these commenters maintained that the SUNSET final rule is HHS's current
``plan'' for periodic review under section 610(a), and therefore
repealing it will leave HHS without the required plan. One commenter
asserted that HHS cannot repeal the SUNSET final rule because section
610 allows agencies only to ``amend'' their plans for retrospective
review. Another commenter asserted that HHS has failed each year to
``publish in the Federal Register a list of the rules . . . which are
to be reviewed pursuant to . . . section [610] during the succeeding
twelve months'' under section 610(c). The commenters also claimed that
the RFA requires (``shall provide for'') that HHS conduct the
retrospective reviews identified in section 610 on the timelines
provided for in that section, and that HHS has not adequately conducted
such reviews.
    Response: We disagree with these commenters' assessments of the
history of the Department's compliance with the RFA and predictions
about the Department's future plans with respect to the RFA. As noted
by commenters, section 610 requires agencies to: Publish in the Federal
Register a plan for the periodic review of the rules issued by the
agency which have or will have a SEISNOSE; and each year publish in the
Federal Register a list of the rules which have a SEISNOSE and are to
be reviewed pursuant to section 610 during the succeeding twelve
months. HHS has complied with these requirements.
    First, following the enactment of the RFA, on July 14, 1981, the
Department published in the Federal Register its plan for periodic
review as required by section 610(a).\16\ That plan provides for, among
other things, the Department's review of regulations that have or will
have a SEISNOSE and identifies processes and principles that guide such
reviews, including principles for prioritizing those reviews.\17\
Accordingly, the Department has had a plan in place since shortly after
the enactment of the RFA. Second, in accordance with that plan and
section 610(c), the Department each year publishes in the Federal
Register a list of the rules with a SEISNOSE that it is reviewing, has
reviewed, or intends to review under section 610, along with a
discussion of the Department's

commitment to compliance with the requirements and intent of section
610.\18\ As required by section 610(c), this document includes for each
such rule a brief description of the rule, its legal basis, and the
opportunity for public comment.\19\ Therefore, the commenters are
incorrect that withdrawal of the SUNSET final rule would leave the
Department without a plan for the periodic review of rules as required
by section 610(a), or that HHS does not comply with section 610(c). The
commenters have not cited any authority that either of these sections
requires more.\20\
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    \16\ See Notice of Plan for Periodic Review of Rules, 46 FR
36332 (July 14, 1981). We note that FDA simultaneously published in
the Federal Register its own plan for periodic review of its rules
as a supplement to the Department's plan. See Notice, 46 FR 36333
(July 14, 1981) (``This notice supplements the Department plan with
additional information about FDA procedures for reviewing existing
rules.'').
    \17\ See, e.g., 46 FR 36332 (``[T]he Department and those staff
divisions which administer rules will inventory and review all
regulations for the purpose of selecting those regulations that
should receive early, in depth review and revision, where necessary,
to reduce regulatory burdens'' and identifying principles to guide
prioritization of review of existing regulations); id. (``[A]gencies
and offices of the Department will seek to identify for earliest
review those regulations for which revision will most advance
[certain] principles,'' including ``[m]inimiz[ing] Federal, State,
local, and private costs'' and ``[p]revent[ing] fraud, abuse, waste,
and inefficiency''); id. (``The Department's semiannual agenda will
advise the public of regulations selected for review''); id. at
36333 (``[I]t is important that to the extent possible the more
costly and burdensome rules by reviewed first'').
    \18\ See, e.g., Semiannual Regulatory Agenda, 86 FR 16892 (Mar.
31, 2021) (publishing under the RFA and E.O. 12866 the Department's
``semiannual . . . inventory of rulemaking actions under development
throughout,'' including ``as required by the [RFA] . . . , those
prospective HHS rulemakings likely to have a [SEISNOSE],''
``offering for public review summarized information about
forthcoming regulatory actions the Department,'' and describing and
identifying examples of the Department's ``agency-wide effort to
support the [Regulatory] Agenda's purpose of encouraging more
effective public participation in the regulatory process'').
    \19\ See, e.g., id. The Department also submits this information
regarding rules it has identified for periodic review under section
610 in its submissions to the Unified Agenda. One commenter
maintained that these Unified Agenda submissions cannot satisfy
section 610 because they are not published in the Federal Register
and they are not contained in a single document. However, as
explained above, the Department publishes information satisfying
section 610 in the Federal Register as a single document. See, e.g.,
Regulatory Information Service Center, Introduction to the Unified
Agenda of Regulatory and Deregulatory Actions--Fall 2021, 87 FR
5002, 5009 (Jan. 31. 2022).
    \20\ Congress considered and rejected a provision included in an
earlier version of the bill that would have supported the
commenter's position. See 46 FR 21449 (section 5(a) of S. 299, which
was amended before being enacted as the RFA, included the following:
``Each agency shall periodically review its rules and regulations in
accordance with the schedule and criteria set forth in its published
plan.'').
---------------------------------------------------------------------------

    The Department also disagrees with the commenter that it cannot
repeal the SUNSET final rule because section 610 permits agencies to
only ``amend[]'' their plans for retrospective review. However, the
language the commenter cites--``[s]uch plan may be amended by the
agency at any time,'' 5 U.S.C. 610(a)--is a broad grant of authority to
agencies with respect to amending their plans for retrospective review,
not a limitation. See, e.g., Adirondack Med. Ctr. v. Sebelius, 740 F.3d
692, 698 (D.C. Cir. 2014) (``Congress generally knows how to use the
word `only' when drafting laws.''). This interpretation of section
610(a) is also consistent with Congress's intent as expressed in the
remaining language of that provision, which sets forth the general
requirement that agencies publish plans for retrospective review but
does not further specify how agencies develop and implement those
plans. Such language stands in stark contrast to section 610(b), which
explicitly imposes specific requirements on agencies' retrospective
reviews. See Fisher, 994 F.3d at 671 (``In an administrative setting, .
. . `the contrast between Congress' mandate in one context with its
silence in another suggests not a prohibition but simply a decision not
to mandate any solution in the second context, i.e., to leave the
question to agency discretion.' '').
    We also disagree with the assertion in the comments that the SUNSET
final rule is HHS's current ``plan.'' As described above, HHS has had a
retrospective review plan in place since 1981, which was unacknowledged
in the SUNSET final rule. Under that plan, among other things, the
Department reviews regulations that have or will have a SEISNOSE and
identifies processes and principles that guide such reviews, including
principles for prioritizing those reviews. Because the SUNSET final
rule never became effective, the Department has never implemented the
SUNSET final rule as its retrospective review plan. Instead, HHS's
longstanding plan remains operative.
    Furthermore, as discussed in the Withdrawal NPRM and as noted by
the commenters to that proposal, the Department has a meaningful track
record of retrospective regulatory review. HHS conducts retrospective
reviews of its regulations with impacts on small entities and publishes
notice of the reviews in the Federal Register. Additionally, as
acknowledged in the SUNSET final rule, the Department in 2016 and 2019
issued final rules resulting from section 610 reviews updating the
requirements of participation in the Medicare and Medicaid programs for
hospitals and critical access hospitals \21\ and long-term care
facilities.\22\ These rulemakings, among other things, allowed these
entities greater flexibility in meeting the requirements and eliminated
unnecessary, obsolete, or overly burdensome requirements.\23\
---------------------------------------------------------------------------

    \21\ See Medicare and Medicaid Programs; Regulatory Provisions
to Promote Program Efficiency, Transparency, and Burden Reduction;
Fire Safety Requirements for Certain Dialysis Facilities; Hospital
and Critical Access Hospital (CAH) Changes to Promote Innovation,
Flexibility, and Improvement in Patient Care, 84 FR 51732 (Sept. 30,
2019) (RIN 0938-AT23); see also Semiannual Regulatory Agenda, 84 FR
29633 (June 24, 2019) (merged with 0938-AT23).
    \22\ See Medicare and Medicaid Programs; Reform of Requirements
for Long-Term Care Facilities, 81 FR 68688 (Oct. 4, 2016); see also
Regulatory Agenda, 81 FR 94754 (Dec. 23, 2016) (0938-AR61).
    \23\ See, e.g., Medicare and Medicaid Programs; Regulatory
Provisions to Promote Program Efficiency, Transparency, and Burden
Reduction; Fire Safety Requirements for Certain Dialysis Facilities;
Hospital and Critical Access Hospital (CAH) Changes to Promote
Innovation, Flexibility, andImprovement in Patient Care, 84 FR 51732
(Sept. 30, 2019).
---------------------------------------------------------------------------

    As described in the Withdrawal NPRM and as noted by commenters to
that proposal, the Department also has undertaken several other recent
and significant retrospective regulatory review efforts. Several
commenters noted the 2015 CMS initiative to modernize Medicaid Managed
Care regulations for Medicaid and CHIP beneficiaries, and we also noted
in the Withdrawal NPRM that the CMS Office of Burden Reduction and
Health Informatics works to eliminate over-burdensome and unnecessary
regulations. Commenters additionally noted that the Department's 2011
Plan for Retrospective Review of Existing Rules,\24\ an initiative
developed in accordance with E.O. 13563 and E.O. 13610, and plans the
Department subsequently published from Fiscal Year 2012 through 2016,
have served as a framework for its retrospective review of existing
regulations. Under these plans, the Department identified rules that
could be potentially eliminated as obsolete, unnecessary, burdensome,
or counterproductive or that could be modified to be more effective,
efficient, flexible, and streamlined. Additionally, as noted in the
Withdrawal NPRM, the Department, in response to E.O. 13771, ``Enforcing
the Regulatory Reform Agenda,'' 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. While this E.O. has
since been revoked, the published summary reports of these reviews for
Fiscal Years 2018-2020 are available on the HHS website.\25\
---------------------------------------------------------------------------

    \24\ Improving Regulation and Regulatory Review, 76 FR 3821
(Jan. 21, 2011).
    \25\ FY 2021 Annual Performance Plan and Report--Regulatory
Reform, HHS, https://www.hhs.gov/about/budget/fy2021/performance/regulatory-reform/index.html.
---------------------------------------------------------------------------

    Also noted in the Withdrawal NPRM, numerous additional regulatory
efforts by HHS routinely involve the review of regulations. The
Department provides technical assistance to Congress on proposed
legislation, which quite often requires an assessment of the proposal's
impact on current regulations. FDA also reviews regulations in
responding to certain citizen petitions submitted

under 21 CFR 10.30, requesting changes in FDA regulations.
Additionally, it is 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 entails review of these sections.\26\ As another example,
regulations are reviewed to determine if guidance documents are needed
to provide recommendations for complying with the regulation, which 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.
---------------------------------------------------------------------------

    \26\ For example, the regulations FDA issued to implement FSMA
included both the addition of new sections of regulation and
revisions and modifications to existing sections. See FSMA Rules &
Guidance for Industry (available at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#Rules).
---------------------------------------------------------------------------

    All of these initiatives demonstrate HHS's commitment to reviewing
its regulations. Thus, the suggestion in the comments that HHS will not
adequately conduct periodic review under section 610 of the RFA moving
forward absent the rule is groundless and speculative. HHS is committed
to effective and appropriate retrospective review of its regulations
and looks forward to exploring ways to improve its processes through
means other than binding regulations.
    Accordingly, the Department believes that the SUNSET rule is not
necessary to ensure its compliance with section 610 and that its
ability to undertake regulatory review efforts in the future would be
undermined by complying with the unnecessary and burdensome
requirements of the SUNSET final rule.
    Comment: Several comments asserted that HHS has essentially
admitted in the SUNSET final rule that, absent the rule, it does not
otherwise comply with the RFA. One comment asserted that HHS admitted
in the SUNSET final rule that ``all prior plans'' for retrospective
review did not meet the requirement to publish a plan under section 610
``because each prior plan hopelessly failed to provide for any review
of each regulation within ten years, if ever.'' The comment also cited
the following statements in the SUNSET final rule: HHS has had
``limited success in performing retrospective regulatory review,'' 86
FR 5738; ``the Department's efforts to comply with 5 U.S.C. 610 have at
times been lacking,'' id. at 5696; and ``The Department's experience
over the last forty years is that, absent a strong incentive such as
the potential expiration of a regulation, the Department will not
review an adequate number of its regulations,'' id. at 5739. Another
comment asserted that HHS admitted that many of its rules have remained
untouched for years. Two of these comments questioned the Withdrawal
NPRM's assertion that many rules have remained untouched because they
work as intended, asserting that the Withdrawal NPRM does not provide
evidence to support this assertion. One comment asserted that if a rule
finalized in the 1980s or 1990s is working as intended, that means it
is likely out of date because rule's drafters could not have envisioned
the technological and informational improvements that have taken place
since the rule's promulgation.
    Response: The Department disagrees with the comments that the
SUNSET final rule concluded or demonstrated that HHS does not comply
with the RFA absent that rule, but, to the extent that the SUNSET final
rule is understood to convey that conclusion, we now think that
conclusion is wrong. First, the SUNSET final rule does not state that
``all prior plans'' for the Department's retrospective review do not
satisfy section 610(a), nor could it. For example, as explained in a
prior comment response, the Department in 1981 published in the Federal
Register a plan for retrospective review that directly responds to the
requirements under the RFA and provides for the Department's periodic
review of regulations that have or will have a SEISNOSE.\27\ Thus, HHS
fulfilled section 610(a)'s ``plan'' requirement long before the
promulgation of the SUNSET final rule. Notably, the SUNSET final rule
does not even refer to this plan, let alone assert that it does not
satisfy section 610(a)'s requirements.
---------------------------------------------------------------------------

    \27\ See Notice of Plan for Periodic Review of Rules, 46 FR
36332 (July 14, 1981).
---------------------------------------------------------------------------

    Second, neither the statements from the SUNSET final rule cited by
the comments, nor the evidence cited for those statements, establish
noncompliance or support the comments' conclusion that HHS does not
otherwise comply with the RFA. For example, the SUNSET final rule's
statement that the Department has had ``limited success in performing
retrospective regulatory review'' does not assert that the Department
does not comply with section 610 specifically. As the SUNSET final rule
shows, the Department under the previous administration expressed the
policy position that extensive retrospective review, across the
Department's entire regulatory portfolio, was appropriate and should be
prioritized above other Department priorities; its statements of
``limited success,'' ``lacking'' efforts, and ``adequate'' review must
be understood in the context of these prior expectations and priorities
rather than compliance with the RFA. Furthermore, the evidence the
Department cited as support also does not specifically pertain to the
Department's section 610 reviews or necessarily reveal anything about
them. Specifically, this evidence includes: (1) An artificial
intelligence (AI) data analysis of HHS regulations identifying that
``85% of Department regulations created before 1990 have not been
edited; the Department has nearly 300 broken citation references in the
CFR; and there are more than 50 instances of HHS regulatory
requirements to submit paper documents in triplicate or
quadruplicate''; and (2) a 2018 study estimating that 68% of Federal
regulations have never been updated. 86 FR 5710. The SUNSET final rule
does not assert that the HHS regulations identified in this analysis
are regulations with a SEISNOSE subject to section 610, and there
appears to be no reason to assume that is the case. See 86 FR 5710
(acknowledging that AI ``cannot at this time easily determine if a
regulation satisfies the criteria listed in 5 U.S.C. 610''). Indeed,
based on the SUNSET final rule's estimate that only 15% of the
Department's regulations have or will have a SEISNOSE, it is possible
that none of the regulations identified in either study are rules that
have or will have a SEISNOSE. Thus, there appears to be no reason to
conclude that the rules identified as unedited or flawed are rules with
SEISNOSE that should be reviewed under section 610.\28\
---------------------------------------------------------------------------

    \28\ Commenters to the SUNSET proposed rule also expressed
concern that the methodology of the AI review was never made public,
and the SUNSET final rule confirmed that the ``Department did not
notify the public about this research project.'' 86 FR 5710.
---------------------------------------------------------------------------

    Another HHS statement cited by the comment--that ``the Department's
efforts to comply with 5 U.S.C. 610 have at times been lacking,'' 86 FR
5696--also does not assert or establish that the Department does not
comply with section 610. The statement merely suggests a belief that,
``at times,'' the Department could have improved its processes for
retrospective review under section 610. It does not explicitly assert
that the Department, then or now, fails to comply with the RFA.
Additionally, like the data discussed above, the data the statement
cites as support does not

pertain specifically to reviews conducted under section 610.
Specifically, the statement cites the number of retrospective analyses
the Department has conducted in response to E.O. 13563. 86 FR 5696.
However, E.O. 13563, unlike section 610, does not contemplate periodic
review of only rules with a SEISNOSE for the purpose of minimizing
SEISNOSE but instead applies to ``existing significant regulations''
for the purpose of assessing a far broader set of factors not focused
on small entities, including ``whether any such regulations should be
modified, streamlined, expanded, or repealed . . . to make [an]
agency's regulatory program more effective or less burdensome in
achieving the regulatory objectives.'' See Improving Regulation and
Regulatory Review, 76 FR 3821, 3822 (Jan. 18, 2011). Therefore, the
Department's reviews conducted in response to that E.O. do not
necessarily indicate anything about the number of reviews the
Department has conducted or should consider conducting under section
610. The SUNSET final rule itself appears to recognize the limited
value of these data by concluding only that ``[t]hese findings are
consistent with government assessments that the Department's efforts to
comply with 5 U.S.C. 610 have at times been lacking.'' 86 FR 5696
(emphasis added).
    The final HHS statement cited by the commenter--``The Department's
experience over the last forty years is that, absent a strong incentive
such as the potential expiration of a regulation, the Department will
not review an adequate number of its regulations''--is equally flawed.
Again, this statement does not explicitly address the adequacy of the
Department's reviews of regulations under section 610 but only
generally refers to ``review . . . of [ ] regulations.'' Moreover, as
explained above, the statement's implication that the Department has
not conducted an ``adequate'' number of reviews must be understood in
the context of the Department's policy position under the previous
administration that extensive retrospective review across its entire
regulatory portfolio was appropriate and should be prioritized above
other agency priorities.
    Third, the SUNSET final rule's discussion of the Department's
section 610 compliance and record of retrospective review contains
errors and misstatements. In relying on studies purporting to
demonstrate that HHS's regulations have not been edited or are
otherwise flawed, the SUNSET final rule appears to incorrectly assume
that the age of a regulation and the fact that it has not been edited
for some period of time suggests that the regulation should be and has
not been reviewed under section 610 or pursuant to any of the
Department's numerous regulatory review efforts. See 86 FR 5710
(concluding the AI data ``suggested that large numbers of Department
regulations would benefit from retrospective review''); id. at 5738
(``These findings suggest regulations are not being updated to reflect
evolving economic conditions and technology, even though this is a goal
of the RFA.''). As the Withdrawal NPRM explained, numerous agency
efforts involving the review of regulations do not result in a change
in the regulation. Moreover, section 610(a) explicitly contemplates
unchanged regulations, stating that ``[t]he purpose of the review shall
be to determine whether such rules should be continued without change,
or should be amended or rescinded'' (emphasis added). Also, as noted in
the Withdrawal NPRM, the broken links and other typographical errors
identified through the AI review 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.\29\
---------------------------------------------------------------------------

    \29\ ``Medical Device Submissions: Amending Premarket
Regulations That Require Multiple Copies and Specify that Paper
Copies To Be Required in Electronic Format,'' 84 FR 68334 (Dec. 16,
2019).
---------------------------------------------------------------------------

    The assumption that unedited rules have not been reviewed is
incorrect for the additional reason that many rules setting industry
standards have remained untouched for years, not from neglect, but
because they work as intended. The OMB memo offering guidance to heads
of executive departments and agencies on implementation of E.O. 13563
explicitly states that, in conducting retrospective analysis of
existing rules: ``Agency plans should not, of course, call into
question the value of longstanding agency rules simply because they are
longstanding. Many important rules have been in place for some time.''
\30\ The Withdrawal NPRM points to numerous longstanding regulations
that bring efficiencies to industry by clarifying applicable statutory
obligations, such as food regulations involving nutrition, food
labeling, standards of identity, food ingredients, and color additives.
Furthermore, the Withdrawal NPRM cited comments to the SUNSET proposed
rule confirming that these longstanding regulations create important
efficiencies for regulated industry. By contrast, the commenter offered
no support for its assumption that the age of a rule and the fact that
it has not been edited must mean that it is out of date with respect to
its technological and informational requirements. Moreover, even if
certain of such requirements could be updated to reflect technological
advances, the commenter does not explain why that would necessarily
mean that the rule has or will have a SEISNOSE and should be reviewed
under section 610. To have a SEISNOSE, a rule must have a significant
economic impact on a substantial number of small entities, and the
Department considers a rule to have a SEISNOSE if it has at least a
three percent impact on revenue on at least five percent of small
entities. See, e.g., 86 FR 5749. Again, based on the SUNSET final
rule's estimates, only 15% of the Department's regulations have a
SEISNOSE, 86 FR 5737, which suggests that many, or potentially all, of
the regulations the commenter claims have outdated technological
requirements are not regulations with SEISNOSE subject to section 610
review.
---------------------------------------------------------------------------

    \30\ OMB Memorandum M-11-10, ``Executive Order 13563, `Improving
Regulation and Regulatory Review' '' (Feb. 2, 2011) (available at
https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2011/m11-10.pdf).
---------------------------------------------------------------------------

    The SUNSET final rule made similar errors with respect to other
data it cited in its discussion of the Department's RFA compliance and
record of retrospective review. Specifically, the SUNSET final rule
cited a review of HHS's entries in the semiannual Unified Agenda over
the last ten years, which identified three entries for final
rulemakings resulting from section 610 reviews. See 86 FR 5737. Based
on these data, the SUNSET final rule suggested that, during that ten-
year time period, the Department conducted section 610 reviews of only
26 of its 370 rulemakings previously determined to have a SEISNOSE. See
id. at 5737-38 (referring to ``lax compliance with periodic review
requirements under the . . . [ ]RFA[ ]''). However, in drawing this
conclusion, the SUNSET final rule appears to improperly assume that the
three final rulemakings resulting in section 610 reviews (which it
estimated

amended CFR sections equivalent to approximately 26 rulemakings)
represented the only section 610 reviews conducted by the Department
during this ten-year time period. See id. at 5737 n.213. In so
concluding, the SUNSET final rule again relied on the flawed assumption
that a section 610 review must result in the amendment of a rule or a
new rule, and thus excluded all other section 610 reviews indicated in
the Unified Agenda during that time period. As a result of that
exclusion, the Department incorrectly assessed the scope of rulemakings
the Department reviewed under section 610 during the last ten years.
    The SUNSET final rule's discussion of the Department's RFA
compliance also contains misstatements and other errors. The SUNSET
final rule cited three ``examples of regulations that [commenters] and/
or Congress have requested the Department to review, but that the
commenters claimed were not reviewed.'' 86 FR 5696. Although the SUNSET
final rule did not take a firm position on the status of these
examples, the implication that these matters are inactive is factually
incorrect. For example, the Fall 2021 Unified Agenda includes planned
action to harmonize the differences between the Basic HHS Policy for
the Protection of Human Research Subjects (45 CFR part 46, subpart A)
and the FDA regulations for the protection of human subjects (21 CFR
parts 50 and 56).\31\ The Fall 2021 Unified Agenda also includes
several planned regulatory actions by FDA's Center for Veterinary
Medicine (CVM) to revise \32\ and in certain instances withdraw several
regulations based, in part, on the comments received in dockets issued
in 2017 seeking comments and information from interested parties to
help FDA identify existing regulations and related paperwork
requirements that could be modified, repealed, or replaced, consistent
with the law, to achieve meaningful burden reduction while allowing us
to achieve our public health mission and fulfill statutory obligations.
In addition, CMS revised the Medicare Beneficiary Program Manual
(MBPM), in accordance with the national settlement agreement in the
Jimmo v. Sebelius litigation.\33\ Moreover, the SUNSET final rule did
not assert that these regulations have or will have a SEISNOSE, or even
that the commenters or Congress asserted that they do, and thus, the
rule failed to demonstrate how, if at all, these examples implicate the
Department's retrospective review efforts under section 610.
---------------------------------------------------------------------------

    \31\ See Protection of Human Subjects and Institutional Review
Boards, RIN 0910-A107 (Fall 2021) (available at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202110&RIN=0910-AI07).
    \32\ See, e.g., Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Food for Animals,
RIN 0910-AI24 (Fall 2021) (available at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202110&RIN=0910-AI24); Phased Review
of New Animal Drug Applications, Electronic Submission, and Master
Files, RIN 0910-A135 (Fall 2021) (available at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202110&RIN=0910-AI35); Revision of Requirements for the Establishment and
Maintenance of Records Related to Medicated Animal Feed and
Veterinary Feed Directive Drugs Office of Information and Regulatory
Affairs, RIN: 0190-AI67 (Fall 2021) (available at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202110&RIN=0910-AI67).
    \33\ See Medicare Beneficiary Policy Manual, Chapters 7 (Home
Health), 8 (Skilled Nursing Facilities) and 15 (Outpatient Therapy)
(available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS012673). We note that
the SUNSET final rule referred to a comment stating that regulations
covering access to skilled therapy services had not been updated to
reflect the national settlement in Jimmo v. Sebelius. See 86 FR
5696. However, the settlement agreement requires HHS to amend the
Medicare Benefit Policy Manual to clarify the coverage standards,
not to amend Medicare regulations. See ``IX. Injunctive Provisions''
in Settlement Agreement, at 8-14 (available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/SNFPPS/Downloads/Jimmo-Settlement-Agreement.pdf).
---------------------------------------------------------------------------

    The remaining data cited in the SUNSET final rule's discussion of
the Department's RFA compliance lacks relevance to that discussion. For
example, the SUNSET final rule asserted that good governance
stewardship actions were deprioritized and relegated to ``rainy day''
activities the Department operating divisions would get to when they
could, citing a review conducted in 2019 that entailed an AI data
analysis of HHS regulations. 86 FR 5697. As already discussed in this
response, the AI review results do not indicate whether any of the
rules it identified as not updated or otherwise flawed have or will
have a SEISNOSE, and thus the rule fails to demonstrate how, if at all,
this review implicates the Department's activities under section 610.
Furthermore, as noted above, the broken links and other typographical
errors identified through the AI review process were successfully
addressed as part of the HHS ``Regulatory Clean-Up Initiative.'' As
another example, the SUNSET final rule also cited ``government
assessments that the Department's efforts to comply with 5 U.S.C. 610
have at times been lacking,'' 86 FR 5696; however, these sources at
most indicate at times in the past the Department could have reviewed
more rules under section 610, and therefore, these sources do not
demonstrate that the Department does not currently comply.\34\
---------------------------------------------------------------------------

    \34\ See, e.g., Curtis W. Copeland, Cong. Rsch. Serv., RL32801,
Reexamining Rules: Section 610 of the Regulatory Flexibility Act 8
(2008) (``[I]t would be reasonable to expect that, since [certain
departments] indicated that they intended to issue a large number of
rules each year with a significant effect on small entities, those
same agencies would need to reexamine a large number of rules each
year under Section 610.''); U.S. Accountability Off., GAO/GGD-94-
105, Regulatory Flexibility Act: Status of Agencies' Compliance
(1994) (citing an SBA report from 1983 suggesting potential for
improving the Department's review plan).
---------------------------------------------------------------------------

    The SUNSET final rule's discussion of ``[m]achine-learning tools .
. . [that] demonstrate the complexity of Department rules'' similarly
lacks relevance to the Department's compliance with section 610. The
rule cites data showing that the Department's regulations in 2019,
``based on the amount of information contained in text,'' were ``more
complex than a typical Shakespeare play,'' and notes that ``reducing
complexity is another goal of the RFA.'' 86 FR 5738. However, as with
much of the data already discussed, these data do not purport to relate
specifically to rules that have or will have a SEISNOSE, and thus,
again do not necessarily implicate the Department's efforts under
section 610. Moreover, even if these data were specific to regulations
with a SEISNOSE, the Department does not agree with the SUNSET final
rule that these data demonstrate that its regulations are overly
complicated. As the SUNSET final rule itself acknowledges, complexity
in the Department's regulations ``is not . . . surprising given that
the regulations often involve science, engineering, or highly technical
material.'' 86 FR 5738.
    Moreover, the Department disagrees that ``the amount of information
in text'' is a reliable proxy for complexity that is unnecessary or
undesirable given that, in the Department's experience, providing more
information in a regulation can often enhance clarity. For example, in
FDA's experience, often in response to a proposed rule, commenters will
request that the agency provide examples in the codified text which can
lengthen the text but clarify the requirements. For example, a good
manufacturing practices rule may require that ``qualified personnel
handle x.'' So, to better explain what constitutes ``qualified
personnel,'' the codified text may include examples such as education,
years of work experience, etc. The examples are general and not
prescriptive so that the regulated entity can exercise flexibility in
determining what is applicable to their industry and their unique

manufacturing processes. Thus, while the codified text may be longer,
it is not inherently more complex or burdensome.
3. Policy Considerations Related to Retrospective Review
    Comment: Some commenters opposed finalizing the Withdrawal NPRM
because, in their view, there is a need for HHS to conduct more
retrospective review. Several commenters asserted that HHS regulations
are outdated. One comment stated that greater retrospective review is
needed because ``the costs of regulations frequently exceed what was
projected at the time of promulgation,'' citing information from the
preamble to the SUNSET final rule. Another comment stated that there is
an ``overall lack of an evidentiary basis for many of [HHS's]
regulations'' and cited a working paper \35\ criticizing the
Department's retrospective review and HHS regulations' identification
of a problem that would be solved by the regulation. Several comments
stated that widespread retrospective review is appropriate because, if
the public must comply with HHS regulations, HHS should have to review
them. Approximately ten identical anonymous comments stated that the
Withdrawal NPRM should not be finalized because withdrawal or repeal of
the SUNSET final rule would ensure Americans continue to be subject to
costly, burdensome regulations and, before adding additional burdens on
the American people, HHS should determine if its existing regulations
are helping or harming them.
---------------------------------------------------------------------------

    \35\ Ellig, Jerry, ``Evaluating the Quality and Use of
Regulatory Impact Analysis: The Mercatus Center's Regulatory Report
Card 2008-2013'' Mercatus Center at George Mason University (July
2016) (available at https://www.mercatus.org/publications/regulation/evaluating-quality-and-use-regulatory-impact-analysis).
---------------------------------------------------------------------------

    Response: HHS does not agree that the SUNSET final rule should be
retained for any of the reasons cited by commenters. First, even
assuming that HHS would benefit from more retrospective review, none of
these comments explain why the onerous procedures and compressed
timeframes of the SUNSET final rule are necessary or desirable to
achieve that goal. Upon review, HHS believes that the procedures set
forth in the SUNSET final rule would be a poor method for achieving the
goal of improved regulations through retrospective review because the
pressure created by the SUNSET final rule process would undermine the
quality of the Department's reviews. The SUNSET final rule's focus on
small-entity impacts also does not seem directly responsive to these
calls for large-scale reconsideration of HHS regulations.
    Second, HHS does not agree that the commenters have demonstrated a
need for widespread retrospective review. For example, HHS disagrees
with the general proposition that its regulations are outdated. The
only evidence offered to support these assertions is the evidence
presented in the SUNSET final rule, which is discussed in the previous
comment response. For example, commenters cited the fact that many HHS
regulations issued prior to 1990 have not been edited. But that fact
does not show that edits are needed, and it certainly does not show
that the underlying policies of those regulations are flawed or that
the regulations have impacts that should be reassessed. Similarly, the
fact that broken links or typographical errors may exist in HHS
regulations does not stand for a broader proposition that the
underlying policies or impact analyses in the regulations are outdated.
Nor is automatic expiration of a regulation an appropriate response to
broken links or typographical errors in that regulation. Overall, HHS
rejects the conclusion that our regulations are generally ``outdated''
because, as discussed throughout this preamble, we review regulations
under many processes, regularly engage with stakeholders regarding the
effects of our regulations, and craft regulations to be flexible and to
account for technological advancement and changed circumstances over
time.
    HHS has also reconsidered the evidence presented in the SUNSET
final rule concerning cost-benefit projections at the time of
promulgation, and we now determine that it is of limited, if any,
relevance to HHS. In particular, in order to reach the conclusion that
limitations in ``government projections'' counsel in favor of
widespread retrospective regulatory review specifically for HHS, the
SUNSET final rule relied on a 2005 OMB report that compared pre- and
post-regulation cost-benefit calculations for 47 regulations at five
agencies. However, the report did not include HHS or any HHS
regulations.\36\ Moreover, the 2005 OMB report looked at rules dating
back from 1975 to 1996.\37\ The SUNSET final rule also relied upon
another study that evaluated OMB's 2005 report to Congress on the
benefits and costs of Federal regulations and a 2005 analysis sponsored
by the SBA, but this study did not evaluate any HHS regulations.\38\ In
addition, the SUNSET final rule presented, as evidence of inaccuracies
in regulatory cost-benefit analysis, a publication that looked at eight
regulations and included only one HHS regulation, an FDA rule related
to food safety.\39\ One single FDA regulation is not a sufficiently
representative sample from which any generalizable conclusions may be
drawn regarding HHS regulations. Finally, another study relied upon in
the SUNSET final rule pertained to only one regulation promulgated by
the Environmental Protection Agency (EPA) to address arsenic in
drinking water.\40\ It is not possible to draw any conclusions about
HHS regulations from a study looking at just one EPA regulation.
---------------------------------------------------------------------------

    \36\ OMB, Validating Regulatory Analysis: 2005 Report to
Congress on the Costs and Benefits of Federal Regulations and
Unfunded Mandates on State, Local, and Tribal Entities (2005), at 42
(available at https://perma.cc/R8LX-BQMJ) (comparing pre- and post-
regulation cost-benefit data for regulations promulgated by the
Occupational Safety and Health Administration, the National Highway
Traffic Safety Administration, the Environmental Protection Agency,
the Department of Energy, and the Nuclear Regulatory Commission).
    \37\ Id.
    \38\ See 86 FR5697 (citing Winston Harrington, Grading Estimates
of the Benefits and Costs of Federal Regulation, Res. for the
Future, Discussion Paper 06-39 (2006)).
    \39\ See 86 FR 5698 (citing Richard Morgenstern, Retrospective
Analysis of U.S. Federal Environmental Regulation, 9 J. of Benefit
Cost Anal., no. 2., 285-304 (2018)).
    \40\ See 86 FR 5698 (citing Cynthia Morgan & Nathalie B. Simon,
National primary drinking water regulation for arsenic: A
retrospective assessment of costs, 5 J. Benefit Cost Anal. no. 2
(2014)).
---------------------------------------------------------------------------

    The Department also strongly disagrees that there is a lack of an
evidentiary basis for many of its regulations. At the most basic level,
the Department relies on evidence to guide it in its public health
mission, including its rulemaking efforts. The economic analyses for
rulemakings include qualitative and quantitative consideration of the
impacts. Evidence, data, and analyses are considered to the extent
available and are reflected in the RIAs for the regulations. The
analyses and supporting data are included and made publicly available
when the rulemaking is published. The same principles apply to the
entire rulemaking.
    We are also not persuaded that the working paper cited by the
commenter supports the proposition that HHS's regulations lack an
evidentiary basis. Critically, the paper limited its assessment to
preliminary regulatory impact analyses accompanying proposed
economically significant regulations. This approach discounts any
additional evidence gathered between a notice of proposed rulemaking
and publication of a final rule, including evidence from public

comment incorporated into the final regulatory impact analysis. Thus,
the commenter likely errs when transferring the findings of the report
to finalized regulations, since HHS is more likely to publish final
rules of actions that are justified. As an additional concern, the
underlying report adopts several assessment criteria that do not speak
to the quality of evidence presented in the preliminary regulatory
impact analyses. For example, the paper awards points based on writing
style, including whether the RIA is ``written in plain English (light
on technical jargon and acronyms, well organized, grammatically
correct, direct language used),'' and on how well a non-specialist
reader would understand the analysis, results, and conclusion. Although
these factors may represent desirable practices, they do not relate to
the evidentiary basis of a regulation. The commenter highlights the
paper's findings related to retrospective review; however, this score
relates to whether a preliminary regulatory impact analysis discusses
whether ``the proposed rule establish[es] measures and goals that can
be used to track the regulation's results in the future'' and whether
it ``indicate[s] the data it will use to assess the regulation's
performance in the future and establish[es] provisions for doing so?''
\41\ Similarly, although these may represent desirable practices, they
do not speak to the evidence contained in regulatory impact analysis of
HHS regulations. Finally, we note that the paper covers proposed rules
published between 2008 and 2013. It is quite likely that a more recent
assessment would yield higher scores for HHS as regards some of the
scoring criteria. For example, the paper assigned points based on
accessibility, including whether an agency publishes proposed rules and
RIAs on its website. FDA now maintains a website containing Economic
Impact Analyses of FDA regulations, which contains links to at least
170 regulatory impact analyses the agency has developed since 2012.\42\
Other HHS agencies currently routinely publish preliminary RIAs in the
same document as notices of proposed rulemaking in the Federal
Register, which is also available online.\43\ Thus, we anticipate that
a more recent assessment of the availability of RIAs online would yield
higher scores in this category. The report also assigned points based
on the verifiability of the models and assumptions used in the
analysis, including whether the RIAs include citations to sources that
justify the models or assumptions. Since the time of the paper, HHS has
updated its approach to valuing reductions in mortality risks in
benefit-cost analysis by commissioning a criteria-driven review of the
empirical literature on the value per statistical life (VSL),\44\ and
has published subsequent documentation of the Department's approach to
updating the VSL to account for income growth and inflation.\45\ HHS
also commissioned research on the approaches used to value changes in
time use and research on estimating impacts related to medical costs in
RIAs, publishing conceptual frameworks and best practices on each of
these topics.46 47 HHS also published Guidelines for
Regulatory Impact Analysis in 2016, which includes best practices for
conducting prospective and retrospective analysis.\48\ Since HHS RIAs
routinely reference these documents, as well as the models and
assumptions contained in these documents, we anticipate that a more
recent assessment of the verifiability of the models and assumptions
used in RIAs would also yield higher scores in this category.
---------------------------------------------------------------------------

    \41\ https://www.mercatus.org/system/files/Ellig-Reg-Report-Card-Eval-v1.pdf. Quotes are located on pages 14 and 94.
    \42\ https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
    \43\ https://www.federalregister.gov/.
    \44\ Robinson, L.A., & Hammitt, J.K., ``Valuing reductions in
fatal illness risks: Implications of recent research,'' 25(8) Health
Economics 1039-52 (2016).
    \45\ Office of the Assistant Secretary for Planning and
Evaluation, U.S. Department of Health and Human Services, ``Appendix
D: Updating Value per Statistical Life (VSL) Estimates for Inflation
and Changes in Real Income'' (June 2021) (available at https://aspe.hhs.gov/reports/updating-vsl-estimates).
    \46\ Office of the Assistant Secretary for Planning and
Evaluation, U.S. Department of Health and Human Services, ``Valuing
Time in U.S. Department of Health and Human Services Regulatory
Impact Analyses: Conceptual Framework and Best Practices'' (June
2017) (available at https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework).
    \47\ Office of the Assistant Secretary for Planning and
Evaluation, U.S. Department of Health and Human Services,
``Estimating Medical Costs for Regulatory Benefit-Cost Analysis:
Conceptual Framework and Best Practices'' (June 2017) (available at
https://aspe.hhs.gov/reports/estimating-medical-costs-regulatory-benefit-cost-analysis-conceptual-framework-best-practices).
    \48\ https://aspe.hhs.gov/reports/guidelines-regulatory-impact-analysis.
---------------------------------------------------------------------------

    The Department also does not agree that the fact that regulated
entities must comply with HHS regulations is a reason to retain the
SUNSET final rule. The commenters appear to suggest that widespread
review of regulations is needed as a sort of quid pro quo for regulated
entities to comply with those regulations. But to the extent that these
comments are purporting to protect the interests of regulated entities,
HHS does not agree that the SUNSET final rule protects those interests.
We have now determined, as discussed in Section VI, that the quantified
costs of the rule far outstrip the quantified benefits, and the
expiration provision threatens the basic regulatory frameworks on which
regulated entities rely. Furthermore, the Department has finite
resources, and we seriously doubt that deploying those resources for
roving review under the SUNSET final rule, rather than other
initiatives important to regulated entities, is in these entities'
interest. We note that almost no regulated entities submitted comments
in support of the SUNSET final rule.
    Although some commenters stated that HHS regulations generally are
burdensome, these commenters did not identify any specific regulations
or offer support for their assertions. In any event, we disagree with
the assertion. HHS regulations enhance public health, safety, and
welfare and provide significant cost savings by, for example:
Facilitating the implementation of programs to benefit millions of
stakeholders, including underserved populations; preventing serious
harm to the public; providing clarity and consistency across the public
health spectrum to streamline compliance with statutory requirements;
creating a level playing field for businesses; and boosting consumer
confidence.
    In general, HHS agrees that there is value in retrospective review,
but it must weigh that value against the value of other competing
regulatory objectives that may be of equal or greater importance.
Weighing those considerations, the Department has determined that the
SUNSET final rule is not an appropriate way to achieve the goals of
retrospective review.
    Comment: Some commenters stated that the SUNSET final rule should
be retained because it provides benefits to the public. These
commenters stated, for example, that the rule: allows HHS to consider
new developments in science and medicine, better respect legal rights
of conscience and religion, and perform more accurate cost-benefit
analyses; gives ``recurring departmental attention to the impact of HHS
regulations on small and independent businesses;'' increases
accountability to real-world impacts; and makes sure that regulations
``do not unnecessarily burden the American public through sheer
inertia.'' Some commenters stated that the rule would ``eliminate red
tape,'' lead to ``faster economic growth'' and ``significant economic
benefits,'' and ``save lives.'' Certain policy advocacy groups
suggested that the

SUNSET final rule benefits individuals because it provides a mechanism
for every American to have their voice heard.
    Response: HHS does not agree that the SUNSET final rule should be
retained based on these purported benefits. First, HHS considers
matters of conscience and religion as relevant and appropriate as a
matter of course, and has an Office for Civil Rights to address such
issues as they arise. We do not see how conducting retrospective
reviews under SUNSET final rule is necessary or even helpful to better
respect legal rights of conscience and religion.
    Second, for the purported benefits of eliminating red tape, faster
economic growth, significant cost savings and other types of broad
economic benefits, and saved lives, HHS considers these speculative and
not obviously attributable to the SUNSET final rule. The commenters
make a number of leaps in their analysis to assert these benefits. For
example, they assume that (1) regulations would be amended or rescinded
following review under the SUNSET final rule; (2) these amendments and
rescissions would have overall economic and/or life-saving benefits;
and (3) no other Department processes would result in these same
amendments or rescissions. We disagree both with these assumptions and
the chain of reasoning leading to the conclusion that the SUNSET final
rule would necessarily have these benefits. As discussed in more detail
in our preliminary and final regulatory impact analyses, see 86 FR
59922 and Section VI, the benefit attributable to the SUNSET final rule
is the benefit of any information learned from completing the
assessments and reviews. We note that the SUNSET final rule's
regulatory impact analysis, similarly, contained very little discussion
of benefits and did not quantify any benefits of the rule. 86 FR 5749.
    Third, for the purported benefit of helping individuals--for
example, by making it easier for them to participate in the process of
regulatory review and have their voices heard--we do not agree that the
SUNSET final rule would provide that benefit. Our view, which is
informed by many comments on this subject as discussed in detail above,
is that the SUNSET final rule generally harms individuals. The rule
poses harm through, among other things, Department and stakeholder
diversion of resources away from other important initiatives,
uncertainty, and loss of regulatory programs through expiration. And,
with respect to regulations that automatically expire, there will have
been no notice and comment process for the expiration of those specific
regulations. Even considering in a vacuum the purported benefit of
increased stakeholder participation, our regulatory impact analysis
recognizes that the approach of the SUNSET final rule creates greater
costs for stakeholders. Furthermore, the sheer volume of rulemakings
under assessment and review risks overwhelming individual commenters
and preventing their participation.
    Fourth, for the remaining benefits asserted by commenters, such as
incorporating new scientific information and updating impact analyses,
HHS recognizes that these could be potential benefits of an
appropriately targeted and manageable retrospective review scheme.
Thus, the RIA notes that the final withdrawal rule will result in
forgone information as a result of not performing the SUNSET final
rule's assessments and reviews. See Section VI below. However, we
disagree that the SUNSET final rule would have generated significant
benefits in these areas that outweigh the costs. Among other things,
the pace and scope of assessments and reviews, combined with the threat
of expiration, would likely curtail the careful and thorough
deliberation needed to produce these types of benefits and could reduce
the quality of regulatory reviews. Moreover, because HHS already
undertakes regulatory review under the RFA and otherwise, benefits in
these areas, if any, would only be incremental over the ones already
produced.
    In light of the limited nature of the potential benefits, and
balancing those potential benefits against the significant harms of the
rule (which include, for example, resource diversion from other key
programs, uncertainty, and the potential loss of regulations through
the expiration mechanism), the Department has determined that the
SUNSET final rule should be withdrawn. The Department recognizes that
it previously concluded, in the SUNSET final rule, that the value of
the rule's retrospective review program outweighed any harms associated
with the rule. However, the Department has since identified multiple
flaws in its prior analysis that have led it to reconsider and reverse
this conclusion. Among other things, finalization of the SUNSET final
rule was premised on a miscalculation of the resources needed to comply
with the rule. Because of that error, the analysis in the SUNSET final
rule failed to recognize the effects the rule would have on other key
programs and initiatives and the likelihood of expiration. The
Department also previously miscalculated the substantial burdens the
rule would place on stakeholders. Overall, HHS now recognizes that any
informational benefits of the rule are greatly outweighed by its harms,
and that the rule is irreconcilable with the Department's public health
mission. Thus, HHS is withdrawing this rule.
    Comment: Several commenters referred to various E.O.s issued over
the years related to retrospective review. One of these commenters
stated that HHS, in withdrawing the SUNSET final rule, must consider
compliance with the E.O.s identified in the preamble to that rule.
    Response: First, we note that many of the E.O.s referred to in
these comments or identified in the SUNSET final rule have been
revoked, including E.O. 12044, E.O. 12291, E.O. 12498, E.O. 13771, and
E.O. 13924. Thus, there is no requirement or expectation of
``compliance'' with these E.O.s.
    Second, HHS has considered these E.O.s and does not agree that they
provide support for retaining the SUNSET final rule. Most of these
E.O.s direct agencies to develop plans for the periodic review of
existing significant regulations to determine whether any such
regulations should be modified or repealed so as to make the agency's
regulatory program more effective or less burdensome. One E.O. focuses
on public engagement and OMB reporting with respect to the same scope
of retrospective review. HHS already took various actions in response
to these E.O.s, including publishing a plan and soliciting
comments.\49\ Moreover, the E.O.s have a different purpose and focus
than the SUNSET final rule, which purports to focus on minimizing the
impacts of regulations on small entities. See, e.g., 86 FR 5751
(defining ``Review'' as ``a process . . . the purpose of which shall be
to determine whether Sections [of the CFR] . . . should be continued
without change, or should be amended or rescinded, consistent with the
stated objectives of applicable statutes, to minimize any significant
economic impact of the Sections upon a substantial number of small
entities.'').
---------------------------------------------------------------------------

    \49\ More information about HHS's actions, including HHS's plan,
progress on the plan, and public engagement, is available here:
https://www.hhs.gov/open/retrospective-review/index.html.
---------------------------------------------------------------------------

    Thus, we disagree that the E.O.s constitute a reason to retain the
SUNSET final rule.
    Comment: In the Withdrawal NPRM, the Department invited comment on
the experience of states and foreign governments implementing laws
requiring ``sunset reviews.'' A few

commenters provided an assessment of the positive experience some
states and foreign governments have had with implementing their own
sunset laws. These commenters opposed the Withdrawal NPRM and pointed
to the experience of North Carolina, Missouri, and Texas, whose state
legislatures have each established a sunset law and a process for the
review of state regulations that feature a sunset mechanism. One
commenter stated that North Carolina's process, under which all agency
rules are slated for automatic repeal in 10 years unless reviewed,
resulted in the repeal of about one state rule out of every ten
reviewed. A second comment described the cost savings attributed to the
Texas Sunset Advisory Commission. A third comment noted that Missouri
connects a sunset provision to a five-year periodic review requirement
in a manner very similar to the SUNSET final rule. In contrast, a
comment submitted by the North Carolina attorney general, together with
19 other State attorneys general, expressed support for withdrawing the
SUNSET final rule, noting that the SUNSET final rule posed a direct
threat to their states' health care systems and the health and safety
of their residents.
    Response: We appreciate that the commenters provided information in
response to our request. The SUNSET final rule cited the experience of
states and foreign governments as a justification for the rule, noting
that the mechanism of retrospective review being implemented by the
SUNSET final rule was informed by the experience of states and other
jurisdictions that allow for the automatic expiration of regulations
subject to review. See 86 FR 5700 (``experience in the States suggests
that sunset provisions can be an important tool to ensure reviews take
place''). However, the SUNSET final rule did not account for myriad
ways in which those state and international frameworks cited are
considerably different from each other, nor did it account for their
considerable differences with the SUNSET final rule.\50\
---------------------------------------------------------------------------

    \50\ See, e.g., N.D. Cent. Code 28-32-18.1 (permitting amendment
or repeal of rules without complying with the other requirements of
North Dakota's Administrative Agencies Practice Act relating to
adoption of rules); 75 OK Stat section 75-307.1 (2014) (directing
the Oklahoma House and Senate to conduct rule review); Tenn. Code
Ann. section 4-56-102 (limiting review to procurement rules). One
state cited had repealed its sunset provision. Rhode Island created
an Office of Regulatory Reform to review proposed and existing rules
and regulations, but the statutory provision requiring all agencies
to conduct periodic review of rules was repealed. See R.I. Gen. Laws
Ann. tit. 42, ch. 64.13; see also 2016 R.I. Pub. Laws 206 (June 29,
2016) (repealing section 42-35-3.4 of Rhode Island's Administrative
Procedures Act).
---------------------------------------------------------------------------

    The Department has given further consideration to differences
between state sunset laws, such as those of North Carolina, Missouri,
and Texas, and the HHS SUNSET final rule. These differences include the
legislative origins, implementation, operations, governing
administrative law requirements, and the scope, breadth and volume of
regulations. More specifically, the states' experience with their
sunset laws is of limited relevance to HHS because of the vastly
greater scope of national regulations that impact tribal, state and
local governments, and international stakeholders; the corresponding
greater extent of the economic and public health impacts of the
regulations; the amount of Department and stakeholder resources
consumed by that larger scope; and differences in governing law,
including the APA. We now conclude that the differences are so stark
the states' experiences have limited relevance for the Department and
do not support retention of the SUNSET final rule.
    For example, with respect to North Carolina, the initial assessment
outlined in its sunset law does not entail the multi-factor review and
assessment required by the SUNSET final rule to evaluate whether a
regulation has significant economic impact on a substantial number of
small entities. Rather, the North Carolina law enacted by the General
Assembly entails periodic review and expiration based on whether the
rule is ``necessary with substantive public interest,'' ``necessary
without substantive public interest,'' or ``unnecessary.'' \51\ Given
that this framework is starkly different from the framework in the
SUNSET final rule, and given the differences in the breadth and
complexity of the underlying HHS regulations as compared to state
regulations, the state experience implementing its own law does not
shed much light on how implementation of the SUNSET final rule would
impact the Department and its stakeholders. For example, the state
experience does not inform the extent of Federal resources which would
be diverted from addressing public health goals to undertake the scale
and pace of reviews required by the SUNSET final rule, and potentially
defend against challenges to each of those actions.
---------------------------------------------------------------------------

    \51\ N.C. Gen. Stat section 150B-21.3A, ``Periodic Review and
Expiration of Existing Rules.''
---------------------------------------------------------------------------

    The commenter also contended that continuing to create regulations
without revisiting them is irresponsible because, with decades passing
by without review, it is reasonable and likely to expect some portion,
possibly sizeable, of HHS rules to be obsolete. The commenter asserted
that North Carolina's experience with regulatory review supports this
assertion. We disagree. The commenter's characterization of HHS
regulations was conclusory and not grounded in any actual evaluation of
current HHS regulations. In particular, it failed to take into account
the regulatory reviews that have taken place and it assumes without
evidence that the passage of time alone makes regulations obsolete.
However, as discussed in greater detail elsewhere in this section, many
regulations remain unchanged because they work as intended. For
example, regulations that establish product standards or public service
programs may not need periodic updates and their automatic expiration
would cause public harm.
    Under the Texas Sunset Law, the Texas Legislature sets an
expiration date in an agency's authorizing statute and a review cycle
to determine whether the Agency should be automatically abolished on
this date or continued. As part of a review cycle, the Agency must
submit a self-evaluation report, the public is invited to submit
comments, and then the Texas Sunset Advisory Commission, a legislative
advisory body, reviews the information and makes a recommendation
whether to abolish or continue the agency. If the recommendation is for
the Agency to continue, the Legislature must pass a bill to continue
the Agency. As explained by Sunset Advisory Commission, in the self-
evaluation report agencies describe their mission, functions, and
programs, provide operational and performance data, and identify
potential issues and opportunities for change through the Sunset
process.\52\ Thus, the Texas agencies are not required to provide an
assessment or review of their regulations. Because this scheme differs
so vastly from the SUNSET final rule, Texas is not an appropriate model
or comparator for the SUNSET final rule.
---------------------------------------------------------------------------

    \52\ Sunset Advisory Commission, ``Sunset in Texas 2022-2023,''
88th Legislature (Sept. 2021) (available at https://www.sunset.texas.gov/public/uploads/files/reports/Sunset%20in%20Texas%202022-23.pdf).
---------------------------------------------------------------------------

    With respect to Missouri, we already explained that the quantity of
regulations subject to review in that state represents a small fraction
of HHS regulations, and their substantive scope is far more limited.
See Section V.B.3. We also note that it was the Missouri General
Assembly that enacted

legislation directing State agencies to conduct periodic review of
rules and rendering rules void if the agency fails to timely file a
report on their review.\53\ Thus, the Missouri example does not show
that the relevant agencies themselves view this type of sunset
framework as advantageous or beneficial to their missions or that they
would choose of their own volition to allocate their resources in this
manner. In contrast, Congress has not directed the Department or any
other agency, under the RFA or any other statute, to adopt a sunset
mechanism for their regulations.
---------------------------------------------------------------------------

    \53\ Missouri Rev. Stat., Title XXXVI section 536.175.5.
---------------------------------------------------------------------------

    One commenter also cited an Organisation for Economic Cooperation
and Development (OECD) \54\ report on the ex post review of laws and
regulations and reiterated that the SUNSET final rule acknowledges that
some countries have sunset provisions. However, no commenters provided
substantive information about the experience of foreign governments
adopting such laws. Thus, the Department concludes that the resource
allocations of foreign governments, and approaches adopted in countries
not bound by the U.S. APA, are not instructive for one department of
the U.S. Government to adopt unilaterally.
---------------------------------------------------------------------------

    \54\ The OECD is forum where 37 democratic governments with
market-based economies collaborate to develop policy standards to
promote sustainable economic growth. See https://www.state.gov/the-organization-for-economic-co-operation-and-development-oecd/.
---------------------------------------------------------------------------

    The comment submitted by the North Carolina attorney general and 19
other State attorneys general in favor of withdrawing the SUNSET final
rule, reflects that these attorneys general do not share the views of
the commenters discussed above. Despite a comment indicating the lack
of reports of accidental expirations of regulations encountered, for
example, in North Carolina's regulatory reform process, the attorneys
general stated that the considerably different process embodied by the
SUNSET final rule would threatens their states' health care systems and
the health and safety of their residents. We agree with this comment
and find it notable that an attorney general from a state with sunset
provisions does not find their experience with the sunset law to be
beneficial enough to encourage HHS to adopt its own. In sum, as
discussed above, we conclude that the states' experience with sunset
laws do not support retention of the SUNSET final rule.

D. Other Legal Comments

    In issuing the Withdrawal NPRM, the Department explained that
questions had been raised in comments on the SUNSET proposed rule as to
whether the SUNSET final rule is consistent with the procedural and
substantive requirements of the APA. 86 FR 59921. Commenters on the
Withdrawal NPRM discussed these and other legal issues. Below, we
respond to the comments on (1) the legal issues with the SUNSET final
rule, (2) legal arguments regarding this withdrawal proceeding, (3)
proposed modifications to the SUNSET final rule, and (4) other legal
issues raised in comments.
1. Legal Objections to the SUNSET Final Rule
    Comment: Multiple comments stated that the expiration portion of
the SUNSET final rule violates the APA because, to amend or repeal a
rule under the APA, an agency must conduct a notice-and-comment process
specific to the individual rule being amended or repealed. Various
comments identified regulations subject to the expiration provision
whose elimination would likely cause harm to the public, and stated
that HHS was obligated to consider the seriousness of these potential
harms. Other comments stated that the expiration provision was unlawful
for other reasons, such as that it lacked or was contrary to statutory
authority.
    One commenter disagreed, arguing that the expiration provision is
consistent with the APA because HHS followed the APA's rulemaking
procedure in adopting the SUNSET rule and because ``the Sunset Rule
merely encoded what the RFA already contemplates.'' Another commenter
stated that HHS must ``specifically address the inconsistency between
its current view that the SUNSET Rule stands on a legally questionable
footing, and its prior conclusion that it was legally sound under the
RFA.''
    Response: The Department agrees with commenters who raised
questions about lawfulness of the expiration provision. Specifically,
we have serious concerns that the SUNSET final rule's automatic
expiration provision, as constructed, was not adequately justified
under the APA. Similarly, we also question whether the SUNSET proposed
rule was sufficiently detailed to provide adequate notice and an
opportunity to comment on the potential expiration of each and every
regulation covered under the SUNSET final rule.
    ``The APA's arbitrary-and-capricious standard requires that agency
action be reasonable and reasonably explained.'' FCC v. Prometheus
Radio Project, 141 S. Ct. 1150, 1158 (2021). An ``agency must examine
the relevant data and articulate a satisfactory explanation for its
action including a `rational connection between the facts found and the
choice made.' '' State Farm, 463 U.S. at 43 (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. If the agency has ``entirely failed to
consider an important aspect of the problem,'' the rule is ``normally .
. . arbitrary and capricious.'' Id. These principles apply in full
force to agency decisions to amend or repeal regulations. See generally
id. 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, the SUNSET final rule would have amended thousands of
regulations to schedule their expiration if the Department failed to
conduct assessments and reviews on a certain timetable. In addressing
this subject, the Department did not provide any particularized
consideration of the regulations subject to expiration. It did not
consider the specific ``facts and circumstances that underlay'' these
regulations, such as the statutory directives and public health
problems that these regulations address and that would be left
unaddressed upon expiration.\55\ It also did not consider the specific
``facts and circumstances that . . . were engendered'' by these
regulations, such as any reliance interests that may have developed
based on the regulations. The Department did not even identify these
specific facts and circumstances for the covered regulations, let alone
treat them as

relevant factors and weigh them against any perceived advantages of the
SUNSET final rule. In addition, the Department did not address the
various statutory purposes that would be undermined by expiration.
Congress empowered the Department to act through its grants of
authority, but there is no evidence that the Department considered
those legislative goals or considered the expiration amendments in
light of those goals. The expiration amendments were promulgated on a
scale that made it nearly impossible to generate this type of
particularized analysis or explanation.
---------------------------------------------------------------------------

    \55\ For example, the SUNSET final rule amended an FDA
regulation requiring an investigational medical device to disclose
that it is ``[l]imited . . . to investigational use.'' 21 CFR
812.5(a). This regulation responds to a legislative directive to
establish an investigational device program, the public-health need
to establish safeguards for investigational use, and the specific
circumstance that investigational devices could be diverted for
ordinary patient use. Merely by introducing the possibility of
expiration of this regulation without any replacement, the SUNSET
final rule undermines these legislative objectives, threatens basic
public-health protections, and creates uncertainty in the
marketplace about the status of this requirement. But these factors
were not considered when this regulation was amended by the SUNSET
final rule.
---------------------------------------------------------------------------

    Instead, the Department offered the categorical 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.
One commenter asserted that this type of rationale, focusing solely on
benefits and importance of retrospective review, meets the satisfactory
explanation requirement in the APA. However, the Department now
questions that assertion. We doubt that this one-sided explanation,
which considers none of the facts, circumstances, or goals of the
regulations subject to expiration, would enable a court to conclude
that the expiration amendment was reasonable and reasonably explained.
Ultimately, the Department failed to genuinely grapple with the
potential harms of each amended regulation expiring, and the Department
now acknowledges that those harms are unquestionably ``relevant
factors.''
    The Department recognizes that it previously stated that it was
``considering the important factors'' in the SUNSET final rule, but
this bare assertion is belied by the fact that the rule did not
elaborate on any factors other than the benefits of retrospective
review. 86 FR 5716. The Department also stated that it had ``provide[d]
the reasoned explanation that would be required if it were a change in
policy,'' but, as previously noted, the Department did not provide any
explanation addressing the relevant factors. Id. at 5702. In addition,
in the final rule, HHS stated that it ``considered each individual
Department regulation'' in connection with deciding whether to exempt
the regulation from the scope of the SUNSET final rule. Id. at 5703.
However, courts have found that ``[s]tating that a factor was
considered . . . is not a substitute for considering it,'' Getty v.
Fed. Sav. & Loan Ins. Corp., 805 F.2d 1050, 1055 (D.C. Cir. 1986), and
the record does not provide further evidence of Departmental
consideration of the individual covered regulations. On the contrary,
the SUNSET final rule contains a list of various regulations that
commenters had proposed for exemption from the SUNSET final rule and
then concludes, without explanation, that the regulations would not be
exempt. 86 FR 5736. This bare conclusion appears to be directly at odds
with the Department's obligations under the APA to consider the
relevant factors and adequately explain its decision.\56\
---------------------------------------------------------------------------

    \56\ The Department also previously justified the SUNSET final
rule by comparing it to an amendment to a specific rule to add an
expiration date, or an amendment to a defined term that is more
widely applicable to a set of regulations. However, those
comparisons do not address the underlying concern that the
expiration provision lacked adequate justification. Because of the
differences in scope, scale, and effect, it is far more likely that
HHS could provide appropriate notice, consider the relevant factors,
and produce the record needed to support those more targeted
amendments, in contrast to the global amendment created by the
SUNSET final rule.
---------------------------------------------------------------------------

    The legal defects described above concerning the SUNSET final
rule's amendments to regulations are the same, only magnified, in the
circumstance that the SUNSET final rule results in the automatic
expiration of a regulation. As reflected elsewhere in this preamble,
the Department has determined that it is likely that at least some
amended regulations would expire because of overburdened resources.
Even if that were not immediately the case, this framework would allow
a future administration with a deregulatory agenda to strategically
repeal regulations through inaction. In the event of such expiration,
the Department would be reversing course on a policy embodied in a
regulation without any specific analysis of, or justification for--and
without notice and an opportunity to comment on--the expiration,
including the original motivating factors for issuing the regulation
and potential relevant reliance interests. The Department likewise
appears not to have examined whether expiration--without notice and
comment--would be consistent with the HHS agency's decision not to
impose a termination date when it promulgated the rule in question.
But, as noted above, when an agency changes course, such as by
repealing a regulation, ``a reasoned explanation is needed for
disregarding facts and circumstances that underlay or were engendered
by the prior policy.'' Fox, 556 U.S. at 515-16.
    The failure to consider reliance interests, in particular, presents
a substantial legal concern in light of the Supreme Court's admonition
that ``[w]hen an agency changes course, . . . it must be cognizant that
longstanding policies may have engendered serious reliance interests
that must be taken into account.'' Dep't of Homeland Sec. v. Regents of
the Univ. of Cal., 140 S. Ct. 1891, 1913 (2020) (internal quotations
omitted). The Court held that agencies in the midst of policy change
are ``required to assess whether there were reliance interests,
determine whether they were significant, and weigh any such interests
against competing policy concerns.'' Id. at 377. The Department's
regulations, which affect a significant sector of the American economy,
undoubtedly could have engendered varying degrees of reliance, and the
expiration of those regulations could undermine any such reliance
interests. At the time that a particular regulation expires under the
SUNSET final rule, however, the Department would not have considered
any of those regulation-specific interests.
    In the SUNSET final rule, HHS acknowledged the significant
potential for there to be reliance interests in existing HHS
regulations. For example, it stated that it had increased the length of
time before the first expiration date from two years to five years in
order to give ``the regulated community . . . five years to adjust to
the changes made by this final rule, so any reliance interests are
significantly reduced as compared to the proposed rule.'' 86 FR 5709.
The Department has reconsidered this statement and has determined that
this additional length of time is unlikely to significantly reduce
reliance interests because the public would not know, likely for most
of the five-year time period, whether a regulation would actually
expire. In any event, the Department did not supply the particularized
analysis regarding reliance interests contemplated by the Supreme
Court, and the Department now doubts that this approach is lawful under
the APA.\57\
---------------------------------------------------------------------------

    \57\ The Department also continues to be concerned that the
specific exemptions included in the SUNSET final rule were not the
product of reasoned decision-making. The Department exempted certain
FDA regulations, for example, because they ``simply create product
identities'' and because, according to the Department, some subset
of those regulations are being reviewed under other processes. 86 FR
5731. However, these regulations do not simply create product
identities; instead, they describe the conditions under which
certain products can be marketed. The stated reasoning does not
appear to support the exemption decision or their scope. In
addition, the existing review processes cited by the Department only
apply to a subset of the exempted regulations, and some of those
review processes are limited to narrow issues, such as whether a
device should be exempt from premarket review. See 86 FR 5731 nn.
199, 200 (citing 21 U.S.C. 360(l), (m) and 85 FR 21795). Finally,
the exemptions are underinclusive: The Department failed to include
other regulations that are similar, such as those codifying the
standards for human blood and blood products or those codifying
animal drug approvals.

---------------------------------------------------------------------------

    HHS also disagrees with the commenter who stated that ``the Sunset
Rule merely encoded what the RFA already contemplates.'' As explained
elsewhere in this preamble, the RFA neither explicitly nor implicitly
provides authority for automatic expiration dates. With respect to the
comment that HHS must specifically address the inconsistency between
its current view that the SUNSET final rule stands on a legally
questionable footing, and its prior conclusion that it was legally
sound under the RFA, the Department now has concluded that the SUNSET
final rule exceeded the requirements of the RFA and did so in a manner
that likely violates the APA.
    Comment: Multiple comments objected to the length of the comment
period for the SUNSET proposed rule. One comment stated that ``HHS did
not provide . . . a meaningful opportunity for comment'' under the APA.
Another comment stated that the Department ``failed to provide any
justification for the unusually short 30-day comment period'' for
portions of the proposed rule. The comment stated that the ``ability of
the public to meaningfully and thoroughly comment on all aspects of the
[SUNSET proposed rule] was compromised by the lack of prior notice and
the shortened comment period.''
    Response: The Department shares the commenters' concerns that the
30-day comment period on the SUNSET proposed rule did not provide a
meaningful opportunity for comment in this particular rulemaking. The
SUNSET final rule was indisputably complex and vast in scope and
impact, affecting thousands of regulations. Given the complexity of
this rule, we are no longer confident in the Department's previous
conclusion that the comment period during the initial SUNSET rulemaking
was adequate. However, because the Withdrawal NPRM provided an
opportunity for additional comment on the SUNSET final rule and because
the SUNSET final rule is now being withdrawn, this procedural concern
about the SUNSET proposed rule is now moot.
2. Legal Objections to Withdrawal of the SUNSET Final Rule
    Comment: One comment asserted that the proposed withdrawal of the
SUNSET final rule would be unlawful under the APA because HHS has not
considered the ``relevant factor'' of compliance with the RFA. The
comment stated that the SUNSET rule put HHS into compliance with the
RFA, and that HHS ``ignored important factors'' when it ``fail[ed] to
explain how [it] will, in the alternative to the SUNSET Rule, comply
with the RFA.'' The comment also stated that HHS was obligated to
explain how ``its actions during the delay [of the SUNSET rule
effective date] complied with its RFA obligations.''
    Response: HHS agrees that it must consider ``relevant factors'' in
issuing this withdrawal decision, including the requirements of
applicable statutes and the impact of the SUNSET final rule on
stakeholders. Thus, the Department's statutory obligations under the
RFA is one of the factors we must consider. Elsewhere in this preamble,
the Department has discussed in detail how it complies with the RFA's
requirements to publish a plan for periodic review and a list of the
rules to be reviewed each year and how it completes regular reviews of
its regulations under section 610. All of these RFA activities
continued during the delay of the effective date for the SUNSET final
rule. HHS intends to continue its current practices under the RFA.
Thus, HHS has considered the factor of compliance with the RFA and does
not believe this factor requires the Department to retain the SUNSET
final rule.
    Comment: One comment identified various factors that, in the
commenter's view, are ``important aspects'' that HHS needs to consider
under the APA in order to withdraw the SUNSET final rule. The comment
stated that these factors include (1) ``the disruption that . . . this
repeal rule would have on the agency and on public participation in the
review process'' and ``the degree of regulatory uncertainty that [this
rule] create[s]''; (2) ``the interests of doctors who would benefit
from the on-time implementation of the SUNSET Rule to rules like the
gender identity [nondiscrimination] mandate in HHS's Section 1557 rule
under the ACA, HHS's gender identity [nondiscrimination] mandate in its
grants rule 45 CFR 75.300(c) and (d), and HHS's conscience rule at 45
CFR part 88''; and (3) the public's ``interests in participating in
notice and comment procedures to lift regulatory burdens on small
entities.''
    Response: We disagree with this comment's characterization of this
rulemaking and its assessment of its impacts. With respect to the first
factor identified in the comment, concerning disruption to the agency
and the public, HHS has determined that it is the SUNSET final rule,
and not withdrawal of the SUNSET final rule, that will disrupt the
Department's operations and create regulatory uncertainty. With
elimination of the SUNSET final rule, HHS agencies and the public can
have confidence that resources will continue to be allocated in the
manner that best promotes the Department's mission, and that HHS's
regulations will be amended or repealed through the well-established
APA rulemaking processes. Because the SUNSET rule never took effect,
the Department has not taken any implementation steps that would be
disrupted by this withdrawal. Furthermore, because the rule never took
effect, HHS has no reason to believe that the public has developed
processes or expectations that would be disrupted by this withdrawal.
This is particularly true given that the SUNSET final rule was issued
on January 19, 2021, and a new administration, with new policies and
priorities, entered office on January 20, 2021. Even in the
unanticipated circumstance that significant reliance interests have
developed, we believe those interests would be outweighed by the
important reasons for withdrawal identified in this preamble.
    With respect to the second factor, the suggestion that the
expiration of regulations under the SUNSET final rule will benefit
certain doctors who disagree in conscience with certain HHS rules is
entirely speculative, and we do not agree that it is an ``important
aspect of the problem'' that must be evaluated in connection with this
withdrawal action. Even if this could be considered a relevant factor,
the interests of this one subgroup do not outweigh the many important
reasons for withdrawing this rule, including differing views on the
same regulations as well as the risks the rule poses to a far larger
sector of the U.S. population.
    With respect to the third factor, concerning the public's interest
in participating in a notice and comment process to lift regulatory
burdens on small entities, HHS notes that under its current processes,
the public already has an opportunity to participate in this type of
notice and comment process when the Department conducts reviews under
section 610. Indeed, section 610(c) requires HHS to ``invite public
comment'' on rules that are being reviewed under the RFA. Furthermore,
the Department publishes its semiannual Regulatory Agenda for the
express ``purpose of . . . encourag[ing] more effective public
participation in the regulatory process.'' \58\ In addition,

HHS implements Department-wide initiatives to support that purpose,
including the Department's regulatory web page with resources such as
links to HHS rules currently open for public comment and an ``HHS
Regulations Toolkit'' providing background information on regulations,
the commenting process, how public comments influence the development
of a rule, and how the public can provide effective comments.\59\ Thus,
to the extent that this is a relevant factor, HHS has considered this
factor and does not agree it justifies retaining the SUNSET final rule.
---------------------------------------------------------------------------

    \58\ See, e.g., Regulatory Agenda, 87 FR 5226 (Jan. 31, 2022).
    \59\ See, e.g., Regulatory Agenda, 86 FR 16892 (Mar. 31, 2021).
---------------------------------------------------------------------------

    Comment: A few comments asserted that HHS has not adequately
considered the benefits of the SUNSET final rule, in violation of the
APA. One comment stated that the Withdrawal NPRM was ``inadequately
supported'' because HHS has not provided ``any meaningful analysis or
balance of the two sides of the issues.'' Another comment asserted that
the benefits of the SUNSET final rule were an ``important aspect of the
problem'' that HHS had ignored.
    Response: In Section V.C.3 of this preamble, the Department has
considered and addressed the various benefits asserted by commenters to
be associated with the SUNSET final rule. Overall, we consider many of
these benefits to be speculative, and we question whether they would
transpire as a result of the SUNSET final rule. Furthermore, we have
confirmed that the SUNSET final rule involves significant costs and
legal vulnerabilities. In light of these considerations, we conclude
that any benefits of the SUNSET final rule do not justify its costs and
do not change the legal analysis of the expiration provision. Because
HHS has considered the purported benefits and weighed them against the
harms in determining that the rule should be withdrawn, we have
fulfilled any applicable obligation under the APA.
    Comment: One comment asserted that ``HHS has not offered sufficient
new reasons to change course'' and withdraw the SUNSET final rule
because ``each reason [provided in the Withdrawal NPRM] had been
considered and rejected in the SUNSET rule.'' The comment also claimed
that the Department did not give the public an adequate opportunity to
comment because the Withdrawal NPRM did not ``disclos[e] to the public
HHS's reasons for changing its views.''
    Response: HHS disagrees with the commenter that its reasons for
withdrawal, as stated in the Withdrawal NPRM and here, are inadequate
or were inadequately communicated to the public. In both documents, HHS
identified a number of reasons why this withdrawal is appropriate, and
we explained in detail why these reasons are persuasive even in light
of the Department's prior analysis. We have been clear that the SUNSET
final rule contained significant errors of fact and law and is contrary
to the policies of the current Administration.
    For example, we explained that in the SUNSET final rule, HHS failed
to give sufficient consideration and weight to the many comments
opposing the SUNSET proposed rule and grossly miscalculated the
resources required to comply with the rule and the manner in which the
rule would affect the Department. Because of that, HHS improperly
dismissed the many concerns raised about the diversion of HHS's
resources from other key initiatives and the harms of expired
regulations, among other things. Although HHS may have previously
``considered and rejected'' these considerations, HHS's decision-making
relied on a fundamentally flawed premise and therefore was unsound.
    In addition, we have explained that, upon review, we believe HHS
previously overlooked key legal defects in the justification for the
expiration provision, which we now must consider in the context of
withdrawal. We have also cited the policy goals of the current
Administration, which strongly support a change in course here. It is
our view that 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. We have also further considered the
evidence HHS previously cited to establish the purported need for or
benefits of the SUNSET final rule, and we have explained why we no
longer consider that evidence to justify the rule. In light of these
and other reasons provided throughout this preamble and in the
Withdrawal NPRM, HHS has adequately justified the change in course.
    Comment: One comment suggested that it is arbitrary and capricious
for HHS to consider the harms of expiration in determining whether to
withdraw the SUNSET final rule. The comment expressed the view that the
SUNSET final rule does not exceed the requirements of the RFA, and
because HHS must comply with the RFA, HHS should assume it can also
comply with the SUNSET final rule and avoid expiration. The comment
posited that, because letting anything expire under the SUNSET rule
would violate the RFA, HHS should not consider expiration (and the
resulting harms) within the realm of possibility.
    Response: We disagree. This comment is premised on the incorrect
assumption that the RFA requires HHS to conduct assessments and reviews
under the processes specified in the SUNSET final rule. As noted
elsewhere in this preamble, that is not true: The requirements of the
SUNSET final rule far exceed the requirements of the RFA. Because of
that, it is entirely reasonable for HHS to predict that it will not be
able to conduct the assessments and reviews in the timeframes required
under the SUNSET final rule, such that regulations will expire, but
that it can, at the same time, fully comply with the RFA. Moreover, HHS
believes that the risk of expiration is exactly the type of relevant
factor it is required to consider. HHS can and must consider whether
its self-imposed retrospective review scheme will consume such
resources, and creates such an existential threat, that duly
promulgated regulations will disappear for reasons that have nothing to
do with their regulatory value.
    Comment: One comment asserted that withdrawal of the SUNSET final
rule will render HHS noncompliant with the RFA's requirements,
including the requirement to publish a plan for periodic review, such
that withdrawal is unconstitutional under the Take Care Clause, the
Supremacy Clause, and the separation-of-powers doctrine. The comment
stated that ``[n]either the President nor HHS can render optional a
statutory directive that HHS publish a plan to periodically review its
code of regulations.''
    Response: HHS disagrees that maintaining the SUNSET final rule is
necessary to prevent non-compliance with the RFA. In Section V.C.2, the
Department discussed its compliance with the RFA, including compliance
with the ``plan'' requirement under section 610(a). In light of this
compliance, to the extent that the Take Care Clause, Supremacy Clause,
or separation-of-powers doctrine are implicated here, the President and
the Department have fully discharged their responsibilities under those
authorities.
3. Proposed Modifications to the SUNSET Final Rule
    Comment: Some commenters stated that HHS should withdraw the SUNSET
final rule in its entirety, citing, for example, the continuing
uncertainty the rule would create. Other commenters identified
modifications to the SUNSET

final rule, short of full withdrawal, that they believed could address
the Department's concerns as described in the Withdrawal NPRM. These
proposed alternatives included providing a longer period for reviewing
existing rules or forgoing the review of existing rules; providing a
longer period for undertaking the reviews; reviewing only a subset of
existing rules, such as those that have already been designated as
having a SEISNOSE, are significant rules, are major rules, have
unfunded mandates, or arise out of a particular section of the CFR,
subagency, or statute; and narrowing or eliminating the expiration
provision. Some of these commenters also suggested that the Withdrawal
NPRM conceded that such targeted approaches are desirable. These
commenters asserted that the Withdrawal NPRM failed to seriously
consider alternatives and asserted that neither of the two alternatives
considered in the Withdrawal NPRM's economic analysis offers a targeted
approach.
    Response: The Department agrees with the commenters who supported
full withdrawal, but thanks the other commenters for offering these
proposed modifications. In evaluating these proposals, we must balance
the relevant factors and determine whether the various proposals
advance the mission, policies, and priorities of the Department. We
must take into account both competing statutory obligations and
significant public health and welfare considerations, among other
things. See Motor Vehicle Mfrs. Ass'n of the U.S., Inc. v. State Farm
Mut. Auto Ins. Co., 463 U.S. 29, 43 (1983) (holding agencies must
consider each ``important aspect of the problem''). After assessing the
benefits and harms of the SUNSET final rule's binding program of
retrospective review, the statutory obligations for HHS to follow
lawful regulatory processes and establish and maintain programs that
serve the public health and welfare, and the Department's basic public
health mission, we have concluded that the relevant factors weigh
heavily in favor of withdrawing the SUNSET final rule in its entirety.
To the extent that there are any issues with HHS's current
retrospective review process, those issues should be addressed through
other means than this rulemaking. Our reasoning is set forth below.
    First, the Department has determined that any version of a
retrospective review program established through binding regulations
could undermine our mission to advance public health and welfare.
Legislative rules impose a legal duty on the Department to conduct
retrospective review regardless of other urgent priorities, and they
create an avenue for litigation based on non-compliance. While the
Department acknowledges that there is value in retrospective review and
has a plan for such review, the resources allocated for retrospective
review can and should vary depending on the circumstances facing an
agency. A prescriptive, binding review framework can improperly skew
priorities, forcing the Department to elevate review above other public
health initiatives that may be more important. The emergence of a
global pandemic, for example, has shown how HHS must have the
flexibility to adapt as new public health demands arise.
    In the RFA, Congress recognized the importance of this type of
flexibility. Importantly, the RFA does not direct agencies to issue
rules binding themselves to a prescriptive program of retrospective
review. Instead, it directs agencies to ``publish in the Federal
Register a plan for the periodic review of [certain] rules.'' 5 U.S.C.
610(a) (emphasis added). This plan can be ``amended by the agency at
any time by publishing the revision in the Federal Register.'' Id.
(emphasis added). Congress could have required agencies to proceed
through notice-and-comment rulemaking to bind themselves to a review
program. It certainly demonstrated awareness of that procedural
mechanism, given that the RFA is squarely focused on rules promulgated
through notice-and-comment rulemaking. But instead, Congress tasked
agencies with establishing a ``plan'' by Federal Register publication
that can be amended ``at any time''--i.e., a plan that can be adjusted
as circumstances arise to preserve and support underlying programs. The
fact that Congress chose not to direct agencies to issue binding
regulation to implement the RFA, and the fact that such binding
regulations would by their nature place outsized importance on
retrospective review, weigh heavily in favor of wholesale withdrawal
(rather than modification) of the SUNSET final rule.
    Second, the Department must keep in mind its statutory obligations
to follow lawful regulatory processes and to fulfill substantive
statutory objectives. As explained earlier in this section, many
comments asserted that the expiration provision in the SUNSET rule
violates the APA. In the SUNSET final rule, HHS previously asserted
that the expiration provision is a cornerstone of the SUNSET rule. It
described the rule as not just creating a framework for retrospective
review but also ``impos[ing] a strong incentive on [the Department] to
perform retrospective review.'' 86 FR 5697. It stated that ``absent
such a forcing mechanism, the Department will not conduct as many
retrospective reviews as desired'' and that ``it is nearly impossible
to see how a satisfyingly comprehensive review could occur without a
sunset mechanism.'' 86 FR 5723, 5702. HHS even considered whether the
expiration provision should be severable from other portions of the
rule, but expressed doubt ``that the proposed rule could properly
function without the expiration dates.'' 86 FR 5734. Thus, the
expiration provision is a key animating feature of the SUNSET final
rule. However, as explained above, HHS now agrees with the many
commenters who asserted that the expiration provision is not adequately
justified and is unlawful under the APA. Moreover, in Section V.C.1, we
expressed doubt that the expiration provision is consistent with the
intent and purpose of the RFA. And, where Congress has empowered the
Department to promulgate specific substantive regulations, automatic
expiration of those regulations could conflict with Congressional
purpose, as well as violate the APA. In light of our new conclusions
about a fundamental premise of the SUNSET final rule, the best course
is for the rule to be retracted and for the Department to then take a
fresh look at next steps.
    Third, even if the Department determined that a binding regulation
for retrospective review were appropriate, and even if the legal issues
with the automatic expiration provision did not fundamentally undermine
the rule, HHS has considered alternatives within the ambit of the
existing policy and has determined that they either are not viable or
should not be adopted.\60\ Most of the alternate proposals presented by
commenters retain the key animating feature of the SUNSET final rule--
automatic expiration. But as explained in the Withdrawal NPRM and in
this preamble, the automatic expiration provision is in our view
unlawful and could lead to significant harm, including a significant
burden on stakeholders such as small entities. The uncertainty
resulting from the sudden expiration and threat of sudden expiration of
regulations could create numerous negative repercussions for
stakeholders and for the public health, including undermining the
effective

implementation of Federal/State partnership programs such as Medicaid
that rely on HHS rules establishing national standards for these
programs, hindering the ability of programs that rely on Federal
funding to apply for or receive that funding or engage in long-term
planning, and impeding product development and innovation. Moreover, as
explained in a prior comment response, regulatory uncertainty created
by the SUNSET final rule, if effective, would disproportionately burden
small entities who rely on regulations to level the playing field and
lack resources to navigate the resulting confusing regulatory
landscape. This result would be inconsistent with the RFA's purpose of
alleviating disproportionate burdens on small entities. Furthermore,
the expiration of any regulations under the SUNSET final rule--which
the Department now predicts would be unavoidable--means the public
would lose any protections, entitlements, and other public health
benefits those regulations provide. Leaving the automatic expiration
provision intact in any form would not address the Department's
concerns that the provision is unlawful under the APA and inconsistent
with the RFA and, in some cases, the Congressional purposes of the
authorizing statutes for particular sets of regulations.
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    \60\ As explained further in the regulatory impact analysis in
Section VI, the Department conducted a quantitative analysis of four
alternatives, including alternatives recommended by commenters.
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    Other commenters proposed modifying the SUNSET final rule to
eliminate the automatic expiration provision. HHS has considered this
alternative as well, and we have determined that a regulation that
retains any of the other key features of the SUNSET final rule--such as
widespread assessments or provisions imposing accelerated timelines for
assessments and reviews--is not viable or appropriate because those
provisions impose significant and unnecessary burdens on the Department
and stakeholders. As explained in a prior comment response, the
requirement to conduct thousands of assessments on a continuing basis,
including the requirement to comply with notice and comment procedures
for each assessment, are both onerous and unnecessary methods of
identifying the minority of rules which have or will have a SEISNOSE
and is inconsistent with the intent of section 610 and the RFA's
purpose. Even if the Department also limited the scope of rules subject
to assessment, as some commenters suggested, those proposals raise the
concerns that (1) the Department could miss rules that have or will
have a SEISNOSE (because the scope would be limited based on criteria
unrelated to SEISNOSE, such as imposing an unfunded mandate), and (2)
the process for assessments under the SUNSET final rule, such as the
inclusion of a comment period, is still unnecessarily burdensome. In
addition, the five-year timeframe for assessing and reviewing existing
regulations and the two-year timeframe for amending or rescinding
regulations based on the results of a SUNSET final rule review impose
additional unnecessary burdens on the Department. Proposals that do not
eliminate these requirements are not viable or desirable because they
fail to resolve the Department's concerns with the drain on resources
resulting from these provisions and force the Department to elevate
retrospective review above other public health initiatives that may be
more important. The Department has the discretion to ``prioritize
regulatory actions in a way that best achieves the objectives'' of the
RFA, other applicable statutes, and its public health and welfare
mission, see WildEarth Guardians v. EPA, 751 F.3d 649, 656 (D.C. Cir.
2014), and the Department has determined that these proposals would not
best achieve its objectives.
    The Department also considered alternatives that combine proposals
from various commenters (even though these combinations were not
specifically proposed), and we reject those alternatives for various
reasons. As discussed, retaining any portion of the SUNSET final rule
would run counter to HHS's view that its section 610 ``plan'' should
not be codified in regulations, and it would not address the concern
that elimination of the expiration provision fundamentally changes the
nature and purpose of the SUNSET final rule such that wholesale
reevaluation of the effort is required. We have also determined that
lengthening the various timelines in the rule would not adequately
address our concerns. The Regulatory Impact Analysis for this
withdrawal rule considers the policy alternative of an initial ten-year
period following the effective date to assess and review all
regulations, for example, and while that policy alternative temporally
shifts some of the burden on HHS, it does not meaningfully reduce the
burdens. Indeed, even if HHS eliminated all of the most concerning
provisions of the SUNSET final rule--such as the expiration provision,
the assessment process, and the narrow timeframes--the remaining
portions of the SUNSET final rule are still fundamentally flawed
because they do not provide for a logical or reasonable approach to
retrospective review under the RFA. For example, these provisions
require recurring review of ``Sections that were issued as part of the
same rulemaking (and any amendments or additions that may have been
issued thereafter).'' See, e.g., 86 FR 5751. But such Sections are
often themselves ``amendments or additions'' to existing rulemakings,
so this language suggests that these Sections would need to be reviewed
multiple times in connection with each of those existing rulemakings
and any future rulemakings amending such Sections. This methodology for
implementing the RFA is unreasonable and should not be retained. As
another example, the SUNSET final rule contains exceptions from the
review processes, but upon review, these exceptions are not only
ambiguous and difficult to implement, but also apparently inconsistent
with the language in section 610 of the RFA that contemplates review of
all regulations based on whether they have or will have a SEISNOSE. In
sum, HHS has not identified any substantive portion of the SUNSET final
rule that is worth retaining.\61\
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    \61\ The Department notes that several comments suggest that
extensively revising the rule would require a new rulemaking under
the APA or at least an additional notice and comment period.
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    As evidenced by the discussion in this preamble, the Department has
considered numerous alternatives to withdrawal of the SUNSET final
rule, including commenters' proposed alternatives, and has explained
its reasons for rejecting those alternatives. Contrary to one
commenter's suggestion, the alternatives considered by HHS were not
limited to the alternatives identified in the Withdrawal NPRM's
economic analysis. Therefore, the Department has satisfied its
obligation to ``consider the `alternative[s]' that are `within the
ambit of the existing [policy],' '' Regents, 140 S. Ct. at 913 (2020)
(quoting State Farm, 463 U.S. at 51), and give ``adequate reasons for
its abandonment'' of any such alternatives, State Farm, 463 U.S. at 51.
Moreover, the Department notes that those precedents make clear that an
agency is ``not required to . . . `consider all policy alternatives in
reaching [its] decision' '' and is ``not compelled to explore `every
alternative device and thought conceivable by the mind of man.' ''
Regents, 140 S. Ct. at 1914 (first quoting State Farm, 463 U.S. at 51;
then quoting Vt. Yankee Nuclear Power Corp. v. Natural Resources
Defense Council, Inc., 425 U.S. 519, 551 (1978)); see State Farm, 463
U.S. at 51 (``Nor do we broadly require an agency to consider all
policy alternatives in reaching

decision. It is true that a rulemaking `cannot be found wanting simply
because the agency failed to include every alternative device and
thought conceivable by the mind of man . . . regardless of how uncommon
or unknown that alternative may have been . . . .''). Therefore, HHS
has satisfied any obligation to consider alternatives to withdrawal of
the SUNSET final rule under State Farm and Regents.
4. Other Legal Issues
    Comment: One comment alleged various legal defects associated with
the Administrative Delay, which delayed the effective date of the
SUNSET final rule under 5 U.S.C. 705. 86 FR 15404. The comment stated,
for example, that the Administrative Delay was untimely, that HHS
unlawfully skipped notice-and-comment processes under 5 U.S.C. 553, and
that the Administrative Delay was not lawfully issued under section
705. The comment stated that because the Withdrawal NPRM ``relies
essentially on the purported legitimacy of the [Administrative
Delay],'' it ``is part and parcel of an unlawful delay, and therefore
is fruit of a poisonous tree that is arbitrary and capricious and abuse
of discretion under the APA.''
    Response: HHS disagrees with the suggestion that the Administrative
Delay suffers from any legal defect, and we are not aware of any legal
basis for the commenter's assertion regarding the applicability of a
fruit-of-the-poisonous-tree doctrine.
    In any event, criticisms of the Administrative Delay are outside
the scope of this rulemaking proceeding. In this proceeding, HHS has
proposed and has sought comment on withdrawal of the SUNSET final rule.
That proposal is separate from the Administrative Delay. While the
Department continues to believe that the Administrative Delay was
lawful, we disagree with the commenter that the Administrative Delay--
whether lawful or unlawful--affects or is otherwise relevant to this
withdrawal action.
    Moreover, the Department is withdrawing the SUNSET final rule well
before the first deadline for completing assessments and reviews of
Department regulations would have occurred if the rule had taken effect
absent the Administrative Delay. Accordingly, any question of the
validity of the Administrative Delay is now moot.
    Comment: One comment noted that the Withdrawal NPRM proposed to
``withdraw or repeal'' the rule and requested that the Department
clarify whether it intends to withdraw vs. repeal the SUNSET final rule
and identify any advantages and disadvantages associated with each
action. Although the comment acknowledged that both withdrawal and
repeal are methods to revoke a rule, it asserted that withdrawal of a
rule from the Office of the Federal Register ordinarily takes place
prior to a rule's publication whereas a notice-and-comment rule that
has become effective generally needs to be repealed through notice-and-
comment rulemaking.
    Response: As used in this rulemaking, the terms ``withdraw'' and
``repeal'' refer to the timing of the issuance of this final rule
relative to the effective date of the SUNSET final rule. When HHS
issued the Withdrawal NPRM, it was not certain about future timing and
therefore referred to both withdrawal and repeal in the alternative.
Because the effective date of this final rule will occur before the
effective date of the SUNSET final rule,\62\ HHS is withdrawing the
SUNSET final rule before it ever becomes effective.
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    \62\ See 86 FR 15404 (extending SUNSET final rule effective date
of until March 22, 2022); 87 FR 12399 (further extending SUNSET
final rule effective date until September 22, 2022).
---------------------------------------------------------------------------

    Because the Department has engaged in notice and comment
rulemaking, it need not address the question of whether it could have
withdrawn the rule without notice and comment procedures. Whether this
final rule is characterized as a ``withdrawal,'' ``repeal,'' or
``rescission'' is ultimately of no consequence to the validity of this
rulemaking,\63\ because HHS has engaged in notice and comment under the
APA, and the revocation (under any label) of the SUNSET final rule is
fully justified for all of the reasons we have set forth in this
preamble. In addition, even if ``withdrawal'' of the SUNSET final rule
were not appropriate due to some alleged defect in the Administrative
Delay (which HHS does not believe exists), the Department would have
repealed the rule, through a process identical to this process, for the
reasons explained throughout this preamble.
---------------------------------------------------------------------------

    \63\ However, we note that, upon judicial review, a decision to
withdraw a rule that is not yet effective may be accorded even more
deference than a decision to repeal a rule in effect. Cf. Int'l
Union, United Mine Workers of Am. v. U.S. Dep't of Lab., 358 F.3d
40, 43 (D.C. Cir. 2004) (courts ``give more deference to an agency's
decision to withdraw a proposed rule than . . . to its decision to
promulgate a new rule or to rescind an existing one''); Williams
Nat. Gas Co. v. F.E.R.C., 872 F.2d 438, 444 (D.C. Cir. 1989) (noting
that the ``application of the `arbitrary and capricious' standard
must be informed by [the court's] recognition that an agency's
decision to retain the status quo may be more easily defensible than
a shift in policy would be'').
---------------------------------------------------------------------------

    Comment: One comment urged HHS to fully incorporate all public
comments to the SUNSET proposed rule into the administrative record for
its withdrawal of the SUNSET final rule. The commenter noted with
approval that the Withdrawal NPRM discusses concerns raised in the
comments to the SUNSET proposed rule.
    Response: The Department agrees with the comment that all public
comments to the SUNSET proposed rule are properly part of the
administrative record for this rulemaking proceeding. As the comment
acknowledged, the Department considered the public comments to the
SUNSET proposed rule before it issued the Withdrawal NPRM. See, e.g.,
86 FR 59906 (``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.''). Therefore, those comments are properly part of the
administrative record for this final rule. See, e.g., 21 CFR 10.3 (FDA
regulation defining ``Administrative record'' as ``documents . . . on
which the Commissioner relies to support the action''); 42 CFR 405.1042
(Office of Medicare Hearings and Appeals regulation defining
administrative record as ``complete record of the evidence and
administrative proceedings on the appealed matter''). The Department
notes that many of the comments to the Withdrawal NPRM discussed or
attached copies of public comments to the SUNSET proposed rule and are
therefore part of the administrative record for this rulemaking for
that reason, as well. See, e.g., 21 CFR 10.40(g) (FDA regulation
instructing that the record of the administrative proceeding for the
promulgation of rules consists of ``[a]ll comments received on the
proposal, including all information submitted as part of the
comments''); 42 CFR 431.416 (CMS regulation defining administrative
record for State Medicaid and CHIP demonstration projects to include
``[w]ritten public comments sent to the CMS and any CMS responses'' and
``all documentation related'' to a project application).

E. Vague and Confusing Provisions

    In the Withdrawal NPRM, we explained that, upon reconsideration,
the Department found many ambiguities in the SUNSET final rule that
could impede the ability of the Department and the public to determine
the scope and timing of the assessment and review process. 87 FR 59922.
This confusion would have increased the burden on stakeholders trying
to navigate the assessment and review process. Process

ambiguities would also increase the risk of the automatic expiration of
HHS regulations due to inadvertent noncompliance or misapplication of
the requirements. We received the following additional comments on this
topic.
    Comment: Many commenters agreed that the SUNSET final rule would
create burdens, confusion, and uncertainty over which regulations are
likely to remain in effect, and overall decrease predictability,
transparency, and public engagement critical to the regulatory process.
Ambiguities in the regulatory text would contribute to those problems.
One comment, for example, stated that the SUNSET final rule contained
many ambiguities that could impede the ability of HHS and the public to
determine the scope and timing of the assessment and review process.
Another comment criticized the SUNSET final rule for confusing
definitions. Another comment opined that the rush to issue the SUNSET
final rule, with the extremely short time for stakeholder comment and
unprecedented acceleration of the timeline for completion of the
rulemaking, resulted in an inadequately considered and drafted final
rule, with provisions that are overly vague, lack needed details, and
are impractical to implement.
    Response: We agree with these concerns. For example, as explained
in Section V.D of this preamble, the SUNSET final rule requires
recurring review of ``Sections that were issued as part of the same
rulemaking (and any amendments or additions that may have been issued
thereafter).'' But such Sections are often themselves ``amendments or
additions'' to existing rulemakings, so this language suggests that
these Sections would need to be reviewed multiple times in connection
with each of those existing rulemakings and any future rulemakings
amending such Sections. This methodology for implementing the RFA is
unreasonable and confusing.
    For example, the FDA rulemaking ``Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human