5694 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

1 85 FR 70096 (Nov. 4, 2020). 

2The transcript of the public hearing is available 

on the docket for the proposed rule. See https://

beta.regulations.gov/docket/HHS-OS-2020-0012/ 

document. 

3Unless otherwise indicated, all references to 

HHS in this proposed rule include HHS’ constituent 

agencies and other components. 

4See, e.g., Exec. Order No. 12866 of Sept. 30, 

1993, 58 FR 51735 (Oct. 4, 1993), Exec. Order No. 

13563 of Jan. 18, 2011, 76 FR 3821 (Jan. 21, 2011). 

5 ‘‘Section,’’ ‘‘Assess,’’ and ‘‘Review’’ are 

capitalized in this preamble where those terms have 

the definitions ascribed to them in the text of this 

final rule. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 6 

Public Health Service 

42 CFR Part 1 

Centers for Medicare and Medicaid 

Services 

42 CFR Part 404 

Office of the Inspector General 

42 CFR Part 1000 

Office of the Secretary 

45 CFR Part 8 

Administration for Children and 

Families 

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

1390 

[Docket No. HHS–OS–2020–0012] 

RIN 0991–AC24 

Securing Updated and Necessary 

Statutory Evaluations Timely 

AGENCY: Department of Health and 

Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: The Regulatory Flexibility Act 

(RFA) requires agencies to publish plans 

to conduct periodic reviews of certain of 

their regulations. Multiple Executive 

Orders also require agencies to submit 

plans for periodic reviews of certain 

regulations. To further comply with the 

RFA and Executive Orders, and to 

ensure the Department’s regulations 

have appropriate impacts, the U.S. 

Department of Health and Human 

Services (HHS or the Department) issues 

this final rule amending its regulations 

to set expiration dates for the 

Department’s regulations (subject to 

certain exceptions), unless the 

Department periodically assesses the 

regulations to determine if they are 

subject to the RFA, and if they are, 

performs a review that satisfies the 

criteria in the RFA. 

DATES: This final rule is effective on 

March 22, 2021. 

FOR FURTHER INFORMATION CONTACT: 

James Lawrence, 200 Independence 

Avenue SW, Washington, DC 20201; or 

by email at reviewnprm@hhs.gov; or by 

telephone at 1–877–696–6775. 

SUPPLEMENTARY INFORMATION: This final 

rule is organized as follows: 

Table of Contents 

I. Summary 

II. Background 

III. Statutory Authority and Legal Basis for 

This Final Rule 

IV. Provisions of Proposed Rule and 

Response to Public Comments 

V. Regulatory Impact Analysis 

I. Summary 

On November 4, 2020, HHS published 

in the Federal Register a notice of 

proposed rulemaking titled 

‘‘Department of Health and Human 

Services Securing Updated and 

Necessary Statutory Evaluations 

Timely’’ (hereinafter, ‘‘proposed rule’’).1

On November 23, 2020, the Department 

held a public hearing on the proposed 

rule.2 For the reasons described herein, 

after considering public comments on 

the proposed rule, HHS now finalizes 

the proposed rule as amended. This 

final rule will enhance the Department’s 

implementation of section 3(a) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 610, and various executive 

orders, and improve accountability and 

the performance of its regulations.3 The 

RFA requires federal agencies to publish 

in the Federal Register ‘‘a plan for the 

periodic review of the rules issued by 

the agency which have or will have a 

significant economic impact upon a 

substantial number of small entities’’ in 

order ‘‘to determine whether such rules 

should be continued without change, or 

should be amended or rescinded, 

consistent with the stated objectives of 

applicable statutes, to minimize any 

significant impact of the rules upon a 

substantial number of small entities.’’ 5 

U.S.C. 610(a). In conducting this 

retrospective review, agencies must 

consider a variety of factors, including 

the continued need for the rule, legal 

issues, public input, overlap and 

duplication with other federal or State 

and local governmental rules, and 

technological, economic, or other 

changes. 5 U.S.C. 610(b). Agency 

compliance with 5 U.S.C. 610 may be 

subject to judicial review. See 5 U.S.C. 

611(a). 

Several Executive Orders have also 

directed agencies to submit plans for the 

periodic review of certain of their 

regulations.4

The Department has tried to carry out 

the evidence-based approach to 

regulation prescribed by Congress and 

the executive orders, but HHS’ efforts 

have met varying levels of success. 

Several States, as well as jurisdictions 

outside the United States, have 

experimented with different ways of 

ensuring agencies engage in 

retrospective regulatory reviews so that 

legal requirements are updated in view 

of emerging evidence and changed 

circumstances. Among the lessons that 

have emerged is that while statutory 

mandates are helpful, one of the most 

important factors for ensuring agencies 

conduct retrospective reviews of their 

regulations is to provide for the sunset 

or automatic expiration of certain 

regulatory requirements after a period of 

time unless a retrospective review 

determines that the regulations should 

be maintained. 

Therefore, in order to ensure 

evidence-based regulation that does not 

become outdated as conditions change, 

HHS finalizes this rule to provide that, 

subject to certain exceptions, all 

regulations issued by the Secretary or 

his delegates or sub-delegates in Titles 

21, 42, and 45 of the CFR shall expire 

at the end of (1) five calendar years after 

the year that this final rule first becomes 

effective, (2) ten calendar years after the 

year of the Section’s promulgation, or 

(3) ten calendar years after the last year 

in which the Department Assessed and, 

if required, Reviewed 5 the Section, 

whichever is latest. The RFA and 

executive orders have only resulted in 

limited retrospective review by the 

Department. The Department believes 

this final rule will effectuate the desire 

for periodic retrospective reviews 

expressed in the RFA and Executive 

Orders, as well as ensure the 

Department’s regulations are having 

appropriate impacts and have not 

become outdated. The literature and the 

Department’s experience suggest that 

many regulations are having estimated 

impacts that, over time, differ from what 

was estimated at the time the 

regulations were promulgated. This 

final rule will enhance both (1) the 

fulfillment of the existing policies that 

led to the Department’s regulations and 

(2) the Department’s longstanding desire 


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6Paul R. Verkuil, A Critical Guide to the 

Regulatory Flexibility Act, 1982 Duke L.J. 213, 259 

(1982). 7Contract with America Advancement Act of 

1996, Public Law 104–121, 110 Stat. 847, 865–66 

(1996). 8H.R. Rep. No. 104–500, at 3 (1996). 

9Exec. Order No. 12044 of Mar. 23, 1978, 43 FR 

12661 (Mar. 24, 1978) (revoked by Exec. Order No. 

12291 of Feb. 17, 1981, 46 FR 13193 (Feb. 19, 

1981)). 10 43 FR at 12663. 11 Id. 12 Id. at 12669. As discussed below, the 

Department is reviewing a different subset of its 

regulations than was directed by Exec. Order No. 

12044, in part because the RFA’s directive to review 

regulations that have a significant economic impact 

upon a substantial number of small entities had not 

yet been enacted at the time of Exec. Order No. 

12044. Moreover, Exec. Order No. 12044 was 

responding to suggestions that the review be 

performed every three to five years. The 

Department’s reviews will be performed every ten 

years (except for regulations that have already been 

in effect for ten years), which should lessen the 

burden on the Department’s resources. 

13 Id. at 12669. 

14Exec. 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). 

15Memorandum on Reducing the Burden of 

Government Regulation (Jan. 28, 1992). 

16Exec. Order No. 12866 of Sept. 30, 1993, 58 FR 

51735 (Oct. 4, 1993). 

17 Id. 

to comply with the RFA and 

periodically review its regulations. 

II. Background 

A. The Regulatory Flexibility Act 

In 1980, Congress enacted the 

Regulatory Flexibility Act (RFA), Public 

Law 96–354, 94 Stat. 1164 (1980) 

(codified as amended at 5 U.S.C. 601– 

612). Congress stated that ‘‘the purpose 

of this Act [is] to establish as a principle 

of regulatory issuance that agencies 

shall endeavor, consistent with the 

objectives of the rule and of applicable 

statutes, to fit regulatory and 

informational requirements to the scale 

of the businesses, organizations, and 

governmental jurisdictions subject to 

regulation.’’ 94 Stat. at 1165. Consistent 

with this purpose, section 3(a) of the 

RFA requires agencies to publish in the 

Federal Register a ‘‘plan for the periodic 

review of rules which have or will have 

a significant economic impact upon a 

substantial number of small entities.’’ 5 

U.S.C. 610(a). The ‘‘purpose of the 

review shall be to determine whether 

such rules should be continued without 

change, or should be amended or 

rescinded . . . to minimize any 

significant economic impact of the rules 

upon a substantial number of small 

entities.’’ Id. In conducting this review, 

Congress provided that agencies ‘‘shall 

consider the following factors’’: 

(a) The continued need for the rule; 

(b) The nature of complaints or 

comments received concerning the rule 

from the public; 

(c) The complexity of the rule; 

(d) The extent to which the rule 

overlaps, duplicates or conflicts with 

other Federal rules, and, to the extent 

feasible, with State and local 

governmental rules; and 

(e) The length of time since the rule 

has been evaluated or the degree to 

which technology, economic conditions, 

or other factors have changed in the area 

affected by the rule. 

5 U.S.C. 610(b)(1)–(5). Congress 

required agencies to conduct an initial 

review within ten years of the effective 

date of the RFA, as well as subsequent 

reviews ‘‘within ten years of the 

publication of’’ future final rules. 5 

U.S.C. 610(a). 

The retrospective review provided for 

in 5 U.S.C. 610 is a congressional 

mandate. Under the plain terms of the 

Act, having a plan for such reviews is 

not optional. Congress fashioned a 

private right of action for small entities 

to ensure agencies satisfy 5 U.S.C. 610. 

See 5 U.S.C. 611(a)(1) (‘‘For any rule 

subject to this chapter, a small entity 

that is adversely affected or aggrieved by 

final agency action is entitled to judicial 

review of agency compliance with the 

requirements of sections 601, 604, 

605(b), 608(b), and 610 in accordance 

with chapter 7.’’). Originally, as one 

commentator explained, the RFA 

‘‘contain[ed] an extremely qualified and 

ambiguous provision for judicial 

review.’’ 6 In 1996, Congress amended 

the RFA to more clearly provide for 

judicial review of violations of 5 U.S.C. 

610.7 As one House Committee report 

explained, the lack of judicial review 

made ‘‘agencies completely 

unaccountable for their failure to 

comply with its requirements,’’ a 

problem the amendment attempted to 

solve.8

B. Executive Orders Directing Agencies 

To Review Existing Regulations 

Other efforts to conduct retrospective 

regulatory review both predate and have 

continued after passage of the RFA. In 

1978, President Carter issued an 

executive order on improving federal 

regulations.9 The order directed 

agencies to ‘‘periodically review their 

existing regulations.’’ 10 In determining 

which existing regulations to review, 

the order required agencies to consider, 

among other things, whether 

‘‘technology, economic conditions or 

other factors have changed in the area 

affected by the regulation.’’ 11 The 

Executive Order considered suggestions 

from the public that all regulations be 

reviewed, usually 3–5 years after 

issuance. But the Carter Administration 

instead instructed that, due to agency 

resource limitations, agencies should 

concentrate their reviews on those 

regulations which no longer serve their 

intended purpose, that have caused 

administrative difficulties, or that have 

been affected by new developments.12

The executive order also considered, but 

rejected, the idea of including a sunset 

provision in regulations on the ground 

that agencies cannot entirely eliminate 

regulations unless the law that 

authorized the regulations allows it.13

However, the Department believes that 

executive order did not consider that 

the authorizing statutes for many 

regulations permit those regulations to 

be rescinded. Moreover, as discussed 

below, experience since 1978 has shown 

it is difficult to adequately conduct 

retrospective regulatory review if 

regulations do not contain sunset 

provisions. 

Like the Carter Administration, every 

subsequent administration has directed 

agencies to engage in retrospective 

review of existing regulations. In 1981, 

President Reagan ordered agencies to 

‘‘review[ ] existing regulations’’ in view 

of cost-benefit principles and potential 

alternatives.14 In 1992, President George 

H.W. Bush issued a memorandum 

instructing agencies to conduct a 90-day 

review ‘‘to evaluate existing regulations 

and programs and to identify and 

accelerate action on initiatives that will 

eliminate any unnecessary regulatory 

burden or otherwise promote economic 

growth.’’ 15 President Clinton similarly 

called for review of existing regulations 

to determine whether they have become 

‘‘unjustified or unnecessary as a result 

of changed circumstances,’’ and ‘‘to 

confirm that regulations are both 

compatible with each other and [are] not 

duplicative or inappropriately 

burdensome in the aggregate.’’ 16

Specifically, that Executive Order 

required agencies to submit to the Office 

of Information and Regulatory Affairs 

(OIRA) a program under which the 

agency ‘‘will periodically review its 

existing significant regulations to 

determine whether any such regulations 

should be modified or eliminated so as 

to make the agency’s regulatory program 

more effective in achieving the 

regulatory objectives, less burdensome, 

or in greater alignment with the 

President’s priorities and the principles 

set forth in this Executive Order.’’ 17 The 

George W. Bush Administration’s 

Acting OIRA Administrator noted that 

the Bush Administration was ‘‘in the 


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18 Draft Report to Congress on the Costs and 

Benefits of Federal Regulations Introduction, 66 FR 

22041, 22054 (May 2, 2001). 19Exec. 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). 20Exec. Order No. 13610 of May 10, 2012, 77 FR 

28469, 28469 (May 14, 2012). 21Exec. Order No. 13771 of Jan. 30, 2017, 82 FR 

9339, 9339 (Feb. 3, 2017). 

22Office 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.’’). 

23Exec. Order No. 13924 of May 19, 2020, 85 FR 

31353, 31354 (May 22, 2020). 

24Testimony 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.’’). 

25See also Retrospective Review of Existing Rules, 

U.S. Dept. of Health & Human Servs., https://

www.hhs.gov/open/retrospective-review/ 

index.html. 

26See 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). 

27Connor Raso, Assessing regulatory retrospective 

review under the Obama administration, Brookings 

Inst., (Jun. 15, 2017), https://www.brookings.edu/ 

research/assessing-regulatory-retrospective-reviewunder-the-obama-administration/. 

28 Id. 

29 Id. 

30See, e.g., Curtis W. Copeland, Cong. Rsch. 

Serv., RL32801, Reexamining Rules: Section 610 of 

the Regulatory Flexibility Act 7–8 (2008); U.S. Gov’t 

Accountability Off., GAO/GGD–94–105, Regulatory 

Flexibility Act: Status of Agencies’ Compliance 12 

(1994) (quoting a 1983 Small Business 

Administration report that stated that the 

Department’s section 610 review plan was ‘‘ ‘very 

general,’ and, as a result, ‘it is difficult to measure 

progress and to make recommendations with 

respect to future review’ ’’); see also Testimony of 

The Hon. Thomas M. Sullivan, Chief Counsel for 

Advocacy, U.S. SBA, U.S. House of Representatives 

Comm. on Small Bus. Subcomm. on Reg.’s, Health 

Care and Trade (July 30, 2008), https://

www.sba.gov/sites/default/files/files/ 

test08_0730.pdf (‘‘Historically, federal agency 

compliance with section 610 has been limited.’’). 

31E.g., Nonrulemaking Docket FDA–2017–N– 

5093: Review of Existing General Regulatory and 

Information Collection Requirements of the Food 

and Drug Administration, https://

beta.regulations.gov/docket/FDA-2017-N-5093. 

process of reviewing a variety of 

existing regulations and regulatory 

programs in an effort to identify areas 

where sensible changes will yield 

greater benefits for the public at lower 

costs.’’ 18

President Obama also instructed 

agencies to engage in retrospective 

regulatory review. In 2011, President 

Obama issued an executive order 

ordering agencies ‘‘[t]o facilitate the 

periodic review of existing significant 

regulations . . . to promote 

retrospective analysis of rules that may 

be outmoded, ineffective, insufficient, 

or excessively burdensome, and to 

modify, streamline, expand, or repeal 

them in accordance with what has been 

learned.’’ 19 Similarly, in 2012, 

President Obama noted that 

retrospective review has particular 

relevance ‘‘[d]uring challenging 

economic times,’’ and that agencies 

should consider whether regulations 

‘‘should be modified or streamlined in 

light of changed circumstances, 

including the rise of new 

technologies.’’ 20

President Trump has attempted to 

identify existing undue regulatory 

burdens and facilitate retrospective 

review of regulations. For example, in 

January 2017, President Trump issued 

an executive order requiring agencies to 

identify at least two regulations to be 

repealed for every one regulation 

proposed or otherwise promulgated.21

Similarly, a 2017 OIRA report to 

Congress explained, ‘‘Rules should be 

written and designed to facilitate 

retrospective analysis of their effects, 

including consideration of the data that 

will be needed for future evaluation of 

the rules’ ex post costs and benefits.’’ 22

In May 2020, in response to the COVID– 

19 pandemic, President Trump ordered 

agencies to ‘‘identify regulatory 

standards that may inhibit economic 

recovery’’ and to ‘‘consider taking 

appropriate action, consistent with 

applicable law,’’ including modifying, 

waiving, or rescinding those regulatory 

requirements.23

In addition to the executive orders, 

other executive branch actions have 

sought to spur agencies to conduct the 

reviews called for by 5 U.S.C. 610. One 

example was the Regulatory Review and 

Reform (r3) initiative, which the Small 

Business Administration launched in 

part to improve compliance with 5 

U.S.C. 610 and further the goals of 

periodic reviews. The r3 initiative was 

a long-term project to help agencies 

pinpoint existing federal rules that 

warrant review—and to revise those 

rules if they are found to be ineffective, 

duplicative, out of date, or otherwise 

deficient.24

Consistent with these actions, HHS 

has conducted retrospective reviews of 

some of its regulations. For example, 

pursuant to Executive Order 13563, 

HHS published a list of regulations the 

Department identified as candidates for 

retrospective review.25 The Department 

also took action. For example, HHS, 

citing Executive Order 13563, 

eliminated certain restrictions on the 

use of telemedicine in rural areas.26

Nonetheless, the Department has only 

conducted retrospective review of 

regulations to a very limited extent. One 

academic analysis determined that, in 

response to Executive Order 13563, the 

Department planned 83 retrospective 

analyses in 2012 and completed 33 

analyses with final action by August 31, 

2013.27 By contrast, the Department 

issued 247 rules between the date 

Executive Order 13563 was issued and 

August 31, 2013.28 As of July 2016, the 

Department had 40 planned 

retrospective analyses and by April 

2017 had completed analyses with final 

action on 19 of them.29 These findings 

are consistent with government 

assessments that the Department’s 

efforts to comply with 5 U.S.C. 610 have 

at times been lacking.30

Commenters on the proposed rule 

listed the following as examples of 

regulations that they and/or Congress 

have requested the Department to 

review, but that the commenters 

claimed were not reviewed: 

• Regulations mandated for review by 

the 21st Century Cures Act, Public Law 

114–255, sec. 2034, 130 Stat. 1033 

(2016). Section 2034 of that Act, 

according to the commenters, requires 

the Secretary to lead a review by 

research funding agencies of all 

regulations and policies related to the 

disclosure and reporting of financial 

conflicts of interest to reduce 

administrative burden on federally 

funded researchers. It also calls for the 

Secretary to harmonize the differences 

between the Basic HHS Policy for the 

Protection of Human Research Subjects 

(45 CFR part 46, subpart A) and the FDA 

regulations for the protection of human 

subjects (21 CFR parts 50 and 56). 

Commenters stated that these 

regulations are well overdue for 

assessment and review. 

• Regulations covering access to 

skilled therapy services, which 

commenters say must be updated to 

reflect the national settlement in the 

Jimmo v. Sebelius litigation to codify 

the fact that skilled services are covered 

for Medicare beneficiaries not just to 

improve function, but to maintain or 

prevent deterioration in function. 

• The dockets established by FDA’s 

Center for Food Safety and Applied 

Nutrition and Center for Veterinary 

Medicine on Sept. 8, 2017,31 in which 

the Centers requested comments and 


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32See Review of Existing General Regulatory and 

Information Collection Requirements of the Food 

and Drug Administration, 82 FR 42506 (Sept. 8, 

2017); FDA–2017–N–5093, https://

beta.regulations.gov/docket/FDA-2017-N-5093. 

33See infra n.68 and accompanying text. 

34 Yoon-Ho Alex Lee, An Options Approach to 

Agency Rulemaking, 65 Admin. L. Rev. 881, 895– 

96 (2013). 

35Office 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/R8LXBQMJ (collecting studies comparing ex ante and ex 

post analyses of regulations’ costs and benefits, 

including examples where cost and benefit 

estimates were off by more than a factor of ten). 

36 Id. at 42. 

37 Id. at 43–46. 

38 Id. at 47. 

39 Id. at 43. 

40 Id. at 47. 

41 Id. 

42Winston 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%. 

information to assist in identifying 

existing regulations and related 

paperwork requirements that could be 

modified, repealed or replaced, 

consistent with the law, to achieve 

meaningful burden reduction while 

allowing FDA to achieve its public 

health mission and fulfill statutory 

obligations. The commenters stated 

these were examples of incomplete 

regulatory review initiatives.32

Commenters stated that despite 

submitting extensive comments that 

detailed numerous regulations that they 

believe could be modified, repealed or 

replaced, the agency did not take any 

further action. 

A review conducted for the 

Department in 2019 (discussed in more 

detail in Section C) concluded that 

related good governance stewardship 

actions were deprioritized and relegated 

to ‘‘rainy day’’ activities that 

Department operating divisions would 

get around to when they could.33

However, the rainy day in many cases 

has never arrived. 

Scholars have also posited reasons 

why agencies may be reluctant to 

perform retrospective reviews. One 

administrative law expert now at 

Northwestern University has written: 

[E]ven with sufficient resources, agencies 

may not be properly incentivized. They are 

less likely to be found at fault for not 

conducting rigorous periodic reviews. Many 

rules, even those with significant effects, are 

often not on the public’s radar once adopted. 

Challenging agency regulation under the RFA 

is more difficult than under the 

Administrative Procedure Act (APA) because 

there is no comment process and standing is 

granted to more limited parties. The harm to 

the public resulting from a cursory analysis 

is also much less clear. If sufficient interests 

exist to modify the rule, strong interest 

groups will directly lobby the agency to 

modify the rule. But in this case, a brand new 

rulemaking effort emerges. 

There are also political reasons and moral 

hazard concerns associated with performing 

retrospective analyses. In most cases, 

retrospective analyses of existing regulations 

are routine business matters left to be 

handled by staff members, rather than 

political appointees. Political appointees, 

such as agency heads, tend to come with 

specific regulatory agendas of their own. By 

contrast, staff members at regulatory agencies 

are best viewed as career members who have 

a vested interest in seeing their agencies 

continue to exist and thrive. All else equal, 

they are not inclined to acknowledge that the 

work of their agency is inefficient or 

unnecessary, and even less inclined to 

conduct analyses that may lead to a 

curtailing of the agency’s authority. Whatever 

the reasons may be, serious ex post reviews 

are few and far between. A majority of rules, 

once adopted, will likely persist without 

significant ex post modification. As to how 

many agency rules currently implemented 

may be costing more resources than yielding 

benefits is anyone’s guess.34

Thus, the Department concludes that it 

needs to impose a strong incentive on 

itself to perform retrospective review, 

given these countervailing incentives to 

not perform such reviews and the 

limited number of retrospective reviews 

that the Department has performed over 

the last 40 years. As discussed in more 

detail in the regulatory impact analysis 

infra, the Department has the resources 

to periodically review the impacts of its 

regulations. 

C. Limitations in Government 

Projections Counsel in Favor of 

Widespread Retrospective Regulatory 

Review 

The Congressional and Presidential 

directives to periodically review 

existing regulations are sound policy. 

When the Department first issues a 

regulation, it makes an educated guess 

about the regulation’s impact. Several 

years after the regulation is 

promulgated, the Department has a 

somewhat greater basis for assessing its 

real-world impacts and can refine the 

regulation or agency enforcement 

practices, as appropriate. This would 

further democratic values such as 

accountability, administrative 

simplification, transparency, and 

performance measurement and 

evaluation. 

Indeed, the literature indicates that 

government projections of regulatory 

impacts would benefit from refinement 

based on experience after the 

regulations are implemented. The 

literature suggests the need for 

refinement is widespread, so 

widespread review would yield greater 

benefits than review of a handful of 

regulations. In 2005, the Office of 

Management and Budget (OMB) 

provided an overview of a sample of 

retrospective analyses based on an 

examination of forty-seven case 

studies.35 OMB considered a preregulation estimate to be accurate if the 

post-regulation estimate was within 

+/¥ 25 percent of the pre-regulation 

estimate.36 This measure of accuracy 

reveals the difficulty and uncertainty 

inherent in prospective cost-benefit 

analysis. OMB found that agencies often 

inaccurately estimated the benefits of 

regulations in its sample of regulations, 

and agencies were more likely to 

overestimate benefits than to 

underestimate them, where benefits 

were estimated.37 Agencies 

overestimated benefits in 19 of 39 

sampled regulations, whereas they 

underestimated benefits in only two of 

the 39 regulations.38 In two cases, 

agencies overestimated benefits by a 

factor of 10.39 Second, agencies 

sometimes overestimated the benefitcost ratio, and in that sense were a bit 

too optimistic about the consequences 

of their rules. Agency estimates were 

accurate in only 11 rules, while the ratio 

was overestimated in 22 rules and 

underestimated in 14 rules.40 Third, 

agencies also overestimated and, less 

frequently, underestimated costs in the 

sampled regulations. Agency cost 

estimates were accurate for only 12 

rules, overestimated for 16 rules, 

underestimated for 12 rules, and not 

estimated for seven rules.41

Academic studies have also identified 

inaccuracies in agency estimates, 

relative to an ex post re-estimation. For 

example, one study of sixty-one rules 

for which benefit-cost ratios could be 

compared before and after the fact 

(including some not included in the 

OMB review) found that the estimated 

ratios were essentially accurate in only 

sixteen of the sixty-one cases, though 

the study found no bias in estimates of 

benefit-cost ratios.42 In this analysis, Dr. 

Harrington criticized certain aspects of 

the OMB analysis. But it is notable that, 

even though OMB and Dr. Harrington 

used somewhat differing methods and 

reviewed samples of regulations that did 

not completely overlap, they both found 

ex ante estimates to be in many cases 

lacking. Dr. Harrington concluded his 

analysis by noting that ‘‘the results 


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5698 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

43 Id. at 34. 

44Richard 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-cambridgecore/content/view/891E36D3DBCEB79C9

69278488E5E1897/S2194588817000173a.pdf/ 

retrospective_analysis_of_us_federal_

environmental_regulation.pdf. 

45 Id. 

46 Id.; see also Cynthia Morgan & Nathalie B. 

Simon, National primary drinking water regulation 

for arsenic: A retrospective assessment of costs, 5 

J. Benefit Cost Anal. no. 2, 2014, at 259–84, https:// 

www.cambridge.org/core/services/aop-cambridgecore/content/view/A7B29CE98E650B4

24E92FF292A8FFC89/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)). 

47This is not to suggest that prospective 

regulatory impact analyses are not helpful. To the 

contrary, they add tremendous value and greatly 

improve agency rule makings. But as explained 

elsewhere herein, even when an agency’s costbenefit analysis uses sound science and the best 

available information to estimate the costs, benefits 

or other impacts associated with a rule, 

technological innovation or subsequent changes in 

the law, among other things, can result in an ex post 

assessment of impacts differing from the agency’s 

estimates at the time it promulgated the rule. 

48See 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. 

49See 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. 

50Cynthia 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-cambridgecore/content/view/A7B29CE98E650B424E92FF29

2A8FFC89/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. 

51Medical Device Submissions: Amending 

Premarket Regulations That Require Multiple 

Copies and Specify Paper Copies To Be Required 

in Electronic Format, 84 FR 68334 (Dec. 16, 2019). 52 Id. at 68334. 53See, e.g., Cass R. Sunstein, The Regulatory 

Lookback, 94 B.U. L. Rev. 579, 599 (2014). 54Winston Harrington, Richard D. Morgenstern 

and Peter Nelson, On the Accuracy of Regulatory 

Cost Estimates, J. Policy Anal. & Management 2000, 

19(2): 297–322. 55See, 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. 

56Cass R. Sunstein, The Regulatory Lookback, 94 

B.U. L. Rev. 579, 591 (2014). 

demonstrate the value of ex post 

analysis. It is frustrating that there is so 

little of it, especially when so many 

close observers, from all points of view, 

claim to be in favor of it.’’ 43

A more recent study of a sample of 

federal regulations found that of the 

eight regulations for which the author 

was able to make ex ante and ex post 

cost comparisons, six regulations 

involved overestimates of costs, two 

involved underestimates of costs, and 

none were deemed accurate.44 A 

regulation was deemed accurate if the 

regulation’s regulatory impact analysis 

fell roughly within +2/¥5% of the ex 

post observation.45 Of the 18 regulatory 

requirements for which the author was 

able to compare benefits (also referred to 

as ‘‘effectiveness’’ in the study) 

estimates on an ex ante and ex post 

basis, he found that 10 involved 

overestimates, six were underestimates, 

and two were relatively accurate.46

These studies all found that in most 

cases the sampled ex ante estimates 

were not within +/¥25% of the ex post 

observations. The studies suggest many 

federal regulations are estimated after 

the fact to have real-world impacts that 

differ from the estimated impacts at the 

time the regulations were promulgated. 

Although these samples were not 

necessarily representative, it would not 

be unreasonable to think that the 

Department could make major 

improvements by conducting 

widespread review of its regulations, 

rather than merely reviewing the small 

number of regulations that interested 

parties ask the Department to consider 

revising.47

Reasons Regulatory Projections Differ 

From Regulations’ Real-World Impacts 

There are several reasons why 

regulations’ ex ante cost-benefit 

estimates tend to be inaccurate. First, 

changes in the legal landscape can cause 

government projections to become 

obsolete. For example, in February 

2010, officials in the Centers for 

Medicare and Medicaid Services’ Office 

of the Actuary (OACT) issued health 

spending and coverage projections 

through 2019.48 A month later, Congress 

enacted the Patient Protection and 

Affordable Care Act, Public Law 111– 

148, 124 Stat. 119 (‘‘ACA’’), and the 

Health Care and Education 

Reconciliation Act of 2010, Public Law 

111–152, 124 Stat. 1029. Largely as a 

result of the ACA’s passage, in October 

2010 OACT issued revised projections 

forecasting that by 2019 the insured 

share of the population would be 92.7 

percent—roughly ten percentage points 

higher than OACT projected nine 

months earlier.49

Second, changes in technology can 

also render projections inaccurate. One 

study has noted that even when an 

agency’s benefit-cost analysis uses 

sound science and the best available 

information to estimate the costs 

associated with a rule, technological 

innovation can result in an ex post 

assessment of costs differing from the 

agency’s cost estimates at the time it 

promulgated the rule.50 As an example 

of technology’s impact on regulations, 

in 2019 the Food and Drug 

Administration (FDA) issued a rule 

amending requirements for medical 

device premarket submissions to 

remove requirements for paper and 

multiple copies, and replace these 

requirements with requirements for a 

single submission in electronic 

format.51 Changes in technology had 

rendered the requirement for multiple 

copies, whether in electronic format or 

paper form, no longer necessary.52 Had 

the Department reviewed more of its 

regulations, it might have learned of 

additional instances where 

technological changes counsel in favor 

of amendment. In addition, some 

scholars have suggested that in some 

cases changes in technology can reduce 

the costs of complying with regulatory 

mandates.53 If retrospective reviews 

conclude that technology has reduced 

compliance costs, that can inform the 

Department’s decision about if or how 

to amend a regulation. 

Yet another reason for potential 

divergence between prospective and 

retrospective regulatory impact 

estimates is non-compliance with the 

regulation being assessed. One study 

found differing accuracy for prospective 

per-unit cost estimates and prospective 

aggregate cost estimates; where there is 

substantial non-compliance with the 

regulation being analyzed, cost 

estimates per unit can sometimes be 

reasonably accurate while aggregates are 

simultaneously overestimated.54 (Noncompliance would, of course, also affect 

the accuracy of benefits estimates.55) As 

such, ex post analysis has the potential 

to inform not just decisions about 

codified regulatory requirements but 

also about agency enforcement 

practices. 

Institutionalizing Retrospective Review 

To Refine Projections That Were 

Lacking 

While the prospective cost-benefit 

analyses performed in connection with 

the promulgation of rules are quite 

useful, former OIRA Administrator Cass 

Sunstein has explained that ‘‘[w]hen 

agencies issue rules, they have to 

speculate about benefits and costs.’’ 56

Therefore,[a]fter rules are in place, 

[agencies] should test those 

speculations, and they should use what 

they learn when revisiting a regulation 


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57 Id. 58 Id. 59 Id. at 588. 60Michael 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 realworld experience living under the regulation, it can 

in many cases be an improvement over earlier 

prospective analysis. 

61Michael 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_Benefit

Report11_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.’’). 

62Michael Greenstone, Toward a Culture of 

Persistent Regulatory Experimentation and 

Evaluation, in New Perspectives on Regulation 111, 

114 (David Moss & John Cisternino eds., 2009). 

63Cass R. Sunstein, The Regulatory Lookback, 94 

B.U. L. Rev. 579, 589 (2014). 

64Administrative 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). 

65ABA 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). 

66See 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.’’). 

67Regulatory Streamlining & Analysis (Mar. 

2019). 

68 Id. at 18 

69 Jason Schwartz, Enhancing the Social Benefits 

of Regulatory Review, Institute for Policy Integrity, 

at 30 (Oct. 2020), https://policyintegrity.org/files/ 

publications/Enhancing_the_Social_Benefits_of_

Regulatory_Review.pdf. Several weeks after 

publishing this article, the author submitted a 

comment opposing the proposed rule. For the 

reasons discussed in the responses to public 

comments, the Department did not find those 

arguments compelling, but believes the quoted 

passage is a fair description of the problem this 

final rule aims to solve. The Department is trying 

to be clear-eyed about past failures, and has 

concluded that a strong incentive, such as that 

included in this final rule, is commensurate with 

the problem to be solved and to more firmly 

institutionalize retrospective review. 

or issuing a new one.’’ 57 Professor 

Sunstein described this as ‘‘one of the 

most important steps imaginable’’ for 

regulatory reform, ‘‘not least because it 

can reduce cumulative burdens and 

promote the goal of simplification.’’ 58

He has noted that agencies’ failure 

‘‘until very recently . . . to gather, let 

alone act on’’ retrospective reviews is 

‘‘an astonishing fact.’’ 59

Michael Greenstone, who served as 

Chief Economist on the Council of 

Economic Advisors between 2009 and 

2010, similarly concluded that the 

‘‘single greatest problem with the 

current system is that most regulations 

are subject to a cost-benefit analysis 

only in advance of their 

implementation. This is the point when 

the least is known and any analysis 

must rest on many unverifiable and 

potentially controversial 

assumptions.’’ 60 According to Professor 

Greenstone, the lack of a regulatory 

lookback created a system ‘‘largely 

based on faith, rather than evidence,’’ 

where the agency ‘‘all too frequently 

takes shots in the dark and we all too 

infrequently fail to find out if we have 

hit anything—or even worse, we only 

find out when things have gone horribly 

wrong.’’ 61 As he explained, ‘‘it is nearly 

impossible to imagine’’ only 

prospective, and not retrospective, 

evaluations ‘‘being used in other 

contexts where people’s lives are on the 

line. For example, I am confident that 

there would be a deafening uproar of 

protest if the FDA announced that it 

would approve drugs without testing 

them in advance. Yet, this is largely 

what we do with regulations that affect 

our health and well-being.’’ 62

If retrospective analysis ‘‘could be 

firmly institutionalized,’’ Professor 

Sunstein observed, then it ‘‘would count 

as the most important structural change 

in regulatory policy since the original 

requirement of prospective analysis 

during the Reagan Administration.’’ 63

Other administrative law experts have 

also urged agencies to more robustly 

institutionalize retrospective review of 

regulations. The Administrative 

Conference of the United States (ACUS) 

has ‘‘urge[d] agencies to remain mindful 

of their existing body of regulations and 

the ever-present possibility that those 

regulations may need to be modified, 

strengthened, or eliminated in order to 

achieve statutory goals while 

minimizing regulatory burdens.’’ 64

More recently, the American Bar 

Association Section of Administrative 

Law and Regulatory Practice, has 

‘‘urge[d] [the Administration] to build 

on the efforts of previous 

administration[s] and take steps to 

institutionalize careful, in-depth 

retrospective review of existing rules.’’ 65

The Need for a Greater Incentive To 

Institutionalize Retrospective Review 

Despite these many calls for 

retrospective review, as noted in section 

II.B., the Department has had limited 

success in implementing retrospective 

review in practice.66 In 2019, the 

Department piloted an approach to 

augment expert policy insights with 

artificial intelligence-driven data 

analysis of its regulations, which 

showed the need to more firmly 

institutionalize retrospective review. 

The artificial intelligence review found 

that 85% of Department regulations 

created before 1990 have not been 

edited; the Department has nearly 300 

broken citation references in the CFR 

(i.e. CFR sections that reference other 

CFR sections that no longer exist); more 

than 50 instances of regulatory 

requirements to submit paper 

documents in triplicate or 

quadruplicate; and 114 parts in the CFR 

with no regulatory entity listed, 17 of 

which may be misplaced.67 The 

Department concluded that some good 

governance stewardship 

recommendations ‘‘were deprioritized 

and relegated to rainy day activities that 

[Department operating divisions] would 

get around to when they could.’’ 68

Unfortunately, in many cases the 

Department has for years not gotten 

around to addressing these issues. 

As one observer recently explained: 

Retrospective review of existing 

regulations . . . is a perennial favorite target 

for advice on how to improve OIRA’s 

processes. Every administration since 

President Carter has developed some 

program to modify, streamline, or expand 

existing regulations, and there is no shortage 

of advice on how to make the process run 

more efficiently. Yet, despite a few notable 

one-off successes from past retrospective 

review efforts, no past retrospective review 

campaign has ever truly succeeded in 

creating a long-term culture of retrospective 

review or of prospectively embedding into 

new regulations a process for data collection 

and pre-set targets for future lookbacks. Any 

future efforts around retrospective review, 

therefore, should be clear-eyed about past 

failures.69

For the reasons discussed in this final 

rule, the Department believes a stronger 


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5700 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

70Regulatory Streamlining & Analysis (Mar. 2019) 

(it ‘‘appears the current set of governance 

structures, incentives and processes to promulgate 

regulatory reform need strengthening to be more 

effective’’). 

71Ala. Code 41–22–5.2; Ariz. Rev. Stat. 41–1056; 

5 Ill. Comp. Stat. Ann. 100/5–130; Iowa Code Ann. 

17A.33; Mich. Comp. Laws 10.151; Missouri Rev. 

Stat., Title XXXVI § 536.175.5; N.J. Stat. Ann. 

52:14B–5.1; N.M. Stat. 14–4A–6; N.C. Gen. Stat. 

150B–21.3A; N.D. Cent. Code 28–32–18.1; Ohio 

Rev. Code Ann. 106.03; Okla. Stat. Ann. tit. 75, 

307.1; 71 Pa. Stat. Ann. 745.2; R.I. Gen. Laws Ann. 

tit. 42, ch. 64.13; Tenn. Code Ann. 4–56–102; Wash 

Rev. Code Ann. 43.70.041, 43.22.052. 

72Although 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. 

73Letter 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. 

74Russell S. Sobel & John A. Dove, State 

Regulatory Review: A 50 State Analysis of 

Effectiveness 36 (Mercatus Ctr., Working Paper No. 

12–18, 2012), https://www.mercatus.org/system/ 

files/State-Regulatory-Review-50-State-AnalysisEffectiveness.pdf. 

75 Jason A. Schwartz, 52 Experiments with 

Regulatory Review: The Political and Economic 

Inputs into State Rulemakings, Inst. for Policy 

Integrity, Rep. No. 6, at 33 (Nov. 2010), https://

policyintegrity.org/files/publications/52_

Experiments_with_Regulatory_Review.pdf. 

76See id. (noting that ‘‘North Carolina was first 

to repeal its sunset law, and many other states 

quickly followed suit’’ after concluding that ‘‘sunset 

provisions quickly proved to be an expensive, 

cumbersome, and disappointing method for 

enhancing legislative control’’). 

77 Id. at 23–24. The report added, without citing 

a great deal of empirical evidence, that ‘‘sunset 

requirements produce perfunctory reviews and 

waste resources.’’ This appears to be based on a law 

review article that noted, not that retrospective 

reviews were per se perfunctory, but that ‘‘unless 

adequate resources are provided, the reviews may 

be relatively perfunctory and meaningless, wasting 

whatever resources are expended.’’ See Neil R. 

Eisner & Judith S. Kaleta, Federal Agency Reviews 

of Existing Regulations, 48 Admin. L. Rev. 139, 160 

(1996) (emphasis added). But this law review article 

noted that adding ‘‘sunset’’ dates to regulations 

unless they are reviewed was ‘‘likely to ensure that 

a review is done.’’ Id. As explained herein, the 

Department intends to commit adequate resources 

to its reviews if this proposed rule were to be 

finalized. The law review article said that sunset 

provisions should be used only in narrowly focused 

situations where it is determined that it is necessary 

to apply some ‘‘pressure’’ and only where 

assessments are made of the available resources and 

the benefits to be derived from the review. Id. But 

the article was written in 1996. As discussed 

herein, subsequent experience with efforts short of 

a forcing mechanism suggest that forcing 

mechanisms are needed to ensure review of a wide 

array of Department regulations, and that the 

benefits from these retrospective reviews would be 

substantial. 

78OECD, Better Regulation in Europe: Executive 

Summaries, GOV/RPC (2010)13, at 113, http://

www.oecd.org/gov/regulatory-policy/45079126.pdf. 

79 Id. at 46. 

80See, 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.’’). 

81OECD, 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_=07701faff9659027

b81a5b5ae2ff041c&itemIGO=oecd&item

ContentType=book. 

82 Id. at ch. 4, Table 4.1. 

incentive is needed to achieve the 

benefits of retrospective review.70 This 

final rule creates a mechanism to more 

firmly institutionalize the retrospective 

reviews that Professors Sunstein and 

Greenstone, as well as ACUS and others, 

have called for. 

D. The Experiences of States and Other 

Jurisdictions With Automatic Expiration 

or ‘‘Sunset’’ Provisions 

This mechanism is based in part on 

the experiences of States and other 

jurisdictions. Several States incorporate 

retrospective regulatory review into 

their laws. New York, for example, 

requires retrospective review of 

regulations ‘‘no later than in the fifth 

calendar year after the year in which the 

rule is adopted,’’ and requires that rules 

be ‘‘re-reviewed at five-year intervals’’ 

thereafter. N.Y. A.P.A. Law sec. 207. 

Similarly, Texas requires State agencies 

to review rules four years after they go 

into effect and then subsequently at 

four-year intervals. Tex. Gov’t Code sec. 

2001.039. In addition to New York and 

Texas, State law requires some form of 

retrospective regulatory review in at 

least Alabama, Arizona, Illinois, Iowa, 

Michigan, Missouri, New Jersey, New 

Mexico, North Carolina, North Dakota, 

Ohio, Oklahoma, Pennsylvania, Rhode 

Island, Tennessee, and Washington.71

Some States with retrospective review 

requirements allow regulations to 

automatically expire or sunset after a 

period of time, unless reviewed or 

readopted. In New Jersey, regulations 

automatically expire ‘‘seven years 

following the effective date of the rule’’ 

unless extended by the agency. N.J. Stat. 

Ann. sec. 52:14B–5.1(b).72 Indiana 

allows regulations to expire on January 

1 following the seven-year anniversary 

of their effective dates. Ind. Code sec. 4– 

22–2.5–2. The Governor of Florida 

recently instructed Florida government 

agencies to ‘‘include a sunset provision 

in all proposed or amended rules,’’ 

which ‘‘may not exceed five years 

unless otherwise required by existing 

statute.’’ 73

Experience in the States suggests that 

sunset provisions can be an important 

tool to ensure reviews take place. An 

analysis of regulation in all 50 States 

found that for a reduction in both 

regulatory creation and enforcement, 

‘‘[t]he single most important policy in a 

state is the presence of a sunset 

provision.’’ 74 On the other hand, one 

report stated that, despite their initial 

popularity in the States,75 sunset 

provisions fell out of favor, not because 

they did not produce more costeffective, cost-justified regulation, but 

because sunset requirements did not 

provide sufficient legislative control 

over executive agencies.76 But that 

observation is inapplicable to the 

Department, because this final rule 

concerns the Department’s review of its 

own regulations. Noting the benefits of 

sunset provisions, the report added that 

sunset ‘‘provisions have been 

responsible for the analysis of 

thousands of state regulations and, on 

average, the repeal of twenty to thirty 

percent of existing regulations and the 

modification of another forty 

percent.’’ 77

Experience outside the United States 

also suggests the utility of sunset 

provisions. The Office for Economic CoOperation and Development (OECD) 

analyzed regulatory practices in the 

European Union. In a 2010 report, the 

OECD recommended, for ‘‘[t]he 

management and rationalization of 

existing regulations,’’ that Germany 

‘‘[k]eep up the ‘spring cleaning’ of 

legislation at regular intervals’’ and 

‘‘consider the inclusion of a review 

mechanism in individual draft 

regulations, or even [include] a sunset 

clause (beyond which the law 

automatically expires) where 

appropriate.’’ 78 With respect to the 

United Kingdom’s regulatory program, 

the OECD noted ‘‘sunset clauses are also 

helpful’’ in order ‘‘to remove 

unnecessary burdens in legislation.’’ 79

Throughout the 2010 report, the OECD 

repeatedly noted the value of 

retrospective regulatory review.80

In 2019, the OECD published an 

additional survey regarding regulatory 

review practices in the European Union. 

The OECD again noted the utility of 

sunset provisions, describing them as a 

‘‘useful ‘failsafe’ mechanism to ensure 

the entire stock of subordinate 

regulation remains fit for purpose over 

time.’’ 81 The report noted as of its 2019 

date that sunset provisions are in place 

for at least some regulations in nine 

different countries, including the United 

Kingdom, France, and Germany.82

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 


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83OECD, Latest Developments on Korea’s 

Regulatory Policy, at 2, https://www.oecd.org/gov/ 

regulatory-policy/45347364.pdf. 

84OECD Reviews of Regulatory Reform, 

Regulatory Policy in Korea, Toward Better 

Regulation, at 86 (2017), https://

publicadministration.un.org/unpsa/Portals/0/ 

UNPSA_Submitted_Docs/2019/4cd3e219-c819- 

40f3-8246-7a024d9a82a9/2020%20UNPSA_

the%20Regulatory%20Reform%20Sinmungo_

Evaluation%20Report_27112019_032807_

e4d166a9-f6ef-4a6c-9aaf-99748fa94284.

pdf?ver=2019-11-27-032807-637. 

85 Id. 

86Occupational Licensing: A Framework for 

Policymakers, The White House, at 48–50 (July 

2015), https://obamawhitehouse.archives.gov/sites/ 

default/files/docs/licensing_report_final_

nonembargo.pdf. 

87 Id. at 48. 

88 Id. at 49. 

89 Id. The report also suggests that to strengthen 

sunset provisions in the States, sunset commissions 

responsible for conducting the cost-benefit analysis 

should be provided adequate resources; the costbenefit review process should be insulated against 

political interference; a minimum number of votes 

should be required to overrule the sunrise agency’s 

recommendation; and specialized committees 

within legislatures be appointed to work with the 

agency in charge of conducting the review. See id. 

at 42. As discussed herein, the Department believes 

it has adequate resources to conduct the required 

reviews. As discussed in footnote 92, it is not clear 

that a federal agency can legally completely insulate 

its reviews from supervision by the agency’s 

leadership, but the Department believes that its 

retrospective reviews will generally be performed 

by career civil servants. Lastly, the Department 

cannot require Congress to appoint committees to 

work with the Department officials performing the 

retrospective reviews, but the Department would 

welcome the opportunity to discuss reviews with 

Congressional staff if Congress so chose. The report 

also suggested ‘‘sunrise’’ reviews can be more 

effective than sunset reviews. But for alreadyexisting regulations, the Department cannot perform 

sunrise reviews, so the Department is has decided 

to take advantage of the benefits of sunset reviews. 

Moreover, the Department already engages in 

‘‘sunrise review’’ to some extent when it develops 

regulatory flexibility analyses, see 5 U.S.C. 603, 

604, and regulatory impact analyses (notably, such 

reviews did not occur for regulations that preceded 

the RFA, many of which still remain in effect). 

90 Greenstone, Toward a Culture of Persistent 

Regulatory Experimentation and Evaluation, in 

New Perspectives on Regulation 111, 121 (David 

Moss & John Cisternino eds., 2009). 

91 Id. 

92 Id. at 123. Professor Greenstone made a 

separate suggestion that a regulatory review board 

be created with the authority to assess the 

effectiveness of regulations and repeal regulations 

deemed ineffective. The Department considered 

this in the proposed rule. First, the Department is 

concerned that such a board raises legal concerns, 

since many Department regulations can only be 

repealed by the Secretary, not by an independent 

board. Second, Professor Greenstone proposed the 

independent review board on the grounds that (1) 

it would remove the board’s functions as much as 

possible from political control, and (2) those most 

deeply involved in implementing a regulation are 

likely to see the benefits more clearly than the costs. 

Id. at 119–121. While these concerns are 

understandable, the Department believes it is 

capable of performing the Review. As an initial 

matter, those who conduct the Review would not 

necessarily be those in the Department who 

implement the Section being Reviewed. Moreover, 

as described herein, Reviews must be performed in 

such a manner that they can withstand judicial 

review under the arbitrary and capricious standard. 

This would require the Reviews to meet a minimum 

standard of rigor and require them to consider 

relevant factors. Moreover, many regulations legally 

cannot be amended or repealed without 

authorization by a political appointee. 

93As discussed below, HHS has roughly 18,000 

regulations total. 

94 85 FR 70102. 

are found to lack feasibility.83 Under the 

ROK’s ‘‘review and sunset,’’ there is a 

duty to carry out a review of a 

regulation on a specified schedule. This 

sunset clause was established upon the 

idea that even a rational regulation 

needs to be examined periodically to 

determine its grounds for remaining in 

force, as its validity may be 

compromised under any change in 

circumstances or its characteristics.84

An OECD report stated that ‘‘[g]iven 

such rationale, the sunset clause is 

considered as a critical component of 

efforts in regulatory quality 

improvement.’’ 85

These authorities indicate an 

emerging awareness that sunset 

provisions are useful in ensuring 

retrospective regulatory review. This is 

consistent with the Department’s 

experience over the last 40 years, which 

suggests that, absent a sunset provision 

or automatic expiration date, 

Congressional and Presidential 

directives to perform periodic 

retrospective reviews of regulations 

have limited success. 

Indeed, previous Administrations 

have recognized the benefits of sunset 

provisions. In a June 2015 report, the 

Department of Treasury’s Office of 

Economic Policy, the Obama 

Administration’s Council of Economic 

Advisors, and the Department of Labor 

discussed sunset provisions as applied 

to occupational licensing.86 That report 

found evidence that sunset reviews that 

automatically terminate regulatory 

boards and agencies absent legislative 

action assist with ‘‘removing 

unnecessary licensing.’’ 87 The report 

explained that sunset review can be 

‘‘useful because, even if licensing was 

justified when first introduced, 

technological and economic changes 

may have rendered it unnecessary or 

overly restrictive.’’ 88 The report found 

‘‘[p]eriodic examination of existing rules 

is thus helpful in maintaining the 

quality of occupational regulation.’’ 89

Professor Greenstone has similarly 

recommended the automatic repeal of 

regulations if their benefits and costs are 

not periodically assessed: 

[Another] step in reforming our regulatory 

system is to require that all regulations 

contain rules specifying the date by which 

the regulatory review board has to assess 

their costs and benefits. If the regulatory 

review board fails to meet one of these 

deadlines, then the regulation should be 

repealed by default. The purpose of this 

sunset provision is to ensure that all 

regulations are evaluated carefully and do 

not stay on the books just because they have 

been on the books in the past.90

Professor Greenstone suggested that 

this review could cause the regulation to 

be expanded if supported by evidence.91

According to Professor Greenstone, this 

would ‘‘ensure that ineffective 

regulations are removed and that society 

fully benefits from the effective ones.’’ 92

This final rule seeks to advance 

democratic values and apply the lessons 

learned from States, foreign 

jurisdictions, and the academic 

community. This final rule would apply 

the benefits of automatic-expirationabsent-periodic-review to a broader 

array of regulations than is currently 

being reviewed by the Department. 

E. The Need for Widespread 

Retrospective Review 

The evidence suggests the Department 

should conduct retrospective review on 

a broad scale to improve impact 

estimates and enhance the Department’s 

ability to fulfil the goals motivating its 

regulations. As explained in Section C, 

studies of federal regulations 

consistently find that, in most sampled 

regulations, the ex ante estimate of costs 

and benefits is not within +/¥25% of 

the ex post observation. Although these 

samples were not necessarily 

representative, taken together they 

suggest that many federal regulations 

are estimated after the fact to have realworld impacts that differ from the 

estimated impacts at the time the 

regulations were promulgated. 

Therefore, HHS believes that review 

should be done on a broad scale, rather 

than reviewing a handful of regulations 

that happen to be brought to the 

Department’s attention. 

The artificial intelligence review 

described in this final rule also suggests 

that large numbers of Department 

regulations would benefit from 

retrospective review. The artificial 

intelligence review identified that 85% 

of Department regulations created before 

1990 have not been edited; the 

Department has nearly 300 broken 

citation references 93 in the CFR; and 

there are more than 50 instances of HHS 

regulatory requirements to submit paper 

documents in triplicate or 

quadruplicate.94 This suggests that 

humans performing a comprehensive 

review of Department regulations would 

find large numbers of requirements that 


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95See, e.g., Coronavirus waivers and flexibilities, 

CMS.gov, https://www.cms.gov/about-cms/ 

emergency-preparedness-response-operations/ 

current-emergencies/coronavirus-waivers. 96E.g., 21 CFR part 112. 

97E.g., 45 CFR part 147. 

98 45 CFR part 261. 

99See FCC v. Fox TV Stations, Inc., 556 U.S. 502, 

515–16 (2009) (‘‘[A] reasoned explanation is needed 

for disregarding facts and circumstances that 

underlay or were engendered by the prior policy,’’ 

but the agency ‘‘need not demonstrate to a court’s 

satisfaction that the reasons for the new policy are 

better than the reasons for the old one; it suffices 

that the new policy is permissible under the statute, 

that there are good reasons for it, and that the 

agency believes it to be better, which the conscious 

change of course adequately indicates’’) (emphasis 

in original). 

100See, e.g., 85 FR 70120. 

101See, e.g., Regulatory Flexibility Act Section 

610 Review of the Testing and Labeling Regulations 

Pertaining to Product Certification of Children’s 

Products, Including Reliance on Component Part 

Testing, 85 FR 52078 (Aug. 24, 2020). 

would benefit from review, and possibly 

amendment or rescission. 

The HHS response to the COVID–19 

pandemic also indicates that the 

Department should perform widespread 

retrospective reviews. During the 

COVID–19 pandemic, the Department’s 

response has largely consisted of 

waiving regulatory requirements or 

exercising enforcement discretion to not 

enforce certain regulatory requirements 

to enhance the Nation’s response to the 

pandemic. Examples include waivers to 

increase hospital capacity, ease 

restrictions on services rendered by 

medical residents, and allowing patients 

to seek more services via telehealth.95

On November 25, 2020, the Department 

published in the Federal Register a nonexhaustive list of 382 enforcement 

discretion announcements, waivers or 

changes to regulations, agency guidance 

materials, or compliance obligations 

made to respond to the COVID–19 

pandemic and its impact on the 

healthcare industry. See Regulatory 

Relief to Support Economic Recovery; 

Request for Information (RFI), 85 FR 

75720 (Nov. 25, 2020) at Attachment A. 

The Department should learn from the 

pandemic and conduct widespread 

reviews to determine whether these or 

other regulatory requirements could 

hinder the Nation’s response to a future 

emergency, or otherwise should be 

amended or rescinded. Determining 

whether the Department’s existing 

18,000 regulations are having 

appropriate impacts is a worthwhile 

enterprise, even if it somewhat reduces 

the time spent issuing new regulations. 

Some commenters at the November 23, 

2020 public hearing on the proposed 

rule suggested that the proposed rule 

was akin to using a missile to kill a 

mouse. But the literature and the 

Department’s experience indicate the 

problem is not a mere mouse. 

Thus, there is a need for widespread 

retrospective review, but it is nearly 

impossible to see how a satisfyingly 

comprehensive review could occur 

without a sunset mechanism. The 

Department recognizes that in many 

cases the Department had strong reasons 

for issuing its regulations. Examples of 

such motivations might include 

enhancing food safety,96 increasing 

access to health insurance,97 or 

increasing the incentive for Temporary 

Assistance for Needy Families 

recipients to work.98 These are all 

important policy goals that the 

Department wishes to achieve. This 

final rule is intended to further these 

goals, as well as the other goals 

motivating the Department’s 

regulations. The literature and the 

Department’s experience suggest that 

large numbers of regulations are having 

impacts that, over time, differ from what 

was estimated at the time the 

regulations were promulgated. 

Therefore, the Department needs to 

conduct periodic reviews of its 

regulations to determine whether the 

policy goals behind the regulations are 

in fact being effected (and if amending 

those regulations could more effectively 

further those goals). 

This final rule is not a reversal of a 

prior Department policy, but in fact an 

effort to enhance both (1) the fulfillment 

of the existing policies that led to the 

Department’s regulations and (2) the 

Department’s longstanding desire to 

comply with the RFA and periodically 

review its regulations. In any event, this 

final rule provides the reasoned 

explanation that would be required if it 

were a change in policy.99

F. Operationalization of This Final Rule 

In this section, the Department 

summarizes aspects of how it will 

operationalize this final rule. 

The proposed rule proposed creating 

a website where the Department would 

announce when it has commenced 

Assessments or Reviews. The proposed 

rule further proposed that the public 

could comment on regulations and 

submit comments requesting that the 

Department Assess or Review a 

regulation.100

In light of public comments, the 

Department is making these procedures 

more robust. Under this final rule, when 

the Department commences the process 

of performing an Assessment or Review, 

it shall state on a Department-managed 

website the sections of the Code of 

Federal Regulations whose Assessment 

or Review it is commencing. The 

Department shall also announce once a 

month in the Federal Register those 

new Assessments or Reviews that it has 

commenced in the last month. Some 

comments on the proposed rule said 

that announcements should be made in 

the Federal Register, which the public 

already monitors, rather than a separate 

website. Therefore, in response to these 

comments, in this final rule the 

Department commits to announcing 

once a month in the Federal Register 

which new Assessments and Reviews it 

has commenced. The Department will 

also create a docket on Regulations.gov 

for each Assessment or Review that the 

Department is conducting. These docket 

numbers will be referenced in the 

Federal Register announcements. The 

public will be able to submit comments 

to the dockets of each rulemaking being 

Assessed or Reviewed. Each docket 

shall specify the date by which 

comments must be received. There shall 

also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department Assess or Review a 

regulation. This addresses the 

commenters’ concern about commenting 

on a Department website, rather than via 

the regular Federal Register method. 

The Department anticipates that the 

process will be similar to that currently 

used by the EPA.101 The Department 

also intends to publish the results of the 

Assessments and Reviews in the dockets 

for the applicable regulations. 

To further aid the public and the 

Department, the Department is placing 

at https://www.hhs.gov/regulations/ 

federal-registry/index.html a list of 

Department rule makings; the year they 

were initially promulgated; the last year 

the rule making was amended; and the 

Federal Register citation from the time 

the rule making was amended. This list 

was generated with artificial 

intelligence and the Department 

believes it is accurate, but it is 

conceivable that some Department 

regulations are not included. This list 

includes all Department regulations, 

including those that may be exempt 

from this final rule. The Department 

believes it would be informative to the 

public to provide a list of all 

Department regulations, as well as their 

Federal Register citations and 

promulgation dates. The Department 

intends to update this list annually with 

newly-issued regulations. 

In addition, the Department intends to 

create on its website a dashboard that 

shows its progress on its Assessments 

and Reviews, including when it 

commenced those Assessments and 

Reviews; its progress; and when it 

expects them to be completed. If they so 


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102The Department’s information technology 

personnel are currently undertaking a large data 

migration that had been planned for a long time. 

Therefore, the dashboard will not be active as of the 

date this final rule is published. But the Department 

intends for this dashboard to be active well in 

advance of 2026, when the first Assessments and 

Reviews must be completed. 

103 Including certain ones inadvertently not listed 

in the proposed rule. 

104See, 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). 

105See, e.g., Control of Communicable Diseases; 

Foreign Quarantine, 85 FR 7874, 7874 (Feb. 12, 

2020) (providing that, unless extended, interim 

final rule ‘‘will cease to be in effect on the earlier 

of (1) the date that is two incubation periods after 

the last known case of 2019–nCoV, or (2) when the 

Secretary determines there is no longer a need for 

this interim final rule’’); Medicare and Medicaid 

Programs, Clinical Laboratory Improvement 

Amendments (CLIA), and Patient Protection and 

Affordable Care Act; Additional Policy and 

Regulatory Revisions in Response to the COVID–19 

Public Health Emergency, 85 FR 54820, 54820 

(Sept. 2, 2020) (providing that an interim final rule 

applies ‘‘for the duration of the [public health 

emergency] for COVID–19’’); U.S. Dep’t of Transp., 

Final Regulatory Impact Analysis: Amendment to 

Federal Motor Vehicle Safety Standard 208 

Passenger Car Front Seat Occupant Protection, at 

XII–35 (July 11, 1984), http://wwwnrd.nhtsa.dot.gov/Pubs/806572.pdf (explaining that 

‘‘[i]f mandatory use laws are passed that will cover 

67 percent of the population effective September 1, 

1989, the rule will be rescinded’’). 

106See, e.g., 21 CFR 1.1(b) (‘‘the definitions and 

interpretations of terms contained in sections 201 

and 900 of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 321 and 387) shall be applicable also 

to such terms when used in regulations 

promulgated under that act’’); 7 CFR 786.113 

(‘‘Notwithstanding any other regulation, interest 

will be due from the date of the disbursement to 

the producer or other recipient of the funds’’); 40 

CFR 455.21 

(‘‘Notwithstanding any other regulation, process 

wastewater flow for the purposes of this subpart 

does not include wastewaters from the production 

of intermediate chemicals’’); 45 CFR 611.12 (‘‘All 

regulations . . . heretofore issued by any officer of 

the Foundation which impose requirements 

designed to prohibit any discrimination against 

individuals on the ground of race, color, or national 

origin under any program to which this part 

applies, and which authorize the suspension or 

termination of or refusal to grant or to continue 

Federal financial assistance to any applicant for or 

recipient of such assistance for failure to comply 

with such requirements, are hereby superseded to 

the extent that such discrimination is prohibited by 

this part,’’ with certain exceptions); 7 CFR 3430.1 

(‘‘In cases where regulations of this part conflict 

with existing regulations of NIFA in Title 7 (i.e., 7 

CFR parts 3400 through 3499) of the Code of 

Federal Regulations, regulations of this part shall 

supersede’’); 24 CFR 943.118 (‘‘The participating 

PHAs must adopt the same fiscal year so that the 

applicable periods for submission and review of the 

joint PHA Plan are the same. Notwithstanding any 

other regulation, PHAs proposing to form consortia 

may request and HUD may approve changes in PHA 

fiscal years to make this possible’’) (emphasis 

added). 

choose, the public can view this 

dashboard to see the Department’s 

progress on its Assessments and 

Reviews of particular regulations. The 

dashboard will also help to keep the 

Department on track to timely complete 

Assessments and Reviews.102

Finally, the Department will, within 

nine months of publication of this final 

rule, publish in the Federal Register its 

schedule for conducting Assessments 

and Reviews. The Department’s goal is 

to provide the public with more 

information on which regulations it 

intends to Assess or Review in the next 

24 months, so that the public can plan 

ahead for any desired engagement on 

those regulations. The Department will 

subsequently publish in the Federal 

Register its schedule for conducting 

Assessments and Reviews of regulations 

that the Department does not intend to 

review in the first 24 months. However, 

the Department expects that this 

schedule will be aspirational in nature 

to ensure Departmental flexibility to 

depart from the plan if needed to 

respond to changing circumstances. The 

Department will update the plan at 

appropriate intervals based on its 

progress. 

III. Statutory Authority and Legal Basis 

for This Final Rule 

The statutory authorities supporting 

this final rule are the statutory 

authorities for the Department’s existing 

regulations.103 85 FR 70103. The 

Department finalizes herein its proposal 

to amend its regulations to add 

expiration dates unless the Department 

periodically conducts the required 

Assessment or Review of the 

regulations, or an exception applies. 

Some of the Department’s primary 

rulemaking authorities include: 

• Section 701(a) of the Federal Food 

Drug and Cosmetic Act (FD&C Act), 21 

U.S.C. 371(a), which authorizes the 

Secretary to ‘‘promulgate regulations for 

the efficient enforcement of [the FD&C 

Act], except as otherwise provided in 

this section’’; 

• Section 1102 of the Social Security 

Act, 42 U.S.C. 1302, which provides 

that the Secretary ‘‘shall make and 

publish such rules and regulations, not 

inconsistent with this Act, as may be 

necessary to the efficient administration 

of the functions with which [he] is 

charged under this Act’’; 

• Section 1871 of the Social Security 

Act, 42 U.S.C. 1395hh, which provides 

that ‘‘the Secretary shall prescribe such 

regulations as may be necessary to carry 

out the administration of the insurance 

programs under this title’’; and 

• 5 U.S.C. 301, which provides that 

‘‘[t]he head of an Executive department 

or military department may prescribe 

regulations for the government of his 

department, the conduct of its 

employees, the distribution and 

performance of its business, and the 

custody, use, and preservation of its 

records, papers, and property. This 

section does not authorize withholding 

information from the public or limiting 

the availability of records to the public.’’ 

It complies with the Administrative 

Procedure Act (APA) to amend 

regulations to add dates by which the 

regulations expire unless a review of the 

regulation is timely performed. An 

agency can, through notice-andcomment rulemaking, amend its 

regulations to provide that they expire 

at a future date.104 An agency can also 

provide that its regulations expire when 

an event occurs or ceases to occur.105

That is what this final rule does. 

Moreover, Agencies can—and often 

do—issue one rule that applies to many 

other agency rules, rather than 

amending or rescinding each affected 

regulation individually. To take one 

example, in 2008 the Department 

revised the definition of ‘‘entity’’ at 42 

CFR 411.351. See 73 FR 48434, 48751 

(Aug. 19, 2008). The revised definition 

had the effect of changing the meaning 

of ‘‘entity’’ each time it was used in 42 

CFR part 411, subpart J. It would be 

burdensome to specify the meaning of 

‘‘entity’’ each time it appears in Subpart 

J, so the Department issued one 

definition that broadly applied to all 

sections of Subpart J. 

There are many other examples where 

an Agency issues a regulation that 

applies to, amends, rescinds, or 

supersedes many other regulations.106

This avoids an unnecessarily 

cumbersome process. A court ruling that 

agencies must amend each individual 

regulation would call into question large 

numbers of agency regulations and 

impose substantial burdens on agencies 

(and the Office of the Federal Register, 

which would be required to print the 

same text over and over) when 

promulgating future regulations. 

Moreover, in this rule making the 

Department considered each individual 

Department regulation, and, as 

discussed further, decided to exempt 

certain regulations. The Department 

concluded that this final rule should 

apply to and amend its remaining 

regulations, because this final rule will 

enhance both (1) the fulfillment of the 

existing policies that led to those 


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107E.g., 21 CFR part 112. 

108E.g., 45 CFR part 147. 

109 45 CFR part 261. 

110The Department proposed to add substantively 

identical provisions to Titles 21, 42, and 45. For 

concision, in this section the Department describes 

these provisions once, rather than repeating the 

same substantive provisions several times. The 

Department uses the phrase ‘‘[XX]’’ to refer to the 

fact that substantively identical provisions will be 

added to chapters in Titles 21, 42, and 45. 

111See 85 FR 70096. 

regulations and (2) the Department’s 

longstanding desire to comply with the 

RFA and periodically review its 

regulations. There is a need for 

widespread retrospective review, but it 

is nearly impossible to see how a 

satisfyingly comprehensive review 

could occur without a sunset 

mechanism. The Department recognizes 

that in many cases the Department had 

strong reasons for issuing its 

regulations. Examples of such 

motivations might include enhancing 

food safety,107 increasing access to 

health insurance,108 or increasing the 

incentive for Temporary Assistance for 

Needy Families recipients to work.109

These are all important policy goals that 

the Department wishes to achieve. This 

final rule is intended to further these 

goals, as well as the other goals 

motivating the Department’s 

regulations. The literature and the 

Department’s experience suggest that 

large numbers of regulations are having 

impacts that, over time, differ from what 

was estimated at the time the 

regulations were promulgated. 

Therefore, the Department needs to 

conduct periodic reviews of its 

regulations to determine whether the 

policy goals behind the regulations are 

in fact being effected (and if amending 

those regulations could more effectively 

further those goals). The Department 

concluded that the benefits of 

retrospective review, and need to more 

strongly incentivize it, justified this 

course of action. Forty years of 

experience since the RFA’s enactment; 

the decades since relevant Executive 

Orders were enacted; and other Federal 

government efforts to spur the 

Department to conduct more 

retrospective reviews indicate that, 

absent this final rule’s pushing 

mechanism, the Department will not 

conduct as many retrospective reviews 

as desired. In addition, the Department 

will consider each individual Section 

when conducting Assessments and (if 

needed) Reviews. 

The Department also notes the text of 

5 U.S.C. 610 indicates Congress believed 

agencies had the authority to 

periodically review at least those 

regulations that have a significant 

economic impact upon a substantial 

number of small entities (and that the 

agency had the authority to assess 

which of its regulations have such an 

impact). 

The Department received comments 

on the statutory authority for the 

proposed rule. Below the Department 

summarizes these comments and 

responds to them. 

IV. Provisions of Proposed Rule and 

Response to Public Comments 110

On November 4, 2020, HHS published 

in the Federal Register the proposed 

rule.111 Part of the proposed rule had a 

30-day public comment period, and part 

of it had a 60-day comment period to 

comply with 42 U.S.C. 1395hh(b). In 

response to the publication of that 

proposed rule, HHS received 486 

comments from industry trade 

organizations, healthcare providers, 

businesses, legal/policy think tanks, 

non-profit public interest groups, and 

members of the U.S. Congress during 

the initial 30-day public comment 

period, and 532 comments total 

throughout the 60-day comment period. 

Commenters generally opposed the 

proposed rule, although some 

commenters supported it. Roughly a 

quarter of commenters requested that 

the Department withdraw the proposed 

rule. Some commenters requested that 

the Department extend the public 

comment period. 

The Department also held a public 

hearing on the proposed rule on 

November 23, 2020. Twenty-one 

members of the public, all representing 

either unions, public-interest groups, or 

industry trade organizations, spoke. The 

speakers at the public hearing all either 

expressed concerns about the proposed 

rule, opposed it, or requested that the 

Department withdraw it. Both a 

transcript and recording of the public 

hearing are available at https://

beta.regulations.gov/docket/HHS-OS2020-0012/document. 

In the following sections, HHS 

includes a summary of the provisions of 

the proposed rule, the public comments 

received, HHS’s responses to the 

comments, and any changes made to the 

regulatory text as a result. 

General Purpose of the Proposal and 

General Comments 

5 U.S.C. 610 and Executive Orders 

12866 and 13563 direct agencies to 

devise plans to periodically review 

certain of their regulations using certain 

criteria. By requiring the Department to 

periodically perform such reviews, this 

final rule implements Congress’s and 

the President’s desires for retrospective 

review of regulations. This final rule 

will lead to the amendment or 

rescission, where appropriate, of 

Department regulations that have a 

significant economic impact upon a 

substantial number of small entities. 

This final rule also furthers democratic 

values such as accountability, 

administrative simplification, 

transparency, and performance 

measurement and evaluation. 

General Comments and Responses 

Comment: A few commenters stated 

that the retrospective review of 

regulations proposed by the rule is an 

important and necessary tool for 

improving agency regulation and 

minimizing unnecessary regulatory 

burdens. Commenters listed the many 

benefits of this approach, including the 

refining of regulations using real-world 

data and experience, improving 

government accountability, avoiding the 

natural tendency of agency officials 

charged with achieving public benefits 

to focus on pursuing those benefits and 

not on reducing the burdens of their 

regulation to the public, and preventing 

the continued enforcement of obsolete, 

outdated, and even unintentionally 

harmful regulations. Some commenters 

stated that it is axiomatic that periodic 

retrospective review is essential to the 

proper functioning of the executive 

branch. 

Response: The Department agrees, 

and believes this final rule will achieve 

these benefits. 

Comment: A few commenters stated 

that beyond simply cutting regulatory 

burdens, the scheduled assessments 

and, when necessary, reviews of 

existing HHS regulations afford HHS the 

opportunity to keep regulations up to 

date with modern trends. Commenters 

noted that not only will this rule 

establish an opportunity for the 

Department to terminate obsolete 

regulations that are no longer fit for 

purpose or that are judged to be 

ineffective, but it will also give HHS and 

the public a reliable framework and a 

set of tools to continually keep 

regulations up to date with evolving 

circumstances. 

Response: The Department agrees and 

emphasizes that the benefits of 

retrospective review—some of which 

are cited by these commenters—are 

substantial. As the proposed rule noted, 

Professor Cass Sunstein, who served as 

OIRA Administrator from 2009 to 2012, 

has observed that ‘‘the requirement of 

retrospective analysis,’’ if ‘‘firmly 

institutionalized,’’ ‘‘would count as the 

most important structural change in 

regulatory policy since the original 


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112Cass R. Sunstein, The Regulatory Lookback, 94 

B.U. L. Rev. 579, 584 (2014). 

requirement of prospective analysis 

during the Reagan Administration.’’ 112

Comment: A large number of 

commenters stated that the proposed 

rule will cause an additional burden to 

the Department and a diversion of the 

Department’s personnel resources. Some 

of these commenters suggested that the 

regulatory review process could 

adversely affect the Department’s ability 

to focus on the administration of current 

programs, to issue new regulations, and 

to appropriately review current 

regulations needing modification. 

Commenters also raised specific 

concern about the initial review of 

regulations that are over ten years old 

within two years after the calendar year 

in which this rule is finalized. Those 

commenters expressed concern that 

HHS would be unable to Assess or 

Review all 12,400 regulations that the 

Department estimates will fall under 

this category because of the high volume 

of regulations. A number of commenters 

stated that two years is an arbitrary and 

inadequate timeline for all 12,400 

regulations to be Assessed or Reviewed, 

and some regulations could expire 

simply because the Department did not 

have enough time to conduct an 

Assessment or Review. Several 

commenters also stated that they believe 

the Department’s estimate that 12,400 of 

its regulations are over ten years old is 

lower than the actual number, although 

no commenter provided an independent 

count of HHS regulations to support this 

assertion. A few commenters pointed 

out that after an Assessment or Review 

occurs, there may be additional need for 

rulemaking or revision of regulations, 

which is an additional cost the 

Department does not contemplate in its 

estimate. A few commenters stated that 

it was unclear where HHS plans to 

obtain the funding and personnel 

resources needed to implement this 

regulatory review process. 

Response: The Department has 

considered the public comments, and 

decided that, for regulations that are 

more than ten years old on the effective 

date of this final rule, the Department 

shall have five years, rather two as 

proposed in the proposed rule, to 

complete the Assessments and (if 

needed) Reviews. This will spread out 

the initial burden and provide the 

opportunity for more robust 

Assessments and Reviews. The 

regulatory impact analysis in this final 

rule explains how HHS has the 

resources and personnel to perform the 

Assessments and Reviews called for by 

this final rule. Moreover, the Regulatory 

Flexibility Act already calls for the 

Department to assess which of its 

regulations have a significant economic 

impact upon a substantial number of 

small entities, and to review those 

regulations every ten years. Therefore, 

assuming full compliance with the RFA, 

this rule does not impose any additional 

burden on the Department beyond what 

was already called for in the RFA. 

To the extent there are additional 

burdens resulting from this regulation, 

HHS believes widespread retrospective 

review is a worthwhile enterprise. The 

literature and the Department’s 

experience suggest that large numbers of 

regulations are having impacts that, over 

time, differ from what was estimated at 

the time of promulgation. The 

Department should conduct periodic 

reviews to determine whether the policy 

goals behind the regulations are in fact 

being effected (and if amending those 

regulations could more effectively 

further those goals). Thus, it is sensible 

to periodically review existing 

regulations, even if it takes some time 

away from issuing new regulations 

(many of which, the literature suggests, 

would have impacts that differ from 

their estimated impacts at the time of 

promulgation). 

HHS also notes that courts ‘‘have no 

basis for reordering agency priorities. 

The agency is in a unique—and 

authoritative—position to view its 

projects as a whole, estimate the 

prospects for each, and allocate its 

resources in the optimal way.’’ In re 

Barr Labs., Inc., 930 F.2d 72, 76 (D.C. 

Cir. 1991). For the reasons discussed 

herein, the Department has done this, 

and determined that Reviews and 

Assessments should be a priority. 

Lastly, we note that the COVID–19 

pandemic imposed a tremendous, 

unforeseen burden on the Department, 

yet there has been no material drop in 

the Department’s ability to promulgate 

new regulations or enforce existing 

regulations. This suggests that after the 

pandemic, the Department will be 

resourceful enough to perform 

Assessments and Reviews, as well as 

promulgate new regulations that need to 

be promulgated and appropriately 

enforce existing regulations. 

Comment: A few commenters stated 

that the benefits of this final rule are 

difficult to fully anticipate, and there 

are a number of reasons to believe that 

the benefits of this rulemaking will 

vastly outweigh the costs. For example, 

if HHS were to find cost savings worth 

0.0025 percent of departmental 

spending or 0.0007 percent of national 

spending, the regulation would pay for 

itself and pass a cost-benefit test at the 

higher end of cost estimates. 

Response: The regulatory impact 

analysis for this final rule describes 

what the Department expects to be the 

primary impacts resulting from this 

final rule. 

Comment: A large number of 

commenters stated that, as proposed, 

this rule would divert resources from 

the Department’s COVID–19 pandemic 

response efforts. Many of these 

commenters stated that it is 

irresponsible for the Department to 

create a retrospective regulatory review 

process at a time when it should be 

devoting all of its resources to 

combatting COVID–19. 

Response: HHS respectfully disagrees 

with this comment. Due to the changes 

made from the proposed rule, under this 

final rule the first Assessments and 

Reviews need not be completed until 

the end of 2026. The Department 

believes the pandemic will be over by 

then. 

In fact, the COVID–19 pandemic has 

reinforced the need for this final rule. 

The Department’s response to the 

pandemic has largely consisted of 

waiving regulatory requirements or 

exercising enforcement discretion to not 

enforce certain regulatory requirements 

during the pandemic. See, e.g., 

Coronavirus waivers and flexibilities, 

CMS.gov, https://www.cms.gov/aboutcms/emergency-preparedness-responseoperations/current-emergencies/ 

coronavirus-waivers; Regulatory Relief 

to Support Economic Recovery; Request 

for Information (RFI), 85 FR 75720 (Nov. 

25, 2020) at Attachment A (nonexhaustive list of enforcement 

discretion announcements or changes to 

regulations, agency guidance materials, 

or compliance obligations made to 

respond to the COVID–19 pandemic and 

its impact on the healthcare industry). 

The Department should learn from the 

pandemic and consider whether to 

retain regulatory requirements that were 

waived or where flexibility was 

provided during the Nation’s response 

to COVID–19, as well as consider the 

impact its regulations could have on the 

response to a future pandemic or other 

emergency. 

Comment: A large number of 

commenters viewed the 30-day 

comment period (which began on 

November 4, 2020, the day that the 

Federal Register published the 

proposed rule and the day after the rule 

went on public display) as too short. A 

large number of these commenters 

stated that the proposed rule should be 

withdrawn for various reasons, or in the 

alternative, requested a longer comment 

period if the proposed rule was not 

withdrawn. Commenters’ reasons for 

asking for an extension included lack of 


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113See N.C. Growers’ Ass’n, Inc. v. United Farm 

Workers, 702 F.3d 755, 770 (4th Cir. 2012) (APA 

requires ‘‘meaningful’’ opportunity to comment); 

Petry v. Block, 737 F.2d 1193, 1201 (D.C. Cir. 1984) 

(relying on Administrative Conference of the United 

States’ view that 30-day comment period is 

inadequate and 60-day comment period is the 

reasonable minimum time for comment). 

114Exec. Order No. 12866 of Sept. 30, 1993, 58 

FR 190 (Oct. 4, 1993). 

115See also Exec. Order No. 13563 of Jan. 18, 

2011, 76 FR 3821 (Jan. 21, 2011) (‘‘To the extent 

feasible and permitted by law, each agency shall 

afford the public a meaningful opportunity to 

comment through the internet on any proposed 

regulation, with a comment period that should 

generally be at least 60 days.’’). 

116A commenter pointed to 21 CFR 10.40(b)(2) as 

counseling in favor of a 60-day comment period. 

But that provision by its terms applies only to the 

FDA Commissioner. The proposed rule was issued 

by the Secretary. 

117For example, fifty-six (56) new rules were 

finalized in the final two (2) full days of the 

previous Administration. See Federal Register, 

https://www.federalregister.gov/documents/ 

search?conditions%5Bpublication_

date%5D%5Bgte%5D=

1%2F18%2F2017&conditions%5Bpublication_

date%5D%5Blte%5D=1%2F20%

2F2017&conditions%5Btype%5D%5B%5D=RULE. 

advanced notice of the proposed rule, 

the perceived magnitude of the rule, 

fewer resources available to commenters 

due to the COVID–19 pandemic and the 

Thanksgiving holiday, and the number 

of topics on which the Department 

requested comment. 

A large number of commenters stated 

that the 30-day comment period violates 

the Administrative Procedure Act 

(‘‘APA’’) because it denies meaningful 

‘‘opportunity to participate in the rule 

making’’ required by 5 U.S.C. 553(c).113

A few commenters specifically 

mentioned that while there is no 

established minimum comment period 

prescribed by the APA, Executive Order 

12866 states that the public’s 

opportunity to comment, ‘‘in most cases 

should include a comment period of not 

less than 60 days,’’ although shorter 

comment periods have been upheld in 

the face of exigent circumstances.114

Other commenters said the Department 

should not finalize the rule until the 

next Administration enters office. 

Response: While HHS understands 

the commenters’ desire for more time, 

the comment period was adequate. 

Neither the APA, nor any other statute 

requires a longer comment period for 

the proposed rule. Instead, the APA 

merely requires that ‘‘[a]fter notice 

required by this section, the agency 

shall give interested persons an 

opportunity to participate in the rule 

making through submission of written 

data, views, or arguments with or 

without opportunity for oral 

presentation.’’ 5 U.S.C. 553(c). This 

occurred here. The comment period 

provided ample time for the submission 

of 486 comments by a variety of 

interested parties, including extensive 

comments by a number of entities just 

by the end of the 30-day period. Those 

comments offer a broad array of 

perspectives on the proposed rule. The 

number and comprehensiveness of the 

comments received disprove 

commenters’ claim that the 30-day 

comment period was insufficient time 

for commenters to provide meaningful 

comment. Accordingly, after reviewing 

the public comments and the requests 

for additional time, the Department does 

not believe that extending the comment 

period is or was necessary for the public 

to receive sufficient notice of, and 

opportunity to meaningfully comment 

on, the proposed rule. Nor is there 

anything that would have required 

additional outreach outside of the 

public notice and comment process and 

the comment period. 

Moreover, under this final rule, the 

public will have a robust opportunity to 

comment on each regulation during the 

Assessment or Review process. 

HHS respectfully disagrees that 

Executive Order 12866 requires a 60-day 

comment period for this rule. Executive 

Order 12866 repeats the baseline 

requirement that ‘‘each agency should 

afford the public a meaningful 

opportunity to comment on any 

proposed regulation,’’ which ‘‘in most 

cases should include a comment period 

of not less than 60 days.’’ 115 Neither 

Executive Order mandates a 60-day 

comment period. That is why many 

HHS, and other agency, regulations are 

issued with shorter comment periods. 

No commenter pointed to a court 

decision vacating a rule based on a 

failure to comply with an Executive 

Order’s supposed 60-day comment 

period requirement. As explained 

above, the volume of comments 

received demonstrates that the public 

has been afforded a meaningful 

opportunity to comment.116

Moreover, a portion of the proposed 

rule had a 60-day public comment 

period because 42 U.S.C. 1395hh(b) 

requires a 60-day comment period 

before issuing or amending certain 

Medicare regulations. The Department 

did not finalize this rule until after the 

60-day comment period closed, and the 

Department has considered all 

comments, including those received 

throughout the 60-day comment period, 

before finalizing this rule. In all, the 

Department received 532 comments by 

the end of the 60-day comment period. 

Lastly, past practice has often been to 

finalize rules that are ready for 

finalization without waiting for the 

incoming Administration to take 

office.117

Comment: A few commenters viewed 

the 30-day comment period as 

insufficient because some of the 

regulations that will be amended by this 

final rule had a comment period that 

lasted more than 30 days when they 

were originally promulgated. 

Response: HHS respectfully disagrees 

with these commenters. Not only did 

the Department not finalize this rule 

until after the 60-day comment period 

closed, but the APA does not specify a 

required length for comment periods 

when issuing or amending regulations. 

The APA has already ‘‘established the 

maximum procedural requirements 

which Congress was willing to have the 

courts impose upon agencies in 

conducting rulemaking procedures.’’ Vt. 

Yankee Nuclear Power Corp. v. Natural 

Res. Def. Council, Inc., 435 U.S. 519, 

524 (1978). Neither courts nor regulated 

entities may ‘‘impose upon [an] agency 

its own notion of which procedures are 

‘best’ or most likely to further some 

vague, undefined public good.’’ Id. at 

549. The number and 

comprehensiveness of the comments 

received disprove commenters’ claim 

that the comment period was 

insufficient. A portion of the proposed 

rule had a 60-day public comment 

period because 42 U.S.C. 1395hh(b) 

requires a 60-day comment period 

before issuing or amending certain 

Medicare regulations. But for many 

other Department regulations, Congress 

has enacted no requirement specifying a 

particular comment period. 

Comment: Several commenters stated 

that they found it unfair that the 

proposed rule had a 30-day comment 

period, but parties regulated by CMS 

have 60 days to comment on the portion 

of the proposed rule pertaining to 

certain CMS regulations. Commenters 

mentioned that they believed this could 

present a fundamental due process 

issue. 

Response: As stated in the proposed 

rule, Congress required a 60-day public 

comment period before issuing or 

amending certain Medicare regulations. 

See 42 U.S.C. 1395hh(b); 85 FR at 70104 

n.87. No similar statutory requirement 

applies to most other Department 

regulations. 

Comment: Several commenters stated 

that seven days’ notice prior to the 

public hearing on the proposed rule was 

insufficient time to prepare remarks for 

the public hearing. The same 

commenters also stated that holding the 

public hearing 10 days before the close 

of the comment period on the rule was 

insufficient time for commenters to 


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118 85 FR at 70097. 

119 Jason A. Schwartz, 52 Experiments with 

Regulatory Review: The Political and Economic 

Inputs into State Rulemakings, Inst. for Policy 

Integrity, Rep. No. 6, at 33 (Nov. 2010), https://

policyintegrity.org/files/publications/52_

Experiments_with_Regulatory_Review.pdf. 120See 85 FR at 70102 n.69. 

meaningfully incorporate the testimony 

and learnings from the public hearing 

into their written comments. 

Response: HHS respectfully disagrees. 

While the specific date of the hearing 

(November 23, 2020) was published in 

the Federal Register on November 16, 

2020, notice that a hearing would be 

held was provided in the proposed rule 

itself.118 Thus, commenters were on 

notice 19 days (November 4, 2020, to 

November 23, 2020) prior to the hearing 

and had 19 days to prepare remarks for 

the hearing. And as these comments 

themselves show, choosing the date for 

the public hearing requires a balance 

between, first, giving the public 

sufficient time to review the proposed 

rule, and second, giving the public 

adequate time to review comments 

made at the hearing before submitting 

written comments. Scheduling the 

hearing on November 23, 2020 reflected 

an appropriate balance of these 

considerations. 

Comment: Several commenters were 

supportive of the rule and expressed 

that the provisions of the Regulatory 

Flexibility Act should be followed to 

increase transparency, public 

participation, and administrative 

accountability. These commenters 

appreciated the Department’s efforts to 

ensure recurring attention to the impact 

of its rules on small and independent 

businesses, and minimize the regulatory 

burden it imposes on these entities. 

These commenters also stated that 

regulatory review is a laudable goal that 

administrative agencies should be 

aiming for. 

Several commenters emphasized the 

importance of periodically reviewing 

old regulations to determine whether 

they should be updated to adapt to 

changing circumstances. For instance, a 

few commenters stated that the COVID– 

19 pandemic drew attention to the fact 

that many of the Health Insurance 

Portability and Accountability Act 

(HIPAA) regulations are out-of-date. 

Some commenters also stated that the 

process for developing regulatory 

impact analyses could be improved if, 

after each regulation is fully 

implemented, public comments were 

solicited on the accuracy of the 

assumptions underlying the original 

impact analysis. These commenters 

appreciated the Department’s efforts to 

consider and update its regulatory 

review process. 

Response: HHS agrees with these 

commenters that the final rule will 

implement the important goals of the 

Regulatory Flexibility Act, including 

transparency, public participation, 

administrative accountability, and a 

more streamlined regulatory structure. 

The process set out in the proposed rule 

that is now being finalized will create a 

structured plan to operationalize the 

Department’s longstanding goals of 

reviewing and updating its regulations 

and—where needed—eliminating 

regulations that no longer serve their 

intended purpose(s) and unduly burden 

both small entities or the public at large. 

Requiring the solicitation of comments 

on the assumptions in regulatory impact 

analyses is beyond the scope of this 

final rule, but the public is welcome to 

submit such comments to the dockets of 

regulations being Assessed or Reviewed. 

Comment: A few commenters stated 

that the proposed rule does not provide 

sufficient examples of how this 

approach has worked in the past. A few 

commenters point out that the proposed 

rule cites an article that indicates that 

states have adopted and then abandoned 

similar approaches to adding automatic 

expirations dates. They also state that 

HHS dismisses this fact in the proposed 

rule without providing a compelling 

reason. Commenters stated that the 

examples where this approach has been 

used that the Department cites to in the 

proposed rule (U.S. states, the European 

Union, and the Republic of Korea) have 

no bearing or authority over federal 

rulemaking in the United States, where 

Congress through the APA has 

established procedures and standards 

for promulgating, updating, and 

rescinding regulations. They also stated 

that the executive actions reviewing 

regulations that are cited to in the 

proposed rule underscore that the 

Department does not need this rule to 

compel periodic regulatory review. 

Response: HHS respectfully disagrees. 

As explained in the proposed rule, 85 

FR at 70102 & nn.66–69, to the extent 

that states abandoned automatic 

expiration dates, they did so for reasons 

that are inapplicable to this situation, 

namely, the provisions’ failure to 

enhance legislative control. As 

explained in the regulatory impact 

analysis, at least one state that undid its 

sunset provision (North Carolina) 

subsequently reenacted a sunset process 

for regulations. The article that one 

commenter referenced 119 did not cite 

any empirical support for the 

proposition that automatic expirations 

produce ineffective or inadequate 

retrospective reviews where sufficient 

resources and staff are provided (as is 

the Department’s intent here).120

Second, the proposed rule referred to 

other jurisdictions’ sunsets to illustrate 

that (1) adding sunset provisions does 

not wreak havoc or cause undue 

uncertainty and (2) experience shows 

sunset provisions can be effective in 

achieving the benefits from robust 

retrospective review of regulations. The 

legal framework of federal rulemaking 

under the APA may differ from other 

jurisdictions, but that does not detract 

from the point that other jurisdictions’ 

experience shows that sunset provisions 

can be effective and do not lead to 

havoc or tremendous uncertainty. For 

the reasons explained in the proposed 

rule and this final rule, this final rule 

complies with the APA. 

The Department also disagrees with 

the commenters’ suggestion that the 

existence of limited and sporadic 

instances of retrospective review 

demonstrate this rule is not necessary. 

As explained in the proposed rule, the 

Department has failed to engage in 

comprehensive retrospective review of 

its rules notwithstanding the RFA and 

long-standing Executive Orders calling 

for such reviews. This history of limited 

compliance shows that the proposed 

rule being finalized is appropriate. 

Comment: Several commenters stated 

that the proposed rule was a political 

effort to cause difficulties for the 

incoming Biden Administration, which 

will be tasked with implementing this 

final rule. 

Response: HHS respectfully disagrees 

with these commenters because the 

purpose of this final rule is to require 

the Department to periodically review 

its regulations. The rule is not 

politically motivated, but is instead an 

effort to ensure the Department 

periodically reviews its regulations that 

have a significant economic impact 

upon a substantial number of small 

entities. In any event, based in part on 

comments received on the proposed 

rule, in this final rule the Department 

has extended the deadline to five 

calendar years to complete the 

Assessments and (if necessary) Reviews 

of regulations that are more than ten 

years old. Thus, the initial deadline will 

not occur in the next Presidential term. 

Comment: A few commenters stated 

that this rule is advancing the Trump 

Administration’s conservative agenda at 

the expense of good regulations that 

regulate health and safety for patients 

and consumers. Many of these 

commenters also indicated that the rule 

would put the interests of Wall Street 

ahead of the individual Americans who 


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121See, e.g., Curtis W. Copeland, Cong. Rsch. 

Serv., RL32801, Reexamining Rules: Section 610 of 

the Regulatory Flexibility Act 7–8 (2008); U.S. Gov’t 

Accountability Off., GAO/GGD–94–105, Regulatory 

Flexibility Act: Status of Agencies’ Compliance 12 

(1994) (quoting a 1983 Small Business 

Administration report that stated that the 

Department’s section 610 review plan was ‘‘ ‘very 

general,’ and, as a result, ‘it is difficult to measure 

progress and to make recommendations with 

respect to future review’ ’’); see also Testimony of 

The Hon. Thomas M. Sullivan, Chief Counsel for 

Advocacy, U.S. SBA, U.S. House of Representatives 

Comm. on Small Bus. Subcomm. on Reg.’s, Health 

Care and Trade (July 30, 2008), 

122See, e.g., Connor Raso, Assessing regulatory 

retrospective review under the Obama 

administration, Brookings Inst., (Jun. 15, 2017), 

https://www.brookings.edu/research/assessingregulatory-retrospective-review-under-the-obamaadministration/. 

123See, e.g., 85 FR at 70111 (explaining that as 

of 2019, 85% of Department regulations created 

before 1990 had not been edited, and the 

Department had nearly 300 broken citation 

references in the CFR). 

are affected by HHS regulations and 

benefit from the regulatory structures 

they create. 

Response: HHS respectfully disagrees. 

As emphasized in the proposed rule, 

(and this final rule) the Department 

intends to timely Assess and Review all 

covered regulations. Moreover, this final 

rule does not favor regulations of any 

particular ideological bent; it applies to 

all Department regulations, subject to 

the exceptions listed herein. Regulations 

that meet the RFA’s criteria will not be 

modified or rescinded. The focus and 

anticipated result of the proposed rule 

is to eliminate or streamline 

unnecessary regulatory burdens on 

small entities. Retrospective review 

enjoys bipartisan support and benefits 

all Americans. Some regulations may 

bestow privileges upon narrow 

constituencies by creating barriers to 

entry in their industry. Such regulations 

may also disproportionately burden 

small businesses, because small 

businesses may be the new entrants 

such regulations are intended to keep 

out. If these regulations do not meet the 

RFA’s criteria and are amended, small 

businesses and consumers may benefit 

from increased competition. 

Comment: A few commenters stated 

that regulations issued after this rule is 

finalized should include the date of 

promulgation to make it easy for the 

public to determine how old the 

regulation is and when it will be 

reviewed. 

Response: Rules already include their 

date of promulgation. To the extent the 

commenter requests that amendments to 

existing rules include the original date 

of promulgation, the Department may 

include this date in prospective 

rulemakings. Moreover, in conjunction 

with this final rule, the Department is 

placing at https://www.hhs.gov/ 

regulations/federal-registry/index.html a 

list of Department rulemakings, the year 

they were initially promulgated, the last 

year the rules were amended, and the 

Federal Register citation from the time 

the rule was last amended. This list was 

generated with artificial intelligence and 

the Department believes it is accurate, 

but it is conceivable that some 

Department regulations are not 

included. This list includes all 

Department regulations, including those 

that may be exempt from this final rule. 

The Department believes it would be 

informative to the public to provide a 

list of all Department regulations, as 

well as their Federal Register citations 

and promulgation dates. The 

Department intends to update this list 

annually with newly-issued regulations. 

Comment: One commenter stated that 

instead of the Department’s proposed 

schedule of regulatory review, each 

agency within HHS should include 

retrospective review compliance into its 

annual objectives and, perhaps, even 

into periodic Congressional reports. 

Response: The Department thanks the 

commenter for this suggestion, but 

experience suggests it would not be 

adequate to solve the problem. As noted 

in the proposed rule, the failure to 

adequately review existing significant 

regulations has already been well 

documented to Congress.121 It is also 

public knowledge.122 Nonetheless, such 

‘‘public shaming,’’ if that is what the 

commenter intends, has not resulted in 

the Department adequately conducting 

retrospective review. 

Comment: A large number of 

commenters stated that the proposed 

rule would be unnecessary and 

duplicative of the Department’s existing 

efforts to review its regulations. These 

commenters stated that the Department 

already updates some of its rules 

annually, and has updated other nonannual rules in the past. Other 

commenters believe that HHS is already 

doing a fulsome review as required by 

the RFA. Several commenters stated that 

in 2011, the Department posted its final 

plan for retrospective review of existing 

regulations, and from 2012–2016 it 

provided semi-annual updates on its 

website listing the rules undergoing or 

scheduled for review. Some commenters 

suggested that previous executive orders 

that called for periodic review of 

existing regulations are a sufficient 

means of ensuring the Department is 

conducting these periodic reviews. 

Commenters suggested that the 

Department continue to conduct 

retrospective reviews using its already 

established process and provide regular 

updates to the public on its progress. 

Other commenters stated that the 

Department does not address why it 

failed to perform the required regulatory 

reviews in the past, nor how the process 

proposed in the proposed rule will 

make a difference. 

A few commenters noted that even 

though previous executive orders have 

prioritized regulatory reviews, most 

observers to date note that these kinds 

of reviews have failed to be 

institutionalized by agencies, including 

HHS. These commenters cited evidence 

suggesting that despite efforts to review 

regulations over the years and to reduce 

regulatory burdens, the total number of 

regulatory restrictions that have been 

issued by HHS continues to grow year 

after year, except for two brief periods 

around 1980 and during the mid-1990s 

(perhaps as part of deregulatory efforts). 

Response: The Department 

respectfully disagrees that this final rule 

is unnecessary and duplicative. While 

commenters are correct that HHS 

annually updates the annual Medicare 

payment rules, those rules and certain 

other rules that are updated annually 

are exempt from this final rule. This 

final rule also exempts the rules at 42 

CFR part 73, since those are periodically 

reviewed. Regarding the 2011–2016 

retrospective review plan and reviews, 

that effort was helpful but sporadic, not 

sustained. As explained in the proposed 

rule, these efforts only resulted in 

review of a small fraction of rules. See 

85 FR at 70099. The failure to 

institutionalize retrospective review 

further underscores the need for this 

final rule and the review process it is 

implementing. A few instances of the 

Department taking the initiative to 

review its regulations cannot reasonably 

be considered a sufficient regulatory 

review when thousands of regulations 

that have been promulgated over the 

decades have not been touched.123

Comment: Many commenters 

questioned the Department’s plan for 

personnel resources to conduct the 

Reviews prescribed by this final rule. 

These commenters believe that the 

Department underestimated the number 

of people who would be needed to 

conduct the Reviews, and stated that the 

personnel resources would be better 

utilized on other projects. For example, 

some commenters stated that the 

Department is already too slow in 

promulgating certain regulations, and 

should task its employees with carrying 

out the Department’s existing duties. 

Response: The regulatory impact 

analysis for this final rule describes the 

personnel resources that the Department 

envisions being used to conduct 

Assessments and Reviews. The 


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124To the extent this uncertainty has been 

lessened because the public has seen how the 

Department has implemented these directives over 

the course of many years, the same can be said for 

this final rule once it has been implemented for 

several years. 

sensitivity analysis therein addresses 

the possibility that costs could be lower 

than estimated in the proposed rule. 

Periodically reviewing regulations with 

a significant economic impact upon a 

substantial number of small entities is 

an existing Department duty. Moreover, 

as discussed elsewhere herein, 

retrospective review can yield 

tremendous benefits. The literature and 

the Department’s experience suggest 

that large numbers of regulations are 

having impacts that, over time, differ 

from what was estimated at the time the 

regulations were promulgated. 

Therefore, the Department should 

prioritize conducting periodic reviews 

of its regulations to determine whether 

the policy goals behind the regulations 

are in fact being effected (and if 

amending those regulations could more 

effectively further those goals). 

Comment: A few commenters 

questioned whether the Department 

should have employees Assess or 

Review regulations if those employees 

are not responsible for implementing 

them. These commenters stated that if 

reviewers have not worked on matters 

connected with the regulations they are 

Reviewing, those reviewers may not 

have an adequate understanding of the 

regulations, which could lead to the 

expiration of regulations that are 

essential to the successful operation of 

the Department’s programs. 

One commenter also disagreed with 

the premise of the Department’s use of 

career civil servants to conduct 

regulatory reviews. This commenter 

stated that the proposed rule was 

logically inconsistent because it 

‘‘maligned’’ career public servants at the 

Department for not reviewing the 

Department’s regulations, but also 

proposes to task these same individuals 

with carrying out the proposed review 

process. 

Response: Which Department officials 

Assess or Review particular regulations 

will be decided on a case-by-case basis, 

but those conducting Assessments and 

Reviews will generally be employees 

who are familiar with those regulations, 

as well as technical experts, including 

economists. The Department strongly 

disagrees with the comment that the 

proposed rule ‘‘maligned’’ career civil 

servants. The proposed rule quoted a 

law professor who was suggesting 

several reasons why retrospective 

reviews do not occur as often as desired. 

The Department believes career civil 

servants can capably Assess and Review 

regulations, just as they capably conduct 

regulatory impact analyses and 

regulatory flexibility analyses. 

Comment: Several commenters stated 

that the two-year timeline for review of 

all regulations over ten years old was 

insufficient. A number of commenters 

suggested that the timeline be extended 

to five years. 

Response: The Department has 

considered these comments and has 

decided to revise the rule in light of 

them. Under this final rule, regulations 

issued more than ten years prior to the 

final rule’s effective date will not expire 

if Assessed and (if necessary) Reviewed 

within five calendar years of the 

effective date of this final rule. 

Moreover, under this final rule, if the 

Secretary makes a written determination 

that the public interest requires 

continuation of the Section (as defined 

in the text of the final rule) in force 

beyond the date on which the Section 

otherwise would expire, the Secretary 

may continue the Section in force one 

time for a period stated in the 

determination, which period shall not to 

exceed one year. 

Comment: Several commenters stated 

that the proposed rule would cause 

significant regulatory uncertainty in the 

healthcare industry, which would not 

know which regulations may or may not 

expire. Some commenters stated that the 

proposed rule would cause uncertainty 

for states, which implement Federal 

programs and rely on Federal 

regulations and funding. Potential 

regulatory changes could create 

additional compliance and regulatory 

costs for healthcare providers which 

may be forced to adapt to a changing 

regulatory framework. Changes may also 

trigger regulated entities to forgo future 

investments because they lack 

regulatory clarity. For example, some 

commenters stated that the uncertainty 

created around the expiration of 

regulations, including those that guide 

eligibility for Medicaid, Medicare 

provider reimbursements, or 

certification of hospitals and clinics, 

could disrupt the efficient operation of 

critical safety-net programs, create 

regulatory gaps and inconsistent 

application of the law, and make 

accessing safety-net services for our 

most vulnerable populations even more 

complicated and difficult than it is 

today. Some commenters said the poor, 

people of color, and/or the LGBTQ 

community, would be particularly 

affected. Additionally, some 

commenters stated that the proposed 

rule would make it difficult for them to 

advise clients on how to comply with 

the Department’s regulations. These 

commenters stated that if HHS 

determined that a regulation required 

modification, it should clearly publicize 

its intention to exercise enforcement 

discretion in not enforcing the thencurrent iteration of the regulation while 

the particular regulation is being 

modified. 

Other commenters stated that the 

regulatory review process set forth in 

this rule would ensure that HHS 

reviews regulations as required by the 

RFA, which means that if HHS were 

currently complying with the RFA in a 

satisfactory manner, there would be 

little additional uncertainty stemming 

from the proposed rule. 

Response: The Department notes that 

there is always a possibility that 

regulations could be amended or 

rescinded, even absent this rule. The 

Department does not believe uncertainty 

among the regulated community will 

add significantly to the costs of this 

rulemaking for the following reasons. 

The Department’s sporadic use of 

periodic retrospective review— 

notwithstanding the RFA and Executive 

Orders—itself leads to ‘‘uncertainty’’ 

about how robustly the Department 

implements directives that make for 

good policy.124 To the extent that the 

Department can maintain compliance 

with its obligations, this should build 

trust in the Department and reduce 

uncertainty (offsetting some or all of the 

uncertainty discussed by the 

commenters, if such uncertainty exists). 

Further, as noted above, the Department 

plans to release information about the 

18,000 regulations under its authority 

and when they were adopted, such that 

any uncertainty surrounding the 

expiration dates of the Department’s 

various rulemakings will be reduced 

substantially, if not entirely. Additional 

measures to mitigate private costs are 

discussed in the ‘‘Operationalization of 

This Final Rule’’ section of this final 

rule. Second, the Department notes that 

many states and foreign jurisdictions 

have sunset provisions that are a routine 

part of their regulatory processes. If the 

sunset reviews in these other 

jurisdictions do not create tremendous 

uncertainty, it stands to reason that 

neither will this final rule. The 

regulatory impact analysis for this final 

rule describes in more detail the sunset 

provisions from these other 

jurisdictions. 

Under this final rule, the regulated 

community has five years to adjust to 

the changes made by this final rule, so 

any reliance interests are significantly 

reduced as compared to the proposed 

rule. Where appropriate, the Department 

would announce the regulations for 


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which it is exercising enforcement 

discretion. 

Comment: A few commenters stated 

that the Department should allow 

reasonable reliance on a regulation 

while that regulation is under review, 

and for a reasonable time after a 

decision to amend, rescind or allow a 

regulation to expire. These commenters 

also stated that the final rule should 

allow the Department to extend a 

regulation for any period of time 

reasonably necessary for regulated 

entities relying the regulation to adjust 

their business practices. 

Response: HHS appreciates the 

commenters’ concern regarding the 

reliance interests of regulated entities; 

however, HHS respectfully disagrees 

with the premises of these comments. 

First, HHS does not intend to allow a 

regulation to simply expire. And as 

explained in the proposed rule, the 

public will have the opportunity to 

provide comments identifying 

regulations that the public believes need 

to be Assessed and Reviewed, which 

mitigates the risk of inadvertent 

expiration. 

Second, with respect to Sections that, 

after Review, the Department 

determines should be amended or 

rescinded, such Sections will be 

amended or rescinded through a 

separate notice-and-comment 

rulemaking process. Considerations 

about the effective dates of such 

amendments or rescissions, including 

the need to allow adequate time for 

transition, will be taken into account in 

that separate rulemaking process. 

Finally, Review under this final rule 

expressly considers ‘‘the continued 

need for the Section,’’ so regulated 

entities’ reliance interests will be taken 

into account during Reviews. 

Comment: Several commenters stated 

that the use of artificial intelligence and 

machine learning technology in 

regulatory review is a novel and 

innovative approach, and members of 

the public should have been afforded 

notice of the Deloitte research project 

and the opportunity to comment on the 

use of this technology. In particular, 

these commenters wanted to understand 

if and how the technology would be 

used by HHS to identify the regulations 

that will be reviewed. Some 

commenters asked HHS to provide 

additional information regarding the 

methodology used, and the underlying 

algorithm. A few commenters stated that 

all code should be posted on a publiclyaccessible website, consistent with best 

practices among academic researchers 

in data science. 

Response: The Department agrees that 

the use of artificial intelligence machine 

learning technology in regulatory review 

is a novel and innovative approach. The 

technology discussed in the proposed 

rule was initially used to perform an 

internal assessment of Department 

regulations, which is why the 

Department did not previously notify 

the public about this research project. 

Artificial intelligence will not be used to 

perform Assessments and Reviews 

pursuant to this final rule. While 

artificial intelligence can determine if a 

regulation has been amended in the last 

thirty years, it cannot at this time easily 

determine if a regulation satisfies the 

criteria listed in 5 U.S.C. 610. The 

artificial intelligence review was useful, 

because it suggested that large numbers 

of Department regulations would benefit 

from retrospective review. The 

technology identified that 85% of 

Department regulations created before 

1990 have not been edited; the 

Department has nearly 300 broken 

citation references in the CFR; and there 

are more than 50 instances of HHS 

regulatory requirements to submit paper 

documents in triplicate or 

quadruplicate. This suggests humans 

performing a comprehensive review of 

Department regulations would find large 

numbers of requirements that would 

benefit from review, and possibly 

amendment or rescission. 

Regarding the technology used to 

perform the 2019 analysis, the analysis 

was performed using a tool called 

RegExplorer. RegExplorer is an 

‘‘augmented intelligence’’ tool, meaning 

it is designed to use artificial 

intelligence in conjunction with subject 

matter experts. While RegExplorer is 

proprietary technology, some of the 

models deployed within RegExplorer 

include keyword technology (a 

structured and iterative approach to 

process, analyze, and return keyword 

search results); a clustering algorithm (a 

cluster is a machine-generated group of 

regulatory documents that have been 

algorithmically gathered together based 

on a set of similar characteristics, such 

as the relevant sub-agency, placement of 

text within the regulatory dataset, 

similarity of text content, and text 

format and structure); citation extraction 

and mapping; and similar section 

analysis. 

Comment: A few commenters asked 

why HHS chose to redact some of the 

‘‘Regulatory Streamlining & Analysis’’ 

published by Deloitte in March 2019 

that the Department cites in support of 

the proposed rule. These commenters 

pointed out that two of three bullet 

points in the ‘‘executive summary’’ 

slide, and all but 25 of the document’s 

170 pages are redacted. These 

commenters asked why this information 

was not made available to the public, 

and why HHS did not have a public 

meeting to discuss the Deloitte findings 

and solicit feedback on its regulatory 

reform ideas back in 2019. 

Response: The Department was 

transparent by including the Deloitte 

analysis in the docket for this 

rulemaking. The redacted information is 

information protected by applicable 

privileges, is confidential information, 

trade secret information, or not relevant 

to this rulemaking. As can be seen from 

the Table of Contents for the analysis, 

the redacted information does not relate 

to the machine learning analysis that 

was conducted to enhance regulatory 

reform that was discussed in the 

proposed rule. In November 2020, the 

Department held a public hearing on the 

proposed rule, which referred to the 

Deloitte presentation. The public was 

able to opine on the analysis at that 

public hearing. The Department did not 

have a public meeting to discuss the 

Deloitte findings and solicit feedback in 

2019, because the Department was at the 

time still undergoing its internal 

deliberative process. 

Comment: A few commenters stated 

that ideally the systematic evaluation of 

regulations should be a regular part of 

the rulemaking process, with the 

evaluation criteria and timeline 

embedded within each new rule so that 

the regulated community has an 

opportunity to opine on how and when 

each regulation will be reviewed. 

Commenters suggested that HHS 

identify up front what data it will use 

to track the progress of the regulation, 

and commit to continually collecting 

the same kinds of data over time. Such 

a process would make future evaluation 

of regulations and programs easier. It 

would also improve public 

accountability because the public would 

have a clearer sense of what the 

regulation is designed to achieve, and 

can monitor HHS’s progress. 

Response: HHS agrees with the 

commenters’ focus on the need to 

systematically evaluate the effectiveness 

of agency regulations—indeed, the 

Department has proposed the instant 

rule in order to make such evaluations 

more frequent and comprehensive. The 

timeline for Review of a given Section 

is set forth in section [XX](c)(1), and the 

criteria for Review are set forth in 

[XX](d). As is current practice, the 

Department intends to explain in the 

preambles to future rules what goals the 

rules are intended to achieve. This will 

enable the public to know what goals 

each regulation is designed to achieve. 

However, the data necessary to evaluate 

a particular rule will differ from rule to 

rule, and the Department cannot 


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125Presidential Memoranda on Government-toGovernment Relations With Native American Tribal 

Governments, 85 FR 22951 (May 4, 1994), 

Presidential Memorandum, Government-toGovernment Relationship with Tribal Governments, 

September 23, 2004, https://www.govinfo.gov/ 

content/pkg/WCPD-2004-09-27/pdf/WCPD-2004-09- 

27-Pg2106.pdf, Presidential Memorandum on Tribal 

Consultation, 74 FR 57879 (Nov. 9, 2009). 

126ACS Demographic and Housing Estimates, 

U.S. Census Bureau, https://data.census.gov/cedsci/ 

table?q=United%20States&g=0100000US&tid=

ACSDP1Y2019.DP05&hidePreview=true. 

generally commit to such collection in 

advance and in the abstract, although it 

may be useful to do so in particular 

cases. 

Comment: One commenter suggested 

that HHS consider performing a costsavings analysis for regulations 

receiving a Review under the proposed 

rule, or for that subset of Assessed 

regulations that are deemed significant 

or economically significant. Such 

analysis could include estimates of the 

costs, cost savings, and the net cost 

savings of the regulation. 

Response: For purposes of this final 

rule, the Department has decided to 

limit the Review criteria to the criteria 

listed in 5 U.S.C. 610, plus whether the 

regulation complies with applicable 

law. These are the criteria that Congress 

directed the Department to use in its 

periodic reviews, plus a review for 

compliance with the law. Determining 

the regulation’s costs, as well as cost 

savings from amendment or rescission, 

will often be subsumed in the five 

criteria listed in 5 U.S.C. 610. 

Comment: A large number of 

commenters stated that the proposed 

rule would negatively impact programs 

if review efforts are underfunded, or 

that the proposed rule was costly and 

unfunded. 

Response: The Department disagrees 

that regulatory review efforts would be 

underfunded. As explained in the 

regulatory impact analysis, this final 

rule will impose relatively low costs on 

the Department. 

Comment: Several commenters, 

including Tribal governments and 

representatives, affiliated groups of 

Indian Tribes, and the IHS Tribal SelfGovernance Advisory Committee, stated 

that the Department should have 

consulted with Tribal governments on 

the rule and failed to notify Tribal 

leaders and representatives of the 

proposed rule in violation of HHS’s 

duty as a federal agency to consult with 

Tribal nations under Exec. Order No. 

13175 of Nov. 6, 2000, 65 FR 67249 

(Nov. 9, 2000) (E.O. 13175) and the 

Department’s own Tribal consultation 

policy. 

Response: The Department and Indian 

Tribes share the goal to establish clear 

policies to further the government-togovernment relationship between the 

Federal Government and Indian Tribes. 

True and effective consultation shall 

result in information exchange, mutual 

understanding, and informed decisionmaking on behalf of the Tribal 

governments involved and the Federal 

Government. The importance of 

consultation with Indian Tribes was 

affirmed through Presidential 

Memoranda in 1994, 2004 and 2009,125

and E.O. 13175. HHS believes that 

neither the proposed nor the final rule 

violate the Department’s Tribal 

consultation policy or E.O. 13175. 

Subject to certain exceptions, the policy 

and E.O. 13175 require consultation 

before any action that will significantly 

affect Indian Tribes, or before 

promulgating any regulation that has 

Tribal implications. HHS believes that 

this final rule does not significantly 

affect Indian Tribes or have Tribal 

implications, as those terms are used in 

the policy and E.O. 13175. This final 

rule amends existing regulations to 

provide that the regulations will expire 

if not Assessed and (if necessary) 

Reviewed by certain dates. HHS intends 

that all rules will be Assessed and (if 

necessary) Reviewed timely. Therefore, 

this final rule would have no direct 

impact on Indian Tribes, beyond their 

costs of participation in the monitoring, 

Assessment, and Review processes. As 

explained in this final rule’s regulatory 

impact analysis, the estimated total 

monitoring costs to the public over ten 

years is estimated to range from $52.2 

million to $156.7 million using a 7% 

discount rate, or $58.8 million to $176.3 

million over ten years using a 3% 

discount rate (all figures using $2020). 

The U.S. Census estimates that in 2019, 

1.7% of the U.S. population was all or 

partially American Indian or Alaska 

Native.126 1.7% of the estimated 

monitoring costs would be roughly 

$887,400 to $2.66 million over ten years 

using a 7% discount rate, or $999,600 to 

roughly $3 million over ten years using 

a 3% discount rate (and the cost to 

Tribes could be less since not every 

American Indian or Alaska Native is 

affiliated with a Tribe). Tribes will be 

able to comment on regulations during 

the Assessment and Review processes. 

Comment: A commenter stated that 

the rule would allow for the sunset of 

regulations that merely implement 

statutory requirements, such as Indian 

preference. The commenter cited as 

examples 42 CFR 136.41–43, 42 CFR 

121, 42 CFR 136a.41–43, all of which, 

the commenter stated, are mandated by 

25 U.S.C. 5117. 

Response: The Department 

respectfully disagrees. This final rule 

exempts from the Assessment and 

Review requirement ‘‘Sections whose 

expiration pursuant to this section 

would violate any other Federal law.’’ 

See Section [XX](g). In any event, the 

Department is not convinced the 

statutory provision cited by the 

commenter mandates the cited 

regulations. There is no obligation 

imposed on HHS in 25 U.S.C. 5117 to 

prescribe any particular regulations on 

Indian preference. Rather, section 5117 

provides that ‘‘any employee entitled to 

Indian preference who is within a 

retention category established under 

regulations prescribed under such 

subsection to provide due effect to 

military preference shall be entitled to 

be retained in preference to other 

employees not entitled to Indian 

preference who are within such 

retention category.’’ Neither 25 U.S.C. 

5117 nor 25 U.S.C. 5116 (which is 

referenced in 25 U.S.C. 5117) are cited 

as statutory authorities for the 

regulations cited by the commenter. 

Comment: A few commenters stated 

that agencies (including HHS) have long 

ignored the retrospective review 

mandate of the RFA and have failed to 

perform such reviews. One reason for 

this, according to the commenters, is 

that the RFA does not create incentives 

for federal agencies to review their 

regulations. These commenters stated 

that this final rule would solve that 

problem by providing a clear incentive 

for agencies within HHS to review their 

regulations to prevent their automatic 

expiration. Commenters stated that 

without such a consequence, agencies 

will continue to fail to conduct 

retrospective reviews of their 

regulations. 

Response: The Department cannot 

speak for other federal agencies and 

would not state that the Department has 

completely ignored retrospective 

review. But the Department would agree 

that it has not performed reviews as 

often as Congress intended. The 

Department agrees that this final rule 

will address this problem by providing 

an incentive to perform retrospective 

reviews. 

Comment: A few commenters stated 

that the Department failed to analyze 

the potential costs of rescinding 

regulations, and only focuses on the 

costs of conducting voluntary 

Assessments and Reviews. A few 

commenters stated that HHS did not 

assess the potential forgone benefits of 

expired regulations. 

Response: This is addressed in the 

regulatory impact analysis for this final 

rule. 


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127See 85 FR 70115 (‘‘Of the 273 rulemakings 

subject to Reviews in the first two years, the 

Department estimates roughly 16%, or 44, of those 

rulemakings were promulgated prior to the 

requirement for prospective regulatory flexibility 

analyses. As described further below, those 44 

Reviews will require more Department resources 

than the estimated 229 Reviews of rulemakings 

promulgated after the prospective analysis 

requirement went into effect’’). 

128 Department of Health and Human Services 

Good Guidance Practices, 85 FR 78785 (Dec. 7, 

2020). 

Comment: A few commenters stated 

that the Department should consider 

doing a regulatory impact analysis when 

reviewing rulemakings that predate the 

Regulatory Flexibility Act and have a 

significant economic impact upon a 

substantial number of small entities 

(‘‘SEISNOSE’’). These commenters also 

noted that conducting additional 

regulatory impact analyses would 

impose an additional cost to the 

Department, which it should account for 

if it chooses to do additional analysis on 

Pre-RFA rulemakings. 

Response: As explained in the 

proposed rule, more resources will be 

required to review regulations that 

predate the RFA.127 The regulatory 

impact analysis for this final rule 

accounts for the additional resources 

required to conduct Reviews of rule 

makings that predate the RFA. But the 

criteria listed in 5 U.S.C. 610 are the 

criteria that Congress directed the 

Department to use when reviewing 

regulations that predate the RFA. 

Therefore, for rule makings that predate 

the RFA and have a SEISNOSE, this 

final rule requires that the Review 

consider the factors listed in 5 U.S.C. 

610, as well as whether the component 

Sections within those rulemakings 

comply with applicable law. 

Comment: A few commenters asked 

for clarification on whether a regulation 

that is identified for amendment 

through the regulatory review process 

set forth in this final rule would be 

prioritized over new regulations the 

Department is promulgating. 

Response: In the scenario described 

by commenters, the Department would 

aim to amend the referenced regulation 

and also promulgate new regulations 

that the Department believes should be 

promulgated. Experience shows the 

Department is able to amend existing 

regulations and promulgate new ones at 

the same time. 

Comment: A few commenters asked if 

regulations that are sunset because they 

were not Assessed or Reviewed by the 

deadline would have to go through 

notice-and-comment rule making to be 

reissued if they were otherwise 

unchanged. These commenters also 

asked how these regulations would be 

prioritized by the Department. 

Response: As explained throughout 

the proposed rule (and this final rule), 

the Department is committed to 

dedicating adequate resources to timely 

Assess and Review its regulations. If a 

regulation did automatically expire, 

though, the Department would be 

required to undertake notice-andcomment rule making to reissue the 

regulation, unless one of the exceptions 

to notice-and-comment rule making in 5 

U.S.C. 553 applies. 

Furthermore, allowing for automatic 

reissuance of an expired regulation 

threatens to undermine the efficacy of 

this final rule. If there were no costs or 

obstacles to simply resurrecting an 

expired regulation in its original, preexpiration form, then there would be no 

compelling incentive to timely Assess 

and Review Department regulations. 

It is impossible to say at this point 

how the Department might ‘‘prioritize’’ 

re-issuance of expired regulations, 

without knowing which regulation is at 

issue and what other competing 

priorities the Department might have at 

the time. That said, the Department 

anticipates it will prioritize re-issuance 

of expired regulations in line with the 

public need for such regulation, 

balancing the same considerations it 

always does in allocating its policymaking resources. As noted above, the 

risk that important, ‘‘priority’’ 

regulations—those that meaningfully 

impact regulated entities—will expire is 

mitigated by the fact that interested 

members of the public can alert the 

Department to a needed Assessment or 

Review. Commenters have also flagged 

regulations to review during the public 

comment process on this rule. 

Comment: A few commenters stated 

that the Department should clarify how 

it will reconcile or update applicable 

guidance documents associated with 

rescinded regulations. If guidance 

documents remain in existence or are 

not updated to account for the 

regulatory changes resulting from the 

process established in this final rule, it 

could lead to confusion for regulated 

entities. A few commenters asked for 

clarification on whether the Department 

is considered to have Reviewed a 

regulation if the Department issues a 

guidance document on that particular 

regulation. 

Response: The Department may not 

issue any guidance document that 

establishes a legal obligation that is not 

reflected in a duly enacted statute or in 

a regulation lawfully promulgated under 

a statute. The Department may not use 

any guidance document for purposes of 

requiring a person or entity outside the 

Department to take any action, or refrain 

from taking any action, beyond what is 

required by the terms of an applicable 

statute or regulation.128 Therefore, any 

guidance document based on an expired 

regulation has no effect. If a guidance 

document addresses expired regulations 

as well as regulations still in effect, the 

Department would seek to expeditiously 

revise the guidance document. 

The Department is not considered to 

have Reviewed a Section simply 

because the Department issues a 

guidance document concerning that 

particular Section. The Department is 

only considered to have Reviewed a 

Section if, with respect to the Section, 

the Department has followed the 

procedures specified in section [XX](f) 

of this final rule. The Department must 

publish the results of the Review, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), in the Federal Register. 

Comment: A few commenters asked 

how other enforcement agencies, such 

as the Office of the Inspector General or 

the Department of Justice, and federal 

healthcare program contractors, would 

be affected by the proposed rule. 

Commenters stated that a lack of 

coordination between agencies and 

other entities with equities in an 

expired regulation could lead to 

different and possibly contrary 

conclusions about how to proceed. 

These commenters also stated that this 

could lead to conflicting requirements, 

resulting in different rules in different 

jurisdictions. Commenters asked the 

Department to clarify how corporate 

compliance programs should advise 

their organizations if a regulation 

expires. 

Response: This final rule applies to 

the HHS Office of Inspector General 

(OIG), which is a component of HHS, 

although certain regulations for which 

OIG has enforcement responsibility are 

exempt, such as 42 CFR 1001.952. For 

regulations that were issued in 

coordination with another Agency, that 

function in concert with another 

Agency’s regulations, or that have a 

specific, direct impact on regulations 

issued by another Federal agency, the 

Department shall consult with that other 

Agency when undertaking the 

Assessment or Review, and consider the 

other Agency’s views when considering 

the factors described in section [XX](d). 

In addition, when Assessing or 

Reviewing regulations that require 

review and approval by the Attorney 

General under Exec. Order No. 12250 of 


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129 85 FR 70112. 

130See, e.g., N.J. Admin. Code § 1:30–6.4 (2020) 

(regulations expire every seven years unless 

readopted, subject to certain exceptions); Ind. Code 

4–22–2.5–2 (imposing seven-year expiration date on 

regulations unless readopted). 

131N.C. Gen. Stat. 150B–21.3A. 

132 85 FR at 70106. 

133Public Law 96–354, 94 Stat. 1164, 1164 (1980) 

(as amended 1996). 

Nov. 2, 1980, 45 FR 72995 (Nov. 4, 

1980), the Department will consult with 

the Department of Justice (DOJ) and 

provide a draft of the findings to DOJ 

well in advance of the Assessment or 

Review deadline so DOJ can review and 

approve prior to the publication of the 

findings. If an HHS regulation is 

amended, rescinded, or expires, no 

other governmental body may take a 

different view of the regulation’s legal 

effect. 

Regarding how corporate compliance 

programs should advise their 

organizations if a regulation expires, an 

HHS regulation that expires no longer 

has legal effect and cannot be enforced 

by any governmental body against a 

regulated entity. 

Comment: One commenter stated that 

HHS observes that the proposed rule’s 

review requirements ‘‘do not impose 

new burdens . . . if incomplete 

compliance [with the Regulatory 

Flexibility Act] is not accounted for in 

the regulatory baseline.’’ 129 But HHS’s 

entire rationale for the proposed pule, 

according to the commenter, is that 

incomplete compliance with existing 

review requirements is and will 

continue to be a problem under the 

regulatory baseline (i.e., absent the 

proposed rule). 

Response: HHS maintains that the 

proposed rule, as well as this final rule, 

does not impose new burdens if 

incomplete compliance with the RFA is 

not accounted for in the regulatory 

baseline. HHS recognizes that, after 

implementation of this final rule, the 

Department’s Assessments and Reviews 

will likely result in an additional 

resource expenditure beyond what 

would occur absent promulgation of this 

final rule. This was analyzed in the 

Regulatory Impact Analysis of the 

proposed rule and in more detail 

(largely due to comments received) in 

the Regulatory Impact Analysis of this 

final rule. It is worth noting, though, 

that the burdens resulting from this final 

rule are burdens that Congress already 

intended for the Department to bear. 

Comment: A few commenters stated 

that the Department does not cite any 

reason why a regulatory review should 

be triggered by the age of a regulation 

or why ten years should be the trigger. 

Some commenters stated that a 

regulatory review could also be based 

on the subject matter of the regulation, 

its economic impact, or the number of 

people it affects. Other commenters 

pointed out that the Department also 

could have used a different time period 

other than ten years to conduct its 

reviews. Commenters point to the 

Department’s citation to a number of 

foreign and sub-national entities that 

mandate the reviews of regulations after 

five or seven years. These commenters 

stated that since there are other options 

for the frequency of regulatory review, 

the proposal to have such rules 

automatically expire after ten years is 

arbitrary and capricious. 

Response: HHS respectfully disagrees. 

The proposed rule explained why the 

Department chose ten years: 

The Department proposes to perform the 

Assessment and (if required) the Review on 

each Regulation every ten years. Some states 

provide that, unless readopted or rereviewed, their regulations expire in seven 

years,130 while at least one state uses a tenyear time period.131 The Department 

proposes to perform the Assessment and (if 

required) the Review every ten years, because 

ten years is the period listed in 5 U.S.C. 610. 

The Department has many Regulations, some 

of which are complex, so having to perform 

the Assessment and Review more than once 

every ten years could unduly burden the 

Department and increase the likelihood that 

a Regulation inadvertently expires because it 

is not Assessed or Reviewed.132

This rationale still holds. In this final 

rule, the Department decides to Review 

rules that have a SEISNOSE, because 

those are the rules that the RFA directed 

HHS to review. 

Comment: A few commenters stated 

that the proposed rule interferes with 

the RFA’s procedure for regulatory 

review. 5 U.S.C. 610–611. These 

commenters note that those sections 

require agencies to publish plans for 

regulatory review, provide a schedule 

for revision that varies by agency, give 

agency heads the right to delay review 

for one-year periods, up to a maximum 

of five years, identify multiple factors 

that must be considered in reviewing 

each rule, prescribe the terms of public 

notice via the Federal Register, and 

specify judicial appeal procedures and 

criteria, including standing rights and 

remedies. These commenters also stated 

that the Department’s proposed rule 

would scrap that process and replace it 

with a default of across-the-board 

regulatory repeal in case of inaction, 

without recourse, using a completely 

different system of judicial review 

premised on the underlying APA, rather 

than the RFA. Commenters stated that 

this would be a usurpation of Congress’s 

role, and would raise constitutional 

questions involving balance of power 

between the branches. According to 

commenters, the Department must 

address this issue or else promulgating 

this final rule would be arbitrary and 

capricious. 

Response: HHS respectfully disagrees. 

This final rule is consistent with the 

RFA’s requirement to publish a plan for 

periodic review—it is such a plan, and 

the RFA does not prohibit the 

Department from including expiration 

dates in its regulations. The Review 

process considers the five factors 

enumerated in the RFA. See 5 U.S.C. 

610(b). This final rule requires 

publication in the Federal Register of 

the results of Assessments and Reviews 

under section [XX](f). This final rule 

does not supplant or purport to 

foreclose any available judicial review 

under 5 U.S.C. 611. And with respect to 

section 610 compliance, the RFA’s 

judicial-review provisions expressly 

cross-reference the broader APA 

judicial-review provisions. See 5 U.S.C. 

611(a)(1) (‘‘For any rule subject to this 

chapter, a small entity that is adversely 

affected or aggrieved by final agency 

action is entitled to judicial review of 

agency compliance with the 

requirements of sections 601, 604, 

605(b), 608(b), and 610 in accordance 

with chapter 7.’’) (emphasis added). 

Because this rule is consistent with the 

RFA, it does not usurp Congress’s role 

or raise constitutional separation-ofpower concerns. To the contrary, it 

implements Congressional intent for 

periodic review of regulations. Section 

II.F of this final rule further addresses 

the commenters’ concerns in discussing 

how the Department will operationalize 

this final rule. 

Comment: Several commenters stated 

that the proposed rule violates the 

RFA’s intent as expressed by Congress. 

In passing the RFA, Congress expressly 

made the following finding: ‘‘the 

practice of treating all regulated 

businesses, organizations, and 

governmental jurisdictions as equivalent 

may lead to inefficient use of regulatory 

agency resources, enforcement problems 

and, in some cases, to actions 

inconsistent with the legislative intent 

of health, safety, environmental and 

economic welfare legislation.’’ 133 These 

commenters stated that the proposed 

rule departs from the Congressional 

intent in passing the RFA because the 

proposed rule would subject every 

regulation to mandatory review as well 

as repeal by default. In this way, the 

proposed rule ‘‘treats all regulated 

businesses, organizations, and 

governmental jurisdictions as 

equivalent’’ by terminating all 


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134See 85 FR 70107. 

135Under the commenters’ argument, the fact that 

the RFA sets forth five factors to be considered (see 

5 U.S.C. 610(b)) would also supposedly be 

inconsistent with Congressional intent. 

136See Public Law 96–354, 94 Stat. 1164, 1164 

(1980) (as amended 1996), Sec. 2(a)(2) (‘‘laws and 

regulations designed for application to large scale 

entities have been applied uniformly to small 

businesses, small organizations, and small 

governmental jurisdictions even though the 

problems that gave rise to government action may 

not have been caused by those smaller entities’’); 

Sec. 2(b) (‘‘It is the purpose of this Act to establish 

as a principle of regulatory issuance that agencies 

shall endeavor, consistent with the objectives of the 

rule and of applicable statutes, to fit regulatory and 

informational requirements to the scale of the 

businesses, organizations, and governmental 

jurisdictions subject to regulation.’’). 

137 85 FR 70112. 

138 85 FR 70107. 

139Cass R. Sunstein, The Regulatory Lookback, 94 

B.U. L. Rev. 579, 584 (2014). 

regulations, without considering the 

unique set of stakeholders affected by 

each regulation. 

Response: HHS respectfully disagrees 

with these comments because these 

commenters fundamentally 

misunderstand the operation of this 

final rule, as well as the Congressional 

finding they quote. This final rule does 

not repeal regulations by default. As 

explained in this final rule, the 

Department intends to timely complete 

the necessary Assessments and Reviews 

and has built in safeguards to mitigate 

the risk of inadvertent expiration. Under 

this final rule, the Department must 

Assess which of its rule makings have 

a significant economic impact upon a 

substantial number of small entities, 

and then perform the more robust 

Reviews on those rule makings. 

Therefore, the Department is paying 

special attention to those regulations 

which have a significant economic 

impact upon a substantial number of 

small entities. As explained in the 

proposed rule, the Department cannot 

know which regulations currently have 

a SEISNOSE without Assessing its 

regulations.134 This process is 

consistent with the RFA, which 

instructs agencies to review ‘‘the rules 

issued by the agency which have or will 

have a significant economic impact 

upon a substantial number of small 

entities.’’ 

Reviews consider the five factors 

expressly included within the RFA, as 

well as an additional factor that is 

indisputably beneficial and appropriate: 

‘‘Whether the rulemaking complies with 

applicable law.’’ See Section [XX](d). 

Subjecting regulations with a SEISNOSE 

to Review does not ‘‘treat all regulated 

businesses, organizations, and 

governmental jurisdictions as 

equivalent’’ because the findings of the 

Review will be tailored to the 

regulation.135

The commenters also quote the 

language from the Congressional 

findings and declaration of purpose out 

of context. Congress was clearly focused 

on agencies ignoring the distinction 

between ‘‘large scale entities’’ and small 

entities.136 Given that this rule closely 

tracks the RFA’s goal of minimizing 

undue burden on small entities, it aligns 

with the Congressional intent behind 

the RFA. 

Comment: A commenter stated that 

automatic expiration of Department 

regulations could frustrate the RFA’s 

purpose by inappropriately sunsetting 

rules that increase economic benefits for 

small entities. This commenter stated 

that the proposed rule does not 

sufficiently address this concern. This 

commenter also stated that the proposed 

rule undermines congressional intent 

because the proposed rule does not 

consider that the Department may be 

impeding its ability to conduct reviews 

under the RFA by instituting added 

procedural requirements and broadly 

applicable regulatory sunsets. This 

commenter further stated that expiration 

dates are particularly contrary to 

effectuating RFA compliance because 

the Department will need to prioritize 

assessing rules without any impact on 

small entities simply due to their 

imminent expiration, rather than using 

Department resources efficiently to 

focus on rules requiring the 

Department’s review under the RFA. 

Response: The Department 

respectfully disagrees. The RFA calls on 

the Department to periodically review 

regulations that have a significant 

economic impact upon a substantial 

number of small entities. This final rule 

intends to increase the number of such 

reviews that occur, and directs the 

Department to review using the criteria 

specified in 5 U.S.C. 610(b) (plus 

whether the rule making complies with 

applicable law). As for Assessing 

regulations not previously determined 

to have a SEISNOSE, implicit in 5 

U.S.C. 610 is the requirement to 

determine which regulations have a 

SEISNOSE.137 Without performing the 

Assessment, the Department may not 

know which regulations have or will 

have a significant economic impact 

upon a substantial number of small 

entities. Due to changed circumstances, 

a regulation that did not have such an 

impact at the time it was promulgated 

may now have such an impact.138 The 

Department does not intend for any 

regulations to inadvertently sunset, and 

it is unlikely that any regulations with 

significant benefits would slip through 

the cracks. The regulatory impact 

analysis addresses this in more detail. 

Comment: A few commenters stated 

that beyond simply cutting regulatory 

burdens, the scheduled regulatory 

review of existing HHS regulations will 

afford HHS the opportunity to keep 

regulations up to date with modern 

trends. These commenters noted that 

not only will this rule establish an 

opportunity for the Department to 

terminate obsolete regulations that are 

no longer fit for purpose or that are 

judged to be ineffective, but it will also 

give HHS and the public a reliable 

framework and a set of tools to 

continually keep regulations up to date 

with evolving circumstances. 

Response: The Department agrees 

with these comments and emphasizes 

that the benefits of retrospective 

review—some of which are cited by 

these commenters—are substantial. As 

the proposed rule noted, Professor Cass 

Sunstein, who served as OIRA 

Administrator from 2009 to 2012, has 

observed that ‘‘the requirement of 

retrospective analysis,’’ if ‘‘firmly 

institutionalized,’’ ‘‘would count as the 

most important structural change in 

regulatory policy since the original 

requirement of prospective analysis 

during the Reagan Administration.’’ 139

Comment: A few commenters stated 

that regulatory review does not create as 

much benefit to regulated entities as the 

proposed rule suggests, because many of 

the costs of regulatory compliance have 

already been factored into the cost of 

doing business, and are essentially 

evanescent over time. 

Response: While some costs of 

regulatory compliance may have been 

factored into the cost of doing business, 

this comment overlooks many of the 

benefits of retrospective review. For 

example, economic, technological, or 

legal changes can make a regulation 

obsolete over time. Retrospective review 

is widely acknowledged to be beneficial 

by scholars across the ideological 

spectrum, many of whom are cited in 

the proposed and this final rule. 

Comment: A commenter asked for 

greater detail on the Assessment and 

Review process, especially planning of 

what is to be included and excluded in 

the retrospective review process. The 

commenter also asked for greater 

explanation of how the Department will 

provide notification of what rules have 

been Assessed. The commenter also 

asked what would happen if a part of a 

rule was reviewed but not other parts of 

it. 


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140See Results of EPA’s Section 610 Review of the 

Final Rule for Control of Emissions of Air Pollution 

from Nonroad Diesel Engines and Fuel, EPA Off. of 

Transp. & Quality (Sept. 2014), https://

www.regulations.gov/document?D=EPA-HQ-OAR2013-0642-0003; Regulatory Flexibility Act Section 

610 Review of the National Pollutant Discharge 

Elimination System (NPDES) Permit Regulation and 

Effluent Limitation Guidelines and Standards for 

Concentrated Animal Feeding Operations (CAFOs), 

EPA Off. of Water (June 3, 2014), https://

www.regulations.gov/document?D=EPA-HQ-OW2012-0813-0216; Results of EPA’s Section 610 

Review of the Final Rule for Lead; Renovation, 

Repair, and Painting Program, EPA Off. of Pollution 

Prevention and Toxics (Apr. (April 2018), https:// 

www.regulations.gov/document?D=EPA-HQ-OPPT2016-0126-0019. 

Response: Section II.F of this final 

rule’s preamble provides greater detail 

on the Assessment and Review process 

and the Department’s planning for 

Assessments and Reviews. Examples of 

Section 610 reviews conducted by the 

EPA are instructive on how the 

Department anticipates the five factors 

set forth in 5 U.S.C. 610(b) will be 

analyzed.140 The results of all 

Assessments and Reviews conducted in 

a calendar year will be published in a 

single document in the Federal Register 

during that calendar year. The 

Department also intends to place the 

results of an Assessment or Review in 

the docket for the rule on 

Regulations.gov. Lastly, this final rule 

defines ‘‘Assess’’ as a determination as 

to whether the ‘‘Sections issued as part 

of the same rulemaking (and any 

amendments or additions that may have 

been added thereafter)’’ currently have a 

significant economic impact upon a 

substantial number of small entities. 

This final rule defines ‘‘Review’’ as a 

process the purpose of which is to 

determine whether ‘‘Sections that were 

issued as part of the same rulemaking 

(and any amendments or additions that 

may have been issued thereafter)’’ 

should be continued without change, 

amended, or rescinded. Thus, while 

Sections are what expire if they are not 

timely Assessed or Reviewed, the 

Department should be Assessing or 

Reviewing all Sections that were part of 

the same rulemaking (and any 

amendments or additions that may have 

been issued thereafter), not just some of 

them. 

Comment: One commenter stated that 

it previously advocated for the review 

and modernization of some of the 

Department’s regulations covering 

Medicare health and safety standards. 

For example, according to the 

commenter, the Medicare Conditions of 

Participation regulations for psychiatric 

hospitals do not align their 

requirements with modern psychiatric 

care. However, the commenter stated 

that no substantive revisions to the 

provisions have occurred since the 

requirements for psychiatric hospitals 

were first implemented, meaning that a 

comprehensive review of these 

regulations has not occurred for at least 

40 years, when psychiatric care was 

delivered much differently. This 

commenter stated that this is a clear 

example of why regular regulatory 

reviews are necessary. 

Response: The Department thanks the 

commenter for identifying these 

regulations. The Department intends to 

timely Assess and (if necessary) Review 

these regulations. If the Assessments 

and Reviews suggest these regulations 

should be amended or rescinded, the 

Department will commence rulemaking 

to amend or rescind them. 

Comment: A few commenters 

applauded the Department for 

continuing the bipartisan work on 

regulatory review to ensure federal 

agencies are continually held 

accountable to taxpayers and that 

regulations remain relevant and updated 

to innovation and changes in market 

conditions. The commenters also asked 

when the planning and drafting of the 

proposed rule began, any recent 

regulatory actions that would 

demonstrate the effects that regulatory 

reviews, suspensions, or updates can 

have on the health care industry, or the 

economy more broadly, and a list of 

Department regulations suspended 

during the pandemic. 

Response: The Department thanks the 

commenters for the first part of this 

comment. Second, for a non-exhaustive 

list of 382 enforcement discretion 

announcements, waivers or changes to 

regulations, agency guidance materials, 

or compliance obligations made to 

respond to the COVID–19 pandemic and 

its impact on the healthcare industry, 

see Regulatory Relief to Support 

Economic Recovery; Request for 

Information (RFI), 85 FR 75720 (Nov. 

25, 2020) at Attachment A. The 

planning and drafting of the proposed 

rule is subject to the deliberative 

process privilege, but evolved out of the 

2019 regulatory streamlining analysis 

discussed in the proposed rule. 

Technical Legal Comments 

Comment: A large number of 

commenters stated that the proposed 

rule would violate the Administrative 

Procedure Act (APA), because it would 

allow the Department to revise or 

rescind thousands of regulations at one 

time instead of conducting notice and 

comment rulemaking on each existing 

individual rule it chooses to repeal. 

Some of these commenters also 

mentioned that the APA requires 

agencies to use substantially the same 

process to repeal a rule as they used to 

promulgate a rule, so a process that 

allows for automatic expiration of a rule 

would not meet this statutory 

requirement. A commenter stated that 

‘‘Revocation constitutes a reversal of the 

agency’s former views as to the proper 

course’’ and ‘‘[w]hile the agency is 

entitled to change its view on [a matter], 

it is obligated to explain its reasons for 

doing so. . . . [A]n agency changing its 

course by rescinding a rule is obligated 

to supply a reasoned analysis for the 

change’’ and ‘‘[g]enerally, one aspect of 

that explanation would be a justification 

for rescinding the regulation . . .’’ 

(quoting Motor Vehicles Mfrs. Ass’n of 

U.S., Inc. v. State Farm Mut. Auto. Ins. 

Co., 463 U.S. 29, 41, 42, 52, 56 (1983)). 

Commenters stated that this rule would 

be arbitrary and capricious on these 

grounds. One commenter stated that if 

the Department does not perform an 

affirmative action to prevent expiration 

of a regulation, the Department would 

fail to articulate a satisfactory 

explanation for its expiration, making 

the agency action arbitrary and 

capricious. 

Response: This final rule complies 

with the APA. The APA generally 

requires, with certain exceptions, notice 

and comment prior to finalizing a ‘‘rule 

making,’’ 5 U.S.C. 553, which is defined 

as ‘‘formulating, amending, or repealing 

a rule.’’ 551(5). See Motor Vehicles Mfrs. 

Ass’n of U.S. v. State Farm Mut. Auto. 

Ins. Co., 463 U.S. 29, 41 (1983) (‘‘We 

believe that the recession or 

modification of an [agency rule] is 

subject to the same test.’’). The APA has 

already ‘‘established the maximum 

procedural requirements which 

Congress was willing to have the courts 

impose upon agencies in conducting 

rulemaking procedures.’’ Vt. Yankee 

Nuclear Power Corp. v. Nat. Res. Def. 

Council, Inc., 435 U.S. 519, 524 (1978). 

Neither courts nor regulated entities 

may ‘‘impose upon [an] agency its own 

notion of which procedures are ‘best’ or 

most likely to further some vague, 

undefined public good.’’ Id. at 549. 

The Department agrees with 

commenters who stated the APA 

generally requires agencies to use 

substantially the same process to amend 

or repeal a rule as they used to 

promulgate a rule. The Department is 

complying with this requirement. See 

Clean Air Council v. Pruitt, 862 F.3d 1, 

9 (2017) (an agency can amend or 

revoke a legislative rule through noticeand-comment rulemaking). In this rule 

making, the Department has gone 

through notice-and-comment rule 

making to amend its regulations by 

establishing conditions under which the 

regulations will either be Assessed and/ 


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141See, e.g., Control of Communicable Diseases; 

Foreign Quarantine 85 FR 7874, 7874 (Feb. 12, 

2020) (providing that, unless extended, interim 

final rule ‘‘will cease to be in effect on the earlier 

of (1) the date that is two incubation periods after 

the last known case of 2019–nCoV, or (2) when the 

Secretary determines there is no longer a need for 

this interim final rule’’); Medicare and Medicaid 

Programs, Clinical Laboratory Improvement 

Amendments (CLIA), and Patient Protection and 

Affordable Care Act; Additional Policy and 

Regulatory Revisions in Response to the COVID–19 

Public Health Emergency, 85 FR 54820, 54820 

(Sept. 2, 2020) (providing that an interim final rule 

applies ‘‘for the duration of the [public health 

emergency] for COVID–19’’); U.S. Dep’t of Transp., 

Final Regulatory Impact Analysis: Amendment to 

Federal Motor Vehicle Safety Standard 208 

Passenger Car Front Seat Occupant Protection, at 

XII–35 (July 11, 1984), http://wwwnrd.nhtsa.dot.gov/Pubs/806572.pdf (explaining that 

‘‘[i]f mandatory use laws are passed that will cover 

67 percent of the population effective September 1, 

1989, the rule will be rescinded’’). 

142See, e.g., 21 CFR 1.1(b) (‘‘the definitions and 

interpretations of terms contained in sections 201 

and 900 of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 321 and 387) shall be applicable also 

to such terms when used in regulations 

promulgated under that act’’).’’); 7 CFR 786.113 

(‘‘Notwithstanding any other regulation, interest 

will be due from the date of the disbursement to 

the producer or other recipient of the funds’’); 40 

CFR 455.21 (‘‘Notwithstanding any other regulation, 

process wastewater flow for the purposes of this 

subpart does not include wastewaters from the 

production of intermediate chemicals’’); 7 CFR 

3430.1 (‘‘In cases where regulations of this part 

conflict with existing regulations of NIFA in Title 

7 (i.e., 7 CFR parts 3400 through 3499) of the Code 

of Federal Regulations, regulations of this part shall 

supersede’’); 45 CFR 611.12 (‘‘All regulations . . . 

heretofore issued by any officer of the Foundation 

which impose requirements designed to prohibit 

any discrimination against individuals on the 

ground of race, color, or national origin under any 

program to which this part applies, and which 

authorize the suspension or termination of or 

refusal to grant or to continue Federal financial 

assistance to any applicant for or recipient of such 

assistance for failure to comply with such 

requirements, are hereby superseded to the extent 

that such discrimination is prohibited by this part,’’ 

with certain exceptions). 

. 143 85 FR 70108. 

or Reviewed or expire. This is 

permissible. The Department is going 

through notice-and-comment rule 

making to amend its regulations to 

apply expiration dates unless certain 

conditions are satisfied. Agencies 

already promulgate regulations that 

expire upon the satisfaction of a future 

event or non-event.141 Nothing in the 

APA forecloses agencies from including 

conditional expirations dates in 

regulations. It would call into question 

many rules—and be extremely 

disruptive—if courts held that 

conditional expiration dates violate the 

APA. 

The Department also rejects the 

argument that it cannot revise many 

regulations in one rule making, but 

instead must conduct notice-andcomment rule making on each 

individual regulation it seeks to amend 

or rescind. The APA does not include 

such a requirement. When 5 U.S.C. 

551(5) defines ‘‘rule making’’ as an 

‘‘agency process for formulating, 

amending, or repealing a rule’’ 

(emphasis added), that includes 

formulating, amending, or repealing 

‘‘rules.’’ See 1 U.S.C. 1 (‘‘In determining 

the meaning of any Act of Congress, 

unless the context indicates otherwise— 

words importing the singular include 

and apply to several persons, parties, or 

things’’). Agencies can—and often do— 

issue one rule that applies to many 

other agency rules, rather than 

amending or rescinding each affected 

regulation individually. To take one 

example, in 2008 the Department 

revised the definition of ‘‘entity’’ at 42 

CFR 411.351. See 73 FR 48434, 48751 

(Aug. 19, 2008). The revised definition 

had the effect of changing the meaning 

of ‘‘entity’’ each time it was used in 42 

CFR part 411, subpart J. It would be 

burdensome to specify the meaning of 

‘‘entity’’ each time it appears in subpart 

J, so the Department issued one 

definition that broadly applied to all 

sections of subpart J. There are many 

other examples where an Agency issues 

a regulation that applies to, amends, 

rescinds, or supersedes many other 

regulations.142 This avoids an 

unnecessarily cumbersome process. A 

court ruling that Agencies must amend 

each individual regulation would call 

into question large numbers of Agency 

regulations and impose substantial 

burdens on agencies (and the Office of 

the Federal Register, which would be 

required to print the same text over and 

over) when promulgating future 

regulations. In addition, the Department 

will consider each individual regulation 

when conducting Assessments and (if 

needed) Reviews. 

Moreover, in this rule making the 

Department considered each individual 

Department regulation, and, as 

discussed further, decided to exempt 

certain regulations from this final rule. 

The Department concluded that the 

benefits of retrospective review, and 

need to more strongly incentivize it, 

justified applying this final rule to the 

Department’s remaining regulations. In 

this rule making, the Department is 

considering the important factors. It 

issues this final rule because, for the 

reasons described herein, the 

Department believes the benefits of 

retrospective review, and the need to 

strongly incentivize it, are so great that 

the risk of a regulation inadvertently 

expiring is justified by the benefit of 

institutionalizing retrospective review 

in this manner. Forty years of 

experience since the RFA’s enactment; 

the decades since relevant Executive 

Orders were enacted; and other Federal 

government efforts to spur the 

Department to conduct more 

retrospective reviews indicate that, 

absent such a pushing mechanism, the 

Department will not conduct as many 

retrospective reviews as desired. Indeed, 

this final rule, rather than being a 

revocation of prior regulations, will 

enhance the fulfillment of the existing 

policies that led to the Department’s 

regulations subject to this final rule. 

Comment: Many commenters stated 

that the proposed rule could create legal 

uncertainty regarding the validity and 

enforceability of regulations that the 

Department, after conducting a Review, 

determines should be amended or 

rescinded. Commenters stated this 

could have negative effects on the HHS 

programs, the healthcare industry, and 

states which administer Medicaid and 

CHIP. Some of these commenters stated 

that HHS admits that enforcing a 

Regulation deemed to require 

amendment or rescission in some cases 

could raise concerns about whether 

such enforcement is arbitrary and 

capricious. Continuing to enforce the 

regulation (or portions thereof) could 

arguably run counter to the evidence 

before the agency. However, these 

commenters stated that, HHS provides 

no insight or explanation on how it 

would address this conundrum. 

Response: The Department 

respectfully disagrees. The commenters’ 

concerns only apply where the 

Department has announced, after 

Review, that a regulation should be 

amended or rescinded. Where that is the 

case, the announced results will suggest 

what portions of the regulation may 

need revision and the Department 

anticipates that commenters will 

generally be able to participate in 

subsequent rule making regarding 

amending or rescinding the regulation. 

The basis for amendment or rescission 

will suggest the extent to which 

continued enforcement in the interim is 

appropriate. That is why the proposed 

rule states the Department would 

exercise enforcement discretion ‘‘on a 

case-by-case basis as appropriate.’’ 143

Consistent with Department practice, 

the Department would announce if it is 

exercising enforcement discretion to not 

enforce a regulation. 

Comment: Several commenters stated 

that if Congress’s intent was to 

effectuate results similar to those in the 

proposed rule, it could have included 

sunset provisions in its statutes. By not 

including sunsets in its statutes, 

Congress must not have perceived a 

need for Congressionally-directed 


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144 85 FR 70107. 

145 85 FR 70118. 

rulemaking to expire in the foreseeable 

future, or at least not automatically. 

Response: HHS disagrees that 

Congress’s choice to not include 

automatic sunset provisions in its 

statutes undercuts or forecloses the 

proposed rule. The RFA requires the 

Department to develop ‘‘a plan for the 

periodic review of the rules issued by 

the agency which have or will have a’’ 

SEISNOSE, but leaves the details of said 

plan to the Department. 5 U.S.C. 610(a). 

The RFA demonstrates Congress’s intent 

that agencies conduct retrospective 

review, and the Department has 

determined, for the reasons explained in 

the proposed rule, that sunset 

provisions are a practical and effective 

way to ensure that Congressional intent 

is honored. The commenters’ position 

suggests it is improper to take steps to 

effectuate Congressional intent if 

Congress itself has not expressly 

legislated such steps—but, of course, 

agencies frequently fill in the details of 

a statutory regime implemented by 

Congress. 

Comment: One commenter stated that 

the proposed rule is misleading, which 

thwarts public comment and violates 

the APA. This commenter stated that it 

was misleading and irrational for HHS 

to suggest that it is hypothetical whether 

any regulation would sunset under the 

rule, because every regulation would 

sunset unless a timely Assessment or 

Review occurs. This commenter 

suggested that the rule’s description is 

inadequate to meet the notice standard 

required by the APA. This commenter 

reasoned that the Department’s 

explanation of the proposed rule and its 

reasoning did not provide the public 

with a meaningful opportunity to 

participate in rulemaking through the 

submission of comments, which violates 

the notice and comment requirement of 

the APA. 5 U.S.C. 553. 

Response: HHS respectfully disagrees. 

‘‘The APA requires that the notice of 

proposed rulemaking contain ‘reference 

to the legal authority under which the 

rule is proposed’ and ‘either the terms 

or substance of the proposed rule or a 

description of the subjects and issues 

involved.’ ’’ Little Sisters of the Poor 

Saints Peter and Paul Home v. Pa., 140 

S. Ct. 2367, 2384 (2020) (quoting 5 

U.S.C. 553(b)(2)–(3)). The notice of 

proposed rulemaking, which spanned 

29 pages of the Federal Register, did 

just that. The adequacy of the notice is 

demonstrated by the fact that the agency 

received 532 comments—both critical 

and in support of the proposed rule— 

that raised general issues as well as 

commented on specific provisions of the 

proposed rule. The volume of comments 

also demonstrates that the public had 

ample, meaningful opportunity to 

participate in this rulemaking. There is 

nothing misleading in the Department’s 

statement that it intends to timely 

Assess and (where required) Review its 

Sections. The proposed rule and this 

final rule adequately explain the basis 

for this final rule. 

Comment: One commenter stated that 

the proposed rule is arbitrary and 

capricious because the stated rationale 

of incentivizing retrospective regulatory 

review is implausible. This commenter 

stated that it is wrong to think that the 

Department is incentivized to Assess or 

Review its regulations, because the 

Department may want its regulations to 

expire. The commenter said that the 

penalty for failure to review regulations 

actually falls on the regulated industry, 

not the Department. The commenter 

stated that HHS unlawfully ignored the 

predictable effects of the proposed rule 

on third parties. 

Response: HHS respectfully disagrees. 

The proposed rule amply explained the 

benefits of retrospective review. It also 

explained why sunset deadlines were 

necessary to incentivize retrospective 

review (including, for example, the 

Department’s experience with underutilization of retrospective review). This 

rationale is not implausible because of 

the speculative possibility that the 

Department will intentionally forego 

Assessments and Reviews. If the 

Department wanted its regulations to 

expire, it would have conducted 

rulemakings to rescind its regulations. 

The proposed rule and this final rule 

demonstrate the Department’s 

commitment to timely Assess and 

(where necessary) Review its 

regulations. For example, the proposed 

rule and final rule include (among other 

things) a clear-eyed analysis of the 

resources and staff time required to 

conduct Assessments and Reviews, and 

provide a mechanism for the public to 

request the Department to conduct 

Assessments and Reviews on certain 

regulations. 

Comment: A few commenters stated 

that the proposed regulatory review 

process is arbitrary and capricious, 

because it elevates the need to 

undertake RFA reviews above any other 

purpose served by the Department’s 

regulations, which commenters state is 

disproportionate to the problem at hand. 

These commenters state that since HHS 

estimates that only 11% of its 

regulations have a SEISNOSE and 

would be subject to the RFA, it is 

arbitrary and capricious to subject the 

other 89% of regulations to possible 

rescission. 

Response: HHS respectfully disagrees. 

As explained in the proposed rule and 

this final rule’s preamble, there is a 

need for widespread retrospective 

regulatory review. It is nearly 

impossible to see how a satisfyingly 

comprehensive review could occur 

without a sunset mechanism. The 

Department recognizes that in many 

cases the Department had strong reasons 

for issuing its regulations. Those 

regulations were motivated by 

important policy goals that the 

Department wishes to achieve. This 

final rule will further these goals. The 

literature and the Department’s 

experience suggest that large numbers of 

regulations are having impacts that, over 

time, differ from what was estimated at 

the time the regulations were 

promulgated. Therefore, the Department 

needs to conduct periodic reviews of its 

regulations to determine whether the 

policy goals behind the regulations are 

in fact being effected (and if amending 

those regulations could more effectively 

further those goals). Therefore, this final 

rule is in fact an effort to enhance both 

(1) the fulfillment of the existing 

policies that led to the Department’s 

regulations and (2) the Department’s 

longstanding desire to comply with the 

RFA and periodically review its 

regulations. 

As for conducting Assessments on 

many regulations, and not just 

Reviewing those regulations previously 

determined to have a SEISNOSE, the 

proposed rule explained that ‘‘[w]ithout 

performing the Assessment, the 

Department may not know which 

regulations have or will have a 

significant economic impact upon a 

substantial number of small entities. 

Due to changed circumstances, a 

regulation that did not have such an 

impact at the time it was promulgated 

may now have such an impact.’’ 144

Comment: One commenter stated that 

the Department may not finalize the 

proposed rule without conducting a 

review under the National 

Environmental Policy Act (NEPA) or 

considering how the proposed rule is 

consistent with Executive Orders 13045 

or 12898. 

This commenter stated that HHS 

violated its obligations under NEPA 

because commenters believe the rule is 

a major federal action. According to the 

commenter, the proposed rule stated 

that it ‘‘will not have a significant 

impact on the environment’’ without 

providing additional explanation.145

The commenter stated that the FDA’s 

own NEPA regulations require it to 

conduct at least an environmental 

assessment before promulgating certain 


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146Exec. Order No. 13045 of Apr. 21, 1997, 62 FR 

19885 (Apr. 23, 1997) (E.O. 13045). 

147Exec. Order No. 12898 of Feb. 11, 1994, 59 FR 

7629 (Feb. 16, 1994) (E.O. 12898). 

148 Id. 

149See also 85 FR 70118 (‘‘HHS has determined 

that the proposed rule will not have a significant 

impact on the environment.’’). 

150See 85 FR 70116–17. 

151 85 FR 70109. 

152 85 FR 70106. 

153E.g., 21 CFR part 112. 

154E.g., 45 CFR part 147. 

155 45 CFR part 261. 

regulations, and FDA cannot rescind 

those regulations without conducting 

NEPA review. See 21 CFR 25.20. 

This commenter also stated that the 

proposed rule does not adequately 

consider Executive Orders 13045 or 

12898. Executive Order 13045 imposes 

requirements on agencies to protect 

children from environmental health 

risks and safety risks.146 The commenter 

stated that because the Department did 

not mention Executive Order 13045 in 

its proposed rule, it must have failed to 

consider it. Executive Order 12898 

directs federal agencies to make 

environmental justice part of their 

mission, and to identify and address the 

disproportionate environmental and 

health effects of their activities.147 This 

commenter expressed that HHS did not 

consider whether the proposed sunset 

rule will cause ‘‘disproportionately high 

and adverse human health or 

environmental effects . . . on minority 

populations and low-income 

populations’’ 148 even though the 

commenter believes there is every 

reason to think that the sunset rule will 

cause such adverse effects. 

Response: HHS respectfully disagrees 

that further analysis under NEPA, E.O. 

12898 (‘‘Federal Actions To Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’), and/or E.O. 13045 

(‘‘Protection of Children From 

Environmental Health Risks and Safety 

Risks’’), is required. The commenter’s 

position is based on a fundamental 

misunderstanding of how the final rule 

functions. As explained in the notice of 

proposed rulemaking, this rule does not 

in and of itself rescind any regulations; 

it provides that certain regulations will 

expire if not Assessed and (if required) 

Reviewed by certain dates. 

Thus, there is no basis to say that this 

final rule itself ‘‘significantly affect[s] 

the quality of the human environment,’’ 

42 U.S.C. 4332(C); may cause 

‘‘disproportionately high and adverse 

human health or environmental effects 

. . . on minority populations and lowincome populations,’’ E.O. 12898, Sec. 

1–101; or ‘‘concern[s] an environmental 

health risk or safety risk that an agency 

has reason to believe may 

disproportionately affect children,’’ E.O. 

13045 Sec. 2–202(b).149

The commenter says an 

environmental assessment may be 

necessary, including consideration of 

alternatives as required by section 

102(2)(E) of NEPA, 40 CFR 1501.5(c)(2), 

if it is unclear whether the rule will 

significantly affect the environment. But 

it is clear that this rule alone does not 

have a significant environmental 

impact. Any rescissions or amendments 

pursuant to Assessments and Reviews 

will be effected through notice-andcomment rulemaking independent of 

this rule and include any required 

environmental (and other) analyses. In 

any event, the Department adequately 

explained the alternatives it considered 

in its proposed rule,150 as well as in the 

regulatory impact analysis for this final 

rule. 

Comment: A few commenters stated 

that HHS mistakenly exempts the 

proposed rule from the regulatory 

review process it creates. The proposed 

rule states that it ‘‘cannot, absent other 

actions, directly impose on the public 

costs that exceed benefits . . . [o]nly the 

failure to perform an Assessment or 

Review in the future could theoretically 

impose on the public costs that exceed 

benefits.’’ 151 These commenters stated 

that it was a mistake for HHS to assume 

that the proposed rule will not ‘‘directly 

impose on the public costs that exceed 

benefits’’ because costs would be 

imposed on the public unless 

Assessment or Review of Regulations 

take place. These commenters took the 

position that the Department’s 

regulations would expire by default, and 

that expiration would impose a cost that 

would exceed benefits. 

Response: HHS respectfully disagrees. 

This final rule would not become 

obsolete due to economic, technological, 

or legal changes the way that many 

other rules can. For the reasons 

discussed herein, the Department 

believes the process set forth in this 

final rule will enable the Department to 

Assess and (where required) Review its 

regulations. It is a mistake, and bereft of 

evidence, to assume that the 

Department’s regulations would expire 

by default. 

Comment: Several commenters stated 

that the Department did not adequately 

explain its reasoning for the proposed 

rule. Some of these commenters stated 

that HHS did not acknowledge the facts 

and circumstances that motivated the 

initial promulgation of its regulations, 

nor did HHS discuss in the proposed 

rule the serious reliance interests that 

have been created by some of these 

regulations. Commenters asserted that 

the Department claims that it ‘‘is 

considering the important factors’’— 

without articulating what those factors 

are—and asserts that it ‘‘believes the 

benefits of retrospective review, and the 

need to strongly incentivize it, are so 

great that the risk of a Regulation 

inadvertently expiring is outweighed by 

the benefit of institutionalizing 

retrospective review in this manner.’’ 152

A few commenters asked HHS to 

identify the regulations that are 

vulnerable to rescission under the rule, 

and to describe the nature and 

magnitude of the harm that might result 

from their expiration. 

Response: The Department believes 

the proposed rule adequately explained 

the facts and circumstances that 

motivated issuing the proposed rule, 

and adequately showed that the 

Department considered the relevant 

factors. The same is true for the 

preamble to this final rule, which 

provides additional explanation for why 

the Department is issuing this final rule 

and the factors it considered. The 

Department recognizes that in many 

cases the Department had strong reasons 

for issuing its regulations. Examples of 

such motivations might include 

enhancing food safety,153 increasing 

access to health insurance,154 or 

increasing the incentive for Temporary 

Assistance for Needy Families 

recipients to work.155 These are all 

important policy goals that the 

Department wishes to achieve. This 

final rule is intended to further these 

goals, as well as the other goals 

motivating the Department’s 

regulations. The literature and the 

Department’s experience suggest that 

large numbers of regulations are having 

impacts that, over time, differ from what 

was estimated at the time the 

regulations were promulgated. 

Therefore, the Department needs to 

conduct periodic reviews of its 

regulations to determine whether the 

policy goals behind the regulations are 

in fact being effected (and if amending 

those regulations could more effectively 

further those goals). Outside of the 

exempted regulations, no particular 

regulations are more ‘‘vulnerable to 

rescission’’ than others under this final 

rule. This final rule is agnostic as to all 

Department regulations. They must all 

be Assessed and, if they have a 

SEISNOSE, Reviewed using the criteria 

specified in section [XX](d). 


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156 85 FR 70103. 

157See, e.g., Medicare and Medicaid Programs; 

Regulatory Provisions To Promote Program 

Efficiency, Transparency, and Burden Reduction; 

Part II, 79 FR 27106, 27153 (May 12, 2014) (citing 

42 U.S.C. 1302 as statutory authority for the 

removal of certain regulatory text); Medicare 

Program; Amendment to Payment Policies Under 

the Physician Fee Schedule and Other Revisions to 

Part B for CY 2011 76 FR 1366, 1367 (Jan. 10, 2011) 

(relying on 42 U.S.C. 1302 and 42 U.S.C. 1395hh, 

among other statutory provisions, to amend or 

remove regulatory text); Color Additives; D&C 

Green No. 6; Uniform Specifications, 51 FR 37908, 

37909 (Oct. 27, 1986) (citing 21 U.S.C. 371 as 

statutory authority for amending and removing 

regulatory text). 

158See 85 FR 70123; id. at 70104–05 (defining 

‘‘Regulations’’ as ‘‘a section of the Code of Federal 

Regulations’’). 159See 85 FR 70119, 70120, 70121, 70123. 

Comments on the Statutory Authority 

for This Final Rule 

Comment: Several commenters stated 

that the Department does not have the 

authority to propose automatic 

expiration of its regulations. Some 

commenters stated that HHS fails to 

explain how Congress’s grants of 

authority to the Department to 

‘‘promulgate,’’ 21 U.S.C. 371(a), to 

‘‘make and publish,’’ 42 U.S.C. 1302(a), 

or to ‘‘prescribe,’’ 42 U.S.C. 1395hh(a), 

regulations also give it the authority to 

rescind those regulations, with that 

rescission subject to future reversal at 

the Department’s discretion. Other 

commenters stated that the proposed 

rule not only falls outside these grants 

of rulemaking authority, but squarely 

contradicts Congress’s instructions that 

HHS ‘‘shall’’ promulgate certain 

regulations. E.g., 21 U.S.C. 371, 42 

U.S.C. 1395hh(a). Some commenters 

cited to section 1102 of the Social 

Security Act, which directs the 

Secretary of HHS to issue regulations 

‘‘not inconsistent with this Act’’ to 

implement the Medicaid and CHIP 

programs but does not provide specific 

statutory authority for the Secretary to 

write automatic expiration dates into 

regulations. 

Response: The Department 

respectfully disagrees. As explained in 

the proposed rule, the statutory 

authorities supporting this rule making 

are the statutory authorities for the 

Department’s existing regulations.156

Moreover, the Department believes that 

the relevant portions of the proposed 

rule, as finalized herein, are fully 

consistent with 42 U.S.C. 1302(a). 

Indeed, it specifically cited this 

provision as one source of statutory 

authority for promulgating the proposed 

rule (85 FR at 70103), and does so in 

this final rule. The commenters’ 

position is incorrect for multiple 

reasons. First, the commenters’ assertion 

seems to suggest that any action by the 

Department to repeal or amend 

Medicaid or CHIP regulations, by the 

mere act of amendment or rescission, is 

‘‘inconsistent’’ with those programs. 

That position is untenable.157 In fact, 

this final rule is the promulgation of a 

regulation that will contribute to ‘‘the 

efficient administration of ’’ the 

Department’s functions under the Social 

Security Act, because the Reviews 

called for by this final rule will take into 

account both the continued need for 

particular regulations, as well as 

whether the burden of those regulations 

on small entities can be minimized 

(among several other factors that will 

enhance efficiency, such as the 

complexity of the Regulation or whether 

it is duplicative). For the same reasons, 

this final rule is the promulgation of a 

regulation for ‘‘the efficient 

enforcement’’ of the Federal Food Drug, 

and Cosmetic Act and necessary to carry 

out the administration of the Medicare 

program. See 21 U.S.C. 371(a); 42 U.S.C. 

1395hh(a)(1). This final rule will 

enhance the fulfillment of the policies 

that motivated the regulations issued 

pursuant to 42 U.S.C. 1302, 42 U.S.C. 

1395hh, and 21 U.S.C. 371. 

Comment: Several commenters stated 

that the proposed rule exceeds the 

statutory authority of the RFA, because 

the RFA only affects regulations that 

‘‘have a significant economic impact 

upon a substantial number of small 

entities.’’ 5 U.S.C. 602, 604, 605. 

However, according to the commenters, 

the proposed rule does not limit its 

reach to those regulations covered by 

the RFA because it adds expiration 

dates to all HHS regulations, not just 

those that ‘‘have a significant economic 

impact upon a substantial number of 

small entities.’’ 158 These commenters 

added that the RFA also does not 

mandate the automatic expiration of 

regulations that have not undergone 

agency review. 

Response: The primary statutory 

authorities for this final rule are the 

statutory authorities for the 

Department’s existing regulations. The 

Department also notes, though, that the 

text of 5 U.S.C. 610 indicates Congress 

believed agencies have the authority to 

periodically review at least those 

regulations that have a significant 

economic impact upon a substantial 

number of small entities (and that 

agencies have the authority to assess 

which of their regulations have such an 

impact). See 5 U.S.C. 610(a)–(b). The 

commenters are correct that the RFA 

does not mandate the automatic 

expiration of rules; however, the RFA 

also does not foreclose this final rule’s 

approach. As explained throughout the 

proposed rule and in this final rule, 

decades of experience, empirical 

evidence, and scholarly commentary all 

support the Department’s view that this 

final rule will enhance compliance with 

the RFA’s directive to periodically 

review regulations with a SEISNOSE. 

Comment: A few commenters stated 

that the proposed rule does not cite the 

RFA (5 U.S.C. 610) as a source of its 

statutory authority. These commenters 

stated that they believe the Department 

omitted the RFA it its list of statutory 

authority because the rule is contrary to 

the statute. 

Response: The proposed rule cited 5 

U.S.C. 610 as one of the statutory bases 

for the proposed rule.159 The statutory 

bases for this rulemaking also include 

the existing statutory authorities for the 

Department’s regulations. This final rule 

is consistent with the RFA, because it 

sets forth a plan for the periodic review 

of the regulations issued by the 

Department which have or will have a 

significant economic impact upon a 

substantial number of small entities. See 

5 U.S.C. 610(a). Moreover, this final rule 

requires such review to consider the 

factors set forth in 5 U.S.C. 610(b). The 

text of 5 U.S.C. 610 indicates Congress 

believed agencies have the authority to 

periodically review at least those 

regulations that have a significant 

economic impact upon a substantial 

number of small entities (and that 

agencies have the authority to assess 

which of their regulations have such an 

impact). See 5 U.S.C. 610(a)–(b). 

Specific Provisions of the Proposed Rule 

and Final Rule 

Section [XX](a) 

In the proposed rule, HHS proposed 

to add Section [XX](a), which provided 

that the proposed rule would apply to 

and amend all Regulations issued by the 

Secretary or his delegates or subdelegates in this title. HHS received no 

comments specific to Section [XX](a). 

However, in this final rule HHS replaces 

‘‘this title’’ with ‘‘this chapter,’’ and 

amends the relevant chapters of Titles 

21, 42, and 45, rather than amending all 

regulations that were issued by the 

Secretary (or his delegates or subdelegates) in the titles. HHS makes this 

change to increase clarity and precision. 

For example, certain chapters in Title 21 

contain Drug Enforcement 

Administration, not HHS or FDA 

regulations. Although the proposed 

rule’s use of the language ‘‘Regulations 

issued by the Secretary or his delegates 

or sub-delegates in this title’’ addressed 

this by limiting the scope of the 


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160 In addition, whereas the proposed rule added 

certain regulatory text to Title 45, Part 6, this final 

rule adds the text to Title 45, Part 8. This is not 

a substantive change. Since the Department 

anticipates that, for good governance and 

streamlining reasons, Part 6 soon may soon be 

subsumed into Part 5, the Department in this final 

rule adds the relevant text to Part 8. 

161 5 U.S.C. 605(b) refers to rules that have a 

‘‘significant economic impact on a substantial 

number of small entities,’’ whereas 5 U.S.C. 610 

refers to rules that have ‘‘significant economic 

impact upon a substantial number of small 

entities.’’ This does not appear to be a material 

difference. 

162See A Guide for Government Agencies: How 

To Comply With The Regulatory Flexibility Act, 

U.S. SBA Off. of Advoc., at 80–81 (2017), https:// 

cdn.advocacy.sba.gov/wp-content/uploads/2019/ 

06/21110349/How-to-Comply-with-the-RFA.pdf, (‘‘If 

Congress meant to limit periodic reviews, it would 

have simply required agencies to review rules that 

originally had a significant impact, rather than rules 

that now have a significant impact.’’). 

163 5 U.S.C. 551(4) (providing that ‘‘ ‘rule’ means 

the whole or a part of an agency statement of 

general or particular applicability and future effect 

designed to implement, interpret, or prescribe law 

or policy or describing the organization, procedure, 

or practice requirements of an agency and includes 

the approval or prescription for the future of rates, 

wages, corporate or financial structures or 

reorganizations thereof, prices, facilities, 

appliances, services or allowances therefor or of 

valuations, costs, or accounting, or practices bearing 

on any of the foregoing’’). 

proposed rule to regulations issued by 

the HHS Secretary or his delegates or 

sub-delegates, HHS in this final rule 

amends the chapters belonging to HHS, 

rather than the entirety of the titles. This 

is not a substantive change and does not 

cause the application of the final rule or 

the rights and obligations it creates to 

differ from the proposed rule.160

Similarly, HHS clarifies that it is 

amending its other regulations through 

the provisions in this final rule by 

generally applying an expiration date to 

those regulations, if certain conditions 

are not met, rather than asking the 

Office of the Federal Register to literally 

amend each other regulation, which 

would be unnecessarily burdensome 

and resource intensive. Accordingly, 

this final rule states that it applies to 

and ‘‘shall be deemed to amend’’ all 

regulations issued by the Secretary or 

his delegates or sub-delegates in the 

applicable chapters. This is not a 

substantive change and does not affect 

the application of the final rule or the 

rights and obligations it creates. 

HHS received no comments specific 

to section [XX](a) of the proposed rule. 

Accordingly, HHS finalizes section 

[XX](a) to read, ‘‘[t]his section applies to 

and shall be deemed to amend all 

regulations issued by the Secretary or 

his delegates or sub-delegates in this 

chapter.’’ 

Section [XX](b) 

HHS proposed to add section [XX](b), 

which defined several terms used in the 

proposed rule. 

i. Section [XX](b)(1) 

HHS proposed to define ‘‘Assess’’ as 

‘‘a determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Regulations issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities.’’ 

5 U.S.C. 610 directs agencies to have 

plans to periodically review those 

regulations that have or will have a 

significant economic impact upon a 

substantial number of small entities. 

Accordingly, in order to determine 

which regulations to periodically review 

using 5 U.S.C. 610’s criteria, the 

Department must first determine which 

rules have a significant economic 

impact upon a substantial number of 

small entities. When promulgating 

regulations, the Department is required 

to determine whether a rule will have a 

significant economic impact on a 

substantial number of small entities. See 

5 U.S.C. 605(b).161 The Assessment 

refers to an essentially identical 

determination. In making the 

Assessment, the Department can look to 

the determination of the regulation’s 

impact on small entities made at the 

time of promulgation, as well as 

experience since promulgation. 

Comments on Section [XX](b)(1) 

HHS received the following comment 

on the proposed definition of ‘‘Assess.’’ 

Comment: A few commenters stated 

that HHS should clarify that periodic 

Assessments must look to the 

determination of the regulation’s impact 

on small entities made at the time of 

promulgations, as well as experience 

since promulgation.162 These 

commenters stated that HHS should 

clarify that any Assessment that only 

contemplates the former and ignores the 

latter will be deficient. 

Response: Assessments must analyze 

the regulation’s impact on small entities 

at the time the regulation is being 

Assessed. The Department believes this 

is clear from the text of the proposed 

rule, which defined ‘‘Assess’’ as ‘‘a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Regulations issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities’’ (emphasis 

added). Accordingly, the Department 

adopts in this final rule the definition of 

‘‘Assess’’ from the proposed rule, except 

that the term ‘‘Regulations’’ in the 

proposed rule is changed to ‘‘Sections’’ 

in this final rule. The determination 

made at the time of promulgation about 

whether a rulemaking had a SEISNOSE 

may be a useful data point in assessing 

the regulation’s current impact on small 

entities. 

Accordingly, HHS is finalizing the 

definition of ‘‘Assess’’ as proposed, with 

the technical amendment just 

mentioned. 

ii. Section [XX](b)(2) 

HHS proposed to define ‘‘Review’’ as 

a process conducted by the Department, 

in consultation with other Federal 

agencies as appropriate, the purpose of 

which shall be to determine whether the 

Regulations that were issued as part of 

the same rulemaking (and any 

amendments or additions that may have 

been issued thereafter) should be 

continued without change, or should be 

amended or rescinded, consistent with 

the stated objectives of applicable 

statutes, to minimize any significant 

economic impact of the Regulations 

upon a substantial number of small 

entities. 

HHS received no comments specific 

to the proposed definition of ‘‘Review.’’ 

Accordingly, HHS is finalizing the 

definition of ‘‘Review’’ as proposed, 

except that it replaces the term 

‘‘Regulations’’ with ‘‘Sections,’’ to 

conform this provision to the rest of this 

final rule. 

iii. Section [XX](b)(3) 

HHS proposed to define ‘‘Regulation’’ 

as ‘‘a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Regulation, and 42 CFR 2.14 is 

another Regulation.’’ This definition 

was proposed to make clear that a 

section of the CFR, as opposed to a part, 

subpart, or paragraph within a section, 

is the unit that must be Assessed and (if 

required) Reviewed, or will otherwise 

expire. Defining ‘‘Regulation’’ in this 

objective way makes it easier for the 

Department and the public to know 

what exactly has to be Assessed or 

Reviewed by the dates listed in the 

proposed rule. Had the Department used 

the Administrative Procedure Act’s 

(APA’s) definition of ‘‘rule,’’ 163 it could 

be unclear in certain circumstances 

what precisely needed to be reviewed. 

In the final rule, HHS changes the 

term ‘‘Regulation’’ to ‘‘Section’’ for the 

reasons previously discussed. 


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164See 85 FR at 70117. 

Comments on Section [XX](b)(3) 

HHS received the following 

comments on the proposed definition of 

‘‘Regulation.’’ 

Comment: A few commenters stated 

that HHS arbitrarily chose to reject the 

APA’s definition of ‘‘Regulation’’ and 

adopted its own definition of 

‘‘Regulation’’ for the purposes of this 

rule, defining regulation as ‘‘a section of 

the Code of Federal Regulations.’’ Some 

commenters stated that using a different 

definition in this rule from the 

definition in the APA (and incorporated 

in Executive Order 12866 and Executive 

Order 13771) is confusing. Commenters 

stated that the Department’s explanation 

that it used a special definition of 

‘‘Regulation’’ to avoid confusion that 

could be created by using the APA’s 

definition was insufficient and lacked 

statutory basis. 

Response: To avoid any confusion, 

HHS uses ‘‘Section,’’ rather than 

‘‘Regulation,’’ in this final rule to refer 

to a section of the Code of Federal 

Regulations. It is crucial to the proper 

function of this final rule that the 

Department and public clearly 

understand the scope and timing of the 

Assessment and Review process. Such 

understanding is made easier with a 

bright-line definition of the agency 

issuances that are subject to Assessment 

and Review. The Department’s use of 

‘‘Section’’ endeavors to provide such 

clarity by using a readily available and 

well-established system of organization, 

the Code of Federal Regulations. It is 

clear when a section of the Code of 

Federal Regulations was first 

promulgated. 

The use of ‘‘Section,’’ rather than 

‘‘Regulation,’’ in this final rule is not a 

substantive change from the proposed 

rule. Rather, it is an attempt to bring 

additional clarity by using ‘‘Section’’ to 

refer to a section of the Code of Federal 

Regulations, rather than using the term 

‘‘Regulation.’’ 

Comment: One commenter expressed 

concern over the proposed rule’s 

definition of ‘‘Regulation,’’ stating that 

the definition is too narrow. This 

commenter stated that under the 

proposed rule, each Regulation would 

be Assessed or Reviewed without the 

context of the preamble language that 

was included in the rulemaking. 

Response: HHS respectfully disagrees. 

‘‘Assessment’’ and ‘‘Review’’ are 

defined in this final rule as 

determinations with respect to 

‘‘Sections that were issued as part of the 

same rulemaking (and any amendments 

or additions that may have been issued 

thereafter).’’ In the proposed rule, 

‘‘Regulation’’ was defined as a section of 

the Code of Federal Regulations so the 

Department and public can know what 

units would expire absent Assessment 

or (if needed) Review. But the text of the 

final rule makes clear that a single 

Assessment or Review should be 

performed on all Sections that were 

issued as part of the same rulemaking 

(and any amendments or additions that 

may have been issued thereafter). The 

Department disagrees with the 

commenters who stated that, under the 

proposed rule, each Regulation would 

be Assessed or Reviewed without the 

context of the preamble language that 

was included in the rulemaking. Under 

this final rule, the Department may 

consider this information when 

conducting Assessments and Reviews. 

Accordingly, HHS is finalizing the 

definition proposed, except that it 

defines the term ‘‘Section’’ rather than 

‘‘Regulation.’’ 

iv. Section [XX](b)(4) 

HHS proposed to define ‘‘Year of the 

Regulation’s Promulgation’’ to mean the 

calendar year the Regulation first 

became effective, irrespective of 

whether it was subsequently amended. 

The purpose of this proposed definition 

was to provide clarity to the Department 

and the public. If a regulation were 

amended, questions could arise whether 

the clock for re-reviewing the rule 

making in which the regulation was first 

promulgated begins on the date the rule 

making was first promulgated; the date 

it was last amended; or whether the 

clock for reviewing the amended 

portion begins on a different date than 

the portion that was initially enacted. 

The proposed definition is more clear 

for the Department and the public, 

because this definition, in conjunction 

with section [XX](c) of the proposed 

rule, makes clear that the clock starts for 

the retrospective review of a regulation 

on the date that the rule making from 

which the regulation originates was first 

promulgated, even if it is subsequently 

amended. 

If, for example, the Department issues 

a regulation as a part of a rule making 

and amends it nine years later, the 

Department may wish to conduct the 

regulatory review of the entire rule 

making at the time of amendment of a 

specific regulation initially promulgated 

in that rule making, particularly since 

the Department is presumably already 

performing a regulatory impact analysis 

with regard to the amendment. Since 

the Department is already conducting a 

regulatory impact analysis, performing 

the regulatory review at that time may 

save Department resources and spare 

the Department from having to perform 

the Review on the regulation the next 

year. In fact, any time the Department 

amends a regulation, it could perform 

the regulatory review at that time, 

thereby conserving Department 

resources. 

HHS received no comments specific 

to the proposed definition of ‘‘Year of 

the Regulation’s Promulgation.’’ 

Accordingly, HHS is finalizing the 

definition of ‘‘Year of the Regulation’s 

Promulgation’’ as proposed, except that 

it changes the term ‘‘Regulation’’ to 

‘‘Section.’’ 

v. Section [XX](b)(5) 

HHS proposed to define ‘‘[s]ignificant 

economic impact upon a substantial 

number of small entities’’ as having the 

meaning ascribed to that term in the 

Regulatory Flexibility Act, Public Law 

96–354, 94 Stat. 1164 (Sept. 19, 1980) 

(as amended 1996). 

HHS received the following 

comments on the proposed definition of 

‘‘Significant economic impact upon a 

substantial number of small entities.’’ 

Comment: A few commenters stated 

that neither the proposed rule, nor the 

RFA gives a clear definition of 

‘‘significant impact’’ or of ‘‘small 

entity,’’ and asked that HHS clarify the 

definition of these terms in the final 

rule. 

Response: HHS declines to add 

definitions of these terms within this 

final rule. ‘‘Significant economic 

impact’’ and ‘‘small entity’’ are terms 

within the RFA, which has been in 

existence for over forty years. These 

terms have been applied by the 

Department and other agencies since the 

RFA’s enactment. Definitions pertinent 

to ‘‘small entity’’ appear at 5 U.S.C. 601. 

As explained in the proposed rule, the 

Department has considered a rule to 

have a significant impact on a 

substantial number of small entities if it 

has at least a three percent impact on 

revenue on at least five percent of small 

entities.164

Comment: One commenter stated that 

the citation in the definition of 

‘‘Significant economic impact upon a 

substantial number of small entities’’ 

found at 21 CFR 6.1(b)(5), 42 CFR 

1.1(b)(5), 42 CFR 404.1(b)(5), and 45 

CFR 6.1(b)(5) was incorrect. The 

proposed rule cited the Regulatory 

Flexibility Act, Public Law 96–354, 94 

Stat. 1164 (Sept. 19, 1980) (as amended 

1996). This commenter stated that 

because the definition in the RFA 

appears in section 610 of title 5 of the 

U.S. Code, the correct citation is to the 

code. This commenter also stated that 

the definition of ‘‘Significant economic 

impact upon a substantial number of 


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165See, 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/R8LXBQMJ; 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-cambridgecore/content/view/A7B29CE98E650B424E92FF292

A8FFC89/S2194588800000774a.pdf/national_

primary_drinking_water_regulation_for_arsenic_a_

retrospective_assessment_of_costs.pdf. 

166The RFA and the Executive Orders direct 

agencies to review overlapping, but not identical, 

sets of regulations. The RFA directs agencies to 

have plans to review regulations that have a 

‘‘significant economic impact upon a substantial 

number of small entities.’’ 5 U.S.C. 610. By contrast, 

Executive Order 12866 directed agencies to submit 

to OIRA programs to periodically review 

‘‘significant regulations.’’ Exec. Order 12866, Sec. 

5(a). ‘‘Significant regulations’’ are not necessarily 

those that have a ‘‘significant economic impact 

upon a substantial number of small entities.’’ Id. at 

Sec. 3(f) (defining ‘‘significant regulatory action’’ as 

any regulatory action that is likely to result in a rule 

that may: (1) Have an annual effect on the economy 

of $100 million or more or adversely affect in a 

material way the economy, a sector of the economy, 

productivity, competition, jobs, the environment, 

public health or safety, or State, local, or tribal 

governments or communities; (2) Create a serious 

inconsistency or otherwise interfere with an action 

taken or planned by another agency; (3) Materially 

alter the budgetary impact of entitlements, grants, 

user fees, or loan programs or the rights and 

obligations of recipients thereof; or (4) Raise novel 

legal or policy issues arising out of legal mandates, 

the President’s priorities, or the principles set forth 

in this Executive order.’’). Executive Order 13563 

also directed agencies to review ‘‘significant 

regulations.’’ Exec. Order 13563, Sec. 6. The 

Department has proposed to Review those 

regulations that satisfy the RFA criteria, since those 

are the regulations that Congress directed agencies 

to have plans to review. The Department requested 

comment on whether additional regulations, such 

as significant regulations, should also be Reviewed. 

167Curtis W. Copeland, Cong. Rsch. Serv., 

RL32801, Reexamining Rules: Section 610 of the 

Regulatory Flexibility Act 11 (2008); see also YoonHo 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). 

168Russell S. Sobel & John A. Dove, State 

Regulatory Review: A 50 State Analysis of 

Effectiveness 36 (Mercatus Ctr., Working Paper No. 

12–18, 2012), https://www.mercatus.org/system/ 

files/State-Regulatory-Review-50-State-AnalysisEffectiveness.pdf;); Occupational Licensing: A 

Framework for Policymakers, The White House, at 

48–50 (July 2015), https://obamawhitehouse.

archives.gov/sites/default/files/docs/licensing_

report_final_nonembargo.pdf. 

169See, e.g., Amendment to the Interim Final 

Regulation for Mental Health Parity, 70 FR 42276, 

42277 (July 22, 2005) (amending interim final rule, 

to provide that ‘‘the requirements of the MHPA 

interim final regulation apply to group health plans 

and health insurance issuers offering health 

insurance coverage in connection with a group 

health plan during the period commencing August 

22, 2005 through December 31, 2005. Under the 

extended sunset date, MHPA requirements do not 

apply to benefits for services furnished after 

December 31, 2005.’’); see generally Clean Air 

Council, 862 F.3d at 9 (an agency can amend or 

revoke a legislative rule through notice-andcomment rulemaking). 

170See, 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’’). 

small entities’’ shall be defined to have 

the meaning ‘‘of’’ that term in 5 U.S.C. 

610, rather than the meaning ‘‘ascribed 

to’’ that term in 5 U.S.C. 610. 

Response: HHS appreciates the 

comments and agrees that citation to the 

Code is proper. This final rule 

incorporates this suggestion, and 

replaces the citation in the proposed 

rule with ‘‘5 U.S.C. 610.’’ It also 

incorporates the comment to use ‘‘of’’ 

instead of ‘‘ascribed to.’’ This revised 

definition may provide increased 

clarity. 

Accordingly, in this final rule HHS is 

finalizing the definition of ‘‘[s]ignificant 

economic impact upon a substantial 

number of small entities’’ to provide 

that this term shall have the meaning of 

that term in section 610 of title 5 of the 

United States Code. 

Section [XX](c) 

i. Section [XX](c)(1)–(2) 

In the proposed rule, HHS proposed 

that unless a Regulation contains an 

earlier expiration date or is rescinded 

earlier, all Regulations issued by the 

Secretary or his delegates or subdelegates in this title shall expire at the 

end of either (1) two calendar years after 

the year that this rule first becomes 

effective, (2) ten calendar years after the 

Year of the Regulation’s Promulgation, 

or (3) ten calendar years after the last 

year in which the Department Assessed 

and (if Review of the Regulation is 

required pursuant to paragraph (d)) 

Reviewed the Regulation, whichever is 

latest. The last year in which the 

Department Assessed and (if Review of 

the Regulation is required) Reviewed 

the Regulation shall be the year during 

which the findings of the Assessment 

and, if required, the Review of the 

Regulation are published in the Federal 

Register pursuant to paragraph (f) of this 

section. 

In other words, under the proposed 

rule the Department must Review all its 

regulations (subject to the exceptions 

listed below) that have a significant 

economic impact upon a substantial 

number of small entities every ten years, 

or such regulations shall expire. To 

determine which regulations have a 

significant economic impact upon a 

substantial number of small entities, the 

proposed rule stated that the 

Department must Assess all its 

regulations (subject to the exceptions 

listed below) every ten years, or such 

regulations shall expire if not Assessed. 

The Department believes all of its 

regulations (subject to the exceptions) 

should be Assessed and, if they have a 

significant economic impact upon a 

substantial number of small entities, 

Reviewed. The proposed rule stated that 

Assessments and Reviews should not be 

performed only on those regulations 

issued after the proposed rule goes into 

effect. After all, it is likely that some 

regulations promulgated decades ago 

may have become outdated.165

Section [XX](c) of the proposed rule 

made clear that Department regulations 

(subject to the exceptions listed below) 

shall expire if their Assessment and (if 

required) Review are not timely 

performed. Both 5 U.S.C. 610 and 

executive orders by multiple presidents 

over several decades direct the 

Department to devise plans to 

periodically review many of its 

regulations.166 Although the Department 

retrospectively reviewed a very limited 

number of its regulations, observers 

have over the decades noted that the 

Department has not always performed 

retrospective review to a satisfactory 

extent, and many of its regulations have 

not been reviewed. Therefore, the 

Department concluded in the proposed 

rule that it was appropriate to impose 

on itself a stronger incentive to ensure 

it complies with the purposes animating 

the RFA and the executive orders, as 

well as to ensure its regulations are not 

unduly burdening the public. As a CRS 

report put it, ‘‘[w]ithout some type of 

enforcement of the review requirement, 

agencies are unlikely to conduct many 

more reviews than have occurred 

pursuant to Section 610.’’ 167 This is one 

reason why analyses have found that 

sunset provisions are an effective way to 

improve governance and reduce undue 

regulatory burdens.168 States have 

imposed similar expiration dates for 

many of their regulations unless they 

are reviewed or readopted. 

It complies with the APA to amend 

regulations to specify dates by which 

regulations expire unless the 

Assessment and/or Review is timely 

performed. An agency can, through 

notice-and-comment rulemaking, amend 

its regulations to provide that they 

expire at a future date.169 An agency can 

also provide that its regulations expire 

upon the occurrence of a condition.170

That is what the Department proposed 


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171 Little Sisters of the Poor Saints Peter and Paul 

Home v. Pa., 140 S. Ct. 2367, 2383–84 (2020) 

(quoting Motor Vehicle Mfrs. Assn. of U.S., Inc. v. 

State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 

(1983)). 

172See, e.g., N.J. Admin. Code § 1:30–6.4 (2020) 

(regulations expire every seven years unless 

readopted, subject to certain exceptions); Ind. Code 

4–22–2.5–2 (2020) (imposing seven-year expiration 

date on regulations unless readopted). 

173N.C. Gen. Stat. 150B–21.3A (2020). 

174See, 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). 

175Current Good Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive Controls for 

Human Food, 80 FR 55,907 (Sept. 17, 2015). https:// 

www.federalregister.gov/documents/2015/09/17/ 

2015-21920/current-good-manufacturing-practicehazard-analysis-and-risk-based-preventive-controlsfor-human. 

in the proposed rule. To be sure, an 

agency generally must ‘‘articulate a 

satisfactory explanation’’ for its action, 

‘‘including a rational connection 

between the facts found and the choice 

made,’’ and cannot ‘‘entirely fail[] to 

consider an important aspect of the 

problem.’’ 171 The Department 

anticipates that if a regulation expires 

because the Department does not timely 

complete its regulatory review, a litigant 

might object to the expiration on the 

grounds that the Department by 

definition did not ‘‘articulate a 

satisfactory explanation’’ or ‘‘failed to 

consider an important factor,’’ because 

in not performing an Assessment or 

Review, the Department failed to 

consider any factors. The Department 

rejects such arguments. In this 

rulemaking, the Department is 

considering the important factors. For 

the reasons described in the proposed 

rule and in this final rule, the 

Department believes the benefits of 

retrospective review, and the need to 

strongly incentivize it, are so great that 

the risk of a regulation inadvertently 

expiring is justified by the benefit of 

institutionalizing retrospective review 

in this manner. Forty years of 

experience since the RFA’s enactment; 

the decades since relevant Executive 

Orders were enacted; and other Federal 

government efforts to spur the 

Department to conduct more 

retrospective reviews indicate that, 

absent such a forcing mechanism, the 

Department will not conduct as many 

retrospective reviews as desired. 

The Department will mitigate this risk 

by setting up two web pages on the 

Department’s website by the date this 

final rule is published; one that lists the 

dates of promulgation of all of its 

rulemakings, and a second that lists the 

rulemakings that contain regulations 

(called ‘‘Sections’’ in this final rule) that 

the Department has decided to Assess or 

Review. The Department will regularly 

update the web page listing the 

rulemakings containing Sections that it 

has decided to Assess or Review with 

all additional rulemakings containing 

Sections that it begins to Assess or 

Review. The Department will also create 

a docket on Regulations.gov, to which 

the public may direct any comments 

requesting that the Department begin 

the Assessment or Review of 

regulations. This requirement is 

described in more detail in the 

discussion of section [XX](h). 

Therefore, in this rulemaking process, 

which amends Department regulations 

through the notice-and-comment 

process, the Department is considering 

the important factors. In addition, the 

Department intends to create on its 

website a dashboard that shows its 

progress on its Assessments and 

Reviews, including when it commenced 

those Assessments and Reviews, its 

progress, and when it expects them to 

be completed. The Department also 

intends to create a dashboard showing 

its progress on conducting Assessments 

and Reviews. See Section II.F. for more 

detail on the dashboard. 

The Department proposed to perform 

the Assessment and (if required) the 

Review on each regulation every ten 

years. Some states provide that, unless 

readopted or re-reviewed, their 

regulations expire in seven years,172

while at least one state uses a ten-year 

time period.173 The Department 

proposed to perform the Assessment 

and (if required) the Review every ten 

years, because ten years is the period 

listed in 5 U.S.C. 610. 

The proposed rule provided that 

regulations promulgated more than ten 

years ago will expire at the end of two 

calendar years from the date the 

proposed rule, if finalized, became 

effective, unless an Assessment and (if 

required) the Review is performed on 

them. In the proposed rule, the 

Department requested public comment 

on whether two years is an appropriate 

time period to Assess and (if required) 

Review Regulations promulgated more 

than ten years ago. 

The Department has decided that all 

of its regulations (subject to the 

exceptions listed below) should be 

periodically Assessed to determine 

whether they have a significant 

economic impact upon a substantial 

number of small entities. Without 

performing the Assessment, the 

Department may not know which 

regulations have or will have a 

significant economic impact upon a 

substantial number of small entities. 

Due to changed circumstances, a 

regulation that did not have such an 

impact at the time it was promulgated 

may now have such an impact. The 

Department is also aware of literature 

suggesting that agencies have not been 

consistent in deciding which rules have 

a significant economic impact on a 

substantial number of small entities, or 

have avoided such a finding in order to 

avoid complying with the RFA’s 

requirements.174 By Assessing all of its 

regulations (subject to the exceptions 

described herein) and publishing the 

results of the Assessments, the 

Department can avoid concern that the 

Department is failing to Assess or 

Review regulations that have a 

significant economic impact upon a 

substantial number of small entities. 

The Department should in many cases 

perform a single Assessment (and, 

where required, a single Review) that 

considers all regulations issued as part 

of the same rulemaking. That would 

generally make sense from an economic 

perspective, for the same reasons that 

the Department in many cases does a 

single regulatory impact analysis on all 

regulations that are issued as part of the 

same rulemaking. That is why the 

proposed rule and this final rule define 

‘‘Assess’’ and ‘‘Review’’ as 

determinations regarding ‘‘Regulations 

issued as part of the same rulemaking 

(and any amendments or additions that 

may have been added thereafter)’’ 

(except that the term ‘‘Regulations’’ is 

replaced with ‘‘Sections’’ in this final 

rule). Indeed, 5 U.S.C. 605(c) provides 

that ‘‘[i]n order to avoid duplicative 

action, an agency may consider a series 

of closely related rules as one rule for 

the purposes of sections 602, 603, 604 

and 610 of this title.’’ Thus, if a series 

of regulations were issued as part of the 

same rulemaking and one of those 

regulations was subsequently amended, 

the Department would in many cases 

take the view that the series of 

regulations could be Assessed or 

Reviewed together for purposes of this 

final rule. 

The same is true for the converse. 

Consider, for example, the 2015 

rulemaking Preventive Controls for 

Human Food that established 21 CFR 

part 117 and also amended or revised 

individual regulations in Parts 1, 106, 

110, 114, 120, 123, 129, 179, and 211 

that were originally issued before 

2015.175 If the Department so chose, 

when the deadline approaches for 

Assessing and (if required) Reviewing 

the amended regulations in 21 CFR part 


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176See, 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). 

177See 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)). 

178See 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). 

179 85 FR 70,105. 

180 Id. 

106, the Department could, as part of 

the same Assessment or Review, also 

assess or review the other regulations 

that were amended in this rulemaking. 

For regulations that were issued in 

coordination with another Agency, that 

function in concert with another 

Agency’s regulations, or that have a 

specific, direct impact on regulations 

issued by another Federal agency, the 

proposed rule proposed that the 

Department would consult with that 

other Agency when undertaking the 

Assessment or Review, and consider the 

other Agency’s views when considering 

the factors described in section [XX](d). 

An example of regulations that have a 

specific, direct impact on regulations 

issued by another Federal agency are the 

Department’s ACA regulations 

concerning the operation of Exchanges 

that affect eligibility for the advance 

premium tax credit. Such regulations 

have a specific, direct impact on 

Department of the Treasury 

regulations.176

The Department’s understanding is 

that the decisions based upon Reviews, 

including the amendment, repeal, or 

continuance of regulations without 

change, will constitute final agency 

action. First, the decisions will mark the 

consummation of the agency’s 

decisionmaking process with respect to 

whether a regulation satisfies the 

criteria described in section [XX](d). 

Second, the decisions constitute action 

by which rights or obligations have been 

determined, or from which legal 

consequences will flow. This is because 

if the Review is not performed, the 

regulation would expire.177 Therefore, 

because the decisions based upon 

Reviews constitute final agency action, 

they must be performed in such a 

manner that they would withstand 

judicial review under the arbitrary and 

capricious standard.178

Similarly, if an Assessment concludes 

that a regulation does not have a 

significant economic impact upon a 

substantial number of small entities, 

that would mark the consummation of 

the Department’s decisionmaking 

process with respect to whether a 

Review must be performed on the 

regulation. Such an Assessment’s 

findings would also constitute action by 

which rights or obligations have been 

determined, or from which legal 

consequences will flow, because if the 

Assessment is not performed, the 

regulation would expire. Therefore, 

Assessments must also be performed in 

such a manner that they would 

withstand judicial review under the 

arbitrary and capricious standard. 

The Department proposed to perform 

the Assessment and (if required) the 

Review on each Regulation every ten 

years. Some states provide that, unless 

readopted or re-reviewed, their 

regulations expire in seven years,179

while at least one state uses a ten-year 

time period.180 The Department 

proposed to perform the Assessment 

and (if required) the Review every ten 

years, because ten years is the period 

listed in 5 U.S.C. 610. The Department 

has many regulations, some of which 

are complex, so having to perform the 

Assessment and Review more than once 

every ten years could unduly burden the 

Department and increase the likelihood 

that a Regulation inadvertently expires 

because it is not Assessed or Reviewed. 

Comments and Responses Regarding 

Section [XX](c) 

HHS received the following 

comments on Section [XX](c) of the 

proposed rule. 

Comment: Several commenters asked 

the Department to extend, from two 

years to five years, the timeframe for 

Assessment or Review of regulations 

that are over ten years old. 

Response: The Department considered 

this comment, and has decided to make 

this change. Under this final rule, 

regulations that are more than ten years 

old when this final rule becomes 

effective shall expire if not Assessed 

and (if needed) Reviewed within five 

calendar years of the year that this final 

rule becomes effective. This will spread 

out the initial burden on the Department 

and provide the opportunity for more 

robust Assessments and Reviews. It also 

reduces any harm to reliance interests, 

since the public will now be on notice 

further in advance of the initial 

Assessment and Review deadlines. 

Comment: Several commenters stated 

that the final rule should provide the 

Secretary with the authority to make 

one-time, case-by-case exceptions to the 

automatic expiration of a rule. 

Response: HHS appreciates this 

comment and has decided to include 

within this final rule a provision that 

allows the Secretary—on a nondelegable basis—to extend on a onetime, case-by-case basis the automatic 

expiration date of a Section by one year. 

The Department shall promptly publish 

in the Federal Register any such 

determination by the Secretary to 

extend the expiration date. 

Comment: A large number of 

commenters stated that the process 

established in the proposed rule could 

result in important regulations slipping 

through the cracks and expiring, which 

could have implications for other rules. 

These commenters stated that the 

Assessment and Review process 

established in the proposed rule would 

be complicated and time-consuming to 

put into practice, which could result in 

the automatic expiration of some 

regulations. A large number of 

commenters specifically mentioned 

regulations at 42 CFR 435.603, on which 

multiple insurance affordability 

programs, including Medicaid and 

CHIP, rely to determine financial 

eligibility using Modified Adjusted 

Gross Income (MAGI) methodologies. 

According to the commenters, the 

expiration of that regulation would 

allow programs to redefine MAGI 

household and income counting rules, 

with no standards, consistency, or 

accountability, which commenters fear 

could wreak havoc in HHS programs. 

Another commenter stated that if some 

critical regulations, such as the 

Medicare health and safety standards 

which provide a baseline for patient 

safety sunset, this could threaten patient 

safety. A large number of commenters 

suggested that safeguards be put in 

place to ensure that regulations that are 

critical to the operation of safety net 

providers do not simply expire because 

an Assessment or Review was not 

completed in time. 

Response: HHS appreciates the 

theoretical possibility raised by these 

commenters that important regulations 

(such as MAGI methodologies or 

Medicare health and safety standards) 

could expire inadvertently. But as 

explained throughout the proposed rule 

and in this final rule, the Department 

intends to timely complete the required 

Assessments and Reviews. As noted in 

the proposed rule, as an additional 

safeguard, in the unlikely event it 

appears HHS has overlooked an 

impending deadline, interested 

members of the public can raise the 

need to Assess or Review specific 

regulation through public comment. As 


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181 85 FR 70105. 

an additional safeguard, the Department 

adds in this final rule that if, prior to the 

expiration of a Section, the Secretary 

makes a written determination that the 

public interest requires continuation of 

the Section in force beyond the date on 

which the Section would otherwise 

expire under this final rule, the 

Secretary may continue the Section in 

force one time for a period stated in the 

determination, which period shall not 

exceed one year. 

Comment: Several commenters 

expressed concern about the precedent 

created by an automatic expiration date, 

which they believe could allow future 

administrations to reject regulations by 

simply letting them lapse. These 

commenters stated that this scenario 

would allow the Department to bypass 

the regulatory process and deprive the 

American people of the opportunity for 

comment and input. 

Response: HHS respectfully disagrees 

that this is a significant enough risk to 

outweigh the tremendous benefits from 

retrospective review. The commenters’ 

concerns assume a lack of good faith by 

future administrations. There would 

also likely be a tremendous public 

outcry if many beneficial regulations 

were permitted to expire. 

This final rule does not bypass the 

regulatory process or deprive the 

American people of the opportunity for 

comment and input. In this rulemaking, 

the Department is going through the 

APA’s ordinary notice-and-comment 

process. This final rule reflects that the 

Department accepted and considered 

over 500 public comments on the 

proposed rule. The Department also 

held a public hearing on the proposed 

rule and considered the comments made 

there in promulgating this final rule. In 

addition, this final rule institutionalizes 

an ongoing opportunity for public 

comment during this regulatory review 

process. 

Comment: Several commenters stated 

that public harm could result from 

removing regulations that protect the 

public health and consumers. A few 

commenters suggested that the 

Assessments and Reviews conducted by 

the Department should specifically 

consider consumer protection. 

Response: For the reasons explained 

in the preamble and regulatory impact 

analysis for this final rule, this final rule 

implements a process by which the 

Department will Assess and Review its 

regulations. HHS intends to undertake a 

careful Assessment, and (if necessary) 

Review of each regulation subject to this 

final rule to determine if the regulation 

should be continued without change, 

amended, or rescinded. HHS has no 

intention to rescind regulations that 

appropriately protect the public health 

or consumers. Reviews will consider the 

factors described in 5 U.S.C. 610(b) (as 

well as whether the regulation complies 

with applicable law). These are the 

factors that Congress directed the 

Department to consider when 

periodically reviewing regulations that 

have a SEISNOSE. Considerations with 

respect to consumer protection will 

often be subsumed in this analysis. 

Comment: A few commenters 

suggested that instead of the proposed 

timeframe for review, the Department 

should instead Review regulations on a 

rolling basis but not less than 10 years 

from the date of first promulgation or 

substantial amendment. 

Response: HHS respectfully disagrees. 

Clear and specific deadlines are needed 

to ensure the efficacy of this rule and to 

secure robust retrospective review of 

agency regulations. Moreover, the 

commenters’ suggestion that review 

occur no less than 10 years from the 

date of promulgation or substantial 

amendment is, in the Department’s 

view, an undue time lapse. It threatens 

to leave long outdated and burdensome 

regulations in place for too long. 

Comment: One commenter stated that 

the proposed timeline for reviewing 

regulations is inconsistent with the 

proposed rule’s goal of reviewing 

regulations based on the likelihood of 

their obsolescence. This commenter 

stated that the proposed rule assumes 

that the passage of time increases the 

likelihood of regulatory obsolescence, 

but the proposed rule defines a 

Regulation’s age based on the date on 

which it was originally promulgated, 

regardless of subsequent amendments. 

Therefore, some regulations that have 

been subsequently amended could reach 

their time for review earlier than 

regulations that were promulgated and 

never amended. For example, a 

Medicaid regulation first adopted in 

1968 but revised repeatedly and as 

recently as 2020 would need to be 

Assessed, possibly Reviewed, and 

possibly revised again even though it 

was just amended. 

This commenter said this timing is 

also incongruent with specific 

provisions in the RFA. The RFA defines 

a ‘‘rule’’ to include ‘‘any rule for which 

the agency publishes a general notice of 

proposed rulemaking pursuant to 

section 553(b),’’ which explicitly 

includes regulatory amendments. See 5 

U.S.C. 553(b) and 551(5). The 

commenter stated that this statutory 

provision requires the proposed rule’s 

‘‘clock’’ for 10-year review to be reset 

based on the most recent regulatory 

amendment that went through APA 

notice and comment procedures. 

Response: HHS respectfully disagrees. 

As an initial matter, 5 U.S.C. 610 refers 

to review ‘‘within’’ ten years; it does not 

foreclose reviewing regulations sooner. 

Second, this rule seeks to balance the 

desire to review older regulations first, 

while also specifying clear, easilyascertainable deadlines for Assessments 

and Reviews. It would be harder for the 

Department and the public to determine 

the Assessment and Review deadlines if 

the deadlines changed each time a 

regulation were amended. Providing 

that the ‘‘clock’’ begins to run from the 

year a Section was first promulgated is 

a reasonable way to balance these 

considerations. Tying deadlines to the 

amendments of Sections threatens to 

make the rule completely unwieldy— 

leaving an open question of when 

certain parts of a rule are up for 

Assessment and Review. 

Also, as explained in the proposed 

rule, if the Department is amending a 

regulation close in time to its ten-year 

Assessment or Review date, then the 

Department can conduct Assessment 

and Review alongside the amendment, 

thereby restarting the ten-year clock if it 

publishes the findings in the Federal 

Register in the manner specified in this 

final rule.181

Amendments to Section [XX](c) 

After considering the public 

comments on the two year time period 

to Assess and (if required) Review 

regulations that are more than ten years 

old, the Department has decided to 

extend this time period to five calendar 

years after the year that this section first 

becomes effective. Furthermore, in this 

final rule the Department amends 

section [XX](c) to read ‘‘this chapter,’’ 

rather than ‘‘this title,’’ as was used in 

the proposed rule. The Department 

makes this change to conform to the fact 

that this final rule amends certain 

chapters, rather than entire titles. The 

Department finalizes sections [XX] 

(c)(1)–(2) as amended. 

ii. Section [XX](c)(3) 

After considering the public 

comments received on the proposed 

rule, the Department decided to add a 

new Section [XX](c)(3) to this final rule. 

Section [XX](c)(3) states that if, prior 

to the expiration of a Section under 

paragraph (c)(1) of this section, the 

Secretary makes a written determination 

that the public interest requires 

continuation of the Section in force 

beyond the date on which the Section 

would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 


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182Administrative 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). 

183OIRA may also coordinate inter-agency 

participation in the Assessment process where there 

are significant inter-agency equities or as otherwise 

appropriate. 

184The RFA also does not include ‘‘whether the 

Regulation complies with applicable law’’ as a 

factor. But it seems uncontroversial to require the 

Department to consider whether its regulations 

comply with applicable law, and this phrase has a 

clear meaning. 

for a period stated in the determination, 

which shall not exceed one calendar 

year. This final rule requires the 

Department to promptly publish any 

such written determination in the 

Federal Register. The authority of the 

Secretary to make this written 

determination is not delegable and may 

be exercised only by the Secretary or, 

when the office of the Secretary is 

vacant or the Secretary has become 

unable to perform the functions and 

duties of the office of the Secretary, by 

the individual acting as Secretary in 

accordance with the law. This 

provision, like other provisions of this 

final rule, is severable. 

The Department adds this provision 

so that, if a pandemic, emergency, or 

other development arises that prevents 

the Department from timely Assessing 

or Reviewing certain Sections and the 

public interest requires their 

continuation, the Department can have 

additional time to Assess and (if 

needed) Review those Sections. 

A. Section [XX](d) 

HHS proposed in Section [XX](d) of 

the proposed rule that the Department 

would be required to Review those 

Regulations that the Department 

Assesses have a significant economic 

impact upon a substantial number of 

small entities. In reviewing Regulations 

to minimize any significant economic 

impact of the Regulation on a 

substantial number of small entities in 

a manner consistent with the stated 

objectives of applicable statutes, the 

proposed rule stated that the 

Department’s Review shall consider (1) 

the continued need for the Regulation, 

consideration of which shall include but 

not be limited to the extent to which the 

Regulation defines terms or sets 

standards used in or otherwise 

applicable to other Federal rules; (2) the 

nature of complaints or comments 

received concerning the Regulation from 

the public; (3) the complexity of the 

Regulation; (4) the extent to which the 

Regulation overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; (5) the degree 

to which technology, economic 

conditions, or other factors have 

changed in the area affected by the 

regulation since the Regulation was 

promulgated or the last time the 

Regulation was Reviewed by the 

Department; (6) whether the Regulation 

complies with applicable law; and (7) 

other considerations as required by 

relevant executive orders and laws. 

This largely mirrors the review 

described in 5 U.S.C. 610. It is also 

consistent with ACUS’ recommendation 

that agencies ‘‘consider whether the 

[existing] regulations are accomplishing 

their intended purpose or whether they 

might, to the extent permitted by law, be 

modified, strengthened or eliminated in 

order to achieve statutory goals more 

faithfully, minimize compliance 

burdens on regulated entities, or more 

effectively confer regulatory 

benefits.’’ 182 Prior to finalization, OIRA 

may review Reviews, including to 

coordinate inter-agency participation in 

the Review process where there are 

significant inter-agency equities or as 

otherwise appropriate.183 For example, 

when Assessing or Reviewing 

regulations that require Executive Order 

12250 review and approval by the 

Attorney General, the Department will 

consult with the Department of Justice 

(DOJ) and provide a draft of the findings 

to DOJ well in advance of the 

Assessment or Review deadline, so that 

DOJ can review and approve prior to the 

publication of the findings. It may be 

appropriate for OIRA to coordinate this 

process. 

Proposed section [XX](d) of the 

proposed rule provided that the 

Department shall consider the 

continued need for the Regulation, 

‘‘consideration of which shall include 

but not be limited to the extent to which 

the Regulation defines terms or sets 

standards used in or otherwise 

applicable to other Federal rules.’’ The 

quoted phrase is not found in 5 U.S.C. 

610, but the Department included it in 

the proposed rule to clarify that 

determining the continued need for a 

regulation includes determining the 

extent to which it defines terms or sets 

standards used in or otherwise 

applicable to other Federal rules. 

However, this was not meant to be the 

only factor the Department should 

consider when determining the 

continued need for a regulation. Under 

the proposed rule, the Department shall 

consider any factors that, for a particular 

regulation, are relevant to determining 

whether there is a continued need for 

the regulation. 

In addition to this phrase, two factors 

listed in section [XX](d) of the proposed 

rule were not found in 5 U.S.C. 610. The 

first is that section [XX](d) of the 

proposed rule stated that the Review 

should take into account ‘‘whether the 

Regulation complies with applicable 

law.’’ Since applicable law may have 

changed since a regulation was 

promulgated, the Department wants to 

ensure that its regulations are regularly 

reviewed to ensure that they comply 

with applicable law. 

Second, section [XX](d) of the 

proposed rule stated that the Review 

should take into account ‘‘other 

considerations as required by relevant 

executive orders and laws.’’ The 

proposed rule stated that to the extent 

Executive Orders or laws enacted since 

the RFA require the Department to 

consider additional factors when 

performing retrospective review of 

particular regulations, the Department 

wishes to comply with those Executive 

Orders and laws. A recent Department 

of Transportation rule similarly required 

that agency, when periodically 

reviewing its regulations, to consider 

‘‘[o]ther considerations as required by 

relevant executive orders and laws.’’ See 

49 CFR 5.13(d)(2)(vi). Upon further 

consideration, the Department has 

decided not to finalize this seventh 

factor. First, this factor is not included 

in the RFA.184 Second, this factor is 

potentially unclear and could be open to 

multiple interpretations. Third, this 

final rule already requires the 

Department to consider whether the 

rulemaking complies with applicable 

law. Thus, the seventh factor is not only 

susceptible to multiple interpretations, 

but seems largely (if not entirely) 

subsumed by other factors in this final 

rule. 

The Department anticipates that the 

Reviews would be similar to the section 

610 analyses currently performed by 

agencies. The Reviews would benefit 

from real-world data and information 

gathered since the regulations were 

promulgated to potentially discern the 

impact of the regulation on small 

entities and on society more generally. 

Section [XX](d) of the proposed rule 

requires that only regulations that have 

a significant economic impact upon a 

substantial number of small entities be 

Reviewed, because those are the 

regulations that 5 U.S.C. 610 requires 

agencies have a plan to periodically 

review. 

Comments on Section [XX](d) 

HHS received the following 

comments on Section [XX](d) of the 

proposed rule. 

Comment: Several commenters 

suggested that HHS consult with trade 


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185See Results of EPA’s Section 610 Review of the 

Final Rule for Control of Emissions of Air Pollution 

from Nonroad Diesel Engines and Fuel, EPA Off. of 

Transp. & Quality (Sept. 2014), https://

www.regulations.gov/document?D=EPA-HQ-OAR2013-0642-0003; Regulatory Flexibility Act Section 

610 Review of the National Pollutant Discharge 

Elimination System (NPDES) Permit Regulation and 

Effluent Limitation Guidelines and Standards for 

Concentrated Animal Feeding Operations (CAFOs), 

EPA Off. of Water (June 3, 2014), https://

www.regulations.gov/document?D=EPA-HQ-OW2012-0813-0216; Results of EPA’s Section 610 

Review of the Final Rule for Lead; Renovation, 

Repair, and Painting Program, EPA Off. of Pollution 

Prevention and Toxics (Apr. (April 2018), https:// 

www.regulations.gov/document?D=EPA-HQ-OPPT2016-0126-0019. 

186 Duplicative, Black’s Law Dictionary (11th ed. 

2019) (defining ‘‘duplicative’’ as ‘‘Having or 

characterized by having overlapping content, 

intentions, or effect’’). 187 ‘‘Regulations’’ in the proposed rule. 

groups and other specialty societies to 

consider the policy recommendations of 

providers and others in the healthcare 

industry to understand the implications 

of modifying or rescinding existing 

regulations. Some of these commenters 

brought up certain regulations for which 

they care deeply and would like to see 

rescinded or maintained. 

Response: HHS appreciates these 

comments and wishes for the public to 

have the opportunity to provide 

meaningful feedback on regulatory 

changes that the Department may 

consider as it conducts its Assessments 

and Reviews. To achieve that goal, the 

proposed rule, as finalized, includes a 

process of soliciting robust public 

comments and feedback, which HHS 

will consider and incorporate into its 

Assessment and Review decisions. As 

stated in [XX](d)(2), ‘‘[t]he nature of 

complaints or comments received 

concerning the Regulation from the 

public’’ is one of the factors that the 

Department is required to consider 

under this rule when it conducts its 

Assessments and Reviews. HHS is 

committed to ensuring that the public 

has ample opportunity to opine on its 

regulations, and looks forward to 

thoughtfully considering public 

comments during the regulatory review 

process resulting from this final rule. 

Comment: A few commenters stated 

that the Department’s process for 

reviewing regulations that have a 

SEISNOSE was unclear from the 

proposed rule. These commenters asked 

that the Department provide at least one 

example of how factors would be 

considered and how HHS would 

conduct its decision-making process. 

Response: Based in part on these 

comments, in this final rule the 

Department removes the final factor 

specified in the proposed rule (‘‘other 

considerations as required by relevant 

executive orders and laws’’). The 

Department does so because this factor’s 

meaning could be unclear, it is not in 

the RFA, and it adds little beyond what 

is already more clearly stated in other 

factors, such as whether the rulemaking 

complies with applicable law. Beyond 

removing this factor, HHS respectfully 

declines to provide additional clarity 

within this final rule as to the exact 

contours of the Review process. As 

explained in the proposed rule, the 

Review takes into account factors that 

already exist under 5 U.S.C. 610(b), 

along with a consideration of whether 

the rulemaking complies with 

applicable law, a factor whose meaning 

is clear and uncontroversial. It is 

anticipated that the Review process will 

track the Department’s and other 

agencies’ past practice with respect to 

Section 610 analyses. In particular, 

examples of Section 610 reviews 

conducted by the EPA are instructive on 

how the Department anticipates the five 

factors set forth in 5 U.S.C. 610(b) will 

be analyzed.185 The Review decisionmaking process will be implemented in 

a manner appropriate for the regulation 

in question, including but not limited to 

input from subject-matter experts within 

the Department and the public. 

Comment: A few commenters asked 

for clarification regarding the 

Department’s decision-making process 

as to whether a regulation would be 

identified as requiring a rescission or 

amendment based on the factors 

provided. For example, if HHS were to 

identify overlap or duplication between 

a regulation under Review and other 

Federal regulations, how would HHS 

assess the factors to make a decision to 

rescind or amend? These commenters 

also asked for clarification on how the 

Department would determine that a 

regulation is duplicative. 

Response: The factors specified in the 

final rule will be balanced, and a 

determination as to whether to amend 

or rescind a Section will be made on a 

case-by-case basis. No one factor by 

itself is dispositive (unless the Section 

does not comply with applicable law). 

The balancing of a series of 

considerations, sometimes complex and 

wide-ranging, is inherent in the 

Department’s policy-making functions, 

even beyond the context of the Review 

process set out in this final rule. In the 

prior comment, the Department 

provided examples of how the Reviews 

will consider the relevant factors. The 

concept of regulatory duplication, 

which has been in the RFA, 5 U.S.C. 

610(b)(4) for over forty years, is largely 

self-explanatory. A regulation may be 

considered duplicative, if, for instance, 

it serves the same function or overlaps 

with another regulation.186 Amending 

or rescinding duplicative regulations 

can reduce complexity and regulatory 

burden. 

Comment: Some commenters asked 

HHS to clarify how it would consider 

public comments about a regulation, 

and whether there would be numerical 

or content benchmarks that HHS would 

use to guide its decision-making 

regarding the public feedback it 

receives. 

Response: The Department will create 

dockets on Regulations.gov for its 

Assessments and Reviews, and the 

public may submit comments to those 

dockets in the same manner as it can 

submit comments on notices of 

proposed rulemaking. The Department’s 

Reviews will be holistic and consider 

the five factors specified in 5 U.S.C. 

610(b), as well as compliance with 

applicable law. No one factor by itself 

is dispositive (unless the Section does 

not comply with applicable law). The 

weight that the Department gives to 

comments will be a case-by-case 

determination. For example, fifty 

complaints about a major rule that also 

had 500 supportive comments might not 

counsel in favor of amending or 

rescinding the rule. But fifty complaints 

about a rule that had no comments 

supporting it might weigh in favor of 

amendment or rescission, particularly if 

the other section 610 factors do not 

counsel strongly in favor of continuing 

the regulation without change. The 

public-comment process, and how 

much weight to give to various 

comments, is familiar to the Department 

and the public from the many instances 

of public comment on Department 

policymaking actions. A similar 

standard will be applied here. 

Accordingly, the Department finalizes 

section [XX](d) of the proposed rule as 

proposed, except that it removes (d)(7), 

which proposed that Reviews consider 

‘‘[o]ther considerations as required by 

relevant executive orders and laws.’’ 

Moreover, in the finalized section 

[XX](d), the Department replaces the 

term ‘‘Regulation’’ with ‘‘rulemaking.’’ 

This is in response to comments 

previously discussed expressing 

concerning about potential ambiguity 

caused by the use of the term 

‘‘Regulation.’’ This change is also made 

to conform section [XX](d) to the fact 

that ‘‘Reviews’’ are defined as 

determinations as to ‘‘whether 

Sections 187 that were issued as part of 

the same rulemaking (and any 

amendments or additions that may have 

been issued thereafter)’’ should be 

continued without change, amended, or 

rescinded. Reviews are therefore not of 

individuals sections but of the sections 


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188 Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State 

Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). 

issued as part of the same rulemaking. 

Thus, this revision to section [XX](d) is 

made for clarity but is not a substantive 

change from the proposed rule. 

Section [XX](e) 

In the proposed rule, HHS proposed 

that if the Review concludes that a 

Regulation should be amended or 

rescinded, the Department shall have 

two years from the date that the findings 

of the Review are published in the 

Federal Register pursuant to paragraph 

(f) to amend or rescind the Regulation. 

The proposed rule further stated that if 

the Secretary determines that 

completion of the amendment or 

rescission is not feasible by the 

established date, he shall so certify in a 

statement published in the Federal 

Register and may extend the completion 

date by one year at a time for a total of 

not more than five years. 

The Department included this 

provision in the proposed rule because, 

if the Review concludes that a 

Regulation should be amended or 

rescinded, the Regulation should in fact 

be amended or rescinded. The 

Department believes that two years will 

generally be an adequate amount of time 

to amend or rescind a Regulation, since 

the Department will have already 

conducted a Review of the Regulation. 

In circumstances where amendment is 

not feasible within that time period, the 

proposed rule stated that the Secretary 

could so certify in a statement 

published in the Federal Register and 

extend the completion date by one year 

at a time for a total of not more than five 

years. 

As stated in the proposed rule, when 

the Review determines that a regulation 

should be amended or rescinded, the 

Department would, on a case-by-case 

basis as appropriate, use enforcement 

discretion to not enforce the regulation 

or a portion of the regulation until it is 

amended or rescinded. This is because 

in many cases the Department would 

not want to enforce regulations (or 

portions of regulations) that it 

determines should be amended or 

rescinded. The Department noted that 

enforcing a regulation deemed to require 

amendment or rescission in some cases 

raises concerns about whether such 

enforcement is arbitrary and capricious. 

Continuing to enforce the regulation (or 

portions thereof) would arguably ‘‘run[ ] 

counter to the evidence before the 

agency.’’ 188

Comments on Section [XX](e) 

HHS received the following 

comments on Section [XX](e) of the 

proposed rule. 

Comment: Some commenters stated 

that the Department should limit the 

length of time for amending or 

rescinding a Regulation from two years 

with three one-year extensions for a 

total of not more than five years to two 

years with the possibility to extend for 

one year (for a total of not more than 

three years). One commenter also stated 

that the current text is ambiguous as to 

whether it is a maximum of five years 

(two years plus three one-year 

extensions) or a maximum of seven 

years (two years plus five one-year 

extensions). 

Response: HHS appreciates these 

comments and, in this final rule, 

modifies the rule’s text to clarify that, if 

a Review concludes that a Section 

should be amended or rescinded, the 

maximum time for amending or 

rescinding the Section (including all 

possible extensions) is five years. That 

is, there is a two-year period to amend 

or rescind, which can be extended no 

more than three times for one year each 

time. 

The Department believes the two-year 

default period is appropriate and 

declines to further limit the number of 

possible extensions. If the Department 

concludes that a regulation should be 

amended or rescinded, it does not want 

to unduly delay doing so. The 

Department believes that two years will 

generally be an adequate amount of time 

to amend or rescind such regulations, 

since the Department has already 

Reviewed them. However, given the 

complexity of some Department 

regulations and competing priorities, in 

some circumstances it may not be 

feasible to amend or rescind a regulation 

within two years. In circumstances 

where amendment or rescission is not 

feasible within that time period, the 

Secretary can so certify in a statement 

published in the Federal Register and 

extend the completion date by one year 

at a time no more than three times, for 

a total of not more than five years 

(inclusive of the initial two-year period). 

Accordingly, after considering the 

public comments, the Department chose 

to clarify the language in section [XX](e) 

of the proposed rule with respect to the 

time period for extension of the 

completion of an amendment or 

rescission. Where the proposed rule 

stated that the Secretary ‘‘may extend 

the completion date by one year at a 

time for a total of not more than five 

years,’’ the final rule clarifies that the 

Secretary ‘‘may extend the completion 

date by one year at a time, no more than 

three times, for a total of not more than 

five years (inclusive of the initial twoyear period)’’ (emphasis added). This 

change does not alter the time period for 

extending the completion date of an 

amendment or rescission, but HHS 

believes that this language clarifies the 

length of time that the completion may 

be extended. The Department finalizes 

Section [XX](e) of the proposed rule, 

with this clarifying language. 

Section [XX](f) 

Section [XX](f) of the proposed rule 

provided that the results of all 

Assessments and Reviews conducted in 

a calendar year, including the full 

underlying analyses and data used to 

support the results (subject to any 

applicable privilege, protections for 

confidential business information, or 

explicit legal prohibition on disclosure), 

shall be published in a single document 

in the Federal Register during that 

calendar year. The proposed rule stated 

that the document shall be organized in 

a manner that enables both the 

Department and the public to readily 

determine which Assessments and 

Reviews were conducted during that 

calendar year. It further proposed that 

the document shall also specify the year 

by which the next Assessment (and, if 

required, the next Review) of the 

Regulation shall be completed. 

The Department included this 

requirement in the proposed rule so that 

both the Department and the public 

could readily know which Regulations 

were Assessed and Reviewed each year. 

If Assessments and Reviews were 

published in disparate places 

throughout the year, it could become 

extraordinarily difficult for both the 

Department and the public to know 

which Regulations were Assessed and 

Reviewed each year. Section [XX](f) was 

proposed to enable both the Department 

and the public to look in one place to 

know which Assessments and Reviews 

were conducted each calendar year, and 

know the findings of those Assessments 

and Reviews. 

The proposed rule stated that when 

publishing the findings of an 

Assessment or Review, the Department 

should include the full underlying 

analyses and data used to support the 

results, subject to any applicable 

privilege, protections for confidential 

business information, or explicit 

prohibition on disclosure. This will 

increase transparency and permit the 

public to see how the Department 

reached its conclusion. By requiring 

publication of the Reviews and the 

underlying analyses and data, the 

Department also incorporated ACUS’ 


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189 79 FR 75114, 75117 (Dec. 17, 2014); see also 

Exec. Order 13563, Sec. 6(a) (Jan. 18, 2011) 

(‘‘retrospective analyses, including supporting data, 

should be released online whenever possible’’). 

Although this final rule incorporates several ACUS’ 

recommendations, it does not incorporate all of 

them. This final rule does not set forth a 

prioritization scheme, although the Department 

intends to subsequently set forth a schedule for 

conducting Assessments and Reviews. 

190See, 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.’’). 191See, e.g., 85 FR 70121. 192 85 FR 70108. 

suggestion that ‘‘[a]gencies should 

disclose relevant data concerning their 

retrospective analyses’’ so as to ‘‘allow 

private parties to recreate the agency’s 

work and to run additional analyses 

concerning existing rules’ 

effectiveness.’’ 189 The Department does 

not believe that the deliberative process 

privilege would generally bar disclosing 

the final underlying analyses and data 

referred to in section [XX](f).190

Section [XX](f) of the proposed rule 

also provides that the document 

published in the Federal Register shall 

specify the year by which the next 

Assessment (and, if required, the next 

Review) of the Regulation shall be 

completed. This can be particularly 

helpful if the Department conducts an 

Assessment or Review of a Regulation 

prior to the deadline year. 

Comments on Section [XX](f) 

HHS received the following 

comments on Section [XX](f) of the 

proposed rule. 

Comment: A few commenters 

suggested that the results of each 

Assessment and Review should be 

published separately in the Federal 

Register as they are completed, with a 

title clearly identifying the affected 

regulation and the Department’s 

responses to the public comments 

received. 

Response: HHS respectfully disagrees 

that the results should be published on 

a rolling basis. Announcing the results 

of all Assessments and Reviews within 

a single document makes it easier for 

the public (and the Department) to 

determine (1) which Sections were 

Assessed and Reviewed, (2) the dates by 

which they were Assessed and 

Reviewed, and (3) when they next need 

to be Assessed and (if needed) 

Reviewed. Interested parties need only 

refer to a single source of information 

for a given year. Publishing all 

Assessments and Reviews for a given 

year in a single document also reduces 

the risk that a Section will inadvertently 

expire. 

The commenters’ concerns about the 

Reviews including the Department’s 

responses to public comments was 

already addressed in the proposed rule. 

Section [XX](d) of the proposed rule 

directed the agency to consider, as part 

of Reviews, ‘‘the nature of complaints or 

comments received concerning the 

Regulation from the public.’’ And the 

document published in the Federal 

Register shall include the ‘‘full 

underlying analyses and data used to 

support the results (subject to any 

applicable privilege, protections for 

confidential business information, or 

explicit legal prohibition on 

disclosure.’’ Section [XX](d)’s 

requirement to consider the nature of 

complaints or comments only applies to 

Reviews, not Assessments. Assessments 

are preliminary determinations that 

only focus on whether a rule making has 

a SEISNOSE, and do not require as 

extensive an analysis as Reviews. If the 

Department receives comments during 

the Assessment process, it would 

endeavor to take them into account in 

determining whether a rule making has 

a SEISNOSE. Moreover, as the proposed 

rule proposed,191 the document 

published in the Federal Register will 

be organized in a manner that enables 

both the Department and the public to 

readily determine which Assessments 

and Reviews were conducted during 

each calendar year. 

Comment: Some commenters stated 

that the Department should commit to 

publishing results of Reviews as they 

are completed, or on no less than a 

monthly basis, so that the interested 

public can truly contemplate each 

regulation now in question. 

Response: The Department intends to 

publish the results of the Assessments 

and Reviews in the dockets for the 

applicable regulations. However, as 

compared to publishing Assessments 

and Reviews in the Federal Register on 

a rolling basis, announcing the results of 

all Assessments and Reviews within a 

single document makes it easier for the 

public (and the Department) to 

determine (1) which Sections were 

Assessed and Reviewed, (2) the dates by 

which they were Assessed and 

Reviewed, and (3) when they next need 

to be Assessed and (if needed) 

Reviewed. Interested parties need only 

refer to a single source of information 

for a given year. Publishing all 

Assessments and Reviews for a given 

year in a single document also reduces 

the risk that a Section will inadvertently 

expire. The Department will announce 

on a periodic basis when it has 

commenced the process of performing 

an Assessment or Review. 

Comment: A few commenters asked 

what role the Office of Information and 

Regulatory Affairs (OIRA) within the 

Office of Management and Budget 

(OMB) would have in reviewing the 

reports, and any proposed revisions to 

standing regulations. 

Response: As noted in the proposed 

rule, ‘‘Prior to finalization, OIRA may 

review Reviews, including to coordinate 

inter-agency participation in the Review 

process where there are significant 

inter-agency equities or as otherwise 

appropriate.’’ 192

Accordingly, after considering the 

public comments, HHS finalizes section 

[XX](f) as proposed. 

Section [XX](g) 

HHS proposed in Section [XX](g) of 

the proposed rule that paragraph (c) of 

the proposed rule would not apply to 

Regulations that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Regulation and as to 

what is prescribed by the Regulation. 

For such Regulations that are adopted 

after the effective date of this section, 

the proposed rule stated that the Federal 

law described shall be cited in the 

notice of adoption. Section [XX](g) of 

the proposed rule also provided that 

paragraph (c) of the proposed rule 

would not apply to (1) Regulations 

whose expiration pursuant to this 

section would violate any other Federal 

law; (2) this section; (3) Regulations that 

involve a military or foreign affairs 

function of the United States; (4) 

Regulations addressed solely to internal 

agency management or personnel 

matters; (5) Regulations related solely to 

Federal Government procurement; and 

(6) Regulations that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

Section[XX](g)(1) of the proposed rule 

excepted Regulations that are prescribed 

by Federal law, such that the 

Department exercises no discretion as to 

whether to promulgate the Regulation 

and as to what is prescribed by the 

Regulation. This is only the case in rare 

circumstances. Because the Department 

lacks discretion over what is contained 

in these Regulations and cannot rescind 

them, they are exempted from section 

[XX](c). For such Regulations that are 

promulgated after the effective date of 

this final rule, the Department shall 

describe in the Regulation’s notice of 

adoption the Federal law that results in 


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193See Health Insurance Portability and 

Accountability Act of 1996, Public Law 104–191, 

110 Stat. 1936 (1996). 

the Department having no discretion as 

to whether to promulgate the Regulation 

and what is prescribed by the 

Regulation. The proposed rule included 

this requirement so the public has 

notice that such Regulations are exempt 

from section [XX](c). 

Section [XX](g) of the proposed rule 

likewise also exempted from section 

[XX](c) any Regulation whose expiration 

pursuant to this section would violate 

any other Federal law. The exceptions 

listed in sections [XX](g)(1) and 

[XX](g)(2) of the proposed rule are not 

satisfied simply because the statutory 

authority for the regulation provides 

that the Secretary ‘‘shall’’ prescribe 

regulations. For example, section 804(b) 

of the Federal Food Drug & Cosmetic 

Act, 21 U.S.C. 384(b), provides that the 

‘‘Secretary, after consultation with the 

United States Trade Representative and 

the Commissioner of U.S. Customs and 

Border Protection, shall promulgate 

regulations permitting pharmacists and 

wholesalers to import prescription 

drugs from Canada into the United 

States’’ (emphasis added). However, 

although the statute was enacted in 

2003, as of January 1, 2020 the 

Department had not issued any 

regulations implementing it, indicating 

the Department’s view that section 

804(b) did not require the Department to 

issue regulations. Similarly, Section 

1102 of the Social Security Act, 42 

U.S.C. 1302, provides that the Secretary 

‘‘shall make and publish such rules and 

regulations, not inconsistent with this 

Act, as may be necessary to the efficient 

administration of the functions with 

which [he] is charged under this Act’’ 

(emphasis added). But the Department 

does not believe every regulation 

promulgated pursuant to section 1102 is 

required to have been issued, or that it 

would violate Federal law to rescind 

such regulations. 

Section [XX](g) of the proposed rule 

also exempted the proposed rule from 

section [XX](c). Assuming that no rules 

expire due to lack of Assessment or 

Review, the proposed rule stated that 

this rule cannot, absent other actions, 

directly impose on the public costs that 

exceed benefits, since the proposed rule 

merely would require the Department to 

periodically Assess and, in some cases, 

Review its Regulations. Only the failure 

to perform an Assessment or Review in 

the future could theoretically impose on 

the public costs that exceed benefits 

(assuming expired Regulations were on 

balance benefiting the public). The 

proposed rule stated that it would 

improve the Department’s regulations 

by requiring the Department to evaluate 

the impact of its regulations and amend 

or rescind those regulations with a 

significant economic impact upon a 

substantial number of small entities that 

the Department determines should be 

amended or rescinded. Therefore, the 

rationale for periodic review would not 

apply to the proposed rule to the extent 

it applies to other Department 

regulations. The Department realizes 

that certain members of the regulated 

community might rely on particular 

regulations, but the Department 

proposed that it would take that into 

account when performing Assessments 

and Reviews. The Department proposed 

that it would only determine that a 

regulation should be amended or 

rescinded if the regulation’s burdens 

outweigh these reliance interests and 

the other benefits of the regulation or if 

other factors, such as a change in law, 

might compel amendment or rescission. 

The Department stated in the proposed 

rule that it does not intend to avoid 

Assessing or, if required, Reviewing any 

regulation and does not anticipate that 

an important regulation would expire 

due to failure to Assess or Review it. 

Accordingly, the Department proposed 

to exempt the proposed rule from 

Section [XX](c). 

The Department also proposed in 

Section [XX](g) of the proposed rule to 

exempt Regulations that involve a 

military or foreign affairs function of the 

United States. For purposes of the 

proposed rule (as well as in this final 

rule), ‘‘a military or foreign affairs 

function of the United States’’ has the 

same meaning as that phrase has under 

5 U.S.C. 553(a). Regulations that involve 

a military or foreign affairs function of 

the United States were exempted from 

the proposed rule for the same reasons 

that Congress exempted them from the 

requirements of 5 U.S.C. 553. 

Section [XX](g) of the proposed rule 

also exempted Regulations addressed 

solely to internal agency management or 

personnel matters and Regulations 

related solely to Federal Government 

procurement. Because such Regulations 

do not directly impact the public, the 

rationale for retrospective review is 

weaker with respect to these 

Regulations. 

The portion of the proposed rule 

applying to Title 42 also exempted 42 

CFR 1001.952 from expiration. 42 CFR 

1001.952 provides a safe harbor for 

various payment and business practices 

that, although they potentially implicate 

the Federal anti-kickback statute, are not 

treated as offenses under the statute. 

The Department proposed to exempt 

this regulation because it was concerned 

that certain otherwise permissible 

behavior could become criminal simply 

because the Department did not Review 

this Regulation. The portion of the 

proposed rule applying to Title 42 also 

exempted 42 CFR part 73. 42 U.S.C. 

262a provides that, with respect to Part 

73, the ‘‘Secretary shall review and 

republish [a list of certain biological 

agents and toxins] biennially, or more 

often as needed, and shall by regulation 

revise the list as necessary in 

accordance with such paragraph.’’ Since 

those regulations are already being 

reviewed biennially, there was no need 

for the proposed rule to apply to 42 CFR 

part 73. Similarly, the portion of the 

proposed rule applying to Title 42 also 

exempted the annual Medicare Part A 

and Part B payment methodology 

update rules. Since these rules are 

amended annually, it does not make 

sense to Review them every ten years. 

Lastly, the portion of the proposed 

applying to Title 42 also exempted 42 

CFR 100.3, since the statutory basis for 

this regulation provides that it cannot be 

amended unless (1) a proposed 

regulation is provided to the Advisory 

Committee on Childhood Vaccines 

(ACCV) and the ACCV is provided at 

least 90 days to make recommendations 

and comments, and (2) there is 

subsequently a 180-day public comment 

period. See 42 U.S.C. 300aa–14(c). For 

these reasons, these regulations are also 

exempted from this final rule. 

Section [XX](g) of the proposed rule 

also exempted any Regulations that 

were issued jointly with other Federal 

agencies, or that were issued in 

consultation with other agencies 

because of a legal requirement to 

consult with that other agency. This is 

because the Department cannot on its 

own rescind or amend a Regulation 

issued jointly with another Federal 

agency. An example of regulations 

issued with other agencies because of a 

legal requirement to consult with those 

other agencies are the regulations issued 

jointly by the Department and the 

Departments of Labor and the Treasury 

in accordance with section 104 of the 

Health Insurance Portability and 

Accountability Act (HIPAA). This 

provision directs the Secretaries of HHS, 

Labor and the Treasury to ensure that 

regulations issued pursuant to 

provisions where the Secretaries share 

interpretive jurisdiction (which 

includes many of the provisions in Title 

XXVII of the Public Health Service 

(PHS) Act) are administered to have the 

same effect at all times.193 An example 

of jointly-issued regulations are 

regulations governing State innovation 

waivers under section 1332 of the 


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194See, e.g., 77 FR 11700 (Feb. 27, 2012). 

195 85 FR 70109. 

196See, e.g., regulations amended in Update of 

Organizational References, 50 FR 8993 (Mar. 6, 

1985) (‘‘Because these amendments related to 

internal agency management and personnel and 

because the amendments are not substantive, the 

rule is exempt from the notice and comment and 

delayed effective date requirements of section 

553(b) and (d)(3) of the Administrative Procedure 

Act’’). 

197See Health Insurance Portability and 

Accountability Act of 1996, Public Law 104–191, 

110 Stat. 1936 (1996). See also 85 FR 70110. 

198 85 FR at 70109. 

199See, e.g., 21 U.S.C. 360(l) (providing that ‘‘at 

least once every 5 years thereafter, as the Secretary 

determines appropriate, the Secretary shall identify, 

through publication in the Federal Register, any 

type of class I device that the Secretary determines 

no longer requires a report under subsection (k) to 

provide reasonable assurance of safety and 

effectiveness’’; 21 U.S.C.(m) (providing that the 

Secretary, ‘‘at least once every 5 years thereafter, as 

the Secretary determines appropriate [ ] publish in 

the Federal Register a notice that contains a list of 

each type of class II device that the Secretary 

determines no longer requires a report under 

subsection (k) to provide reasonable assurance of 

safety and effectiveness’’). 

200See https://www.federalregister.gov/ 

documents/2020/04/20/2020-08182/foodstandards-general-principles-and-food-standardsmodernization-extension-of-comment-period. 

Patient Protection and the Affordable 

Care Act.194

The Department retains these 

exemptions for the reasons discussed in 

the proposed rule. For the reasons 

discussed below, this final rule also 

exempts certain other regulations from 

this final rule. 

Comments on Section [XX](g) 

HHS received the following 

comments on Section [XX](g) of the 

proposed rule. 

Comment: Several commenters asked 

for further clarity on the proposed 

exemptions from the proposed rule. 

These commenters stated that it is 

unclear how the public would know 

which regulations are eligible for an 

exemption under the proposed rule. 

They suggested that the Department 

may be interpreting ‘‘Regulations that 

are prescribed by Federal law, such that 

the Department exercises no discretion 

as to whether to promulgate the 

Regulation and as to what is prescribed 

in the Regulation’’ very narrowly, 

because the proposed rule stated that it 

is ‘‘rare’’ that the Department has ‘‘no 

discretion as to whether to promulgate 

[a] regulation and what is prescribed by 

the regulation.’’ 195 These commenters 

stated that the examples given in the 

proposed rule were insufficient and 

open to interpretation, and members of 

the public should not be expected to be 

able to conduct their own statutory 

analysis. Some commenters specifically 

asked for at least one example of a 

regulation that would be exempted 

under this rule. Commenters also asked 

for examples of regulations that ‘‘were 

issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency.’’ 

Response: The Department thanks 

these commenters for their comments. 

Regulations that ‘‘involve a military or 

foreign affairs function of the United 

States’’ are regulations that would 

satisfy that standard under 5 U.S.C. 

553(a)(1). ‘‘Regulations addressed solely 

to internal agency management or 

personnel matters’’ refers to regulations 

that would satisfy the ‘‘matter relating to 

agency management or personnel’’ 

standard under 5 U.S.C. 553(a)(2).196

An example of regulations issued 

with other agencies because of a legal 

requirement to consult with those other 

agencies are the regulations issued 

jointly by the Department and the 

Departments of Labor and the Treasury 

in accordance with section 104 of 

HIPAA. This provision directs the 

Secretaries of HHS, Labor and the 

Treasury to ensure that regulations 

issued pursuant to provisions where the 

Secretaries share interpretive 

jurisdiction (which includes many of 

the provisions in Title XXVII of the PHS 

Act) are administered to have the same 

effect at all times.197 Such regulations 

constitute a small percentage of the 

Department’s overall number of 

regulations (although they may have an 

outsize impact), and the Department is 

not aware of many regulations outside 

those promulgated pursuant to the 

relevant HIPAA provisions that would 

satisfy this exception. Regulations that 

are prescribed by Federal law, such that 

the Department exercises no discretion 

as to whether to promulgate the 

regulation and as to what is prescribed 

in the regulation is also a very small 

category. 

Comment: A few commenters stated 

that it was disingenuous for HHS to 

specifically decide to exempt this rule 

from the assessment and review process. 

These commenters stated that this 

decision is at best disingenuous or at 

worst an attempt to permanently impose 

a rigid review structure. 

Response: HHS respectfully disagrees. 

This final rule does not permanently 

impose a rigid review structure, because 

this rule can be amended or rescinded 

under the APA. As explained in the 

notice of proposed rulemaking, the 

nature of this rule means that ‘‘the 

rationale for periodic review does not 

apply to this proposed rule to the extent 

it applies to other Department 

regulations.’’ 198 This final rule would 

not become obsolete due to economic, 

technological, or legal changes the way 

that many other rules can. 

Comment: Several commenters stated 

that they do not want the annual Notice 

of Benefits and Payment Parameters 

(NBPP) rule to be subject to this rule. 

Response: The Department agrees and 

has decided to exempt the annual 

Notice of Benefit and Payment 

Parameters update rules. Just as the 

proposed rule exempted the annual 

Medicare payment rules, this final rule 

need not apply to NBPP rules that are 

already reviewed and updated annually. 

The 2021 NBPP annual rules can be 

found at 85 FR 29164 (May 14, 2020). 

These and the equivalents for other 

years are exempt from this final rule. 

Final Section [XX](g) 

Based in part on comments, the 

Department has decided in the portion 

of the final rule applying to Title 21, 

Chapter I to also exempt the following 

provisions from this final rule: 

• 21 CFR parts 131, 133, 135–137, 

139, 145, 146, 150, 152, 155, 156, 158, 

160, 161, 163–166, 168, 169. 

• 21 CFR parts 331–333, 335–336, 

338, 340–341, 343–344, 346–350, 352, 

355, 357, 358. 

• 21 CFR parts 862, 864, 866, 868, 

870, 872, 874, 876, 878, 880, 882, 884, 

886, 888, 890, 892, 895, 898. 

Based in part on comments, the 

Department decided in the portion of 

the file rule applying to Title 45, 

Subchapter A, to also exempt the annual 

Notice of Benefit and Payment 

Parameters update rules. 

The first three bullets encompass 

FDA’s food standard, device-specific, 

and over-the-counter drug regulations 

that specify characteristics of certain 

foods, devices, and over-the-counter 

drugs. These are regulations that specify 

the characteristics of particular foods, 

devices, and over-the-counter drugs. 

Many of the device regulations are 

already required to be reviewed in some 

way every five years.199 Similarly, FDA 

is already undergoing a process to 

establish a set of general principles for 

food standards for FDA to use when 

considering whether to establish, revise, 

or eliminate a food standard.200 Thus, 

there is less need to review these 

regulations every ten years, since these 

are being reviewed, or new processes for 

reviewing these regulations are being 

established. In addition, the exempt 

food standard, device, and OTC drug 

regulations simply create product 

identities. 

As explained supra, the annual Notice 

of Benefit and Payment Parameters 

update rules are also now being exempt 

because those are already updated 


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201See, e.g., Regulatory Flexibility Act Section 

610 Review of the Testing and Labeling Regulations 

Pertaining to Product Certification of Children’s 

annually. Thus, there is no need to 

Assess or Review them every ten years. 

In addition, whereas the proposed 

rule exempted in Title 42 the ‘‘annual 

Medicare Part A and Part B payment 

methodology update rules,’’ this final 

rule exempts the ‘‘annual Medicare 

payment update rules.’’ All annual 

Medicare payment update rules are 

revised annually, so there is no need to 

require Assessment or Review of them 

every ten years. 

Other than adding or revising these 

exemptions and changing the term 

‘‘Regulation’’ to ‘‘Section,’’ the 

Department finalizes Section [XX](g) as 

proposed. 

Section [XX](h) 

HHS proposed in Section [XX](h) of 

the proposed rule that when the 

Department commences the process of 

performing an Assessment or Review, it 

shall state on a Department-managed 

website the Regulation(s) whose 

Assessment or Review it is 

commencing. As proposed, the public 

would be able to submit comments 

regarding these Regulation(s) in the 

manner specified on this website. HHS 

proposed that members of the public 

could also submit comments in the 

manner specified on the website 

requesting that the Department begin 

the Assessment or Review of a 

Regulation, particularly if they are 

concerned that the deadline is nearing 

and the Department has not stated that 

it has commenced the Assessment or 

Review. 

The Department included this 

provision in the proposed rule so that, 

when the Department is Assessing or 

Reviewing a regulation, the public can 

submit comments for the Department’s 

consideration. The Department stated in 

the proposed rule that it believes this 

will maximize transparency, public 

participation, and the Department’s 

knowledge of the real-world impacts of 

its regulations. 

The Department also proposed in this 

provision to allow the public to submit 

comments on the Department website 

requesting that the Department begin 

the Assessment or Review of a 

regulation. The Department stated that it 

considered the risk that a regulation 

could expire because the Department 

inadvertently did not Assess or Review 

it. The Department proposed to mitigate 

this risk by allowing members of the 

public to submit comments requesting 

that the Department commence the 

Assessment or Review of a regulation. If 

a person is concerned that the 

Department has not announced the 

Assessment or Review of a Regulation 

and the deadline is nearing, the person 

can request that the Department to 

conduct the Assessment or Review. 

The Department stated in the 

proposed rule that it intends to timely 

Assess and, where required, Review all 

its regulations. The Department noted, 

however, that if it has not announced 

that it is Assessing or Reviewing a 

Regulation, and the deadline is nearing, 

those who rely on the regulation are on 

notice that it might expire, just as the 

public is on notice that a regulation 

might be rescinded when an agency 

issues a notice of proposed rulemaking 

to rescind the Regulation. 

Comments on Section [XX](h) 

HHS received the following 

comments on section [XX](h) of the 

proposed rule. 

Comment: Several commenters 

questioned the adequacy of the 

proposed process for soliciting 

comments on the regulations that are 

reaching their time for Assessment or 

Review. Some of these commenters 

stated that the public should be given 

ample notice of upcoming Assessments 

and Reviews, and a clear and adequate 

timeframe for providing comments. 

Other commenters expressed concern 

about the process of posting information 

regarding Assessments and Reviews to a 

Department-managed website. Some 

commenters stated that instead of 

providing notice of Assessments and 

Reviews and instructions on how to 

submit public comments exclusively on 

a Department-managed website, the 

Department should also put this 

information on the Federal Register. 

Several commenters stated that 

members of the public should not be 

responsible for monitoring an HHS 

website to see if Assessment or Review 

of a particular regulation is 

commencing. Some commenters cited 

the added expense on the regulated 

industry that would be created if an 

additional review process is created by 

this rule, which would 

disproportionately fall on small 

businesses. One commenter even 

suggested this was a purposeful 

decision by the Department to create a 

system that favors well-funded special 

interests that can afford lawyers and 

lobbyists to advocate for their favored 

policies. Commenters stated that 

although HHS proposes to create a 

website to enable the public to comment 

and request a review when the deadline 

for assessing a rule is approaching, this 

website would not be governed by APA 

rules and the Department would not be 

required to meaningfully respond to 

those comments. Commenters stated 

that, as a result, rules that govern the 

administration of Medicaid and CHIP 

and affect access to care for millions of 

beneficiaries could automatically expire 

without public comment. 

A potential solution suggested by one 

commenter is that the Department could 

include in the final rule a requirement 

that it include a notice of all regulations 

scheduled for review during the next 12 

months in its semi-annual regulatory 

agendas published in the Federal 

Register. This commenter also suggested 

that HHS publish semi-annually in the 

Federal Register a list of regulations 

that are scheduled to expire in the next 

12 months if they are not Assessed and 

Reviewed. 

Other commenters requested 

clarification on how HHS will treat the 

comments it receives. For example, 

some commenters asked whether the 

comments would be included as a part 

of the public record. Other commenters 

mentioned that the proposed rule does 

not clarify whether HHS will be 

required to respond to all comments 

made by the public. These commenters 

asked the Department to ensure that it 

publicly display the comments it 

receives. 

Response: The Department 

appreciates these comments and seeks 

to minimize costs for the public. 

Accordingly, this final rule makes some 

revisions in response to these 

comments. Under this final rule, when 

the Department commences the process 

of performing an Assessment or Review, 

it shall state on a Department-managed 

website the Section(s) whose assessment 

or Review it is commencing. It shall also 

announce once a month in the Federal 

Register those new Assessments or 

Reviews that it has commenced in the 

last month. The Department will create 

a docket on Regulations.gov for each 

Assessment or Review that the 

Department is conducting. These docket 

numbers will be referenced in the 

Federal Register announcements. The 

public will be able to submit comments 

to the dockets of each rule making being 

Assessed or Reviewed. Each docket 

shall specify the date by which 

comments must be received. There shall 

also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department Assess or Review a 

regulation. These changes address the 

concern about putting the information 

on a Department website, rather than in 

the Federal Register. The Department 

anticipates that the process will be 

similar to that currently used by the 

EPA.201 The Department also intends to 


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Products, Including Reliance on Component Part 

Testing, 85 FR 52078 (Aug. 24, 2020). 

202 85 FR 70118 & n.145. 

203See also Maeve P. Carey, Cong. Rsch. Serv., 

R46190, Petitions for Rulemaking: An Overview 1 

(2020) (describing § 553(e) as ‘‘arguably 

Continued 

publish the results of the Assessments 

and Reviews in the dockets for the 

applicable regulations. 

Separately, in conjunction with this 

final rule, the Department is placing at 

https://www.hhs.gov/regulations/ 

federal-registry/index.html a list of 

Department rule makings, the year they 

were initially promulgated, the last year 

the rule making was amended, and the 

Federal Register citation from the time 

the rule making was last amended. This 

list was generated with artificial 

intelligence and the Department 

believes it is accurate, but it is 

conceivable that some Department 

regulations are not included. This list 

includes all Department regulations, 

including those that may be exempt 

from this final rule. The Department 

believes it would be informative to the 

public to provide a list of all 

Department regulations, as well as their 

Federal Register citations and 

promulgation dates. The Department 

intends to update this list annually with 

newly-issued regulations. The schedule 

for Assessment and Review is discussed 

in Section II.F. 

HHS disagrees that this final rule is 

for the benefit of well-financed special 

interests. As the Department observed in 

the proposed rule, empirical evidence 

confirms that, due to the inherent 

advantage from economies of scale, 

large, well-capitalized entities are better 

positioned to absorb compliance costs 

than small entities.202 By announcing 

Assessments and Reviews on 

Regulations.gov, and putting the dockets 

for Assessments and Reviews on 

Regulations.gov, this final rule reduces 

the costs associated with having to 

monitor two separate websites. The 

regulatory impact analysis for this final 

rule addresses the estimated impacts for 

this final rule, including monitoring and 

comment costs. 

Comment: A few commenters 

suggested that instead of the process set 

forth in the proposed rule, HHS should 

provide a means of soliciting public 

comment at least every ten years on the 

Department’s existing rules, which the 

Department would then be required to 

consider. 

Response: The Department is 

incorporating aspects of this suggestion. 

This final rule makes the nature of 

complaints or comments on a regulation 

one of the factors to be considered when 

performing Reviews. But the 

commenters’ suggestion by itself would 

not be adequate to address the problem. 

The Department’s rules have always 

been open for public comment under 5 

U.S.C. 553(e), yet only limited 

retrospective review has taken place, 

contrary to Congressional intent. The 

suggestion that the Department take a 

passive role in retrospective review is 

inconsistent with the RFA, which 

intends for HHS to engage in this 

analysis on its own initiative. 

Comment: Several commenters stated 

that, according to the process set forth 

in the proposed rule, it would be 

difficult, if not impossible, for the 

public to accurately determine whether 

a regulation is subject to an Assessment, 

and if so, the deadline for informing the 

agency and commenting. These 

commenters surmise that there could be 

scenarios where a regulation was not 

Assessed, but it is unclear whether it 

has expired or was exempt from the 

regulatory review process and is still in 

place. This could leave regulated 

entities subject to the regulation without 

guidance on what is expected of them, 

or could result in regulations being 

inadvertently removed with negative 

impacts on beneficiaries, consumers, 

and the public in general. 

Response: The Department 

respectfully disagrees. Again, as stated 

above, the Department intends to timely 

Assess and (if needed) Review its 

regulations. This final rule provides that 

un-Reviewed and un-Assessed Sections 

expire based on the time elapsed since 

the Year of the Section’s promulgation. 

To aid the public, in conjunction with 

this final rule the Department is placing 

at https://www.hhs.gov/regulations/ 

federal-registry/index.html a list of 

Department rule makings, the year they 

were initially promulgated, the last year 

the rule making was amended, and the 

Federal Register citation from the time 

the rule making was last amended. This 

list was generated with artificial 

intelligence and the Department 

believes it is accurate, but it is 

conceivable that some Department 

regulations are not included. This list is 

meant to be an aid to the public and the 

Department, but the Federal Register 

and Code of Federal Regulations are 

what have legal force and determine the 

dates of promulgation. Moreover, a 

regulated entity can use the Federal 

Register and Code of Federal 

Regulations to determine the year in 

which a Section was promulgated. From 

there, the regulated entity can determine 

the year by which a Section must be 

Assessed and (if needed) Reviewed. The 

regulated entity can consult the Federal 

Register document containing the 

findings of the Department’s 

Assessments and Reviews from that year 

to determine if the Section was timely 

Assessed and (if needed) Reviewed. 

This is less burdensome than many legal 

research activities that regulated entities 

need to do to determine whether they 

are in compliance with the law. 

Regulated entities frequently must 

determine whether a particular statute 

or regulation is still in effect, has been 

amended, or whether there is a 

proposed change to the statute or 

regulation before Congress or in front of 

an agency. 

Comment: Several commenters had 

comments related to APA petitions. A 

commenter stated that the APA also 

includes a process for the public to 

petition for retrospective review of 

existing rules. See 5 U.S.C. 553(e). Other 

commenters noted the APA does not 

specify the process for receiving 

petitions. As a result, according to the 

commenters, how petitions are received 

and treated varies across—and even 

within—agencies. These commenters 

stated that to date, HHS has not adopted 

any particular regulations concerning 

the form that petitions under section 

553(e) must take. Nor has HHS adopted 

recommendations by the Administrative 

Conference of the United States for 

receiving, processing, and responding to 

petitions. A few commenters noted that 

they had submitted petitions but no 

action had been taken to date on their 

request. For example, one commenter 

stated that it filed citizen petitions in 

August 2016 and February 2017 asking 

the agency to remove outdated 

recordkeeping requirements. Another 

commenter stated that in February 2018 

it commented to the Food and Drug 

Administration Center for Veterinary 

Medicine (CVM) on regulations that the 

commenter claimed are outdated or 

needing improvement. 

Response: The Department 

respectfully disagrees with the 

commenters’ suggestion that the petition 

mechanism in 5 U.S.C. 553(e) somehow 

undercuts or forecloses this final rule. 

Indeed, the substantive point of these 

comments—that the agency should 

retrospectively review its rules to 

determine whether amendment or 

rescission is necessary, especially where 

pressed to do so by the public—is fully 

consistent with this final rule. The 

commenters who stated they petitioned 

the Department to amend or rescind 

regulations, yet the Department took no 

action, further supports why this final 

rule is needed (although the Department 

takes no position in this final rule on 

whether any particular commenters’ 

petition had merit).203 The comments 


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underused’’); ACUS, ‘‘Adoption of 

Recommendations,’’ 79 FR 75114, 75117–18 

(describing long-standing problems in agencies’ 

handling of § 553(e) petitions). 

204See Section II, supra. 

205See, e.g., 21 CFR 10.20, 10.30, 10.33. 

206See, e.g., Am. Horse Protection Assoc. v. Lyng, 

812 F.2d 1 (D.C. Cir. 1987). Case law also suggests 

that an agency’s failure to respond may also be 

subject to judicial redress. See Jason A. Schwartz 

and Richard L. Revesz, ‘‘Petitions for Rulemaking— 

Final Report to the Administrative Conference of 

the United States’’ at 13 & n.55, 28–29 (Nov. 5, 

2014). 207 85 FR 70110. 

suggest the Department is not examining 

its existing regulations as often as is 

desired. Moreover, 5 U.S.C. 553(e)’s 

petition process does not make this final 

rule unnecessary, because there is 

reason to believe that even some rules 

that have not been the subject of any 

petitions would benefit from 

amendment or rescission.204 The 

literature and the Department’s 

experience suggest that large numbers of 

regulations are having impacts that, over 

time, differ from what was estimated at 

the time of promulgation. 

Some HHS components have 

regulations governing petitions.205 But 

whether the Department should have 

additional or different petition 

procedures is outside the scope of this 

final rule, which, like 5 U.S.C. 610, 

operates independently of 5 U.S.C. 

553(e)’s petition process. 

Comment: Some commenters stated 

that it was arbitrary for HHS to not 

meaningfully consider other ‘‘strong 

incentives’’ to revisit its own rules 

besides the process it proposes. For 

example, commenters suggested that 

HHS could have explored creating a 

petition process whereby parties could 

request review of certain rules, or could 

have convened a Federal Advisory 

Committee to advise the Department on 

which rules merit review. In both these 

scenarios, HHS could incentivize itself 

to act by giving parties a right of judicial 

review if the Department failed to 

respond to a petition or a Committee 

recommendation. 

Response: HHS respectfully disagrees. 

The APA itself already affords a process 

for petitioning for review of rules. 5 

U.S.C. 553(e) (‘‘Each agency shall give 

an interested person the right to petition 

for the issuance, amendment, or repeal 

of a rule.’’). And denials of such 

petitions may be subject to the APA’s 

judicial review procedures.206

Notwithstanding the existence of 

section 553(e), comprehensive 

retrospective review of agency rules has 

not taken hold. The literature suggests 

large numbers of Department 

regulations are having impacts that 

differ from their estimated impacts. It is 

unlikely that a Federal Advisory 

Committee could undertake the scale of 

review needed to comprehensively 

advise on which regulations merit 

review. 

Comment: Some commenters stated 

that the Department should provide 

clear notice to the public of when a 

Regulation may be about to expire, and 

provide actual notice of rescissions. 

Response: The Department reiterates 

its previous response to a similar 

comment. The Department intends to 

timely Assess and, where required, 

Review all its regulations. However, if 

the Department has not announced that 

it is Assessing or Reviewing a 

regulation, and the deadline is nearing, 

the public is on notice that it might 

expire, just as the public is on notice 

that a regulation might be rescinded 

when an agency issues a notice of 

proposed rulemaking to rescind the 

regulation.207 Moreover, section [XX](f) 

requires that the Department, in 

announcing the results of Assessments 

and Reviews, ‘‘shall also specify the 

year by which the next assessment (and, 

if required, the next review) of the 

Section shall be completed.’’ 

The Department plans to periodically 

announce in the Federal Register 

regulations that have expired, and have 

the Code of Federal Regulations revised 

accordingly. 

Final Section [XX](h) 

Accordingly, based on public 

comments, HHS finalizes section 

[XX](h) to provide that when the 

Department commences the process of 

performing an Assessment or Review, it 

shall state on a Department-managed 

website the Section(s) whose 

Assessment or Review it is 

commencing. It shall also announce 

once a month in the Federal Register 

those new Assessments or Reviews that 

it has commenced in the last month. 

The Department will create a docket on 

Regulations.gov for each Assessment or 

Review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rule making being Assessed or 

Reviewed. Each docket shall specify the 

date by which comments must be 

received. There shall also be a general 

docket on Regulations.gov where the 

public can submit comments requesting 

that the Department assess or review a 

Section. 

Section [XX](i) 

Lastly, the proposed rule included a 

severability clause. The Department 

stated in the proposed rule that it 

believes the proposed rule fully 

complies with applicable law, but does 

not wish to see the entire proposed rule 

vacated in the event that a portion of it 

is vacated. For example, the Department 

does not wish to see the entire final rule 

vacated because one of the exceptions 

listed in section [XX](g) is invalidated. 

However, the Department requested 

comment in the proposed rule on 

whether the amendments to add 

expiration dates should be severable 

from other portions of the proposed 

rule, including the requirements to 

perform Assessments and Reviews. The 

Department stated that it was requesting 

comments on this because it is not clear 

that the proposed rule could properly 

function without the expiration dates. 

HHS received no comments specific 

to Section [XX](i) of the proposed rule. 

Accordingly, for the reasons stated in 

the proposed rule, HHS finalizes the 

provisions of Section [XX](i) as 

proposed. 

Additional Comments on Particular 

Regulations 

Comment: Commenters identified 

certain regulations that they would not 

want to expire under the proposed rule. 

These regulations include, but are not 

limited to: 

• Regulations implementing 

Medicare, Medicaid, CHIP, and other 

large programs that HHS administers. 

• Regulations implementing the 

Affordable Care Act (ACA). 

• Regulations that operate Temporary 

Assistance for Needy Families (TANF) 

program, the Child Care and 

Development Fund (CCDF) program, 

Head Start and Early Head Start 

Programs, and the Family Violence 

Prevention and Services (FVPSA) 

Program. 

• FDA Regulations at 21 CFR Chapter 

1. 

• Provisions at 42 CFR 435.603 which 

determine financial eligibility using the 

Modified Adjusted Gross Income 

(MAGI) methodologies. 

• Regulations implementing Income 

and Eligibility Verification requirements 

at 42 CFR 435.940–435.965. 

• 42 CFR 435.907, related to 

Medicaid application requirements. 

• Medicaid cost-sharing regulations. 

• Regulations governing Medicaid 

waivers, including Section 1115 and 

Section 1332 waivers and Home & 

Community-Based Services (HCBS) 

waivers. 

• Fair Hearings for Applicants and 

Beneficiaries requirements in 42 CFR 

431 Subpart E. 

• Confidentiality regulations in 42 

CFR part 431 Subpart F. 

• Regulations relating to 

comparability or services for groups of 


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beneficiaries and sufficiency of amount, 

duration, and scope of Medicaid 

services, found at 42 CFR 440.230– 

440.250. 

• The Medicaid balanced billing 

regulation at 42 CFR 447.15. 

• Regulations that shape children’s 

access to care in a wide range of areas, 

including but not limited to: 42 CFR 

438.1–438.930—Medicaid Managed 

Care; 42 CFR 447.56—Limitations on 

premiums and cost sharing; 42 CFR 

447.203—Documentation of access to 

care and service payment rates; 42 CFR 

447.204—Medicaid provider 

participation and public process to 

inform access to care; 42 CFR 447.400— 

Payments for Primary Care Services 

Furnished by Physicians; 42 CFR 

410.78—Telehealth services; 45 CFR 

156.10–156.1256—Health Insurance 

Issuer Standards Under the Affordable 

Care Act, Including Standards Related 

to Exchanges. 

• Regulations concerning infant 

formula, including: 21 CFR 101: Food 

Labeling; 21 CFR 105.65: Infant Foods; 

21 CFR 106: Infant Formula 

Requirements Pertaining to Current 

Good Manufacturing Practice, Quality 

Control; Procedures, Quality Factors, 

Records and Reports, and Notifications; 

21 CFR 107: Infant Formula; and 21 CFR 

312: Investigational New Drug 

Application. 

• Regulations implementing the 

Vaccines for Children Program at 42 

CFR 441.600–441.615 and Grants for 

Childhood Immunization Programs at 

42 CFR 51b.201–51b.206. 

• Regulations implementing title IV– 

E programs that HHS administers, 

which provide funds for States and 

Tribes to provide foster care, 

transitional independent living 

programs for children, guardianship 

assistance, and adoption assistance for 

children with special needs at 45 CFR 

part 1356. 

• Regulations that pertain to maternal 

and child health project grants 

administered by the Health Resources 

and Services Administration’s Maternal 

and Child Health Bureau at 42 CFR 

51a.1–42 CFR 51a.8. 

• Medicaid regulations that outline 

the mandatory and optional benefits 

that States commonly use to finance 

home visiting services, such as: 

Extended pregnancy services (42 CFR 

440.210, 42 CFR 440.220); Targeted case 

management (42 CFR 440.169(b)); 

Medical or other remedial care by 

licensed practitioners (42 CFR 440.60); 

Early and Periodic Screening, 

Diagnostic and Treatment (42 CFR 

440.40(b)); Medicaid Administrative 

Claiming (42 CFR 433.15); and Managed 

care (42 CFR part 438). 

• Regulations in 45 CFR Subchapter B 

that require insurance coverage of 

essential health benefits (EHBs) such as 

preventive health services, prohibit 

preexisting condition exclusions, and 

establish fair practices in setting health 

insurance premiums and mental health 

parity, among other protections. 

• Regulations in 42 CFR part 441, 

which sets forth State Medicaid plan 

requirements and Federal Financial 

Participation for specific services. 

Commenters specifically mentioned 

Early and Periodic Screening, Diagnosis, 

and Treatment (EPSDT) regulations 

found throughout Part 441, which 

provide essential comprehensive and 

preventive services to children who are 

covered by Medicaid. 

• Regulations that protect nursing 

home patients by requiring reasonable 

promptness for medical assistance fair 

hearing obligations (42 CFR 435.930(a), 

42 CFR 431.10(c)(3); 435.1200(b). 

• Regulations found in 42 CFR part 

483 protecting long term care facility 

residents, and specifically Subpart G, 

which protects children in psychiatric 

residential treatment facilities (PRTFs) 

from restraint and seclusion used as a 

means of ‘‘coercion, discipline, 

convenience or retaliation.’’ 

• Regulations found in 42 CFR part 

460, implementing Programs of AllInclusive Care for the Elderly (PACE). 

• Regulations implementing the 

Medicare Low Income Subsidy program 

under 42 CFR part 423. 

• Regulations at 42 CFR part 438 

which implement Medicaid Managed 

Care. 

• Regulations related to food 

ingredients, including color additives 

(21 CFR parts 70–82), Generally 

Recognized as Safe (GRAS) regulations, 

and procedural regulations governing 

the agency’s premarket review 

functions, among others. 

• Regulations implementing the Food 

Safety Modernization Act (FSMA), Good 

Manufacturing Practices (GMPs), low 

acid canned foods/acidified foods 

(LACF/AF), Hazard Analysis and 

Critical Control Point (HACCP) 

regulations for juice and seafood, 

Dietary Supplement GMPs, import/ 

export requirements, and infant 

formula, among others). 

• Nutrition labeling regulations. 

• Regulations implementing Food 

Standards of Identity and Quality (e.g., 

dairy standards, bottled water (21 CFR 

165.110), cacao products, and other food 

categories). 

• Regulations implementing the 

Family Smoking Prevention and 

Tobacco Control Act (the ‘‘TCA’’). 

• Regulations governing the Indian 

health system, the Indian Health 

Service’s (IHS) Tribal Self-Governance 

program, and Indian specific provisions 

in the Medicaid, Medicare CHIP and 

Marketplace regulations. 

• Regulations implementing the 

Indian Child Welfare Act, which 

impacts all Indian Health Service 

regulations (42 CFR parts 136 and 136a) 

and the Department’s Tribal SelfGovernance regulations (42 CFR part 

137). 

• Regulations implementing the 

Mental Health Parity and Addiction 

Equity Act (MHPAEA), which requires 

that mental health and substance use 

disorder coverage be comparable to 

general medical coverage. 

• Regulations that implement 

programs authorized by the 

Developmental Disabilities Assistance 

and Bill of Rights Act that help ensure 

people with intellectual or 

developmental disabilities and their 

families have access to needed 

community services and individualized 

supports, and other programs that are 

important to people with disabilities, 

such as the Independent Living 

programs and critical safety net 

programs such as Medicaid. 

• 42 CFR 457.520, relating to cost 

sharing for well-baby and well-child 

care services. 

• Regulations in 42 CFR part 407 

relating to Hospital Insurance 

Entitlement and Supplementary 

Medical Insurance Enrollment and 

Entitlement, Part B enrollment 

including so-called state buy-in plans 

would harm seniors, and retroactive 

liability for Part B premiums when a 

beneficiary loses eligibility for a buy-in 

plan. 

• Provisions found at 45 CFR 146.136 

that apply the federal law requiring 

parity between private health insurance 

coverage for physical ailments and for 

mental illness and substance use 

disorders would be at risk. 

• Regulations that implement the 

Title X Family Planning Program. 

• Regulations guiding the practice of 

social work. 

• Regulations implementing the 

Health Insurance Portability and 

Accountability Act of 1996 (HIPAA), 

found in 45 CFR parts 160, 162, and 

164, particularly 45 CFR 164.502, which 

clarifies and strengthens privacy 

protections people with HIV. 

• Preadmission Screening and 

Resident Review (PASRR) regulations 

found at 483.100 through 483.138. 

• Regulations protecting the 

confidentiality of Substance Use 

Disorder (SUD) patient records, found at 

42 CFR part 2. 

• Regulations that prohibit insurance 

plans and issuers from imposing 


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208E.g., Nonrulemaking Docket FDA-2017-N5093: Review of Existing General Regulatory and 

Information Collection Requirements of the Food 

and Drug Administration, https://

beta.regulations.gov/docket/FDA-2017-N-5093. 

209See Review of Existing General Regulatory and 

Information Collection Requirements of the Food 

and Drug Administration, 82 FR 42506 (Sept. 8, 

2017); FDA-2017-N-5093, https://

beta.regulations.gov/docket/FDA-2017-N-5093. 

financial requirements or treatment 

limitations on mental health and SUD 

benefits that are more restrictive than 

those that apply to medical/surgical 

benefits. 

• Office of Human Research 

Protections (OHRP) regulations in 45 

CFR part 46, and FDA regulations at 21 

CFR part 50, which protect human 

research subjects. 

• Regulations in 45 CFR part 96, 

which govern block grants. 

• 42 CFR 489.24, related to the 

special responsibilities of Medicare 

hospitals in emergency cases. 

• Regulations concerning Section 

1557 of the Affordable Care Act, which 

prevents discrimination on the basis of 

race, sex, sexual orientation, and gender 

identity in healthcare settings. 

• Regulations implementing the Ryan 

White Program 

• Regulations governing Medicare’s 

Six Protected Classes. 

• Regulations related to the 

Congregate and Home-Delivered 

Nutrition Programs. 

• Regulations related to over-thecounter medicine products. 

• Regulations at 42 CFR 425.612 

identify the circumstances under which 

specific payment regulations are waived 

under the accountable care organization 

(ACO) program. 

• Regulations related to nonemergency medical transportation 

(NEMT). 

• Regulations affecting the domestic 

and global seafood industry. 

• Regulations affecting the pet food 

industry. 

• Regulations implementing the 

Medicare Modernization Act, such as 42 

CFR 422.2268, which establishes 

standards for marketing by MA plans. 

• Regulations requiring CMS 

programs to include an extraordinary 

circumstances exception (ECE) policy 

for natural disasters and other 

circumstances (see 42 CFR 412.140(c)(2) 

for the inpatient quality reporting (IQR) 

program and 42 CFR 412.160(c)(1)–(4) 

for the value-based purchasing 

program). 

• Regulations at 42 CFR 441.62, 

which require, according to the 

commenters, that states assure 

transportation for periodic screening 

and treatment for Medicaid eligible 

children, and regulations at 42 CFR 

440.170(a), which provide the definition 

for what constitutes transportation, e.g., 

ambulance, taxicab, common carrier or 

other appropriate means, as well as 

meals and lodging for both the child and 

necessary attendant. 

• 42 CFR 440.230(b)–(d), which 

requires that services be ‘‘sufficient in 

amount, duration, and scope to 

reasonably achieve their purpose,’’ 

directs states not to ‘‘arbitrarily deny or 

reduce the amount, duration, or scope of 

such services to an otherwise eligible 

individual solely because of the 

diagnosis, type of illness, or condition,’’ 

and permits states to place appropriate 

limits on a service based on such 

criteria as ‘‘medical necessity’’ or on 

utilization review criteria. 

• 42 CFR 435.831, which establishes 

the standards for determining eligibility 

for the ‘‘medically needy’’—an optional 

category that may enable aged, blind 

and disabled persons in certain states 

who have ‘‘excess income’’ above the 

Medicaid limits to qualify for Medicaid, 

if they incur certain medical expenses. 

• 42 CFR 415.174 Exception: 

Evaluation and management services 

furnished in certain centers. 

• 42 CFR 457.496—Parity in mental 

health and substance use disorder 

benefits. 

• 42 CFR 457.410—Health benefits 

coverage options. 

• What commenters characterized as 

many highly important and sensitive 

Medicare provisions in Title 42, CFR 

parts 400–499 that directly impact 

beneficiaries and health care providers. 

Some of these provisions include 

beneficiary and provider appeal rights 

(Part 405); Part A eligibility and 

entitlement provisions (Part 406); Part B 

enrollment and entitlement provisions 

(Part 407); provisions that outline the 

scope of Part A Benefits, including 

hospital and skilled nursing facility 

coverage (Part 409); Medicare 

Advantage coverage rules and enrollee 

protections (Part 422); and, Part D 

prescription drug parameters (Part 423). 

Response: The Department thanks the 

commenters for identifying these 

regulations. The Department intends to 

timely Assess and (if necessary) Review 

these regulations. 

Comment: Commenters identified 

certain regulations for which they 

would like the Department to prioritize 

amendment through its proposed 

retrospective regulatory review process. 

These regulations include, but are not 

limited to: 

• Regulations mandated for review by 

the 21st Century Cures Act, Public Law 

114–255, sec. 2034, 130 Stat. 1033 

(2016). Section 2034 of that Act requires 

the Secretary to lead a review by 

research funding agencies of all 

regulations and policies related to the 

disclosure and reporting of financial 

conflicts of interest to reduce 

administrative burden on federally 

funded researchers. It also calls for the 

Secretary to harmonize the differences 

between the Basic HHS Policy for the 

Protection of Human Research Subjects 

(45 CFR part 46, subpart A) and the FDA 

regulations for the protection of human 

subjects (21 CFR parts 50 and 56). 

Commenters stated that these 

regulations are well overdue for 

assessment and review. 

• Regulations covering access to 

skilled therapy services, which 

commenters say must be updated to 

reflect the national settlement in the 

Jimmo v. Sebelius litigation to codify 

the fact that skilled services are covered 

for Medicare beneficiaries not just to 

improve function, but to maintain or 

prevent deterioration in function. 

• The dockets established by FDA’s 

Center for Food Safety and Applied 

Nutrition and Center for Veterinary 

Medicine on Sept. 8, 2017,208 in which 

the Centers requested comments and 

information to assist in identifying 

existing regulations and related 

paperwork requirements that could be 

modified, repealed or replaced, 

consistent with the law, to achieve 

meaningful burden reduction while 

allowing FDA to achieve its public 

health mission and fulfill statutory 

obligations are examples of incomplete 

regulatory review initiatives.209

Commenters stated that despite 

submitting extensive comments that 

detailed numerous regulations that they 

believe could be modified, repealed or 

replaced, the agency did not take any 

further action. 

Response: The Department thanks the 

commenters for identifying these 

regulations. The Department intends to 

timely Assess and (if necessary) Review 

these regulations. If the Assessments 

and Reviews suggest these regulations 

should be amended or rescinded, the 

Department will commence rulemaking 

to amend or rescind them. 

Comment: Commenters identified 

certain regulations that they would want 

amended or rescinded. These 

regulations include, but are not limited 

to: 

• What the commenters characterized 

as unnecessary burdens in post-acute 

care (PAC) regulations. 

• What the commenters characterized 

as the outdated and inappropriate ‘‘in 

the home’’ requirement for coverage of 

durable medical equipment (DME), 

which commenters believe significantly 

limits the mobility devices available to 

beneficiaries with mobility disabilities. 


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210This analysis was informed by public 

comments and also by work of Dr. James Broughel. 

211Note that some rules labeled as 610 reviews 

in Department semi-annual agendas were not, in 

actuality, a result of section 610 reviews. 

212There are roughly 3,600 rulemakings (18,000 

divided by 5). 11% of this figure is 396. Ten percent 

of 396 is roughly 40. 

213A review of Department semiannual regulatory 

agendas issued between June of 2016 and August 

of 2020 confirms the three rules listed in table 1 are 

the only three final rulemakings to be completed in 

the last five years that are also associated with 

section 610 reviews. One rule, 0938–AT23, was 

merged with another rule, 0938–AS21. See Dept. 

Health & Human Servs., Semiannual Regulatory 

Agenda, 81 FR 37,294 (Jun. 9, 2016); 81 FR 94742 

(Dec. 23, 2016); 82 FR 40278 (Aug. 24, 2017); 83 

FR 27126 (Jun. 11, 2018); 83 FR 58020 (Nov. 16, 

2018); 84 FR 29624 (Jun. 24, 2019); 84 FR 71130 

(Dec. 26, 2019); and 85 FR 52704 (Aug. 26, 2020). 

Response: The Department thanks the 

commenters for identifying these 

regulations. The Department intends to 

timely Assess and (if necessary) Review 

these regulations. If the Assessments 

and Reviews suggest these regulations 

should be amended or rescinded, the 

Department will commence rulemaking 

to amend or rescind them. 

Comment: Some commenters 

provided feedback on what baseline the 

Department could use when conducting 

an analysis of an existing regulation. 

Commenters suggested that HHS could 

simply conduct an ex ante analysis of 

how the regulation is likely to perform 

going forward compared with the 

baseline scenario of what would happen 

if the regulation were allowed to expire. 

The benefits of this approach, according 

to the commenters, are that HHS already 

produces ex ante analyses (so this 

approach would not be departing from 

present practices), the analysis could 

still include a backward-looking 

component to the extent that data on 

past performance could be used to 

forecast the regulation’s future 

performance, and the regulation’s future 

performance is what should ultimately 

determine whether the regulation 

should continue as-is or be amended or 

rescinded. Another option, according to 

commenters, is that the Department 

could perform a retrospective costbenefit analysis that looks at how the 

regulation performed relative to the 

baseline of what would have happened 

in the absence of the regulation, or 

relative to the regulation as it stood 

before it was last significantly amended. 

Response: The Department 

appreciates this comment. The 

comments suggest different approaches 

may make sense for different 

regulations. Accordingly, the 

Department declines to adopt in this 

final rule a single method for 

conducting retrospective reviews. 

Reviews must be conducted in a manner 

that is not arbitrary and capricious 

under the APA, so that will provide a 

minimum level of rigor that all Reviews 

will have to meet, though different 

methodologies may be appropriate in 

different cases. The Department intends 

to take into account these comments 

when conducting Reviews pursuant to 

this final rule. 

V. Regulatory Impact Analysis 

(Executive Orders 12866, 13563, 13771) 

A. Executive Order 12866 Determination 

Executive Order 12866 directs 

agencies to assess the costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary and not 

prohibited by statute, to select 

regulatory approaches that maximize 

net benefits. Section 3(f) of Executive 

Order 12866 defines a ‘‘significant 

regulatory action’’ as an action that is 

likely to result in a regulation (1) having 

an annual effect on the economy of $100 

million or more in any one year, or 

adversely and materially affecting a 

sector of the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or State, local, 

or tribal governments or communities 

(also referred to as ‘‘economically 

significant’’). OMB has designated this 

rule as economically significant for the 

purposes of Executive Order 12866. 

This regulatory impact analysis fulfills 

analytical obligations under section 3(f) 

of Executive Order 12866 for 

economically significant 

rulemakings.210

B. Need for Regulation 

The first principle of regulation, 

according to Executive Order 12866, is 

that ‘‘Each agency shall identify the 

problem that it intends to address 

(including, where applicable, the 

failures of private markets or public 

institutions that warrant new agency 

action) as well as assess the significance 

of that problem.’’ The regulation being 

finalized by the Department addresses 

lax compliance with periodic review 

requirements under the Regulatory 

Flexibility Act (RFA) of 1980 and the 

need to periodically review existing 

regulations to determine if they are 

having their intended impacts. Section 

610 of the RFA calls upon the 

Department to have a plan to conduct 

periodic reviews of its regulations that 

have or will have a significant economic 

impact upon a substantial number of 

small entities (SEISNOSE). The RFA 

directs agencies to consider the 

following factors as part of those 

reviews: (1) The continued need for the 

rule; (2) the nature of complaints or 

comments received concerning the rule 

from the public; (3) the complexity of 

the rule; (4) the extent to which the rule 

overlaps, duplicates or conflicts with 

other rules; and (5) the length of time 

since the rule has been evaluated or the 

degree to which technology, economic 

conditions, or other factors have 

changed in the area affected by the rule. 

A review of department semi-annual 

agenda reports over the last ten years, as 

well as a review of specific rules 

identified in those agendas as 

completed rulemakings resulting from 

section 610 reviews, indicated three 

completed final rulemakings that 

emanated from section 610 reviews 

since 2011.211 (These rules are 

presented in table 1 below). To put this 

in context, the Department estimates it 

has roughly 18,000 regulations under its 

purview and that five regulations on 

average are part of the same rulemaking. 

Further, (as discussed in more detail 

below) the Department estimates 

approximately 11% of its regulations 

have a SEISNOSE, which suggests that 

approximately 396 Department 

rulemakings have a SEISNOSE. The 

three rules in table 1 amend 

approximately 130 sections of the CFR. 

(If an average rulemaking contains five 

sections, 130 sections correspond to the 

number of sections on average in 

approximately 26 rulemakings.) Given 

that Section 610 of the RFA sets a 10- 

year schedule for review of rulemakings, 

one might expect that roughly ten 

percent of regulations with a SEISNOSE 

would be reviewed each year, which 

would be approximately 40 rulemakings 

every year.212 Moreover, many of these 

regulations should likely be updated to 

reflect evolving circumstances. 

However, this does not appear to be 

occurring.213


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214Regulatory Streamlining & Analysis, at 11 

(Mar. 2019). 215 Id. 216William D. Eggers & Mike Turley, The Future 

of Regulation: Principles for Regulating Emerging 

Technologies, Deloitte Ctr. for Gov’t Insights (2018), 

https://www2.deloitte.com/content/dam/Deloitte/ 

lu/Documents/risk/lu-future-of-regulation.pdf. 

217See, e.g., Exec. Order No. 12866; Exec. Order 

13563, sec. 1; and various presidential memoranda 

and guidance on plain language. 

TABLE 1—FINAL ACTIONS AS A RESULT OF SECTION 610 REVIEWS SINCE 2011 

Name of rulemaking CFR citation and RIN Year Regulatory changes made as a result of Section 

610 reviews 

Medicare and Medicaid Programs; 

Regulatory Provisions To Promote 

Program Efficiency, Transparency, 

and Burden Reduction; Fire Safety 

Requirements for Certain Dialysis 

Facilities; Hospital and Critical Access Hospital (CAH) Changes To 

Promote Innovation, Flexibility, and 

Improvement in Patient Care.

42 CFR Parts 403, 416, 

418, 441, 460, 482, 

483, 484, 485, 486, 

488, 491, and 494.

RIN 0938–AT23 ..............

2019 (Final Rule) ...... Reformed Medicare regulations that were identified 

as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, 

and increased the ability of health 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; 

Conditions of Participation for Home 

Health Agencies.

42 CFR Parts 409, 410, 

418, 440, 484, 485 and 

488.

RIN 0938–AG81 .............

2017 (Final Rule) ...... Revised the conditions of participation that home 

health agencies (HHAs) must meet in order to 

participate in the Medicare and Medicaid programs. The new requirements focus on the care 

delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs 

greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. 

Medicare and Medicaid Programs; Reform of Requirements for LongTerm Care Facilities.42 CFR Parts 405, 431, 

447, 482, 483, 485, 

488, and 489.

RIN 0938–AR61 .............

2016 (Final Rule) ....... Revised the requirements that Long-Term Care facilities must meet to 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. 

The Department’s limited success in 

performing retrospective regulatory 

review is further supported by a 

regulatory reform project the 

Department piloted, which utilized AIdriven data analysis. Machine-learning 

algorithms identified over 1,200 CFR 

section citations that merited 

consideration for reform and 159 CFR 

sections that could benefit from 

regulatory streamlining based on their 

similarities to other sections.214 That 

project uncovered that 85% of 

Department regulations created before 

1990 have not been edited, and that the 

Department has nearly 300 broken 

citation references in the CFR (i.e., CFR 

sections that reference other CFR 

sections that no longer exist).215 These 

findings are consistent with a 2018 

study by the same consulting firm that 

estimated that 68 percent of federal 

regulations have never been updated.216

These findings suggest regulations are 

not being updated to reflect evolving 

economic conditions and technology, 

even though this is a goal of the RFA. 

Machine-learning tools also 

demonstrate the complexity of 

Department rules—and reducing 

complexity is another goal of the RFA. 

See, e.g., 5 U.S.C. 610(b)(3). Data from 

the Mercatus Center show that the 

Department’s regulations in 2019 

received a Shannon entropy score of 8.2. 

Shannon Entropy is a measure of 

complexity based on the amount of 

information contained in text. It can be 

thought of as measuring the number of 

new ideas that are introduced in a 

document, or, alternatively, how much 

computational effort would be required 

to understand a document. To put the 

Shannon entropy score into context, a 

typical Shakespeare play receives a 

Shannon entropy score of 8.0. The 

complexity of Department regulations is 

not entirely surprising given that 

regulations often involve science, 

engineering, or other highly technical 

material. However, having regulations 

that are more complex than a typical 

Shakespeare play would seem to be at 

odds with various directives that fall on 

the Department for regulations to be 

simple, easy to understand, and written 

in plain language.217

TABLE 2—2019 SHANNON ENTROPY

SCORE FOR HHS REGULATIONS

Department 

Shannon 

entropy 

score 

Department of Health and 

Human Services .................... 8.2 

Source: Quantgov.org. 

Without a consistent process for 

periodically reviewing regulations, there 

is no guarantee that regulations will be 


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Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 5739 

218See Exec. Order No. 12044 of Mar. 23, 1978, 

43 FR 12661 (Mar. 24, 1978) (President Carter) 

(revoked by Exec. Order No. 12291 of Feb. 17, 1981, 

46 FR 13193 (Feb. 19, 1981) (President Reagan)); 

Memorandum on Reducing the Burden of 

Government Regulation (Jan. 28, 1992) (President 

H.W. Bush); Exec. Order No. 12866 of Sept. 30, 

1993, 58 FR 190 (Oct. 4, 1993) (President Clinton); 

Exec. Order No. 13563 of Jan. 18, 2011, 76 FR 3821 

(Jan. 21, 2011) (President Obama); Exec. Order No. 

13771 of Jan. 30, 2017, 82 FR 9339 (Feb. 3, 2017) 

(President Trump). 

219See Regulatory Relief to Support Economic 

Recovery; Request for Information (RFI), 85 FR 

75720, at Attachment A (Nov. 25, 2020). 

220See, for example, Alec Stapp, ‘‘Timeline: The 

Regulations—and Regulators—That Delayed 

Coronavirus Testing,’’ The Dispatch (March 20, 

2020). 

221See also Yoon-Ho Alex Lee, An Options 

Approach to Agency Rulemaking, 65 Admin. L. 

Rev. 881, 895–96 (2013) (positing reasons why 

agencies may be reluctant to perform retrospective 

reviews). 222 Daniel Kahneman et al., Anomalies: The 

Endowment Effect, Loss Aversion, and Status Quo 

Bias, 5 J. Econ. Persp. 193 (1991). 

223Richard H. Thaler et al., Choice Architecture, 

in The Behavioral Foundations of Public Policy 

428, (Eldar Shafir ed., 2012). 

224Office 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/R8LXBQMJ (collecting studies comparing ex ante and ex 

post analyses of regulations’ costs and benefits, 

including examples where cost and benefit 

estimates were off by more than a factor of ten); 

Winston Harrington, Grading Estimates of the 

Benefits and Costs of Federal Regulation 33 (Res. 

for the Future, Discussion Paper 06–39, 2006), 

http://papers.ssrn.com/sol3/papers.cfm?abstract_

id=937357.; Richard Morgenstern, Retrospective 

Analysis of U.S. Federal Environmental Regulation, 

J. of Benefit Cost Anal. 9 no. 2, 2018, at 285. 

225Curtis W. Copeland, Cong. Rsch. Serv., 

RL32801, Reexamining Rules: Section 610 of the 

Regulatory Flexibility Act (2008); Michael 

Greenstone, Toward a Culture of Persistent 

Regulatory Experimentation and Evaluation, in 

New Perspectives on Regulation 111, 113 (David 

Moss & John Cisternino eds., 2009); Australian 

Gov’t Att’y Gen.’s Dep’t, Guide to Managing the 

Sunsetting of Legislative Instruments, at 3 (July 

Continued 

reviewed and revised to align with 

technological, economic, and other 

developments. Section 5 of Executive 

Order 12866 requires agencies to submit 

to the Office of Information and 

Regulatory Affairs (OIRA) a plan to 

periodically review their existing 

significant regulations to determine 

whether any such regulations should be 

modified or eliminated so as to make 

the agency’s regulatory program more 

effective in achieving regulatory 

objectives, less burdensome, or in 

greater alignment with the President’s 

priorities and principles. Section 6 of 

Executive Order 13563 similarly 

requires agencies to submit to OIRA a 

plan to periodically review their 

existing significant regulations to 

determine whether any such regulations 

should be modified, streamlined, 

expanded, or repealed so as to make the 

agency’s regulatory program more 

effective or less burdensome in 

achieving regulatory objectives. 

However, existing executive orders 

have not institutionalized a process for 

retrospective review and periodic 

updating of regulations, as evidenced by 

the fact that relatively few Department 

regulations are updated. Furthermore, 

every president since Jimmy Carter, 

including all those elected after 

enactment of 5 U.S.C. 610, has ordered 

some form of retrospective review of 

regulations,218 with mixed effects. This 

suggests that stronger incentives and 

forcing mechanisms are needed to 

ensure retrospective review occurs to an 

appropriate extent. 

Some commenters suggested that a 

review of existing regulations does not 

make sense during a pandemic, but this 

misses the broader point that the 

Department has waived, suspended, or 

exercised enforcement discretion not to 

enforce many regulations in order to 

respond to the pandemic.219 Had the 

Department not done so, this may have 

hampered the Department’s ability to 

respond nimbly, flexibly and quickly to 

the emergency.220 For example, the 

Department has issued waivers or 

exemptions, or exercised enforcement 

discretion with respect to, certain 

Medicare, Medicaid, CHIP, and HIPAA 

restrictions, including waivers to 

increase hospital capacity, ease 

restrictions on services rendered by 

medical residents, and allow patients to 

seek more services via telehealth. 

Meanwhile, other regulations that may 

have facilitated pandemic response have 

remained in place. 

The Department’s position is that 

retrospective review would require 

some change from the status quo, and 

unless there is a strong incentive to 

change, continuing business as usual is 

the path of least resistance.221 Thus, the 

status quo is maintained. Moreover, 

rescinding a regulation that has already 

been promulgated is likely to meet 

greater resistance than resistance to 

foregoing promulgating a regulation not 

yet enacted. This reflects a phenomenon 

known as loss aversion.222

The Department’s determination is 

that this final rule will address these 

issues by changing the choice 

architecture facing the Department by 

enacting a new default rule when the 

Department fails to conduct 

retrospective reviews. Sunset provisions 

change the default from rules staying on 

the books indefinitely to rules being 

eliminated after some predetermined 

amount of time unless evidence is 

presented for why rules should 

continue. When a default rule is 

changed, the choice architecture 

confronting decision makers is altered 

and can spur changes in behavior. A 

consistent finding in the literature on 

behavioral anomalies is that choice 

architecture and default rules have an 

important influence on decision 

making.223 Changes in the Department’s 

choice architecture can ultimately result 

in changes in public wellbeing. 

To conclude, this final rule is 

intended to address a failure to 

periodically review regulations as often 

as desired in line with the RFA and 

other directives for retrospective review. 

The Department believes that this final 

rule, by changing the default for 

regulations from continued existence to 

expiration unless periodic review is 

conducted, will result in more 

widespread retrospective review of 

regulations. Requiring the expiration of 

rules that have not been assessed or 

reviewed in accordance with section 

610 of the RFA should result in more 

regulations being updated to reflect 

evolving circumstances. 

C. Alternatives Considered 

The Department considered several 

alternatives to the proposed regulation. 

First, it considered not issuing this final 

rule. However, the RFA and certain 

Executive Orders direct the Department 

to periodically review certain 

Department regulations. Moreover, the 

literature and the Department’s 

experience suggest that large numbers of 

regulations are having estimated 

impacts that, over time, differ from what 

was estimated at the time the 

regulations were promulgated, so many 

regulations should be periodically 

reviewed.224 The Department’s 

experience over the last forty years is 

that, absent a strong incentive such as 

the potential expiration of a regulation, 

the Department will not review an 

adequate number of its regulations. 

Next, the Department considered 

seeking to perform the reviews called 

for by the RFA without implementing a 

new forcing mechanism. Given past 

experience, however, it seems 

unrealistic to assume this would bring 

about meaningful change. First, the fact 

that these reviews are not already 

occurring is evidence they are unlikely 

to occur in the future. Second, as 

discussed above, there is a strong bias 

towards the status quo in governmental 

action, and this may stand in the way 

of behavior changes. Third, the 

literature suggests that enforcement 

mechanisms are needed to spur more 

periodic reviews, and specifically that 

sunset provisions are a useful 

enforcement mechanism.225 Moreover, 


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5740 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

2020), https://www.ag.gov.au/sites/default/files/ 

2020-07/Guide%20to%20Managing%20Sunsetting

%20of%20Legislative%20Instruments.pdf. 

226The Department estimates that 16% of its 

regulations that are more than ten years old were 

promulgated prior to 1980, when Congress passed 

the RFA. 

227See, e.g., Regulatory Reform: Hearings on S. 

104, S. 262, S. 755, S. 1291 Before the Subcomm. 

on Admin. Practice & Procedure of the Comm. on 

the Judiciary, 96th Cong. 3–4 (1979) (statement of 

Peter J. Petkas, Director, The Regulatory Council) 

(describing the disproportionate impact on small 

businesses and uncertainty about benefits resulting 

from burdensome regulations); 142 Cong. Rec. 

S1637 (daily ed. Mar. 7, 1996) (statement of Sen. 

Bond) (‘‘The SBA chief counsel for advocacy 

released a report that said that small businesses 

bear a disproportionate share of the regulatory 

burden.’’); Nicole V. Crain & W. Mark Crain, The 

Impact of Regulatory Costs on Small Firms, (U.S. 

Small Bus. Admin., Office of Advocacy, 

Washington, DC), at 55, 57 (2010) (finding that 

‘‘regulations cost small firms an estimated $10,585 

per employee. Regulations cost medium-sized firms 

$7,454 per employee, and large firms $7,755 per 

employee,’’ and that in the health care sector, the 

cost per employee is 45 percent higher in small 

firms than in medium-sized firms, and 28 percent 

higher in small firms than in large firms). 

228Mancur Olson, The Logic of Collective Action 

(Harv. U. Press 1971). 

229The Department welcomes comments from all 

members of the public on (1) regulations being 

Assessed or Reviewed pursuant to this final and (2) 

future notices of proposed rulemaking. The 

Department will consider comments received from 

all members of the public. We merely make this 

observation to explain why relying solely on 

stakeholders may not enable the Department to 

identify certain regulations that should be amended 

or rescinded. 

230See, 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). 

231See Enhancing Regulatory Reform Through 

Advanced Machine Learning Findings (internal 

even if the Department conducted the 

reviews called for by the RFA absent a 

new forcing mechanism, there might be 

benefits to this final rule, albeit ones 

that are hard to quantify. For example, 

this final rule could guard against a 

decrease in the frequency of Department 

retrospective reviews in future years. 

Another alternative the Department 

considered is conducting in-depth 

Reviews of all of its Regulations (absent 

those that are exempt from this 

rulemaking), not just those designated 

as having a SEISNOSE. The Department 

sees value in conducting such 

widespread Reviews. However, the 

Department has opted not to require a 

complete Review of all Department 

regulations at the present time, although 

it leaves open the option to require such 

Reviews in the future. 

The Department also considered 

conducting Reviews of significant 

regulations, as that term is defined in 

Executive Order 12866. The Department 

is choosing to Review those regulations 

that have a SEISNOSE, in order to 

maintain a close connection between 

this final rule and the RFA. The 

Department sought comment on 

whether to Review additional 

regulations, such as those that are 

significant under Executive Order 

12866. Given limited responses to this 

request, the Department will not Review 

other regulations at this time beyond 

those designated as having a SEISNOSE. 

However, the Department leaves open 

the possibility to conduct Reviews of 

other regulations in the future. 

The Department considered only 

Reviewing those regulations that, at the 

time of promulgation, the Department 

determined had a SEISNOSE. However, 

such determinations were not made for 

regulations that were promulgated prior 

to the passage of the RFA,226 and some 

post-RFA regulations that did not have 

such a SEISNOSE at the time of 

promulgation might have such a 

SEISNOSE today. One commenter 

suggested that an alternative to the 

proposed rule would be to attach sunset 

dates only prospectively for regulations 

finalized after the effective date of this 

rule. The same commenter suggested 

requiring retrospective reviews only for 

those regulations specifically identified 

by stakeholders as problematic. But as a 

general matter, the Department believes 

that older regulations are more likely to 

be obsolete. As a result, the Department 

believes that this final rule should apply 

to them. Moreover, only reviewing 

regulations identified by stakeholders is 

unlikely to suffice. Regulations are 

known to create entry barriers into 

industries and these barriers often affect 

small businesses disproportionally.227

Therefore, the Department believes 

stakeholder input cannot be the only 

source of information to spur reviews. 

Concentrated interest groups will lobby 

to protect regulations that have been 

specifically constructed for their benefit. 

Meanwhile, consumers, small 

businesses, and the public more 

generally often experience dispersed 

costs that are not taken into account by 

these stakeholders. The work of political 

scientist Mancur Olson explains why 

these groups that comprise broader 

society, because they are larger, face 

collective action problems and often 

find it costly to organize and lobby on 

behalf of their own interests.228

Meanwhile, more narrow, concentrated 

interests find it relatively easier to 

organize and lobby for their own 

interests. Thus, stakeholders may not 

identify to the Department many 

regulations that are unduly burdensome 

to the public at large.229

The Department is also aware of 

literature suggesting that agencies have 

not been consistent in deciding which 

rules have a SEISNOSE or have avoided 

such a finding in order to avoid the 

RFA’s requirements.230 Moreover, 5 

U.S.C. 610 presupposes the agency will 

make a determination about which 

regulations have or will have a 

SEISNOSE. This suggests there is good 

reason to Assess most of the 

Department’s regulations. For these 

reasons, the Department has chosen to 

Assess all of its Regulations (subject to 

the exceptions listed herein) to 

determine which have a SEISNOSE and 

to Review those Regulations that have a 

SEISNOSE using the criteria listed in 5 

U.S.C. 610 (as well as whether they 

comply with applicable law). 

Finally, some commenters suggested 

that the Department include a provision 

granting the Secretary the authority to 

extend the expiration date in certain 

circumstances. Other commenters 

suggested that the proposed rule’s twoyear Assessment and Review period 

affecting some of the Department’s older 

regulations was too short. In response, 

the Department has made several 

modifications to the final rule from its 

proposed form. First, regulations older 

than ten years will expire after five 

years, as opposed to expiring after two 

years, if these Regulations are not 

Assessed and (when necessary) 

Reviewed. Second, this final rule grants 

the Secretary a one-time option to push 

back this expiration date by one year for 

a given Regulation. Both of these 

modifications have the effect of 

lowering some costs of this final rule as 

compared to the proposed rule, because 

these changes lengthen the expected 

Assessment and Review period, pushing 

some costs into the future. This reduces 

the present value of these costs. 

D. Cost Analysis 

5 U.S.C. 610 already directs the 

Department to undertake periodic 

reviews of its regulations. Nevertheless, 

because the Department believes this 

final rule will stimulate a behavior 

change at the Department and among 

the public, the regulation has some costs 

associated with it. Therefore, the 

Department performed the following 

analysis to estimate the costs and 

burdens to the Department and the 

public from (1) Assessing which 

Department regulations have a 

SEISNOSE, and (2) Reviewing those 

regulations. 

The Department has roughly 18,000 

regulations, the vast majority of which 

it believes would need to be 

Assessed.231 Roughly 12,400 of these 


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HHS slide) (the sum of the numbers listed in the 

table under the column denoted ‘‘#’’ is 17,890 

Department regulations). 232See id. (adding the figures listed in the ‘‘#’’ 

columns for the 1950s, 1960s, 1970s, 1980s, 1990s, 

and 2000s yields 12,383 regulations. 17,200 

regulations are estimated to have been issued by the 

end of 2016). 

233These data are available at Quantgov.org. 

234The exempt parts may on average have more 

Sections than other parts. But even still, it seems 

unlikely the exemptions would significantly alter 

the costs of this final rule. If the Department were 

incorrect about this assumption, costs from this 

final rule would likely be lower than estimated 

herein. Similarly, the Department does not have 

enough information at present to determine 

whether the CFR sections that could potentially 

benefit from regulatory streamlining based on their 

similarities to, overlap with, or duplicativeness of 

other Sections will lead to a reduction in 

Department costs of Assessments and Reviews, due 

to duplication of work. The initial Assessment of 

all non-exempt regulations would determine 

whether this is the case. 

235With the aid of a random number generator, 

the Department selected Department regulations in 

each of its three main titles (21, 42, and 45) of the 

Code of Federal Regulations. The random number 

generator was used to identify the relevant part of 

each title of the CFR to assess. 

regulations are over ten years old, and 

roughly 17,200 are more than five years 

old.232 The vast majority of these would 

need to be Assessed within five years of 

this final rule’s effective date (or six 

years if the optional extension is 

exercised by the Secretary). The 

Department estimates that roughly five 

regulations on average are part of the 

same rulemaking due to the number of 

unique Federal Register citations 

associated with its regulations. This 

would suggest the Department would 

have to perform roughly 3,440 

Assessments in the first five years (or 

six for certain of these regulations if the 

extension is exercised by the Secretary, 

and 3,600 Assessments in total. 

However, some of these rulemakings 

are exempt from this final rule. The 

Department estimates that 

approximately 66 parts of the CFR that 

the Department actively updates contain 

the vast majority of the regulations that 

are exempt from this final rule. 

According to analysis from the Mercatus 

Center, however, the Department has 

approximately 8,574 active parts of the 

CFR.233 66 parts are therefore less than 

1% of the Department’s active parts. As 

a result, the Department does not 

believe the exemptions will 

significantly alter the costs of this final 

rule.234

To help estimate the impact of this 

final rule, the Department conducted a 

limited randomized sampling 235 of its 

regulations and assessed whether the 

sampled regulations would be exempt 

from this final rule and whether, at the 

time of issuance, the regulations were: 

Economically significant; found to have 

a SEISNOSE; or subject to the Unfunded 

Mandates Reform Act (UMRA) of 1995. 

This information is included in table 3. 

Also included in table 3 is the estimated 

impact of the regulations when they 

were first promulgated. 

TABLE 3—SAMPLED DEPARTMENT REGULATIONS

Title Rulemaking Citation 

Exempt 

from this 

Final 

Rule? 

Economically 

significant? SEISNOSE? Subject to UMRA? Impact estimates at issuance 

21 ........... Toll-Free Number for Reporting Adverse Events on Labeling for Human 

Drug Products.

73 FR 63886 ......... No .......... No .................... No ..................... No ............................................. ‘‘[O]ne-time costs will range 

from approximately $38.0 million to $49.6 million and annual costs will range from 

$12.4 million to $46.3 million.’’ 236

21 ........... Unique Device Identification System ..... 78 FR 58786 ......... No .......... Yes .................. Yes .................... Yes ............................................ ‘‘Over 10 years, the estimated 

present value of the total domestic costs is $642.2 million 

using a 7 percent discount 

rate and $737.7 million using 

a 3 percent rate, and the 

annualized costs are $85.7 

million using a 7 percent discount rate and $84.1 million 

using a 3 percent discount 

rate.’’ 237

21 ........... Requirements for 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 ......... No .......... No .................... No ..................... No ............................................. ‘‘We estimate one-time total 

costs of $59.7 million and recurring costs of $0.5 million. 

These costs represent total 

annualized costs of $9 million 

when calculated at a 7-percent discount rate over 10 

years, and $7.5 million when 

calculated using a 3-percent 

discount rate. The largest 

cost elements will be for registrants reading and understanding the final rule and 

making changes to their 

standard operating procedures.’’238

21 ........... Human Tissue Intended for Transplantation.62 FR 40429 ......... No .......... No .................... No ..................... No ............................................. FDA confirmed ‘‘that the only 

economic impact of the rule 

would be related to recordkeeping burdens’’ that already existed.239

42 ........... Medicare Program; Health Care Infrastructure Improvement Program; Selection Criteria of Loan Program for 

Qualifying Hospitals Engaged in Cancer-Related Health Care.

70 FR 57368 ......... No .......... Yes .................. No ..................... No ............................................. ‘‘The Congress provided 

$142,000,000 for the loan 

program effective July 1, 

2004 through September 30, 

2008, and not more than 

$2,000,000 may be used for 

the administration of the loan 

program for each of the fiscal 

years (that is, 2004 through 

2008).’’240


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236Toll-Free Number for Reporting Adverse 

Events on Labeling for Human Drug Products, 73 FR 

63,886, 63,892 (Oct. 28, 2008). 237Unique Device Identification System, 78 FR 

58786, 58811 (Sept. 24, 2013). 238Requirements 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). 239Human Tissue Intended for Transplantation, 

62 FR 40429, 40442 (Jul. 29, 1997). 240Medicare 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). 241Organ Procurement and Transplantation 

Network, 63 FR 16296, 16321–29 (Apr. 2, 1998). 242Medicare Program; Hospital Insurance 

Entitlement and Supplementary Medical Insurance 

Enrollment and Entitlement, 53 FR 47199, 47201 

(Nov. 22, 1988). 243Cooperation in Identifying and Providing 

Information To Assist States in Pursuing Third 

Party Health Coverage, 56 FR 8926, 8929 (Mar. 4, 

1991). 244Responsibility 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). 

245Rate Increase Disclosure and Review, 76 FR 

29964, 29978 (May 23, 2011). 

246Michael R. See, Willful Blindness: Federal 

Agencies’ Failure to Comply with the Regulatory 

Flexibility Act’s Periodic Review Requirement—And 

Current Proposals to Reinvigorate the Act, 33 

Fordham Urb. L. J. 1199, 1217 (2006). 

247Connor Raso, Agency Avoidance of 

Rulemaking Procedures, 67 Admin. L. Rev. 65, 69 

(2015). 

248The Department chooses 11%, rather than 8% 

or 10%, because the study that found 11.1% of 

Department regulations had a significant economic 

impact upon a substantial number of small entities 

was focused solely on the Department’s regulations. 

TABLE 3—SAMPLED DEPARTMENT REGULATIONS—Continued 

Title Rulemaking Citation 

Exempt 

from this 

Final 

Rule? 

Economically 

significant? SEISNOSE? Subject to UMRA? Impact estimates at issuance 

42 ........... Organ Procurement and Transplantation Network.63 FR 16296 ......... No .......... Yes .................. No ..................... No ............................................. Although incremental effects attributable to the rule were not 

estimated, impact categories 

would have included lifeyears saved by non-renal 

organ transplants, quality of 

life improvements for kidney 

recipients, and the admittedly 

expensive costs of transplantation.241

42 ........... Medicare Program; Hospital Insurance 

Entitlement and Supplementary Medical Insurance Enrollment and Entitlement.

53 FR 47199 ......... No .......... No .................... No ..................... N/A (rule issued prior to UMRA 

being enacted).

N/A: ‘‘We have determined that 

a regulatory impact analysis 

is not required for these rules 

because they would not have 

an annual impact of $100 

million or more.’’242

45 ........... Cooperation in Identifying and Providing Information To Assist States in 

Pursuing Third Party Health Coverage.

56 FR 8926 ........... No .......... No .................... No ..................... N/A (rule issued prior to UMRA 

being enacted).

‘‘[T]he cost of implementation is 

expected to be insignificant.’’243

45 ........... Responsibility of Applicants for Promoting Objectivity in Research for 

which Public Health Service Funding 

is Sought and Responsible Prospective Contractors.

76 FR 53256 ......... No .......... No .................... No ..................... No ............................................. Estimated annual cost of 

$23,236,238.244

45 ........... Rate Increase Disclosure and Review .. 76 FR 29964 ......... No .......... No .................... No ..................... No ............................................. ‘‘CMS estimates that issuers 

will incur approximately $10 

million to $15 million in onetime administrative costs, and 

$0.6 million to $5.5 million in 

annual ongoing administrative costs related to complying with the requirements 

of this final rule from 2011 

through 2013. In addition, 

States will incur very small 

additional costs for reporting 

the results of their reviews to 

the Federal government, and 

the Federal government will 

incur approximately $0.7 million to $5.9 million in annual 

costs to conduct reviews of 

justifications filed by issuers 

in States that do not perform 

effective reviews.’’ 245

None of the sampled regulations 

would be exempt from this final rule, 

meaning all sampled rules would need 

to be Assessed. This is consistent with 

the assumption that few enough 

regulations would be exempt from this 

final rule to significantly affect the cost 

estimates presented here. At the time 

the ten sampled regulations were 

promulgated, the Department believed 

that one of the ten had a SEISNOSE. If 

the Assessments’ findings mirror the 

findings from the time of issuance, one 

of the ten sampled regulations would 

need to be Reviewed. Similarly, an 

academic study found 11.1% of 

Department final rules issued in 1993 

had a SEISNOSE.246 A more recent 

study found that 92% of agency rules 

were found to not be subject to the RFA, 

suggesting agencies believe roughly 8% 

of their regulations have a 

SEISNOSE.247

Assuming the Department has roughly 

3,600 total rulemakings that are subject 

to this final rule; 3,440 of these are more 

than five years old (i.e. would be ten 

years old by the end of 2026); and that 

roughly 11% 248 have a SEISNOSE, then 

the Department might have to perform 

roughly 396 Reviews in total, of which 

378 would have to be completed in the 

five years after this rule is finalized. 

However, some of these rulemakings 

might be reviewed as part of section 610 

reviews even in absence of this final 

rule (i.e., in the baseline scenario). As 

noted above, the Department estimates 

that the three completed rulemakings 

emanating from section 610 reviews 

over the last decade amend 

approximately 130 sections of the CFR. 


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249Since approximately 95 percent of Department 

rules were finalized before 2016, this analysis 

assumes 25 Reviews in the baseline scenario would 

occur in the first five years following 

implementation of this final rule, and one Review 

would occur in the subsequent five years. 

250Here, 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). 

251 ‘‘Age in,’’ meaning that the rules become ten 

years old during years six through ten. 

If the decade following implementation 

of this final rule is similar to the 

previous decade, then the Department 

can expect to review and amend 130 

sections of the CFR, which is equivalent 

to 26 average rulemakings if 5 

regulations correspond with one 

rulemaking on average. These 26 

rulemakings are assumed to be what 

would be Reviewed in the baseline 

scenario. Therefore, the Department 

expects to conduct 370 Reviews in total, 

of which 353 would have to be 

completed in the five years after this 

rule is finalized.249

Of the 353 rulemakings subject to 

Reviews in the first five years (or six 

years if the Secretary exercises the oneyear extension authority), the 

Department estimates roughly 44 

rulemakings were promulgated prior to 

the requirement for prospective 

regulatory flexibility analyses. Those 44 

Reviews will require more Department 

resources than the estimated 309 

Reviews of rulemakings promulgated 

after the prospective analysis 

requirement went into effect. 

Therefore, as a result of this final rule, 

the Department expects to have to 

conduct 370 Reviews in total. These 

include approximately 44 rulemakings 

that were promulgated prior to the 

requirement for prospective regulatory 

flexibility analyses, and 326 Reviews of 

rulemakings promulgated after the 

prospective analysis requirement went 

into effect. Of these 326, the Department 

assumes most Reviews will occur earlier 

in the coming ten years such that 309 

Reviews are conducted in the first five 

calendar years following 

implementation of this final rule and 17 

of the Reviews occur in the second five 

calendar years. This is consistent with 

the fact that the vast majority, roughly 

95 percent, of Department regulations 

are older than five years (and therefore 

will be more than ten years old by the 

end of 2026). 

1. Costs Related to Section 610 Reviews 

of Regulations More Than Five Years 

Old 

The majority of the Reviews 

conducted in response to this regulation 

will have to be conducted in the first 

five calendar years following 

implementation of this regulation, 

because the vast majority of the 

Department’s regulations were finalized 

before the end of 2016. A full initial 

Regulatory Flexibility Act (RFA) 

analysis requires 250 to 500 hours to 

complete because federal agencies must 

analyze the impact of their regulatory 

actions on small entities (small 

businesses, small non-profit 

organizations and small jurisdictions of 

government) and, where the regulatory 

impact is likely to be ‘‘significant’’ and 

affecting a ‘‘substantial number’’ of 

these small entities, seek less 

burdensome alternatives for them. This 

involves defining the market and 

determining costs for each small entity. 

The section 610 review is a more 

streamlined analysis because the 

regulatory flexibility analysis is the 

starting point. The section 610 review 

focuses on five areas of analysis: (1) 

Whether there is a continued need for 

the rule, (2) the number and nature of 

complaints, (3) the complexity of the 

regulation, (4) whether there is 

duplication, and (5) the degree to which 

technology, economic conditions, or 

other factors have changed in the area 

affected by the rule, as well as whether 

the Regulation complies with applicable 

law. As such, the Department estimates 

that a Review will require significantly 

less time than a full RFA analysis. 

The Department recognizes that some 

regulations were promulgated prior to 

when the requirement for prospective 

regulatory analysis went into effect, and 

that a section 610 review of such 

rulemakings may be more time 

intensive. The Department estimates 

309 rulemakings from 2016 or earlier 

will be subject to section 610 review 

where some prospective analysis has 

been performed, in which case such 

reviews will take 40 to 100 hours. The 

Department estimates it will undertake 

section 610 reviews of 44 rules for 

which no prospective regulatory 

analysis was performed. The 

Department assumes that between 250 

to 500 hours may be required for these 

reviews, even though the section 610 

review is more circumscribed than a full 

regulatory flexibility analysis and will 

therefore generally take less time to 

perform. The Department also notes that 

there could be costs associated with 

publishing the notices of Assessments 

and Reviews to the Department’s 

website and the Federal Register for 

public comment, but that such costs 

will be minimal and would not require 

the hiring of additional personnel. 

Therefore, the Department estimates 

that a total of between 23,360 and 

52,900 hours will be spent on Reviews 

outside the Assessment process during 

the first five years (the number of hours 

may ultimately be slightly less if the 

Secretary exercises the optional oneyear extension with respect to some 

regulations), which will clear the 

backlog of section 610 reviews for 

regulations at least five years old. The 

Department assumes 40 to 100 hours per 

Review for the estimated 309 Reviews 

for which an initial prospective analysis 

was performed. The Department 

assumes 250 to 500 hours per Review 

for the estimated 44 Reviews where no 

such initial prospective analysis was 

performed. 

The Department estimates that the 

fully-loaded cost per hour to the 

Department to employ a person to 

conduct a Review or Assessment is 

$244.98 per hour (referred to as 

‘‘LaborCost’’).250 Assuming the 23,360 

to 52,900 estimated hours are spread 

evenly across the first five years 

following implementation of this final 

rule, and assuming a 7 percent discount 

rate, the present value of these costs 

ranges from $4.7 to $10.6 million in 

total. Without discounting, this is equal 

to 20.1 to 45.6 full-time equivalents 

(FTEs) working at LaborCost to initiate 

and conduct Reviews of regulations in 

the first 5 years. 

2. Costs Related to Rulemakings That 

‘‘Age In’’ To Section 610 Review 

The Department estimates 17 

rulemakings would ‘‘age in’’ 251 to the 

section 610 review requirement during 

years six through ten after this rule is 

finalized. The Department estimates it 

will require between 680 to 1,700 hours 

to Review these rules, because the 

Department assumes those 17 Reviews 

would take between 40 to 100 hours per 

Review, as each of those rulemakings 

were promulgated after prospective 

regulatory analysis was required. 

Assuming hours reviewing these 

rulemakings are spread equally across 

years six through ten, the Department 

estimates the present value of the cost 

of Reviewing 17 rulemakings in years 

six through ten to be between $0.1 

million and $0.3 million at a seven 

percent discount rate. Without 

discounting, this represents 0.6 to 1.5 

FTEs working at LaborCost to conduct 

17 Reviews of rules that age into the 

Review requirement during the decade 

following implementation of this 

regulation. 


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252 3,062 is 3,440 total Department rulemakings 

older than 2016, minus 25 rulemakings Reviewed 

in the baseline scenario, minus the 353 rulemakings 

Reviewed in the first five years. 142 is 160 

rulemakings affected by this final rule in the second 

five years, minus one rulemaking Reviewed in the 

baseline scenario, minus the 17 rulemakings 

expected to be Reviewed in the second five years. 

253 5% of 3,062 is 153. 

254 5% of 142 is 7. 

255Each review will take 40–100 hours. 

256Organisation for Economic Co-operation and 

Development, ‘‘Reviewing the Stock of Regulation’’ 

(2020). 

3. Costs Related to Assessments 

In addition to conducting Reviews of 

rulemakings that have a SEISNOSE, the 

Department will allocate resources 

towards conducting Assessments of its 

rulemakings to determine whether a 

Review is required. At the time of 

promulgation, regulations are evaluated 

as to whether they had a SEISNOSE 

under the RFA. However, some 

regulations were promulgated prior to 

the RFA, while others were certified 

exempt from having to produce a 

regulatory flexibility analysis because 

they were certified as not having a 

SEISNOSE. This final rule will require 

the Department to make a determination 

as to whether covered rulemakings 

currently have a SEISNOSE and, if so, 

to Review those regulations. Because 

circumstances could change over time, 

the designation that a regulation has a 

SEISNOSE is likely to change for some 

rules. As a result, this final rule requires 

the Department to timely Assess all of 

its regulations (subject to the exceptions 

in this final rule) to determine whether 

they have a SEISNOSE, otherwise the 

regulations would expire. As discussed 

above, some rulemakings may overlap 

with or be duplicative of one another, 

reducing the number of Reviews that 

will be eventually required. However, 

the Department believes an initial 

Assessment of all rulemakings (subject 

to this final rule’s exceptions) will likely 

be required first to determine the extent 

of such overlap or duplication. 

The Department believes each 

Assessment will require between three 

and 10 hours to perform. The 

Department estimates that it will have to 

conduct roughly 3,062 Assessments in 

the first five years after this rule is 

finalized, and an additional 142 

Assessments in the subsequent five 

years, for a total of 3,204 Assessments 

across ten years.252

As such, the Department believes 

9,186 to 30,620 hours will be spent on 

Assessments in the first five years. The 

Department believes 426 to 1,420 hours 

will be spent on Assessments in the 

following five years. Assuming these 

hours are spread evenly across their 

respective ranges of years, the present 

value of costs associated with these 

Assessments ranges from $1.9 to $6.4 

million at a 7 percent discount rate. 

Without discounting, this represents 8.3 

to 27.6 FTEs working on a total of 3,204 

Assessments over ten years. If, as seems 

plausible, Assessments of regulations 

more than ten years old will 

disproportionately occur in the latter 

half of the 2021–2026 time period, the 

present value of the cost of Assessments 

will be slightly less than estimated 

herein. 

4. Costs Related to Review of Additional 

Rulemakings Found To Have a 

SEISNOSE 

Depending on the outcome of the 

Assessments, the Department may have 

to Review additional rulemakings. The 

Department estimates roughly 5% of 

Assessments of Regulations not initially 

found to have a SEISNOSE will 

conclude that a Review is required. The 

Department believes this is a reasonable 

estimate because the 5% rate is roughly 

half of the percentage of all Department 

regulations that the Department 

currently believes have a SEISNOSE. 

Accordingly, the Department estimates 

153 Reviews will be required in the first 

five years,253 and seven Reviews will be 

required in the subsequent five years,254

for a total of 160 additional Reviews. 

The Department estimates the 153 

Reviews will require 6,120 to 15,300 

hours,255 and that the seven Reviews 

will require 280 to 700 hours in the 

subsequent five years. 

Assuming these hours are spread 

evenly across the corresponding time 

frames, multiplying these hour 

estimates by LaborCost and discounting 

at a seven percent discount rate yields 

an estimated $1.3 to $3.2 million over 

ten years, which corresponds with 5.5 to 

13.8 FTEs for additional postAssessment Reviews over ten years 

(without discounting). If, as seems 

plausible, Reviews of regulations in this 

category will not be spread evenly 

across the corresponding time frames 

but will disproportionately occur in the 

latter half of the time frames, the present 

value of the cost of these Reviews will 

be slightly less than estimated herein. 

5. Monitoring Costs 

Some commenters argued that the 

proposed rule’s regulatory impact 

analysis underestimated the costs of this 

rulemaking, because it did not consider 

the costs to the regulated community of: 

Monitoring which regulations may 

expire; commenting either during the 

Assessment and Review process or to 

request that the Department conduct an 

Assessment or Review; and, when 

necessary, writing and submitting 

comments on regulations amended as a 

result of retrospective reviews 

conducted pursuant to this final rule. 

The Department believes the cost of 

monitoring Assessments will be 

relatively trivial. This final rule requires 

the Department to announce on its 

website, as well as on Regulations.gov, 

when it has commenced Reviews and 

Assessments. Making the announcement 

on Regulations.gov (as opposed to only 

on the Department’s website, as 

proposed) will reduce the monitoring 

costs raised by the commenters, because 

the regulated community already 

monitors Regulations.gov. 

Moreover, in conjunction with this 

final rule, the Department is placing at 

https://www.hhs.gov/regulations/ 

federal-registry/index.html a list of 

Department regulations, the year they 

were initially promulgated, the last year 

the rule was amended, and the Federal 

Register citation from the time the rule 

was initially promulgated. This list was 

generated with artificial intelligence and 

the Department believes it is accurate, 

but it is conceivable that some 

Department regulations are not 

included. This list can be used to easily 

create a schedule of expiration dates, so 

that the monitoring public does not 

need to identify these dates itself. 

Announcements of this kind conform to 

Organisation for Economic Co-operation 

and Development guidelines that 

recommended creating a predetermined 

schedule for when regulations are due 

for assessment and review.256 This type 

of ‘‘programmed review’’ would give 

both the Department and the public 

ample time to prepare for the Review 

and to submit comments as needed. It 

would also reduce the time and effort 

required of the public to track those 

regulations that are set to expire or be 

revised. As such, the monitoring public 

should not bear any significant expense 

keeping track of when regulations are 

set to expire or reminding the 

Department of when regulations are set 

to expire. Additionally, monitoring 

costs associated with Assessments are 

likely to not be significant because 

Assessments are unlikely to result in 

amendments of regulations, absent a 

subsequent Review also occurring. This 

final rule only mandates amendment or 

rescission of certain regulations that 

have been Reviewed. 

In addition, the Department intends to 

create on its website a dashboard that 

shows its progress on its Assessments 

and Reviews, including when it 

commenced those Assessments and 

Reviews, its progress, and when it 


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257 Jon Sanders, Rule removal under periodic 

review has slowed down, but a new law tightens the 

process, The John Locke Found.: The Locker Room 

(July 22, 2019), https://lockerroom.johnlocke.org/ 

2019/07/22/rule-removal-under-periodic-reviewhas-slowed-down-but-a-new-law-tightens-theprocess/. 258This is 370 Reviews from rules that were 

initially identified as having a SEISNOSE plus the 

160 Reviews from Assessments determining that 

additional rulemakings have a SEISNOSE. 259See Bureau of Labor Statistics, Occupational 

Employment Statistics, 23–1011 Lawyers. https://

www.bls.gov/oes/current/oes231011.htm. 

260This assumption is in line with Department 

guidelines on regulatory analysis. See U.S. Dep’t of 

Health & Hum. Servs., Guidelines for Regulatory 

Impact Analysis, at 28 (2016). 

261This is 159 rulemakings × 486 commenters × 

$143.20 per hour × 5 to 15 hours per comment. 

262Office of Gov. Brad Little, Idaho’s Historic 

Regulatory Cuts (July 2019). 

263The fact that there seemed to be little 

controversy surrounding rescinded rules may imply 

some of those rescissions were fairly trivial in some 

cases. While data on the extent to which rescissions 

were trivial or nontrivial are unavailable, news 

stories provide some basis for this belief. Note that 

rescinded rules being relatively trivial is not 

evidence that amended rules were trivial. See, e.g., 

Editorial, Idaho Quits Worrying About Snails, Wall 

St. J., June 28, 2019, https://www.wsj.com/articles/ 

idaho-quits-worrying-about-snails-11561763217. 

264The Office of Management and Budget 

recommends a 7 percent base-case default discount 

rate be used in regulatory impact analysis. OMB 

also recommends a 3 percent consumption rate of 

interest be used as an alternative. See Office of 

Mgmt. & Budget, Circular A–4, Regulatory Analysis 

(Sept. 17, 2003). 

expects them to be completed. If they so 

choose, the public can view this 

dashboard to see the Department’s 

progress on its Assessments and 

Reviews of particular regulations. The 

dashboard will also help to keep the 

Department on track to timely complete 

Assessments and Reviews. 

Based on the experience of North 

Carolina,257 the Department estimates 

that approximately 10 percent of 

Reviewed rulemakings will be rescinded 

and 30 percent of Reviewed 

rulemakings will be amended in some 

way. Since 530 rulemakings are 

expected to be Reviewed in total,258 this 

suggests 53 regulations will be 

rescinded and 159 will be updated. 

To estimate how much interest these 

expiring and amended regulations are 

likely to generate, the Department notes 

that it received 486 comments on the 

proposed rule as of the close of the 30- 

day public comment period. A typical 

commenter is likely to be someone with 

a legal background. According to the 

Bureau of Labor Statistics,259 the mean 

hourly wage of a lawyer is $71.60 

(2020$). Assuming base salary 

constitutes one half of fully-loaded 

wages,260 this suggests the fully loaded 

cost per hour of writing comments is 

$143.20. 

If a typical comment takes 5 to 15 

hours to write, and if the 486 comments 

the Department received on the 

proposed rule is a good proxy for the 

interest the Department will receive on 

the 159 rulemakings expected to be 

amended as a result of this final rule 

over the next decade, then the total 

(undiscounted) monitoring cost related 

to writing comments on those 159 

regulations is $55.3 to $166.0 million.261

However, rulemakings are not likely to 

all be amended at the same time. 

Further, if the Secretary determines that 

completion of an amendment or a 

rescission is not feasible by the required 

date, he or she can certify this in a 

statement published in the Federal 

Register and may extend the completion 

date by one year at a time, no more than 

three times. 

Assuming the Secretary does not 

extend the completion date (this 

assumption is relaxed in the sensitivity 

analysis below), the Department expects 

152 of the amended rulemakings will be 

Reviewed in the first five years and 

seven regulations Reviewed in the 

second five years. Assuming monitoring 

costs are spread equally across these 

timeframes (with the understanding that 

this may overestimate costs somewhat 

since rulemakings are likely to be 

amended after they are Reviewed, 

which would push amendment to the 

later end of the timeframe) the present 

value of these monitoring costs ranges 

from $44.8 to $134.3 million at a seven 

percent discount rate. 

The Department expects it will 

receive less interest in regulations that 

are rescinded after being Reviewed, 

given that many regulations that are 

sunset in states often face little 

resistance from the public, perhaps 

because their rescission is 

uncontroversial. For example, the state 

of Idaho underwent a sunset review 

process for its entire regulatory code in 

2019. As a result of the review, 19 

percent of rule chapters, 10 percent of 

pages, and more than 19,000 regulatory 

restrictions were rescinded when the 

code was rewritten in the summer of 

2019.262 This occurred with little 

controversy, suggesting many 

regulations that were rescinded were 

obviously outdated or 

counterproductive, such that their 

removal was uncontroversial.263

The North Carolina experience, which 

has been ongoing for several years, may 

be a better representation of what the 

Department can expect from its reviews, 

since the circumstances in Idaho were 

somewhat unique. Nonetheless, the 10 

percent of reviewed rules being 

rescinded in North Carolina is 

comparable to the 10 percent of pages of 

rules repealed during Idaho’s mid-2019 

review. The Department assumes 

rescinded regulations will receive half 

as many comments as amended 

regulations. In that case, 53 rescinded 

regulations, of which 51 are expected in 

the first five years, should generate costs 

of $7.5 to $22.4 million (discounted at 

a 7 percent discount rate, assuming 

rescinded regulations are spread across 

corresponding timeframes in a manner 

consistent with the amended regulations 

described above). Thus, the total cost of 

monitoring is likely to range from $52.2 

to $156.7 million (at a seven percent 

discount rate). 

6. Total Estimated Costs From 

Implementing This Rulemaking 

The Department estimates a total cost 

of between $60.2 to $199.3 million over 

ten years in order to do the following: 

(a) Conduct section 610 Reviews for 

Department rulemakings from 2016 or 

earlier in years 1 to 5, (b) conduct 

section 610 Reviews of rulemakings that 

‘‘age in’’ to section 610 review in years 

6 to 10, (c) conduct Assessments of 

rulemakings in years 1 to 10, and (d) 

conduct section 610 Reviews of 

rulemakings deemed to be subject to 

Review following an Assessment in 

years 1 to 10. The total number of 

Department employees required to 

conduct these activities is estimated to 

be 34.5 to 88.5 FTEs over ten years. The 

Department has also estimated the cost 

of increased monitoring falling on 

regulated entities. Results are presented 

in table 4 below, which also includes 

cost estimates discounted at a 3 percent 

discount rate for sensitivity purposes.264

TABLE 4—PRESENT VALUE OF ESTIMATED COST OF ASSESSING AND REVIEWING DEPARTMENT REGULATIONS OVER TEN

YEARS (MILLIONS OF 2020$), AT 3 AND 7 PERCENT DISCOUNT RATES

Type of cost Cost 

(7%) 

Cost 

(3%) FTEs 

Department Costs: 


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5746 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

265To the extent this uncertainty has been 

lessened because the public has seen how the 

Department has implemented these directives over 

the course of many years, the same can be said for 

this final rule once it has been implemented for 

several years. 

TABLE 4—PRESENT VALUE OF ESTIMATED COST OF ASSESSING AND REVIEWING DEPARTMENT REGULATIONS OVER TEN

YEARS (MILLIONS OF 2020$), AT 3 AND 7 PERCENT DISCOUNT RATES—Continued 

Type of cost Cost 

(7%) 

Cost 

(3%) FTEs 

A. Costs Related to Section 610 Reviews of Regulations More Than Five 

Years Old.

$4.7 to $10.6 million.$5.2 to $11.9 ......... 20.1 to 45.6. 

B. Costs Related to Rulemakings That ‘‘Age In’’ to Section 610 Review .... $0.1 to $0.3 ........... $0.2 to $0.4 ........... 0.6 to 1.5. 

C. Costs Related to Assessments ................................................................ $1.9 to $6.4 ........... $2.1 to $7.1 ........... 8.3 to 27.6. 

D. Costs Related to Review of Additional Rulemakings Found to Have a 

SEISNOSE.

$1.3 to $3.2 ........... $1.4 to $3.6 ........... 5.5 to 13.8. 

Private Costs: 

E. Cost to Monitoring Public .......................................................................... $52.2 to $156.7 ..... $58.8 to $176.3 ..... N/A. 

Total ........................................................................................................ $60.2 to $177.2 ..... $67.7 to $199.3 ..... 34.5 to 88.5. 

These figures can also be presented on 

an annualized basis, calculations of 

which are presented in table 5 below. 

Annualized costs are estimated to range 

from $7.9 million to $25.2 million per 

year over the decade following 

implementation of this final rule. 

TABLE 5—ACCOUNTING STATEMENT: ANNUALIZED COSTS OF FINAL RULES

Present value 

(millions of 2020$) 

Discount rate 

(percent) Time horizon Annualized, millions of 2020$ per year 

$60.2 to $177.2 ................................................................................................................. 7 2021–2030 $8.6 to $25.2. 

$67.7 to $199.3 ................................................................................................................. 3 2021–2030 $7.9 to $23.4. 

7. Sensitivity Analysis 

One commenter noted that 

conducting a retrospective analysis can 

be as time-consuming and expensive as 

a prospective regulatory analysis, 

suggesting the Department’s estimates of 

the time and expense of Reviews may be 

understated. The Department believes 

that on average Reviews of rulemakings 

implemented after the RFA are likely to 

be less time consuming than those 

implemented before. Moreover, 250 to 

500 hours is the amount of time 

estimated to produce a full initial RFA 

analysis, which requires more time than 

a section 610 review, even one where no 

RFA analysis was conducted when the 

rulemaking was promulgated. 

Nevertheless, for the sake of testing the 

sensitivity of the cost estimates for 

Reviews, the Department calculates the 

costs of Reviews assuming all Reviews 

take 250 to 500 hours, rather than the 

assumption of 40 to 100 hours for postRFA regulations made above. In this 

case, the present value of the total cost 

of Reviews (A, B and D in table 4) 

would rise to $26.5 to $53.0 million 

from $6.1 to $14.1 million (at a seven 

percent discount rate), and would rise to 

$29.7 to $59.4 million from $6.8 to 

$15.8 million (at a three percent 

discount rate). 

However, there are also reasons to 

believe the costs estimated in table 4 are 

overestimated. First, this final rule 

permits the Secretary to extend by up to 

one year the expiration date for 

particular regulations. Having this 

option might have the effect of pushing 

back the time horizon for certain 

Reviews and Assessments by one year. 

This would suggest the costs presented 

in table 4 above are overestimated to the 

extent that the present value of these 

costs will fall as some costs are pushed 

into the future. Assuming all costs are 

pushed back by one year, discounting 

the total costs by one additional year at 

a seven percent discount rate yields a 

present value of total costs in the range 

of $56.3 million to $165.6 million, and 

at a three percent rate yields a present 

value of total costs in the range of $65.7 

to $193.5 million. These potential 

reduced costs are one reason the 

Department has decided to modify the 

final rule from its proposed form. 

Similarly, the costs of monitoring 

might be pushed into the future if the 

Secretary exercises his or her right to 

extend the completion date by one year 

at a time, up to three times, with respect 

to amendment or rescission of 

regulations after Review. Assuming 

amended or rescinded regulations are 

pushed back three years in the future, 

the present value of monitoring costs 

would fall to $42.6 to $127.9 million at 

a seven percent discount rate and to 

$53.8 to $161.3 million at a three 

percent discount rate. If, as some 

commenters stated, this final rule 

resulted in the Department issuing 

fewer new notices of proposed 

rulemaking, the reduction in 

commenting costs from the reduction in 

new notices of proposed rulemaking 

would cause the monitoring costs from 

this final rule to drop. 

8. Other Possible Costs 

Some commenters noted that there 

might be other sources of cost associated 

with this rulemaking other than those 

cited in the regulatory impact analysis 

accompanying the proposed rule. Some 

of these costs have been accounted for 

above, such as the cost of monitoring or 

the potential for Reviews to take longer 

than estimated in the proposed rule. 

Other commenters cited increased 

uncertainty to businesses and members 

of the regulated community as a 

possible cost due to the increased 

chance that rules may expire in the 

future. The Department does not believe 

uncertainty among the regulated 

community will add significantly to the 

costs of this rulemaking for the 

following reasons. The Department’s 

sporadic use of periodic retrospective 

review—notwithstanding the RFA and 

Executive Orders—itself leads to 

‘‘uncertainty’’ about how robustly the 

Department implements directives that 

make for good policy.265 To the extent 

that the Department can maintain 

compliance with its obligations, this 

should build trust in the Department 


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266Missouri Revised Statutes, Title XXXVI 

§ 536.175.5. 

267Utah Code Ann. § 63G–3–502(2) (2020); Idaho 

Code Ann. § 67–5292 (2020). 

268 James Broughel, The Mighty Waves of 

Regulatory Reform: Regulatory Budgets and the 

Future of Cost-Benefit Analysis, 3 Bus. 

Entrepreneurship & Tax L. Rev. 206, at 216 (2019). 

269See FDA Reauthorization Act of 2017, Public 

Law 115–52 (Aug. 18, 2017). 

270OECD, Reviewing the Stock of Regulation, at 

25 (2020). 

271 Legislation Act 2003 (Cth) (Austl.) 

272Australian Gov’t Att’y Gen.’s Dep’t, Guide to 

Managing the Sunsetting of Legislative Instruments, 

at 6 (July 2020), https://www.ag.gov.au/sites/ 

default/files/2020-07/Guide%20to%20Managing

%20Sunsetting%20of%20Legislative

%20Instruments.pdf. 

273 ‘‘Federal Register of Legislation,’’ Australian 

Government, accessed November 30, 2020, https:// 

www.legislation.gov.au/Browse/Results/ 

BySunsetDate/LegislativeInstruments/ 

SunsettingSoon/2022/0/0/. 

274 Id. at 3. 

275OECD, Regulatory Policy in Korea: Towards 

Better Regulation (2017). 

276 Id. at 20. 

277 Id.at 71. 

278 Id. at 41. 

279 Id. at 84. 

280Personal communication with an official from 

the New Jersey Office of Administrative Law (Dec. 

9, 2020). 

281Personal communication with an official from 

the Missouri Office of the Attorney General (Dec. 

31, 2020). 

282 Jon Sanders, Rule removal under periodic 

review has slowed down, but a new law tightens the 

Continued 

and reduce uncertainty (offsetting some 

or all of the uncertainty discussed by 

the commenters, if such uncertainty 

exists). Further, as noted above, the 

Department plans to release information 

about the 18,000 regulations under its 

authority and when they were adopted, 

such that any uncertainty surrounding 

the expiration dates of the Department’s 

various rulemakings will be reduced 

substantially, if not entirely. Additional 

measures to mitigate private costs are 

discussed in the ‘‘Operationalization of 

This Final Rule’’ section of this final 

rule. 

Second, the Department notes that 

many states have sunset provisions that 

are a routine part of their regulatory 

processes. New Jersey, Indiana, and 

North Carolina have sunset provisions 

for their regulations. Missouri has a 

sunset provision for regulations, which 

is tied to a periodic review 

requirement.266 Colorado, California, 

and Texas have sunset review processes 

for entire boards, commissions, and 

agencies. Some states have an annual 

sunset review process for their entire 

administrative code.267 Although the 

sunset clause is rarely exercised, there 

nevertheless is always the possibility 

the entire regulatory code will expire in 

these states in any particular year. In 

fact, two states (Idaho and Rhode Island) 

replaced their regulatory codes in recent 

years as part of sunset processes, and 

these experiences seemed to work 

relatively seamlessly.268

Similarly, many major federal laws 

have sunset clauses attached to them. 

Notable among these are the Patriot Act, 

enacted in the aftermath of the 9/11 

terrorist attack, and tax laws passed as 

part of the budget reconciliation process 

under the Byrd Rule in the U.S. Senate. 

Federal agencies like the Food and Drug 

Administration within the Department 

periodically go through a 

reauthorization process, not unlike a 

sunset review.269 Sunset provisions are 

also routinely used in other countries, 

notably in Australia, Canada and the 

United Kingdom. A recent OECD report 

noted that just under half of OECD 

member countries have some form of 

sunsetting arrangements in place.270 In 

Australia, since the passage of the 

Legislation Act of 2003,271 all 

regulations (known as legislative 

instruments), with some exceptions, 

automatically expire 10 years after 

enactment unless parliament acts to 

extend the period or a replacement 

instrument is adopted.272 The 

Australian Federal Register of 

Legislation (the equivalent of the 

Federal Register in the United States) 

maintains the sunset dates for qualifying 

legislation and provides notice about 

legislative instruments set to expire 

soon.273 The Department also plans to 

provide advance notice of expiration 

dates, and will provide updates on its 

progress conducting its regulatory 

reviews. 

The Australian government also notes 

that sunset provisions are a useful way 

to spur periodic review of regulations, 

stating in a report that ‘‘Sunsetting 

provides an opportunity for agencies to 

review and streamline legislative 

instruments. It is an important 

mechanism for reducing red tape, 

delivering clearer laws and aligning 

existing legislation with current 

government policy.’’ 274

The Republic of Korea (ROK) enacted 

regulatory sunset legislation in the late 

1990s and formed a Regulatory Reform 

Committee (RRC) to review newlyintroduced regulations and to improve 

the quality of existing regulations.275

According to a report from the OECD, 

‘‘The overall aim of the sunset clause is 

to periodically review regulations in 

order to determine whether it will be 

retained or abolished.’’ 276 In 2009, ROK 

broadened the scope of its regulatory 

sunset process by tying in requirements 

for retrospective analysis.277 About 20 

percent of existing regulations are 

reviewed every three to five years and 

rescinded if found to ‘‘not serve the 

originally intended purpose.’’ 278

Moreover, according to the OECD, ‘‘[i]n 

2014, the RRC set goals to reduce the 

economic regulations by 10% . . . As a 

result, 995 out of 9,876 economic 

regulations were improved, which 

amounts to 10.1% of the total.’’ 279

These jurisdictions’ sunset provisions 

do not all work identically to this final 

rule. However, in some ways this final 

rule is more lax than these other 

jurisdictions’ sunset provisions, because 

the requirements to extend expiration 

dates are more modest compared to 

some other jurisdictions. For example, 

conducting an Assessment, and when 

necessary, a Review, is a relatively easy 

way to extend an expiration date 

compared to having to initiate an 

entirely new rulemaking. If the sunset 

reviews in these other jurisdictions do 

not create tremendous uncertainty, it 

stands to reason that neither will this 

final rule. 

Some commenters expressed concern 

that regulations might accidentally 

expire due to the Department not timely 

conducting an Assessment or Review. 

The Department intends to review all 

regulations subject to this final rule, and 

that any regulations that are eliminated 

will be formally rescinded following the 

Review process. This is consistent with 

the experiences of other jurisdictions 

with sunset provisions, where rules (or 

boards or commissions) are first 

subjected to a review process before 

they are reauthorized or rescinded. As 

an example, Idaho recently conducted a 

sunset review of its entire regulatory 

code. While a significant number of rule 

chapters were eliminated as part of that 

effort, those chapters were rescinded as 

part of a deliberate review process. 

New Jersey is a state that attaches a 7- 

year sunset provision to regulations. 

According to the Office of 

Administrative Law in the state, it is a 

relatively rare phenomenon that rules 

expire due to administrative error.280

Similarly, accidental expiration of rules 

appears to be uncommon in Missouri, a 

state that connects a sunset provision to 

a periodic review requirement, much 

like this final rule.281

Data from North Carolina’s sunset 

review process can be informative about 

the extent to which rules are likely to be 

rescinded, modified, or kept without 

change as part of a sunset review. A 

North Carolina public policy 

organization found that 19,361 rules 

were reviewed as part of that state’s 

sunset review process in recent years.282


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5748 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

process, The John Locke Found.: The Locker Room 

(July 22, 2019), https://lockerroom.johnlocke.org/ 

2019/07/22/rule-removal-under-periodic-reviewhas-slowed-down-but-a-new-law-tightens-theprocess/. 

283 Jon Sanders, Rule removal under periodic 

review has slowed down, but a new law tightens the 

process, The John Locke Found.: The Locker Room 

(July 22, 2019), https://lockerroom.johnlocke.org/ 

2019/07/22/rule-removal-under-periodic-reviewhas-slowed-down-but-a-new-law-tightens-theprocess/. 

284Randall Lutter, Regulatory Policy: What Role 

for Retrospective Analysis and Review?, 4 J. BenefitCost Analysis 17 (2013). 

285Office 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/R8LXBQMJ (collecting studies comparing ex ante and ex 

post analyses of regulations’ costs and benefits, 

including examples where cost and benefit 

estimates were off by more than a factor of ten); 

Winston Harrington, Grading Estimates of the 

Benefits and Costs of Federal Regulation, at 33 

(Resources for the Future, Discussion Paper No. 06– 

39, 2006), http://papers.ssrn.com/sol3/papers.cfm?

abstract_id=937357.; Richard Morgenstern, 

Retrospective Analysis of U.S. Federal 

Environmental Regulation, 9 J. Benefit-Cost 

Analysis 285, at 294 (2018). 

286See also In re Barr Labs., Inc., 930 F.2d 72, 76 

(D.C. Cir. 1991) (courts ‘‘have no basis for 

reordering agency priorities. The agency is in a 

unique—and authoritative—position to view its 

projects as a whole, estimate the prospects for each, 

and allocate its resources in the optimal way.’’). 

Of these, 5,542 were sent back through 

the rule adoption process (28.6%), 

presumably to be updated, and 11,811 

rules were automatically re-upped with 

no change (61.0%). About 10 percent of 

regulations reviewed under the recent 

sunset review process were 

rescinded,283 and this occurred under 

the supervision of the state Rules 

Review Commission that was overseeing 

the process. 

These numbers reinforce that there is 

little empirical basis to support fears 

that thousands of regulations might 

accidentally expire as a result of the 

Department’s final regulation. The 

experiences in Idaho, New Jersey, 

Missouri and North Carolina 

demonstrate that sunset reviews tend to 

be orderly processes. Even in states like 

Idaho and Rhode Island, where 

significant portions of their regulatory 

codes were eliminated in recent years, 

these processes took place in an orderly 

fashion under the supervision of the 

state budget offices in those states. 

Moreover, the Department has built in 

safeguards to prevent inadvertent 

expiration of regulations, such as 

seeking comment on the proposed rule 

regarding regulations that are important 

to Assess and Review, and enabling the 

public to submit comments requesting 

that the Department commence an 

Assessment or Review. Most 

importantly, the Department plans to 

release a list of when all of the 

regulations under its authority were 

created and last modified. This can be 

used to easily determine the expiration 

date of all regulations under its 

authority, which will significantly lower 

the chance any regulation might expire 

accidentally. The fact that a schedule of 

the Department’s rules, along with their 

corresponding creation and 

modification dates, will be made public 

by the Department means the public 

will also be aware of which rules are 

scheduled to expire and when, thereby 

providing an additional safeguard 

against accidental expirations. 

Additionally, the timeline for initial 

reviews of older regulations has also 

been extended to five years in this final 

rule, with the option of a one-year 

extension, which should give the 

Department ample time to conduct 

Assessments and Reviews and should 

result in few, if any, accidental 

expirations. 

One might worry that periodic 

reviews may distract from other 

potentially beneficial rulemakings, 

which could impose a cost that the 

Department has not fully considered in 

the proposed rule. However, there is 

some indication that when regulators 

are undergoing retrospective review 

efforts, if a rulemaking is an urgent 

priority to them, they often find ways to 

justify it as part of their reviews, even 

if the rulemaking would have occurred 

absent the review.284 In other words, 

regulators maintain some flexibility to 

enact necessary new regulations by 

folding them into retrospective reviews, 

including the amendment and 

rescission process, alleviating some of 

the concern raised by the commenters. 

To the extent that any new rulemaking 

is displaced as a result of reviews 

required by the current regulation, it is 

likely to be the case that relatively lower 

priority rulemakings are displaced first 

(as presumably the Department will first 

implement high priority regulations 

before moving on to lower priority 

regulations). 

Unfortunately, it is unknown with 

certainty whether Department rules 

impose benefits in excess of costs on 

average. The vast majority of 

Department rules do not have costbenefit reports associated with them. 

Even for those that do, there are large 

uncertainties, and the literature suggests 

that many regulations are having 

estimated impacts that, over time, differ 

from what was estimated at the time the 

regulations were promulgated.285 This 

suggests that if a regulation did expire 

accidentally, this could be a cost or a 

benefit of this final rule, depending on 

the circumstances, since it is unknown 

whether the net benefits of the 

preponderance of Department rules are 

positive or negative. Regulations that are 

rescinded through sunset procedures are 

sometimes obviously problematic, such 

that their removal is uncontroversial. 

And if a regulation accidentally expired, 

it could very well be because neither the 

Department nor interested members of 

the public saw a discernible benefit 

from the regulation. Regulations with 

discernible benefits are unlikely to go 

under the radar. 

A related concern in comments is that 

Assessments and Reviews will take 

Department time and resources away 

from responding to the COVID–19 

pandemic. Under this final rule, no 

Assessments or Reviews need to be 

completed until the end of 2026, well 

after the COVID–19 pandemic is likely 

to have subsided. Hence it is unlikely 

that this final rule will hamper the 

response to the pandemic. 

The Department recognizes that this 

final rule requires the Department to 

undertake certain tasks. But given the 

importance of retrospective review, the 

Department believes that review should 

be a priority and it is willing to commit 

the necessary resources towards 

performing Assessments and 

Reviews.286

The expertise of Department analysts 

may also be best leveraged through 

Assessments and Reviews that could 

facilitate the Department’s response to 

future pandemics or emergencies. As 

noted earlier, the Department waived or 

exercised enforcement discretion with 

respect to many regulations as part of its 

response to the pandemic. A review of 

those regulations is entirely appropriate 

to determine whether those regulations 

are undermining Department goals. 

Additionally, the COVID–19 pandemic 

has raised serious questions about 

whether certain Department regulations 

are protecting public health or 

otherwise achieving their objectives. In 

fact, it is possible that in the coming 

years even absent this final rule the 

Department would find it necessary to 

conduct in-depth reviews of Department 

regulations given the need to suspend, 

waive, or exercise enforcement 

discretion with respect to certain 

regulations during the COVID–19 

pandemic. If such reviews would have 

taken place even absent this final rule, 

the cost of this final rule could be 

significantly lower than estimated (since 

those costs would be built into the 

baseline scenario). 

Some commenters cited a report that 

stated ‘‘sunset requirements produce 

perfunctory reviews and waste 


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Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 5749 

287 Jason A. Schwartz, 52 Experiments with 

Regulatory Review, Inst. for Pol’y Integrity, at 24 

(Nov. 2010), https://policyintegrity.org/files/ 

publications/52_Experiments_with_Regulatory_

Review.pdf. 

288 Id. at 33. 

289Regulatory Reform Act of 2013, H.B. 74, 2013 

Gen. Assemb., 2013 Sess. (N.C. 2013). 

290 Jonathan H. Adler & Christopher Walker, 

Delegation and Time, 105 Iowa L. Rev. 1931 (2020). 

291Robert W. Hahn, State and Federal Regulatory 

Reform: A Comparative Analysis, 29 The J. Legal 

Stud. 873 (2000). 

resources.’’ 287 Indeed, the same report 

was cited in the preamble of the 

proposed version of this rule. However, 

as noted in the proposed rule’s 

preamble, this statement from the report 

does not appear to be supported by the 

evidence. For example, the report noted 

that some states have repealed their 

sunset provisions, highlighting that 

‘‘North Carolina was first to repeal its 

sunset law, and many other states 

quickly followed suit,’’ and concluded 

that ‘‘sunset provisions quickly proved 

to be an expensive, cumbersome, and 

disappointing method for enhancing 

legislative control.’’ 288 However, North 

Carolina reenacted a sunset process for 

regulations in 2013 289 (after the report 

in question was published). Moreover, 

not every jurisdiction uses sunset 

provisions as a mechanism for 

enhancing legislative control. As 

already noted, the purpose of sunset 

provisions is often to spur retrospective 

review and analysis of regulation or 

legislation, not necessarily to empower 

the legislative branch of government. 

Nor is it the Department’s intention 

with this final rule to enhance 

legislative control, but instead to 

encourage more retrospective review 

and improve outcomes resulting from 

the Department’s regulations. 

Sunset provisions are set up in 

institutionally diverse ways across 

diverse jurisdictions. Different 

jurisdictions set different expiration 

time horizons on rules and grant 

authority to different governing bodies 

to decide whether regulations should be 

extended or not. New Jersey and Indiana 

grant the authority to renew regulations 

to the regulating agency, not the 

legislature (similar to this final rule). 

Meanwhile, Idaho and Tennessee task 

the legislature with renewing 

regulations. 

While legal scholars have sometimes 

argued that sunset provisions have a 

useful role to play in strengthening 

legislative control,290 sunset provisions’ 

benefits in terms of improving the 

impacts of regulations are equally if not 

more important than these legislative 

oversight or separation of powers issues. 

It may be the case that sometimes 

legislators do not want or do not have 

time to devote to in-depth reviews of 

large numbers of regulations, which is 

perhaps why sunset reviews that engage 

the legislature have sometimes turned 

into pro forma exercises.291 In other 

words, it seems likely that the criticisms 

of sunset provisions that have appeared 

sporadically in the academic literature 

may relate to whether sunsets spur 

legislative engagement in rulemaking, 

rather than whether they are useful in 

terms of spurring retrospective review 

(where there seems to be less 

controversy). 

To conclude, the Department 

acknowledges that some categories of 

costs have not been quantified here. 

While other categories of costs do exist 

than those calculated in table 4, they 

may be subject to greater uncertainty, be 

more challenging to estimate, or be 

relatively minor such that their 

estimation would not substantially alter 

the conclusions of this cost analysis. 

As is common practice, this 

regulatory impact analysis has not 

sought to quantify the benefits of this 

final rule, but the Department believes 

they will be substantial. 

E. Summary of Regulatory Impact 

Analysis 

A forcing mechanism will help ensure 

robust compliance with the 

Department’s statutory obligations, 

which will strengthen the rule of law in 

the United States. Given how much of 

federal spending is driven by 

Department spending, regulatory 

reviews may also constitute a way to cut 

the federal budget deficit. If the 

Department is not able to review its own 

regulations in a timely manner, it is not 

clear how any member of the public can 

be expected to comply with all of the 

regulations the Department has written 

for them (plus all of the regulations 

issued by other federal, state, and local 

agencies). Fortunately, the Department 

intends to timely Assess and (where 

needed) Review those regulations not 

exempt from this final rule. Even if for 

some reason the Department cannot, it 

has provided itself an opportunity to 

delay the expiration date where the 

public interest requires so doing. 

Regulatory Flexibility Act 

The Department has examined the 

economic implications of this final rule 

as required by the RFA (5 U.S.C. 601– 

612). The RFA generally requires that 

when an agency issues a proposed rule, 

or a final rule pursuant to section 553(b) 

of the APA or another law, the agency 

must prepare a regulatory flexibility 

analysis that meets the requirements of 

the RFA and publish such analysis in 

the Federal Register. 5 U.S.C. 603, 604. 

Specifically, the RFA normally requires 

agencies to describe the impact of a 

rulemaking on small entities by 

providing a regulatory impact analysis. 

Such analysis must address the 

consideration of regulatory options that 

would lessen the economic effect of the 

rule on small entities. The RFA defines 

a ‘‘small entity’’ as (1) a proprietary firm 

meeting the size standards of the Small 

Business Administration (SBA); (2) a 

nonprofit organization that is not 

dominant in its field; or (3) a small 

government jurisdiction with a 

population of less than 50,000. 5 U.S.C. 

601(3)–(6). Except for such small 

government jurisdictions, neither State 

nor local governments are ‘‘small 

entities.’’ Similarly, for purposes of the 

RFA, individual persons are not small 

entities. The requirement to conduct a 

regulatory impact analysis does not 

apply if the head of the agency ‘‘certifies 

that the rule will not, if promulgated, 

have a significant economic impact on 

a substantial number of small entities.’’ 

5 U.S.C. 605(b). The agency must, 

however, publish the certification in the 

Federal Register at the time of 

publication of the rule, ‘‘along with a 

statement providing the factual basis for 

such certification.’’ Id. If the agency 

head has not waived the requirements 

for a regulatory flexibility analysis in 

accordance with the RFA’s waiver 

provision, and no other RFA exception 

applies, the agency must prepare the 

regulatory flexibility analysis and 

publish it in the Federal Register at the 

time of promulgation or, if the rule is 

promulgated in response to an 

emergency that makes timely 

compliance impracticable, within 180 

days of publication of the final rule. 5 

U.S.C. 604(a), 608(b). 

The Department considers a rule to 

have a significant impact on a 

substantial number of small entities if it 

has at least a three percent impact on 

revenue on at least five percent of small 

entities. Department regulations impact 

at least NAICS industry sectors 11, 31– 

33, 42, 44–45, 48–49, 52, 54, 62, 81, and 

92. 

The Regulatory Impact Analysis in the 

prior section also satisfies the 

Department’s obligation to conduct a 

regulatory flexibility analysis under 

section 604. For the reasons described 

in this final rule, this final rule will 

benefit small entities. 

Congressional Review Act 

The Congressional Review Act (CRA) 

defines a ‘‘major rule’’ as ‘‘any rule that 

the Administrator of the Office of 

Information and Regulatory Affairs 


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5750 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

(OIRA) of the Office of Management and 

Budget finds has resulted in or is likely 

to result in—(A) an annual effect on the 

economy of $100,000,000 or more; (B) a 

major increase in costs or prices for 

consumers, individual industries, 

Federal, State, or local government 

agencies, or geographic regions; or (C) 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

enterprises to compete with foreignbased enterprises in domestic and 

export markets.’’ 5 U.S.C. 804(2). Based 

on the analysis of this final rule under 

Executive Order 12866, this rule is 

expected to be a major rule for purposes 

of the CRA. The Department will 

comply with the CRA’s requirements to 

inform Congress. 

Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 

(Unfunded Mandates Act) (2 U.S.C. 

1532) requires that covered agencies 

prepare a budgetary impact statement 

before promulgating a rule that includes 

any Federal mandate that may result in 

the expenditure by State, local, and 

tribal governments, in the aggregate, or 

by the private sector, of $100 million in 

1995 dollars, updated annually for 

inflation. Currently, that threshold is 

approximately $156 million. If a 

budgetary impact statement is required, 

section 205 of the Unfunded Mandates 

Act also requires covered agencies to 

identify and consider a reasonable 

number of regulatory alternatives before 

promulgating a rule. 

National Environmental Policy Act 

(NEPA) 

HHS has determined that the 

proposed rule will not have a significant 

impact on the environment. 

Executive Order 12988: Civil Justice 

Reform 

HHS has reviewed this rule under 

Executive Order 12988 on Civil Justice 

Reform and has determined that this 

final rule complies with this Executive 

Order. 

Executive Order 13132: Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a rule 

that imposes substantial direct costs on 

State and local governments or has 

federalism implications. The 

Department has determined that this 

final rule does not impose substantial 

direct costs on State and local 

governments or have federalism 

implications as defined in Executive 

Order 13132. The final rule requires the 

Department to periodically review 

certain of its regulations, and provides 

that if the regulations are not reviewed 

by a certain date, they will expire. Any 

rescission of a regulation would only 

occur because of acts independent of 

this final rule—either the findings of a 

Review determining a regulation should 

be amended, or a failure to perform an 

Assessment or Review. Thus, this final 

rule would impose no substantial direct 

costs on State and local governments. 

The Department notes, though, that 

this final rule might indirectly have 

beneficial federalism implications. 

Among other things, the Reviews called 

for by this final rule require the 

Department to determine if certain 

Department regulations overlap, 

duplicate or conflict with State and 

local government rules and, if so, to 

consider that when determining 

whether to amend or rescind the 

regulations. If a Review conducted 

pursuant to this final rule were to find 

that a Department regulation should be 

amended or rescinded, the Department 

would comply with Executive Order 

13132 in amending or rescinding the 

regulation. 

Plain Writing Act of 2010 

Under the Plain Writing Act of 2010 

(Pub. L. 111–274, October 13, 2010), 

executive departments and agencies are 

required to use plain language in 

documents that explain to the public 

how to comply with a requirement the 

federal government administers or 

enforces. The Department has attempted 

to use plain language in promulgating 

this proposed rule, consistent with the 

Federal Plain Writing Act guidelines. 

Assessment of Federal Regulation and 

Policies on Families 

Section 654 of the Treasury and 

General Government Appropriations 

Act of 1999, Public Law 105–277, sec. 

654, 112 Stat. 2681 (1998) requires 

Federal departments and agencies to 

determine whether a policy or 

regulation could affect family wellbeing. Section 601 (note) required 

agencies to assess whether a regulatory 

action (1) impacted the stability or 

safety of the family, particularly in 

terms of marital commitment; (2) 

impacted the authority of parents in the 

education, nurturing, and supervision of 

their children; (3) helped the family 

perform its functions; (4) affected 

disposable income or poverty of families 

and children; (5) was justified if it 

financially impacted families; (6) was 

carried out by State or local government 

or by the family; and (7) established a 

policy concerning the relationship 

between the behavior and personal 

responsibility of youth and the norms of 

society. 

This final rule would apply to and 

amend certain Department regulations 

to add dates by which they would 

expire unless the Department 

periodically reviews the regulations 

using certain criteria. Standing alone, 

absent the failure to perform an 

Assessment or Review, this final rule 

would have no direct impact, other than 

resulting in the Department amending 

or rescinding Regulations that it 

determines do not satisfy the Review 

criteria. 

If the family well-being determination 

requirement were still in force, for the 

reasons described in this final rule’s 

Regulatory Impact Analysis, the 

Department concludes that the benefits 

to the public, including families, that 

flow from periodic Assessments and 

Reviews of Regulations far outweigh any 

potential adverse impact on family wellbeing that might result from a regulation 

expiring because the Department did 

not Assess or Review it. The Department 

believes that impacted families benefit 

greatly when a regulatory body 

considers the real-world impacts of its 

regulations, and whether changes in 

technology, the economy, or the legal 

landscape counsel in favor of amending 

or rescinding regulations. It is 

conceivable that a regulation affecting 

the disposable income or poverty of 

families or children could expire. It is 

also possible that the expiration of a 

regulation that the Department does not 

Review could have beneficial impacts 

on family well-being. If, pursuant to this 

final rule, the Department amends or 

rescinds a regulation, it would conduct 

any required assessment of the policy 

on families at the time of such 

rulemaking. 

Paperwork Reduction Act of 1995 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3506; 

5 CFR 1320 Appendix A.1), HHS has 

reviewed this final rule and has 

determined that there are no new 

collections of information contained 

therein. 

List of Subjects 

21 CFR Part 6 

Administrative practice and 

procedure. 

42 CFR Part 1 

Administrative practice and 

procedure. 

42 CFR Part 404 

Administrative practice and 

procedure. 


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Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 5751 

42 CFR Part 1000 

Administrative practice and 

procedure. 

45 CFR Part 8 

Administrative practice and 

procedure. 

45 CFR Part 200 

Administrative practice and 

procedure. 

45 CFR Part 300 

Administrative practice and 

procedure. 

45 CFR Part 403 

Administrative practice and 

procedure. 

45 CFR Part 1010 

Administrative practice and 

procedure. 

45 CFR Part 1390 

Administrative practice and 

procedure. 

For the reasons set forth in the 

preamble, the Department amends 21 

CFR, chapter I, 42 CFR chapters I, IV, 

and V; 45 CFR subtitle A; and 45 CFR 

subtitle B, chapters II, III, IV, X, and 

XIII, as follows: 

Title 21—Food and Drugs 

CHAPTER I—FOOD AND DRUG 

ADMINISTRATION, DEPARTMENT 

OF HEALTH AND HUMAN SERVICES 

■ 1. Add part 6 to read as follows: 

PART 6—REVIEW OF REGULATIONS 

Sec. 

6.1 Retrospective Review of Existing 

Regulations. 

6.2 through 6.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 610; 15 

U.S.C. 402; 15 U.S.C. 409; 15 U.S.C. 1261– 

1276; 15 U.S.C. 1333; 15 U.S.C. 1451–1461; 

15 U.S.C. 4402; 18 U.S.C. 1905; 19 U.S.C. 

1490–1491; 19 U.S.C. 2531–2582; 21 U.S.C. 

41–50; 21 U.S.C. 141–149; 21 U.S.C. 301 et 

seq.; 21 U.S.C. 355 note; 21 U.S.C. 301–397; 

21 U.S.C. 467f; 21 U.S.C. 679; 21 U.S.C. 821; 

21 U.S.C. 1034; 21 U.S.C. 1401–1403; 28 

U.S.C. 2112; 35 U.S.C. 156; 42 U.S.C. 201– 

262; 42 U.S.C. 263a; 42 U.S.C. 263b–263n; 42 

U.S.C. 264; 42 U.S.C. 265; 42 U.S.C. 271; 42 

U.S.C. 300aa–28; 42 U.S.C. 300u–300u–5; 42 

U.S.C. 4321; 42 U.S.C. 4332, 42 U.S.C. 7671 

et seq.; Sec. 121, Pub. L. 105–115, 111 Stat. 

2296; Pub. L. 107–109; Pub. L. 107–188, 116 

Stat. 594, 668–69; Pub. L. 108–155; Secs. 201 

and 202, Pub. L. 111–31, 123 Stat. 1776; Secs. 

901(b) and 906(d), Pub. L. 111–31; Pub. L. 

111–353, 124 Stat. 3885, 3889; Pub. L. 113– 

54. 

§ 6.1 Retrospective Review of Existing 

Regulations. 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this chapter. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 

required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 

(e) If the review concludes the Section 

should be amended or rescinded, the 

Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 


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5752 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(8) 21 CFR parts 131, 133, 135–137, 

139, 145, 146, 150, 152, 155, 156, 158, 

160, 161, 163–166, 168, and 169. 

(9) 21 CFR parts 331–333, 335–336, 

338, 340–341, 343–344, 346–350, 352, 

355, 357, and 358. 

(10) 21 CFR parts 862, 864, 866, 868, 

870, 872, 874, 876, 878, 880, 882, 884, 

886, 888, 890, 892, 895, and 898. 

(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

§§ 6.2 through 6.5 [Reserved]. 

Title 42—Public Health 

CHAPTER I—PUBLIC HEALTH 

SERVICE, DEPARTMENT OF HEALTH 

AND HUMAN SERVICES 

■ 2. Add part 1 to read as follows: 

PART 1—REVIEW OF REGULATIONS 

Sec. 

1.1 Retrospective Review of Existing 

Regulations 

1.2 through 1.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 610, 8 

U.S.C. 1182, 8 U.S.C. 1222, 29 U.S.C. 670(a), 

30 U.S.C. 957, 31 U.S.C. 9701, 42 U.S.C. 216, 

42 U.S.C. 241, 42 U.S.C. 300a-4, 42 U.S.C. 

10801, 42 U.S.C. 1302, 42 U.S.C. 1395hh, 42 

U.S.C. 702(a), 42 U.S.C. 702(b)(1)(A), 42 

U.S.C. 706(a)(3), 42 U.S.C. 243, 42 U.S.C. 

247b, 247c, 42 U.S.C. 247d–6e, 31 U.S.C. 

1243 note, 42 U.S.C. 252, 42 U.S.C. 254c, 42 

U.S.C. 262a, 42 U.S.C. 256b, 42 U.S.C. 263, 

42 U.S.C. 263a, 42 U.S.C. 264–271, 42 U.S.C. 

273–274d; 42 U.S.C. 274e; 42 U.S.C. 

290aa(m), 42 U.S.C. 284g, 42 U.S.C. 285a– 

6(c)(1)(E), 42 U.S.C. 285a–7(c)(1)(G), 42 

U.S.C. 285b–4, 42 U.S.C. 285c–5, 42 U.S.C. 

285c–8, 42 U.S.C. 285d–6, 42 U.S.C. 285e–2, 

42 U.S.C. 285e–3, 42 U.S.C. 285e–10a, 42 

U.S.C. 285f–1, 42 U.S.C. 285g–5, 42 U.S.C. 

285g–7, 42 U.S.C. 285g–9, 42 U.S.C. 285m– 

3, 42 U.S.C. 285o–2, 42 U.S.C. 286a– 

7(c)(1)(G), 42 U.S.C. 287c–32(c), 42 U.S.C. 

288, 42 U.S.C. 289a, 42 U.S.C. 289b, 42 

U.S.C. 290aa, et seq., 42 U.S.C. 290aa(d), 42 

U.S.C. 290aa(m), 42 U.S.C. 290cc–21, et seq., 

42 U.S.C. 290dd–2, 42 U.S.C. 290kk, et seq., 

42 U.S.C. 300 through 300a-6, 42 U.S.C. 

300cc–16, 42 U.S.C. 300mm-300mm-61, 42 

U.S.C. 300x–21, et seq, 42 U.S.C. 7384n, 42 

U.S.C. 7384q, 42 U.S.C. 6939a. 

§ 1.1 Retrospective Review of Existing 

Regulations. 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this chapter. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 


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required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 

(e) If the review concludes the Section 

should be amended or rescinded, the 

Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(8) 42 CFR part 73. 

(9) 42 CFR 100.3. 

(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

§§ 1.2 through 1.5 [Reserved] 

CHAPTER IV—CENTERS FOR 

MEDICARE & MEDICAID SERVICES, 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

■ 3. Add part 404 to subchapter A to 

read as follows: 

PART 404—REVIEW OF 

REGULATIONS 

Sec. 

404.1 Retrospective Review of Existing 

Regulations 

404.2 through 404.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 610; 31 

U.S.C. 9701; 42 U.S.C. 263a; 42 U.S.C. 273; 

42 U.S.C. 300e; 42 U.S.C. 300e–5; 42 U.S.C. 

300e–9; 42 U.S.C. 405(a), 42 U.S.C. 1302; 42 

U.S.C. 1306; 42 U.S.C. 1315a; 42 U.S.C. 

1320a–7; 42 U.S.C. 1320a–7j; 42 U.S.C. 

1320b–8; 42 U.S.C. 1320b–12; 42 U.S.C. 

1395; 42 U.S.C. 1395aa(m); 42 U.S.C. 1395cc; 

42 U.S.C. 1395d(d); 42 U.S.C. 1395ddd; 42 

U.S.C. 1395eee(f); 42 U.S.C. 1395f(b); 42 

U.S.C. 1395ff; 42 U.S.C. 1395g; 42 U.S.C. 

1395hh; 42 U.S.C. 1395i; 42 U.S.C. 1395i–3; 

42 U.S.C. 1395l(a), (i), (n), and (t); 42 U.S.C. 

1395jjj; 42 U.S.C. 1395kk; 42 U.S.C. 1395m; 

42 U.S.C. 1395nn; 42 U.S.C. 1395rr; 42 U.S.C. 

1395rr(b)(l); 42 U.S.C. 1395tt; 42 U.S.C. 

1395w–5; 42 U.S.C. 1395w–101 through 

1395w–152; 42 U.S.C. 1395ww; 42 U.S.C. 

1395ww(k); 42 U.S.C. 1395x; 1395x(e), the 

sentence following 1395x(s)(11) through 

1395x(s)(16)); 42 U.S.C. 1395x(v); 42 U.S.C. 

1395y(a); 42 U.S.C. 1396r; 42 U.S.C. 1396r– 

8; 42 U.S.C. 1396u–4(f); 44 U.S.C. Chapter 35; 

Section 1331 of the Patient Protection and 

Affordable Care Act of 2010 (Pub. L. 111– 


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148, 124 Stat. 119), as amended by the Health 

Care and Education Reconciliation Act of 

2010 (Pub. L. 111–152, 124 Stat 1029); Pub. 

L. 112–202 amendments to 42 U.S.C. 263a; 

sec. 105, Pub. L. 114–10, 129 Stat. 87. 

§ 404.1 Retrospective Review of Existing 

Regulations. 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this chapter. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 

required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 

(e) If the review concludes the Section 

should be amended or rescinded, the 

Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(8) The annual Medicare payment 

update rules. 


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(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

§§ 404.2 through 404.5 [Reserved] 

CHAPTER V—OFFICE OF INSPECTOR 

GENERAL—HEALTH CARE, 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

■ 4. Add subpart A to part 1000 to read 

as follows: 

PART 1000—Introduction, General 

Definitions 

Subpart A—Review of regulations 

Sec. 

1000.1 Retrospective Review of Existing 

Regulations 

1000.2 through 1000.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 610; 31 

U.S.C. 6101 note; 42 U.S.C. 262a; 42 U.S.C. 

405(a); 42 U.S.C. 405(b); 42 U.S.C. 405(d); 42 

U.S.C. 405(e); 42 U.S.C. 1302; 42 U.S.C.1320; 

42 U.S.C. 1320a–7d(b); 1320b–10; 42 U.S.C. 

1320c–5; 42 U.S.C. 1395cc(b)(2)(D), (E), and 

(F); 42 U.S.C. 1395cc(j); 42 U.S.C. 

1395dd(d)(1); 42 U.S.C. 1395hh; 42 U.S.C. 

1395mm; 42 U.S.C. 1395nn(g); 42 U.S.C. 

1395ss(d); 42 U.S.C. 1395u(j); 42 U.S.C. 

1395u(k); 42 U.S.C. 1395w–104(e)(6); 42 

U.S.C. 1395w–141(i)(3); 42 U.S.C. 1395y(d); 

42 U.S.C. 1395y(e); 42 U.S.C. 1396(a)(4)(A); 

42 U.S.C. 1396a(p); 42 U.S.C. 1396a(a)(39); 42 

U.S.C. 1396a(a)(41); 42 U.S.C. 1396a(a)(61); 

42 U.S.C. 1396b(a)(6); 42 U.S.C. 1396b(b)(3); 

42 U.S.C. 1396b(i)(2); 42 U.S.C. 1396b(m); 42 

U.S.C. 1396b(q); 42 U.S.C. 1842(j)(1)(D)(iv); 

42 U.S.C. 1842(k)(1); 42 U.S.C. 11131(c); 42 

U.S.C. 11137(b)(2). 

§ 1000.1 Retrospective Review of Existing 

Regulations. 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this chapter. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 

required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 

(e) If the review concludes the Section 

should be amended or rescinded, the 


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Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(8) 42 CFR 1001.952. 

(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

§§ 1000.2 through 1000.5 [Reserved] 

Title 45—Public Welfare 

Subtitle A—Department of Health and 

Human Services 

■ 5. Add part 8 to read as follows: 

PART 8—REVIEW OF REGULATIONS 

Sec. 

8.1 Retrospective Review of Existing 

Regulations 

8.2 through 8.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 504(c)(1); 

5 U.S.C. 552; 5 U.S.C. 552a; 5 U.S.C. 553; 5 

U.S.C. 5514; 5 U.S.C. 7301; 8 U.S.C. 1182(e)); 

8 U.S.C. 1182(j)(2)(A); 18 U.S.C. 207(j); 18 

U.S.C. 1905; 20 U.S.C. 91; 20 U.S.C. 1405; 20 

U.S.C. 1681 et seq.; 20 U.S.C. 1681 through 

1688; 21 U.S.C. 1174; 22 U.S.C. 2151b(f) (e.g., 

Pub. L. 116–6, Div. F, sec. 7018); 22 U.S.C. 

2451 et seq.; 22 U.S.C. 7631(d); 22 U.S.C. 

7631(f); 26 U.S.C. 36B; 26 U.S.C. 5000A(d)(2); 

28 U.S.C. 2672; 29 U.S.C. 669(a)(5); 29 U.S.C. 

794; 31 U.S.C. 1243 note; 31 U.S.C. 1352; 31 

U.S.C. 3711(d); 31 U.S.C. 3720A; 31 U.S.C. 

3720D; 31 U.S.C. 3721; 31 U.S.C. 3801–3812; 

31 U.S.C. 6506; 31 U.S.C. 7501–7507; 31 

U.S.C. 9701; 40 U.S.C. 121(c); 40 U.S.C. 318– 

318d; 40 U.S.C. 484; 40 U.S.C. 484(k); 40 

U.S.C. 486; 42 U.S.C. 216; 42 U.S.C. 216(b); 

42 U.S.C. 238n; 42 U.S.C. 263a(f)(1)(E); 42 

U.S.C. 280g–1(d); 42 U.S.C. 289(a); 42 U.S.C. 

289b–1; 42 U.S.C. 290bb–36(f); 42 U.S.C. 

290dd–2; 42 U.S.C. 299c–4; 42 U.S.C. 300a– 

7; 42 U.S.C. 300aa–11; 42 U.S.C. 300gg 

through 300gg–63; 42 U.S.C. 300gg–1 through 

300gg–5; 42 U.S.C. 300gg–11 through 300gg– 

23; 42 U.S.C. 300gg–18; 42 U.S.C. 300gg–91; 

42 U.S.C. 300gg–92; 42 U.S.C. 300gg–94; 42 

U.S.C. 300jj–11; 42 U.S.C 300jj–14; 42 U.S.C. 

300jj–52; 42 U.S.C. 300w et seq.; 42 U.S.C. 

300x et seq.; 42 U.S.C. 300y et seq.; 42 U.S.C. 

618; 42 U.S.C. 622(b); 42 U.S.C. 629b(a); 42 

U.S.C. 652(a); 42 U.S.C. 652(d); 42 U.S.C. 

654A; 42 U.S.C. 671(a); 42 U.S.C. 701 et seq.; 

42 U.S.C. 1302; 42 U.S.C. 1302(a); 42 U.S.C. 

1306(c); 42 U.S.C. 1310; 42 U.S.C. 1315; 42 

U.S.C. 1315a; 42 U.S.C. 1320a–1; 42 U.S.C. 

1320a–7e; 42 U.S.C. 1320c–11; 42 U.S.C. 

1395cc(f); 42 U.S.C. 1320d–2 (note); 42 

U.S.C. 1320d–1320d–9; 42 U.S.C. 1395i–3; 42 

U.S.C. 1395i–5; 42 U.S.C. 1395w–22(j)(3)(B); 

42 U.S.C. 1395w–26; 42 U.S.C. 1395w–27; 42 

U.S.C. 1395x; 42 U.S.C. 1396a; 42 U.S.C. 

1396a(a); 42 U.S.C. 1396a(w)(3); 42 U.S.C. 

1396f; 42 U.S.C. 1396r; 42 U.S.C. 1396r–2; 42 

U.S.C. 1396s(c)(2)(B)(ii); 42 U.S.C. 1396u– 

2(b)(3)(B); 42 U.S.C. 1397 et seq.; 42 U.S.C. 

1397j–1(b); 42 U.S.C. 2000d et seq.; 42 U.S.C. 

2000d–1; 42 U.S.C. 2942; 42 U.S.C. 3334; 42 

U.S.C. 3505; 42 U.S.C. 3535(d); 42 U.S.C. 

5106i(a); 42 U.S.C. 6101 et seq.; 42 U.S.C. 

8621 et seq.; 42 U.S.C. 9858; 42 U.S.C. 9901 

et seq.; 42 U.S.C. 11101–11152; 42 U.S.C. 

11411; 42 U.S.C. 14406; 42 U.S.C. 18021– 

18024; 42 U.S.C. 18031–18033; 42 U.S.C. 

18041(a); 42 U.S.C. 18041–18042; 42 U.S.C. 

18044; 42 U.S.C. 18051; 42 U.S.C. 18054; 42 

U.S.C. 18061 through 18063; 42 U.S.C. 

18071; 42 U.S.C. 18081–18083; 42 U.S.C. 

18113; 42 U.S.C. 18116; 48 U.S.C. 1469a; 50 

U.S.C. App. 2061–2171; 27 Stat. 395; Sec. 

1(a), 80 Stat. 306; secs. 1, 5, 6, and 7 of 

Reorganization Plan No. 1 of 1953, 18 FR 

2053, 67 Stat. 631 and authorities cited in the 

Appendix; Sec. 203, 63 Stat. 385; Section 

213, Uniform Relocation Assistance and Real 

Property Acquisition Policies Act of 1970, 

Pub. L. 91–646, 84 Stat. 1894 (42 U.S.C. 

4633) as amended by the Surface 

Transportation and Uniform Relocation 

Assistance Act of 1987, Title IV of Pub. L. 

100–17, 101 Stat. 246–256 (42 U.S.C. 4601 

note); Sec. 223, 58 Stat. 683, as amended by 

81 Stat. 539: 42 U.S.C. 217b; Sec. 602, 78 

Stat. 252; Sec. 501 of Pub. L. 100–77, 101 

Stat. 509–10, 42 U.S.C 11411; Pub. L. 100– 

259, 102 Stat. 28 (Mar. 22, 1988); 5 U.S.C. 

301, Pub. L. 100–259, 102 Stat. 28 (Mar. 22 

1988); Public Law 101–410, Sec. 701 of 

Public Law 114–74, 31 U.S.C. 3801–3812; 

Section 5301 of Pub. L. 100–690, the Anti– 

Drug Abuse Act of 1988, 102 Stat. 4310, 21 

U.S.C. 853a; secs. 13400–13424, Pub. L. 111– 

5, 123 Stat. 258–279; Sec. 1101 of the Patient 

Protection and Affordable Care Act (Pub. L. 

111–148); Section 1103 of the Patient 

Protection and Affordable Care Act (Pub. L. 

111–148); secs. 1104 and 10109 of Pub. L. 

111–148, 124 Stat. 146–154 and 915–917; 

Title I of the Affordable Care Act, Sections 

1311, 1312, 1411, 1412, Pub. L. 111–148, 124 

Stat. 119; Medicare Advantage (e.g., Pub. L. 

115–245, Div. B, sec. 209); the Weldon 

Amendment (e.g., Pub. L. 115–245, Div. B, 

sec. 507(d)); 5 U.S.C. 610. 

§ 8.1 Retrospective Review of Existing 

Regulations. 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this subtitle. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 


khammond on DSKJM1Z7X2PROD with RULES7
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consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 

required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 

(e) If the review concludes the Section 

should be amended or rescinded, the 

Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(8) The annual Notice of Benefit and 

Payment Parameters update rules. 

(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 


khammond on DSKJM1Z7X2PROD with RULES7
5758 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

§ 8.2 through 8.5 [Reserved] 

Subtitle B—Regulations Relating to 

Public Welfare 

CHAPTER II—OFFICE OF FAMILY 

ASSISTANCE (ASSISTANCE 

PROGRAMS), ADMINISTRATION FOR 

CHILDREN AND FAMILIES, 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

■ 6. Add part 200 to read as follows: 

PART 200—REVIEW OF 

REGULATIONS 

Sec. 

200.1 Retrospective Review of Existing 

Regulations 

200.2 through 200.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 610; 24 

U.S.C. 321–329; 31 U.S.C. 7501 et seq.; 42 

U.S.C. 301; 42 U.S.C. 303; 42 U.S.C. 601; 42 

U.S.C. 601 note; 42 U.S.C. 602; 42 U.S.C. 602 

(note); 42 U.S.C. 602(a)(44); 42 U.S.C. 603; 42 

U.S.C. 603(a)(4); 42 U.S.C. 604; 42 U.S.C. 

605; 42 U.S.C. 606; 42 U.S.C. 607; 42 U.S.C. 

608; 42 U.S.C. 609; 42 U.S.C. 610; 42 U.S.C. 

611; 42 U.S.C. 612; 42 U.S.C. 613; 42 U.S.C. 

613(i); 42 U.S.C. 616; 42 U.S.C. 619; 42 

U.S.C. 654; 42 U.S.C. 862a; 42 U.S.C. 1202; 

42 U.S.C. 1203; 42 U.S.C. 1301; 42 U.S.C. 

1302; 42 U.S.C. 1306(a); 42 U.S.C. 1308; 42 

U.S.C. 1313; 42 U.S.C. 1316; 1320b–7: 42 

U.S.C. 1973gg–5; 42 U.S.C. 1337; 42 U.S.C. 

1352; 42 U.S.C. 1353; 42 U.S.C. 1382 (note); 

42 U.S.C. 1383 (note); sections 1, 5, 6, and 

7 of Reorganization Plan No. 1 of 1953, 67 

Stat. 631; Secs. 1–11, 74 Stat. 308–310; Sec. 

302, 75 Stat. 142, sec. 1102, 49 Stat. 647; sec. 

6 of Pub. L. 94–114, 89 Stat. 579; Pub. L. No. 

97–248, 96 Stat. 324, and Pub. L. No. 99–603, 

100 Stat. 3359; sec. 4 of Pub. L. 97–458, 96 

Stat. 2513; sec. 2 of Pub. L. 98–64, 97 Stat. 

365; sec. 1883 of Pub. L. 99–514, 100 Stat. 

2916; sec. 15 of Pub. L. 100–241, 101 Stat. 

1812; sec. 105(f) of Pub. L. 100–383, 102 Stat. 

908; sec. 206(d) of Pub. L. 100–383, 102 Stat. 

914; sec. 105(i) of Pub. L. 100–707, 102 Stat. 

4693; sec. 1(a) of Pub. L. 101–201, 103 Stat. 

1795; sec. 10405 of Pub. L. 101–239, 103 Stat. 

2489; sec. 501(c) of Pub. L. 101–392, 104 Stat. 

831; sec. 6(h)(2) of Pub. L. 101–426, 104 Stat. 

925; and sec. 471(a) of Pub. L. 102–325, 106 

Stat. 606; Sec. 7102, Pub. L. 109–171, 120 

Stat. 135; Public Law 111–5; Sec. 4004, Pub. 

L. 112–96, 126 Stat. 197; 49 Stat. 647. 

§ 200.1 Retrospective Review of Existing 

Regulations. 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this chapter. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 

required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 


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(e) If the review concludes the Section 

should be amended or rescinded, the 

Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting.The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

§ 200.2 through 200.5 [Reserved] 

CHAPTER III—OFFICE OF CHILD 

SUPPORT ENFORCEMENT (CHILD 

SUPPORT ENFORCEMENT 

PROGRAM), ADMINISTRATION FOR 

CHILDREN AND FAMILIES, 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

■ 7. Add part 300 to read as follows: 

PART 300—REVIEW OF 

REGULATIONS 

Sec. 

300.1 Retrospective Review of Existing 

Regulations 

300.2 through 300.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 610; 25 

U.S.C. 1603(12); 25 U.S.C. 1621e; 42 U.S.C. 

609(a)(8); 42 U.S.C. 651 through 658; 42 

U.S.C. 652(a)(4) and (g); 42 U.S.C. 654(15)(A); 

42 U.S.C. 655(f); 42 U.S.C. 658a; 42 U.S.C. 

659a; 42 U.S.C. 660; 42 U.S.C. 663; 42 U.S.C. 

664; 42 U.S.C. 666 through 669A; 42 U.S.C. 

1301; 42 U.S.C. 1302; 42 U.S.C. 1396a(a)(25); 

42 U.S.C. 1396b(d)(2); 42 U.S.C. 1396b(o); 42 

U.S.C. 1396b(p); 42 U.S.C. 1396(k). 

§ 300.1 Retrospective Review of Existing 

Regulations. 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this chapter. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 

required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 


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5760 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 

(e) If the review concludes the Section 

should be amended or rescinded, the 

Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

§ 300.2 through 300.5 [Reserved] 

CHAPTER IV—OFFICE OF REFUGEE 

RESETTLEMENT, ADMINISTRATION 

FOR CHILDREN AND FAMILIES 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

■ 8. Add part 403 to read as follows: 

PART 403—REVIEW OF 

REGULATIONS 

Sec. 

403.1 Retrospective Review of Existing 

Regulations 

403.2 through 403.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 610; 6 

U.S.C. 279; 8 U.S.C. 1103(a)(3); 8 U.S.C. 

1232; 8 U.S.C. 1255a note; 8 U.S.C. 1522 

note; 8 U.S.C. 1522(a)(9); 42 U.S.C. 15607(d). 

§ 403.1 Retrospective Review of Existing 

Regulations. 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this chapter. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 


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Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 5761 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 

required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 

(e) If the review concludes the Section 

should be amended or rescinded, the 

Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 


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5762 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

§ 403.2 through 403.5 [Reserved] 

CHAPTER X—OFFICE OF COMMUNITY 

SERVICES, ADMINISTRATION FOR 

CHILDREN AND FAMILIES, 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

■ 9. Add part 1010 to read as follows: 

PART 1010—REVIEW OF 

REGULATIONS 

Sec. 

1010.1 Retrospective Review of Existing 

Regulations 

1010.2 through 1010.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 610; 42 

U.S.C. 604 nt.; 42 U.S.C. 9901 et seq.; 42 

U.S.C. 11302 (101 Stat. 485); 42 U.S.C. 

11461–11464; 42 U.S.C. 11472 (101 Stat. 

532–533). 

§ 1010.1 Retrospective Review of Existing 

Regulations 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this chapter. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 

required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 

(e) If the review concludes the Section 

should be amended or rescinded, the 

Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 


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Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 5763 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

§ 1010.2 through 1010.5 [Reserved] 

CHAPTER XIII—ADMINISTRATION FOR 

CHILDREN AND FAMILIES, 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

■ 10. Add subchapter A to read as 

follows: 

SUBCHAPTER A—[include your 

preferred subchapter heading] 

PART 1300—REVIEW OF 

REGULATIONS 

Sec. 

1300.1 Retrospective Review of Existing 

Regulations. 

1300.2 through 1390.5 [Reserved] 

Authority: 5 U.S.C. 301; 5 U.S.C. 610; 29 

U.S.C. 709; 29 U.S.C. 3343; 42 U.S.C. 620 et 

seq., 42 U.S.C. 670 et seq.; 42 U.S.C. 1302; 

42 U.S.C. 1395b–4; 42 U.S.C. 2991, et seq.; 

42 U.S.C. 3001 et seq.; Title III of the Older 

Americans Act; 42 U.S.C. 3001; Title VI, Part 

A of the Older Americans Act; 42 U.S.C. 

3001; Title VI Part B of the Older Americans 

Act; 42 U.S.C. 3515e; 42 U.S.C. 5701; 42 

U.S.C. 9801 et seq.; 42 U.S.C. 10401 et seq.; 

42 U.S.C. 15001 et seq. 

§ 1300.1 Retrospective Review of Existing 

Regulations. 

(a) This section applies to and shall be 

deemed to amend all regulations issued 

by the Secretary or his delegates or subdelegates in this chapter. 

(b) For purposes of this section, 

(1) Assess shall refer to a 

determination by the Department, in 

consultation with other Federal agencies 

as appropriate, as to whether the 

Sections issued as part of the same 

rulemaking (and any amendments or 

additions that may have been added 

thereafter) currently have a significant 

economic impact upon a substantial 

number of small entities. 

(2) Review shall refer to a process 

conducted by the Department, in 

consultation with other Federal agencies 

as appropriate, the purpose of which 

shall be to determine whether Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter) should be continued without 

change, or should be amended or 

rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities. 

(3) Section (when capitalized) shall 

mean a section of the Code of Federal 

Regulations. For example, 42 CFR 2.13 

is a Section, and 42 CFR 2.14 is another 

Section (see 1 CFR 21.11). 

(4) Year of the Section’s promulgation 

shall mean the year the Section first 

became effective, irrespective of 

whether it was subsequently amended. 

(5) Significant economic impact upon 

a substantial number of small entities 

shall have the meaning of that term in 

section 610 of title 5 of the United States 

Code. 

(c)(1) Unless a Section expires earlier 

or is rescinded, all Sections issued by 

the Secretary or his delegates or subdelegates in this chapter shall expire at 

the end of: 

(i) Five calendar years after the year 

that this section first becomes effective; 

(ii) Ten calendar years after the year 

of the Section’s promulgation; or 

(iii) Ten calendar years after the last 

year in which the Department assessed 

and (if review of the Section is required 

pursuant to paragraph (d) of this 

section) reviewed the Section, 

whichever is latest. 

(2) The last year in which the 

Department assessed and (if review of 

the Section is required) reviewed the 

Section shall be the year during which 

the findings of the assessment and (if 

required) the review of a Section are 

published in the Federal Register 

pursuant to paragraph (f) of this section. 

(3)(i) If, prior to the expiration of a 

Section under paragraph (c)(1) of this 

section, the Secretary makes a written 

determination that the public interest 

requires continuation of the Section in 

force beyond the date on which the 

Section would otherwise expire under 

paragraph (c)(1), the Secretary may 

continue the Section in force one time 

for a period stated in the determination, 

which shall not exceed one calendar 

year. 

(ii) The Department shall promptly 

publish in the Federal Register any 

written determination under paragraph 

(c)(3)(i) of this section. 

(iii) The authority of the Secretary 

under paragraph (c)(3)(i) of this section 

is not delegable and may be exercised 

only by the Secretary or, when the office 

of the Secretary is vacant or the 

Secretary has become unable to perform 

the functions and duties of the office of 

the Secretary, by the individual acting 

as Secretary in accordance with the law. 

(d) The Department is required to 

review those rulemakings (and any 

amendments or additions that may have 

been added thereafter) that the 

Department assesses have a significant 

economic impact upon a substantial 

number of small entities. In reviewing 

rulemakings to minimize any significant 

economic impact on a substantial 

number of small entities in a manner 

consistent with the stated objectives of 

applicable statutes, the Department’s 

review shall consider the following 

factors: 

(1) The continued need for the 

rulemaking, consideration of which 

shall include but not be limited to the 

extent to which the rulemaking defines 

terms or sets standards used in or 

otherwise applicable to other Federal 

rules; 

(2) The nature of complaints or 

comments received concerning the 

rulemaking from the public; 

(3) The complexity of the rulemaking; 

(4) The extent to which the 

rulemaking overlaps, duplicates or 

conflicts with other Federal rules, and, 

to the extent feasible, with State and 

local governmental rules; 

(5) The degree to which technology, 

economic conditions, or other factors 

have changed in the area affected by the 

rulemaking since the rulemaking was 


khammond on DSKJM1Z7X2PROD with RULES7
5764 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

promulgated or the last time the 

rulemaking was reviewed by the 

Department; and 

(6) Whether the rulemaking complies 

with applicable law. 

(e) If the review concludes the Section 

should be amended or rescinded, the 

Department shall have two years from 

the date that the findings of the review 

are published in the Federal Register 

pursuant to paragraph (f) of this section 

to amend or rescind the Section. If the 

Secretary determines that completion of 

the amendment or rescission is not 

feasible by the established date, he shall 

so certify in a statement published in 

the Federal Register and may extend the 

completion date by one year at a time, 

no more than three times, for a total of 

not more than five years (inclusive of 

the initial two-year period). 

(f) The results of all assessments and 

reviews conducted in a calendar year, 

including the full underlying analyses 

and data used to support the results 

(subject to any applicable privilege, 

protections for confidential business 

information, or explicit legal prohibition 

on disclosure), shall be published in a 

single document in the Federal Register 

during that calendar year. The 

document shall be organized in a 

manner that enables both the 

Department and the public to readily 

determine which assessments and 

reviews were conducted during that 

calendar year. The document shall also 

specify the year by which the next 

assessment (and, if required, the next 

review) of the Section shall be 

completed. 

(g) Paragraph (c) of this section shall 

not apply to: 

(1) Sections that are prescribed by 

Federal law, such that the Department 

exercises no discretion as to whether to 

promulgate the Section and as to what 

is prescribed by the Section. For 

Sections described in this paragraph 

(g)(1) that are adopted after the effective 

date of this section, the Federal law 

described in this paragraph (g)(1) shall 

be cited in the notice of adoption. 

(2) Sections whose expiration 

pursuant to this section would violate 

any other Federal law. 

(3) This section. 

(4) Sections that involve a military or 

foreign affairs function of the United 

States. 

(5) Sections addressed solely to 

internal agency management or 

personnel matters. 

(6) Sections related solely to Federal 

Government procurement. 

(7) Sections that were issued jointly 

with other Federal agencies, or that 

were issued in consultation with other 

agencies because of a legal requirement 

to consult with that other agency. 

(h) When the Department commences 

the process of performing an assessment 

or review, it shall state on a Departmentmanaged website the Section(s) whose 

assessment or review it is commencing. 

It shall also announce once a month in 

the Federal Register those new 

assessments or reviews that it has 

commenced in the last month. The 

Department will create a docket on 

Regulations.gov for each assessment or 

review that the Department is 

conducting. The public will be able to 

submit comments to the dockets of each 

rulemaking being assessed or reviewed. 

Each docket shall specify the date by 

which comments must be received. 

There shall also be a general docket on 

Regulations.gov where the public can 

submit comments requesting that the 

Department assess or review a Section. 

(i) Any provision of this section held 

to be invalid or unenforceable by its 

terms, or as applied to any person or 

circumstance, shall be construed so as 

to continue to give the maximum effect 

to the provision permitted by law, 

unless such holding shall be one of utter 

invalidity or unenforceability, in which 

event the provision shall be severable 

from this section and shall not affect the 

remainder thereof or the application of 

the provision to persons not similarly 

situated or to dissimilar circumstances. 

§ 1300.2 through 1300.5 [Reserved] 

Dated: January 8, 2021. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–00597 Filed 1–15–21; 8:45 am] 

BILLING CODE 4150–26–P 


khammond on DSKJM1Z7X2PROD with RULES7