Food'' (Preventive Controls for Human Food) was published on September
17, 2015 (80 FR 55907). However, in addition to new sections first
promulgated in 2015, the rule also included revisions to sections of
the CFR that were first promulgated in 1975, 1979, 1986, 1995, 1997,
2001, 2004, and 2008. The SUNSET final rule suggests that, because
these revised sections were issued as part of the 2015 rulemaking, the
Department would need to review these revised sections multiple times--
first, as part of a review of the 2015 rulemaking, and then again as
part of the Department's reviews of the rulemakings in which those
sections were first promulgated or previously revised. Moreover, the
complexity of this process would be compounded by the fact that each of
these sections of the CFR, because they were promulgated at different
times, would have different expiration dates under the SUNSET final
rule.
    Comment: The Withdrawal NPRM also expressed concern about ambiguity
in the categories of exceptions described in the proposed rule and
included in the final rule.\64\ Numerous commenters on the SUNSET
proposed rule noted the lack of examples provided, and stated the lack
of clarity for the categorical exceptions would leave the public unable
to know which regulations would be eligible for the exceptions.
Accordingly, some commenters stated that stakeholders would face a
burden to conduct their own legal analysis.
---------------------------------------------------------------------------

    \64\ The regulatory text of the SUNSET final rule consisted of
one regulation, with multiple subsections, substantially replicated
10 times. Subsection (g) in the replicated regulatory text excluded
(1) Sections that are prescribed by Federal law, such that the
Department exercises no discretion as to whether to promulgate the
Section and as to what is prescribed by the Section; (2) Sections
whose expiration pursuant to this section would violate any other
Federal law; (3) The SUNSET final rule; (4) Sections that involve a
military or foreign affairs function of the United States; (5)
Sections addressed solely to internal agency management or personnel
matters; (6) Sections related solely to Federal Government
procurement; and (7) Sections that were issued jointly with other
Federal agencies, or that were issued in consultation with other
agencies because of a legal requirement to consult with that other
agency. Subsection (g) also excludes individual regulations specific
to each HHS agency. 86 FR 5729.
---------------------------------------------------------------------------

    Response: In the Withdrawal NPRM, we agreed with these comments,
and we continue to agree with them now. We explained that the SUNSET
final rule failed to provide meaningful examples of these exceptions
and recognized the possibility that this lack of clarity could delay
the completion of the assessment process and place further strain on
the resources and effort needed to avoid the expiration of regulations.
Commenters on the Withdrawal NPRM confirmed this view. For example, one
commenter explained that, rather than vaguely indicate that certain
types of regulations may be subject to exceptions, the SUNSET final
rule should have identified the regulations more specifically, so that
commenters could engage in the comment process, and stakeholders could
better understand the rule if implemented. Another commenter criticized
the scope of the exceptions in the SUNSET final rule for their failure
to ensure that these exceptions would avert the expiration of a
regulation in the event of a pandemic or other declared national or
public health emergency.
    In addition, many commenters on the original SUNSET proposed rule
stated that it was improper for the final rule to exclude the SUNSET
final rule itself from the requirements of Section (c) of each of the
codified provisions, meaning that under the rule, the rule itself is
not subject to assessment, review, or expiration. The SUNSET final rule
based this exemption on an assumption that the SUNSET final rule would
not ``directly impose on the public costs that exceed benefits''
because no rules would expire due to lack of assessment or review. 86
FR 5730. The Department now concludes that this assumption was
incorrect and therefore does not justify the double-standard inherent
in this aspect of the SUNSET final rule.

VI. Final Regulatory Impact Analysis

A. Introduction, Summary, and Background

1. Introduction
    We have examined the impacts of the final withdrawal rule under
E.O. 12866, E.O. 13563, the Regulatory Flexibility Act (RFA) (5 U.S.C.
601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
E.O.s 12866 and 13563 direct us to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
final withdrawal rule is a significant regulatory action as defined by
E.O. 12866.
    The RFA requires us to analyze regulatory options that would
minimize any significant impact of a rule on small entities. Because
the final withdrawal rule would result in cost savings to regulated
entities, this analysis concludes, and the Secretary certifies, that
the final withdrawal rule will not have a significant economic impact
on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $165 million,

using the most current (2021) Implicit Price Deflator for the Gross
Domestic Product. This final withdrawal rule will result in an
expenditure in at least one year that meets or exceeds this amount.
2. Summary of Costs and Benefits
    The final withdrawal rule will withdraw the SUNSET final rule. This
regulatory action will reduce the time spent by the Department
performing retrospective assessments and reviews of its regulations,
and time spent by the general public on comments related to these
assessments and reviews anticipated under the SUNSET final rule. We
monetize the likely reductions in time spent by the Department and the
general public and report these impacts as cost savings. Our primary
estimate of these cost savings in 2020 dollars, annualized over 10
years, using a 3% discount rate, totals $69.9 million. Using a 7%
discount rate, we estimate $75.5 million in annualized cost savings.
Table 1 reports these primary estimates alongside a range of estimates
that capture uncertainty in the amount of time it will take the
Department to perform each assessment and review, and uncertainty in
the amount of time the public will spend on comments.
    In addition to these monetized effects, the final withdrawal rule
will also reduce regulatory uncertainty and regulatory confusion
anticipated under the SUNSET final rule. Given the scope of the SUNSET
final rule, these impacts would have been experienced by small
businesses but also the general public, larger businesses, Tribes,
States, non-governmental organizations, and other regulated entities
and stakeholders across a wide range of industrial sectors. The final
withdrawal rule will also reduce the time spent by the Department on
other activities that we have not monetized or quantified, such as the
time developing Small Entity Compliance Guides (SECGs), and it will
reduce the time spent by the public monitoring regulations undergoing
assessment or review and set to expire. The final withdrawal rule will
also result in a disbenefit with respect to forgone information as a
result of not performing the assessments and reviews.

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

3. Summary of Changes
    Compared to the preliminary regulatory impact analysis, this final
regulatory impact analysis expands the discussion of regulatory
alternatives, including a quantitative analysis of two additional
alternatives recommended in public comments. Specifically, we analyze a
policy option that would maintain the general framework of the SUNSET
final rule but limit its scope to regulations that the Department
previously identified as having a significant economic impact on a
substantial number of small entities. We also analyze a policy option
that would maintain the SUNSET final rule's requirements related to the
timeline for assessing and reviewing all of the Department's existing
regulations, but without the automatic expiration provision contained
in the SUNSET final rule.
    We have revised the discussion and estimates contained in this
regulatory impact analysis to reflect regulatory action that
administratively postponed the effective date of the SUNSET final rule.
This analysis now states that the regulatory action will withdraw the
SUNSET final rule, whereas the preliminary regulatory impact analysis

covered regulatory actions to withdraw or repeal the SUNSET final rule.
We have made minor edits for clarity throughout the document. Finally,
we have read and considered public comments addressing the regulatory
impact analysis and respond to these comments in Sections V.A.3, C.3,
and D.3 of this preamble.
4. Background
    On January 19, 2021, HHS issued the ``Securing Updated and
Necessary Statutory Evaluations Timely'' final rule. Under the SUNSET
final rule, all HHS regulations less than ten years old, with certain
exceptions, will expire ten years after issuance, unless HHS performs
an assessment of the regulations and a more detailed review of those
regulations that have a significant economic impact upon a substantial
number of small entities. The SUNSET final rule also provides for
regulations older than ten years to expire unless assessed and, if
applicable, reviewed within an initial five-year period. After this
initial assessment and review process, the SUNSET final rule requires
continuing assessments and reviews every ten years under threat of
expiration. HHS published a regulatory impact analysis (SUNSET RIA)
alongside the final rule, providing estimates of the likely impact of
the policy on Departmental resources and time spent by the general
public related to these efforts. Following the initiation of
litigation, HHS issued an administrative delay of effective date,
effective as of March 19, 2021, which extended the effective date of
the SUNSET final rule by one year to March 22, 2022. HHS issued a
second administrative delay of effective date, effective as of March 4,
2022, which further extended the effective date of the final rule by
six months to September 22, 2022. For the purposes of this analysis, we
refer to the January 19, 2021, final rule and the two administrative
delays collectively as the SUNSET final rule. On October 19, 2021, HHS
published a proposed rule to withdraw or repeal the SUNSET final rule.

B. Market Failure or Social Purpose Requiring Federal Regulatory Action

    The SUNSET final rule established automatic expiration dates for
most of the Department's regulations, and a recurring assessment and
review process that it must follow to avoid such expirations. The
SUNSET final rule's RIA likely underestimated both the time commitment
of a credible assessment and review process, and the time spent by the
general public commenting on regulations undergoing assessment and
review. Given the volume and heterogeneity of regulations affected, our
current evaluation of the time commitment necessary to conduct credible
assessments and reviews, the timeframes for completing these
retrospective analyses, and subsequent regulatory actions anticipated
as a result of these analyses, it is likely that regulations will
automatically expire. The potential for regulations to automatically
expire introduces regulatory uncertainty, with potential negative
repercussions for stakeholders. The actuality of having regulations
expire automatically could lead to regulatory confusion among
stakeholders and harm the public health in numerous ways, as described
in the preamble and this analysis. This final withdrawal rule is
therefore needed to improve the functioning of government and to reduce
the costs to the Department and the general public associated with the
SUNSET final rule.

C. Purpose of the Final Withdrawal Rule

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

D. Baseline Conditions

    We adopt a baseline that assumes the requirements of the January
19, 2021, SUNSET final rule \65\ remain in place over the period of our
analysis, accounting for the administrative delays of the effective
date.\66\ The SUNSET final rule RIA contains monetized estimates of the
costs to the Department to perform retrospective analyses of existing
regulations and the costs to the public to monitor and respond to
anticipated regulatory actions taken by the Department following these
retrospective analyses. For the purpose of estimating the time spent on
retrospective analyses under the baseline of this analysis, we maintain
the assumption in the SUNSET final rule RIA that the Department will
satisfy the requirements of the SUNSET final rule and no regulations
will automatically expire.\67\ We also maintain various assumptions in
the SUNSET final rule RIA relating to the timing of the effects and
treatment of the one-year waiver provision that allows the Secretary to
make one-time, case-by-case exceptions to the automatic expiration of a
rule. We also maintain the SUNSET final rule RIA's choice of a 10-year
time horizon for the analysis and adopt a base year of 2022 for
discounting purposes. In this section, we reconsider several other
assumptions underlying the cost estimates in the SUNSET final rule RIA,
and discuss additional cost drivers not identified and monetized in the
analysis. These revised estimates inform our baseline scenario of no
further regulatory action. This analysis of the baseline scenario
concludes that the SUNSET final rule likely underestimated to a
significant degree the resources needed for the required undertaking.
---------------------------------------------------------------------------

    \65\ 86 FR 5694.
    \66\ 86 FR 15404; 87 FR 12399.
    \67\ This approach allows for a more direct comparison with the
estimates contained in the SUNSET final rule RIA and follows a
common practice in regulatory impact analysis to assess costs
assuming full compliance with the regulation. We supplement the
full-compliance estimates by identifying the likely impacts
associated with less than full compliance. The HHS Guidelines for
Regulatory Impact Analysis (available at https://aspe.hhs.gov/system/files/pdf/242926/HHS_RIAGuidance.pdf.), Chapter 4 ``Assess
Costs,'' contains a more complete discussion of this approach.
---------------------------------------------------------------------------

Regulations Subject to the SUNSET Final Rule
    We adopt the SUNSET final rule RIA's estimate of 18,000 regulations
potentially subject to the SUNSET final rule that will need to be
assessed in the first ten years. For each of these regulations, the
Department will need to perform an assessment to determine whether the
regulation imposes a significant economic impact on a substantial
number of small entities. The SUNSET final rule RIA estimates that
roughly five regulations on average are part of the same rulemaking and
could be assessed at one time. We maintain this assumption and
terminology, which results in a total of 3,600 assessments in the first
ten years. Although we adopt the SUNSET final rule RIA's estimate that
the Department would perform 3,600 assessments, this estimate may
understate the number of assessments performed under the SUNSET final
rule, since certain regulations would need to be assessed multiple
times as part of separate

assessments. The SUNSET final rule RIA assumes that 11% of these
assessments, or 396, are for regulations previously determined to have
a significant economic impact on a substantial number of small
entities, but reduces this figure to 370 to account for rulemakings
that are likely to be reviewed for reasons other than the SUNSET final
rule. This adjustment similarly reduces the estimate of the number of
rulemakings impacted by the SUNSET final rule to 3,574 [=3600-(396-
370)].
    For each of these 370 rulemakings, the Department will need to
perform a review, which includes a retrospective regulatory flexibility
analysis. The SUNSET final rule RIA distinguishes between the 44
rulemakings that predate the RFA and are unlikely to have an existing
prospective regulatory flexibility analysis, and the remaining 326
rulemakings that are assumed to have an existing prospective analysis.
The SUNSET final rule RIA also estimates there will be an additional
160 rulemakings assessed to have a significant impact on a substantial
number of small entities that have not previously been identified as
having a significant economic impact. The Department will need to
perform a review of these rulemakings under the SUNSET final rule.
    The SUNSET final rule provides for an initial five-year period for
the Department to address regulations older than ten years. We maintain
the assumption in the SUNSET final rule RIA that assessments and
reviews required in the first five years will be completed evenly
across this time period, and that the remaining assessments and reviews
will be completed evenly across the next five-year time period. Of the
3,574 total assessments anticipated under the SUNSET final rule, 3,415
would occur during the first five-year period, an average of 683.0
assessments per year; while 159 assessments would occur during the
second five-year period, an average of 31.8 assessments per year. Of
the total reviews anticipated under the SUNSET final rule, 506 would
occur during the first five-year period, an average of 101.2 reviews
per year; while 24 assessments would occur during the second five-year
period, an average of 4.8 reviews per year. Table D1 presents yearly
counts of assessments and reviews anticipated under the baseline
scenario. These figures are broadly consistent with the figures
contained in the SUNSET final rule RIA; however, unlike that analysis,
we do not reduce the number of assessments under the SUNSET final rule
by the number of reviews performed, since these assessments occur first
and serve to identify those regulations requiring review.

                     Table D1--Baseline Assessments and Reviews Under the SUNSET Final Rule
----------------------------------------------------------------------------------------------------------------
                                                                              Reviews
              Year                     Total     ---------------------------------------------------------------
                                    assessments       Pre-RFA        Post-RFA      Not specified       Total
----------------------------------------------------------------------------------------------------------------
2022............................           683.0             8.8            61.8            30.6           101.2
2023............................           683.0             8.8            61.8            30.6           101.2
2024............................           683.0             8.8            61.8            30.6           101.2
2025............................           683.0             8.8            61.8            30.6           101.2
2026............................           683.0             8.8            61.8            30.6           101.2
2027............................            31.8             0.0             3.4             1.4             4.8
2028............................            31.8             0.0             3.4             1.4             4.8
2029............................            31.8             0.0             3.4             1.4             4.8
2030............................            31.8             0.0             3.4             1.4             4.8
2031............................            31.8             0.0             3.4             1.4             4.8
                                 -------------------------------------------------------------------------------
    Total.......................          3574.0            44.0           326.0           160.0           530.0
----------------------------------------------------------------------------------------------------------------

Time per Assessment and per Review
    The SUNSET final rule RIA contains estimates of the time per
assessment and time per review performed under the SUNSET final rule.
For each assessment, the SUNSET final rule RIA assumes that it will
require between 3 and 10 hours to assess a rulemaking. For each review,
the SUNSET RIA assumes that it will require between 250 and 500 hours
to review rulemakings that predate the RFA, and between 40 and 100
hours to review rulemakings that postdate the RFA. For the 160
rulemakings newly found to have a significant impact, the SUNSET RIA
assumes that it will take between 40 and 100 hours to complete a
review.
    The Department now concludes the SUNSET RIA likely underestimates
the time necessary to credibly assess whether a regulation imposes a
significant economic impact on a substantial number of small entities
by a significant degree. The Small Business Administration (SBA) Office
of Advocacy published ``A Guide for Government Agencies: How to Comply
with The Regulatory Flexibility Act,'' detailing a step-by-step
approach for analysts.\68\ For each of the 3,574 rulemakings requiring
an assessment under the SUNSET final rule, the Department will need to
define the problem and describe the regulated entities, estimate
economic impacts by size categories, and determine which size
categories incur significant impacts. The SBA guide presents a two-page
checklist containing the elements of an adequate certification. In
practice, when performing a threshold analysis, analysts will face
novel conceptual issues and data challenges, both of which require
thoughtful consideration and professional judgement. The SUNSET final
rule also requires HHS to open a docket and review public comments on
each rulemaking being assessed. Furthermore, SBA indicates that it is
not sufficient to rely on an assessment made at the time a regulation
was published:
---------------------------------------------------------------------------

    \68\ Available at https://cdn.advocacy.sba.gov/wp-content/uploads/2019/06/21110349/How-to-Comply-with-the-RFA.pdf.

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

    We assume that, under the baseline scenario of the SUNSET final
rule, the Department will follow the

recommendations in the SBA guidance, and will perform a credible
threshold analysis for each rulemaking to assess whether it imposes a
significant economic impact on a substantial number of small entities.
Each assessment will likely require time by an economist or other
analyst to perform and document the threshold analysis, with input from
at least one subject matter expert on the area of the regulation.
Recognizing the need to fully respond to all the requirements, we
modify the assumption in the SUNSET final rule RIA and adopt an
estimate of 40 to 100 hours to complete a credible threshold analysis
for each rulemaking requiring an assessment.
    As described earlier, the SUNSET final rule RIA contains two
estimates for the time necessary to perform a retrospective analysis as
part of a review. For rulemakings published before the RFA was enacted,
the SUNSET final rule RIA assumes between 250 and 500 hours per review.
For rulemakings published after the RFA was enacted, the SUNSET final
rule RIA assumes that a prospective regulatory flexibility analysis is
available and further assumes that this will reduce the time necessary
to complete a review, adopting a range of 40 and 100 hours per review.
For the 160 rulemakings newly found to have a significant impact, the
SUNSET RIA assumes that it will take between 40 and 100 hours to
complete a review. The Sensitivity Analysis Section of the SUNSET final
rule RIA acknowledges that ``[o]ne commenter noted that conducting a
retrospective analysis can be as time-consuming and expensive as a
prospective regulatory analysis, suggesting the Department's estimates
of the time and expense of Reviews may be understated.'' Upon further
consideration, the Department agrees that the commenter is likely
correct.
    For the analysis of this final withdrawal rule, we adopt the SUNSET
final rule RIA estimate of 250 to 500 hours for all retrospective
analyses performed as part of a review, regardless of when the
underlying rulemaking was published, and regardless of whether the
rulemaking was previously found to have a significant impact on a
substantial number of small entities. If previously published
prospective or retrospective regulatory flexibility analyses are
generally available, analysts may be able to build off of these
previous analytic efforts when developing a retrospective analysis
under the SUNSET final rule. All else equal, this would suggest the
average time per retrospective analysis may be closer to the lower-
bound estimate of 250 hours. If these analyses are not generally
available, this would suggest an average time per retrospective
analysis closer to the upper-bound estimate of 500 hours. We do not
address the assumption in the SUNSET final rule RIA that a prospective
regulatory flexibility analysis is available for every rulemaking
published after the RFA was enacted, because it does not impact the
estimate of the overall time spent on reviews under the baseline
scenario. Our approach also allows us to ignore the apparent internal
inconsistency in the SUNSET final rule RIA underlying the time per
review of the 160 rulemakings that are newly assessed to have a
significant impact.
    The SUNSET final rule RIA is not clear on what activities are
included in its estimates of the time per review other than the time
spent developing a retrospective analysis. We interpret the magnitudes
of these estimates to exclude consideration of time spent on activities
other than drafting the retrospective analysis. For example, the
Department may need to conduct a study or survey to gather data to
inform its analyses. We therefore include an additional 250 hours to
500 hours per review to account for this omission. This estimate
reflects time spent by Department subject matter experts, lawyers, and
other reviewers informing the retrospective analysis and providing
feedback on draft analyses. It also reflects time spent by economists
and other analysts developing the retrospective analysis to respond to
this feedback, and time spent reading and incorporating evidence from
other sources, including public comments. Table D2 summarizes the
assumptions in the SUNSET final rule RIA and our revised assumptions
for the final withdrawal rule of the time per assessment and time per
review performed under the baseline scenario of the SUNSET final rule.
Combining the time spent on retrospective analysis and on other related
activities, we estimate that each review will take between 500 and
1,000 hours to complete.

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

Time Spent by the Public To Monitor and Comment
    Under the SUNSET final rule, the Department would create a docket
on www.Regulations.gov for each assessment or review that the
Department is conducting. The public would then be able to submit
comments to the dockets of each rulemaking being assessed or reviewed.
The SUNSET final rule RIA includes a discussion of the costs to the
stakeholders to monitor and comment on regulations as these are
undergoing assessment and review; however, the analysis assigns no
costs to the Department associated with setting up these dockets or
engaging with the comments. The analysis also does not monetize any
other costs associated with operationalization of the SUNSET final
rule, which also requires developing a schedule for activities
associated with the SUNSET final rule, publishing monthly updates on
the commencement of assessments and reviews, publishing the results of
assessments and review (``including the full underlying analyses and
data used to support the results'') once a year, and establishing a
website dashboard to help the public monitor the Department's progress.
    When estimating the impact on the public, the SUNSET final rule RIA
assumes the public will wait until the assessments and reviews are
complete and the Department has announced it intends to rescind or
amend a rulemaking before commenting. Thus,

for example, the SUNSET final rule RIA first estimates that 53
rulemakings will be rescinded and another 159 rulemakings amended as a
result of the retrospective analyses initiated as a result of the
SUNSET final rule, monetizing the time spent by the public responding
to those 212 rulemakings. The SUNSET final rule RIA assumes that, for
each of the 53 rulemakings rescinded following a review completed under
the SUNSET final rule, the public will submit 243 comments; and for
each of the 159 rulemakings amended, the public will submit 486
comments. This will result in an estimated 90,153 comments, for which
the SUNSET final rule RIA assumes will take between 5 and 15 hours to
prepare. Presumably, this estimate is inclusive of finding out that the
rulemaking is likely to be rescinded or amended, reading and
understanding the rulemaking, completing further research,
communicating with other stakeholders, identifying concerns, and
drafting and submitting comments. The preamble to the SUNSET final rule
anticipates that the Department will create on its website a dashboard
that shows its progress on its Assessments and Reviews. Therefore, we
assume that any reduction in the time spent by the public attributable
to this dashboard is accounted for in these time estimates.
    We have reconsidered the SUNSET final rule RIA's assumption that
the public will wait until the Department has announced it intends to
rescind or amend a rulemaking before commenting. Upon further
consideration, the Department finds it more likely that the public will
comment on rulemakings undergoing assessment and review rather than
wait until learning the specific rulemakings that will be rescinded or
amended as a result of these assessments and reviews. The Department's
prior assumptions appear at odds with the decision to invite public
comment during both the assessment and review processes. Furthermore,
as discussed by the SBA, ``insights about an existing regulation
received from regulated entities and other interested parties should be
a key component of a retrospective rule review. By making the review
process transparent and accessible, agencies are more likely to
identify improvements that will benefit all parties at the conclusion
of the review.'' \69\
---------------------------------------------------------------------------

    \69\ Available at https://cdn.advocacy.sba.gov/wp-content/uploads/2019/06/21110349/How-to-Comply-with-the-RFA.pdf pg. 83.
---------------------------------------------------------------------------

    This means that we assume that the public will comment on all 3,600
rulemakings subject to the SUNSET final rule that will be available for
public comment in connection with a Department assessment or review, in
contrast with the SUNSET final rule RIA, which assumes the public will
offer no comments. We adopt the SUNSET final rule RIA's estimate of 486
comments per rulemaking, but instead apply this to the 530 rulemakings
that, following a threshold analysis in an assessment, the Department
will begin to review. We believe that the public will submit fewer
comments for rulemakings undergoing an assessment (rather than a
review), and adopt an assumption of 25 comments per assessment. We also
adopt the SUNSET final rule RIA's assumption about the time spent per
comment (between 5 and 15 hours) and apply it in the context of
assessments and reviews. Table D3 summarizes a comparison of the
assumptions in the SUNSET final rule RIA and in the baseline analysis
of this final withdrawal rule of the comments per assessment and
review, and for the subsequent regulatory actions to rescind or amend
rulemakings.

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

Considerations Related to Rescissions and Amendments
    As described earlier, the SUNSET final rule RIA envisions the
Department identifying and rescinding 53 rulemakings and amending 159
rulemakings following completed reviews under the SUNSET final rule.
Upon further reflection and analysis, the Department no longer believes
it was appropriate to unambiguously attribute subsequent regulatory
actions of this nature to the SUNSET final rulemaking in the context of
a regulatory impact analysis. Even if the challenging attribution
questions could be resolved, we maintain that the SUNSET final rule RIA
understates the impact of the SUNSET final rule since it implicitly
assumes that the Department would not have to spend any time to develop
and publish subsequent regulatory actions to rescind or amend existing
regulations. This unstated assumption is difficult to justify given the
resources required to undertake a full notice-and-comment rulemaking
proceeding. Since these anticipated regulatory actions relate to
regulations that have a significant economic impact on a substantial
number of small entities, we expect that these actions will need to
involve subject matter experts, legal review, policy coordination,
Departmental clearance, and a communications strategy to bring
transparency to the process. For certain regulatory actions, we
anticipate review by the Office of Management and Budget. We have not
attempted to estimate the time and resources associated with developing
these regulatory actions or unambiguously attributed the costs of those
actions to the SUNSET final rule.
Baseline Effect of the SUNSET Final Rule
    To quantify the likely effect of the SUNSET final rule on the
Department, we multiply the number of assessments and number of reviews
from Table D1 by the assumptions relating to the time per assessment
and time per review described in Table D2. To quantify the likely
effect of the SUNSET final rule on the public, we multiply the figures
in Table D1 by the assumptions relating to the comments per assessment
and comments per review described in Table D3. This gives us estimates
for the number of comments, which we then multiply by the time
estimates per comment (between 5 and 15 hours) to estimate the total
time spent by the public. Table D4 presents yearly estimates of hours
spent related to assessments performed under the

SUNSET final rule to the Department and the public. Table D5 presents
comparable figures related to reviews. Table D6 presents the total time
anticipated under the SUNSET final rule related to assessments and
reviews.

                       Table D4--Hours Related to Assessments Under the SUNSET Final Rule
----------------------------------------------------------------------------------------------------------------
                                                            Department                        Public
              Year                  Assessments  ---------------------------------------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
2022............................           683.0          27,320          68,300          85,375         256,125
2023............................           683.0          27,320          68,300          85,375         256,125
2024............................           683.0          27,320          68,300          85,375         256,125
2025............................           683.0          27,320          68,300          85,375         256,125
2026............................           683.0          27,320          68,300          85,375         256,125
2027............................            31.8           1,272           3,180           3,975          11,925
2028............................            31.8           1,272           3,180           3,975          11,925
2029............................            31.8           1,272           3,180           3,975          11,925
2030............................            31.8           1,272           3,180           3,975          11,925
2031............................            31.8           1,272           3,180           3,975          11,925
----------------------------------------------------------------------------------------------------------------

                         Table D5--Hours Related to Reviews Under the SUNSET Final Rule
----------------------------------------------------------------------------------------------------------------
                                                            Department                        Public
              Year                    Reviews    ---------------------------------------------------------------
                                                        Low            High             Low            High
----------------------------------------------------------------------------------------------------------------
2022............................           101.2          50,600         101,200         245,916         737,748
2023............................           101.2          50,600         101,200         245,916         737,748
2024............................           101.2          50,600         101,200         245,916         737,748
2025............................           101.2          50,600         101,200         245,916         737,748
2026............................           101.2          50,600         101,200         245,916         737,748
2027............................             4.8           2,400           4,800          11,664          34,992
2028............................             4.8           2,400           4,800          11,664          34,992
2029............................             4.8           2,400           4,800          11,664          34,992
2030............................             4.8           2,400           4,800          11,664          34,992
2031............................             4.8           2,400           4,800          11,664          34,992
----------------------------------------------------------------------------------------------------------------

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

    While these time estimates are significant, they are not inclusive
of all costs expected under the SUNSET final rule. In addition to the
quantified estimates above, we expect that the Department will
experience other costs related to the requirements of the SUNSET final
rule under the baseline scenario. For example, the estimates above do
not include time spent reviewing guidance documents related to
rulemaking undergoing assessment and review. They also do not include
the time associated with developing SECGs for the 160 rulemakings newly
found to have a significant impact on a substantial number of small
entities, or the time associated with updating existing guidances for
the same or related rulemakings. The figures above also omit the
monetary costs to purchase data and data subscriptions that we
anticipate will serve as critical inputs for the assessments and
reviews, and costs associated with conducting formal evaluations to
understand the impact of the rules. In addition, the estimates do not
include the costs of resolving and communicating the meaning of
ambiguous provisions in the SUNSET final rule. For example, HHS
anticipates that it will take considerable work to determine when
regulations must be assessed and reviewed as part of a particular
rulemaking and when regulations fall within an exception. Even after
that work is complete, additional resources are required to share those
interpretations with the public. Furthermore, the figures do not
account for the time and costs associated with HHS's efforts to
reevaluate and redirect resources to support assessments and reviews
and thereby preserve regulations.
    As an additional consideration, we estimate that assessing and
reviewing regulations will require the equivalent of 67 and 146 full-
time employees in each of the first five years of the analysis,
adopting the SUNSET final

rule RIA's estimate of 1,160 hours of work per year per employee.\70\
Given current staffing and other Departmental needs and priorities, we
anticipate the need to hire non-government experts to perform a share
of the retrospective work. This approach will likely result in
additional overhead costs that we have not quantified. We also
anticipate the need to spend Departmental resources to find, hire,
train, and transfer personnel with technical expertise to conduct the
analyses, the costs of which have not been quantified in this analysis.
---------------------------------------------------------------------------

    \70\ This 1,160-hour estimate corresponds to a measure of the
``Net Supported Direct FDA Work Hours Available for Assignments''
(86 FR 5743).
---------------------------------------------------------------------------

E. Benefits of the Final Withdrawal Rule

    The monetized benefits of this regulatory action to withdraw the
SUNSET final rule are the cost savings to the Department from not
completing the assessments and reviews required under the baseline
scenario, and the cost savings to the public from not commenting on
these assessments and reviews. To monetize these cost savings, we
multiply the hours related to the SUNSET final rule in Table D6 by the
cost per hour of these activities. We adopt the SUNSET final rule RIA's
``estimates that the fully-loaded cost per hour to the Department to
employ a person to conduct a Review or Assessment is $244.98 per hour''
\71\ and ``fully loaded cost per hour of writing comments is $143.20.''
\72\ Table E1 presents the yearly cost savings to the Department and
the public expected under the final withdrawal rule compared to the
baseline scenario. We combine the low estimates for the Department and
the public to generate an overall low estimate, and similarly combine
the high estimates for the Department and the public to generate an
overall high estimate. We also report an overall primary estimate,
which is the midpoint between the low and high estimates. Finally, we
report the present discounted value (PDV) and annualized cost savings
under the final withdrawal rule for both a 3% and 7% discount rate. All
figures are reported in 2020 dollars, in millions.
---------------------------------------------------------------------------

    \71\ 86 FR 5743.
    \72\ 86 FR 5745.

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

    For comparison, in present value terms, these estimates of
annualized cost savings are more than four times the size of the
annualized cost estimates included in the SUNSET final rule RIA. This
reflects what the Department has now concluded are more reasonable
assumptions about the effect of the SUNSET final rule rather than a
claim that the combination of these two regulatory actions will
generate net cost savings. These cost savings estimates attributed to
the final withdrawal rule are consistent with a scenario that the
Department returns to its approach to Section 610 reviews that
immediately predate the publication of the SUNSET final rule on January
19, 2021. We believe that this represents a credible and appropriate
approach for estimating the likely cost savings that will be
attributable to the final withdrawal rule. Other considerations
relating to the appropriate frequency or nature of retrospective
economic analyses of existing Departmental regulations are beyond the
scope of this final rule RIA.
    In the previous section, we discussed concerns about potential
costs of the SUNSET final rule that were overlooked in the SUNSET final
rule RIA. To the extent that we are unable to quantify or monetize
these costs, such as the purchase of data, conducting studies to
evaluate the impacts of rules, additional overhead costs associated
with contracting with non-government entities to perform a share of the
retrospective work, and other personnel costs, the cost savings
anticipated under the final withdrawal rule are equally underestimated.
    In addition to cost savings, the final withdrawal rule will
generate non-quantified benefits from reduced regulatory uncertainty.
Although we calculate the cost savings estimates in this analysis by
adopting an assumption that the Department will fulfill the
requirements of the SUNSET final rule rather than to let any regulation
expire automatically, it is highly likely that some regulations will
automatically expire. Withdrawing the SUNSET final rule will remove the
expiration provisions, which will also remove the likelihood of any
automatic expiration of regulatory requirements. The final withdrawal
rule will also eliminate the potential for regulatory confusion among
stakeholders, and harm to the public health related to the actuality of
having regulations expire automatically.

F. Costs of the Final Withdrawal Rule

    The costs of the final withdrawal rule will be the forgone benefits
of the information learned from the assessments and reviews completed
under the baseline scenario. We adopt the approach taken in the SUNSET
final

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

G. Analysis of Regulatory Alternatives to the Final Withdrawal Rule

    We quantitatively analyze four alternative options to the final
withdrawal rule. First, we consider an option to maintain the general
approach of the SUNSET final rule, but adopt a two-year period
following the effective date to assess and review all regulations older
than ten years. This option, Alternative 1, follows the timeline
envisioned under the November 4, 2020, proposed SUNSET rule.\73\
Second, we consider an option to maintain the general approach of the
SUNSET final rule, but adopt an initial ten-year period following the
effective date to assess and review all regulations, regardless of when
these were first published. This option, Alternative 2, evenly
distributes the time spent by the Department assessing and reviewing
existing regulations. Third, we consider an option to maintain the
general framework of the SUNSET final rule but limit its scope to
regulations that the Department previously identified as having a
significant economic impact on a substantial number of small entities.
This option, Alternative 3, would include the 326 Reviews of Post-RFA
rulemakings identified in Table D1. Fourth, we consider an option,
Alternative 4, that would maintain the SUNSET final rule's requirements
related to the timeline for assessing and reviewing all of the
Department's existing regulations, but without the automatic expiration
provision contained in the SUNSET final rule.
---------------------------------------------------------------------------

    \73\ 85 FR 70096.
---------------------------------------------------------------------------

    Table G1 presents the primary estimates of yearly cost savings
under the final withdrawal rule and under the four policy alternatives
described above. Each of these policy options are compared to the
common baseline scenario described in section D. We report the PDV and
annualized cost savings under the final withdrawal rule and two policy
alternatives for both a 3% and 7% discount rate. All figures are
reported in 2020 dollars, in millions. Negative cost-savings estimates
indicate that a policy alternative would likely result in net cost
increases compared to the baseline scenario.

           Table G1--Primary Estimate of Cost Savings Under the Final Withdrawal Rule and Alternatives
                                                      [$M]
----------------------------------------------------------------------------------------------------------------
              Year                  Final rule     Alternative 1   Alternative 2   Alternative 3   Alternative 4
----------------------------------------------------------------------------------------------------------------
2022............................          $125.2         -$187.8           $59.6           $70.8            $0.0
2023............................           125.2          -187.8            59.6            70.8             0.0
2024............................           125.2           121.5            59.6            70.8             0.0
2025............................           125.2           121.5            59.6            70.8             0.0
2026............................           125.2           121.5            59.6            70.8             0.0
2027............................             5.9             2.2           -59.6             2.9             0.0
2028............................             5.9             2.2           -59.6             2.9             0.0
2029............................             5.9             2.2           -59.6             2.9             0.0
2030............................             5.9             2.2           -59.6             2.9             0.0
2031............................             5.9             2.2           -59.6             2.9             0.0
PDV, 3%.........................           596.7           -26.6            37.5           335.9             0.0
PDV, 7%.........................           530.6           -54.5            70.2           298.9             0.0
Annualized, 3%..................            69.9            -3.1             4.4            39.4             0.0
Annualized, 7%..................            75.5            -7.8            10.0            42.6             0.0
----------------------------------------------------------------------------------------------------------------

    The cost savings reported for the Sunset final rule match the
estimates contained in Table E1 of this analysis. For Alternative 1, we
estimate annualized cost savings of -$3.1 million using a 3% discount
rate. This indicates that Alternative 1 would result in incremental
annualized costs of $3.1 million above the baseline scenario of the
SUNSET final rule. In addition to this quantified impact on cost
savings, Alternative 1 would increase the likelihood that the
Department would need to hire non-government experts to perform a share
of the retrospective work, resulting in additional overhead costs that
we have not monetized. Alternative 1 would also result in additional
unquantified benefits associated with earlier completion of some of the
retrospectives, and therefore earlier access to information from these
assessments and reviews.
    For Alternatives 2 and 3, we estimate annualized cost savings of
$4.4 million and $335.9 million, respectively. Compared to the SUNSET
final rule, Alternatives 2 and 3 would reduce the likelihood that the
Department would need to hire non-government experts to perform a share
of the retrospective work, and thus reduce the potential for additional
overhead costs. Compared to the SUNSET final rule, Alternative 2 would
result in non-quantified forgone benefits associated with later
completion of some of the retrospective analyses, and therefore later
access to information from these assessments and reviews. Alternative 3
would reduce the number of retrospective analyses and result in more
foregone information.
    For Alternative 4, we do not identify any incremental costs or cost
savings compared to the baseline scenario of the SUNSET final rule,
maintaining the assumption in the main analysis that the Department
will fulfill the analytic requirements of the SUNSET final rule.
However, compared to SUNSET final rule, Alternative 4 would generate
non-quantified benefits from reduced regulatory uncertainty associated
with the automatic expiration provision of the SUNSET final rule.
Alternative 4 would, therefore, result in non-quantified benefits from
reduced regulatory confusion among stakeholders, and non-quantified
benefits from reduced harm to the public health related to the
actuality of having regulations expire automatically.

H. Final Small Entity Analysis

    The Department has examined the economic implications of this final
withdrawal rule as required by the Regulatory Flexibility Act. This
analysis, as well as other sections in this Regulatory Impact Analysis,
serves as the Final Regulatory Flexibility Analysis, as required under
the Regulatory Flexibility Act.
1. Description and Number of Affected Small Entities
    The SBA maintains a Table of Small Business Size Standards Matched
to North American Industry Classification System Codes (NAICS).\74\ We
replicate the SBA's description of this table:
---------------------------------------------------------------------------

    \74\ U.S. Small Business Administration (2019). ``Table of Size
Standards.'' August 19, 2019. https://www.sba.gov/document/support--table-size-standards.

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

    The SUNSET final rule will potentially impact small entities across
at least NAICS industry sectors 11 (Agriculture, Forestry, Fishing and
Hunting), 31-33 (Manufacturing), 42 (Wholesale Trade), 44-45 (Retail
Trade), 48-49 (Transportation and Warehousing), 52 (Finance and
Insurance), 54 (Professional, Scientific, and Technical Services), 62
(Health Care and Social Assistance), 81 (Other Services (except Public
Administration)), and 92 (Public Administration). Given the wide range
of entities affected, and various sources of uncertainty described in
this section, it is not practical to directly estimate the number of
small entities that will potentially be impacted under the baseline
scenario of the SUNSET final rule. Similarly, it is impractical to
identify the small entities that will be impacted by the final
withdrawal rule. The Congressional Research Service observes that
``about 97% of all employer firms qualify as small under the SBA's size
standards. These firms represent about 30% of industry receipts.'' \75\
For practicality, we assume that the bulk of the potential impacts of
the final withdrawal rule to private sector regulated entities are
small entities.
---------------------------------------------------------------------------

    \75\ Robert Jay Dilger (2021). ``Small Business Size Standards:
A Historical Analysis of Contemporary Issues.'' Congressional
Research Service Report R40860. Updated May 28, 2021. Page 2.
https://crsreports.congress.gov/product/pdf/R/R40860.
---------------------------------------------------------------------------

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

considers a rule to have a significant impact on a substantial number
of small entities if it has at least a three percent impact on revenue
on at least five percent of small entities. This cost-saving benefit is
well below this threshold.

XII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in E.O. 13132, ``Federalism.'' The Department has determined
that this final rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.

VIII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this final rule in accordance with the principles
set forth in E.O. 13175, ``Consultation and Coordination With Indian
Tribal Governments.'' As we acknowledged and agreed in the Withdrawal
NPRM, multiple comments from representatives of several Tribes and
related groups expressed concern that the SUNSET final rule would have
significant tribal implications, if implemented, and that consultation
with Tribal governments on the SUNSET proposed rule was not adequate.
See 86 FR 59931. However, the Department further explained that tribal
consultation on the Withdrawal NPRM was unnecessary because the
withdrawal of the SUNSET final rule would continue the status quo, and
because of the numerous comments already received from Tribal
governments and representatives asking for the SUNSET final rule to be
withdrawn. The Department nevertheless provided notice of the
Withdrawal NPRM to Tribes, acknowledging tribal concerns with the lack
of tribal consultation on the earlier rulemaking and encouraging them
to share any additional feedback by providing written comments on the
proposed withdrawal. The Department continues to conclude that the
final withdrawal rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes.

IX. Analysis of Environmental Impacts

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

X. Paperwork Reduction Act

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

XI. References

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

    Dated: May 24, 2022.
Xavier Becerra,
Secretary.
[FR Doc. 2022-11477 Filed 5-26-22; 8:45 am]
BILLING CODE 4150-26-P


[Federal Register Volume 79, Number 149 (Monday, August 4, 2014)]
[Notices]
[Pages 45196-45197]
[FR Doc No: 2014-18302]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1072]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Application for Participation in the Food and Drug
Administration Commissioner's Fellowship Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the application for participation in the
FDA Commissioner's Fellowship Program (CFP).

DATES: Submit either electronic or written comments on the collection
of information by October 3, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Application for Participation in the FDA Commissioner's Fellowship
Program; (OMB Control Number 0910--New)

    Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of
Title 5 of the United States Code authorize Federal Agencies to rate
applicants for Federal jobs. Collecting applications for the CFP will
allow FDA's Office of the Commissioner to easily and efficiently elicit
and review information from students and health care professionals who
are interested in becoming involved in FDA-wide activities. The process
will reduce the time and cost of submitting written documentation to
the Agency and lessen the likelihood of applications being misrouted
within the Agency mail system. It will assist the Agency in promoting
and protecting the public health by encouraging outside persons to
share their expertise with FDA.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    Activity/5 U.S.C. Section        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
1104,1302, 3301, 3304, 3320,                 600               1             600            1.33             798
 3361, 3393, and 3394...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             798
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA based these estimates on the number of inquiries that have been
received concerning the program and the number of requests for
application forms over the past 5 years.

    Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18302 Filed 8-1-14; 8:45 am]
BILLING CODE 4164-01-P