[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Proposed Rules]
[Pages 70096-70124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23888]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

21 CFR Part 6

42 CFR Parts 1 and 404

45 CFR Part 6

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


Securing Updated and Necessary Statutory Evaluations Timely

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

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Regulatory Flexibility Act (RFA) requires agencies to 
publish plans to conduct periodic reviews of certain of their 
regulations. Multiple Executive Orders also require agencies to submit 
plans for periodic reviews of certain regulations. To further comply 
with the RFA and Executive Orders, and to ensure the Department's 
regulations have appropriate impacts, the U.S. Department of Health and 
Human Services (HHS) issues this notice of proposed rulemaking to set 
expiration dates for its regulations (subject to certain exceptions), 
unless the Department periodically assesses the regulations to 
determine if they are subject to the RFA, and if they are, performs a 
review that satisfies the criteria in the RFA.

DATES: Submit either electronic or written comments on the proposed 
rule by December 4, 2020, except that electronic or written comments on 
the portion of the proposed rule amending

[[Page 70097]]

42 CFR parts 400-429 and parts 475-499 are due January 4, 2021.

ADDRESSES: You may submit comments, identified by Docket No. HHS-OS-
2020-0012, by the following method:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted to http://regulations.gov, including any personal information provided. For 
access to the docket to read background documents or comments received, 
go to http://www.regulations.gov. Comments must be identified by RIN 
0991-AC24. Because of staff and resource limitations, all comments must 
be submitted electronically to www.regulations.gov. Follow the ``Submit 
a comment'' instructions.
    Warning: Do not include any personally identifiable information 
(such as name, address, or other contact information) or confidential 
business information that you do not want publicly disclosed. All 
comments may be posted on the internet and can be retrieved by most 
internet search engines. No deletions, modifications, or redactions 
will be made to comments received.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including personally identifiable or confidential business information 
that is included in a comment. You may wish to consider limiting the 
amount of personal information that you provide in any voluntary public 
comment submission you make. HHS may withhold information provided in 
comments from public viewing that it determines may impact the privacy 
of an individual or is offensive. For additional information, please 
read the Privacy Act notice that is available via the link in the 
footer of http://www.regulations.gov.
    Follow the search instructions on that website to view the public 
comments.
    A public hearing on this proposed rule will be held before the end 
of the public comment period. A separate notice will be published in 
the Federal Register providing details of this hearing. Subject to 
consideration of the comments received, the Secretary intends to 
publish a final regulation.

FOR FURTHER INFORMATION CONTACT: James Lawrence, 200 Independence 
Avenue SW, Washington, DC 20201; or by email at [email protected]; or 
by telephone at 1-877-696-6775.

SUPPLEMENTARY INFORMATION: This notice of proposed rulemaking is 
organized as follows:

Table of Contents

I. Summary
II. Background
III. Statutory Authority
IV. Provisions of Proposed Rule
V. Request for Comment
VI. Regulatory Impact Analysis

I. Summary

    The U.S. Department of Health and Human Services (HHS or the 
Department) issues this notice of proposed rulemaking to enhance the 
Department's implementation of section 3(a) of the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 610, and various executive orders, and 
improve accountability and the performance of its regulations.\1\ The 
RFA requires federal agencies to publish in the Federal Register ``a 
plan for the periodic review of the rules issued by the agency which 
have or will have a significant economic impact upon a substantial 
number of small entities'' in order ``to determine whether such rules 
should be continued without change, or should be amended or rescinded, 
consistent with the stated objectives of applicable statutes, to 
minimize any significant impact of the rules upon a substantial number 
of small entities.'' 5 U.S.C. 610(a). In conducting this retrospective 
review, agencies must consider a variety of factors, including the 
continued need for the rule, legal issues, public input, overlap and 
duplication with other federal or State and local governmental rules, 
and technological, economic, or other changes. 5 U.S.C. 610(b). Agency 
compliance with 5 U.S.C. 610 may be subject to judicial review. See 5 
U.S.C. 611(a).
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    \1\ Unless otherwise indicated, all references to HHS in this 
proposed rule include HHS' constituent agencies and other 
components.
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    Several Executive Orders have also directed agencies to submit 
plans for the periodic review of certain of their regulations. See, 
e.g., Executive Orders 12866 and 13563.
    The Department has tried to carry out the evidence-based approach 
to regulation prescribed by Congress and the executive orders, but HHS' 
efforts have met varying levels of success. Several States, as well as 
jurisdictions outside the United States, have experimented with 
different ways of ensuring agencies engage in retrospective regulatory 
reviews so that legal requirements are updated in view of emerging 
evidence and changed circumstances. Among the lessons that have emerged 
is that while statutory mandates are helpful, one of the most important 
factors for ensuring agencies conduct retrospective reviews of their 
regulations is to provide for the sunset or automatic expiration of 
certain regulatory requirements after a period of time unless a 
retrospective review determines that the regulations should be 
maintained.
    Therefore, in order to ensure evidence-based regulation that does 
not become outdated as conditions change, HHS proposes that, subject to 
certain exceptions, all regulations issued by the Secretary or his 
delegates or sub-delegates in Titles 21, 42, and 45 of the CFR shall 
expire at the end of (1) two calendar years after the year that this 
proposed rule first becomes effective, (2) ten calendar years after the 
year of the regulation's promulgation, or (3) ten calendar years after 
the last year in which the Department Assessed and, if required, 
Reviewed the regulation, whichever is latest.\2\ The RFA and executive 
orders have only resulted in limited retrospective review by the 
Department. The Department believes this proposed rule would effectuate 
the desire for periodic retrospective reviews expressed in the RFA and 
Executive Orders, as well as ensure the Department's regulations are 
having appropriate impacts and have not become outdated.
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    \2\ As ``Assessed'' and ``Reviewed'' are defined herein.
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II. Background

A. The Regulatory Flexibility Act

    In 1980, Congress enacted the Regulatory Flexibility Act (RFA), 
Public Law 96-354, 94 Stat. 1164 (Sept. 19, 1980). Congress stated that 
``the purpose of this Act [is] to establish as a principle of 
regulatory issuance that agencies shall endeavor, consistent with the 
objectives of the rule and of applicable statutes, to fit regulatory 
and informational requirements to the scale of the businesses, 
organizations, and governmental jurisdictions subject to regulation.'' 
94 Stat. at 1165. Consistent with this purpose, section 3(a) of the RFA 
requires agencies to publish in the Federal Register a ``plan for the 
periodic review of rules which have or will have a significant economic 
impact upon a substantial number of small entities.'' 5 U.S.C. 610(a). 
The ``purpose of the review shall be to determine whether such rules 
should be continued without change, or should be amended or rescinded . 
. . to minimize any significant economic impact of the rules upon a 
substantial number of small entities.'' Id. In conducting this review,

[[Page 70098]]

Congress provided that agencies ``shall consider the following 
factors'':
    (a) The continued need for the rule;
    (b) The nature of complaints or comments received concerning the 
rule from the public;
    (c) The complexity of the rule;
    (d) The extent to which the rule overlaps, duplicates or conflicts 
with other Federal rules, and, to the extent feasible, with State and 
local governmental rules; and
    (e) The length of time since the rule has been evaluated or the 
degree to which technology, economic conditions, or other factors have 
changed in the area affected by the rule.
    5 U.S.C. 610(b)(1)-(5). Congress required agencies to conduct an 
initial review within ten years of the effective date of the RFA, as 
well as subsequent reviews ``within ten years of the publication of'' 
future final rules. 5 U.S.C. 610(a).
    The retrospective review provided for in 5 U.S.C. 610 is a 
congressional mandate. Under the plain terms of the Act, having a plan 
for such reviews is not optional. Congress fashioned a private right of 
action for small entities to ensure agencies satisfy 5 U.S.C. 610. See 
5 U.S.C. 611(a)(1) (for ``any rule subject to this chapter, a small 
entity that is adversely affected or aggrieved by final agency action 
is entitled to judicial review of agency compliance with the 
requirements of sections 601, 604, 605(b), 608(b), and 610 in 
accordance with chapter 7''). Originally, as one commentator explained, 
the RFA ``contain[ed] an extremely qualified and ambiguous provision 
for judicial review.'' \3\ In 1996, Congress amended the RFA to more 
clearly provide for judicial review of violations of 5 U.S.C. 610.\4\ 
As one House Committee report explained, the lack of judicial review 
made ``agencies completely unaccountable for their failure to comply 
with its requirements,'' a problem the amendment attempted to solve.\5\
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    \3\ Paul R. Verkuil, A Critical Guide to the Regulatory 
Flexibility Act, 1982 Duke L.J. 213, 259 (1982).
    \4\ Contract with America Advancement Act of 1996, Public Law 
104-121, 110 Stat. 847, 865-66 (1996).
    \5\ H.R. Rep. No. 104-500, at 3 (1996).
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B. Executive Orders Directing Agencies To Review Existing Regulations

    Other efforts to conduct retrospective regulatory review both 
predate and have continued after passage of the RFA. In 1978, President 
Carter issued an executive order on improving federal regulations.\6\ 
The order directed agencies to ``periodically review their existing 
regulations.'' \7\ In determining which existing regulations to review, 
the order required agencies to consider, among other things, whether 
``technology, economic conditions or other factors have changed in the 
area affected by the regulation.'' \8\ The Executive Order considered 
suggestions from the public that all regulations be reviewed, usually 
3-5 years after issuance. But the Carter Administration instead 
instructed that, due to agency resource limitations, agencies should 
concentrate their reviews on those regulations which no longer serve 
their intended purpose, which have caused administrative difficulties, 
or which have been affected by new developments.\9\ The executive order 
also considered, but rejected, the idea of including a sunset provision 
in regulations on the ground that agencies cannot entirely eliminate 
regulations unless the law which authorized the regulations allows 
it.\10\ However, the Department believes that executive order did not 
consider that the authorizing statutes for many regulations permit 
those regulations to be rescinded. Moreover, as discussed below, 
experience since 1978 has shown it is difficult to adequately conduct 
retrospective regulatory review if regulations do not contain sunset 
provisions.
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    \6\ Exec. Order No. 12044 of Mar. 23, 1978, 43 FR 12661 (Mar. 
24, 1978) (revoked by Exec. Order No. 12291 of Feb. 17, 1981, 46 FR 
13193 (Feb. 19, 1981)).
    \7\ 43 FR at 12663.
    \8\ Id.
    \9\ Id. at 12669. As discussed below, the Department is 
proposing to review a different subset of its regulations than was 
directed by Exec. Order No. 12044, in part because the RFA's 
directive to review regulations that have a significant economic 
impact upon a substantial number of small entities had not yet been 
enacted at the time of Exec. Order No. 12044. Moreover, Exec. Order 
No. 12044 was responding to suggestions that the review be performed 
every three to five years. The Department is proposing that its 
reviews be performed every ten years (except for regulations that 
have already been in effect for ten years), which should lessen the 
burden on the Department's resources.
    \10\ Id. at 12669.
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    Like the Carter Administration, every subsequent administration has 
directed agencies to engage in retrospective review of existing 
regulations. In 1981, President Reagan ordered agencies to ``review[ ] 
existing regulations'' in view of cost-benefit principles and potential 
alternatives.\11\ In 1992, President George H.W. Bush issued a 
memorandum instructing agencies to conduct a 90-day review ``to 
evaluate existing regulations and programs and to identify and 
accelerate action on initiatives that will eliminate any unnecessary 
regulatory burden or otherwise promote economic growth.'' \12\ 
President Clinton similarly called for review of existing regulations 
to determine whether they have become ``unjustified or unnecessary as a 
result of changed circumstances,'' and ``to confirm that regulations 
are both compatible with each other and [are] not duplicative or 
inappropriately burdensome in the aggregate.'' \13\ Specifically, that 
Executive Order required agencies to submit to the Office of 
Information and Regulatory Affairs (OIRA) a program under which the 
agency ``will periodically review its existing significant regulations 
to determine whether any such regulations should be modified or 
eliminated so as to make the agency's regulatory program more effective 
in achieving the regulatory objectives, less burdensome, or in greater 
alignment with the President's priorities and the principles set forth 
in this Executive Order.'' \14\ The George W. Bush Administration's 
Acting OIRA Administrator noted that the Bush Administration was ``in 
the process of reviewing a variety of existing regulations and 
regulatory programs in an effort to identify areas where sensible 
changes will yield greater benefits for the public at lower costs.'' 
\15\
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    \11\ Exec. Order No. 12291 of Feb. 17, 1981, 46 FR 13193, 13193 
(Feb. 19, 1981) (revoked by Exec. Order 12866 of Sept. 30, 1993, 58 
FR 51735 (Oct. 4, 1993)); see also Exec. Order 12498 of Jan. 4, 
1985, 50 FR 1036 (Jan. 8, 1985) (creating annual regulatory planning 
program), revoked by Exec. Order 12866 of Sept. 30, 1993, 58 FR 
51735 (Oct. 4, 1993)).
    \12\ Memorandum on Reducing the Burden of Government Regulation 
(Jan. 28, 1992).
    \13\ Exec. Order No. 12866 of Sept. 30, 1993, 58 FR 51735 (Oct. 
4, 1993).
    \14\ Id.
    \15\ Draft Report to Congress on the Costs and Benefits of 
Federal Regulations Introduction, 66 FR 22041, 22054 (May 2, 2001).
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    President Obama also instructed agencies to engage in retrospective 
regulatory review. In 2011, President Obama issued an executive order 
ordering agencies ``[t]o facilitate the periodic review of existing 
significant regulations . . . to promote retrospective analysis of 
rules that may be outmoded, ineffective, insufficient, or excessively 
burdensome, and to modify, streamline, expand, or repeal them in 
accordance with what has been learned.'' \16\ Similarly, in 2012, 
President Obama noted that retrospective review has particular 
relevance ``[d]uring challenging economic times,'' and that agencies 
should consider whether regulations ``should be modified or streamlined 
in

[[Page 70099]]

light of changed circumstances, including the rise of new 
technologies.'' \17\
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    \16\ Exec. Order No. 13563 of Jan. 18, 2011, 76 FR 3821, 3822 
(Jan. 21, 2011); see also Exec. Order No. 13579 of July 11, 2011, 76 
FR 41587, 41587 (July 14, 2011) (applying the same requirement to 
independent regulatory agencies).
    \17\ Exec. Order No. 13610 of May 10, 2012, 77 FR 28469, 28469 
(May 14, 2012).
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    President Trump has attempted to identify existing undue regulatory 
burdens and facilitate retrospective review of regulations. For 
example, in January 2017, President Trump issued an executive order 
requiring agencies to identify at least two regulations to be repealed 
for every one regulation proposed or otherwise promulgated.\18\ 
Similarly, a 2017 OIRA report to Congress explained, ``Rules should be 
written and designed to facilitate retrospective analysis of their 
effects, including consideration of the data that will be needed for 
future evaluation of the rules' ex post costs and benefits.'' \19\ In 
May 2020, in response to the COVID-19 pandemic, President Trump ordered 
agencies to ``identify regulatory standards that may inhibit economic 
recovery'' and to ``consider taking appropriate action, consistent with 
applicable law,'' including modifying, waiving, or rescinding those 
regulatory requirements.\20\
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    \18\ Exec. Order No. 13771 of Jan. 30, 2017, 82 FR 9339, 9339 
(Feb. 3, 2017).
    \19\ Office of Mgmt. & Budget, 2017 Report to Congress on the 
Benefits and Costs of Federal Regulations and Agency Compliance with 
the Unfunded Mandates Reform Act at 5 (2017), https://www.whitehouse.gov/wp-content/uploads/2019/12/2019-CATS-5885-REV_DOC-2017Cost_BenefitReport11_18_2019.docx.pdf; see also id. at 
16 (``[I]t is important to consider retrospective, as opposed to ex 
ante, estimates of both benefits and costs.'').
    \20\ Exec. Order No. 13924 of May 19, 2020, 85 FR 31353, 31354 
(May 22, 2020).
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    In addition to the executive orders, other executive branch actions 
have sought to spur agencies to conduct the reviews called for by 5 
U.S.C. 610. One example was the Regulatory Review and Reform (r3) 
initiative, which the Small Business Administration launched in part to 
improve compliance with 5 U.S.C. 610 and further the goals of periodic 
reviews. The r3 initiative was a long-term project to help agencies 
pinpoint existing federal rules that warrant review--and to revise 
those rules if they are found to be ineffective, duplicative, out of 
date, or otherwise deficient.\21\
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    \21\ Testimony of The Hon. Thomas M. Sullivan, Chief Counsel for 
Advocacy, U.S. SBA, U.S. House of Representatives Comm. on Small 
Bus. Subcomm. on Reg.'s, Health Care and Trade (July 30, 2008), 
https://www.sba.gov/sites/default/files/files/test08_0730.pdf 
(``Historically, federal agency compliance with section 610 has been 
limited.'') (last visited Oct. 19, 2020).
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    Consistent with these actions, HHS has conducted retrospective 
reviews of some of its regulations. For example, pursuant to Executive 
Order 13563, HHS published a list of regulations the Department 
identified as candidates for retrospective review.\22\ The Department 
also took action. For example, HHS, citing Executive Order 13563, 
eliminated certain restrictions on the use of telemedicine in rural 
areas.\23\
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    \22\ See also Retrospective Review of Existing Rules, U.S. Dept. 
of Health & Human Servs., https://www.hhs.gov/open/retrospective-review/index.html (last visited Oct. 19, 2020).
    \23\ See Medicare and Medicaid Programs: Changes Affecting 
Hospital and Critical Access Hospital Conditions of Participation: 
Telemedicine Credentialing and Privileging, 76 FR 25550 (May 5, 
2011); see also Medicare and Medicaid Programs; Regulatory 
Provisions To Promote Program Efficiency, Transparency, and Burden 
Reduction; Part II, 79 FR 27106 (May 12, 2014) (finalizing several 
rules to remove unnecessary regulatory and reporting requirements 
previously imposed on hospitals and other health care providers).
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    Nonetheless, the Department has only conducted retrospective review 
of regulations to a very limited extent. One academic analysis 
determined that, in response to Executive Order 13563, the Department 
planned 83 retrospective analyses in 2012 and completed 33 analyses 
with final action by August 31, 2013.\24\ By contrast, the Department 
issued 247 rules between the date Executive Order 13563 was issued and 
August 31, 2013.\25\ As of July 2016, the Department had 40 planned 
retrospective analyses and by April 2017 had completed analyses with 
final action on 19 of them.\26\ These findings are consistent with 
government assessments that the Department's efforts to comply with 5 
U.S.C. 610 have at times been lacking.\27\
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    \24\ Connor Raso, Assessing regulatory retrospective review 
under the Obama administration, Brookings Inst., (Jun. 15, 2017) 
https://www.brookings.edu/research/assessing-regulatory-retrospective-review-under-the-obama-administration/.
    \25\ Id.
    \26\ Id.
    \27\ See, e.g., Curtis W. Copeland, Cong. Research Serv., 
RL32801, Reexamining Rules: Section 610 of the Regulatory 
Flexibility Act 7-8 (2008); U.S. Gov't Accountability Off., GAO/GGD-
94-105, Regulatory Flexibility Act: Status of Agencies' Compliance 
12 (1994) (quoting a 1983 Small Business Administration report that 
stated that the Department's section 610 review plan was `` `very 
general,' and, as a result, `it is difficult to measure progress and 
to make recommendations with respect to future review' ''); see also 
Testimony of The Hon. Thomas M. Sullivan, Chief Counsel for 
Advocacy, U.S. SBA, U.S. House of Representatives Comm. on Small 
Bus. Subcomm. on Reg.'s, Health Care and Trade (July 30, 2008), 
https://www.sba.gov/sites/default/files/files/test08_0730.pdf 
(``Historically, federal agency compliance with section 610 has been 
limited.'') (last visited Oct. 19, 2020).
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    Scholars have posited reasons why agencies may be reluctant to 
perform retrospective reviews. One administrative law expert has 
written:

    [E]ven with sufficient resources, agencies may not be properly 
incentivized. They are less likely to be found at fault for not 
conducting rigorous periodic reviews. Many rules, even those with 
significant effects, are often not on the public's radar once 
adopted. Challenging agency regulation under the RFA is more 
difficult than under the Administrative Procedure Act (APA) because 
there is no comment process and standing is granted to more limited 
parties. The harm to the public resulting from a cursory analysis is 
also much less clear. If sufficient interests exist to modify the 
rule, strong interest groups will directly lobby the agency to 
modify the rule. But in this case, a brand new rulemaking effort 
emerges.
    There are also political reasons and moral hazard concerns 
associated with performing retrospective analyses. In most cases, 
retrospective analyses of existing regulations are routine business 
matters left to be handled by staff members, rather than political 
appointees. Political appointees, such as agency heads, tend to come 
with specific regulatory agendas of their own. By contrast, staff 
members at regulatory agencies are best viewed as career members who 
have a vested interest in seeing their agencies continue to exist 
and thrive. All else equal, they are not inclined to acknowledge 
that the work of their agency is inefficient or unnecessary, and 
even less inclined to conduct analyses that may lead to a curtailing 
of the agency's authority. Whatever the reasons may be, serious ex 
post reviews are few and far between. A majority of rules, once 
adopted, will likely persist without significant ex post 
modification. As to how many agency rules currently implemented may 
be costing more resources than yielding benefits is anyone's 
guess.\28\
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    \28\ Yoon-Ho Alex Lee, An Options Approach to Agency Rulemaking, 
65 Admin. L. Rev. 881, 895-96 (2013).

Thus, the Department proposes that it needs to impose a strong 
incentive on itself to perform retrospective review, given these 
countervailing incentives to not perform such reviews and the limited 
number of retrospective reviews that the Department has performed over 
the last 40 years. As discussed in more detail in the regulatory impact 
analysis infra, the Department has the resources to periodically review 
the impacts of its regulations. Only a handful of Department employees 
are needed to perform the periodic reviews.

C. Limitations in Government Projections Counsel in Favor of 
Retrospective Regulatory Review

    The Congressional and Presidential directives to periodically 
review existing regulations are sound policy. When the Department first 
issues a regulation, it makes an educated guess about the regulation's 
impact. Several years after the regulation is promulgated, the 
Department has a somewhat greater basis for assessing its real-world 
impacts and can refine the regulation or agency enforcement practices, 
as appropriate. This would

[[Page 70100]]

further democratic values such as accountability, administrative 
simplification, transparency, and performance measurement and 
evaluation.
    Indeed, the literature indicates that government projections of 
regulatory impacts would benefit from refinement based on experience 
after the regulations are implemented. In 2005, the Office of 
Management and Budget (OMB) provided an overview of a sample of 
retrospective analyses based on an examination of forty-seven case 
studies.\29\ OMB considered a pre-regulation estimate to be accurate if 
the post-regulation estimate was within +/-25 percent of the pre-
regulation estimate.\30\ This measure of accuracy reveals the 
difficulty and uncertainty inherent in prospective cost-benefit 
analysis. OMB found that agencies often inaccurately estimated the 
benefits of regulations in its sample of regulations, and agencies were 
more likely to overestimate benefits than to underestimate them, where 
benefits were estimated.\31\ Agencies overestimated benefits in 19 of 
39 sampled regulations, whereas they underestimated benefits in only 
two of the 39 regulations.\32\ In two cases, agencies overestimated 
benefits by a factor of 10.\33\ Second, agencies sometimes 
overestimated the benefit-cost ratio, and in that sense were a bit too 
optimistic about the consequences of their rules. Agency estimates were 
accurate in only 11 rules, while the ratio was overestimated in 22 
rules and underestimated in 14 rules.\34\ Third, agencies also 
overestimated and, less frequently, underestimated costs in the sampled 
regulations. Agency cost estimates were accurate for only 12 rules, 
overestimated for 16 rules, underestimated for 12 rules, and not 
estimated for seven rules.\35\
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    \29\ Office of Mgmt. & Budget, Validating Regulatory Analysis: 
2005 Report to Congress on the Costs and Benefits of Federal 
Regulations and Unfunded Mandates on State, Local, and Tribal 
Entities, at 46-47 (2005) http://perma.cc/R8LX-BQMJ (collecting 
studies comparing ex ante and ex post analyses of regulations' costs 
and benefits, including examples where cost and benefit estimates 
were off by more than a factor of ten).
    \30\ Id. at 42.
    \31\ Id. at 43-46.
    \32\ Id. at 47.
    \33\ Id. at 43.
    \34\ Id. at 47.
    \35\ Id.
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    Academic studies have also identified inaccuracies in agency 
estimates, relative to an ex post re-estimation. For example, one study 
of sixty-one rules for which benefit-cost ratios could be compared 
before and after the fact (including some not included in the OMB 
review) found that in only sixteen of the sixty-one cases were the 
estimated ratios essentially accurate, though the study found no bias 
in estimates of benefit-cost ratios.\36\ In this analysis, Dr. 
Harrington criticized certain aspects of the OMB analysis. But it is 
notable that, even though OMB and Dr. Harrington used somewhat 
differing methods and reviewed samples of regulations that did not 
completely overlap, they both found ex ante estimates to be in many 
cases lacking. Dr. Harrington concluded his analysis by noting that 
``the results demonstrate the value of ex post analysis. It is 
frustrating that there is so little of it, especially when so many 
close observers, from all points of view, claim to be in favor of it.'' 
\37\
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    \36\ Winston Harrington, Grading Estimates of the Benefits and 
Costs of Federal Regulation, Res. for the Future, Discussion Paper 
06-39, 2006, at 33, http://papers.ssrn.com/sol3/papers.cfm?abstract_id=937357. Dr. Harrington used the same measure 
of accuracy as OMB. While both OMB and Dr. Harrington noted that 
using +/-25% as the measure of accuracy could be arbitrary, it is 
nonetheless informative that in many cases the ex ante estimates in 
the sampled regulations differed from ex post estimates by more than 
+/-25%.
    \37\ Id. at 34.
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    A more recent study of a sample of federal regulations found that 
of the eight regulations for which the author was able to make ex ante 
and ex post cost comparisons, six regulations involved overestimates of 
costs, two involved underestimates of costs, and none were deemed 
accurate.\38\ A regulation was deemed accurate if the regulation's 
regulatory impact analysis fell roughly within +/-25% of the ex post 
observation.\39\ Of the 18 regulatory requirements for which the author 
was able to compare benefits (also referred to as ``effectiveness'' in 
the study) estimates on an ex ante and ex post basis, he found that 10 
involved overestimates, six were underestimates, and two were 
relatively accurate.\40\
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    \38\ Richard Morgenstern, Retrospective Analysis of U.S. Federal 
Environmental Regulation, 9 J. of Benefit Cost Anal., no. 2, 2018, 
at 294 https://www.cambridge.org/core/services/aop-cambridge-core/content/view/891E36D3DBCEB79C969278488E5E1897/S2194588817000173a.pdf/retrospective_analysis_of_us_federal_environmental_regulation.pdf.
    \39\ Id.
    \40\ Id.; see also Cynthia Morgan & Nathalie B. Simon, National 
primary drinking water regulation for arsenic: A retrospective 
assessment of costs, 5 J. Benefit Cost Anal. no. 2, 2014, at 259-84 
https://www.cambridge.org/core/services/aop-cambridge-core/content/view/A7B29CE98E650B424E92FF292A8FFC89/S2194588800000774a.pdf/national_primary_drinking_water_regulation_for_arsenic_a_retrospective_assessment_of_costs.pdf (finding that the EPA methodology 
overestimated predicted capital costs from its arsenic rule in most 
studied cases, especially as the size of the system increases (as 
measured by the design flow rate)).
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    Inaccurate estimates are not always the result of poor analysis by 
the agency. Sometimes changes in the legal landscape can cause 
government projections to become obsolete. For example, in February 
2010, officials in the Centers for Medicare and Medicaid Services' 
Office of the Actuary (OACT) issued health spending and coverage 
projections through 2019.\41\ A month later, Congress enacted the 
Patient Protection and Affordable Care Act, Public Law 111-148, 124 
Stat. 119, and the Health Care and Education Reconciliation Act of 
2010, Public Law 111-152, 124 Stat. 1029 (``ACA''). Largely as a result 
of the ACA's passage, in October 2010 OACT issued revised projections 
forecasting that by 2019 the insured share of the population would be 
92.7 percent--roughly ten percentage points higher than OACT projected 
nine months earlier.\42\
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    \41\ See Truffer CJ, et al. Health Spending Projections Through 
2019: The Recession's Impact Continues, 29 Health Aff. no. 3, 2010, 
at 522-29, https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2009.1074.
    \42\ See Sisko, et al., National Health Spending Projections: 
The Estimated Impact Of Reforms Through 2019, 29 Health Aff. no. 10, 
at 1936, https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2010.0788.
---------------------------------------------------------------------------

    Changes in technology can also render projections inaccurate. One 
study has noted that even when an agency's benefit-cost analysis uses 
sound science and the best available information to estimate the costs 
associated with a rule, technological innovation can result in an ex 
post assessment of costs differing from the agency's cost estimates at 
the time it promulgated the rule.\43\ As an example of technology's 
impact on regulations, in 2019 the Food and Drug Administration (FDA) 
issued a rule amending requirements for medical device premarket 
submissions to remove requirements for paper and multiple copies, and 
replace these requirements with requirements for a single submission in 
electronic format.\44\ Changes in technology had rendered the 
requirement for multiple

[[Page 70101]]

copies, whether in electronic format or paper form, no longer 
necessary.\45\ Had the Department reviewed more of its regulations, it 
might have learned of additional instances where technological changes 
counsel in favor of amendment. In addition, some scholars have 
suggested that in some cases changes in technology can reduce the costs 
of complying with regulatory mandates.\46\ If retrospective reviews 
conclude that technology has reduced compliance costs, that can inform 
the Department's decision about if or how to amend a regulation.
---------------------------------------------------------------------------

    \43\ Cynthia Morgan & Nathalie B. Simon, National primary 
drinking water regulation for arsenic: A retrospective assessment of 
costs, 5 J. Benefit Cost Anal. no. 2, 2014, at 259-84, https://www.cambridge.org/core/services/aop-cambridge-core/content/view/A7B29CE98E650B424E92FF292A8FFC89/S2194588800000774a.pdf/national_primary_drinking_water_regulation_for_arsenic_a_retrospective_assessment_of_costs.pdf. One example referred to in this study is 
that technological innovation or regulatory or technical constraints 
could result in water systems using different treatment technologies 
for arsenic removal than assumed by the agency when it promulgated a 
regulation.
    \44\ Medical Device Submissions: Amending Premarket Regulations 
That Require Multiple Copies and Specify Paper Copies To Be Required 
in Electronic Format, 84 FR 68334 (Dec. 16, 2019).
    \45\ Id. at 68334.
    \46\ See, e.g., Cass R. Sunstein, The Regulatory Lookback, 94 
B.U. L. Rev. 579, 599 (2014).
---------------------------------------------------------------------------

    Yet another reason for potential divergence between prospective and 
retrospective regulatory impact estimates is non-compliance with the 
regulation being assessed. One study found differing accuracy for 
prospective per-unit cost estimates and prospective aggregate cost 
estimates; where there is substantial non-compliance with the 
regulation being analyzed, the study claimed, cost estimates per unit 
can sometimes be reasonably accurate while aggregates are 
simultaneously overestimated.\47\ (Non-compliance would, of course, 
also affect the accuracy of benefits estimates.\48\) As such, ex post 
analysis has the potential to inform not just decisions about codified 
regulatory requirements but also about agency enforcement practices.
---------------------------------------------------------------------------

    \47\ Winston Harrington, Richard D. Morgenstern and Peter 
Nelson, On the Accuracy of Regulatory Cost Estimates, J. Policy 
Anal. & Management 2000, 19(2): 297-322.
    \48\ See, e.g., Si Kyung Seong and John Mendeloff, Assessing the 
Accuracy of OSHA's Projections of the Benefits of New Safety 
Standards, Am. J. Industrial Medicine 2004, 45(4): 313-328.
---------------------------------------------------------------------------

    While the prospective cost-benefit analyses performed in connection 
with the promulgation of rules are quite useful, former OIRA 
Administrator Cass Sunstein has explained that `` [w]hen agencies issue 
rules, they have to speculate about benefits and costs.'' \49\ 
Therefore, ``[a]fter rules are in place, [agencies] should test those 
speculations, and they should use what they learn when revisiting a 
regulation or issuing a new one.'' \50\ Professor Sunstein described 
this as ``one of the most important steps imaginable'' for regulatory 
reform, ``not least because it can reduce cumulative burdens and 
promote the goal of simplification.'' \51\ He has noted that agencies' 
failure ``until very recently . . . to gather, let alone act on'' 
retrospective reviews is ``an astonishing fact.'' \52\
---------------------------------------------------------------------------

    \49\ Cass R. Sunstein, The Regulatory Lookback, 94 B.U. L. Rev. 
579, 591 (2014).
    \50\ Id.
    \51\ Id.
    \52\ Id. at 588.
---------------------------------------------------------------------------

    Michael Greenstone, who served as Chief Economist on the Council of 
Economic Advisors between 2009 and 2010, similarly concluded that the 
``single greatest problem with the current system is that most 
regulations are subject to a cost-benefit analysis only in advance of 
their implementation. This is the point when the least is known and any 
analysis must rest on many unverifiable and potentially controversial 
assumptions.'' \53\ According to Professor Greenstone, the lack of a 
regulatory lookback created a system ``largely based on faith, rather 
than evidence,'' where the agency ``all too frequently takes shots in 
the dark and we all too infrequently fail to find out if we have hit 
anything--or even worse, we only find out when things have gone 
horribly wrong.'' \54\ As he explained, ``it is nearly impossible to 
imagine'' only prospective, and not retrospective, evaluations ``being 
used in other contexts where people's lives are on the line. For 
example, I am confident that there would be a deafening uproar of 
protest if the FDA announced that it would approve drugs without 
testing them in advance. Yet, this is largely what we do with 
regulations that affect our health and well-being.'' \55\
---------------------------------------------------------------------------

    \53\ Michael Greenstone, Toward a Culture of Persistent 
Regulatory Experimentation and Evaluation, in New Perspectives on 
Regulation 111, 113 (David Moss & John Cisternino eds., 2009). It 
should not be inferred, however, that retrospective analysis is free 
of assumptions (including potentially controversial assumptions) or 
is generally without challenges, especially with respect to 
establishing relevant counterfactuals. For discussion and recent 
examples related to just two of the many areas of Department 
regulatory activity, see Trinided Beleche et al., Are Graphic 
Warning Labels Stopping Millions of Smokers? A Comment on Huang, 
Chaloupka, and Fong, 15 Econ Journal Watch 129 (2018) and Aaron 
Kearsley et al., A Retrospective and Commentary on FDA's Bar Code 
Rule, 9 J. Benefit-Cost Analysis 496 (2018). Moreover, to the extent 
that retrospective analysis is used to inform policy choices going 
forward, it becomes, or is at least being used as, prospective 
analysis and thus relies on assumptions about the future, including 
as regards technology and the legal and regulatory landscape. But 
since retrospective analysis is conducted after some real-world 
experience living under the regulation, it can in many cases be an 
improvement over earlier prospective analysis.
    \54\ Michael Greenstone, Toward a Culture of Persistent 
Regulatory Experimentation and Evaluation, in New Perspectives on 
Regulation 111, 111-12 (David Moss & John Cisternino eds., 2009); 
see also Office of Mgmt. & Budget, 2017 Report to Congress on the 
Benefits and Costs of Federal Regulations and Agency Compliance with 
the Unfunded Mandates Reform Act at 5 (2017), https://www.whitehouse.gov/wp-content/uploads/2019/12/2019-CATS-5885-REV_DOC-2017Cost_BenefitReport11_18_2019.docx.pdf (``The aim of 
retrospective analysis is to understand and improve the accuracy of 
prospective analysis and to provide a basis for potentially 
modifying rules as a result of ex post evaluations.'').
    \55\ Michael Greenstone, Toward a Culture of Persistent 
Regulatory Experimentation and Evaluation, in New Perspectives on 
Regulation 111, 114 (David Moss & John Cisternino eds., 2009).
---------------------------------------------------------------------------

    If retrospective analysis ``could be firmly institutionalized,'' 
Professor Sunstein observed, then it ``would count as the most 
important structural change in regulatory policy since the original 
requirement of prospective analysis during the Reagan Administration.'' 
\56\
---------------------------------------------------------------------------

    \56\ Cass R. Sunstein, The Regulatory Lookback, 94 B.U. L. Rev. 
579, 589 (2014).
---------------------------------------------------------------------------

    Other administrative law experts have also urged agencies to more 
robustly institutionalize retrospective review of regulations. The 
Administrative Conference of the United States (ACUS) has ``urge[d] 
agencies to remain mindful of their existing body of regulations and 
the ever-present possibility that those regulations may need to be 
modified, strengthened, or eliminated in order to achieve statutory 
goals while minimizing regulatory burdens.'' \57\ More recently, the 
American Bar Association Section of Administrative Law and Regulatory 
Practice, has ``urge[d] [the Administration] to build on the efforts of 
previous administration[s] and take steps to institutionalize careful, 
in-depth retrospective review of existing rules.'' (Emphasis in 
original).\58\
---------------------------------------------------------------------------

    \57\ Administrative Conference of the United States, 
Recommendation 2014-5, Appendix--Recommendations of the 
Administrative Conference of the United States, 79 FR 75114, 75114 
(Dec. 17, 2014); see also ABA Sec. of Admin. Law & Reg. Prac., 
Improving the Administrative Process: A Report to the President-
Elect of the United States (2016), 69 Admin. L. Rev. 205 (2017).
    \58\ ABA Sec. of Admin. Law & Reg. Prac., Improving the 
Administrative Process: A Report to the President-Elect of the 
United States (2016), 69 Admin. L. Rev. 205, 219 (2017) (emphasis in 
original).
---------------------------------------------------------------------------

    Yet, despite these many calls for retrospective review, as noted in 
section II.B., the Department has had limited success in implementing 
retrospective review in practice.\59\ In 2019, the Department piloted 
an approach to augment expert policy insights with artificial 
intelligence-driven data analysis of its regulations, which showed the 
need to more firmly institutionalize retrospective review. The 
artificial intelligence review found that 85% of Department regulations 
created before 1990 have not been

[[Page 70102]]

edited; the Department has nearly 300 broken citation references in the 
CFR (i.e., CFR sections that reference other CFR sections that no 
longer exist); more than 50 instances of regulatory requirements to 
submit paper documents in triplicate or quadruplicate; and 114 parts in 
the CFR with no regulatory entity listed, 17 of which may be 
misplaced.\60\ The Department concluded that some good governance 
stewardship recommendations ``were deprioritized and relegated to rainy 
day activities that [Department operating divisions] would get around 
to when they could.'' \61\ Unfortunately, in many cases the Department 
has for years not gotten around to addressing these issues.
---------------------------------------------------------------------------

    \59\ See also Yoon-Ho Alex Lee, An Options Approach to Agency 
Rulemaking, 65 Admin. L. Rev. 881, 894 (2013), (``one might think 
that agencies would faithfully take advantage of [] opportunities to 
conduct rigorous retrospective [cost-benefit analyses] of their 
existing regulations and test their effectiveness and efficiency. 
This would be the surest way of incorporating ex post learning in 
rule implementation. This is far from the truth in practice, 
however.'').
    \60\ Regulatory Streamlining & Analysis (Mar. 2019).
    \61\ Id. at 18
---------------------------------------------------------------------------

    For the reasons discussed in this section, the Department believes 
a stronger incentive is needed to achieve the benefits of retrospective 
review.\62\ This proposed rule proposes a mechanism to more firmly 
institutionalize the retrospective reviews that Professors Sunstein and 
Greenstone, as well as ACUS and others, have called for.
---------------------------------------------------------------------------

    \62\ Id. (it ``appears the current set of governance structures, 
incentives and processes to promulgate regulatory reform need 
strengthening to be more effective'').
---------------------------------------------------------------------------

D. The Experiences of States and Other Jurisdictions With Automatic 
Expiration or ``Sunset'' Provisions

    The proposed mechanism is based in part on the experiences of 
States and other jurisdictions. Several States incorporate 
retrospective regulatory review into their laws. New York, for example, 
requires retrospective review of regulations ``no later than in the 
fifth calendar year after the year in which the rule is adopted,'' and 
requires that rules be ``re-reviewed at five-year intervals'' 
thereafter. N.Y. A.P.A. Law sec. 207. Similarly, Texas requires State 
agencies to review rules four years after they go into effect and then 
subsequently at four-year intervals. Tex. Gov't Code sec. 2001.039. In 
addition to New York and Texas, State law requires some form of 
retrospective regulatory review in at least Alabama, Arizona, Illinois, 
Iowa, Michigan, New Jersey, New Mexico, North Carolina, North Dakota, 
Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, and 
Washington.\63\
---------------------------------------------------------------------------

    \63\ Ala. Code 41-22-5.2; Ariz. Rev. Stat. 41-1056; 5 Ill. Comp. 
Stat. Ann. 100/5-130; Iowa Code Ann. 17A.33; Mich. Comp. Laws 
10.151; N.J. Stat. Ann. 52:14B-5.1; N.M. Stat. 14-4A-6; N.C. Gen. 
Stat. 150B-21.3A; N.D. Cent. Code 28-32-18.1; Ohio Rev. Code Ann. 
106.03; Okla. Stat. Ann. tit. 75, 307.1; 71 Pa. Stat. Ann. 745.2; 
R.I. Gen. Laws Ann. tit. 42, ch. 64.13; Tenn. Code Ann. 4-56-102; 
Wash Rev. Code Ann. 43.70.041, 43.22.052.
---------------------------------------------------------------------------

    Some States with retrospective review requirements allow 
regulations to automatically expire or sunset after a period of time, 
unless reviewed or readopted. In New Jersey, regulations automatically 
expire ``seven years following the effective date of the rule'' unless 
extended by the agency. N.J. Stat. Ann. sec. 52:14B-5.1(b).\64\ Indiana 
allows regulations to expire on January 1 following the seven-year 
anniversary of their effective dates. Ind. Code sec. 4-22-2.5-2. The 
Governor of Florida recently instructed Florida government agencies to 
``include a sunset provision in all proposed or amended rules,'' which 
``may not exceed five years unless otherwise required by existing 
statute.'' \65\
---------------------------------------------------------------------------

    \64\ Although the New Jersey law permits the Governor, within 
five days of the expiration of a rule, to restore it, the Department 
does not include a similar provision in this proposed rule. That is 
because the RFA contains no such similar provision and the 
Department is giving itself ten years, as opposed to seven years, to 
perform Assessments and (when required) Reviews of Regulations.
    \65\ Letter from Gov. Ron DeSantis to Florida Agency Heads (Nov. 
11, 2019) https://www.floridahasarighttoknow.myflorida.com/content/download/147113/980326/FINAL_Directive_to_Agencies_11.19.pdf.
---------------------------------------------------------------------------

    Experience in the States suggests that sunset provisions can be an 
important tool to ensure reviews take place. An analysis of regulation 
in all 50 States found that for a reduction in both regulatory creation 
and enforcement, ``[t]he single most important policy in a state is the 
presence of a sunset provision.'' \66\ On the other hand, one report 
stated that, despite their initial popularity in the States,\67\ sunset 
provisions fell out of favor, not because they did not produce more 
cost-effective, cost-justified regulation, but because sunset 
requirements did not provide sufficient legislative control over 
executive agencies.\68\ That observation is inapplicable to the 
Department, because this proposed rule concerns the Department's review 
of its own regulations. Noting the benefits of sunset provisions, the 
report added that sunset ``provisions have been responsible for the 
analysis of thousands of state regulations and, on average, the repeal 
of twenty to thirty percent of existing regulations and the 
modification of another forty percent.'' \69\
---------------------------------------------------------------------------

    \66\ Russell S. Sobel & John A. Dove, State Regulatory Review: A 
50 State Analysis of Effectiveness (Mercatus Ctr., Working Paper No. 
12-18, at 36 (2012), https://www.mercatus.org/system/files/State-Regulatory-Review-50-State-Analysis-Effectiveness.pdf.
    \67\ Jason A. Schwartz, 52 Experiments with Regulatory Review: 
The Political and Economic Inputs into State Rulemakings, Inst. for 
Policy Integrity, Rep. No. 6, at 33 (Nov. 2010), https://policyintegrity.org/files/publications/52_Experiments_with_Regulatory_Review.pdf.
    \68\ See id. (noting that ``North Carolina was first to repeal 
its sunset law, and many other states quickly followed suit'' after 
concluding that ``sunset provisions quickly proved to be an 
expensive, cumbersome, and disappointing method for enhancing 
legislative control'').
    \69\ Id. at 23-24. The report added, without citing a great deal 
of empirical evidence, that ``sunset requirements produce 
perfunctory reviews and waste resources.'' This appears to be based 
on a law review article that noted, not that retrospective reviews 
were per se perfunctory, but that ``unless adequate resources are 
provided, the reviews may be relatively perfunctory and meaningless, 
wasting whatever resources are expended.'' See Neil R. Eisner & 
Judith S. Kaleta, Federal Agency Reviews of Existing Regulations, 48 
Admin. L. Rev. 139, 160 (1996) (emphasis added). But this law review 
article noted that adding ``sunset'' dates to regulations unless 
they are reviewed was ``likely to ensure that a review is done.'' 
Id. As explained herein, the Department intends to commit adequate 
resources to its reviews if this proposed rule were to be finalized. 
The law review article said that sunset provisions should be used 
only in narrowly focused situations where it is determined that it 
is necessary to apply some ``pressure'' and only where assessments 
are made of the available resources and the benefits to be derived 
from the review. Id. But the article was written in 1996. As 
discussed herein, subsequent experience with efforts short of a 
forcing mechanism suggest that forcing mechanisms are needed to 
ensure review of a wide array of Department regulations, and that 
the benefits from these retrospective reviews would be substantial.
---------------------------------------------------------------------------

    Experience outside the United States also suggests the utility of 
sunset provisions. The Office for Economic Co-Operation and Development 
(OECD) analyzed regulatory practices in the European Union. In a 2010 
report, the OECD recommended, for ``[t]he management and 
rationalization of existing regulations,'' that Germany ``[k]eep up the 
`spring cleaning' of legislation at regular intervals'' and ``consider 
the inclusion of a review mechanism in individual draft regulations, or 
even [include] a sunset clause (beyond which the law automatically 
expires) where appropriate.'' \70\ With respect to the United Kingdom's 
regulatory program, the OECD noted ``sunset clauses are also helpful'' 
in order ``to remove unnecessary burdens in legislation.'' \71\ 
Throughout the 2010 report, the OECD repeatedly noted the value of 
retrospective regulatory review.\72\
---------------------------------------------------------------------------

    \70\ OECD, Better Regulation in Europe: Executive Summaries, 
GOV/RPC(2010)13, at 113 http://www.oecd.org/gov/regulatory-policy/45079126.pdf.
    \71\ Id. at 46.
    \72\ See, e.g., id. at 107 (``The ex post evaluation of 
regulations which is provided for in the impact assessment process 
provides a framework in principle for checking what really happens, 
and whether regulations have actually achieved the objectives 
originally set.'').
---------------------------------------------------------------------------

    In 2019, the OECD published an additional survey regarding 
regulatory review practices in the European Union. The OECD again noted 
the utility of

[[Page 70103]]

sunset provisions, describing them as a ``useful `failsafe' mechanism 
to ensure the entire stock of subordinate regulation remains fit for 
purpose over time.'' \73\ The report noted as of its 2019 date that 
sunset provisions are in place for at least some regulations in nine 
different countries, including the United Kingdom, France, and 
Germany.\74\
---------------------------------------------------------------------------

    \73\ OECD, Better Regulation Practices across the European 
Union, at ch. 4, Box 4.1 (2019), https://www.oecd-ilibrary.org/sites/9789264311732-en/1/2/4/index.html?itemId=/content/publication/9789264311732-en&_csp_=07701faff9659027b81a5b5ae2ff041c&itemIGO=oecd&itemContentType=book.
    \74\ Id. at ch. 4, Table 4.1.
---------------------------------------------------------------------------

    In 2009, the Republic of Korea (ROK) enacted a law under which 
about 20% of the existing regulations are to be reviewed on a regular 
basis (about every 3 to 5 years) and become invalid if they are found 
to lack feasibility.\75\ Under the ROK's ``review and sunset,'' there 
is a duty to carry out a review of a regulation on a specified 
schedule. This sunset clause was established upon the idea that even a 
rational regulation needs to be examined periodically to determine its 
grounds for remaining in force, as its validity may be compromised 
under any change in circumstances or its characteristics.\76\ An OECD 
report stated that ``[g]iven such rationale, the sunset clause is 
considered as a critical component of efforts in regulatory quality 
improvement.'' \77\
---------------------------------------------------------------------------

    \75\ OECD, Latest Developments on Korea's Regulatory Policy, at 
2, https://www.oecd.org/gov/regulatory-policy/45347364.pdf.
    \76\ OECD Reviews of Regulatory Reform, Regulatory Policy in 
Korea, Toward Better Regulation, at 86 (2017), https://publicadministration.un.org/unpsa/Portals/0/UNPSA_Submitted_Docs/2019/4cd3e219-c819-40f3-8246-7a024d9a82a9/2020%20UNPSA_the%20Regulatory%20Reform%20Sinmungo_Evaluation%20Report_27112019_032807_e4d166a9-f6ef-4a6c-9aaf-99748fa94284.pdf?ver=2019-11-27-032807-637.
    \77\ Id.
---------------------------------------------------------------------------

    These authorities indicate an emerging awareness that sunset 
provisions are useful in ensuring retrospective regulatory review. This 
is consistent with the Department's experience over the last 40 years, 
which suggests that, absent a sunset provision or automatic expiration 
date, Congressional and Presidential directives to perform periodic 
retrospective reviews of regulations have limited success.
    Indeed, previous Administrations have recognized the benefits of 
sunset provisions. In a June 2015 report, the Department of Treasury's 
Office of Economic Policy, the Obama Administration's Council of 
Economic Advisors, and the Department of Labor discussed sunset 
provisions as applied to occupational licensing.\78\ That report found 
evidence that sunset reviews that automatically terminate regulatory 
boards and agencies absent legislative action assist with ``removing 
unnecessary licensing.'' \79\ The report explained that sunset review 
can be ``useful because, even if licensing was justified when first 
introduced, technological and economic changes may have rendered it 
unnecessary or overly restrictive.'' \80\ The report found ``[p]eriodic 
examination of existing rules is thus helpful in maintaining the 
quality of occupational regulation.'' \81\ Professor Greenstone has 
similarly recommended the automatic repeal of regulations if their 
benefits and costs are not periodically assessed:
---------------------------------------------------------------------------

    \78\ Occupational Licensing: A Framework for Policymakers, The 
White House, at 48-50 (July 2015), https://obamawhitehouse.archives.gov/sites/default/files/docs/licensing_report_final_nonembargo.pdf.
    \79\ Id. at 48.
    \80\ Id. at 49.
    \81\ Id. The report also suggests that to strengthen sunset 
provisions in the States, sunset commissions responsible for 
conducting the cost-benefit analysis should be provided adequate 
resources; the cost-benefit review process should be insulated 
against political interference; a minimum number of votes should be 
required to overrule the sunrise agency's recommendation; and 
specialized committees within legislatures be appointed to work with 
the agency in charge of conducting the review. See id. at 42. As 
discussed herein, the Department believes it has adequate resources 
to conduct the required reviews. As discussed in footnote 84, it is 
not clear that a federal agency can legally completely insulate its 
reviews from supervision by the agency's leadership, but the 
Department believes that its retrospective reviews will generally be 
performed by career civil servants. Lastly, the Department cannot 
require Congress to appoint committees to work with the Department 
officials performing the retrospective reviews, but the Department 
would welcome the opportunity to discuss reviews with Congressional 
staff if Congress so chose. The report also suggested ``sunrise'' 
reviews can be more effective than sunset reviews. But for already-
existing regulations, the Department cannot perform sunrise reviews, 
so the Department is proposing to take advantage of the benefits of 
sunset reviews. Moreover, the Department already engages in 
``sunrise review'' to some extent when it develops regulatory 
flexibility analyses, see 5 U.S.C. 603, 604, and regulatory impact 
analyses (notably, such reviews did not occur for regulations that 
preceded the RFA, many of which still remain in effect).

    [Another] step in reforming our regulatory system is to require 
that all regulations contain rules specifying the date by which the 
regulatory review board has to assess their costs and benefits. If 
the regulatory review board fails to meet one of these deadlines, 
then the regulation should be repealed by default. The purpose of 
this sunset provision is to ensure that all regulations are 
evaluated carefully and do not stay on the books just because they 
have been on the books in the past.\82\
---------------------------------------------------------------------------

    \82\ Greenstone, Toward a Culture of Persistent Regulatory 
Experimentation and Evaluation, in New Perspectives on Regulation 
111, 121 (David Moss & John Cisternino eds., 2009).

Professor Greenstone suggested that this review could cause the 
regulation to be expanded if supported by evidence.\83\ According to 
Professor Greenstone, this would ``ensure that ineffective regulations 
are removed and that society fully benefits from the effective ones.'' 
\84\
---------------------------------------------------------------------------

    \83\ Id.
    \84\ Id. at 123. Professor Greenstone made a separate suggestion 
that a regulatory review board be created with the authority to 
assess the effectiveness of regulations and repeal regulations 
deemed ineffective. The Department considered this, but has decided 
not to include this proposal in this notice of proposed rulemaking. 
First, the Department is concerned that such a board raises legal 
concerns, since many Department regulations can only be repealed by 
the Secretary, not by an independent board. Second, Professor 
Greenstone proposed the independent review board on the grounds that 
(1) it would remove the board's functions as much as possible from 
political control, and (2) those most deeply involved in 
implementing a regulation are likely to see the benefits more 
clearly than the costs. Id. at 119-121. While these concerns are 
understandable, the Department believes it is capable of performing 
the Review. As an initial matter, those who conduct the Review would 
not necessarily be those in the Department who implement the 
Regulation. Moreover, as described herein, Reviews must be performed 
in such a manner that they can withstand judicial review under the 
arbitrary and capricious standard. This would require the Reviews to 
meet a minimum standard of rigor and require them to consider 
relevant factors. Moreover, many regulations legally cannot be 
amended or repealed without authorization by a political appointee.
---------------------------------------------------------------------------

    This proposed rule seeks to advance democratic values and apply the 
lessons learned from States, foreign jurisdictions, and the academic 
community. This proposed rule would apply the benefits of automatic-
expiration-absent-periodic-review to a broader array of regulations 
than is currently being reviewed by the Department.

III. Statutory Authority

    The statutory authorities supporting this rulemaking are the 
statutory authorities for the Department's existing regulations. The 
Department proposes herein to amend its regulations to add expiration 
dates unless the Department periodically conducts the required review 
of the regulations or an exception applies. Some of the Department's 
primary rulemaking authorities include:
     Section 701(a) of the Federal Food Drug and Cosmetic Act 
(FD&C Act), 21 U.S.C. 371(a) which authorizes the Secretary to 
``promulgate regulations for the efficient enforcement of [the FD&C 
Act], except as otherwise provided in this section'';
     Section 1102 of the Social Security Act, 42 U.S.C. 1302, 
which provides that the Secretary ``shall make and publish such rules 
and regulations, not inconsistent with this Act, as may be

[[Page 70104]]

necessary to the efficient administration of the functions with which 
[he] is charged under this Act'';
     Section 1871 of the Social Security Act, 42 U.S.C. 1395hh, 
which provides that ``the Secretary shall prescribe such regulations as 
may be necessary to carry out the administration of the insurance 
programs under this title''; and
     5 U.S.C. 301, which provides that ``[t]he head of an 
Executive department or military department may prescribe regulations 
for the government of his department, the conduct of its employees, the 
distribution and performance of its business, and the custody, use, and 
preservation of its records, papers, and property. This section does 
not authorize withholding information from the public or limiting the 
availability of records to the public.''
    It complies with the Administrative Procedure Act (APA) to amend 
regulations to add dates by which the regulations expire unless a 
review of the regulation is timely performed. An agency can, through 
notice-and-comment rulemaking, amend its regulations to provide that 
they expire at a future date.\85\ An agency can also provide that its 
regulations expire when an event occurs or ceases to occur.\86\ That is 
what the Department is proposing in this proposed rule. This is 
discussed in more detail in the description of section [XX](c) in 
Section IV infra.
---------------------------------------------------------------------------

    \85\ See, e.g., Amendment to the Interim Final Regulation for 
Mental Health Parity, 70 FR 42276, 42277 (July 22, 2005) (amending 
interim final rule, to provide that ``the requirements of the MHPA 
interim final regulation apply to group health plans and health 
insurance issuers offering health insurance coverage in connection 
with a group health plan during the period commencing August 22, 
2005 through December 31, 2005. Under the extended sunset date, MHPA 
requirements do not apply to benefits for services furnished after 
December 31, 2005.''); see generally Clean Air Council v. Pruitt, 
862 F.3d 1, 9 (D.C. Cir. 2017) (an agency can amend or revoke a 
legislative rule through notice-and-comment rulemaking).
    \86\ See, e.g., Control of Communicable Diseases; Foreign 
Quarantine, 85 FR 7874, 7874 (Feb. 12, 2020) (providing that, unless 
extended, interim final rule ``will cease to be in effect on the 
earlier of (1) the date that is two incubation periods after the 
last known case of 2019-nCoV, or (2) when the Secretary determines 
there is no longer a need for this interim final rule''); Medicare 
and Medicaid Programs, Clinical Laboratory Improvement Amendments 
(CLIA), and Patient Protection and Affordable Care Act; Additional 
Policy and Regulatory Revisions in Response to the COVID-19 Public 
Health Emergency, 85 FR 54820, 54820 (Sept. 2, 2020) (providing that 
an interim final rule applies ``for the duration of the [public 
health emergency] for COVID-19'').
---------------------------------------------------------------------------

    The Department also notes the text of 5 U.S.C. 610 indicates 
Congress believed agencies had the authority to periodically review at 
least those regulations that have a significant economic impact upon a 
substantial number of small entities (and that the agency had the 
authority to assess which of its regulations have such an impact).

IV. Provisions of Proposed Rule 87
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    \87\ The Department proposes to add substantively identical 
provisions to Titles 21, 42, and 45. For concision, in this section 
the Department describes these provisions once, rather than 
repeating the same substantive provisions several times. The 
Department uses the phrase ``[XX]'' to refer to the fact that 
substantively identical provisions will be added to Titles 21, 42, 
and 45. Because certain regulations in Title 42 cannot be amended 
without a 60-day comment period, see 42 U.S.C. 1395hh(b), the 
Department has written two proposed regulations for Title 42. One 
applies to the parts of that title that require a 60-day comment 
period, and the other applies to the remainder of the Department's 
regulations in Title 42.
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    Section 3(a) of the RFA, 5 U.S.C. 610, and Executive Orders 12866 
and 13563 direct agencies to devise plans to periodically review 
certain of their regulations using certain criteria. By requiring the 
Department to periodically perform such reviews, this proposed rule 
would implement Congress' and the President's desires for retrospective 
review of regulations. This proposed rule would lead to the amendment 
or rescission, where appropriate, of Department regulations that have a 
significant economic impact upon a substantial number of small 
entities. The proposed rule would also further democratic values such 
as accountability, administrative simplification, transparency, and 
performance measurement and evaluation. Below the Department discusses 
each provision of this proposed rule.
Section [XX](a)
    Section [XX](a) provides that this section applies to and amends 
all Regulations issued by the Secretary or his delegates or sub-
delegates in this title.
Section [XX](b)
    Section [XX](b) defines several terms used in the proposed rule.
Section [XX](b)(1)
    Section [XX](b)(1) defines ``Assess'' \88\ as ``a determination by 
the Department, in consultation with other Federal agencies as 
appropriate, as to whether the Regulations issued as part of the same 
rulemaking (and any amendments or additions that may have been added 
thereafter) currently have a significant economic impact upon a 
substantial number of small entities.''
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    \88\ ``Assess,'' ``Review,'' and ``Regulation'' are capitalized 
in this preamble where those terms have the definitions ascribed to 
them in the text of this proposed rule.
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    5 U.S.C. 610 directs agencies to have plans to periodically review 
those regulations that have or will have a significant economic impact 
upon a substantial number of small entities. Accordingly, in order to 
determine which regulations to periodically review using 5 U.S.C. 610's 
criteria, the Department must first determine which rules have a 
significant economic impact upon a substantial number of small 
entities. When promulgating regulations, the Department is required to 
determine whether a rule will have a significant economic impact on a 
substantial number of small entities. See 5 U.S.C. 605(b).\89\ The 
Assessment refers to an essentially identical determination. In making 
the Assessment, the Department can look to the determination of the 
regulation's impact on small entities made at the time of promulgation, 
as well as experience since promulgation.
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    \89\ 5 U.S.C. 605(b) refers to rules that have a ``significant 
economic impact on a substantial number of small entities,'' whereas 
5 U.S.C. 610 refers to rules that have ``significant economic impact 
upon a substantial number of small entities.'' This does not appear 
to be a material difference.
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Section [XX](b)(2)
    Section [XX](b)(2) defines ``Review'' as a process conducted by the 
Department, in consultation with other Federal agencies as appropriate, 
the purpose of which shall be to determine whether the Regulations that 
were issued as part of the same rulemaking (and any amendments or 
additions that may have been issued thereafter) should be continued 
without change, or should be amended or rescinded, consistent with the 
stated objectives of applicable statutes, to minimize any significant 
economic impact of the Regulations upon a substantial number of small 
entities. The Department discusses the Reviews in more detail in the 
discussion of section [XX](d) below.
Section [XX](b)(3)
    Section [XX](b)(2) defines ``Regulation'' for purposes of this 
proposed rule as ``a section of the Code of Federal Regulations. For 
example, 42 CFR 2.13 is a Regulation, and 42 CFR 2.14 is another 
Regulation.'' This definition makes clear that a section of the CFR, as 
opposed to a part, subpart, or paragraph within a section, is the unit 
that must be assessed and (if required) reviewed, or will otherwise 
expire. Defining ``Regulation'' in this objective way makes it easier 
for the Department and the public to know what exactly has to be 
reviewed by the dates listed in this proposed rule. Had

[[Page 70105]]

the Department used the Administrative Procedure Act's (APA's) 
definition of ``rule,'' \90\ it could be unclear in certain 
circumstances what precisely needed to be reviewed.
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    \90\ 5 U.S.C. 551(4) (providing that `` `rule' means the whole 
or a part of an agency statement of general or particular 
applicability and future effect designed to implement, interpret, or 
prescribe law or policy or describing the organization, procedure, 
or practice requirements of an agency and includes the approval or 
prescription for the future of rates, wages, corporate or financial 
structures or reorganizations thereof, prices, facilities, 
appliances, services or allowances therefor or of valuations, costs, 
or accounting, or practices bearing on any of the foregoing'').
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Section [XX](b)(4)
    Third, this proposed rule defines ``Year of the Regulation's 
Promulgation'' to mean the calendar year the Regulation first became 
effective, irrespective of whether it was subsequently amended. The 
purpose of this definition is to provide clarity to the Department and 
the public. If a Regulation were amended, questions could arise whether 
the clock for re-reviewing a Regulation begins on the date the 
Regulation was first promulgated; the date it was last amended; or 
whether the clock for reviewing the amended portion begins on a 
different date than the portion that was initially enacted. This 
definition creates simplicity for the Department and the public, 
because this definition, in conjunction with section [XX](c), makes 
clear that the clock starts for the retrospective review of an entire 
Regulation on the date that the Regulation was first promulgated, even 
if it is subsequently amended.
    If, for example, the Department issues a Regulation and amends it 
nine years later, the Department may wish to conduct the Review at the 
time of amendment, particularly since the Department is presumably 
already performing a regulatory impact analysis with regard to the 
amendment. Since the Department is already conducting a regulatory 
impact analysis, performing the Review at that time may save Department 
resources and spare the Department from having to perform the Review on 
the Regulation the next year. In fact, any time the Department amends a 
Regulation, it could perform the Review of the Regulation at that time, 
thereby restarting the Regulation's ten-year clock.
Section [XX](b)(5)
    Section [XX](b)(5) provides that ``[s]ignificant economic impact 
upon a substantial number of small entities'' shall have the meaning 
ascribed to that term in the Regulatory Flexibility Act, Public Law 96-
354, 94 Stat. 1164 (Sept. 19, 1980) (as amended 1996).
Section [XX](c)
    Section [XX](c) provides that unless a Regulation contains an 
earlier expiration date or is rescinded earlier, all Regulations issued 
by the Secretary or his delegates or sub-delegates in this title shall 
expire at the end of either (1) two calendar years after the year that 
this proposed rule first becomes effective, (2) ten calendar years 
after the Year of the Regulation's Promulgation, or (3) ten calendar 
years after the last year in which the Department Assessed and (if 
Review of the Regulation is required pursuant to paragraph (d)) 
Reviewed the Regulation, whichever is latest. The last year in which 
the Department Assessed and (if Review of the Regulation is required) 
Reviewed the Regulation shall be the year during which the findings of 
the Assessment and, if required, the Review of the Regulation are 
published in the Federal Register pursuant to paragraph (f) of this 
section.
    In other words, the Department must Review all its Regulations 
(subject to the exceptions listed below) that have a significant 
economic impact upon a substantial number of small entities every ten 
years, or such Regulations shall expire. To determine which Regulations 
have a significant economic impact upon a substantial number of small 
entities, the Department must Assess all its Regulations (subject to 
the exceptions listed below) every ten years, or such Regulations shall 
expire if not Assessed. For Regulations that have already been in 
effect at the time this proposed rule goes into effect, the Department 
would have two years from this proposed rule's effective date, or ten 
years from the Regulation's promulgation, whichever is later, to 
conduct the Assessment and, if required, the Review. The Department 
believes all of its Regulations (subject to the exceptions listed 
below) should be Assessed and, if they have a significant economic 
impact upon a substantial number of small entities, Reviewed. 
Assessments and Reviews should not be performed only on those 
Regulations issued after this proposed rule goes into effect. After 
all, it is likely that some Regulations promulgated decades ago may 
have become outdated.\91\
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    \91\ See, e.g., Office of Mgmt. & Budget, Validating Regulatory 
Analysis: 2005 Report to Congress on the Costs and Benefits of 
Federal Regulations and Unfunded Mandates on State, Local, and 
Tribal Entities, at 46-47 (2005) http://perma.cc/R8LX-BQMJ; Cynthia 
Morgan and Nathalie B. & Nathalie B. Simon, National primary 
drinking water regulation for arsenic: A retrospective assessment of 
costs, 5 J. Benefit Cost Anal. no. 2, 2014, at 259-84 https://www.cambridge.org/core/services/aop-cambridge-core/content/view/A7B29CE98E650B424E92FF292A8FFC89/S2194588800000774a.pdf/national_primary_drinking_water_regulation_for_arsenic_a_retrospective_assessment_of_costs.pdf.
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    Section [XX](c) makes clear that Department Regulations (subject to 
the exceptions listed below) shall expire if the Assessment and (if 
required) the Review are not timely performed on them. Both section 
3(a) of the RFA and executive orders by multiple presidents over 
several decades direct the Department to devise plans to periodically 
review many of its regulations.\92\ Although the Department 
retrospectively reviewed a very limited number of its regulations, it 
has not reviewed many of its regulations, notwithstanding that 
observers have over the decades noted that the Department has not 
always performed retrospective review to a satisfactory extent. 
Therefore, the Department has concluded that it is appropriate to 
impose on itself a stronger incentive to ensure it complies with the 
purposes animating the RFA and the executive orders, as well as to 
ensure its regulations are not unduly burdening the public. As a CRS 
report put it, ``[w]ithout some type of enforcement of the review 
requirement, agencies are unlikely to conduct many more reviews than 
have occurred pursuant to Section 610.'' \93\ This is one reason why 
analyses

[[Page 70106]]

have found that sunset provisions are an effective way to improve 
governance and reduce undue regulatory burdens.\94\ States have imposed 
similar expiration dates for many of their regulations unless they are 
reviewed or readopted.
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    \92\ The RFA and the Executive Orders direct agencies to review 
overlapping, but not identical, sets of regulations. The RFA directs 
agencies to have plans to review regulations that have a 
``significant economic impact upon a substantial number of small 
entities.'' 5 U.S.C. 610. By contrast, Executive Order 12866 
directed agencies to submit to OIRA programs to periodically review 
``significant regulations.'' Exec. Order 12866, sec. 5(a). 
``Significant regulations'' are not necessarily those that have a 
``significant economic impact upon a substantial number of small 
entities.'' Id. at sec. 3(f) (defining ``significant regulatory 
action'' as any regulatory action that is likely to result in a rule 
that may: (1) Have an annual effect on the economy of $100 million 
or more or adversely affect in a material way the economy, a sector 
of the economy, productivity, competition, jobs, the environment, 
public health or safety, or State, local, or tribal governments or 
communities; (2) Create a serious inconsistency or otherwise 
interfere with an action taken or planned by another agency; (3) 
Materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) Raise novel legal or policy issues arising out of 
legal mandates, the President's priorities, or the principles set 
forth in this Executive order.''). Executive Order 13563 also 
directed agencies to review ``significant regulations.'' Exec. 
Order. 13563, sec. 6. The Department has proposed to Review those 
regulations that satisfy the RFA criteria, since those are the 
regulations that Congress directed agencies to have plans to review. 
The Department requests comment on whether additional regulations, 
such as significant regulations, should also be Reviewed.
    \93\ Curtis W. Copeland, Cong. Research Serv., RL32801, 
Reexamining Rules: Section 610 of the Regulatory Flexibility Act 11 
(2008); see also Yoon-Ho Alex Lee, An Options Approach to Agency 
Rulemaking, 65 Admin. L. Rev. 881, 895-96 (2013) (setting forth 
possible reasons why agencies, even when they have adequate 
resources, may be reluctant to perform retrospective reviews).
    \94\ Russell S. Sobel & John A. Dove, State Regulatory Review: A 
50 State Analysis of Effectiveness (Mercatus Ctr., Working Paper No. 
12-18 (2012), at 36); Occupational Licensing: A Framework for 
Policymakers, at 48-50 (July 2015).
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    It complies with the APA to amend Regulations to add dates by which 
Regulations expire unless the Assessment and/or Review is timely 
performed. An agency can, through notice-and-comment rulemaking, amend 
its regulations to provide that they expire at a future date.\95\ An 
agency can also provide that its regulations expire upon the occurrence 
of a condition.\96\ That is what the Department is proposing in this 
proposed rule. To be sure, an agency generally must ``articulate a 
satisfactory explanation'' for its action, ``including a rational 
connection between the facts found and the choice made,'' and cannot 
``entirely fail[] to consider an important aspect of the problem.'' 
\97\ The Department anticipates that if a Regulation expires because 
the Department does not timely Review it, a litigant might object to 
the expiration on the grounds that the Department by definition did not 
``articulate a satisfactory explanation'' or ``failed to consider an 
important factor,'' because in not performing a Review, the Department 
failed to consider any factors. The Department rejects such arguments. 
In this rulemaking, the Department is considering the important 
factors. It issues this notice of proposed rulemaking because, for the 
reasons described herein, the Department believes the benefits of 
retrospective review, and the need to strongly incentivize it, are so 
great that the risk of a Regulation inadvertently expiring is 
outweighed by the benefit of institutionalizing retrospective review in 
this manner. Forty years of experience since the RFA's enactment; the 
decades since relevant Executive Orders were enacted; and other Federal 
government efforts to spur the Department to conduct more retrospective 
reviews indicate that, absent such a forcing mechanism, the Department 
will not conduct as many retrospective reviews as desired.
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    \95\ See, e.g., Amendment to the Interim Final Regulation for 
Mental Health Parity, 70 FR 42276 (July 22, 2005) (amending interim 
final rule, to provide that ``the requirements of the MHPA interim 
final regulation apply to group health plans and health insurance 
issuers offering health insurance coverage in connection with a 
group health plan during the period commencing August 22, 2005 
through December 31, 2005. Under the extended sunset date, MHPA 
requirements do not apply to benefits for services furnished after 
December 31, 2005.''); see generally Clean Air Council, 862 F.3d at 
9 (an agency can amend or revoke a legislative rule through notice-
and-comment rulemaking).
    \96\ See, e.g., Control of Communicable Diseases; Foreign 
Quarantine 85 FR 7874, 7874 (Feb. 12, 2020 (providing that, unless 
extended, interim final rule ``will cease to be in effect on the 
earlier of (1) the date that is two incubation periods after the 
last known case of 2019-nCoV, or (2) when the Secretary determines 
there is no longer a need for this interim final rule''); Medicare 
and Medicaid Programs, Clinical Laboratory Improvement Amendments 
(CLIA), and Patient Protection and Affordable Care Act; Additional 
Policy and Regulatory Revisions in Response to the COVID-19 Public 
Health Emergency, 85 FR 54820, 54820 (Sept. 2, 2020) (providing that 
an interim final rule applies ``for the duration of the [public 
health emergency] for COVID-19'').
    \97\ Little Sisters of the Poor Saints Peter and Paul Home v. 
Pennsylvania, 140 S. Ct. 2367, 2383-84 (2020) (quoting Motor Vehicle 
Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile 
Ins. Co., 463 U.S. 29, 43 (1983)).
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    The Department believes that the benefits of retrospective review 
also outweigh the burden from any additional work that the Department 
would be required to perform. The Department intends to timely Assess 
all its Regulations (and timely Review those it must Review), but has 
considered that there is some risk that a Regulation could expire 
because the Department failed to timely Assess or Review it. The 
Department proposes to mitigate this risk by setting up a website 
where, if the deadline for publishing an Assessment or Review is 
nearing and the Department has not yet announced that it has commenced 
the Assessment or Review, the public can submit a comment requesting 
that the Department begin the Assessment or Review. This requirement is 
described in more detail in the discussion of proposed Section [XX](g). 
Therefore, in this rulemaking process, which amends Department 
regulations through the notice-and-comment process, the Department is 
considering the important factors.
    The Department proposes to perform the Assessment and (if required) 
the Review on each Regulation every ten years. Some states provide 
that, unless readopted or re-reviewed, their regulations expire in 
seven years,\98\ while at least one state uses a ten-year time 
period.\99\ The Department proposes to perform the Assessment and (if 
required) the Review every ten years, because ten years is the period 
listed in 5 U.S.C. 610. The Department has many Regulations, some of 
which are complex, so having to perform the Assessment and Review more 
than once every ten years could unduly burden the Department and 
increase the likelihood that a Regulation inadvertently expires because 
it is not Assessed or Reviewed.
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    \98\ See, e.g., N.J.A.C 1:30-6.4 (regulations expire every seven 
years unless readopted, subject to certain exceptions); Ind. Code 4-
22-2.5-2 (imposing seven-year expiration date on regulations unless 
readopted).
    \99\ N.C. Gen. Stat. 150B-21.3A.
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    The proposed rule would provide that Regulations promulgated more 
than ten years ago will expire at the end of two calendar years from 
the date this proposed rule, if finalized, becomes effective, unless 
the Assessment and (if required) the Review is performed on those 
Regulations. The Department believes that two years is a sufficient 
amount of time to conduct the initial Assessments and (if required) 
Reviews of those Regulations. The Assessments will be similar to, but 
not as burdensome as, the determinations made during rulemaking about 
whether a rule has a significant economic impact upon a substantial 
number of small entities. Assessments will be less burdensome because 
those performing the Assessments can in many instances benefit from the 
work already performed when the Regulation is initially promulgated. 
Likewise, the Reviews will be similar to the section 610 reviews that 
agencies currently perform. The Reviews will be less burdensome than 
regulatory impact analyses or regulatory flexibility analyses, because 
they are limited to assessing the five factors listed in 5 U.S.C. 610 
and certain legal considerations. The regulatory flexibility analyses 
and regulatory impact analyses for HHS' rulemakings are typically 
performed in far less than two years. Therefore, even if this proposed 
rule increases substantially the volume of Assessments and Reviews to 
perform,\100\ two years should be a sufficient amount of time to 
perform the Reviews that need to be performed during that time frame. 
This is discussed in more detail in the regulatory impact analysis 
below. The Department believes Regulations promulgated more than ten 
years ago should be Assessed and, if needed, Reviewed in fairly short 
order, since they are presumably generally the ones most likely to have 
become obsolete. The Department is interested in public

[[Page 70107]]

comment on whether two years is an appropriate time period to Assess 
and (if required) Review Regulations promulgated more than ten years 
ago.
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    \100\ The Department has roughly 12,400 regulations that were 
promulgated more than ten years ago. See Enhancing Regulatory Reform 
Through Advanced Machine Learning Findings (internal HHS slide). 
Since many of these regulations were promulgated as part of the same 
rulemakings, the numbers of Reviews to be performed in two years is 
roughly a fifth this number.
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    The Department has decided that all of its Regulations (subject to 
the exceptions listed below) should be periodically assessed to 
determine whether they have a significant economic impact upon a 
substantial number of small entities. Without performing the 
Assessment, the Department may not know which regulations have or will 
have a significant economic impact upon a substantial number of small 
entities. Due to changed circumstances, a regulation that did not have 
such an impact at the time it was promulgated may now have such an 
impact. The Department is also aware of literature suggesting that 
agencies have not been consistent in deciding which rules have a 
significant economic impact on a substantial number of small entities, 
or have avoided such a finding in order to avoid complying with the 
RFA's requirements.\101\ By Assessing all of its Regulations (subject 
to the exceptions described herein) and publishing the results of the 
Assessments, the Department can avoid concern that the Department is 
failing to Assess or Review Regulations that have a significant 
economic impact on a substantial number of small entities.
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    \101\ See, e.g., Connor Raso, Agency Avoidance of Rulemaking 
Procedures, 67 Admin. L. Rev. 65, 93-95, 99-101 (2015); Michael R. 
See, Willful Blindness: Federal Agencies' Failure to Comply with the 
Regulatory Flexibility Act's Periodic Review Requirement--And 
Current Proposals to Reinvigorate the Act, 33 Fordham Urb. L. J. 
1199, 1222-25 (2006).
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    The Department should in many cases perform a single Assessment 
(and, where required, a single Review) that considers all Regulations 
issued as part of the same rulemaking. That would generally make sense 
from an economic perspective, for the same reasons as why the 
Department in many cases does a single regulatory impact analysis on 
all Regulations that are issued as part of the same rulemaking. Such an 
approach is not only permissible, but is encouraged, under this 
proposed rule. It would in some cases be nonsensical to Assess or 
Review a Regulation in isolation from the other Regulations promulgated 
as part of the same or a related rulemaking. Indeed, 5 U.S.C. 605(c) 
provides that ``[i]n order to avoid duplicative action, an agency may 
consider a series of closely related rules as one rule for the purposes 
of sections 602, 603, 604 and 610 of this title.'' Moreover, if a 
series of Regulations were issued as part of the same rulemaking and 
one of those Regulations was subsequently amended, the Department would 
in many cases take the view that the series of Regulations could be 
Assessed or Reviewed together for purposes of this proposed rule.
    For Regulations that were issued in coordination with another 
Agency, that function in concert with another Agency's regulations, or 
that have a specific, direct impact on regulations issued by another 
Federal agency, the Department shall consult with that other Agency 
when undertaking the Assessment or Review, and consider the other 
Agency's views when considering the factors described in section 
[XX](d). An example of Regulations that have a specific, direct impact 
on regulations issued by another Federal agency are the Department's 
ACA regulations concerning the operation of Exchanges that affect 
eligibility for the advance premium tax credit. Such regulations have a 
specific, direct impact on Department of the Treasury regulations.\102\
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    \102\ See, e.g., 45 CFR 155.340 (regarding administration of 
advance payments of the premium tax credit and cost-sharing 
reductions and requiring the Exchange to comply with Treasury 
regulations).
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    The Department's understanding is that the decisions based upon 
Reviews, including the amendment, repeal, or affirmation of 
Regulations, will constitute final agency action. First, the decisions 
will mark the consummation of the agency's decisionmaking process with 
respect to whether a Regulation satisfies the criteria described in 
section [XX](d). Second, the decisions constitute action by which 
rights or obligations have been determined, or from which legal 
consequences will flow. This is because if the Review is not performed, 
the Regulation would expire.\103\ Therefore, because the decisions 
based upon Reviews constitute final agency action, they must be 
performed in such a manner that they would withstand judicial review 
under the arbitrary and capricious standard.\104\
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    \103\ See U.S. Army Corps of Engineers v. Hawkes Co., Inc., 136 
S. Ct. 1807, 1813 (2016) (to have final agency action, ``First, the 
action must mark the consummation of the agency's decisionmaking 
process--it must not be of a merely tentative or interlocutory 
nature. And second, the action must be one by which rights or 
obligations have been determined, or from which legal consequences 
will flow'' (quoting Bennett v. Spear, 520 U.S. 154, 177-78 (1997)).
    \104\ See 5 U.S.C. 704 (final agency action is reviewable); 5 
U.S.C. 706 (a reviewing court shall hold unlawful and set aside 
agency action, findings, and conclusions found to be arbitrary, 
capricious, an abuse of discretion, or otherwise not in accordance 
with law).
---------------------------------------------------------------------------

    Similarly, if an Assessment concludes that a Regulation does not 
have a significant economic impact upon a substantial number of small 
entities, that would mark the consummation of the Department's 
decisionmaking process with respect to whether a Review must be 
performed on the Regulation. Such an Assessment's findings would also 
constitute action by which rights or obligations have been determined, 
or from which legal consequences will flow, because if the Assessment 
is not performed, the Regulation would expire. Therefore, Assessments 
must also be performed in such a manner that they would withstand 
judicial review under the arbitrary and capricious standard.
Section [XX](d)
    Section [XX](d) provides that the Department is required to Review 
those Regulations that the Department Assesses have a significant 
economic impact upon a substantial number of small entities. In 
reviewing Regulations to minimize any significant economic impact of 
the Regulation on a substantial number of small entities in a manner 
consistent with the stated objectives of applicable statutes, the 
Department's Review shall consider (1) the continued need for the 
Regulation, consideration of which shall include but not be limited to 
the extent to which the Regulation defines terms or sets standards used 
in or otherwise applicable to other Federal rules; (2) the nature of 
complaints or comments received concerning the Regulation from the 
public; (3) the complexity of the Regulation; (4) the extent to which 
the Regulation overlaps, duplicates or conflicts with other Federal 
rules, and, to the extent feasible, with State and local governmental 
rules; (5) the degree to which technology, economic conditions, or 
other factors have changed in the area affected by the regulation since 
the Regulation was promulgated or the last time the Regulation was 
Reviewed by the Department; (6) whether the Regulation complies with 
applicable law; and (7) other considerations as required by relevant 
executive orders and laws.
    This largely mirrors the review described in 5 U.S.C. 610. It is 
also consistent with ACUS' recommendation that agencies ``consider 
whether the [existing] regulations are accomplishing their intended 
purpose or whether they might, to the extent permitted by law, be 
modified, strengthened or eliminated in order to achieve statutory 
goals more faithfully, minimize compliance burdens on regulated 
entities, or more effectively confer regulatory

[[Page 70108]]

benefits.'' \105\ Prior to finalization, OIRA may review Reviews, 
including to coordinate inter-agency participation in the Review 
process where there are significant inter-agency equities or as 
otherwise appropriate.\106\ For example, when Assessing or Reviewing 
Regulations that require Executive Order 12250 review and approval by 
the Attorney General, the Department will consult with the Department 
of Justice (DOJ) and provide a draft of the findings to DOJ well in 
advance of the Assessment or Review deadline, so that DOJ can review 
and approve prior to the publication of the findings. It may be 
appropriate for OIRA to coordinate this process.
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    \105\ Administrative Conference of the United States, 
Recommendation 2014-5, 79 Fed. App'x--Recommendations of the 
Administrative Conference of the United States, 79 FR 75114, 75117 
(Dec. 17, 2014).
    \106\ OIRA may also coordinate inter-agency participation in the 
Assessment process where there are significant inter-agency equities 
or as otherwise appropriate.
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    Section [XX](d) provides that the Department shall consider the 
continued need for the Regulation, ``consideration of which shall 
include but not be limited to the extent to which the Regulation 
defines terms or sets standards used in or otherwise applicable to 
other Federal rules.'' The quoted phrase is not found in 5 U.S.C. 610, 
but the Department includes it to clarify that determining the 
continued need for the Regulation includes determining the extent to 
which it defines terms or sets standards used in or otherwise 
applicable to other Federal rules. However, this is not meant to be the 
only factor the Department should consider when determining the 
continued need for the Regulation. The Department shall consider any 
factors that, for the particular Regulation, are relevant to 
determining whether there is a continued need for the Regulation.
    In addition to this phrase, two factors listed in section [XX](d) 
are not found in 5 U.S.C. 610. The first is that section [XX](d) states 
that the Review should take into account ``whether the Regulation 
complies with applicable law.'' Since applicable law may have changed 
since the Regulation was promulgated, the Department wants to ensure 
that its Regulations are regularly reviewed to ensure that they comply 
with applicable law. Second, section [XX](d) states that the Review 
should take into account ``other considerations as required by relevant 
executive orders and laws.'' To the extent Executive Orders or laws 
enacted since section 610 require the Department to consider additional 
factors when performing retrospective review of particular regulations, 
the Department wishes to comply with those Executive Orders and laws. A 
recent Department of Transportation rule similarly required that 
agency, when periodically reviewing its regulations, to consider 
``[o]ther considerations as required by relevant executive orders and 
laws.'' See 49 CFR 5.13(d)(2)(vi).
    The Department anticipates that the Reviews would be similar to the 
section 610 analyses currently performed by agencies. The Reviews would 
benefit from real-world data and information gathered since the 
Regulation was promulgated to potentially discern the impact of the 
Regulation on small entities and on society more generally.
    Section [XX](d) requires only that regulations that have a 
significant economic impact upon a substantial number of small entities 
be Reviewed, because those are the regulations that 5 U.S.C. 610 
requires agencies have a plan to periodically review.
Section [XX](e)
    Section [XX](e) provides that if the Review concludes that a 
Regulation should be amended or rescinded, the Department shall have 
two years from the date that the findings of the Review are published 
in the Federal Register pursuant to paragraph (f) to amend or rescind 
the Regulation. If the Secretary determines that completion of the 
amendment or rescission is not feasible by the established date, he 
shall so certify in a statement published in the Federal Register and 
may extend the completion date by one year at a time for a total of not 
more than five years.
    The Department includes this provision, because if the Review 
concludes that a Regulation should be amended or rescinded, the 
Regulation should in fact be amended or rescinded. The Department 
believes that two years will generally be an adequate amount of time to 
amend or rescind a Regulation, since the Department has already 
conducted a Review of the Regulation. In circumstances where amendment 
is not feasible within that time period, the Secretary can so certify 
in a statement published in the Federal Register and extend the 
completion date by one year at a time for a total of not more than five 
years.
    When the Review determines that a Regulation should be amended or 
rescinded, the Department would, on a case-by-case basis as 
appropriate, use enforcement discretion to not enforce the Regulation 
or a portion of the Regulation until it is amended or rescinded. This 
is because in many cases the Department would not want to enforce 
Regulations (or portions of Regulations) that it determines should be 
amended or rescinded. The Department notes that enforcing a Regulation 
deemed to require amendment or rescission in some cases raises concerns 
about whether such enforcement is arbitrary and capricious. Continuing 
to enforce the Regulation (or portions thereof) would arguably ``run[ ] 
counter to the evidence before the agency.'' \107\
---------------------------------------------------------------------------

    \107\ Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. 
Auto. Ins. Co., 463 U.S. 29, 43 (1983).
---------------------------------------------------------------------------

Section [XX](f)
    Next, section [XX](f) provides that the results of all Assessments 
and Reviews conducted in a calendar year, including the full underlying 
analyses and data used to support the results (subject to any 
applicable privilege, protections for confidential business 
information, or explicit legal prohibition on disclosure), shall be 
published in a single document in the Federal Register during that 
calendar year. The document shall be organized in a manner that enables 
both the Department and the public to readily determine which 
Assessments and Reviews were conducted during that calendar year. The 
document shall also specify the year by which the next Assessment (and, 
if required, the next Review) of the Regulation shall be completed.
    The Department includes this requirement so that both the 
Department and the public can readily know which Regulations were 
Assessed and Reviewed each year. If Assessments and Reviews were 
published in disparate places throughout the year, it could become 
extraordinarily difficult for both the Department and the public to 
know which Regulations were Assessed and Reviewed each year. Section 
[XX](f) will enable both the Department and the public to look in one 
place to know which Assessments and Reviews were conducted each 
calendar year, and know the findings of those Assessments and Reviews.
    When publishing the findings of an Assessment or Review, the 
Department should include the full underlying analyses and data used to 
support the results, subject to any applicable privilege, protections 
for confidential business information, or explicit prohibition on 
disclosure. This will increase transparency and permit the public to 
see how the Department reached its conclusion. By requiring publication 
of the Reviews and the underlying analyses and data, the Department 
also incorporates ACUS' suggestion that ``[a]gencies should

[[Page 70109]]

disclose relevant data concerning their retrospective analyses'' so as 
to ``allow private parties to recreate the agency's work and to run 
additional analyses concerning existing rules' effectiveness.'' \108\
---------------------------------------------------------------------------

    \108\ 79 FR 75114, 75117 (Dec. 17, 2014); see also Exec. Order 
13563, sec. 6(a) (Jan. 18, 2011) (``retrospective analyses, 
including supporting data, should be released online whenever 
possible''). Although this proposed rule incorporates several ACUS' 
recommendations, it does not incorporate all of them. This proposed 
rule does not set forth a prioritization scheme. That is in part 
because it is difficult to determine which regulations should be 
prioritized without having performed Reviews. HHS also invites 
public comment on how best to integrate retrospective review into 
new rulemakings, which was another ACUS recommendation.
---------------------------------------------------------------------------

    The Department does not believe that the deliberative process 
privilege would generally bar disclosing the final underlying analyses 
and data referred to in section [XX](f).\109\
---------------------------------------------------------------------------

    \109\ See, e.g., Coastal States Gas Corp. v. Dep't of Energy, 
617 F.2d 854, 866 (D.C. Cir. 1980) (``[E]ven if the document is 
predecisional at the time it is prepared, it can lose that status if 
it is adopted, formally or informally, as the agency position on an 
issue or is used by the agency in its dealings with the public.'').
---------------------------------------------------------------------------

    Section [XX](f) also provides that the document published in the 
Federal Register shall specify the year by which the next Assessment 
(and, if required, the next Review) of the Regulation shall be 
completed. This can be particularly helpful if the Department conducts 
an Assessment or Review of a Regulation prior to the deadline year.
Section [XX](g)
    Section [XX](g) provides that paragraph (c) of the proposed rule 
shall not apply to Regulations that are prescribed by Federal law, such 
that the Department exercises no discretion as to whether to promulgate 
the Regulation and as to what is prescribed by the Regulation. For such 
Regulations that are adopted after the effective date of this section, 
the Federal law described shall be cited in the notice of adoption. 
Section [XX](g) also provides that paragraph (c) of the proposed rule 
shall not apply to (1) Regulations whose expiration pursuant to this 
section would violate any other Federal law; (2) this section; (3) 
Regulations that involve a military or foreign affairs function of the 
United States; (4) Regulations addressed solely to internal agency 
management or personnel matters; (5) Regulations related solely to 
Federal Government procurement; and (6) Regulations that were issued 
jointly with other Federal agencies, or that were issued in 
consultation with other agencies because of a legal requirement to 
consult with that other agency.
    Section [XX](g)(1) excepts Regulations that are prescribed by 
Federal law, such that the Department exercises no discretion as to 
whether to promulgate the Regulation and as to what is prescribed by 
the Regulation. This is only the case in rare circumstances. Because 
the Department lacks discretion over what is contained in these 
Regulations and cannot rescind them, they are exempted from section 
[XX](c). For such Regulations that are promulgated after the effective 
date of this proposed rule, the Department shall describe in the 
Regulation's notice of adoption the Federal law that results in the 
Department having no discretion as to whether to promulgate the 
Regulation and what is prescribed by the Regulation. The proposed rule 
includes this requirement so the public has notice that such 
Regulations are exempt from section [XX](c).
    Section [XX](g) likewise also exempts from section [XX](c) any 
Regulation whose expiration pursuant to this section would violate any 
other Federal law. The exceptions listed in sections [XX](g)(1) and 
[XX](g)(2) are not satisfied simply because the statutory authority for 
the Regulation provides that the Secretary ``shall'' prescribe 
regulations. For example, section 804(b) of the Federal Food Drug & 
Cosmetic Act, 21 U.S.C. 384(b), provides that the ``Secretary, after 
consultation with the United States Trade Representative and the 
Commissioner of U.S. Customs and Border Protection, shall promulgate 
regulations permitting pharmacists and wholesalers to import 
prescription drugs from Canada into the United States'' (emphasis 
added). However, although the statute was enacted in 2003, as of 
January 1, 2020 the Department had not issued any regulations 
implementing it, indicating the Department's view that section 804(b) 
did not require the Department to issue regulations. Similarly, Section 
1102 of the Social Security Act, 42 U.S.C. 1302, provides that the 
Secretary ``shall make and publish such rules and regulations, not 
inconsistent with this Act, as may be necessary to the efficient 
administration of the functions with which [he] is charged under this 
Act'' (emphasis added). But the Department does not believe every 
regulation promulgated pursuant to section 1102 is required to have 
been issued, or that it would violate Federal law to rescind such 
regulations.
    Section [XX](g) also exempts this proposed rule from section 
[XX](c). Assuming that no rules expire due to lack of Assessment or 
Review, this proposed rule cannot, absent other actions, directly 
impose on the public costs that exceed benefits, since this proposed 
rule merely requires the Department to periodically Assess and, in some 
cases, Review its Regulations. Only the failure to perform an 
Assessment or Review in the future could theoretically impose on the 
public costs that exceed benefits (assuming expired Regulations were on 
balance benefiting the public). This proposed rule would improve the 
Department's Regulations by requiring the Department to evaluate the 
impact of its Regulations and amend or rescind those Regulations with a 
significant economic impact upon a substantial number of small entities 
that the Department determines should be amended or rescinded. 
Therefore, the rationale for periodic review does not apply to this 
proposed rule to the extent it applies to other Department regulations. 
The Department realizes that certain members of the regulated community 
might rely on particular regulations, but the Department will take that 
into account when performing Assessments and Reviews. The Department 
would only determine that a Regulation should be amended or rescinded 
if the Regulation's burdens outweigh these reliance interests and the 
other benefits of the Regulation or if other factors, such as a change 
in law, might compel amendment or rescission. The Department does not 
intend to avoid Assessing or, if required, Reviewing any Regulation and 
does not anticipate that an important Regulation would expire due to 
failure to Assess or Review it. Moreover, the Department anticipates 
that the public would remind the Department to perform the Assessment 
or Review if the deadline is nearing and the Department has not yet 
commenced the Assessment or Review.\110\ Accordingly, the Department 
proposes to exempt this proposed rule from Section [XX](c).
---------------------------------------------------------------------------

    \110\ See the discussion of section [XX](h) infra.
---------------------------------------------------------------------------

    Section [XX](g) also exempts Regulations that involve a military or 
foreign affairs function of the United States. For purposes of this 
proposed rule, ``a military or foreign affairs function of the United 
States'' shall have the same meaning as that phrase has under 5 U.S.C. 
553(a). Regulations that involve a military or foreign affairs function 
of the United States are exempted from this proposed rule for the same 
reasons that Congress exempted them from the requirements of 5 U.S.C. 
553.
    Section [XX](g) also exempts Regulations addressed solely to 
internal agency management or personnel matters and Regulations related 
solely to

[[Page 70110]]

Federal Government procurement. Because such Regulations do not 
directly impact the public, the rationale for retrospective review is 
weaker with respect to these Regulations.\111\
---------------------------------------------------------------------------

    \111\ The portion of the proposed rule applying to Title 42 also 
exempts 42 CFR 1001.952 from expiration. 42 CFR 1001.952 provides a 
safe harbor for various payment and business practices that, 
although they potentially implicate the Federal anti-kickback 
statute, are not treated as offenses under the statute. The 
Department exempts this regulation because it is concerned that 
certain otherwise permissible behavior could become criminal simply 
because the Department did not Review this Regulation. The portion 
of the proposed rule applying to Title 42 also exempts 42 CFR part 
73. 42 U.S.C. 262a provides that, with respect to Part 73, the 
``Secretary shall review and republish [a list of certain biological 
agents and toxins] biennially, or more often as needed, and shall by 
regulation revise the list as necessary in accordance with such 
paragraph.'' Since those regulations are already being reviewed 
biennially, there is no need for this proposed rule to apply to 42 
CFR part 73. Similarly, the portion of the proposed rule applying to 
Title 42 also exempts the annual Medicare Part A and Part B payment 
methodology update rules. Since these are amended annually, it does 
not make sense to Review them every ten years. Lastly, the portion 
of the proposed applying to Title 42 also exempts 42 CFR 100.3, 
since the statutory basis for this regulation provides that it 
cannot be amended unless (1) a proposed regulation is provided to 
the Advisory Committee on Childhood Vaccines (ACCV) and the ACCV is 
provided at least 90 days to make recommendations and comments, and 
(2) there is subsequently a 180-day public comment period. See 42 
U.S.C. 300aa-14(c).
---------------------------------------------------------------------------

    Section [XX](g) also exempts any Regulations that were issued 
jointly with other Federal agencies, or that were issued in 
consultation with other agencies because of a legal requirement to 
consult with that other agency. This is because the Department cannot 
on its own rescind or amend a Regulation issued jointly with another 
Federal agency. An example of a regulation issued in consultation with 
other agencies because of a legal requirement to consult with that 
other agency is section 104 of the Health Insurance Portability and 
Accountability Act, which directs the Secretaries of HHS, Labor and the 
Treasury to ensure that regulations issued pursuant to provisions where 
the Secretaries share interpretive jurisdiction (which includes many of 
the provisions in Title XXVII of the Public Health Service (PHS) Act) 
are administered to have the same effect at all times.\112\
---------------------------------------------------------------------------

    \112\ See Health Insurance Portability and Accountability Act of 
1996, Public Law 104-191, 110 Stat. 1978.
---------------------------------------------------------------------------

    The Department considered excepting additional Regulations, but 
wanted to limit the exceptions to Regulations that legally cannot be 
rescinded, are otherwise being periodically reviewed by the Department, 
do not substantially impact the public, or have a very strong 
countervailing policy. The exceptions listed herein are the only ones 
the Department tentatively believes satisfy these criteria. The 
Department seeks comment on whether to retain all these exceptions in a 
final rule or whether to add additional exceptions.
Section [XX](h)
    Section [XX](h) provides that when the Department commences the 
process of performing an Assessment or Review, it shall state on a 
Department-managed website the Regulation(s) whose Assessment or Review 
it is commencing. The public will be able to submit comments regarding 
these Regulation(s) in the manner specified on this website. Members of 
the public can also submit comments in the manner specified on the 
website requesting that the Department begin the Assessment or Review 
of a Regulation, particularly if they are concerned that the deadline 
is nearing and the Department has not stated that it has commenced the 
Assessment or Review.
    The Department includes this provision so that, when the Department 
is Assessing or Reviewing a Regulation, the public can submit comments 
for the Department's consideration. The Department believes this will 
maximize transparency, public participation, and the Department's 
knowledge of the real-world impacts of its Regulations.
    The Department also proposes in this provision to allow the public 
to submit a comment on the website requesting that the Department begin 
the Assessment or Review of a Regulation. The Department has considered 
the risk that a Regulation could expire because the Department 
inadvertently did not Assess or Review it. The Department proposes to 
mitigate this risk by allowing members of the public to submit comments 
requesting that the Department commence the Assessment or Review of a 
Regulation. If a person is concerned that the Department has not 
announced the Assessment or Review of a Regulation and the deadline is 
nearing, the person can remind the Department to conduct the Assessment 
or Review.
    The Department intends to timely Assess and, where required, Review 
all its Regulations. The Department notes, however, that if it has not 
announced that it is Assessing or Reviewing a Regulation, and the 
deadline is nearing, those who rely on the Regulation are on notice 
that it might expire, just as the public is on notice that a regulation 
might be rescinded when an agency issues a notice of proposed 
rulemaking to rescind the regulation.
Section [XX](i)
    Lastly, this proposed rule includes a severability clause. The 
Department believes this proposed rule fully complies with applicable 
law, but does not wish to see the entire proposed rule vacated in the 
event that a portion of it is vacated. For example, the Department does 
not wish to see this entire proposed rule vacated because one of the 
exceptions listed in section [XX](g) is invalidated. However, the 
Department requests comment on whether the amendments to add expiration 
dates should be severable from other portions of the proposed rule, 
including the requirements to perform Assessments and Reviews. It is 
not clear that this proposed rule could properly function without the 
expiration dates, so the Department requests comment on this.

V. Request for Comment

    HHS requests comment on all aspects of this notice of proposed 
rulemaking, including its likely costs and benefits. HHS is 
particularly interested in comments on:
     Whether the exceptions listed in section [XX](g) should be 
retained in the final rule.
     Whether the exceptions listed in section [XX](g), if 
worded as they currently are, will lead to uncertainty and litigation 
and, if so, how they should be revised.
     Whether additional exceptions should be included in 
section [XX](g).
     Regulations of particular importance that HHS needs to 
ensure are Assessed or Reviewed so they do not expire.
     Whether the Review should consider, in addition to the 
factors listed in 5 U.S.C. 610, whether the Regulation remains cost-
effective and/or cost-justified. If so, how should the Department 
determine if a Regulation is cost-effective and/or cost-justified?
     When the Department performs a Review and determines that 
a Regulation should be amended or rescinded, what course of conduct 
should the Department take during the interim period before the 
Regulation is amended or rescinded? For example, should the final rule 
mandate that such a regulation cannot be enforced prior to amendment or 
rescission; should the Department determine whether to exercise 
enforcement discretion on a case-by-case basis; should the Department 
continue to enforce the Regulation in the same manner as prior to the 
Review; or should the Department follow a different course of conduct?
     If, when the Review concludes that a Regulation should be 
amended or

[[Page 70111]]

rescinded, should the Secretary be allowed to extend the completion 
date for amendment or rescission beyond two years? If extensions are 
permitted, should the Secretary be allowed to extend the completion 
date by one year at a time for a total of not more than five years, or 
should he be permitted to extend for a shorter or longer period of 
time?
     Whether the Department should Review a different set of 
regulations than those that have a significant economic impact upon a 
substantial number of small entities (i.e., whether it should Review 
all Department regulations; those that were, upon issuance, designated 
significant under Executive Order 12866; those that have a significant 
adverse economic impact upon a substantial number of small entities; or 
some other group). If the Department reviews a different set of 
regulations, should it review them using the criteria described in 5 
U.S.C. 610(b) or different criteria, such as the criteria described in 
section 5(a) of Executive Order 12866?
     How best to integrate plans for retrospective review into 
new rulemakings.
     What timeframe to use when Assessing or Reviewing 
Regulations, and whether the timeframe should vary based on how old the 
Regulation is.
     What the baseline should be when Assessing or Reviewing 
Regulations, and what factors to consider when determining the 
baseline.
     Any other factors that would improve the rigor or 
methodology of the Assessments or Reviews.
     The regulatory impact of this proposed rule.
     The impact of this proposed rule on small entities, as 
that term is defined in the RFA.
     How this proposed rule, if finalized, should be designated 
under Executive Order 13771.

VI. Regulatory Impact Analysis

Executive Orders 12866, 13563, and 13771

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary and not prohibited by statute, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, and public health and safety effects; 
distributive impacts; and equity). Executive Order 13563 emphasizes the 
importance of quantifying both costs and benefits, reducing costs, 
harmonizing rules, and promoting flexibility. Section 3(f) of Executive 
Order 12866 defines a ``significant regulatory action'' as an action 
that is likely to result in a regulation (1) having an annual effect on 
the economy of $100 million or more in any one year, or adversely and 
materially affecting a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local, or tribal governments or communities (also referred to as 
``economically significant''); (2) creating a serious inconsistency or 
otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlement 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or (4) raising novel legal or policy issues arising 
out of legal mandates, the President's priorities, or the principles 
set forth in the Executive Order. OMB has designated this rule as 
economically significant for the purposes of Executive Orders 12866 and 
13563. This proposed rule's designation under Executive Order 13771 
will be informed by comments received.
    Section 5 of Executive Order 12866 requires agencies to submit to 
the Office of Information and Regulatory Affairs (OIRA) a plan to 
periodically review their existing significant regulations to determine 
whether any such regulations should be modified or eliminated so as to 
make the agency's regulatory program more effective in achieving the 
regulatory objectives, less burdensome, or in greater alignment with 
the President's priorities and principles. Section 6 of Executive Order 
13563 similarly requires agencies to submit to OIRA a plan to 
periodically review their existing significant regulations to determine 
whether any such regulations should be modified, streamlined, expanded, 
or repealed so as to make the agency's regulatory program more 
effective or less burdensome in achieving the regulatory objectives.
    This proposed rule would require the Department to assess whether 
its regulations have a significant economic impact upon a substantial 
number of small entities, and periodically review the impacts of such 
regulations using the criteria listed in section 3(a) of the RFA (as 
well as determine whether such regulations comply with applicable law).
    The need for a Department-wide regulatory review process is also 
supported by the Department's regulatory reform project, which piloted 
an approach to augment expert policy insights with AI-driven data 
analysis. Machine learning surfaced a number of potential reform 
opportunities, identifying over 1,200 CFR section citations that 
merited consideration for reform and 159 CFR sections that could 
benefit from regulatory streamlining based on their similarities to 
other sections.\113\ The project also uncovered that 85% of Department 
regulations created before 1990 have not been edited, and the 
Department has nearly 300 broken citation references in the CFR (i.e., 
CFR sections that reference other CFR sections that no longer exist). 
Without a clear process for periodically reviewing these regulations, 
there is no guarantee that regulations will be reviewed and revised (if 
needed) to align with technological, economic, and other developments. 
(Supra Section II.)
---------------------------------------------------------------------------

    \113\ Regulatory Streamlining & Analysis, at 11 (Mar. 2019).
---------------------------------------------------------------------------

    This proposed rule would result in the Department assessing which 
of its regulations have a significant economic impact upon a 
substantial number of small entities, and Reviewing those regulations 
to determine whether they should be continued without change, amended, 
or rescinded. Where the Review determines that the Department's 
Regulations should be continued without change, those Regulations will 
be maintained in their current form. Where the Review determines that, 
based upon current data and information, the Regulation should be 
amended or rescinded, the Department will begin rulemaking to amend or 
rescind the Regulation. Thus, Regulations that have become outmoded 
will be amended or rescinded, whereas those Regulations that satisfy 
the Review criteria will be maintained. The Department believes it can 
complete Reviews for all Regulations that are more than ten years old 
in the proposed two-year timeframe. However, the Department recognizes 
that there is a risk that a Regulation whose benefits outweigh its 
costs could expire because the Department failed to Assess or Review 
it. The Department believes that risk may be lowered by members of the 
public reminding the Department if the Assessment or Review deadline is 
nearing and the Department has not commenced the Assessment or Review 
of a Regulation.
    The Department recognizes that this proposed rule requires the 
Department to undertake certain tasks. But the Department believes that 
retrospective review of regulations should be a priority, and is 
willing to commit the necessary resources towards performing the 
Assessments and Reviews. Moreover, in assessing the burdens of this 
proposed rule on the Department, it is important to note that the 
Department

[[Page 70112]]

is already required to periodically review its regulations that have a 
significant economic impact upon a substantial number of small 
entities. See 5 U.S.C. 610. Implicit in 5 U.S.C. 610 is the requirement 
to determine which regulations have a significant economic impact upon 
a substantial number of small entities. Therefore, the Review 
requirements in the proposed rule do not impose new burdens not already 
imposed on the Department, if incomplete compliance is not accounted 
for in the regulatory baseline. If the Department believes a Regulation 
is important enough to justify imposing its requirements on the public, 
the Department should be able to prioritize periodically assessing the 
Regulation's impact.
    To obtain additional insight into the potential benefits, costs, 
and burdens of this proposed rule, the Department performed several 
analyses. First, it examined recently-completed actions that occurred 
as a result of the relatively rare section 610 reviews that the 
Department has performed:

                      Table--Recently-Completed Actions as a Result of Section 610 Reviews
----------------------------------------------------------------------------------------------------------------
                                                                                      Regulatory changes made as
         Name of rulemaking           CFR citation and RIN            Year             a result of section 610
                                                                                               reviews
----------------------------------------------------------------------------------------------------------------
Medicare and Medicaid Programs;      42 CFR Parts 403, 416,  2019 (Final Rule).....  Reformed Medicare
 Regulatory Provisions To Promote     418, 441, 460, 482,                             regulations that were
 Program Efficiency, Transparency,    483, 484, 485, 486,                             identified as unnecessary,
 and Burden Reduction; Fire Safety    488, 491, and 494.                              obsolete, or excessively
 Requirements for Certain Dialysis   RIN 0938-AT23.........                           burdensome on health care
 Facilities; Hospital and Critical                                                    providers and suppliers,
 Access Hospital (CAH) Changes To                                                     and increased the ability
 Promote Innovation, Flexibility,                                                     of health care
 and Improvement in Patient Care.                                                     professionals to devote
                                                                                      resources to improving
                                                                                      patient care by
                                                                                      eliminating or reducing
                                                                                      requirements that impede
                                                                                      quality patient care or
                                                                                      that divert resources away
                                                                                      from furnishing high
                                                                                      quality patient care.
                                                                                      Updated fire safety
                                                                                      standards for Medicare and
                                                                                      Medicaid participating End-
                                                                                      Stage Renal Disease (ESRD)
                                                                                      facilities by adopting the
                                                                                      2012 edition of the Life
                                                                                      Safety Code and the 2012
                                                                                      edition of the Health Care
                                                                                      Facilities Code, and
                                                                                      updated the requirements
                                                                                      that hospitals and
                                                                                      Critical Access Hospitals
                                                                                      must meet to participate
                                                                                      in the Medicare and
                                                                                      Medicaid programs.
                                                                                      Requirements were intended
                                                                                      to conform to current
                                                                                      standards of practice and
                                                                                      support improvements in
                                                                                      quality of care, reduce
                                                                                      barriers to care, and
                                                                                      reduce some issues that
                                                                                      may exacerbate workforce
                                                                                      shortage concerns.
Medicare and Medicaid Programs;      42 CFR Parts 409, 410,  2017 (Final Rule).....  Revised the conditions of
 Conditions of Participation for      418, 440, 484, 485                              participation that home
 Home Health Agencies.                and 488.                                        health agencies (HHAs)
                                     RIN 0938-AG81.........                           must meet in order to
                                                                                      participate in the
                                                                                      Medicare and Medicaid
                                                                                      programs. The new
                                                                                      requirements focus on the
                                                                                      care delivered to patients
                                                                                      by HHAs, reflect an
                                                                                      interdisciplinary view of
                                                                                      patient care, allow HHAs
                                                                                      greater flexibility in
                                                                                      meeting quality care
                                                                                      standards, and eliminate
                                                                                      unnecessary procedural
                                                                                      requirements.
Medicare and Medicaid Programs;      42 CFR Parts 405, 431,  2016 (Final Rule).....  Revised the requirements
 Reform of Requirements for Long-     447, 482, 483, 485,                             that Long-Term Care
 Term Care Facilities.                488, and 489.                                   facilities must meet to
                                     RIN 0938-AR61.........                           participate in the
                                                                                      Medicare and Medicaid
                                                                                      programs. These changes
                                                                                      are necessary to reflect
                                                                                      the substantial advances
                                                                                      that have been made over
                                                                                      the past several years in
                                                                                      the theory and practice of
                                                                                      service delivery and
                                                                                      safety.
----------------------------------------------------------------------------------------------------------------

    These results suggest that, if the Department performs additional 
Reviews, additional benefits will be achieved from revising and 
streamlining certain regulatory requirements.
    The Department also performed the following analysis to estimate 
the costs and burdens to the Department from (1) assessing which 
Department regulations have a significant economic impact upon a 
substantial number of small entities, and (2) Reviewing those 
regulations.\114\ The Department has roughly 18,000 regulations, the 
vast majority of which it believes would need to be Assessed.\115\ 
Roughly 12,400 of these regulations are over ten years old.\116\ The 
vast majority of these would need to be Assessed within two years if 
this proposed rule were finalized. But because the Department estimates 
that roughly five regulations on average are part of the same 
rulemaking, the number of Assessments to perform in the first two years 
is estimated to be roughly 2,480.
---------------------------------------------------------------------------

    \114\ The Department is generally already required to undertake 
reviews under 5 U.S.C. 610. The Department includes this analysis 
because it may be informative for the public to see an estimate of 
the costs and burdens of assessing which regulations have a 
significant economic impact upon a substantial number of small 
entities, and Reviewing the Regulations that have such an impact.
    \115\ See Enhancing Regulatory Reform Through Advanced Machine 
Learning Findings (internal HHS slide) (the sum of the numbers 
listed in the table under the column denoted ``#'' is 17,890 
Department regulations).
    \116\ See id. (adding the figures listed in the ``#'' columns 
for the 1950s, 1960s, 1970s, 1980s, 1990s, and 2000s yields 12,383 
regulations).
---------------------------------------------------------------------------

    To help estimate the impact of this proposed rule, the Department 
conducted a random sample \117\ of its regulations and assessed whether 
the sampled regulations would be exempt from this proposed rule and 
whether, at the time of issuance, the regulations were: Economically 
significant; found to have a significant economic impact upon a 
substantial number of small entities (SEISNOSE); or subject to the

[[Page 70113]]

Unfunded Mandates Reform Act of 1995. Also included in the table is the 
estimated impact of the regulations when they were first promulgated. 
The findings of this sample are below:
---------------------------------------------------------------------------

    \117\ With the aid of a random number generator, the Department 
selected Department regulations in the Code of Federal Regulations. 
The Department then reviewed the relevant rulemaking associated with 
the specific regulation selected and analyzed those rulemakings in 
view of the categories listed in the table.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Exempt from this            Economically                                                       Impact estimates at
         Title                Rulemaking                Citation               proposed rule?             significant?                SEISNOSE?           Subject to UMRA?         issuance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
21.....................  Toll-Free Number for  73 FR 63886..............  No......................  No......................  No......................  No.................  ``[O]ne-time costs
                          Reporting Adverse                                                                                                                                   will range from
                          Events on Labeling                                                                                                                                  approximately
                          for Human Drug                                                                                                                                      $38.0 million to
                          Products.                                                                                                                                           $49.6 million and
                                                                                                                                                                              annual costs will
                                                                                                                                                                              range from $12.4
                                                                                                                                                                              million to $46.3
                                                                                                                                                                              million.'' \118\
21.....................  Unique Device         78 FR 58786..............  No......................  Yes.....................  Yes.....................  Yes................  ``Over 10 years,
                          Identification                                                                                                                                      the estimated
                          System.                                                                                                                                             present value of
                                                                                                                                                                              the total domestic
                                                                                                                                                                              costs is $642.2
                                                                                                                                                                              million using a 7
                                                                                                                                                                              percent discount
                                                                                                                                                                              rate and $737.7
                                                                                                                                                                              million using a 3
                                                                                                                                                                              percent rate, and
                                                                                                                                                                              the annualized
                                                                                                                                                                              costs are $85.7
                                                                                                                                                                              million using a 7
                                                                                                                                                                              percent discount
                                                                                                                                                                              rate and $84.1
                                                                                                                                                                              million using a 3
                                                                                                                                                                              percent discount
                                                                                                                                                                              rate.'' \119\
21.....................  Requirements for      81 FR 60170..............  No......................  No......................  No......................  No.................  ``We estimate one-
                          Foreign and                                                                                                                                         time total costs
                          Domestic                                                                                                                                            of $59.7 million
                          Establishment                                                                                                                                       and recurring
                          Registration And                                                                                                                                    costs of $0.5
                          Listing for Human                                                                                                                                   million. These
                          Drugs, Including                                                                                                                                    costs represent
                          Drugs That Are                                                                                                                                      total annualized
                          Regulated Under a                                                                                                                                   costs of $9
                          Biologics License                                                                                                                                   million when
                          Application, and                                                                                                                                    calculated at a 7-
                          Animal Drugs.                                                                                                                                       percent discount
                                                                                                                                                                              rate over 10
                                                                                                                                                                              years, and $7.5
                                                                                                                                                                              million when
                                                                                                                                                                              calculated using a
                                                                                                                                                                              3-percent discount
                                                                                                                                                                              rate. The largest
                                                                                                                                                                              cost elements will
                                                                                                                                                                              be for registrants
                                                                                                                                                                              reading and
                                                                                                                                                                              understanding the
                                                                                                                                                                              final rule and
                                                                                                                                                                              making changes to
                                                                                                                                                                              their standard
                                                                                                                                                                              operating
                                                                                                                                                                              procedures.''
                                                                                                                                                                              \120\
21.....................  Human Tissue          62 FR 40429..............  No......................  No......................  No......................  No.................  FDA confirmed
                          Intended for                                                                                                                                        ``that the only
                          Transplantation.                                                                                                                                    economic impact of
                                                                                                                                                                              the rule would be
                                                                                                                                                                              related to
                                                                                                                                                                              recordkeeping
                                                                                                                                                                              burdens'' that
                                                                                                                                                                              already
                                                                                                                                                                              existed.\121\
42.....................  Medicare Program;     70 FR 57368..............  No......................  Yes.....................  No......................  No.................  ``The Congress
                          Health Care                                                                                                                                         provided
                          Infrastructure                                                                                                                                      $142,000,000 for
                          Improvement                                                                                                                                         the loan program
                          Program; Selection                                                                                                                                  effective July 1,
                          Criteria of Loan                                                                                                                                    2004 through
                          Program for                                                                                                                                         September 30,
                          Qualifying                                                                                                                                          2008, and not more
                          Hospitals Engaged                                                                                                                                   than $2,000,000
                          in Cancer-Related                                                                                                                                   may be used for
                          Health Care.                                                                                                                                        the administration
                                                                                                                                                                              of the loan
                                                                                                                                                                              program for each
                                                                                                                                                                              of the fiscal
                                                                                                                                                                              years (that is,
                                                                                                                                                                              2004 through
                                                                                                                                                                              2008).'' \122\

[[Page 70114]]

 
42.....................  Organ Procurement     63 FR 16296..............  No......................  Yes.....................  No......................  No.................  Although
                          and Transplantation                                                                                                                                 incremental
                          Network.                                                                                                                                            effects
                                                                                                                                                                              attributable to
                                                                                                                                                                              the rule were not
                                                                                                                                                                              estimated, impact
                                                                                                                                                                              categories would
                                                                                                                                                                              have included life-
                                                                                                                                                                              years saved by non-
                                                                                                                                                                              renal organ
                                                                                                                                                                              transplants,
                                                                                                                                                                              quality of life
                                                                                                                                                                              improvements for
                                                                                                                                                                              kidney recipients,
                                                                                                                                                                              and the admittedly
                                                                                                                                                                              expensive costs of
                                                                                                                                                                              transplantation.\1
                                                                                                                                                                              23\
42.....................  Medicare Program;     53 FR 47199..............  No......................  No......................  No......................  N/A (rule issued     N/A: ``We have
                          Hospital Insurance                                                                                                             prior to UMRA        determined that a
                          Entitlement and                                                                                                                being enacted).      regulatory impact
                          Supplementary                                                                                                                                       analysis is not
                          Medical Insurance                                                                                                                                   required for these
                          Enrollment and                                                                                                                                      rules because they
                          Entitlement.                                                                                                                                        would not have an
                                                                                                                                                                              annual impact of
                                                                                                                                                                              $100 million or
                                                                                                                                                                              more.'' \124\
45.....................  Cooperation in        56 FR 8926...............  No......................  No......................  No......................  N/A (rule issued     ``[T]he cost of
                          Identifying and                                                                                                                prior to UMRA        implementation is
                          Providing                                                                                                                      being enacted).      expected to be
                          Information To                                                                                                                                      insignificant.''
                          Assist States in                                                                                                                                    \125\
                          Pursuing Third
                          Party Health
                          Coverage.
45.....................  Responsibility of     76 FR 53256..............  No......................  No......................  No......................  No.................  Estimated annual
                          Applicants for                                                                                                                                      cost of
                          Promoting                                                                                                                                           $23,236,238.\126\
                          Objectivity in
                          Research for which
                          Public Health
                          Service Funding is
                          Sought and
                          Responsible
                          Prospective
                          Contractors.
45.....................  Rate Increase         76 FR 29964..............  No......................  No......................  No......................  No.................  ``CMS estimates
                          Disclosure and                                                                                                                                      that issuers will
                          Review.                                                                                                                                             incur
                                                                                                                                                                              approximately $10
                                                                                                                                                                              million to $15
                                                                                                                                                                              million in one-
                                                                                                                                                                              time
                                                                                                                                                                              administrative
                                                                                                                                                                              costs, and $0.6
                                                                                                                                                                              million to $5.5
                                                                                                                                                                              million in annual
                                                                                                                                                                              ongoing
                                                                                                                                                                              administrative
                                                                                                                                                                              costs related to
                                                                                                                                                                              complying with the
                                                                                                                                                                              requirements of
                                                                                                                                                                              this final rule
                                                                                                                                                                              from 2011 through
                                                                                                                                                                              2013. In addition,
                                                                                                                                                                              States will incur
                                                                                                                                                                              very small
                                                                                                                                                                              additional costs
                                                                                                                                                                              for reporting the
                                                                                                                                                                              results of their
                                                                                                                                                                              reviews to the
                                                                                                                                                                              Federal
                                                                                                                                                                              government, and
                                                                                                                                                                              the Federal
                                                                                                                                                                              government will
                                                                                                                                                                              incur
                                                                                                                                                                              approximately $0.7
                                                                                                                                                                              million to $5.9
                                                                                                                                                                              million in annual
                                                                                                                                                                              costs to conduct
                                                                                                                                                                              reviews of
                                                                                                                                                                              justifications
                                                                                                                                                                              filed by issuers
                                                                                                                                                                              in States that do
                                                                                                                                                                              not perform
                                                                                                                                                                              effective
                                                                                                                                                                              reviews.'' \127\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 70115]]

    None of the sampled regulations would be exempt from this proposed 
rule. At the time the ten sampled regulations were promulgated, the 
Department believed that one of the ten had a significant economic 
impact upon a substantial number of small entities. If the Assessments' 
findings mirror the findings from the time of issuance, one of the ten 
sampled regulations would need to be Reviewed. Similarly, an academic 
study that found 11.1% of Department final rules issued in 1993 had a 
significant economic impact upon a substantial number of small 
entities.\128\ A more recent study found that agencies exempted over 
92% of their rules from the RFA.\129\ If the Department has roughly 
2,480 rulemakings that are more than ten years old, and roughly 11% 
have a significant economic impact upon a substantial number of small 
entities, the Department would need to perform roughly 273 Reviews 
\130\ in the two years after this proposed rule is finalized. If the 
Department has roughly 3,600 total rulemakings and roughly 11% \131\ 
have a significant economic impact upon a substantial number of small 
entities, the Department would have to perform roughly 396 Reviews in 
the ten years after this proposed rule is finalized.\132\
---------------------------------------------------------------------------

    \118\ Toll-Free Number for Reporting Adverse Events on Labeling 
for Human Drug Products, 73 FR 63886, 63892 (Oct. 28, 2008).
    \119\ Unique Device Identification System, 78 FR 58786, 58811 
(Sept. 24, 2013).
    \120\ Requirements for Foreign and Domestic Establishment 
Registration And Listing for Human Drugs, Including Drugs That Are 
Regulated Under a Biologics License Application, and Animal Drugs, 
81 FR 60170, 60171 (Aug. 31, 2016).
    \121\ Human Tissue Intended for Transplantation, 62 FR 40429, 
40442 (Jul. 29, 1997).
    \122\ Medicare Program; Health Care Infrastructure Improvement 
Program; Selection Criteria of Loan Program for Qualifying Hospitals 
Engaged in Cancer-Related Health Care, 70 FR 57368, 57372 (Sept. 30, 
2005).
    \123\ Organ Procurement and Transplantation Network, 63 FR 
16296, 16321-29 (Apr. 2, 1998).
    \124\ Medicare Program; Hospital Insurance Entitlement and 
Supplementary Medical Insurance Enrollment and Entitlement, 53 FR 
47199, 47201 (Nov. 22, 1988).
    \125\ Cooperation in Identifying and Providing Information To 
Assist States in Pursuing Third Party Health Coverage, 56 FR 8926, 
8929 (Mar. 4, 1991).
    \126\ Responsibility of Applicants for Promoting Objectivity in 
Research for which Public Health Service Funding is Sought and 
Responsible Prospective Contractors, 76 FR 53256, 53280 (Aug. 25, 
2011).
    \127\ Rate Increase Disclosure and Review, 76 FR 29964, 29978 
(May 23, 2011).
    \128\ Michael R. See, Willful Blindness: Federal Agencies' 
Failure to Comply with the Regulatory Flexibility Act's Periodic 
Review Requirement--And Current Proposals to Reinvigorate the Act, 
33 Fordham Urb. L. J. 1199, 1218 (2006).
    \129\ Connor Raso, Agency Avoidance of Rulemaking Procedures, 67 
Admin. L. Rev. 65, 69 (2015).
    \130\ This figure is a bit high, since some of these regulations 
will be exempt from this proposed rule.
    \131\ The Department chooses 11%, rather than 8% or 10%, to err 
on the side of assuming a larger burden to the Department and 
because the study that found 11.1% of Department regulations had a 
significant economic impact upon a substantial number of small 
entities was focused solely on the Department's regulations.
    \132\ Roughly 273 of these would be performed in the first two 
years after this proposed rule were finalized, and the other 123 
Reviews would occur in years 3-10. For purposes of this analysis, 
the Department assumes it will have to Review all Department 
regulations that the Department previously found had a SEISNOSE. If 
some of those regulations are determined to no longer have a 
SEISNOSE, the cost and burden to the Department would be less than 
estimated in this proposed rule.
---------------------------------------------------------------------------

    Of the 273 rulemakings subject to Reviews in the first two years, 
the Department estimates roughly 16%,\133\ or 44, of those rulemakings 
were promulgated prior to the requirement for prospective regulatory 
flexibility analyses. As described further below, those 44 Reviews will 
require more Department resources than the estimated 229 Reviews of 
rulemakings promulgated after the prospective analysis requirement went 
into effect.
---------------------------------------------------------------------------

    \133\ 16% is the percentage of Department regulations that are 
more than ten years old that were promulgated prior to 1980, when 
Congress passed the RFA.
---------------------------------------------------------------------------

A. Costs Related to Section 610 Reviews of Regulations More Than Ten 
Years Old

    The Department estimates that a total of between 20,160 and 44,900 
hours will be spent on Reviews outside the Assessment process during 
the first two years, which will clear the backlog of section 610 
reviews for regulations ten years old or older. The Department assumes 
40 to 100 hours per Review for the estimated 229 Reviews for which an 
initial prospective analysis was performed. The Department assumes 250 
to 500 hours per Review for the estimated 44 Reviews where no such 
initial prospective analysis was performed.
    HHS estimates that the fully-loaded cost per hour to the Department 
to employ a person to conduct a Review or Assessment is $244.98 per 
hour (referred to as ``LaborCost'').\134\ Accordingly, multiplying the 
20,160 to 44,900 estimated hours by LaborCost yields an estimated cost 
of between roughly $4,938,797 to $10,999,602, or approximately 17.4 to 
38.7 FTEs working at LaborCost, to initiate and conduct Reviews in the 
first two years if this proposed rule were finalized. Thus, the average 
cost per year in the first two years would be between roughly 
$2,469,399 and $5,499,801.
---------------------------------------------------------------------------

    \134\ Here, the Department uses the reported ``FY 2021 average 
fully supported cost to [FDA of] $284,174 per FTE,'' divided by 
1,160 ``Net Supported Direct FDA Work Hours Available for 
Assignments'' per year to arrive at $244.98 per hour. Food Safety 
Modernization Act Domestic and Foreign Facility Reinspection, 
Recall, and Importer Reinspection Fee Rates for Fiscal Year 2021, 85 
FR 46669, 46670 (Aug. 3, 2020).
---------------------------------------------------------------------------

B. Costs Related to Rulemakings That ``Age In'' to Section 610 Review
    For years three through ten after this proposed rule were 
finalized, the Department estimates it will require between 4,920 to 
12,300 hours to Review the estimated 123 rulemakings that ``age in'' 
\135\ to the section 610 review during that time period. The Department 
assumes those 123 Reviews would take between 40 to 100 hours per 
Review, as each of those rulemakings were promulgated after prospective 
regulatory analysis was required. Multiplying the estimated 4,920 to 
12,300 estimated hours by LaborCost yields total costs of between 
roughly $1,205,302 and $3,013,254, or approximately 4.2 to 10.6 FTEs 
working at LaborCost, to conduct 123 Reviews in the eight years 
following the first two years if the proposed rule were finalized, 
i.e., years 3 to 10.
---------------------------------------------------------------------------

    \135\ ``Age in,'' meaning that the rules become ten years old 
during years three through ten.
---------------------------------------------------------------------------

C. Costs Related to Assessments
    In addition to performing Reviews of rulemakings already deemed to 
have a SEISNOSE, the Department will allocate resources to conducting 
Assessments of its rulemakings to determine whether a Review is 
required. The Department believes each Assessment will require between 
three and 10 hours to perform. The Department estimates that it will 
have to conduct roughly 2,207 \136\ Assessments in the first two years 
if this proposed rule were finalized, and an additional roughly 997 
\137\ Assessments in the subsequent eight years, for a total of 3,204 
Assessments across ten years. As such, the Department believes 6,621 to 
22,070 hours will be spent on Assessments in the first two years and 
2,991 to 9,970 hours over the next eight years. Multiplying those hour 
estimates by LaborCost yields roughly $1,622,013 to $5,406,709, or 
approximately 5.7 to 19.0 FTEs working at LaborCost, to conduct 2,207 
Assessments in the first two years, and roughly $732,735 to $2,442,451, 
or approximately 2.6 to 8.6 GS-15 FTEs working at LaborCost, to conduct 
997 Assessments in the

[[Page 70116]]

following eight years. Therefore, the Department estimates $2,354,748 
to $7,849,160 will be incurred on Assessments in the first ten years if 
the proposed rule were finalized.
---------------------------------------------------------------------------

    \136\ 2,207 is derived from 2,480 Department rulemakings that 
are at least 10 years old minus the 273 rulemakings reviewed in 
years 1 and 2.
    \137\ 3,600 total rulemakings minus the 2,480 rulemakings that 
are over 10 years old yields 1,120 rulemakings that are left to be 
assessed during years 3-10. 123 of these rulemakings will be 
reviewed in years 3-10, leaving 997 rulemakings to be assessed 
(1,120 less 123 equals 997).
---------------------------------------------------------------------------

D. Costs Related to Review of Rulemakings Found to Have a SEISNOSE
    Depending on the outcome of the Assessments, the Department may 
have to Review additional rulemakings. The Department estimates roughly 
5% of Assessments of Regulations not initially found to have a SEISNOSE 
will conclude that a Review is required. The Department believes this 
is a reasonable estimate, because the 5% rate is roughly half of the 
percentage of all Department regulations the Department currently 
believes have a SEISNOSE. Accordingly, the Department estimates 110 
\138\ Reviews will be required in the first two years, and 50 \139\ 
Reviews will be required in the subsequent eight years, for a total of 
160 Reviews. During the first two years, the Department estimates the 
110 Reviews will require 4,400 to 11,000 hours,\140\ and that the 50 
Reviews will require 2,000 to 5,000 hours in the subsequent eight 
years. Multiplying these hour estimates by LaborCost yields an 
estimated roughly $1,077,912 to $2,694,780, or 3.8 to 9.5 FTEs for 
post-Assessment Reviews in the first two years, and roughly $489,960 to 
$1,224,900, or 1.7 to 4.3 FTEs for post-Assessment Reviews in the 
subsequent eight years, for a total cost of $1,567,872 to $3,919,680 
over ten years for post-Assessment Reviews.
---------------------------------------------------------------------------

    \138\ Which is 5% of the 2,207 assessments done in years 1-2.
    \139\ Which is 5% of the 997 assessments done in years 3-10.
    \140\ Each review will take 40-100 hours to assess.
---------------------------------------------------------------------------

E. Total Estimated Costs to the Department From Implementing This 
Rulemaking
    In sum, the Department estimates a total cost of between roughly 
$10,066,719 to $25,781,696, or approximately 35.4 to 90.7 FTEs working 
at LaborCost, over ten years in order to do the following: (a) Clear 
the backlog of section 610 reviews for Department rulemakings more than 
ten years old that have never been subject to retrospective review in 
years 1 to 2, (b) conduct section 610 reviews of rulemakings that ``age 
in'' to section 610 review in years 3 to 10, (c) conduct Assessments of 
3,204 rulemakings in years 1 to 10, and (d) conduct section 610 reviews 
of an estimated 160 rulemakings deemed to be subject to Review 
following an Assessment in years 1 to 10.\141\ The cost in the first 
two years is estimated to be roughly $7,638,722 to $19,101,091, and 
roughly $2,427,997 to $6,680,605 in the following eight years. If the 
proposed rule were finalized, the Department estimates a total 
investment of 26.9 to 67.2 FTEs in the first two years, and 8.5 to 23.5 
FTEs in the subsequent eight years, each FTE working at LaborCost. The 
Department estimates the annual cost of conducting Assessments and 
Reviews of between roughly $1,006,672 to $2,578,170 per year over ten 
years.
---------------------------------------------------------------------------

    \141\ In reality, the total cost will likely be less, since this 
analysis does not account for certain Regulations being exempt from 
the Assessment and Review requirements.
---------------------------------------------------------------------------

    As noted above, the Department estimates one Review will take 
between 40 and 100 hours on average to perform. A full initial 
Regulatory Flexibility Act (RFA) analysis requires 250 to 500 hours to 
complete, because federal agencies must analyze the impact of their 
regulatory actions on small entities (small businesses, small non-
profit organizations and small jurisdictions of government) and, where 
the regulatory impact is likely to be ``significant,'' affecting a 
``substantial number'' of these small entities, seek less burdensome 
alternatives for them. This involves defining the market and 
determining costs for each small entity. The section 610 review is a 
more streamlined analysis because the regulatory flexibility analysis 
is the starting point, and it will focus on, in addition to certain 
legal considerations, 5 areas of analysis: (1) Whether there is a 
continued need for the rule, (2) whether there is duplication, (3) the 
number and nature of complaints, (4) the complexity of the regulation, 
and (5) the degree to which technology, economic conditions, or other 
factors have changed in the area affected by the rule. As such, the 
Department estimates that a Review will require significantly less time 
than a full RFA analysis.
    The Department recognizes that some regulations were promulgated 
prior to when the requirement for prospective regulatory analysis went 
into effect, and that section 610 review of such rulemakings may be 
more time-intensive. The Department estimates 203 rulemakings will be 
subject to section 610 review where some prospective analysis has been 
performed, in which case such reviews will take 40 to 100 hours. HHS 
estimates it will undertake section 610 reviews of 39 rules for which 
no prospective regulatory review was performed. HHS assumes that 
between 250 to 500 hours may be required for these reviews, even though 
the section 610 review is more circumscribed than a full regulatory 
flexibility analysis and will therefore generally take less time to 
perform.
    The Department also notes that there could be costs associated with 
publishing the notices of Assessments and Reviews to the Department's 
website for public comment, but that such costs will be minimal and 
would not require the hiring of additional personnel.

Alternatives Considered

    The Department considered alternatives, including not issuing this 
proposed rule. But the RFA and certain Executive Orders direct the 
Department to periodically review certain Department regulations. 
Moreover, the literature suggests that in some cases the actual impacts 
of regulations differ from the projected impacts at the time of 
promulgation, so regulations should be periodically reviewed. The 
Department's experience over the last forty years suggests that, absent 
a strong incentive such as the potential expiration of a regulation, 
the Department will not review an adequate number of its regulations. 
The Department considered Reviewing all of its Regulations, but 
determined that that might be too burdensome. It also considered only 
Reviewing those regulations that, at the time of promulgation, the 
Department determined had a significant economic impact upon a 
substantial number of small entities. But such determinations were not 
made for regulations that precede the RFA, and some post-RFA 
regulations that did not have such an impact at the time of 
promulgation might have such an impact today. In addition, the 
Department is aware of literature suggesting that agencies have not 
been consistent in deciding which rules have a significant economic 
impact on a substantial number of small entities, or have avoided such 
a finding in order to avoid complying with the RFA's requirements.\142\ 
Therefore, the Department proposes to Assess all of its Regulations 
(subject to the exceptions listed herein) to determine which have a 
significant economic impact upon a substantial number of small 
entities, and Review those Regulations using the criteria listed in 5 
U.S.C. 610. The Department also considered reviewing

[[Page 70117]]

all significant regulations, as that term is defined in Executive Order 
12866. The Department is proposing to Review those regulations that 
have a significant economic impact upon a substantial number of small 
entities, in order to hew closely to the RFA. But the Department 
requests comment on whether to also review additional regulations, such 
as those that are significant under Executive Order 12866.
---------------------------------------------------------------------------

    \142\ See, e.g., Connor Raso, Agency Avoidance of Rulemaking 
Procedures, 67 Admin. L. Rev. 65, 93-95, 99-101 (2015); Michael R. 
See, Willful Blindness: Federal Agencies' Failure to Comply with the 
Regulatory Flexibility Act's Periodic Review Requirement--And 
Current Proposals to Reinvigorate the Act, 33 Fordham Urb. L. J. 
1199, 1222-25 (2006).
---------------------------------------------------------------------------

    The Department also considered including in the proposed rule an 
opportunity for the Department to extend the ten-year deadline to 
Assess or Review Regulations in certain circumstances. However, the 
Department decided against including such a provision. First, the RFA 
does not permit such an extension for rules issued after the RFA's 
enactment, even though it allows the Department to extend the time to 
complete the review of rules existing at the time of the RFA's 
enactment. See 5 U.S.C. 610(a). Second, ten years is a long time and 
the Department believes it affords adequate time to perform the 
Assessments and (where required) Reviews. The Department is concerned 
that if it granted itself extensions, that would cause the Department 
to have more work to do in future years and therefore require it to 
grant extensions to Assess or Review Regulations whose expiration dates 
are in subsequent years. This could become a vicious cycle.\143\
---------------------------------------------------------------------------

    \143\ Section [XX](c) proposes to allow the Department to extend 
the deadline to amend or rescind Regulations that the Department 
concludes should be amended or rescinded. The Department does so in 
part because the vicious cycle concern does not apply with equal 
force to such circumstances. That is because the Department expects 
that only a subset of its Regulations will need to be amended, 
whereas the Review Assessment must be performed on nearly all of the 
Department's Regulations. In addition, the universe of Regulations 
to be Reviewed will presumably be larger than the universe of 
Regulations to amend or rescind.
---------------------------------------------------------------------------

Regulatory Flexibility Act

    The Department has examined the economic implications of this 
proposed rule as required by the RFA (5 U.S.C. 601-612). The RFA 
generally requires that when an agency issues a proposed rule, or a 
final rule pursuant to section 553(b) of the APA or another law, the 
agency must prepare a regulatory flexibility analysis that meets the 
requirements of the RFA and publish such analysis in the Federal 
Register. 5 U.S.C. 603, 604. Specifically, the RFA normally requires 
agencies to describe the impact of a rulemaking on small entities by 
providing a regulatory impact analysis. Such analysis must address the 
consideration of regulatory options that would lessen the economic 
effect of the rule on small entities. The RFA defines a ``small 
entity'' as (1) a proprietary firm meeting the size standards of the 
Small Business Administration (SBA); (2) a nonprofit organization that 
is not dominant in its field; or (3) a small government jurisdiction 
with a population of less than 50,000. 5 U.S.C. 601(3)-(6). Except for 
such small government jurisdictions, neither State nor local 
governments are ``small entities.'' Similarly, for purposes of the RFA, 
individual persons are not small entities. The requirement to conduct a 
regulatory impact analysis does not apply if the head of the agency 
``certifies that the rule will not, if promulgated, have a significant 
economic impact on a substantial number of small entities.'' 5 U.S.C. 
605(b). The agency must, however, publish the certification in the 
Federal Register at the time of publication of the rule, ``along with a 
statement providing the factual basis for such certification.'' Id. If 
the agency head has not waived the requirements for a regulatory 
flexibility analysis in accordance with the RFA's waiver provision, and 
no other RFA exception applies, the agency must prepare the regulatory 
flexibility analysis and publish it in the Federal Register at the time 
of promulgation or, if the rule is promulgated in response to an 
emergency that makes timely compliance impracticable, within 180 days 
of publication of the final rule. 5 U.S.C. 604(a), 608(b).
    The Department considers a rule to have a significant impact on a 
substantial number of small entities if it has at least a three percent 
impact on revenue on at least five percent of small entities. 
Department regulations impact at least NAICS industry sectors 11, 31-
33, 42, 44-45, 48-49, 52, 54, 62, 81, and 92.
    This proposed rule would require the Department to review its 
existing regulations (subject to certain exceptions) that have a 
significant economic impact upon a substantial number of small entities 
using the criteria described in the RFA. To the extent that the review 
determines that the criteria described in section 3(a) of the RFA favor 
rescinding or amending a regulation, HHS would do so. Thus, this 
proposed rule is not expected to impose direct burdens on small 
entities, as defined in the RFA. In the event that the Department does 
not announce that it has commenced an Assessment or Review, there may 
be some burden on small entities associated with requesting that the 
Department perform an Assessment or Review. The Department assumes that 
regulated entities would already be familiar with any regulations that 
they would not want to expire, and thus the burden associated with the 
request to perform an Assessment or Review would be minimal. The 
Department seeks comment on this assumption. Any other burdens on small 
entities would result from future actions independent of this proposed 
rule (i.e. the determination that a regulation should be amended or 
rescinded based on the RFA review criteria and other legal 
considerations).
    The indirect costs and benefits from this proposed rule cannot be 
fully determined until the Department performs the Reviews of its 
Regulations and determines their present-day impacts. However, the 
Department believes that the benefits to small entities from this 
proposed rule will outweigh its costs to them. When the Department 
first promulgates regulations, it often has to speculate about the 
economic impact of the regulations on small entities. After a 
regulation has been in place for years, however, the Department will be 
able to learn from the real-world impacts of its regulations and 
minimize any significant economic impact of the regulations on a 
substantial number of small entities and promote simplification. To the 
extent this proposed rule resulted in amendment or rescission of a 
Regulation, the Department would be doing so to minimize any 
significant economic impact upon a substantial number of small 
entities. Moreover, the Department anticipates that any amendment or 
rescission undertaken by the Department in response to the reviews 
would be conducted in a manner that complies with the RFA. For the same 
reasons, this proposed rule would minimize any significant economic 
impact on a substantial number of small rural hospitals.
    The Department recognizes that there is a risk that small entities 
could be adversely impacted if a Regulation that has a positive 
economic impact on small entities expires because the Department failed 
to Review it. But the Department believes that risk is low, 
particularly since members of the public will remind the Department if 
the Review deadline is nearing and the Department has not commenced the 
Review of a Regulation that the public believes is important or 
beneficial.\144\ Even if a Regulation with

[[Page 70118]]

a positive economic impact on small entities somehow expired because 
the Department did not Review it, the Department believes such costs 
are far outweighed by the benefits achieved by periodically Reviewing 
Regulations and amending or rescinding those determined to no longer be 
appropriate based on current data and information. In addition, both 
the hearings that spurred passage of the RFA and subsequent data 
suggest that regulations tend to disproportionately burden small 
entities.\145\ To the extent this is the case, any rescission could 
very well benefit small entities. Moreover, the opportunity for small 
entities to comment on Regulations during the Review process will 
enable the Department to better assess the economic impacts of its 
Regulations on small entities and minimize any significant economic 
impacts that its Regulations are having upon a substantial number of 
small entities. The Department realizes that this proposed rule, if 
finalized, could result in some uncertainty for small entities in that 
there is a possibility that a regulation could expire. However, small 
entities will be on notice that a regulation could expire if the Review 
deadline is nearing and the Department has not announced that it has 
commenced the Review of the regulation. Moreover, there is always some 
risk that any particular regulation could be rescinded.
---------------------------------------------------------------------------

    \144\ While the Department does not anticipate that every small 
entity will closely monitor the Department-managed website, the 
Department believes that for Regulations that have a truly 
significant impact on small entities, at least one affected small 
entity, or small entity trade association(s), would.
    \145\ See, e.g., Regulatory Reform: Hearings on S. 104, S. 262, 
S. 755, S. 1291 Before the Subcomm. on Admin. Practice & Procedure 
of the Comm. on the Judiciary, 96th Cong. 3-4 (1979) (statement of 
Peter J. Petkas, Director, The Regulatory Council) (describing the 
disproportionate impact on small businesses and uncertainty about 
benefits resulting from burdensome regulations); 142 Cong. Rec. 3881 
(1996) (statement of Sen. Bond) (``The SBA chief counsel for 
advocacy released a report that said that small businesses bear a 
disproportionate share of the regulatory burden.''); Nicole V. Crain 
& W. Mark Crain, The Impact of Regulatory Costs on Small Firms, 
(U.S. Small Bus. Admin., Office of Advocacy, Washington, DC), at 55, 
57 (2010) (finding that ``regulations cost small firms an estimated 
$10,585 per employee. Regulations cost medium-sized firms $7,454 per 
employee, and large firms $7,755 per employee,'' and that in the 
health care sector, the cost per employee is 45 percent higher in 
small firms than in medium-sized firms, and 28 percent higher in 
small firms than in large firms).
---------------------------------------------------------------------------

    Therefore, the Department believes the benefits from the widespread 
retrospective reviews to minimize the substantial economic impact upon 
a significant number of small entities that would result from this 
proposed rule would far outweigh the costs from any uncertainty 
resulting from this proposed rule. Small entities may incur additional 
costs if the regulatory environment turns out to be different than 
anticipated.
    As a result, the Department has determined, and the Secretary 
certifies, that this proposed rule will not have a significant impact 
on the operations of a substantial number of small entities.
    The Department seeks comment on this analysis of the impact of the 
proposed rule on small entities and small rural hospitals, and the 
assumptions that underlie this analysis.

Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded 
Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a 
budgetary impact statement before promulgating a rule that includes any 
Federal mandate that may result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of $100 
million in 1995 dollars, updated annually for inflation. Currently, 
that threshold is approximately $154 million. If a budgetary impact 
statement is required, section 205 of the Unfunded Mandates Act also 
requires covered agencies to identify and consider a reasonable number 
of regulatory alternatives before promulgating a rule. The Department 
has preliminarily determined that this proposed rule is not expected to 
result in expenditures by State, local, and tribal governments, or by 
the private sector, of $154 million or more in any one year. The 
Department seeks comment on this determination. This proposed rule 
would establish a requirement for the Department to periodically assess 
and, in some cases, review its regulations. Accordingly, the Department 
has not prepared a budgetary impact statement. The Department has 
nonetheless in this proposed rule addressed regulatory alternatives 
that it considered.

National Environmental Policy Act (NEPA)

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

Executive Order 12988: Civil Justice Reform

    HHS has reviewed this rule under Executive Order 12988 on Civil 
Justice Reform and has determined that this proposed rule complies with 
this Executive Order.

Executive Order 13132: Federalism

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct costs on State and local governments or has federalism 
implications. The Department has determined that this proposed rule 
does not impose substantial direct costs on State and local governments 
or have federalism implications as defined in Executive Order 13132. 
The proposed rule requires the Department to periodically review 
certain of its regulations, and provides that if the regulations are 
not reviewed by a certain date, they will expire. Any rescission of a 
regulation would only occur because of acts independent of this 
proposed rule--either the findings of a Review determining a regulation 
should be amended, or a failure to perform an Assessment or Review. 
Thus, this proposed rule would impose no substantial direct costs on 
State and local governments.
    The Department notes, though, that the proposed rule might, if 
finalized, indirectly have beneficial federalism implications. Among 
other things, the Reviews called for by this proposed rule require the 
Department to determine if its regulations overlap, duplicate or 
conflict with State and local government rules and, if so, to consider 
that when determining whether to amend or rescind the regulations. If a 
Review conducted pursuant to this proposed rule were to find that a 
Department regulation should be amended or rescinded, the Department 
would comply with Executive Order 13132 in amending or rescinding the 
regulation.
    The Department requests comment on this analysis.

Plain Writing Act of 2010

    Under the Plain Writing Act of 2010 (Pub. L. 111-274, October 13, 
2010), executive departments and agencies are required to use plain 
language in documents that explain to the public how to comply with a 
requirement the federal government administers or enforces. The 
Department has attempted to use plain language in promulgating this 
proposed rule, consistent with the Federal Plain Writing Act 
guidelines.

Assessment of Federal Regulation and Policies on Families

    Section 654 of the Treasury and General Government Appropriations 
Act of 1999, Public Law 105-277, sec. 654, 112 Stat. 2681 (1998) 
requires Federal departments and agencies to determine whether a policy 
or regulation could affect family well-being. Section 601 (note) 
required agencies to assess whether a regulatory action (1) impacted 
the stability or safety of the family, particularly in

[[Page 70119]]

terms of marital commitment; (2) impacted the authority of parents in 
the education, nurturing, and supervision of their children; (3) helped 
the family perform its functions; (4) affected disposable income or 
poverty of families and children; (5) was justified if it financially 
impacted families; (6) was carried out by State or local government or 
by the family; and (7) established a policy concerning the relationship 
between the behavior and personal responsibility of youth and the norms 
of society.
    This proposed rule would amend Department Regulations to add dates 
by which they would expire unless the Department periodically reviews 
the Regulations using certain criteria. Standing alone, absent the 
failure to perform a Review, this proposed rule would have no direct 
impact, other than resulting in the Department amending or rescinding 
Regulations that it determines do not satisfy the Review criteria.
    If the family well-being determination requirement were still in 
force, the Department assumes that the benefits to the public, 
including families, that flow from periodic Reviews of Regulations far 
outweigh any potential adverse impact on family well-being that might 
result from a Regulation expiring because the Department did not Review 
it. The Department believes that impacted families benefit greatly when 
a regulatory body considers the real-world impacts of its regulations, 
and whether changes in technology, the economy, or the legal landscape 
counsel in favor of amending or rescinding regulations. It is 
conceivable that a Regulation affecting the disposable income or 
poverty of families or children could expire. It is also possible that 
the expiration of a Regulation that the Department does not Review 
could have beneficial impacts on family well-being.

Paperwork Reduction Act of 1995

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3506; 5 CFR 1320 Appendix A.1), HHS has reviewed this proposed rule and 
has determined that there are no new collections of information 
contained therein.

List of Subjects

21 CFR Part 6

    Administrative practice and procedure.

42 CFR Part 1

    Administrative practice and procedure.

42 CFR Part 404

    Administrative practice and procedure.

45 CFR Part 6

    Administrative practice and procedure.

    For the reasons set forth in the preamble, the Department amends 21 
CFR, chapter I, 42 CFR chapters I and IV and 45 CFR subtitle A as 
follows:

Title 21--Food and Drugs

0
1. Add 21 CFR part 6 to read as follows:

PART 6--REVIEW OF REGULATIONS

Sec.
1.1 Retrospective Review of Existing Regulations.
1.2 through 1.5 [Reserved]

    Authority:  5 U.S.C. 301; 15 U.S.C. 402, 409, 1261-1276, 1333, 
1451-1461, 4402; 18 U.S.C. 1905; 19 U.S.C. 1490-1491, 2531-2582; 21 
U.S.C. 321-394, 679, 802, 811-812, 821-831, 842, 875, 877, 951-958, 
965, 971, 1034; 28 U.S.C. 2112; 35 U.S.C. 156; 42 U.S.C. 201-263, 
263a, 263b-264, 265, 300aa-28, 300u through 300u-5, 300aa-1, 300aa-
28, 4321, 7671 et seq.; Pub. L. 113-54; Pub. L. 111-353, 124 Stat. 
3885, 3889; Pub. L. 111-31, 123 Stat. 1776; Pub. L. 108-155; Pub. L. 
107-188, 116 Stat. 594, 688-690; Pub. L. 107-109; Pub. L. 105-115, 
111 Stat. 2322, 5 U.S.C. 610.


Sec.  6.1  Retrospective review of existing regulations.

    (a) This section applies to and amends all Regulations issued by 
the Secretary or his delegates or sub-delegates in this title.
    (b) For purposes of this section:
    (1) ``Assess'' shall refer to a determination by the Department, in 
consultation with other Federal agencies as appropriate, as to whether 
the Regulations issued as part of the same rulemaking (and any 
amendments or additions that may have been added thereafter) currently 
have a significant economic impact upon a substantial number of small 
entities.
    (2) ``Review'' shall refer to a process conducted by the 
Department, in consultation with other Federal agencies as appropriate, 
the purpose of which shall be to determine whether Regulations that 
were issued as part of the same rulemaking (and any amendments or 
additions that may have been issued thereafter) should be continued 
without change, or should be amended or rescinded, consistent with the 
stated objectives of applicable statutes, to minimize any significant 
economic impact of the Regulations upon a substantial number of small 
entities.
    (3) ``Regulation'' shall mean a section of the Code of Federal 
Regulations. For example, 42 CFR 2.13 is a Regulation, and 42 CFR 2.14 
is another Regulation.
    (4) ``Year of the Regulation's promulgation'' shall mean the year 
the Regulation first became effective, irrespective of whether it was 
subsequently amended.
    (5) ``Significant economic impact upon a substantial number of 
small entities'' shall have the meaning ascribed to that term in the 
Regulatory Flexibility Act, Public Law 96-354, 94 Stat. 1164 (Sept. 19, 
1980) (as amended 1996).
    (c)(1) Unless a Regulation contains an earlier expiration date or 
is rescinded earlier, all Regulations issued by the Secretary or his 
delegates or sub-delegates in this title shall expire at the end of:
    (i) Two calendar years after the year that this section first 
becomes effective;
    (ii) Ten calendar years after the year of the Regulation's 
promulgation; or
    (iii) Ten calendar years after the last year in which the 
Department assessed and (if review of the Regulation is required 
pursuant to paragraph (d)) reviewed the Regulation, whichever is 
latest.
    (2) The last year in which the Department assessed and (if review 
of the Regulation is required) reviewed the Regulation shall be the 
year during which the findings of the assessment and (if required) the 
review of a Regulation are published in the Federal Register pursuant 
to paragraph (f) of this section.
    (d) The Department is required to review those Regulations that the 
Department Assesses have a significant economic impact upon a 
substantial number of small entities. In reviewing Regulations to 
minimize any significant economic impact of the Regulation on a 
substantial number of small entities in a manner consistent with the 
stated objectives of applicable statutes, the Department's Review shall 
consider the following factors--
    (1) The continued need for the Regulation, consideration of which 
shall include but not be limited to the extent to which the Regulation 
defines terms or sets standards used in or otherwise applicable to 
other Federal rules;
    (2) The nature of complaints or comments received concerning the 
Regulation from the public;
    (3) The complexity of the Regulation;
    (4) The extent to which the Regulation overlaps, duplicates or 
conflicts with other Federal rules, and, to the extent feasible, with 
State and local governmental rules;

[[Page 70120]]

    (5) The degree to which technology, economic conditions, or other 
factors have changed in the area affected by the Regulation since the 
Regulation was promulgated or the last time the Regulation was reviewed 
by the Department;
    (6) Whether the Regulation complies with applicable law; and
    (7) Other considerations as required by relevant executive orders 
and laws.
    (e) If the review concludes the Regulation should be amended or 
rescinded, the Department shall have two years from the date that the 
findings of the review are published in the Federal Register pursuant 
to paragraph (f) to amend or rescind the Regulation. If the Secretary 
determines that completion of the amendment or rescission is not 
feasible by the established date, he shall so certify in a statement 
published in the Federal Register and may extend the completion date by 
one year at a time for a total of not more than five years.
    (f) The results of all assessments and eviews conducted in a 
calendar year, including the full underlying analyses and data used to 
support the results (subject to any applicable privilege, protections 
for confidential business information, or explicit legal prohibition on 
disclosure), shall be published in a single document in the Federal 
Register during that calendar year. The document shall be organized in 
a manner that enables both the Department and the public to readily 
determine which assessments and reviews were conducted during that 
calendar year. The document shall also specify the year by which the 
next assessment (and, if required, the next review) of the Regulation 
shall be completed.
    (g) Paragraph (c) of this section shall not apply to
    (1) Regulations that are prescribed by Federal law, such that the 
Department exercises no discretion as to whether to promulgate the 
Regulation and as to what is prescribed by the Regulation. For 
Regulations described in this paragraph (g)(1) that are adopted after 
the effective date of this section, the Federal law described in this 
paragraph (g)(1) shall be cited in the notice of adoption.
    (2) Regulations whose expiration pursuant to this section would 
violate any other Federal law.
    (3) This section.
    (4) Regulations that involve a military or foreign affairs function 
of the United States.
    (5) Regulations addressed solely to internal agency management or 
personnel matters.
    (6) Regulations related solely to Federal Government procurement.
    (7) Regulations that were issued jointly with other Federal 
agencies, or that were issued in consultation with other agencies 
because of a legal requirement to consult with that other agency.
    (h) When the Department commences the process of performing an 
assessment or review, it shall state on a Department-managed website 
the Regulation(s) whose assessment or review it is commencing. The 
public will be able to submit comments regarding the Regulation(s) in 
the manner specified on this website. The public can also submit 
comments in the manner specified on the website requesting that the 
Department assess or review a Regulation.
    (i) Any provision of this section held to be invalid or 
unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give the maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this section and shall not affect the 
remainder thereof or the application of the provision to persons not 
similarly situated or to dissimilar circumstances.


Sec. Sec.  6.2 through 6.5   [Reserved].

Title 42--Public Health

0
2. Add 42 CFR part 1 to read as follows:

PART 1--REVIEW OF REGULATIONS

Sec.
1.1 Retrospective Review of Existing Regulations
1.2 through 1.5 [Reserved]

    Authority:  5 U.S.C. 301, 42 U.S.C. 216, 42 U.S.C. 300a-4, 42 
U.S.C. 10801, 42 U.S.C. 1302, 42 U.S.C. 702(a), 42 U.S.C. 
702(b)(1)(A), 42 U.S.C. 706(a)(3), 42 U.S.C. 247b, 247c, 31 U.S.C. 
1243 note, 42 U.S.C. 254c, 42 U.S.C. 262a, 42 U.S.C. 264-271, 42 
U.S.C. 290aa(m), 42 U.S.C. 284g, 42 U.S.C. 285a-6(c)(1)(E), 42 
U.S.C. 285a-7(c)(1)(G), 42 U.S.C. 285b-4, 42 U.S.C. 285c-5, 42 
U.S.C. 285c-8, 42 U.S.C. 285d-6, 42 U.S.C. 285e-2, 42 U.S.C. 285e-3, 
42 U.S.C. 285e-10a, 42 U.S.C. 285f-1, 42 U.S.C. 285g-5, 42 U.S.C. 
285g-7, 42 U.S.C. 285g-9, 42 U.S.C. 285m-3, 42 U.S.C. 285o-2, 42 
U.S.C. 286a-7(c)(1)(G), 42 U.S.C. 287c-32(c), 42 U.S.C. 288, 42 
U.S.C. 300cc-16, 42 U.S.C. 1302, 5 U.S.C. 610.


Sec.  1.1   Retrospective review of existing regulations.

    (a) This section applies to and amends all Regulations issued by 
the Secretary or his delegates or sub-delegates in this title (other 
than those Regulations in parts 400-429 and parts 475-499).
    (b) For purposes of this section,
    (1) ``Assess'' shall refer to a determination by the Department, in 
consultation with other Federal agencies as appropriate, as to whether 
the Regulations issued as part of the same rulemaking (and any 
amendments or additions that may have been added thereafter) currently 
have a significant economic impact upon a substantial number of small 
entities.
    (2) ``Review'' shall refer to a process conducted by the 
Department, in consultation with other Federal agencies as appropriate, 
the purpose of which shall be to determine whether Regulations that 
were issued as part of the same rulemaking (and any amendments or 
additions that may have been issued thereafter) should be continued 
without change, or should be amended or rescinded, consistent with the 
stated objectives of applicable statutes, to minimize any significant 
economic impact of the Regulations upon a substantial number of small 
entities.
    (3) ``Regulation'' shall mean a section of the Code of Federal 
Regulations. For example, 42 CFR 2.13 is a Regulation, and 42 CFR 2.14 
is another Regulation.
    (4) ``Year of the Regulation's promulgation'' shall mean the year 
the Regulation first became effective, irrespective of whether it was 
subsequently amended.
    (5) ``Significant economic impact upon a substantial number of 
small entities'' shall have the meaning ascribed to that term in the 
Regulatory Flexibility Act, Public Law 96-354, 94 Stat. 1164 (Sept. 19, 
1980) (as amended 1996).
    (c)(1) Unless a Regulation contains an earlier expiration date or 
is rescinded earlier, all Regulations issued by the Secretary or his 
delegates or sub-delegates in this title (other than those Regulations 
in parts 400-429 and parts 475-499) shall expire at the end of:
    (i) Two calendar years after the year that this section first 
becomes effective;
    (ii) Ten calendar years after the year of the Regulation's 
promulgation; or
    (iii) Ten calendar years after the last year in which the 
Department assessed and (if review of the Regulation is required 
pursuant to paragraph (d)) reviewed the Regulation, whichever is 
latest.
    (2) The last year in which the Department Assessed and (if review 
of the Regulation is required) reviewed the Regulation shall be the 
year during which the findings of the assessment and (if required) the 
review of a Regulation are published in the Federal Register pursuant 
to paragraph (f) of this section.

[[Page 70121]]

    (d) The Department is required to review those Regulations that the 
Department assesses have a significant economic impact upon a 
substantial number of small entities. In reviewing Regulations to 
minimize any significant economic impact of the Regulation on a 
substantial number of small entities in a manner consistent with the 
stated objectives of applicable statutes, the Department's review shall 
consider the following factors--
    (1) The continued need for the Regulation, consideration of which 
shall include but not be limited to the extent to which the Regulation 
defines terms or sets standards used in or otherwise applicable to 
other Federal rules;
    (2) The nature of complaints or comments received concerning the 
Regulation from the public;
    (3) The complexity of the Regulation;
    (4) The extent to which the Regulation overlaps, duplicates or 
conflicts with other Federal rules, and, to the extent feasible, with 
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other 
factors have changed in the area affected by the Regulation since the 
Regulation was promulgated or the last time the Regulation was reviewed 
by the Department;
    (6) Whether the Regulation complies with applicable law; and
    (7) Other considerations as required by relevant executive orders 
and laws.
    (e) If the review concludes the Regulation should be amended or 
rescinded, the Department shall have two years from the date that the 
findings of the review are published in the Federal Register pursuant 
to paragraph (f) to amend or rescind the Regulation. If the Secretary 
determines that completion of the amendment or rescission is not 
feasible by the established date, he shall so certify in a statement 
published in the Federal Register and may extend the completion date by 
one year at a time for a total of not more than five years.
    (f) The results of all assessments and reviews conducted in a 
calendar year, including the full underlying analyses and data used to 
support the results (subject to any applicable privilege, protections 
for confidential business information, or explicit legal prohibition on 
disclosure), shall be published in a single document in the Federal 
Register during that calendar year. The document shall be organized in 
a manner that enables both the Department and the public to readily 
determine which assessments and reviews were conducted during that 
calendar year. The document shall also specify the year by which the 
next assessment (and, if required, the next Review) of the Regulation 
shall be completed.
    (g) Paragraph (c) of this section shall not apply to
    (1) Regulations that are prescribed by Federal law, such that the 
Department exercises no discretion as to whether to promulgate the 
Regulation and as to what is prescribed by the Regulation. For 
Regulations described in this paragraph (g)(1) that are adopted after 
the effective date of this section, the Federal law described in this 
paragraph (g)(1) shall be cited in the notice of adoption.
    (2) Regulations whose expiration pursuant to this section would 
violate any other Federal law.
    (3) This section.
    (4) Regulations that involve a military or foreign affairs function 
of the United States.
    (5) Regulations addressed solely to internal agency management or 
personnel matters.
    (6) Regulations related solely to Federal Government procurement.
    (7) Regulations that were issued jointly with other Federal 
agencies, or that were issued in consultation with other agencies 
because of a legal requirement to consult with that other agency.
    (8) 42 CFR part 73.
    (9) 42 CFR 1001.952.
    (10) 42 CFR 100.3.
    (h) When the Department commences the process of performing an 
assessment or review, it shall state on a Department-managed website 
the Regulation(s) whose assessment or review it is commencing. The 
public will be able to submit comments regarding the Regulation(s) in 
the manner specified on this website. The public can also submit 
comments in the manner specified on the website requesting that the 
Department assess or review a Regulation.
    (i) Any provision of this section held to be invalid or 
unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give the maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this section and shall not affect the 
remainder thereof or the application of the provision to persons not 
similarly situated or to dissimilar circumstances.


Sec. Sec.  1.2 through 1.5  [Reserved].

0
3. Add 42 CFR part 404 to read as follows:

PART 404--REVIEW OF REGULATIONS

Sec.
404.1 Retrospective Review of Existing Regulations
404.2 through 404.5 [Reserved]

    Authority:  5 U.S.C. 301, 42 U.S.C. 216, 42 U.S.C. 300a-4, 42 
U.S.C. 10801, 42 U.S.C. 1302, 42 U.S.C. 702(a), 42 U.S.C. 
702(b)(1)(A), 42 U.S.C. 706(a)(3), 42 U.S.C. 247b, 247c, 31 U.S.C. 
1243 note, 42 U.S.C. 254c, 42 U.S.C. 262a, 42 U.S.C. 264-271, 42 
U.S.C. 290aa(m), 42 U.S.C. 284g, 42 U.S.C. 285a-6(c)(1)(E), 42 
U.S.C. 285a-7(c)(1)(G), 42 U.S.C. 285b-4, 42 U.S.C. 285c-5, 42 
U.S.C. 285c-8, 42 U.S.C. 285d-6, 42 U.S.C. 285e-2, 42 U.S.C. 285e-3, 
42 U.S.C. 285e-10a, 42 U.S.C. 285f-1, 42 U.S.C. 285g-5, 42 U.S.C. 
285g-7, 42 U.S.C. 285g-9, 42 U.S.C. 285m-3, 42 U.S.C. 285o-2, 42 
U.S.C. 286a-7(c)(1)(G), 42 U.S.C. 287c-32(c), 42 U.S.C. 288, 42 
U.S.C. 300cc-16, 42 U.S.C. 1302, 42 U.S.C. 1395hh, 5 U.S.C. 610.


Sec.  404.1  Retrospective review of existing regulations.

    (a) This section applies to and amends all Regulations issued by 
the Secretary or his delegates or sub-delegates in parts 400-429 and 
parts 475-499 of this title.
    (b) For purposes of this section,
    (1) ``Assess'' shall refer to a determination by the Department, in 
consultation with other Federal agencies as appropriate, as to whether 
the Regulations issued as part of the same rulemaking (and any 
amendments or additions that may have been added thereafter) currently 
have a significant economic impact upon a substantial number of small 
entities.
    (2) ``Review'' shall refer to a process conducted by the 
Department, in consultation with other Federal agencies as appropriate, 
the purpose of which shall be to determine whether Regulations that 
were issued as part of the same rulemaking (and any amendments or 
additions that may have been issued thereafter) should be continued 
without change, or should be amended or rescinded, consistent with the 
stated objectives of applicable statutes, to minimize any significant 
economic impact of the Regulations upon a substantial number of small 
entities.
    (3) ``Regulation'' shall mean a section of the Code of Federal 
Regulations. For example, 42 CFR 2.13 is a Regulation, and 42 CFR 2.14 
is another Regulation.
    (4) ``Year of the Regulation's promulgation'' shall mean the year 
the Regulation first became effective, irrespective of whether it was 
subsequently amended.
    (5) ``Significant economic impact upon a substantial number of 
small entities'' shall have the meaning ascribed to that term in the 
Regulatory

[[Page 70122]]

Flexibility Act, Public Law 96-354, 94 Stat. 1164 (Sept. 19, 1980) (as 
amended 1996).
    (c)(1) Unless a Regulation contains an earlier expiration date or 
is rescinded earlier, all Regulations issued by the Secretary or his 
delegates or sub-delegates in parts 400-429 and parts 475-499 of this 
title shall expire at the end of:
    (i) Two calendar years after the year that this section first 
becomes effective;
    (ii) Ten calendar years after the year of the Regulation's 
promulgation; or
    (3) Ten calendar years after the last year in which the Department 
assessed and (if review of the Regulation is required pursuant to 
paragraph (d)) reviewed the Regulation, whichever is latest.
    (2) The last year in which the Department assessed and (if review 
of the Regulation is required) reviewed the Regulation shall be the 
year during which the findings of the assessment and (if required) the 
review of a Regulation are published in the Federal Register pursuant 
to paragraph (f) of this section.
    (d) The Department is required to review those Regulations that the 
Department assesses have a significant economic impact upon a 
substantial number of small entities. In reviewing Regulations to 
minimize any significant economic impact of the Regulation on a 
substantial number of small entities in a manner consistent with the 
stated objectives of applicable statutes, the Department's review shall 
consider the following factors--
    (1) The continued need for the Regulation, consideration of which 
shall include but not be limited to the extent to which the Regulation 
defines terms or sets standards used in or otherwise applicable to 
other Federal rules;
    (2) The nature of complaints or comments received concerning the 
Regulation from the public;
    (3) The complexity of the Regulation;
    (4) The extent to which the Regulation overlaps, duplicates or 
conflicts with other Federal rules, and, to the extent feasible, with 
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other 
factors have changed in the area affected by the Regulation since the 
Regulation was promulgated or the last time the Regulation was Reviewed 
by the Department;
    (6) Whether the Regulation complies with applicable law; and
    (7) Other considerations as required by relevant executive orders 
and laws.
    (e) If the review concludes the Regulation should be amended or 
rescinded, the Department shall have two years from the date that the 
findings of the review are published in the Federal Register pursuant 
to paragraph (f) to amend or rescind the Regulation. If the Secretary 
determines that completion of the amendment or rescission is not 
feasible by the established date, he shall so certify in a statement 
published in the Federal Register and may extend the completion date by 
one year at a time for a total of not more than five years.
    (f) The results of all assessments and reviews conducted in a 
calendar year, including the full underlying analyses and data used to 
support the results (subject to any applicable privilege, protections 
for confidential business information, or explicit legal prohibition on 
disclosure), shall be published in a single document in the Federal 
Register during that calendar year. The document shall be organized in 
a manner that enables both the Department and the public to readily 
determine which assessments and reviews were conducted during that 
calendar year. The document shall also specify the year by which the 
next assessment (and, if required, the next review) of the Regulation 
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:
    (1) Regulations that are prescribed by Federal law, such that the 
Department exercises no discretion as to whether to promulgate the 
Regulation and as to what is prescribed by the Regulation. For 
Regulations described in this paragraph (g)(1) that are adopted after 
the effective date of this section, the Federal law described in this 
paragraph (g)(1) shall be cited in the notice of adoption.
    (2) Regulations whose expiration pursuant to this section would 
violate any other Federal law.
    (3) This section.
    (4) Regulations that involve a military or foreign affairs function 
of the United States.
    (5) Regulations addressed solely to internal agency management or 
personnel matters.
    (6) Regulations related solely to Federal Government procurement.
    (7) Regulations that were issued jointly with other Federal 
agencies, or that were issued in consultation with other agencies 
because of a legal requirement to consult with that other agency.
    (8) The annual Medicare Part A and Part B payment methodology 
update rules.
    (h) When the Department commences the process of performing an 
assessment or review, it shall state on a Department-managed website 
the Regulation(s) whose assessment or review it is commencing. The 
public will be able to submit comments regarding the Regulation(s) in 
the manner specified on this website. The public can also submit 
comments in the manner specified on the website requesting that the 
Department assess or review a Regulation.
    (i) Any provision of this section held to be invalid or 
unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give the maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this section and shall not affect the 
remainder thereof or the application of the provision to persons not 
similarly situated or to dissimilar circumstances.


Sec. Sec.  404.2 through 404.5   [Reserved].

Title 45--Public Welfare

0
4. Add 45 CFR part 6 to read as follows:

PART 6--REVIEW OF REGULATIONS

Sec.
6.1 Retrospective Review of Existing Regulations
6.2 through 6.5 [Reserved]

    Authority:  5 U.S.C. 301, 504, 552, 552a, 552b, 553, 3401-3408, 
5514, 7301; 5 U.S.C. App. 1, App. 8G(a)(2); 6 U.S.C. 279; 8 U.S.C. 
1103(a)(3), 1182, 1232, 1255a, 1522 and note; 10 U.S.C. 4594; 16 
U.S.C. 2401 et seq.; 18 U.S.C. 207, 506, 701, 1017, 1905; 20 U.S.C. 
91, 959, 971-977, 1405, 1501 et seq., 1681-1688, 2001-2012, 4501 et 
seq.; 21 U.S.C. 853a, 1174; 21 U.S.C. 853a, 1174; 22 U.S.C. 
1621(a)(2), 1622, 2151b(f), 2451 et seq., 7631; 24 U.S.C. 321-329; 
25 U.S.C. 1603(12), 1621e; 28 U.S.C. 1746, 2461 and note, 2672; 29 
U.S.C. 669(a)(5), 709, 791 et seq., 2996e(d)(5), 3343; 31 U.S.C. 
200-212, 1243 note, 1352, 3701-3720A, 3720D, 3721, 3801-3812, 6505-
6506, 7501-7507, 9701; 35 U.S.C. 200-212; 36 U.S.C. 124; 39 U.S.C. 
3220; 40 U.S.C. 72, 104, 106, 121, 318-318d, 484, 486, 1001; 41 
U.S.C. 701 et seq.; 42 U.S.C. 216, 217b, 238n, 263a(f)(1)(E), 280g-
1(d), 289(a), 289b-1, 290bb-36(f), 290dd-2, 299c-4, 300a-7, 300v-
1(b), 300w et seq., 300x et seq., 300y et seq., 300aa-11, 300gg 
through 300gg-63, 300gg-91, 300gg-92, 300gg-94, 300jj-11, 300jj-14, 
300jj-52, 303, 601 and note, 602 and note, 603, 604, 605, 606, 607, 
608, 608, 609, 610, 611, 612, 613(i), 616, 618, 619, 620 et seq., 
651 through 658, 658a, 659a, 660, 663, 664, 666 through 669A, 670 et 
seq., 701 et seq., 862a, 1202, 1203, 1301, 1301, 1302, 1302, 1306, 
1308, 1308, 1310, 1313, 1315, 1315a, 1316, 1320a-1, 1320a-7e, 1320c-
11, 1320d through 1320d-9, 1337, 1352, 1353, 1382 note, 1383 note, 
1395b-4, 1395cc(f), 1395i-3, 1395i-5, 1395w-22(j)(3)(B), 1395w-26, 
1395w-27, 1395x, 1396a, 1396b, 1396f,

[[Page 70123]]

1396k, 1396r, 1396r-2, 1396s(c)(2)(B)(ii), 1396u-2(b)(3)(B), 1397 et 
seq., 1397j-1(b), 1870, 1871, 1973gg-5, 1975, 1975a, 1975b, 2000d to 
2000d-7, 2991 et seq., 2996(5), 2996(b)(2), 2996c(g), 2996d(b)(2), 
2996e, 2996f, 2996g, 3001 et seq., 3121, 3334, 3505, 3515e, 3535(d), 
4950 et seq., 4321, 4371 et seq., 4601 note, 4633, 4950 et seq., 
4951 et seq., 5024, 5043, 5044(a), 5052, 5057, 5059, 5060, 5065, 
5106i(a), 5701, 6101-6107, 7609, 8621 et seq., 9801 et seq., 9858, 
9901 et seq., 10401 et seq., 11101-11152, 11302, 11411, 11461-11464, 
11472, 12501 et seq., 12521-12529, 12541-12547, 12561, 12571-12595, 
12601-12606, 12631-12638, 12645g, 12651b through 12651d, 12653, 
12653o, 12657, 14406, 15001 et seq., 15607(d), 18021-18024, 18031-
18032, 18041-18042, 18044, 18051, 18054, 18061, 18063, 18071, 18081-
18083, 18113, 18116; 44 U.S.C. 2104(a); 48 U.S.C. 1469a; 49 U.S.C. 
794; 50 U.S.C. App. 2001, App. 2061-2171; Pub. L. 115-245, div. B, 
secs. 209, 507(d), 132 Stat. 2981; Pub. L. 114-328, sec. 1705(a)(2), 
130 Stat. 2644; Pub. L. 114-74, sec. 701, 129 Stat. 584; Pub. L. 
112-96, sec. 4004, 126 Stat. 197; Pub. L. 111-5, secs. 13400-13424, 
123 Stat. at 258-279; Pub. L. 111-148, secs. 1019, 1104, 1311, 1312, 
1334, 1411, 1412, 124 Stat. 119; Pub. L. 111-13, sec. 1612, 123 
Stat. 1459; Pub. L. 109-171, sec. 7102, 120 Stat. 135; Pub. L. 105-
277, 112 Stat. 2681; Pub. L. 105-119, tit. V, secs. 501(b) and (c), 
502, 503, 504, and 505, 111 Stat. 2440, 2510-12; Pub. L. 104-208, 
110 Stat. 3009; Pub. L. 104-134, tit. V, secs. 503(f), 504, 509(c), 
110 Stat. 1321, 1321-53, 1321-59; Pub. L. 102-325, sec. 471(a), 106 
Stat. 606; Pub. L. 101-426, sec. 6(h)(2), 104 Stat. 925; Pub. L. 
101-410, 104 Stat. 890; Pub. L. 101-392, sec. 501(c), 104 Stat. 831; 
Pub. L. 101-239, sec. 10405, 103 Stat. 2489; Pub. L. 101-201, sec. 
1(a), 103 Stat. 1795; Pub. L. 101-121, 103 Stat. 701; Pub. L. 100-
707, sec. 105(i), 102 Stat. 4693; Pub. L. 100-383, secs. 105(f) and 
206(d), 102 Stat. at 908, 914; Pub. L. 100-259, 102 Stat. 28; Pub. 
L. 100-241, sec. 15, 101 Stat. 1812; Pub. L. 100-77, sec. 501, 101 
Stat. 509-10; Pub. L. 99-603, 100 Stat. 3359; Pub. L. 99-514, sec. 
1883, 100 Stat. 2916; Pub. L. 98-64, sec. 2, 97 Stat. 365; Pub. L. 
97-458, sec. 4, 96 Stat. 2513; Pub. L. 97-248, 96 Stat. 324; Pub. L. 
95-437, 92 Stat. 1055; Pub. L. 94-114, sec. 6, 89 Stat. 579; Pub. L. 
93-579, 88 Stat. 1896; Pub. L. 93-113, secs. 402(14), 417, 420, 87 
Stat. 398, 407, and 414; Pub. L. 93-113, 87 Stat. 394; Pub. L. 89-
506, sec. 1(a), 80 Stat. 306; Pub. L. 87-293, sec. 5(a), 75 Stat. 
613; Pub. L. 86-571, secs. 1-11, 74 Stat. 308-310; Pub. L. 81-808, 
64 Stat. 903; Pub. L. 81-152, sec. 203, 63 Stat. 377, 385; 
Reorganization Plan No. 1 of 1953, secs. 1, 5, 6, and 7, 67 Stat. 
631; 5 U.S.C. 610.


Sec.  6.1  Retrospective Review of Existing Regulations.

    (a) This section applies to and amends all Regulations issued by 
the Secretary or his delegates or sub-delegates in this title.
    (b) For purposes of this section,
    (1) ``Assess'' shall refer to a determination by the Department, in 
consultation with other Federal agencies as appropriate, as to whether 
the Regulations issued as part of the same rulemaking (and any 
amendments or additions that may have been added thereafter) currently 
have a significant economic impact upon a substantial number of small 
entities.
    (2) ``Review'' shall refer to a process conducted by the 
Department, in consultation with other Federal agencies as appropriate, 
the purpose of which shall be to determine whether Regulations that 
were issued as part of the same rulemaking (and any amendments or 
additions that may have been issued thereafter) should be continued 
without change, or should be amended or rescinded, consistent with the 
stated objectives of applicable statutes, to minimize any significant 
economic impact of the Regulations upon a substantial number of small 
entities.
    (3) ``Regulation'' shall mean a section of the Code of Federal 
Regulations. For example, 42 CFR 2.13 is a Regulation, and 42 CFR 2.14 
is another Regulation.
    (4) ``Year of the Regulation's promulgation'' shall mean the year 
the Regulation first became effective, irrespective of whether it was 
subsequently amended.
    (5) ``Significant economic impact upon a substantial number of 
small entities'' shall have the meaning ascribed to that term in the 
Regulatory Flexibility Act, Public Law 96-354, 94 Stat. 1164 (Sept. 19, 
1980) (as amended 1996).
    (c)(1) Unless a Regulation contains an earlier expiration date or 
is rescinded earlier, all Regulations issued by the Secretary or his 
delegates or sub-delegates in this title shall expire at the end of:
    (i) Two calendar years after the year that this section first 
becomes effective;
    (ii) Ten calendar years after the year of the Regulation's 
promulgation, or
    (iii) Ten calendar years after the last year in which the 
Department assessed and (if review of the Regulation is required 
pursuant to paragraph (d)) reviewed the Regulation, whichever is 
latest.
    (2) The last year in which the Department assessed and (if review 
of the Regulation is required) reviewed the Regulation shall be the 
year during which the findings of the assessment and (if required) the 
review of a Regulation are published in the Federal Register pursuant 
to paragraph (f) of this section.
    (d) The Department is required to review those Regulations that the 
Department assesses have a significant economic impact upon a 
substantial number of small entities. In Reviewing Regulations to 
minimize any significant economic impact of the Regulation on a 
substantial number of small entities in a manner consistent with the 
stated objectives of applicable statutes, the Department's review shall 
consider the following factors--
    (1) The continued need for the Regulation, consideration of which 
shall include but not be limited to the extent to which the Regulation 
defines terms or sets standards used in or otherwise applicable to 
other Federal rules;
    (2) The nature of complaints or comments received concerning the 
Regulation from the public;
    (3) The complexity of the Regulation;
    (4) The extent to which the Regulation overlaps, duplicates or 
conflicts with other Federal rules, and, to the extent feasible, with 
State and local governmental rules;
    (5) The degree to which technology, economic conditions, or other 
factors have changed in the area affected by the Regulation since the 
Regulation was promulgated or the last time the Regulation was reviewed 
by the Department;
    (6) Whether the Regulation complies with applicable law; and
    (7) Other considerations as required by relevant executive orders 
and laws.
    (e) If the review concludes the Regulation should be amended or 
rescinded, the Department shall have two years from the date that the 
findings of the review are published in the Federal Register pursuant 
to paragraph (f) to amend or rescind the Regulation. If the Secretary 
determines that completion of the amendment or rescission is not 
feasible by the established date, he shall so certify in a statement 
published in the Federal Register and may extend the completion date by 
one year at a time for a total of not more than five years.
    (f) The results of all assessments and reviews conducted in a 
calendar year, including the full underlying analyses and data used to 
support the results (subject to any applicable privilege, protections 
for confidential business information, or explicit legal prohibition on 
disclosure), shall be published in a single document in the Federal 
Register during that calendar year. The document shall be organized in 
a manner that enables both the Department and the public to readily 
determine which assessments and reviews were conducted during that 
calendar year. The document shall also specify the year by which the 
next assessment (and, if required, the next review) of the Regulation 
shall be completed.
    (g) Paragraph (c) of this section shall not apply to:

[[Page 70124]]

    (1) Regulations that are prescribed by Federal law, such that the 
Department exercises no discretion as to whether to promulgate the 
Regulation and as to what is prescribed by the Regulation. For 
Regulations described in this paragraph (g)(1) that are adopted after 
the effective date of this section, the Federal law described in this 
paragraph (g)(1) shall be cited in the notice of adoption.
    (2) Regulations whose expiration pursuant to this section would 
violate any other Federal law.
    (3) This section.
    (4) Regulations that involve a military or foreign affairs function 
of the United States.
    (5) Regulations addressed solely to internal agency management or 
personnel matters.
    (6) Regulations related solely to Federal Government procurement.
    (7) Regulations that were issued jointly with other Federal 
agencies, or that were issued in consultation with other agencies 
because of a legal requirement to consult with that other agency.
    (h) When the Department commences the process of performing an 
assessment or review, it shall state on a Department-managed website 
the Regulation(s) whose assessment or review it is commencing. The 
public will be able to submit comments regarding the Regulation(s) in 
the manner specified on this website. The public can also submit 
comments in the manner specified on the website requesting that the 
Department assess or review a Regulation.
    (i) Any provision of this section held to be invalid or 
unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give the maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this section and shall not affect the 
remainder thereof or the application of the provision to persons not 
similarly situated or to dissimilar circumstances.


Sec.  6.2 through 6.5   [Reserved].

    Dated: October 21, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-23888 Filed 11-3-20; 4:15 pm]
BILLING CODE 4150-26-P