUNSET final rule could degrade confidence in our 
regulatory stewardship.
    Among the evidence cited to explain the need for the SUNSET final 
rule was an artificial intelligence review of all HHS regulations that 
identified that 85% of regulations before 1990 had not been edited. 86 
FR 5699.\29\ However, the final rule incorrectly inferred that just 
because no edit has been made to a regulation, it has never been 
reviewed. There are numerous regulatory efforts that take place within 
agencies that involve the review of regulations without resulting in a 
change to the regulation. As noted above, some commenters explained 
that many rules setting industry standards have remained untouched for 
years--not

[[Page 59921]]

through neglect, but because they work as intended. There have also 
been instances where an agency has included certain regulations on past 
Unified Agendas (UA) and yet never completed these proposals and thus 
these were eventually withdrawn from the UA. But this ultimate result 
does not mean that review did not occur. Often review of an existing 
regulation may result in an agency developing a draft of a new or 
amended regulation that, upon further deliberation or because of 
intervening events, the agency decides not to finalize.
---------------------------------------------------------------------------

    \29\ The final rule stated that the findings of this artificial 
intelligence review indicated that ``humans performing a 
comprehensive review of Department regulations would find large 
numbers of requirements that would benefit from review, and possibly 
amendment or rescission.'' 86 FR 5701-02. However, commenters 
expressed concern that the methodology of this search was never made 
public, and the final rule acknowledged that the ``Department did 
not previously notify the public about this research project'' as 
well as certain limitations on the capabilities of this tool. 86 FR 
5710.
---------------------------------------------------------------------------

    The SUNSET final rule also credited this artificial intelligence 
review with the identification of broken links in regulations and 
regulations that require multiple paper copies and provided these as 
examples that show the need to ``more firmly institutionalize 
retrospective review.'' 86 FR 5699. HHS notes that the broken links and 
other typographical errors identified through this process were 
successfully addressed as part of the HHS ``Regulatory Clean-Up 
Initiative,'' a final rule published on November 16, 2020 (85 FR 72899) 
that made miscellaneous corrections, including correcting references to 
other regulations, misspellings and other typographical errors in 
regulations issued by FDA, CMS, the Office of the Inspector General, 
and the ACF. In addition, FDA issued a final rule to amend regulations 
on medical device premarket submissions to remove requirements for 
paper and multiple copies and replace them with requirements for a 
single submission in electronic format.\30\ However, neither the 
assessment-and-review process required by the SUNSET rule, nor the 
threat of expiring regulations, were necessary to incentivize these 
actions. Rather, HHS now believes the Department's ability to 
efficiently undertake such regulatory housekeeping in the future could 
be undermined if staff were overwhelmed by the implementation of the 
SUNSET final rule.
---------------------------------------------------------------------------

    \30\ ``Medical Device Submissions: Amending Premarket 
Regulations That Require Multiple Copies and Specify that Paper 
Copies To Be Required in Electronic Format.'' Final Rule. 84 FR 
68334. Dec. 16, 2019.
---------------------------------------------------------------------------

D. APA Considerations

    Commenters questioned the legality of the SUNSET final rule under 
the APA, which may be an additional ground for reconsideration and 
repeal. Under the APA, agency action is unlawful and can be set aside 
by a court when it is ``arbitrary, capricious, an abuse of discretion, 
or otherwise not in accordance with law'' or ``without observance of 
procedure required by law.'' 5 U.S.C. 706(2)(A), (D). Commenter 
asserted that the SUNSET final rule may be vulnerable under these 
standards in light of its stated justification for the rule and the 
process it followed in promulgating the rule.
1. Consideration of the Relevant Factors
    The APA requires an agency, in issuing a final rule, to ``examine 
the relevant data and articulate a satisfactory explanation for its 
action including a `rational connection between the facts found and the 
choice made.' '' Motor Vehicle Mfrs. Ass'n v. State Farm, 463 U.S. 29, 
43 (1983) (quoting Burlington Truck Lines, Inc. v. United States, 371 
U.S. 156, 168 (1962)). That explanation must show that ``the decision 
was based on a consideration of the relevant factors.'' Id.
    After a regulation is promulgated, the same process applies for 
amending or rescinding that regulation. 5 U.S.C. 551(5) (``rule 
making'' encompasses the formulation, amendment, or repeal of a rule); 
Perez v. Mortg. Bankers Ass'n, 575 U.S. 92, 101 (2015) (``agencies use 
the same procedures when they amend or repeal a rule as they used to 
issue the rule in the first instance''). Thus, an agency must ``present 
an adequate basis and explanation'' for the amendment or repeal; if the 
agency has ``entirely failed to consider an important aspect of the 
problem,'' the rule is ``normally . . . arbitrary and capricious.'' 
State Farm, 463 U.S. at 41, 43. In particular, when an agency changes 
course, including by amending a regulation, ``a reasoned explanation is 
needed for disregarding facts and circumstances that underlay or were 
engendered by the prior policy.'' FCC v. Fox TV Stations, Inc., 556 
U.S. 502, 515-16 (2009).
    As discussed above, the SUNSET final rule establishes a 
retrospective review scheme and amends most of HHS's regulations ``to 
apply expiration dates unless certain conditions are satisfied''--i.e., 
the completion of retrospective review. 86 FR 5716. To support this 
approach, the Department provided the rationale that ``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.'' 86 FR 5723.
    Several commenters questioned the validity of HHS's approach. 
Commenters asserted that HHS cannot amend or revoke a legislative rule 
in a rulemaking that does not address the particulars of that 
legislative rule because it did not contain any particularized 
consideration of the regulations subject to expiration, such as the 
facts, circumstances, and policies originally motivating the 
promulgation of these regulations. In the preamble to the SUNSET final 
rule, the Department acknowledged the submission of a large number of 
comments stating that the rule would violate the APA on this ground. 86 
FR 5715. The Department rejected these arguments and asserted that the 
rulemaking was permissible by comparing the global amendment to an 
amendment to a specific rule to add an expiration date, or to amending 
a definition of a term that is more widely applicable to a set of 
regulations. See 86 FR 5703-04. We now question the relevance of that 
comparison: Because of the differences in scope, scale, and effect, it 
is far more likely that HHS could consider the relevant factors and 
produce the record needed to support the rulemaking for these more 
targeted amendments, in contrast to the global amendment proposed in 
the SUNSET final rule. The Department also addressed these comments by 
asserting that it had ``considered the relevant factors'' and 
``considered each individual Department regulation'' in connection with 
deciding whether to exempt the regulation from the scope of the SUNSET 
final rule. 86 FR 5703, 5718. However, these statements were 
conclusory; the final rule did not contain particularized consideration 
of the rules that were amended. Because of this absence, the Department 
arguably did not adequately consider the factors relevant to the 
amendments as required under the APA.
    These questions are particularly pronounced in the circumstance 
that the SUNSET final rule leads to the automatic repeal of a 
regulation. As reflected elsewhere in this preamble, the Department 
believes that at least some amended regulations are likely to expire. 
In the event of such expiration, the Department would be changing 
course on a policy embodied in a regulation. As noted above, such a 
change needs to be supported by a reasoned explanation.
    In addition, the Department is concerned that the exemptions in the 
SUNSET final rule may not have been adequately justified. The 
Department exempted certain FDA regulations, for example, on the basis 
that they create product identities and are being reviewed under other 
processes. 86 FR 5731. It is not clear that the stated reasoning 
supports the exemption decisions or their scope. For example, it is not 
clear why other FDA regulations that are similar, such as those 
codifying the standards for human blood and blood products, were 
excluded.

[[Page 59922]]

2. Length of the Comment Period
    When HHS promulgated the SUNSET final rule, as discussed above, it 
provided a 30-day comment period for most comments. Many commenters 
asserted that the amount of time was inadequate under the APA, in light 
of the scale and complexity of the SUNSET proposed rule and in the 
absence of any public health or welfare emergency basis for the 
expedited timeline. The SUNSET final rule acknowledged the many 
comments received objecting to the length of the comment period, but 
concluded that the comment period was sufficient based primarily on the 
numerous comments received from a diverse array of stakeholders. 86 FR 
5705-06.
    The APA does not specify a duration for comment periods in the 
context of notice-and-comment rulemaking, but agencies must provide 
``adequate time for comments.'' Fla. Power & Light Co. v. United 
States, 846 F.2d 765, 771 (D.C. Cir. 1988). The timing considerations 
will vary depending on the nature of the proposal and its impact on the 
public. Generally, the comment period for issuing new Department 
regulations is at least sixty days and can be longer depending on the 
issue and complexity. The SUNSET final rule was determined by OIRA to 
be an economically significant regulatory action. 86 FR 5737. 
Furthermore, the SUNSET final rule was vast in scope and impact, 
affecting thousands of regulations. In light of that, the Department 
believes commenters raised credible concerns that they could not 
adequately consider the rule in the time that was allotted for comments 
for the SUNSET proposed rule, and, as a result, the procedure may be 
vulnerable under the APA.\31\
---------------------------------------------------------------------------

    \31\ Because the instant notice proposes to continue the status 
quo by withdrawing a rule that has not yet taken effect, and because 
commenters have already had the opportunity to submit comments on 
the topic, the Department believes that 60 days for commenting at 
this stage of the rulemaking is sufficient.
---------------------------------------------------------------------------

E. Vague and Confusing Provisions

    The SUNSET final rule states that ``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.'' 
86 FR 5721. However, upon reconsideration, the Department has found 
many ambiguities that could impede the ability of the Department and 
the public to determine the scope and timing of the assessment and 
review process. This confusion may increase the burden on stakeholders 
trying to navigate the assessment and review process. Process 
ambiguities also increase the risk of the automatic expiration of HHS 
regulations due to inadvertent noncompliance or misapplication of the 
requirements.
    The final rule was revised to use the term ``Section'' rather than 
``Regulation'' to refer to a section of the CFR. The preamble explained 
that this revision would enhance process clarity because ``it is clear 
when a section of the CFR was first promulgated.'' Id. However, in 
making this revision, the Department failed to consider that the rule 
also requires that assessments and reviews be performed on all sections 
of the CFR that HHS issued as part of the same rulemaking (and any 
amendments or additions that may have been issued thereafter). As a 
result, for any rulemakings that include revisions or cross-references 
to previously promulgated sections of regulations alongside newly 
promulgated sections of regulations, the scope and timing of the 
assessment process prescribed in the SUNSET final rule could be 
ambiguous.
    For example, the FDA rulemaking ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
Food'' (Preventive Controls for Human Food) was published on September 
17, 2015 (80 FR 55907), and therefore would be expected by stakeholders 
to be less than ten years old. However, in addition to new sections 
first promulgated in 2015, the rule also included revisions to sections 
of the CFR that were first promulgated in 1975, 1979, 1986, 1995, 1997, 
2001, 2004, and 2008. Under the final rule, it is not clear how the 
Department would determine when to assess CFR parts and sections that 
are comprised of pieces initially promulgated at various times.
    Commenters also expressed concern about ambiguity in the 
categorical exceptions described in the proposed rule and included in 
the final rule.\32\ Numerous commenters noted the lack of examples 
provided, and stated the lack of clarity for the categorical exceptions 
would leave the public unable to know which regulations would be 
eligible for the exceptions. Accordingly, some commenters stated that 
stakeholders would face a burden to conduct their own legal analysis.
---------------------------------------------------------------------------

    \32\ Paragraph (g) in the regulatory text for each rule excluded 
(1) 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; (2) 
Regulations whose expiration pursuant to this section would violate 
any other Federal law; (3) The SUNSET final rule; (4) Regulations 
that involve a military or foreign affairs function of the United 
States; (5) Regulations addressed solely to internal agency 
management or personnel matters; (6) Regulations related solely to 
Federal Government procurement; and (7) 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. 86 FR 5729.
---------------------------------------------------------------------------

    Upon reexamination, the final rule may have failed to provide 
additional meaningful examples of these exceptions and only offered 
unspecific direction that categorical exceptions would be ``rare'' or 
only applicable to ``a very small category.'' See 86 FR 5731. The 
Department now recognizes the possibility that this lack of clarity 
could delay the completion of the assessment process and place further 
strain on the resources and effort needed to avoid the expiration of 
regulations.
    In addition, many commenters stated that it was improper for the 
final rule to exclude the SUNSET rule itself from the requirements of 
paragraph (c) of each of the codified provisions, meaning that under 
the rule, the rule itself is not subject to assessment, review, or 
expiration. The final rule based this exemption on an assumption that 
the SUNSET rule would not ``directly impose on the public costs that 
exceed benefits'' because no rules would expire due to lack of 
assessment or review. 86 FR 5730. The Department now believes, as 
described above, that this assumption was likely incorrect.

VI. Preliminary Regulatory Impact Analysis

A. Introduction, Summary, and Background

Introduction
    We have examined the impacts of the proposed withdrawal or repeal 
rule under E.O. 12866, E.O. 13563, the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. 
L. 104-4). EOs 12866 and 13563 direct us to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). We believe 
that this proposed withdrawal or repeal rule is a significant 
regulatory action as defined by E.O. 12866.
    The RFA requires us to analyze regulatory options that would 
minimize any significant impact of a rule on small entities. Because 
the proposed withdrawal or repeal rule would result in cost savings to 
regulated entities, we propose to certify that the proposed withdrawal 
or repeal rule will not have a significant economic impact on a 
substantial number of small entities.

[[Page 59923]]

    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any 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 $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $158 million, using the most current (2020) Implicit 
Price Deflator for the Gross Domestic Product. This proposed withdrawal 
rule would result in an expenditure in at least one year that meets or 
exceeds this amount.
Summary of Costs and Benefits
    The proposed withdrawal or repeal rule would withdraw or repeal the 
SUNSET final rule. This proposed regulatory action would reduce the 
time spent by the Department performing retrospective assessments and 
reviews of its regulations, and time spent by the general public on 
comments related to these assessments and reviews. We would monetize 
the likely reductions in time spent by the Department and the general 
public as cost savings. Our primary estimate of these cost savings in 
2020 dollars, annualized over 10 years, using a 3% discount rate, 
totals $69.9 million. Using a 7% discount rate, we estimate $75.5 
million in annualized cost savings. Table 1 reports these primary 
estimates alongside a range of estimates that capture uncertainty in 
the amount of time it will take the Department to perform each 
assessment and review, and uncertainty in the amount of time the public 
will spend on comments.
    In addition to these monetized effects, the proposed withdrawal or 
repeal rule would also reduce regulatory uncertainty and regulatory 
confusion anticipated under the SUNSET final rule. It would also reduce 
the time spent by the Department on other activities that we have not 
monetized or quantified, such as the time developing SECGs, and would 
reduce the time spent by the public monitoring regulations undergoing 
assessment or review and set to expire. The proposed withdrawal rule or 
repeal would also result in forgone information as a result of not 
performing the assessments and reviews.

                               Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Withdrawal Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                   Units
                                                                                   ------------------------------------
                   Category                       Primary       Low        High                  Discount                             Notes
                                                 estimate    estimate    estimate      Year        rate       Period
                                                                                      dollars    (percent)    covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.......  ..........  ..........  ..........  ..........           7
                                                                                                         3
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7
                                                                                                         3
                                               ---------------------------------------------------------------------------------------------------------
    Qualitative...............................  --Reduction in regulatory
                                                uncertainty and confusion.
                                                --Disbenefits from the information
                                                foregone from not performing
                                                assessments and reviews.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized................................      -$75.5      -$40.1     -$110.9        2020           7   2022-2031  Cost savings from not performing
    Monetized $millions/year..................       -69.9       -37.2      -102.7        2020           3   2022-2031   assessments and reviews, and
                                                                                                                         time spent by the public on
                                                                                                                         comments.
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7
                                                                                                         3
    Qualitative...............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/     ..........  ..........  ..........  ..........           7
     year.                                                                                               3
                                               ---------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:
                                               ---------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/year.  ..........  ..........  ..........  ..........           7
                                                                                                         3
                                               ---------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:
    Small Business:
    Wages:
    Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We request comment on our estimates of costs and benefits of this 
proposed withdrawal or repeal rule.
Background
    On January 19, 2021, HHS issued the ``Securing Updated and 
Necessary Statutory Evaluations Timely'' final rule. Under the SUNSET 
final rule, all HHS regulations less than ten years old, with certain 
exceptions, will cease to be effective ten years after issuance, unless 
HHS performs an assessment of the regulation and a more detailed review 
of those regulations that have a significant economic impact upon a 
substantial number of small entities. The final rule also provides for 
regulations older than ten years to cease to be effective unless 
assessed and reviewed within an initial five-year period. HHS published 
a regulatory impact analysis (SUNSET

[[Page 59924]]

RIA) alongside the final rule, providing estimates of the likely impact 
of the policy on Departmental resources and time spent by the general 
public related to these efforts. Following the initiation of 
litigation, HHS issued an administrative delay of effective date, 
effective as of March 19, 2021, which extended the effective date of 
the final rule by one year to March 22, 2022. For the purposes of this 
analysis, we refer to the January 19, 2021, final rule and March 19, 
2021, administrative delay collectively as the SUNSET final rule.

B. Market Failure or Social Purpose Requiring Federal Regulatory Action

    The SUNSET final rule establishes automatic expiration dates for 
the Department's regulations, and a recurring assessment and review 
process that it can follow to avoid such expirations. The SUNSET final 
rule's RIA likely underestimates both the time commitment of a credible 
assessment and review process, and the time spent by the general public 
commenting on regulations undergoing assessment and review. Given the 
volume of regulations affected, our revised expectations of the time 
commitment necessary to conduct credible assessments and reviews, the 
timeframes for completing these retrospective analyses, and subsequent 
regulatory actions anticipated as a result of these analyses, it is 
likely that regulations will automatically expire without substantive 
review. The potential for regulations to automatically expire 
introduces regulatory uncertainty, with potential negative 
repercussions for stakeholders. The actuality of having regulations 
expire automatically could lead to regulatory confusion among 
stakeholders and harm the public health in numerous ways, as described 
in the preamble to the proposed withdrawal rule. This proposed 
withdrawal or repeal rule is therefore needed to improve the 
functioning of Government and to reduce the costs to the Department and 
the general public associated with the SUNSET final rule.

C. Purpose of the Proposed Withdrawal or Repeal Rule

    The purpose of the proposed withdrawal or repeal rule is to revoke 
the SUNSET final rule. If finalized, this regulatory action would 
directly address the potential harm from the automatic expiration of 
the Department's regulations. The proposed withdrawal or repeal rule 
would generate cost savings to the Department from reductions in staff 
time spent on assessments and reviews, and on related activities. It 
would also generate cost savings to the general public by reducing time 
spent on public comments related to these assessments and reviews, and 
on other activities, such as monitoring potentially expiring 
regulations. The proposed withdrawal rule would also reduce any 
regulatory uncertainty from the potential automatic expiration of 
rules.

D. Baseline Conditions

    We adopt a baseline that assumes the requirements of the January 
19, 2021, SUNSET final rule \33\ remain in place over the period of our 
analysis, accounting for a one-year administrative delay of effective 
date.\34\ The SUNSET RIA contains monetized estimates of the costs to 
the Department to perform retrospective analyses of existing 
regulations and the costs to the public to monitor and respond to 
anticipated regulatory actions taken by the Department following these 
retrospective analyses. For the purpose of estimating the time spent on 
retrospective analyses under the baseline of this analysis, we maintain 
the assumption in the SUNSET RIA that the Department will satisfy the 
requirements of the SUNSET final rule and no regulations will 
automatically expire.\35\ We also maintain various assumptions in the 
SUNSET RIA relating to the timing of the effects and treatment of the 
one-year waiver provision that allows the Secretary to make one-time, 
case-by-case exceptions to the automatic expiration of a rule. We also 
maintain the SUNSET RIA's choice of a 10-year time horizon for the 
analysis and adopt a base year of 2022 for discounting purposes. In 
this section, we reconsider several other assumptions underlying the 
cost estimates in the SUNSET RIA, and discuss additional cost drivers 
not identified and monetized in the analysis. These revised estimates 
inform our baseline scenario of no further regulatory action.
---------------------------------------------------------------------------

    \33\ 86 FR 5694.
    \34\ 86 FR 15404.
    \35\ This approach allows for a more direct comparison with the 
estimates contained in the SUNSET RIA and follows a common practice 
in regulatory impact analysis to assess costs assuming full 
compliance with the regulation. We supplement the full-compliance 
estimates by identifying the likely impacts associated with less 
than full compliance. The HHS Guidelines for Regulatory Impact 
Analysis (available at https://aspe.hhs.gov/system/files/pdf/242926/HHS_RIAGuidance.pdf.), Chapter 4 ``Assess Costs,'' contains a more 
complete discussion of this approach.
---------------------------------------------------------------------------

Regulations Subject to the SUNSET Final Rule
    We adopt the SUNSET RIA's estimate of 17,200 regulations 
potentially subject to the SUNSET final rule that would need to be 
assessed in the first ten years. For each of these regulations, the 
Department will need to perform an assessment to determine whether the 
regulation imposes a significant economic impact on a substantial 
number of small entities. The SUNSET RIA estimates that roughly five 
regulations on average are part of the same rulemaking and could be 
assessed at one time. We maintain this assumption and terminology, 
which results in a total of 3,600 assessments in the first ten years. 
The SUNSET RIA assumes that 11% of these assessments, or 396, impose a 
significant economic impact on a substantial number of small entities, 
but reduces this figure to 370 to account for rulemakings that are 
likely to be reviewed for reasons other than the SUNSET final rule. 
This adjustment similarly reduces the estimate of the number of 
rulemakings impacted by the SUNSET final rule to 3,574.
    For each of these 370 rulemakings, the Department will need to 
perform a review, which includes a retrospective regulatory flexibility 
analysis. The SUNSET RIA distinguishes between the 44 rulemakings that 
predate the Regulatory Flexibility Act and are unlikely to have an 
existing prospective regulatory flexibility analysis, and the remaining 
326 rulemakings that are assumed to have an existing prospective 
analysis. The SUNSET RIA also estimates there will be 160 rulemakings 
assessed to have a significant impact on a substantial number of small 
entities that have not previously been identified as having a 
significant economic impact. An Agency will need to perform a review of 
these rulemakings under the SUNSET final rule.
    The SUNSET final rule provides for an initial five-year period for 
the Department to address regulations older than ten years. We maintain 
the assumption in the SUNSET RIA that assessments and reviews required 
in the first five years will be completed evenly across this time 
period, and that the remaining assessments and reviews will be 
completed evenly across the next five-year time period. Table D1 
presents the yearly count of assessments and reviews anticipated under 
the baseline scenario. These figures are broadly consistent with the 
figures contained in the SUNSET RIA; however, unlike that analysis, we 
do not reduce the number of assessments under the SUNSET final rule by 
the number of reviews

[[Page 59925]]

performed, since these assessments occur first and serve to identify 
regulations requiring review.

                        Table D1--Baseline Assessments and Reviews Under the SUNSET Rule
----------------------------------------------------------------------------------------------------------------
                                                                      Reviews
              Year                     Total     ------------------------------------------------      Total
                                    assessments       Pre-RFA        Post-RFA      Not specified
----------------------------------------------------------------------------------------------------------------
2022............................           683.0             8.8            61.8            30.6           101.2
2023............................           683.0             8.8            61.8            30.6           101.2
2024............................           683.0             8.8            61.8            30.6           101.2
2025............................           683.0             8.8            61.8            30.6           101.2
2026............................           683.0             8.8            61.8            30.6           101.2
2027............................            31.8             0.0             3.4             1.4             4.8
2028............................            31.8             0.0             3.4             1.4             4.8
2029............................            31.8             0.0             3.4             1.4             4.8
2030............................            31.8             0.0             3.4             1.4             4.8
2031............................            31.8             0.0             3.4             1.4             4.8
                                 -------------------------------------------------------------------------------
    Total.......................         3,574.0            44.0           326.0           160.0           530.0
----------------------------------------------------------------------------------------------------------------

Time Per Assessment and Per Review
    The SUNSET RIA contains estimates of the time per assessment and 
time per review performed under the SUNSET final rule. For each 
assessment, the SUNSET RIA assumes that it will require between 3 and 
10 hours to assess a rulemaking. For each review, the SUNSET RIA 
assumes that it will require between 250 and 500 hours to review 
rulemakings that predate the RFA, and between 40 and 100 hours to 
review rulemakings that postdate the RFA.
    The Department now believes the SUNSET RIA likely underestimates 
the time necessary to credibly assess whether a regulation imposes a 
significant economic impact on a substantial number of small entities. 
The SBA Office of Advocacy published ``A Guide for Government Agencies: 
How to Comply with The Regulatory Flexibility Act,'' detailing a step-
by-step approach for analysts.\36\ For each of the 3,574 rulemakings 
requiring an assessment under the SUNSET final rule, an Agency will 
need to define the problem and describe the regulated entities, 
estimate economic impacts by size categories, and determine which size 
categories incur significant impacts. The SBA guide presents a two-page 
checklist containing the elements of an adequate certification. In 
practice, when performing a threshold analysis, analysts will face 
novel conceptual issues and data challenges, both of which require 
thoughtful consideration and professional judgement. Furthermore, SBA 
indicates that it is not sufficient to rely on an assessment made at 
the time a regulation was published:
---------------------------------------------------------------------------

    \36\ Available at https://cdn.advocacy.sba.gov/wp-content/uploads/2019/06/21110349/How-to-Comply-with-the-RFA.pdf.

    In some cases, even if an agency was originally able to certify 
properly under section 605 of the RFA that a rule would not have a 
significant economic impact on a substantial number of small 
entities, changed conditions may mean that the rule now does have a 
significant impact and therefore should be reviewed under section 
610. For example, many more small businesses may be subject to the 
rule now than when the rule was promulgated. The cost of compliance 
with a current rule may have increased sharply because of a required 
---------------------------------------------------------------------------
new technology. (SBA, pp. 80-81)

    We assume that, under the baseline scenario of the SUNSET final 
rule, the Department will follow the recommendations in the SBA 
guidance, and will perform a credible threshold analysis for each 
rulemaking to assess whether it imposes a significant economic impact 
on a substantial number of small entities. Each assessment will likely 
require time by an economist or other analyst to perform and document 
the threshold analysis, with input from at least one subject matter 
expert on the area of the regulation. Recognizing the need to fully 
respond to all the requirements, we modify the assumption in the SUNSET 
RIA and adopt an estimate of 40 to 100 hours to complete a credible 
threshold analysis for each rulemaking requiring an assessment.
    As described earlier, the SUNSET RIA contains two estimates for the 
time necessary to perform a retrospective analysis. For rulemakings 
published before the RFA was enacted, the SUNSET RIA assumes between 
250 and 500 hours per review. For rulemakings published after the RFA 
was enacted, the SUNSET RIA assumes that a prospective regulatory 
flexibility analysis is available and further assumes that this will 
reduce the time necessary to complete a review, adopting a range of 40 
and 100 hours per review. For the 160 rulemakings newly found to have a 
significant impact, the SUNSET RIA assumes that it will take between 40 
and 100 hours to complete a review. The Sensitivity Analysis Section of 
the SUNSET RIA acknowledges that ``[o]ne 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.'' Upon further consideration, the Department believes that 
the commenter is likely correct.
    For the analysis of this proposed withdrawal rule, we adopt the 
SUNSET RIA estimate of 250 to 500 hours for all retrospective analyses, 
regardless of when the underlying rulemaking was published. If 
previously published prospective or retrospective regulatory 
flexibility analyses are generally available, analysts may be able to 
build off of these previous analytic efforts when developing a 
retrospective analysis under the SUNSET rule. All else equal, this 
would suggest the average time per retrospective may be closer to the 
lower-bound estimate of 250 hours. If these analyses are not generally 
available, this would suggest an average time per retrospective closer 
to the upper-bound estimate of 500 hours. We do not address the 
assumption in the SUNSET RIA that a prospective regulatory flexibility 
analysis is available for every rulemaking published after the RFA was 
enacted, because it does not impact the estimate of the overall time 
spent on reviews under the baseline scenario. Our approach also allows 
us to ignore the apparent internal inconsistency in the SUNSET RIA 
underlying the time

[[Page 59926]]

per review of the 160 rulemakings that are newly assessed to have a 
significant impact.
    The SUNSET RIA is not clear on what activities are included in its 
estimates of the time per review other than the time spent developing a 
retrospective analysis. We interpret the magnitudes of these estimates 
to exclude a consideration of time spent on activities other than 
drafting the retrospective analysis. For example, the agency may need 
to conduct a study or survey to gather data to inform its analyses. We 
therefore include an additional 250 hours to 500 hours per review to 
account for this omission. This estimate reflects time spent by the 
Department by subject matter experts, lawyers, and other reviewers 
informing the retrospective analysis and providing feedback on draft 
analyses. It also reflects time spent by economists and other analysts 
developing the retrospective analysis to respond to this feedback, and 
time spent reading and incorporating evidence from other sources, 
including public comments. Table D2 summarizes the assumptions in the 
SUNSET RIA and our revised assumptions for the proposed withdrawal rule 
of the time per assessment and time per review performed under the 
baseline scenario of the SUNSET final rule. Combining the time spent on 
retrospective analysis and on other related activities, we estimate 
that each review will take between 500 and 1,000 hours to complete.

                                    Table D2--Hours per Assessment and Review
----------------------------------------------------------------------------------------------------------------
                                                            Sunset RIA               Proposed withdrawal rule
              Baseline requirement               ---------------------------------------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
Assessment......................................               3              10              40             100
Review: Retrospective Analysis, pre-RFA                      250             500             250             500
 regulation.....................................
Review: Retrospective Analysis, post-RFA                      40             100             250             500
 regulation.....................................
Review: Retrospective Analysis, Not Specified...              40             100             250             500
Review: Other Activities........................               0               0             250             500
----------------------------------------------------------------------------------------------------------------

Time Spent by the Public To Monitor and Comment
    Under the SUNSET final rule, the Department would create a docket 
on www.Regulations.gov for each assessment or review that the 
Department is conducting. The public would then be able to submit 
comments to the dockets of each rulemaking being assessed or reviewed. 
The SUNSET RIA includes a discussion of the costs to the stakeholders 
to monitor and comment on regulations as they are undergoing assessment 
and review; however, the analysis assigns no costs to the Department 
associated with setting up these dockets or engaging with the comments. 
The analysis also does not monetize any other costs associated with 
operationalization of the SUNSET final rule, which also requires 
developing a schedule for activities associated with the SUNSET final 
rule, publishing monthly updates, and establishing a website dashboard 
to help the public monitor the Department's progress.
    When estimating the impact on the public, the SUNSET RIA first 
estimates that 53 rulemakings will be rescinded and another 159 
rulemakings amended as a result of the retrospective analyses initiated 
as a result of the SUNSET final rule, monetizing the time spent by the 
public responding to those 212 rulemakings. The SUNSET RIA assumes 
that, for each of the 53 rulemakings rescinded following a review 
completed under the SUNSET final rule, the public will submit 243 
comments; and for each of the 159 rulemakings amended, the public will 
submit 486 comments. This will result in an estimated 90,153 comments, 
for which the SUNSET RIA assumes that each commenter will spend between 
5 and 15 hours. Presumably, this estimate is inclusive of finding out 
that the rulemaking is likely to be rescinded or amended, reading and 
understanding the rulemaking, completing further research, 
communicating with other stakeholders, identifying concerns, and 
drafting and submitting comments. The Preamble to the SUNSET final rule 
anticipates that the Department will create on its website a dashboard 
that shows its progress on its Assessments and Reviews. Therefore, we 
assume that any reduction in the time spent by the public attributable 
to this dashboard is accounted for in these time estimates. For the 
purposes of this analysis, we adopt the SUNSET RIA's assumption about 
the time spent per comment.
    The SUNSET RIA's discussion of the timing assumptions suggests the 
public will wait until the retrospective is complete and an Agency has 
announced it intends to rescind or amend a rulemaking before 
commenting. Furthermore, for the remaining 3,388 rulemakings subject to 
the SUNSET final rule that will be available for public comment prior 
to an Agency assessment or review, the SUNSET RIA assumes the public 
will offer no comments. These assumptions appear at odds with the 
decision to invite public comment during both the assessment and review 
processes. Furthermore, as discussed by the SBA,\37\ ``[i]nsights about 
an existing regulation received from regulated entities and other 
interested parties should be a key component of a retrospective rule 
review. By making the review process transparent and accessible, 
agencies are more likely to identify improvements that will benefit all 
parties at the conclusion of the review.''
---------------------------------------------------------------------------

    \37\ Available at https://cdn.advocacy.sba.gov/wp-content/uploads/2019/06/21110349/How-to-Comply-with-the-RFA.pdf pg. 83.
---------------------------------------------------------------------------

    Upon further consideration, the Department finds it more likely 
that the public will comment on rulemakings undergoing assessment and 
review rather than wait until learning the specific rulemakings that 
will be rescinded or amended as a result of these assessment and 
reviews. We adopt the SUNSET RIA's estimate of 486 comments per 
rulemaking, but instead apply this to the 570 rulemakings that, 
following a threshold analysis in an assessment, an Agency will begin 
to review. We believe that the public will submit fewer comments for 
rulemakings undergoing an assessment, and adopt an assumption of 25 
comments per assessment. Table D3 summarizes a comparison of the 
assumptions in the SUNSET RIA and in the baseline analysis of this 
proposed withdrawal rule of the comments per assessment and review, and 
for the subsequent

[[Page 59927]]

regulatory actions to rescind or amend rulemakings.

                  Table D3--Baseline Comments per Action
------------------------------------------------------------------------
                                                            Proposed
       Baseline requirement             SUNSET RIA      withdrawal rule
------------------------------------------------------------------------
Assessment........................                  0                 25
Review............................                  0                486
Rescission........................                486                N/A
Amendment.........................                243                N/A
------------------------------------------------------------------------

Considerations Related to Rescissions and Amendments
    As described earlier, the SUNSET RIA envisions the Department 
identifying and rescinding 53 rulemakings and amending 159 rulemakings 
following completed reviews under the SUNSET final rule. Upon further 
reflection, the Department no longer believes it was appropriate to 
unambiguously attribute to the SUNSET rulemaking subsequent regulatory 
actions of this nature in the context of a regulatory impact analysis. 
Even if the challenging attribution questions could be resolved, we 
believe that the SUNSET RIA understates the impact of the SUNSET rule 
since it implicitly assumes that the Department would not have to spend 
any time to develop and publish subsequent regulatory actions to 
rescind or amend existing regulations. This unstated assumption is 
difficult to justify. Since these anticipated regulatory actions relate 
to regulations that have a significant economic impact on a substantial 
number of small entities, we expect that these actions will need to 
involve subject matter experts, legal review, policy coordination, 
Departmental clearance, and a communications strategy to bring 
transparency to the process. For certain regulatory actions, we 
anticipate the need for review by the Office of Management and Budget. 
We have not attempted to estimate the time associated with developing 
these regulatory actions.
Baseline Effect of the SUNSET Rule
    To quantify the likely effect of the SUNSET final rule on the 
Department, we multiply the number of assessments and number of reviews 
from Table D1 by the assumptions relating to the time per assessment 
and time per review described in Table D2. To quantify the likely 
effect of the SUNSET final rule on the public, we multiply the figures 
in Table D1 by the assumptions relating to the comments per assessment 
and comments per review described in Table D3. This gives us estimates 
for the number of comments, which we then multiply by the time 
estimates per comment, described above, to estimate the total time 
spent by the public. Table D4 presents yearly estimates of hours spent 
related to assessments performed under the SUNSET final rule to the 
Department and the public. Table D5 presents comparable figures related 
to reviews. Table D6 presents the total time anticipated under the 
SUNSET rule related to assessments and reviews.

                           Table D4--Hours Related to Assessments Under the SUNSET Rule
----------------------------------------------------------------------------------------------------------------
                                                            Department                        Public
              Year                  Assessments  ---------------------------------------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
2022............................             683          27,320          68,300          85,375         256,125
2023............................             683          27,320          68,300          85,375         256,125
2024............................             683          27,320          68,300          85,375         256,125
2025............................             683          27,320          68,300          85,375         256,125
2026............................             683          27,320          68,300          85,375         256,125
2027............................              32           1,272           3,180           3,975          11,925
2028............................              32           1,272           3,180           3,975          11,925
2029............................              32           1,272           3,180           3,975          11,925
2030............................              32           1,272           3,180           3,975          11,925
2031............................              32           1,272           3,180           3,975          11,925
----------------------------------------------------------------------------------------------------------------


                             Table D5--Hours Related to Reviews Under the SUNSET Rule
----------------------------------------------------------------------------------------------------------------
                                                            Department                        Public
              Year                    Reviews    ---------------------------------------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
2022............................             101          50,600         101,200         245,916         737,748
2023............................             101          50,600         101,200         245,916         737,748
2024............................             101          50,600         101,200         245,916         737,748
2025............................             101          50,600         101,200         245,916         737,748
2026............................             101          50,600         101,200         245,916         737,748
2027............................               5           2,400           4,800          11,664          34,992
2028............................               5           2,400           4,800          11,664          34,992
2029............................               5           2,400           4,800          11,664          34,992
2030............................               5           2,400           4,800          11,664          34,992
2031............................               5           2,400           4,800          11,664          34,992
----------------------------------------------------------------------------------------------------------------


[[Page 59928]]


                                 Table D6--Total Hours Related to the SUNSET Rule
----------------------------------------------------------------------------------------------------------------
                                                            Department                        Public
                      Year                       ---------------------------------------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
2022............................................          77,920         169,500         331,291         993,873
2023............................................          77,920         169,500         331,291         993,873
2024............................................          77,920         169,500         331,291         993,873
2025............................................          77,920         169,500         331,291         993,873
2026............................................           77920         169,500         331,291         993,873
2027............................................           3,672           7,980          15,639          46,917
2028............................................           3,672           7,980          15,639          46,917
2029............................................           3,672           7,980          15,639          46,917
2030............................................           3,672           7,980          15,639          46,917
2031............................................           3,672           7,980          15,639          46,917
----------------------------------------------------------------------------------------------------------------

    While these time estimates are significant, they are not inclusive 
of all costs expected under the SUNSET final rule. In addition to the 
quantified estimates above, we expect that the Department will 
experience other costs related to the requirements of the SUNSET rule 
under the baseline scenario. For example, the estimates above do not 
include time spent reviewing guidance documents related to rulemaking 
undergoing assessment and review. They also do not include the time 
associated with developing SECGs for the 160 rulemakings newly found to 
have a significant impact on a substantial number of small entities, or 
the time associated with updating existing guides for other 
rulemakings. The figures above also omit the monetary costs to purchase 
data and data subscriptions that we anticipate will serve as critical 
inputs for the assessments and reviews, and costs associated with 
conducting formal evaluations to understand the impact of the rules.
    As an additional consideration, we estimate that assessing and 
reviewing regulations will require the equivalent of 67 and 146 full-
time employees in each of the first five years of the analysis, 
adopting the SUNSET RIA's estimate of 1,160 hours of work per year per 
employee. Given current staffing and other Departmental needs and 
priorities, we anticipate the need to hire non-government experts to 
perform a share of the retrospective work. This approach will likely 
result in additional overhead costs that we have not quantified. We 
also anticipate the need to spend Departmental resources to find, hire, 
train, and transfer personnel with technical expertise to conduct the 
analyses, which have not been quantified in this analysis.

E. Benefits of the Proposed Withdrawal or Repeal Rule

    The monetized benefits of this regulatory action to withdraw or 
repeal the SUNSET final rule are the cost savings to the Department 
from not completing the assessments and reviews required under the 
baseline scenario, and the cost savings to the public from not 
commenting on these assessments and reviews. To monetize these cost 
savings, we multiply the hours related to the SUNSET final rule in 
Table D6 by the cost per hour of these activities. We adopt the SUNSET 
RIA's estimates of 244.98 per hour developing assessments and reviews 
and 143.20 per hour spent submitting comments. Table E1 presents the 
yearly cost savings to the Department and the public expected under the 
proposed withdrawal or repeal rule compared to the baseline scenario. 
We combine the low estimates for the Department and the public to 
generate an overall low estimate, and similarly combine the high 
estimates for the Department and the public to generate an overall high 
estimate. We also report an overall primary estimate, which is the 
midpoint between the low and high estimates. Finally, we report the 
present discounted value (PDV) and annualized cost savings under the 
proposed withdrawal or repeal rule for both a 3% and 7% discount rate. 
All figures are reported in 2020 dollars, in millions.

                                                Table E1--Cost Savings Under the Proposed Withdrawal Rule
                                                                     [Millions of $]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Department                        Public                                  Overall
                  Year                   ---------------------------------------------------------------------------------------------------------------
                                                Low             High            Low            High             Low           Central          High
--------------------------------------------------------------------------------------------------------------------------------------------------------
2022....................................           $19.1           $41.5           $47.4          $142.3           $66.5          $125.2          $183.8
2023....................................            19.1            41.5            47.4           142.3            66.5           125.2           183.8
2024....................................            19.1            41.5            47.4           142.3            66.5           125.2           183.8
2025....................................            19.1            41.5            47.4           142.3            66.5           125.2           183.8
2026....................................            19.1            41.5            47.4           142.3            66.5           125.2           183.8
2027....................................             0.9             2.0             2.2             6.7             3.1             5.9             8.7
2028....................................             0.9             2.0             2.2             6.7             3.1             5.9             8.7
2029....................................             0.9             2.0             2.2             6.7             3.1             5.9             8.7
2030....................................             0.9             2.0             2.2             6.7             3.1             5.9             8.7
2031....................................             0.9             2.0             2.2             6.7             3.1             5.9             8.7
PDV, 3%.................................            91.0           197.9           226.1           678.3           317.1           596.7           876.2
PDV, 7%.................................            80.9           176.0           201.1           603.2           282.0           530.6           779.2
Annualized, 3%..........................            10.7            23.2            26.5            79.5            37.2            69.9           102.7
Annualized, 7%..........................            11.5            25.1            28.6            85.9            40.1            75.5           110.9
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 59929]]

    For comparison, in present value terms, these estimates of 
annualized cost savings are more than four times the size of the 
annualized cost estimates included in the SUNSET RIA. This reflects 
what the Department has now concluded are more reasonable assumptions 
about the effect of the SUNSET final rule rather than a claim that the 
combination of these two regulatory actions would generate net cost 
savings. These cost savings estimates are consistent with a scenario 
that the Department returns to its approach to Section 610 reviews that 
immediately predate the publication of the SUNSET final rule on January 
19, 2021. We believe that this represents a credible and appropriate 
approach for estimating the likely cost savings that would be 
attributable to the proposed withdrawal or repeal rule, if it is 
finalized. Other considerations relating to the appropriate frequency 
or nature of retrospective economic analyses of existing Departmental 
regulations are beyond the scope of this preliminary regulatory impact 
analysis.
    In the previous section, we discussed concerns about potential 
costs of the SUNSET final rule that were overlooked in the SUNSET RIA. 
To the extent that we are unable to quantify or monetize these costs, 
such as the purchase of data, conducting studies to evaluate the 
impacts of rules, additional overhead costs associated with contracting 
with non-government entities to perform a share of the retrospective 
work, and other personnel costs, the cost savings anticipated under the 
proposed withdrawal or repeal rule would be equally underestimated.
    In addition to cost savings, the proposed withdrawal or repeal rule 
would generate non-quantified benefits from reduced regulatory 
uncertainty. Although we calculate the cost savings estimates in this 
analysis by adopting an assumption that the Department will fulfill the 
requirements of the SUNSET final rule rather than to let any regulation 
expire automatically, it is highly likely that some regulations will 
automatically expire without substantive review. Revoking the SUNSET 
final rule would remove the expiration provisions, which would also 
remove the likelihood of any automatic expiration of regulatory 
requirements. The proposed rule would also eliminate the potential for 
regulatory confusion among stakeholders, and harm to the public health 
related to the actuality of having regulations expire automatically.

F. Costs of the Proposed Withdrawal or Repeal Rule

    The costs of the proposed withdrawal or repeal rule would be the 
forgone benefits of the information learned from the assessments and 
reviews completed under the baseline scenario. We adopt the approach 
taken in the SUNSET RIA and make no attempt to quantify or monetize the 
value of this information. The SUNSET RIA also describes potential 
benefits from subsequent regulatory actions to rescind or amend 
existing regulations as a result of the SUNSET final rule; however, the 
Department now believes that any effects associated with future 
regulatory actions raise challenging questions of attribution (entirely 
to those regulatory actions themselves, or at least partially to the 
SUNSET final rule). We therefore do not unambiguously identify these as 
a source of foregone benefits under the proposed withdrawal rule.

G. Analysis of Regulatory Alternatives to the Proposed Withdrawal or 
Repeal Rule

    We analyze two alternative options to the proposed withdrawal rule. 
First, we consider an option to maintain the general approach of the 
SUNSET final rule, but adopt a two-year period following the effective 
date to assess and review all regulations older than ten years. This 
option, Alternative 1, follows the timeline envisioned under the 
November 4, 2020, proposed rule.\38\ Second, we consider an option to 
maintain the general approach of the SUNSET rule, but adopt an initial 
ten-year period following the effective date to assess and review all 
regulations, regardless of when they were first published. This option, 
Alternative 2, evenly distributes the time spent by the Department 
assessing and reviewing existing regulations.
---------------------------------------------------------------------------

    \38\ 85 FR 70096.
---------------------------------------------------------------------------

    Table G1 presents the primary estimates of yearly cost savings 
under the proposed withdrawal rule and under the two policy 
alternatives described above. All three policy options are compared to 
the common baseline scenario described in section D. We report the PDV 
and annualized cost savings under the proposed withdrawal or repeal 
rule and two policy alternatives for both a 3% and 7% discount rate. 
All figures are reported in 2020 dollars, in millions. In addition to 
the monetized estimates below, Alternative 1 would increase the 
likelihood that the Department would need to hire non-government 
experts to perform a share of the retrospective work, resulting in 
additional overhead costs that we have not monetized. Compared to the 
baseline scenario, Alternative 2 reduces this likelihood and thus 
reduces these overhead costs.

          Table G1--Primary Estimate of Cost Savings Under the Proposed Withdrawal Rule and Alternatives
                                                 [Millions of $]
----------------------------------------------------------------------------------------------------------------
                                                              Proposed
                          Year                            withdrawal rule     Alternative 1      Alternative 2
----------------------------------------------------------------------------------------------------------------
2022...................................................             $125.2            -$187.8              $59.6
2023...................................................              125.2             -187.8               59.6
2024...................................................              125.2              121.5               59.6
2025...................................................              125.2              121.5               59.6
2026...................................................              125.2              121.5               59.6
2027...................................................                5.9                2.2              -59.6
2028...................................................                5.9                2.2              -59.6
2029...................................................                5.9                2.2              -59.6
2030...................................................                5.9                2.2              -59.6
2031...................................................                5.9                2.2              -59.6
PDV, 3%................................................              596.7              -26.6               37.5
PDV, 7%................................................              530.6              -54.5               70.2
Annualized, 3%.........................................               69.9               -3.1                4.4
Annualized, 7%.........................................               75.5               -7.8               10.0
----------------------------------------------------------------------------------------------------------------


[[Page 59930]]

H. Initial Small Entity Analysis

    The Department has examined the economic implications of this 
proposed withdrawal or repeal rule as required by the Regulatory 
Flexibility Act. This analysis, as well as other sections in this 
Regulatory Impact Analysis, serves as the Initial Regulatory 
Flexibility Analysis, as required under the Regulatory Flexibility Act.
1. Description and Number of Affected Small Entities
    The U.S. Small Business Administration (SBA) maintains a Table of 
Small Business Size Standards Matched to North American Industry 
Classification System Codes (NAICS).\39\ We replicate the SBA's 
description of this table:
---------------------------------------------------------------------------

    \39\ U.S. Small Business Administration (2019). ``Table of Size 
Standards.'' August 19, 2019. https://www.sba.gov/document/support-table-size-standards.

    This table lists small business size standards matched to 
industries described in the North American Industry Classification 
System (NAICS), as modified by the Office of Management and Budget, 
effective January 1, 2017. The latest NAICS codes are referred to as 
NAICS 2017.
    The size standards are for the most part expressed in either 
millions of dollars (those preceded by ``$'') or number of employees 
(those without the ``$''). A size standard is the largest that a 
concern can be and still qualify as a small business for Federal 
Government programs. For the most part, size standards are the 
average annual receipts or the average employment of a firm.

    The SUNSET rule will potentially impact small entities across at 
least NAICS industry sectors 11 (Agriculture, Forestry, Fishing and 
Hunting), 31-33 (Manufacturing), 42 (Wholesale Trade), 44-45 (Retail 
Trade), 48-49 (Transportation and Warehousing), 52 (Finance and 
Insurance), 54 (Professional, Scientific, and Technical Services), 62 
(Health Care and Social Assistance), 81 (Other Services (except Public 
Administration)), and 92 (Public Administration). Given the wide range 
of entities affected, and various sources of uncertainty described in 
this section, it is not practical to directly estimate the number of 
small entities that would potentially be impacted under the baseline 
scenario of the SUNSET rule. Similarly, it is impractical to identify 
the small entities that would be impacted by the proposed withdrawal or 
repeal rule, if it is finalized. The Congressional Research Service 
observes that ``about 97% of all employer firms qualify as small under 
the SBA's size standards. These firms represent about 30% of industry 
receipts.'' \40\ For practicality, we assume that the bulk of the 
potential impacts of the proposed withdrawal or repeal rule to private 
sector regulated entities are small entities.
---------------------------------------------------------------------------

    \40\ Robert Jay Dilger (2021). ``Small Business Size Standards: 
A Historical Analysis of Contemporary Issues.'' Congressional 
Research Service Report R40860. Updated May 28, 2021. Page 2. 
https://crsreports.congress.gov/product/pdf/R/R40860.
---------------------------------------------------------------------------

2. Description of the Potential Impacts of the Rule on Small Entities
Impacts to Small Entities Related to Rescissions and Amendments
    When estimating the impact on the public, the SUNSET RIA first 
estimates that 53 regulations will be rescinded and another 159 
regulations will be amended as a result of the retrospective analyses 
initiated as a result of the SUNSET rule. Since the particular 
regulations impacted are unknowable prior to conducting the 
retrospectives, this results in uncertainty over the types of small 
entities that will be affected under the baseline scenario of the 
SUNSET rule. The nature of this uncertainty means it is infeasible to 
estimate the number of small entities affected by these potential 
rescinded or amended regulations without first completing the 
retrospectives.
    As described earlier, the Department no longer believes it was 
appropriate to unambiguously attribute to the SUNSET rulemaking 
subsequent regulatory actions of this nature in the context of a 
regulatory impact analysis. We therefore do not attribute any impacts 
of this nature to the proposed withdrawal or repeal rule, nor do we 
identify any impacts to small entities.
Impacts to Small Entities Related to the Automatic Expiration of 
Regulations
    When identifying the potential benefits of the proposed withdrawal 
or repeal rule, we note that, while the Department will seek to fulfill 
the requirements of the SUNSET rule rather than to let any regulation 
expire automatically, it is highly likely that some regulations will 
automatically expire without substantive review. This potential impact 
under the SUNSET rule does not introduce similar questions of 
attribution; however, there remains uncertainty over the particular 
regulations that will be impacted. The nature of this uncertainty means 
we cannot identify the small entities that are most likely to be 
affected by regulations that automatically expire without substantive 
review.
    Revoking the SUNSET rule would remove the expiration provisions, 
which would also remove the likelihood of any automatic expiration of 
regulatory requirements. The proposed withdrawal or repeal rule would 
also eliminate the potential for regulatory confusion among 
stakeholders, including small entities. We anticipate that a large 
share of these non-quantified benefits would accrue to small entities.
Impacts to Small Entities Related to Commenting on Assessments and 
Reviews
    When identifying the potential benefits of the proposed withdrawal 
or repeal rule, we estimate the cost savings to the public from not 
commenting on these assessments and reviews that would be performed 
under the baseline scenario of the SUNSET rule. Table E1 summarizes 
these estimates, including a range of cost-savings to the public sector 
between $26.5 million and $79.5 million in annualized terms under a 3% 
discount rate. Under a 7% discount rate, the comparable range of cost 
savings is $28.6 million and $85.9 million. Although these represent 
substantial cost savings in the aggregate, these include comments not 
just from small entities but also the general public, larger 
businesses, Tribes, States, non-governmental organizations, and other 
regulated entities and stakeholders.
    To evaluate the likely magnitude of the impact to a single small 
entity, we consider an illustrative scenario of a full-time sole 
proprietor that submits 1 or fewer comment per year. As described 
earlier, we estimate that each comment takes between 5 and 15 hours to 
prepare and submit. If the proposed withdrawal or repeal rule is 
finalized, this would reduce the time spent on comments for this small 
entity by 5 to 15 hours per year. This represents between 0.2% to 0.7% 
of annual labor time saved, computed using an assumption that the 
individual works 2,087 hours per year. As an additional sensitivity 
analysis, we computed the number of comments that a sole proprietor 
would need to submit in one year such that the time spent on comments 
would exceed 3% of total time spent on labor. Assuming 2,087 hours of 
labor time per year, the total time spent on comments to meet this 
threshold is about 63 hours. Using a central estimate of 10 hours to 
prepare and submit each comment, the sole proprietor could prepare up 
to 6 comments per year without exceeding the 3% threshold. We expect 
that fewer than 5 percent of small entities will share more than 6 
comments per year on regulations undergoing a retrospective analysis 
under the SUNSET rule. This indicates that the potential cost savings 
to small entities under the proposed

[[Page 59931]]

withdrawal or repeal rule, if it is finalized, are unlikely to be 
significant for a substantial number of small entities. 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. This cost-saving benefit is 
well below this threshold.

VII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13132. We have determined that because the 
SUNSET final rule has not become effective, this proposal to withdraw 
the final rule, if finalized, will continue the status quo, and 
therefore does not contain policies that have substantial direct 
effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the E.O. and, consequently, a 
federalism summary impact statement is not required.

VIII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13175. Multiple comments from 
representatives of several Tribes and related groups expressed concern 
that the SUNSET final rule would have significant tribal implications, 
if implemented, and that consultation with Tribal governments on the 
SUNSET proposed rule was not adequate. We agree.\41\ HHS remains 
committed to holding meaningful tribal consultation consistent with the 
HHS Tribal Consultation Policy. However, this proposed rule to withdraw 
or repeal the final rule, if finalized, will continue the status quo, 
and therefore does not contain policies that would have a substantial 
direct effect on one or more Indian Tribes, on the relationship between 
the Federal Government and Indian Tribes, or on the distribution of 
power and responsibilities between the Federal Government and Indian 
Tribes. Based on this status, as well as the comments already received 
on this issue, we do not believe tribal consultation is required. We 
plan to provide notice to Tribes of this proposed rule, acknowledging 
tribal concerns with the lack of tribal consultation on the earlier 
rulemaking and encouraging them to share any additional feedback by 
providing written comments on this proposed withdrawal or repeal.
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    \41\ As explained in greater detail in the Administrative Delay 
Order, Tribes should have been ``afforded an opportunity to comment 
meaningfully on the rule's impact,'' but ``HHS failed to consult 
with Tribal governments (or even notify them regarding the 
proposal).'' 86 FR 15407.
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IX. Analysis of Environmental Impacts

    HHS had determined that the proposed rule will not have a 
significant impact on the environment.

X. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 and its 
implementing regulations, 44 U.S.C. 3501-3521; 5 CFR part 1320, 
appendix A.1, the Department has reviewed this proposed rule and has 
tentatively determined that it proposes no new collections of 
information.

XI. References

1. OIRA dashboard screenshot (Dec. 18, 2020).
2. Complaint, County of Santa Clara v. HHS, Case No. 5:21-cv-01655-
BLF (N.D. Cal. Mar. 9, 2021).

Xavier Becerra,
Secretary.
[FR Doc. 2021-23472 Filed 10-28-21; 8:45 am]
BILLING CODE 4150-26-P