32246 Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Rules and Regulations 

1The terms ‘‘Section,’’ ‘‘Assess,’’ and ‘‘Review’’ 

were capitalized in the preamble to the SUNSET 

final rule where those terms have the definitions 

ascribed to them in the text of that final rule. For 

ease of readability, these terms are not capitalized 

in the following discussion of this withdrawal final 

rule unless directly quoting or paraphrasing the 

SUNSET 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 

1300 

[Docket No. HHS–OS–2020–0012] 

RIN 0991–AC24 

Withdrawing Rule on Securing 

Updated and Necessary Statutory 

Evaluations Timely 

AGENCY: Department of Health and 

Human Services. 

ACTION: Final rule; withdrawal. 

SUMMARY: The Department of Health and 

Human Services (HHS or Department) is 

issuing a final rule withdrawing a rule 

entitled ‘‘Securing Updated and 

Necessary Statutory Evaluations 

Timely’’ (SUNSET final rule), which 

published in the Federal Register of 

January 19, 2021. The SUNSET final 

rule was originally scheduled to take 

effect on March 22, 2021. However, after 

a lawsuit was filed on March 9, 2021, 

seeking to overturn the SUNSET final 

rule, HHS extended the effective date of 

the SUNSET final rule until September 

22, 2022. HHS is now withdrawing the 

SUNSET final rule. 

DATES: As of July 26, 2022, the final rule 

published on January 19, 2021 (86 FR 

5694), which was delayed on March 23, 

2021 (86 FR 15404), and March 4, 2022 

(87 FR 12399), is withdrawn. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to https://

www.regulations.gov and insert the 

docket number found in brackets in the 

heading of this final rule into the 

‘‘Search’’ box and follow the prompts. 

FOR FURTHER INFORMATION CONTACT: 

Daniel J. Barry, Acting General Counsel, 

200 Independence Avenue SW, 

Washington, DC 20201; or by email at 

SunsetRepeal@hhs.gov; or by telephone 

at 1–877–696–6775. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Final Withdrawal Rule 

B. Summary of Major Provisions 

C. Legal Authority 

D. Costs and Benefits 

II. Table of Abbreviations/Commonly Used 

Acronyms in This Document 

III. Background 

A. History of the SUNSET Rulemaking 

B. The Department’s Review 

IV. Legal Authority 

V. Analysis of and Responses to Public 

Comments on the Withdrawal NPRM 

A. Comments on Implementation Burdens 

on the Department and Stakeholders 

B. Comments on Potential Harms From the 

Possible and Actual Expiration of 

Regulations 

C. Comments on the Regulatory Flexibility 

Act and Retrospective Review 

D. Other Legal Comments 

E. Comments on Vague and Confusing 

Provisions 

VI. Final Regulatory Impact Analysis 

A. Introduction, Summary, and 

Background 

B. Market Failure or Social Purpose 

Requiring Federal Regulatory Action 

C. Purpose of the Final Withdrawal Rule 

D. Baseline Conditions 

E. Benefits of the Final Withdrawal Rule 

F. Costs of the Final Withdrawal Rule 

G. Analysis of Regulatory Alternatives to 

the Final Withdrawal Rule 

H. Final Small Entity Analysis 

VII. Federalism 

VIII. Consultation and Coordination With 

Indian Tribal Governments 

IX. Analysis of Environmental Impact 

X. Paperwork Reduction Act 

XI. References 

I. Executive Summary 

A. Purpose of the Final Withdrawal Rule 

HHS issued the SUNSET final rule on 

January 19, 2021. 86 FR 5694. The 

SUNSET final rule provides, among 

other things, that all regulations, subject 

to certain exceptions, issued by the 

Secretary of the Department of Health 

and Human Services (Secretary) or his 

delegates or sub-delegates shall expire at 

the end of (1) five calendar years after 

the year that the SUNSET final rule first 

becomes effective, (2) ten calendar years 

after the year of the regulation’s 

promulgation, or (3) ten calendar years 

after the last year in which the 

Department ‘‘Assessed’’ and, if required, 

‘‘Reviewed’’ the regulation, whichever 

is latest.1 The SUNSET final rule was 

scheduled to take effect on March 22, 

2021. However, after a lawsuit seeking 

to overturn the SUNSET final rule was 

filed on March 9, 2021, HHS issued an 

Administrative Delay of Effective Date, 

effective as of March 19, 2021, which 

postponed the effective date of the 

SUNSET final rule, pending judicial 

review, until March 22, 2022 

(Administrative Delay). 86 FR 15404 

(Mar. 23, 2021). HHS subsequently 

extended the effective date of the 

SUNSET final rule until September 22, 

2022. 87 FR 12399 (Mar. 4, 2022). 

The Department undertook to 

reexamine the SUNSET final rule in 

light of the allegations in the lawsuit, 

the many substantive comments 

submitted on the SUNSET proposed 

rule, and the different policy views held 

by the Biden-Harris Administration as 

compared to the previous 

administration which issued the 

SUNSET final rule. That review 

considered the processes followed in 

issuing the SUNSET final rule, its policy 

goals and objectives, the projected 

effects and analysis of impacts in its 

implementation, and the legal 

evaluation of and support for its 

provisions, including whether the rule 

is consistent with HHS statutory 

obligations and its mission to promote 

and protect the public health. Based on 

that reevaluation, HHS published a 

notice of proposed rulemaking to 

withdraw or repeal the SUNSET final 

rule (Withdrawal NPRM). 86 FR 59906 

(Oct. 29, 2021). 

HHS has reviewed the comments on 

the Withdrawal NPRM and now issues 

this final rule to withdraw the SUNSET 

final rule in its entirety. 

B. Summary of Major Provisions 

We are withdrawing the SUNSET 

final rule in its entirety. 

C. Legal Authority 

The primary statutory authorities 

supporting this rulemaking are the 

general rulemaking authorities for the 

various substantive areas under the 

Department’s umbrella, as well as a 

general authorization for agencies to 

issue regulations regarding the 

administrative processes to be followed 

by that agency. These provisions 

include: 21 U.S.C. 371(a); 42 U.S.C. 216; 

42 U.S.C. 1302; 42 U.S.C. 1395hh; 42 

U.S.C. 2003; and 5 U.S.C. 301. 


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2The initial draft of the RIA for the SUNSET final 

rule was prepared by an outside economist. See 86 

FR 5737 n. 210. As far as the Department is 

currently aware, no Department economist 

participated in considering, drafting, or revising the 

economic evaluation of the SUNSET proposed or 

final rule. These deviations from usual practice in 

developing the original SUNSET rule may help 

explain why our current RIA differs so greatly from 

the previous RIA. 

We also note that the Department, in developing 

the original SUNSET rule, did not follow other 

routine internal review procedures, such as 

distributing the draft proposed and final rules to the 

relevant HHS agencies to solicit their review, 

comments, and concurrences. These irregularities 

may have also contributed to the flawed execution 

and analysis in the original SUNSET rule. 

D. Costs and Benefits 

This regulatory action will reduce the 

time spent by the Department 

performing retrospective assessments 

and reviews of its regulations that 

would have been required by the 

SUNSET final rule, and time spent by 

regulated entities and other 

stakeholders, including the general 

public, small and large businesses, nongovernmental organizations, Tribes and 

state and local governments, on 

comments related to these assessments 

and reviews. The impact of the 

withdrawal is analyzed in the final 

Regulatory Impact Analysis (RIA) for 

this final rule. See Section VI below. In 

that section, we monetize the likely 

reductions in time spent by the 

Department and the general public as 

cost savings. Our primary estimate of 

these cost savings in 2020 dollars, 

annualized over 10 years, using a 3% 

discount rate, totals $69.9 million. 

Using a 7% discount rate, we estimate 

$75.5 million in annualized cost 

savings. Table 1 in Section VI reports 

these primary estimates alongside a 

range of estimates that capture 

uncertainty in the amount of time it 

would have taken the Department to 

perform each regulatory assessment and 

review, and uncertainty in the amount 

of time the public would have spent on 

comments. 

II. Table of Abbreviations/Commonly 

Used Acronyms in This Document 

As used in this preamble, the 

following terms and abbreviations have 

the meanings noted below. 

Term Meaning 

ACA .......................................................................................... Affordable Care Act. 

ACF .......................................................................................... Administration for Children and Families. 

AI/ANs ...................................................................................... American Indian and Alaska Native people. 

AI .............................................................................................. Artificial intelligence. 

APA .......................................................................................... Administrative Procedure Act. 

CDC .......................................................................................... Centers for Disease Control and Prevention. 

CFR .......................................................................................... Code of Federal Regulations. 

CHIP ......................................................................................... Children’s Health Insurance Program. 

CMS .......................................................................................... Centers for Medicare & Medicaid Services. 

COVID–19 ................................................................................ Coronavirus Disease 2019. 

E.O. .......................................................................................... Executive Order. 

FD&C Act ................................................................................. Federal Food, Drug, and Cosmetic Act. 

FDA .......................................................................................... Food and Drug Administration. 

FSMA ........................................................................................ FDA Food Safety Modernization Act. 

HHS or Department .................................................................. U.S. Department of Health and Human Services. 

IHS ............................................................................................ Indian Health Service. 

OCR .......................................................................................... Office for Civil Rights. 

OIRA ......................................................................................... Office of Information and Regulatory Affairs. 

PDV .......................................................................................... Present Daily Value. 

PHS Act .................................................................................... Public Health Service Act. 

RFA .......................................................................................... Regulatory Flexibility Act. 

RIA ............................................................................................ Regulatory Impact Analysis. 

SAMHSA .................................................................................. Substance Abuse and Mental Health Services Administration. 

SBA .......................................................................................... Small Business Administration. 

SEISNOSE ............................................................................... Significant Economic Impact Upon a Substantial Number of Small Entities. 

SECG ....................................................................................... Small Entity Compliance Guide. 

SSA .......................................................................................... Social Security Act. 

SUNSET ................................................................................... Securing Updated and Necessary Statutory Evaluations Timely. 

Unified Agenda ......................................................................... Unified Agenda of Regulatory and Deregulatory Actions. 

III. Background 

The SUNSET final rule, if 

implemented, would have significantly 

altered the operations of HHS with 

considerable negative repercussions for 

a diverse array of stakeholders. We now 

conclude that these significant 

repercussions were not adequately 

considered in issuing the SUNSET final 

rule in part because the process to 

promulgate the rule was extremely 

unusual, if not unprecedented. We note 

a few of the key considerations here. 

The SUNSET final rule is expansive 

in scope and impact, faced considerable 

opposition from stakeholders (and very 

little support), and lacked a public 

health or welfare rationale for 

expediting rulemaking. In contrast to 

the Department’s historical approach to 

rulemaking in these circumstances, HHS 

completed the rulemaking—from the 

publication of the proposal to 

publication of the final rule—in less 

than three months. In issuing the 

Withdrawal NPRM, we explained that, 

given the lack of a public health or 

welfare reason to expedite the 

rulemaking and other procedural 

shortcomings, we were reconsidering 

the commenters’ significant objections 

to the SUNSET proposed rule. As 

summarized and discussed in the 

Withdrawal NPRM, we found that those 

comments raised compelling concerns 

that the SUNSET final rule would harm 

the public health and welfare, but were 

given insufficient weight in issuing the 

SUNSET final rule. Many of those same 

concerns have been further confirmed in 

the comments on the Withdrawal 

NPRM. 

We also conducted a reanalysis of the 

regulatory impact of the SUNSET final 

rule, and found that the rule rested on 

flawed assumptions and analysis.2 We 

now conclude that the SUNSET final 

rule likely underestimated to a 

significant degree the resources needed 

for the required undertaking. In 

particular, because the implementation 

of the SUNSET final rule would have 

required a significant expenditure of 


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resources, the Department would have 

been forced to make resource allocation 

decisions that would have impeded the 

Department’s routine operations and 

hampered its ability to carry out other 

key priorities and goals. 

We have also reconsidered the impact 

of the expiration provision in the 

SUNSET final rule and, upon further 

examination of the comments and the 

relevant legal standards, we have 

determined that the provision is 

unsound and in our view unlawful. The 

expiration provision was a key element 

of the SUNSET final rule (as its name 

suggests); however, the final rule erred 

in misjudging the likelihood that HHS 

regulations would expire if the SUNSET 

final rule were to go into effect and be 

implemented. As a result, the final rule 

failed to examine the instability, 

uncertainty, and confusion that could be 

generated by automatically expiring 

regulations. Further, we now believe 

that amending thousands of regulations 

to schedule their expiration based on 

the Department’s purported failure to 

conduct a small-entity analysis, without 

any corresponding notice regarding or 

evaluation of the public health 

importance of the individual regulations 

or the public’s reliance on them, 

violates the Administrative Procedure 

Act (APA) and is inconsistent with the 

purpose and intent of the Regulatory 

Flexibility Act (RFA). The policy 

ramifications and legal defects of the 

expiration provision call the entire 

rulemaking into question. 

In addition to our reconsideration of 

the expiration provision, we have 

reconsidered more broadly the public 

comments, the stated legal bases for the 

rule, and its RIA, including a 

consideration of the impacts that are not 

quantified or monetized. We have 

determined that the SUNSET final rule 

prioritized regulatory review over other 

Department operations to a degree that 

would negatively impact many 

stakeholders and the general public in a 

variety of ways. We no longer agree with 

our previous decision-making in 

promulgating the SUNSET final rule, 

because that decision-making was 

predicated on: (1) An inaccurate 

assessment of the effects of this rule, as 

indicated in the comments on both the 

SUNSET proposed rule and Withdrawal 

NPRM, and as discussed in the current 

RIA; (2) errors of law; and (3) a different 

set of policy priorities. We therefore 

have decided to withdraw the SUNSET 

final rule in its entirety. 

A. History of the SUNSET Rulemaking 

1. Proposed Rule, Comment Period, and 

Final Rule 

On November 4, 2020, HHS published 

a notice of proposed rulemaking entitled 

‘‘Securing Updated and Necessary 

Statutory Evaluations Timely’’ (SUNSET 

proposed rule). 85 FR 70096. Under the 

proposed rule, subject to certain 

exceptions, Department regulations 

would expire at the end of (1) two 

calendar years after the year that the 

SUNSET rule first became effective, (2) 

ten calendar years after the year of the 

regulation’s promulgation, or (3) ten 

calendar years after the last year in 

which the Department ‘‘Assessed’’ and, 

if required, ‘‘Reviewed’’ the regulation, 

whichever was latest. Thus, under the 

SUNSET proposed rule, unless HHS 

assessed and, if required, reviewed most 

of its regulations within a certain 

timeframe specified in the rule (for most 

existing regulations, within two years) 

and every ten years thereafter, the 

regulations would automatically expire. 

The SUNSET proposed rule also 

provided that if a review led to a finding 

that a regulation should be amended or 

rescinded, the Department must amend 

or rescind the regulation within a 

specified timeframe (generally two 

years). In addition, the SUNSET 

proposed rule contained certain 

publication requirements, including that 

(1) the Department publish the results of 

all ‘‘Assessments’’ and ‘‘Reviews,’’ 

including the full underlying analyses 

and data used to support the results, in 

the Federal Register, and (2) the 

Department announce the 

commencement of an ‘‘Assessment’’ or 

‘‘Review’’ of a particular regulation on 

a Department-managed website, with an 

opportunity for public comment. The 

SUNSET proposed rule provided that 

comments to the proposed rule had to 

be submitted by December 4, 2020, 

except for comments on the portion of 

the rule amending 42 Code of Federal 

Regulations (CFR) parts 400–429 and 

parts 475–499 (Medicare program 

regulations), which were to be 

submitted by January 4, 2021. 

On November 16, 2020, HHS 

announced a public hearing, scheduled 

for November 23, 2020, to receive 

information and views on the proposed 

rule (Public Hearing). 85 FR 73007. All 

of the commenters, which included 

industry/trade organizations, medical 

organizations, and public interest 

organizations, criticized the proposed 

rule in its substance, the rulemaking 

process, or both. See Transcript, Public 

Hearing on the Securing Updated and 

Necessary Statutory Evaluations Timely 

Notice of Proposed Rulemaking (Nov. 

23, 2020) (available at https://

www.regulations.gov/document/HHSOS-2020-0012-0501) (Public Hearing 

Transcript). 

In addition to the oral comments, a 

wide range of stakeholders submitted 

over 500 comments on the proposed 

rule. Almost all of the comments 

opposed the proposal. Comments 

opposing the rule were submitted by, for 

example, health care and medical 

organizations; Federally Qualified 

Health Centers and advocates for 

beneficiaries of Federal health care 

programs; State attorneys general and 

other state government representatives; 

Tribal governments and Tribal 

organizations; large industry 

associations and trade associations; 

consumer and public interest groups; 

and interested individuals. Only a 

handful of commenters supported the 

SUNSET proposed rule, and two of 

those comments were submitted by an 

individual who, under an agreement 

with HHS, also provided a draft RIA for 

the SUNSET final rule. See 86 FR 5737 

n.210. Other commenters supporting the 

rule included independent business 

advocacy organizations and a nonprofit 

legal organization. 

On December 18, 2020, the Office of 

Information and Regulatory Affairs 

(OIRA) in the White House Office of 

Management and Budget (OMB) 

received the SUNSET final rule for 

review and clearance and posted on the 

OIRA dashboard for E.O. 12866 

regulatory review (Ref. 1). This 

preceded the January 4, 2021, 

conclusion of the comment period for 

the parts of the proposed rule relating to 

42 CFR parts 400–429 and parts 475– 

499. 

HHS issued the SUNSET final rule on 

January 19, 2021. 86 FR 5694. The final 

rule provided that all regulations issued 

by the Secretary or their delegates or 

sub-delegates in titles 21, 42, and 45 of 

the CFR, subject to certain exceptions, 

shall expire at the end of (1) five 

calendar years after the year that the 

SUNSET final rule first becomes 

effective, (2) ten calendar years after the 

year of the regulation’s promulgation, or 

(3) ten calendar years after the last year 

in which the Department ‘‘Assessed’’ 

and, if required, ‘‘Reviewed’’ the 

regulation, whichever is latest. Thus, 

the final rule contained the same basic 

expiration framework as the proposed 

rule, but extended the timeframe for 

assessment and any applicable review of 

most existing regulations from two 

calendar years to five calendar years. 

The final rule also provided for a onetime ‘‘continuation’’ of a regulation 

subject to expiration if the Secretary 

makes a written determination that the 


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public interest requires continuation. 

The continuation period, stated in the 

determination, is not to exceed one year. 

In addition, the final rule contained 

exemptions for a small set of HHS 

regulations applicable to the Food and 

Drug Administration (FDA), the Centers 

for Disease Control and Prevention 

(CDC), and the Centers for Medicare & 

Medicaid Services (CMS). The final rule 

maintained the timeframe for 

amendment or rescission of regulations, 

and included a new Federal Register 

publication requirement in addition to 

the publication requirements proposed 

in the SUNSET proposed rule. 

2. Litigation and Delay of Effective Date 

On March 9, 2021, the County of 

Santa Clara and several other plaintiffs 

sued the Department seeking to overturn 

the SUNSET final rule under the APA. 

Complaint, County of Santa Clara v. 

HHS, Case No. 5:21–cv–01655–BLF 

(N.D. Cal. Mar. 9, 2021) (Santa Clara) 

(Ref. 2). 

On March 18, 2021, the Acting 

Secretary of HHS signed, pursuant to 5 

U.S.C. 705 of the APA, the 

Administrative Delay, which extended 

the effective date of the SUNSET final 

rule until March 22, 2022. 86 FR 15404. 

On March 3, 2022, the Secretary further 

extended the effective date of the 

SUNSET final rule until September 22, 

2022. 87 FR 12399 (Mar. 4, 2022). At the 

parties’ joint request, the Santa Clara 

litigation has thus far been stayed. 

3. The Withdrawal NPRM 

HHS published the Withdrawal 

NPRM on October 29, 2021, in which it 

proposed to withdraw or repeal the 

SUNSET final rule in its entirety. 86 FR 

59906. In the Withdrawal NPRM, the 

Department explained that—in issuing 

the SUNSET final rule—it should have 

engaged in a more robust consideration 

of the comments, and should have given 

greater weight to the potential harms to 

stakeholders and the public health. 

Therefore, before issuing the 

Withdrawal NPRM, the Department 

reexamined the SUNSET final rule in 

light of the allegations in the Santa 

Clara complaint, the many substantive 

comments submitted to the SUNSET 

proposed rule docket and raised at the 

Public Hearing, and the changed policy 

views in the current Administration. 

That review considered the processes 

followed in issuing the SUNSET final 

rule, its policy goals and objectives, the 

projected effects and analysis of impacts 

in its implementation, and the legal 

evaluation of and support for its 

provisions, including whether the rule 

is consistent with HHS statutory 

obligations and its mission to promote 

and protect the public health. 

The comment period on the 

Withdrawal NPRM closed on December 

28, 2021, and HHS received 

approximately 80 comments. A 

substantial majority of comments from a 

wide range of stakeholders supported 

the repeal or withdrawal of the SUNSET 

final rule. These commenters included 

health care and medical organizations; 

Federally Qualified Health Centers and 

advocates for beneficiaries of Federal 

health care programs; State attorneys 

general and other state and local 

government representatives; Tribal 

governments and Tribal organizations; 

large industry associations and trade 

associations; insurance plans and 

organizations; and consumer and public 

interest groups. Most of the comments 

that supported retention of the SUNSET 

final rule and opposed its withdrawal 

came from policy advocacy groups, 

including one business association and 

one submission from the individual 

who, as previously noted, provided a 

draft RIA for the SUNSET final rule. See 

86 FR 5737 n.210. One comment that 

supported retention of the original rule 

was submitted by a group of state 

legislators led by a former HHS official 

who presented the overview of the 

SUNSET proposed rule at the Public 

Hearing, and another comment was 

submitted by a different HHS official 

from the previous administration. There 

were also several identical anonymous 

comments that supported the original 

rule and opposed its repeal or 

withdrawal. 

B. The Department’s Review 

As described above, before issuing the 

Withdrawal NPRM, the Department 

reexamined the SUNSET final rule in 

light of the allegations in the Santa 

Clara complaint, the many comments 

submitted to the SUNSET proposed rule 

docket and raised at the Public Hearing, 

and changed policy views in the current 

Administration. This review considered 

the processes followed in issuing the 

rule, its policy goals and objectives, the 

projected effects and analysis of impacts 

in its implementation, and the legal 

evaluation of and support for its 

provisions, including whether the rule 

is consistent with HHS statutory 

obligations and its mission to promote 

and protect the public health. It should 

be noted at the outset that HHS 

recognizes the importance of 

retrospective review, already conducts 

retrospective reviews, and intends to 

continue to consider how to improve 

these existing processes. See Section 

V.C.2. The purpose of this review, 

however, was to reconsider whether the 

new requirements imposed in the 

SUNSET final rule would achieve the 

goals of retrospective review in a 

manner that best serves the 

Department’s public health and welfare 

mission and that is consistent with 

applicable law. 

We have now carefully considered the 

comments submitted on the Withdrawal 

NPRM. As described further below, our 

consideration of the comments has 

confirmed our tentative conclusions 

described in the Withdrawal NPRM and 

our decision to withdraw the SUNSET 

final rule. In this section, we summarize 

the key considerations, addressed in 

greater detail throughout the preamble, 

that have led us to conclude, as 

proposed in the Withdrawal NPRM, that 

the SUNSET final rule should be 

withdrawn in its entirety. Many of these 

considerations, including the burdens of 

implementing the rule, the harms of 

expiration, and the various legal 

infirmities, each provide independent 

and sufficient reasons for this 

withdrawal. 

First, to be consistent with the 

Department’s usual practices when 

engaging in rulemaking, the Department 

should have engaged in a more thorough 

consideration of the comments, and 

should have given greater weight to the 

potential harms to stakeholders and the 

public health. We have found that there 

were several procedural shortcuts taken 

in issuing the SUNSET final rule which 

may have impeded full consideration of 

the commenters’ significant objections 

to the proposal as well as the care and 

meticulousness devoted to the final 

product. The SUNSET final rule was 

issued on a timeline of less than three 

months, which is unusually expedited 

for a rule of this significance, 

particularly given the potential impacts 

not just on small businesses but also the 

general public, larger businesses, Tribes, 

States, non-governmental organizations, 

and other regulated entities and 

stakeholders across a wide range of 

industrial sectors. The SUNSET rule 

was also remarkably expansive in scope, 

requiring review and possibly regulatory 

or deregulatory activity across a variety 

of distinct substantive statutes within 

the jurisdiction of several operating 

divisions (e.g., CMS, FDA, CDC, 

Substance Abuse and Mental Health 

Services Administration (SAMHSA), the 

Office for Civil Rights (OCR), and the 

Administration for Children and 

Families (ACF)). However, it appears 

that the comments were not adequately 

considered (as evidenced by the 

summary mention in the preamble to 

the SUNSET final rule, as discussed 

further elsewhere in this preamble), 

and, contrary to policy, the Department 


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3See E.O. 13175, ‘‘Consultation and Coordination 

With Indian Tribal Governments,’’ 65 FR 67249 

(Nov. 6, 2000). 

4The SUNSET final rule also cited ‘‘Regulatory 

Relief To Support Economic Recovery,’’ (85 FR 

31353, May 22, 2020) (E.O. 13924 of May 19, 2020), 

which was revoked in E.O. 14018. 86 FR 11855 

(Feb. 24, 2021). 

5See ‘‘Advancing Racial Equity and Support for 

Underserved Communities Through the Federal 

Government,’’ 86 FR 7009 (Jan. 25, 2021) (E.O. 

13985 of Jan. 20, 2021); ‘‘Tribal Consultation and 

Strengthening Nation-to-Nation Relationships,’’ 86 

FR 7491 (Jan. 29, 2021) (Memorandum of Jan. 26, 

2021); ‘‘Strengthening Medicaid and the Affordable 

Care Act,’’ 86 FR 7793 (Feb. 2, 2021) (E.O. 14009 

of Jan. 28, 2021); ‘‘Continuing to Strengthen 

Americans’ Access to Affordable, Quality Health 

Coverage,’’ 87 FR 20689 (April 8, 2022) (E.O. 14070 

of April 5, 2022). 

did not consult with tribal 

governments.3

Second, the Department should have 

more thoroughly examined the factual 

basis of the SUNSET final rule before 

issuing it. Our thinking is informed by 

a reevaluation of the factual premises 

and conclusions in the SUNSET final 

rule that are central to the analysis of 

the rule’s implications and effects. In 

particular, based on a reanalysis of the 

regulatory impact of the rule, we have 

now concluded that the rule rested on 

a flawed understanding of the resources 

required for implementing the SUNSET 

final rule, which implicates the 

likelihood that HHS regulations would 

have expired, and which would have 

required the Department to make 

resource allocation decisions which 

could have impeded the Department’s 

ability to carry out other key priorities. 

In particular, the resources required to 

comply with the assessment and review 

requirements would be substantial. For 

each regulation covered by the SUNSET 

final rule, HHS agencies would need to: 

announce on a Department-managed 

website and in the Federal Register the 

commencement of an assessment or 

review; open and publicize public 

dockets for each assessment or review 

that the Department conducts; collect 

data to conduct the relevant evaluation 

(which may require time for additional 

public notice and comment, and OMB 

review and approval, under the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq., in addition to the time 

needed for data collection and analysis); 

engage subject matter experts and others 

to complete an assessment (and possibly 

a review); consult with state and local 

jurisdictions and Tribes, as appropriate; 

consider any comments to the public 

docket related to the evaluation; 

participate in interagency review, as 

appropriate; and publish the results of 

this process in the Federal Register, 

‘‘including the full underlying analyses 

and data used to support the results.’’ 86 

FR 5712. If the Department could not 

complete this extensive process within 

the final rule’s timeframes, the 

regulations would then automatically 

expire. The original RIA for the 

SUNSET final rule had erroneously 

assumed, for example, that an 

assessment—which requires each of the 

steps previously discussed—would take 

between 3 and 10 hours. We have now 

revised that estimate to between 40 and 

100 hours. 

Beyond assessments and reviews, the 

SUNSET final rule would demand other 

significant resources, including the 

resources required to implement the 

overall framework, such as determining 

which regulations are exempt, and to 

amend or repeal regulations within a 

two-year time period (unless an 

extension is granted). These proceedings 

to amend or rescind the regulations 

would require an additional investment 

of HHS agencies’ resources and public 

input. In addition, after those processes, 

the Department would likely then need 

to revise guidance documents and/or 

forms associated with both expiring 

regulations and regulations still in 

effect. Overall, we have determined that 

the SUNSET final rule miscalculated the 

extent of the resources needed for this 

undertaking and likely underestimated 

the costs of complying with the rule at 

least by a factor of four. 

This reanalysis shows the SUNSET 

final rule, if implemented, would harm 

the public health and welfare and 

diminish the Department’s ability to 

protect and advance the public health 

and welfare. The diversion of resources 

to implement the SUNSET final rule 

processes, the potential for automatic 

expiration of rules, and the actual 

expiration of regulations could 

undermine the operation of existing 

programs and otherwise harm the public 

health in numerous ways, discussed in 

greater detail below. For example, the 

resulting regulatory uncertainty could 

have several negative repercussions for 

stakeholders, by interfering with 

planning, contracting, and product 

development. The actual expiration of 

regulations could lead to confusion 

among stakeholders and undermine 

predictability and confidence in many 

sectors regulated by the Department. 

Third, upon review, HHS has 

determined that the SUNSET final rule 

is contrary to several policy goals of the 

current Administration. The SUNSET 

final rule cited for support an Executive 

order (E.O.) entitled ‘‘Reducing 

Regulation and Controlling Regulatory 

Costs’’ (E.O. 13771), which placed limits 

on agencies’ ability to issue new 

regulations. 86 FR 5696 (citing 82 FR 

9339 (Jan. 30, 2017)). President Biden, 

on his first day in office, issued an E.O. 

entitled ‘‘Revocation of Certain 

Executive Orders Concerning Federal 

Regulation,’’ which revoked E.O. 

13771.4 86 FR 7049 (Jan. 25, 2021) (E.O. 

13992). As stated in E.O. 13992, the 

current Administration’s policy is to 

equip executive departments and 

agencies with flexibility to use available 

tools such as robust regulatory action to 

confront the urgent challenges facing 

the Nation, including the coronavirus 

disease 2019 (COVID–19) pandemic, 

economic recovery, racial justice, and 

climate change. Accordingly, E.O. 13992 

revoked ‘‘harmful policies and 

directives that threaten to frustrate the 

Federal Government’s ability to confront 

these problems and empowers agencies 

to use appropriate regulatory tools to 

achieve these goals.’’ Id. 

The Biden-Harris Administration has 

further committed to using available 

tools of Federal administrative agencies 

to, among other things: Pursue a 

comprehensive approach to advancing 

equity for all, including people of color 

and others who have been historically 

underserved, marginalized, and 

adversely affected by persistent poverty 

and inequality; make respect for Tribal 

sovereignty, self-governance, and 

regular, meaningful, and robust 

consultation with Tribal Nations 

cornerstones of Federal policy 

pertaining to American Indian and 

Alaska Native people (AI/ANs); and 

protect and strengthen Medicaid and the 

Affordable Care Act (ACA) and make 

high-quality healthcare accessible and 

affordable for every American.5

If implemented, the SUNSET final 

rule would negatively impact diverse 

groups of stakeholders, including 

historically underserved, marginalized, 

and adversely affected communities, 

and undermine the Department’s public 

health mission. For example, as 

discussed in more detail in Section V.A 

of this preamble, numerous commenters 

expressed concern about the anticipated 

impacts on various populations 

including children, the elderly, the 

disabled, those living in poverty, and 

communities marginalized by racism 

and prejudice, who could lose eligibility 

for programs and services if the 

regulations underpinning the eligibility 

requirements were to expire. Public 

commenters, including Tribes and tribal 

representatives, assert that the SUNSET 

final rule would threaten the regulatory 

underpinnings of the Indian health 

system, completely disrupt the ability of 

that system’s mission to provide care to 

tribal communities, undermine the 

delivery of HHS public health and 


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6U.S. Department of Health and Human Services, 

HHS Tribal Consultation Policy (Dec. 12, 2010) 

(available at https://www.hhs.gov/about/agencies/ 

iea/tribal-affairs/consultation/index.html). 

7The Department is not questioning the legality 

of the well-considered establishment of sunsetting 

provisions in other, more-targeted circumstances, 

such as the inclusion of a sunset provision in a 

single rule. In such a case, the agency would have 

provided notice and the opportunity for comment 

on, and given due consideration of, the potential 

sunset of that particular regulation. In contrast, the 

SUNSET final rule was unusually sweeping and 

superficial, in that it established automatic 

expiration for a large swath of diverse regulations 

without due consideration of the substance of each 

regulation and the impact of the added sunset 

provision on affected entities under that regulation. 

See Section V.D.1 (discussing, e.g., Dep’t of 

Homeland Sec. v. Regents of the Univ. of Cal., 140 

S. Ct. 1891, 1913 (2020)). 

social service programs for tribal 

members, and generate a level of 

uncertainty that is the antithesis of the 

goals of the HHS Tribal Consultation 

Policy.6 HHS now acknowledges that 

the SUNSET final rule does not provide 

for advance notice of regulations that 

might automatically expire, which we 

believe conflicts with the Department’s 

policy to engage in meaningful 

consultation with Tribal Nations. We 

further note, however, that attempting to 

address the lack of adequate notice of 

expiring regulations would not resolve 

more fundamental problems with the 

SUNSET framework for tribal and other 

stakeholders. 

Fourth, the Department should have 

more carefully considered the legal 

basis for the SUNSET final rule, 

including the expiration provision, 

which is a cornerstone of the rule. 

Commenters on the SUNSET proposed 

rule had asserted that the Department 

did not adequately consider the legal 

questions raised by the automatic 

expiration provisions, which would 

potentially eliminate regulations 

without due notice and consideration of 

the implications of that specific 

expiration. After further review, we 

have concluded that the legal reasoning 

offered in support of the expiration 

provision did not address foundational 

Supreme Court case law requiring 

agencies to consider, among other 

things, the factual bases for a regulation 

before eliminating that regulation.7

The SUNSET final rule dismissed 

these concerns regarding the public 

health and legal repercussions of the 

SUNSET final rule in part by assuming 

that regulations would not expire. See, 

e.g., 86 FR 5710 (‘‘HHS does not intend 

to allow a regulation to simply expire’’); 

id. at 5712 (‘‘the Department is 

committed to dedicating adequate 

resources to timely Assess and Review 

its regulations’’); id. at 5714 (‘‘the 

Department intends to timely complete 

the necessary Assessments and Reviews 

and has built in safeguards to mitigate 

the risk of inadvertent expiration’’). The 

Department failed to consider, however, 

that public health and legal problems 

with the SUNSET final rule exist even 

if no expiration occurs. For example, the 

resources diverted from other key 

programs would still undermine the 

Department’s public health mission and 

even the possibility of expiration would 

create serious instability. The SUNSET 

final rule did not provide an adequate 

justification for, or even acknowledge, 

either of these likely consequences. 

Moreover, we no longer agree with the 

Department’s previous assumption that 

no regulations would expire. Preventing 

the automatic expiration of regulations 

would require prioritizing retrospective 

review above many other Department 

programs and missions. With its finite 

set of resources, the Department would 

be faced with a quandary of how best to 

triage the needs of its existing programs 

(as well as new public health priorities) 

and the new regulatory review process 

under the SUNSET final rule. On the 

one hand, given the large scale of 

resources necessary to conduct the 

required reviews, compliance with these 

new review requirements would lead to 

the diversion of resources from existing 

and new priority programs to the 

detriment of the other programs. This 

diversion of resources would constrain 

HHS’s capabilities to carry out missioncritical objectives such as protecting the 

health of Americans, strengthening their 

economic and social well-being, and 

fostering sound, sustained advances in 

medical innovation and health sciences. 

On the other hand, the automatic 

expiration of regulations could also 

undermine mission-critical objectives. 

Based on our reconsideration and expert 

judgment, we no longer consider 

prioritizing resources to avoid 

expiration to be in the best interests of 

the public health and welfare. 

Therefore, we believe that this 

assumption—that no regulations would 

expire—was not well founded. The 

Department’s previous reliance on this 

unsupported assumption, together with 

the miscalculation regarding the 

resources necessary to comply with the 

rule, are in themselves detrimental to 

the viability of the SUNSET final rule. 

Upon review, we now conclude that 

the burdens imposed by the SUNSET 

final rule could undermine the 

Department’s ability to fulfill its public 

health and human services missions, 

promote national priorities, and 

confront the challenges facing the 

nation—contrary to its statutory 

mandates and the policies expressed in 

EOs 13992, 13985, 14009, and 14070. As 

further described below, see Section 

V.C, the Department already has a 

longstanding retrospective review plan 

in place, and each year publishes in the 

Federal Register a list of the rules that 

it is reviewing, has reviewed, or intends 

to review under section 610 of the RFA. 

And although the Department is 

committed to exploring additional ways 

to improve its processes for conducting 

retrospective reviews under the RFA 

and identify and retire obsolete rules, 

the approach in the SUNSET final rule 

imposes requirements that are far more 

onerous than what is needed to meet 

those objectives and that would 

undermine essential Department 

priorities. In essence, implementation of 

the SUNSET final rule would likely 

have led to a sharply diminished ability 

of the Department to provide Federal 

leadership in public health and human 

services. On full consideration, the 

Department believes that 

implementation of the SUNSET final 

rule fundamentally conflicts with our 

policies and ability to achieve our 

statutory missions. 

IV. Legal Authority 

The primary statutory authorities 

supporting this final rule are the general 

rulemaking authorities for the various 

substantive areas under the 

Department’s umbrella, as well as a 

general provision authorizing agencies 

to issue regulations regarding the 

administrative processes to be followed 

by that agency. These include: 

• Section 701(a) of the Federal Food, 

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

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

Secretary to ‘‘promulgate regulations for 

the efficient enforcement of [the FD&C 

Act], except as otherwise provided in 

this section;’’ 

• Section 215 of the Public Health 

Service Act (PHS Act), 42 U.S.C. 216, 

which provides that ‘‘The Surgeon 

General, with the approval of the 

Secretary, unless specifically otherwise 

provided, shall promulgate all other 

regulations necessary to the 

administration of the Service[];’’ 

• Section 1102 of the Social Security 

Act (SSA), 42 U.S.C. 1302, which 

provides that the Secretary ‘‘shall make 

and publish such rules and regulations, 

not inconsistent with this Act, as may 

be necessary to the efficient 

administration of the functions with 

which [they are] charged under this 

Act;’’ 

• Section 1871 of the SSA, 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;’’ 


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• 42 U.S.C. 2003, which provides that 

‘‘the Secretary of Health and Human 

Services is also authorized to make such 

other regulations as [they] deem 

desirable to carry out the provisions of 

this subchapter [transferring to the 

Indian Health Service (IHS) the 

authority to provide health care services 

to AI/ANs];’’ and 

• 5 U.S.C. 301, which provides that 

‘‘[t]he head of an Executive department 

or military department may prescribe 

regulations for the government of his 

department, the conduct of its 

employees, the distribution and 

performance of its business, and the 

custody, use, and preservation of its 

records, papers, and property. This 

section does not authorize withholding 

information from the public or limiting 

the availability of records to the public.’’ 

Congress’s grant of broad, 

discretionary rulemaking authority 

necessarily includes the authority not to 

promulgate—and therefore also to 

withdraw or repeal—a proposed or final 

rule. See Natural Res. Def. Council, Inc. 

v. SEC, 606 F.2d 1031, 1045 (D.C. Cir. 

1979); see also 5 U.S.C. 551(5) (defining 

‘‘rule making’’ to include formulating, 

amending, and repealing a rule). In 

addition, ‘‘[t]he power to reconsider is 

inherent in the power to decide,’’ 

Albertson v. FCC, 182 F.2d 397, 399 

(1950), and, thus, ‘‘[a]dministrative 

agencies have an inherent authority to 

reconsider their own decisions.’’ 

Trujillo v. Gen. Elec. Co., 621 F.2d 1084, 

1086 (10th Cir. 1980). 

V. Analysis of and Responses to Public 

Comments on the Withdrawal NPRM 

During the 60-day public comment 

period, we received approximately 80 

public comments. The majority of 

commenters expressed support for the 

Withdrawal NPRM, and in general these 

comments closely aligned with 

comments received in opposition to the 

SUNSET proposed rule. A substantial 

number of these commenters had 

submitted comments on the SUNSET 

proposed rule and either restated, 

submitted, or referenced their earlier 

comments in explaining their support 

for the Withdrawal NPRM. In the 

Withdrawal NPRM, we discussed the 

substantial number of comments on the 

SUNSET proposed rule, and we 

incorporate the comments on the 

SUNSET proposed rule and the 

discussion of the underlying issues and 

comments in the Withdrawal NPRM by 

reference as part of the basis for this 

final rule. Below we summarize and 

respond to the comments on the 

Withdrawal NPRM. 

A. Comments on Implementation 

Burdens on the Department and 

Stakeholders 

In issuing the Withdrawal NPRM, the 

Department explained that it was 

concerned that implementation of the 

SUNSET final rule would create 

burdens on the Department and on 

stakeholders that would divert resources 

from pressing public health matters and 

thus harm the public. 89 FR 59911. 

Below we respond to the comments on 

the Withdrawal NPRM on this subject. 

1. Burden on the Department 

Comment: The Department received 

numerous comments agreeing with 

HHS’s explanation in the Withdrawal 

NPRM that the SUNSET final rule rested 

on a significantly flawed understanding 

of the time and resources that would 

have been needed to carry out the scope 

and pace of assessments and reviews 

required under the rule. In general, 

these commenters asserted that there are 

simply not enough HHS staff or 

resources to undertake such a sweeping 

process and simultaneously evaluate 

thousands of regulations in a short 

period of time. Several of the 

commenters further explained that the 

SUNSET final rule would create more 

burdens than it would ease and would 

be unlikely to benefit industry and 

consumers. In contrast, one commenter 

asserted that the SUNSET rule can and 

should be implemented and that 

concern regarding the enormous scope 

of the task and pace of reviews that 

would be required under the SUNSET 

final rule is not a valid reason to 

withdraw or rescind the rule. The 

commenter explained that, without the 

SUNSET framework, the quantity of 

regulatory reviews that the Department 

should undertake will grow ever more 

daunting as time passes and rulemaking 

persists. 

Response: We agree with the 

commenters who stated that the 

framework set forth in the SUNSET final 

rule would create a tremendous 

economic and workload burden on the 

Department and would require pursuing 

the objective of regulatory review at 

great expense to the public and to the 

small business community it purports to 

benefit. Our current RIA, revised from 

the SUNSET final rule, provides ample 

support for these assertions. See Section 

VI. The assessments and reviews 

required by the SUNSET final rule 

would be a colossal undertaking with 

significant resource implications. 

Among other things, approximately 

12,400 of the Department’s estimated 

18,000 sections in the CFR are over ten 

years old and would be subject to 

review during the initial five-year 

period. Assessing more than two-thirds 

of all HHS regulations simultaneously 

in a compressed 5-year timeframe, and 

assessing them again on a recurring 

basis ten years after conclusion of the 

prior assessment, is infeasible. Many of 

these comments underscored that the 

SUNSET final rule failed to appreciate 

the scope of its effects on the 

Department, including that the rule 

could compromise some of the 

Department’s most important public 

health and public safety initiatives. As 

stated in the Withdrawal NPRM, HHS 

continues to conclude that the SUNSET 

final rule ‘‘did not explain how HHS 

could devote numerous employees to 

full-time retrospective review without 

compromising the Department’s and its 

sub-agencies’ many other crucial tasks, 

such as protecting the country from 

future pandemics or other public health 

emergencies.’’ 86 FR 59911. 

We disagree with one commenter’s 

suggestion that we should disregard 

these concerns because we should 

prioritize retrospective review as 

provided under the SUNSET final rule. 

First, we disagree that the framework 

that would have been established by the 

SUNSET final rule is an appropriate 

model for engaging in retrospective 

review. As discussed in further detail in 

Sections V.C. and D. of this preamble, 

the framework that would have been 

implemented under the SUNSET final 

rule is inconsistent with the 

requirements and objectives of the RFA; 

does not fulfill the directives of EOs 

related to retrospective review, such as 

E.O. 13563 on ‘‘Improving Regulation 

and Regulatory Review;’’ and likely 

violates the APA. Second, the 

disruption to the Department’s normal 

operations that would have been caused 

by the implementation of the SUNSET 

final rule is too sizable to disregard and 

is an entirely valid reason to reject these 

self-imposed procedures. As discussed 

in Section V.C below, the Department 

intends to continue to engage in 

retrospective review and to explore 

ways to improve those processes in a 

manner that is consistent with 

applicable law and does not undermine 

its core missions. 

Comment: A number of commenters 

supporting the Withdrawal NPRM 

highlighted the concern that the 

SUNSET final rule would shift the 

Department’s focus away from its public 

health mission. Several of these 

commenters particularly focused on 

concerns that the SUNSET final rule 

would divert resources and attention 

from the urgent COVID–19 pandemic 

response and impact the Department’s 

ability to develop policy and 


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promulgate regulations implementing 

new Federal laws and programs to 

address pandemic relief. In describing 

the need for the Department to remain 

flexible and have the capacity to 

respond quickly to crises and changing 

circumstances, one commenter gave the 

example of CMS needing to take action 

during the pandemic to swiftly approve 

hundreds of waivers and state plan 

amendments so people with disabilities 

could remain safely in their home. The 

commenter concluded that, if the 

SUNSET final rule had been in effect 

and CMS staff were hamstrung by 

assessments and reviews, they may not 

have been able to pivot quickly and 

review and approve states’ crucial 

changes. Some commenters also 

expressed concern that the SUNSET 

final rule would divert resources and 

attention from other public health 

emergencies like the opioid epidemic. 

Commenters also expressed concern 

that the volume of assessments and 

reviews would detract from the 

Department’s overarching work to 

address the needs of vulnerable 

populations including children, the 

elderly, the disabled, those living in 

poverty, the LGBTQ community, 

patients living with HIV/AIDS, tribal 

members, and communities of color. 

Commenters stated that the SUNSET 

final rule would frustrate the objectives 

articulated in E.O. 13985, ‘‘Advancing 

Racial Equity and Support for 

Underserved Communities Through the 

Federal Government,’’ 86 FR 7009, by 

burdening the programs that serve 

vulnerable populations and 

communities of color. 

In addition, commenters asserted that 

implementation of the SUNSET final 

rule would detract from public health 

and innovation in the health sector by 

diverting FDA staff time from regulatory 

science, engagement with sponsors to 

support product development, 

communication of standards to 

stakeholders on new therapeutic areas 

such as gene editing, and the conduct of 

timely reviews of new drug 

applications. Other commenters 

expressed concern that the SUNSET 

final rule would undermine FDA’s 

ability to ensure the safety of food and 

medicines because the burden of 

assessments and reviews could divert 

resources from the implementation and 

enforcement of existing regulations 

impacting public safety, patient safety, 

and public health. 

Response: We agree that redirecting 

significant resources from core HHS 

functions and priorities to undertake 

assessments and reviews and preserve 

regulations from automatic expiration 

under the SUNSET final rule would be 

contrary to the Department’s role as the 

U.S. Government’s principal agency for 

protecting the health of all Americans 

and providing essential human services, 

especially for those who are least able 

to help themselves. The Department’s 

ongoing experience with the current 

pandemic reinforces the need for the 

Department to remain flexible and 

focused on the management and 

utilization of HHS resources. The 

SUNSET final rule, however, would 

require HHS to redirect subject matter 

experts, including program analysts and 

administrators, economists, and 

counsel, to perform assessments and 

reviews. The SUNSET framework would 

require prioritizing retrospective review 

above many other Department programs 

and missions, including both ongoing 

program operations and the 

development of new policies and 

regulations (often necessitated by new 

statutory requirements) to address 

public health needs such as the needs 

of vulnerable populations and advances 

in health care products and services. 

Because of these effects, the SUNSET 

final rule poses a significant risk of 

future harm. 

Moreover, as described in the 

Withdrawal NPRM, the SUNSET final 

rule provides no good cause exception 

to avert the expiration of a regulation, 

such as in the event of a pandemic, a 

public health emergency, or another 

declared national emergency. 86 FR 

59912. Although the SUNSET final rule 

added a provision to permit the 

Secretary to extend the period for 

assessments and reviews, the extension 

could only be applied one time, for up 

to one year, per each section of 

regulation, and the extension could only 

be exercised through a determination 

published in the Federal Register. 86 FR 

5725. Given the brief extension 

available for the assessment and review 

and the potential duration of an 

emergency (as evidenced by the current 

2 years plus duration of the COVID–19 

pandemic), the Department has 

determined that the SUNSET final rule 

was incorrect to conclude that this 

option would be sufficient to avoid the 

diversion of resources and the automatic 

expiration of regulations in the event of 

a pandemic, emergency, or other 

development that prevents the 

Department from timely assessing or 

reviewing certain sections. Id. at 5726. 

Even if a broader good cause exception 

were included, the option of employing 

an exceptional process for emergencies 

would not begin to address the 

substantial burdens imposed by, and 

fundamental policy and legal problems 

with, the SUNSET final rule, with its 

application to virtually all of HHS 

regulations. 

2. Burden on Stakeholders 

Comment: Commenters representing 

industry and public interest groups 

supported withdrawing or repealing the 

SUNSET final rule because of the 

expected burden on the general public 

and entities with an interest in the 

underlying regulations. These 

stakeholders explained that the rule 

failed to adequately consider the burden 

imposed on regulated industry and 

others to both track HHS regulations for 

potential expiration and submit 

comments related to the assessments 

and reviews. For example, one 

commenter expressed concern that if the 

SUNSET final rule is not withdrawn, 

their advocacy organization would need 

to redirect resources to monitor the 

status of the approximately 2,000 FDA 

regulations and then, if needed, invest 

at least 40 to 100 hours per rule to 

provide comments. Another coalition 

estimated that over 1,000 CMS 

regulations would require their 

immediate attention if the SUNSET final 

rule was not withdrawn or repealed. 

Among industry stakeholders, one 

commenter stated that, rather than 

having a deregulatory impact, the 

SUNSET final rule would require near 

constant vigilance as relatively stable 

regulatory schemes like Medicaid 

programs would become subject to 

constant change. 

Response: The Department believes 

that any retrospective review process 

should not impose an undue burden on 

the public and agrees that the SUNSET 

final rule would be extremely 

burdensome on stakeholders to monitor 

and provide input on both assessments 

and reviews. As noted in the 

Withdrawal NPRM, approximately 

12,400 of the Department’s estimated 

18,000 sections in the CFR are over ten 

years old, and each of these are 

regulations that could automatically 

expire five years after the SUNSET final 

rule’s effective date if the rule were 

implemented. Under the timeline and 

definitions provided in the final rule, 

over 7,000 sections of the CFR that were 

promulgated by the FDA are more than 

ten years old, or would become more 

than ten years old during the first five 

years the rule would be in effect, 

representing over 95 percent of this 

agency’s current regulations. 

86 FR 59912. These numbers indicate 

that the burden of public participation 

is significant. In addition, HHS no 

longer agrees with its previous approach 

of putting the onus on the public to 

monitor the Department’s progress 

under the rule to prevent expiration. 


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8See OMB Circular A–4 (available at https://

www.whitehouse.gov/wp-content/uploads/legacy_

drupal_files/omb/circulars/A4/a-4.pdf); HHS 

Guidelines for Regulatory Impact Analysis (2016) 

(available at https://aspe.hhs.gov/sites/default/files/ 

migrated_legacy_files//171981/HHS_

RIAGuidance.pdf). 

The SUNSET final rule stated that a 

‘‘safeguard’’ to mitigate the risk of 

inadvertent expiration was for the 

public to perform this monitoring 

function and submit comments 

requesting that the Department 

commence an assessment or review. 86 

FR 5714. We no longer believe it is 

appropriate to set up a system that 

depends on stakeholders, including 

non-profits and state, tribal, and local 

governments, to ensure that a 

Department performs an administrative 

function properly, due to the significant 

resources it would require those 

stakeholders to invest in such an effort. 

Comment: Several commenters 

expressing support for the Withdrawal 

NPRM stated that it would be difficult, 

if not impossible, for the public to 

accurately determine whether and when 

a regulation would be subject to review 

under the SUNSET final rule, and if so, 

the deadline for informing the 

Department and commenting. Many of 

these commenters noted, in response to 

similar comments on the SUNSET 

proposed rule, the Department had 

attempted to mitigate those concerns in 

the SUNSET final rule by providing that 

the Department would (1) publish a 

monthly list of new assessment or 

review that have commenced and (2) 

establish a general docket where the 

public could alert the Department when 

a regulation may be at risk of expiration 

because of an approaching deadline for 

assessment or review. 86 FR 5702. 

However, the commenters explained 

that these mitigation efforts are 

insufficient to address the difficulty of 

continuously monitoring the pace of 

assessments and reviews and the burden 

on stakeholders to alert the Department 

regarding potentially expiring rules. 

Another commenter disagreed and 

stated that, if a section of a regulation 

were to inadvertently expire under the 

SUNSET final rule, HHS could follow 

the APA’s flexible rulemaking 

procedure to readopt it. 

Response: The Department agrees that 

the overall framework of the SUNSET 

final rule would make it difficult and 

confusing for the Department to 

implement and for stakeholders to 

follow. For example, the SUNSET final 

rule would require each section of the 

CFR to be assessed and, if applicable, 

reviewed in the context of the final rule 

under which it was promulgated. 

However, final rules often crossreference or amend previously 

promulgated sections of the CFR. Given 

this complication, it would be difficult 

for the HHS to accurately and 

comprehensively develop and maintain 

a list for stakeholders regarding 

regulations that could expire under the 

SUNSET final rule framework. 

Moreover, the Department agrees that it 

is unreasonable to expect stakeholders 

to navigate such a process. We conclude 

it is inappropriate for the SUNSET final 

rule to rely in part on the public 

submitting comments requesting that 

the Department assess or review a 

regulation in order to operationalize the 

final rule. 

The Department also has determined 

that addressing the inadvertent 

expiration of a regulation under the 

SUNSET final rule by reissuing the 

implicated regulation would be 

inefficient, costly, wasteful, and 

confusing—with insufficient, and in 

many cases, no countervailing benefit. 

Such an effort would require a full 

notice and comment process, as well as 

a full economic assessment, for a 

proposed and final rule during which 

stakeholders and programs would 

experience the legal and regulatory 

uncertainty of an expired regulation. 

3. Comments on Economic Evaluation of 

Burdens 

Comment: A few commenters 

disagreed with the Department’s 

assessment in the Withdrawal NPRM of 

the burden of the SUNSET final rule 

and asserted that the Withdrawal 

NPRM’s RIA overstated the cost 

estimated for implementing the 

SUNSET final rule. More specifically, 

some commenters questioned the 

estimates for burdens on stakeholders to 

comment on assessments and reviews 

based on these commenters’ prediction 

that most members of the public have 

little incentive to take an interest in the 

assessment and review of individual 

HHS policies. One comment suggested 

the costs were overstated because the 

regulations that were the subject of 

stakeholder comments would be 

eliminating costs on these (and other) 

commenters. The comment also asserted 

that any uncertainty created by the 

SUNSET final rule is a ‘‘short-term 

cost[]’’ that ‘‘will be resolved as the 

schedules for expiration are discovered’’ 

and may be offset by the reduction in 

uncertainty associated with diverting 

HHS resources away from other actions. 

Another comment asserted that HHS 

ignored the concept of ‘‘rent-seeking’’ 

when it considered the costs of HHS 

regulatory actions and the ‘‘likely 

unrepresentative nature of the 

comments received by HHS’’ on the 

SUNSET proposed rule. The commenter 

further stated that ‘‘rent-seeking costs’’ 

may also affect the Department’s cost 

estimates. The commenter concluded 

that ‘‘[i]f the entities that submit 

comments to the department while it is 

undergoing retrospective reviews would 

have been rent-seeking in absence of 

having to write comments, then the 

private costs to these individuals and 

groups from writing comments could 

well constitute social benefits to society 

writ large.’’ 

In addition, one comment questioned 

the estimates for burdens on the 

Department. The commenter stated that 

the Withdrawal NPRM’s RIA used cost 

estimates for burdens on the Department 

that were inconsistent with guidance in 

OMB Circular A–4 and HHS Guidelines 

for Regulatory Impact Analysis.8 In the 

commenter’s view, the RIA incorrectly 

projected ‘‘accounting costs’’ from 

hiring new personnel to perform these 

tasks. The commenter asserted that, 

instead, the RIA should have assessed 

the real opportunity costs to the 

Department and taxpayers from the 

forgone activities such staff would have 

performed in the absence of the process 

required by the SUNSET final rule. The 

commenter also questioned the 

Department’s assumption in the RIA for 

the Withdrawal NPRM that HHS would 

follow Small Business Administration 

(SBA) guidance in conducting reviews, 

and asserted that the costs of conducting 

reviews would lessen over time. 

Response: We disagree with these 

commenters concerning the cost 

estimates in the Withdrawal NPRM RIA 

and continue to believe that the RIA in 

the SUNSET final rule likely 

underestimated the costs of 

implementing that rule to a significant 

degree. With regard to the estimated 

burden on stakeholders, as discussed in 

greater detail in Section VI, the SUNSET 

final rule likely underestimated the time 

and resource commitment of a credible 

assessment and review process. The 

Department acknowledges that there is 

uncertainty in the amount of time the 

public would spend commenting on 

assessments and reviews under the 

SUNSET final rule. We have 

appropriately incorporated this 

uncertainty into the estimates of the 

burden to stakeholders by incorporating 

a range of estimates of the time spent 

per comment into our current 

evaluation of the burden of the SUNSET 

final rule. To the extent that the 

commenters indicate that the public 

would submit fewer, rather than zero, 

comments prior to the assessments, we 

have incorporated this into the 

Withdrawal NPRM’s preliminary RIA by 

incorporating a lower estimate of 25 


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9As noted above, a wide range of stakeholders 

submitted over 500 comments on the SUNSET 

proposed rule, almost all in opposition, and several 

stakeholders filed the Santa Clara lawsuit seeking 

to overturn the SUNSET final rule. As discussed in 

the Withdrawal NPRM and in Sections IV.A.2 and 

IV.B.1. of this preamble, many stakeholders 

opposed the SUNSET final rule because the threat 

of regulations automatically expiring would 

increase cost and confusion, impede competition, 

and harm the public health in numerous ways. 

Moreover, if the SUNSET final rule were to be 

implemented, many of these stakeholders have 

indicated that they would expect to expend 

considerable resources tracking HHS regulations for 

potential expiration and submitting comments. See 

Section V.A.2. 

10HHS Guidelines for Regulatory Impact Analysis 

at 27 (2016) (available at https://aspe.hhs.gov/sites/ 

default/files/migrated_legacy_files//171981/HHS_

RIAGuidance.pdf). This default assumption is 

discussed in greater detail in Valuing Time in U.S. 

Department of Health and Human Services 

Regulatory Impact Analyses: Conceptual 

Framework and Best Practices’’ (Sept. 17, 2017) 

(available at https://aspe.hhs.gov/reports/valuingtime-us-department-health-human-servicesregulatory-impact-analyses-conceptual-framework). 

11 ‘‘A Guide for Government Agencies: How to 

Comply with The Regulatory Flexibility Act,’’ (Aug. 

2017) (available at https://cdn.advocacy.sba.gov/ 

wp-content/uploads/2019/06/21110349/How-toComply-with-the-RFA.pdf). 

comments per assessment into our 

current evaluation of the burden of the 

SUNSET final rule. This estimate is 

about five percent of the comments 

anticipated in the SUNSET final rule’s 

RIA for regulations that the Department 

announces would be rescinded 

following a review. 

In contrast, the SUNSET final rule’s 

RIA incorrectly based its burden 

estimates on an assumption that the 

public would forego commenting until 

the retrospective analysis was complete 

and the Department announced its 

intent to rescind or amend a 

rulemaking. We now find this 

assumption puzzling: It would not make 

sense to require a comment process for 

assessments if the Department thought 

no one would be interested in 

commenting. In any event, we disagree 

with the assumption that stakeholders 

will forego commenting until late in the 

process because it is illogical, lacks any 

evidentiary basis, and is contrary to the 

weight of the comments. Indeed, 

stakeholders have already demonstrated 

a high level of interest in the subject of 

this rulemaking.9 We understand that 

these stakeholders would be motivated 

to comment because they would want to 

ensure that HHS has up-to-date 

information to correctly evaluate both 

the impacts of a rulemaking and 

potential changes to the regulations. We 

also note that Congress, in drafting the 

RFA, appeared to believe the public 

would be interested in commenting on 

reviews because it required agencies to 

provide an opportunity for public 

participation in the review process. 

We also do not agree that uncertainty 

is a short term cost. The SUNSET final 

rule creates a continuing threat of 

expiration because, regardless of the 

‘‘schedules for expiration,’’ the public 

cannot know what public health 

exigencies may arise in the future and 

what decisions the Department will 

make to serve its mission. The same 

uncertainty does not exist with more 

typical rulemakings because they have 

built-in safeguards, such as notice and 

opportunity for comment. 

With regard to the comment about 

‘‘rent-seeking,’’ this comment appears to 

confuse several economic concepts, 

including ‘‘rent-seeking,’’ ‘‘rent-seeking 

costs,’’ and economic rent, which makes 

the comment difficult to parse and 

understand. Additionally, we do not 

unambiguously attribute to the SUNSET 

final rule the impacts of regulations that 

would be rescinded or amended 

following a review under the SUNSET 

final rule. It is also not clear why the 

commenter anticipates that the SUNSET 

final rule, which would invite public 

comment on about 18,000 regulations 

over ten years, would result in public 

comments that are more representative 

of the views of the general public than 

the notice-and-comment rulemaking 

process the Department follows under 

the APA in this rulemaking. As such, it 

is not clear how the SUNSET final rule 

would provide a superior approach to 

addressing economic rents attributable 

to existing regulations. 

With respect to the comment on the 

Withdrawal NPRM preliminary RIA’s 

estimated burden on the Department, 

we agree with the commenter that there 

would be real opportunity costs to the 

Department and taxpayers attributable 

to forgone activities that would have 

been performed in the absence of the 

process required by the SUNSET final 

rule. While we cannot predict all of the 

likely forgone activities, they could 

include, for example, actions to address 

urgent public health matters such as 

COVID–19 pandemic relief efforts or 

similar efforts to respond to future 

emergent threats, FDA review of 

applications and the fulfillment of user 

fee commitments, work to ameliorate 

the opioid crisis, stem outbreaks of 

foodborne illness, and conduct 

inspections, recalls and other public 

health priorities. To the extent that 

Department would need to defend 

challenges related to expired 

regulations, such effort would further 

require the Department to divert 

resources from other public health 

priorities. To measure these opportunity 

costs, we adopt the standard approach 

recommended in the HHS Guidelines 

for Regulatory Impact Analysis of a 

‘‘default assumption’’ ‘‘that the value of 

activities conducted during paid work 

time can be best approximated by the 

cost of labor to the employer. The 

standard economic model assumes that 

employers are willing to incur labor 

costs equal to the value of workers’ 

marginal product. Conceptually, this 

amount represents the value of what the 

employee would have otherwise 

produced in the absence of the 

regulation. Thus, the opportunity cost of 

paid work time can be approximated 

based on the employer costs, including 

pay, benefits, taxes, and associated 

overhead.’’ 10

However, the commenter is incorrect 

that the assessments and reviews would 

be achieved solely through the 

reallocation of existing staff resources. 

As described in Section VI, 

implementation of the SUNSET final 

rule would require contributions from 

current and new Department subject 

matter experts, lawyers, and other 

reviewers informing the retrospective 

analysis and providing feedback on 

draft analyses, time spent by economists 

and other analysts developing the 

retrospective analysis to respond to this 

feedback, time spent reading and 

incorporating evidence from other 

sources, including public comments, 

and other activities. The SUNSET final 

rule RIA did not explicitly include these 

important activities in its estimates of 

the time per review. The consequence of 

excluding these activities in its analysis 

is that the SUNSET final rule likely 

underestimated the total costs to the 

Department of the SUNSET final rule to 

a significant degree. Our current 

evaluation of these costs indicates that 

the Department would incur additional 

costs to hire, train, and transfer 

personnel with technical expertise. 

One comment argued that the 

Department’s cost estimates in the 

Withdrawal NPRM are likely to be 

inaccurate because the comment 

disagreed with our assumption that the 

Department would follow the 

recommendations in the SBA 

guidance.11 The commenter cited an 

analysis of regulatory impact analyses 

performed between 2008 and 2013 as 

support. This analysis, which predates 

the SBA Guidance published in August 

2017, does not reference ‘‘Regulatory 

Flexibility Act,’’ ‘‘regulatory flexibility 

analysis,’’ ‘‘Section 610 reviews,’’ 

‘‘small business,’’ ‘‘small entity,’’ or 

otherwise contain any evidence that the 

Department does not currently follow 

the recommendations in the SBA 

guidance, or any evidence that the 

Department would not follow these 


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12See, e.g., Regulatory Information Service 

Center, ‘‘Introduction to the Unified Agenda of 

Regulatory and Deregulatory Actions—Fall 2021’’, 

87 FR 5002, 5009 (Jan. 31, 2022). 

recommendations for assessments or 

reviews performed under the SUNSET 

final rule. 

The commenter also discussed the 

potential that the costs of conducting 

reviews will lessen over time. We are 

not able to fully evaluate the merits of 

comment since it does not provide any 

guide for when the Department would 

begin to experience these lower costs, 

and because it does not include a 

quantification of the reduction in time 

per assessment or review resulting in 

lower costs over time. See Section VI. 

B. Comments on Potential Harms From 

the Possible and Actual Expiration of 

Regulations 

In issuing the Withdrawal NPRM, the 

Department explained that it was 

concerned that, if the SUNSET final rule 

were implemented, both the possibility 

of automatic expiration of HHS 

regulations, and the actual expiration of 

HHS regulations, could harm the public. 

89 FR 59914. Below we respond to the 

comments on the Withdrawal NPRM on 

this subject. 

1. Impact on Stakeholders in General 

Comment: A number of commenters, 

including health care providers, public 

interest groups, and private sector 

entities, urged HHS to withdraw the 

SUNSET final rule because it would 

create unpredictability for industry and 

consumers. These commenters noted 

that the lack of predictability 

concerning the potential automatic 

expiration of regulations could result in 

the haphazard vacating of numerous 

existing rules without appropriate 

communication to regulated entities, 

and potentially upend long-standing 

foundational rules with provisions that 

are inter-related with other rules. The 

commenters expressed concern that 

such unpredictability regarding large 

swathes of the rules governing public 

health and welfare could lead to adverse 

impacts for stakeholders. 

Several of these comments expressed 

concern that the SUNSET final rule 

would introduce uncertainty regarding 

the validity and enforceability of 

regulations and wreak havoc on HHS 

programs. Commenters noted that there 

would be uncertainty and confusion 

regarding the current and future 

regulatory status of rules slated for 

review and assessment, and that 

expiring regulations could leave vast, 

gaping holes in the regulatory 

framework implementing HHS programs 

and policies and introduce confusion 

and sudden shifts in regulatory 

requirements. Commenters further 

noted that if the intent of the SUNSET 

final rule was to ease burdens upon 

small businesses, it would more likely 

have the opposite effect. All businesses, 

but most especially small ones, benefit 

from transparent regulation that can be 

planned for, budgeted for, and 

implemented. 

Among these commenters, several 

representatives of industry coalitions 

whose membership includes small 

entities also warned that, if not 

withdrawn or repealed, the SUNSET 

final rule could engender chaos and 

harm to both industry and consumers. 

Several commenters discussed the time, 

resources, and capital investments made 

by the food industry because of reliance 

on durable public standards that have 

been codified in regulation. The 

commenters expressed significant 

concerns about the expansive and 

accelerated approach taken in the 

SUNSET final rule and the 

disproportionate burden and 

uncertainty small entities would face 

should the final rule lead to the 

expiration of regulations that have been 

in place for years and are essential to a 

level playing field within the industry. 

Commenters also described the 

impacts of regulatory uncertainty on 

public health. One commenter 

described the potential damaging effects 

the SUNSET final rule would have on 

the drug development process, where 

drug sponsors rely on a predictable 

regulatory environment to plan their 

development programs. The commenter 

stated that an environment in which 

FDA or other HHS regulations may be 

capriciously eliminated could hamper 

progress on much needed therapies in 

the drug development pipeline. One 

commenter specifically referenced the 

consequences of a lack of public 

confidence in food labeling, including 

the rules that inform consumers about 

the ingredients and nutrient content of 

their food, and safety rules concerning 

Salmonella, Shiga toxin-producing E. 

coli, and other potentially deadly 

foodborne pathogens. Other commenters 

provided examples of harms of 

uncertainty to the HHS programs such 

as Temporary Assistance for Needy 

Families (TANF) and the Child Care and 

Development Fund (CCDF), where a 

strong regulatory framework provides 

the clarity needed to run these programs 

on a day-to-day basis, gives providers 

guidance on their obligations, and 

explains to beneficiaries what their 

benefits mean. 

Response: We agree with these 

comments about the importance of a 

relatively steady and predictable 

regulatory environment and appreciate 

the examples of the ways the SUNSET 

final rule would introduce 

unpredictability regarding HHS 

regulations and the associated harms. 

Given the complicated resource 

allocation decisions necessary to 

implement the review framework 

prescribed in the SUNSET final rule, 

HHS is unable to forecast the number of 

or identify specific regulations that may 

expire without a completed assessment 

and, if applicable, review. It therefore 

may be difficult for stakeholders to 

know which regulations would remain 

in place because that would depend on 

whether the Department could actually 

complete each regulation’s assessment 

and/or review by the assessment or 

review deadline. We concur that the 

potential automatic expiration of large 

swathes of rules, or even one complex 

rule, without notice of the reasoned 

justification for retiring that rule or set 

of rules, could create uncertainty and 

unpredictability regarding regulatory 

programs going forward. 

Although the SUNSET final rule 

stated that it ‘‘does not believe 

uncertainty among the regulated 

community will add significantly to the 

costs of this rulemaking’’ because ‘‘there 

is always a possibility that regulations 

could be amended or rescinded, even 

absent this rule,’’ 86 FR 5709, HHS now 

concludes that this reasoning was 

flawed. The rule’s automatic expiration 

of regulations is very different from 

amendment or rescission through notice 

and comment rulemaking, because there 

is no built-in safeguard of prior notice 

for automatic expiration, and no process 

for obtaining stakeholder input on the 

implications of losing the regulation. 

Therefore, expiration could be 

haphazard and unpredictable and 

without appropriate notice to and input 

from stakeholders. This outcome would 

be far more disruptive than the existing 

possibility of targeted changes to 

regulations based on a reasoned 

justification such as a change in the 

governing law, technology, policy, or 

other circumstances. Moreover, the 

Department generally uses mechanisms 

such as the Unified Agenda of 

Regulatory and Deregulatory Actions 

(Unified Agenda) and the HHS 

Regulatory Agenda, which are 

published in the Federal Register, to 

provide advance notice and 

predictability to affected stakeholders 

about specific regulations that may be 

amended or rescinded.12

We have now determined that the 

mechanisms described in the SUNSET 

final rule, which include a dashboard 

on the HHS website that shows the 


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progress of Assessments and Reviews 

and when HHS expects them to be 

completed, are insufficient to provide 

adequate clarity concerning regulations 

that may be subject to automatic 

expiration. As discussed in greater 

detail in Section V.E, the rule includes 

a number of vague and confusing 

provisions that would make it difficult 

to determine when any given section of 

the CFR is subject to expiration. For 

example, a section may need to be 

reviewed multiple times as part of 

multiple rulemakings to avoid 

expiration, or it may require no review 

at all because it has been determined to 

fall within an exception. The public 

could not necessarily predict, from 

looking at the dashboard, the fate of that 

particular section. Moreover, 

rulemakings could be added or deleted 

from the dashboard at HHS’s discretion, 

so the fact that a particular rulemaking 

is absent would not necessarily mean 

that the public could draw conclusions 

regarding the rule’s expiration status 

until the expiration date is near. For 

these reasons, a dashboard indicating 

the progress of assessments and reviews 

would not adequately alleviate public 

uncertainty about the loss of 

regulations. These uncertainties could 

have several adverse repercussions as 

discussed in the Withdrawal NPRM, 

comments to the SUNSET proposed rule 

and Withdrawal NPRM, and below, for 

example, in the following comment and 

response. 

Comment: A variety of commenters 

including states, tribes, municipalities, 

hospital systems, insurers, healthcare 

providers, and patient advocacy 

organizations expressed support for the 

Withdrawal NPRM, citing the potential 

consequences of the SUNSET final rule 

creating uncertainty about the stability 

and predictability of HHS regulations 

and causing harm if HHS regulations 

were to actually expire. A number of 

commenters described the risk of such 

uncertainty for the Modified Adjusted 

Gross Income (MAGI) regulations, 

which are relied upon by states and 

state agencies to determine who is 

eligible for certain Medicare and 

Medicaid programs, Medicare 

Advantage, the Children’s Health 

Insurance Program (CHIP), and 

insurance affordability programs 

through the Health Insurance 

Marketplace, as well as the 

consequences of such uncertainty for 

individuals in trying to ascertain their 

likely eligibility for these programs. 

Commenters underscored that Medicaid 

and CHIP are large, complex, Federalstate health insurance programs that 

affect not only all of the states and 

territories, but also millions of 

beneficiaries, tens of thousands of 

providers, and hundreds of managed 

care plans. They stated that these 

stakeholders have a legitimate 

expectation of stability in the Federal 

regulatory guidelines for these programs 

and that predictable and reliable Federal 

regulations are essential to facilitate 

their effective implementation, so that 

providers understand what their 

obligations are, and beneficiaries can 

understand what they are entitled to 

receive. Commenters emphasized the 

significance of these and other HHS 

administered healthcare programs for 

seniors, children, the disabled, lowincome and rural communities, and 

other vulnerable segments of the 

population including people of color, 

members of the LGBTQ+ community, 

and others who suffer health disparities, 

and the dire consequences they would 

suffer if regulations were to expire 

under the SUNSET final rule and safety 

net programs were disrupted. 

Commenters noted that the SUNSET 

final rule is at odds with the policy 

goals of E.O. 14009, ‘‘Strengthening 

Medicaid and the Affordable Care Act’’, 

86 FR 7793, by weakening the strong 

regulatory framework necessary for 

states to implement these complex 

programs that provide health care access 

to millions of otherwise uninsured 

Americans. 

Other commenters described the 

potential impact of expiration on 

stakeholders in the food industry and on 

consumer confidence in the safety of 

food and medical products. They 

provided examples of harms that would 

result in the event FDA regulations 

concerning false and misleading 

medical product labeling and 

advertising, nutrition labeling, food 

safety, or food standards of identity 

were to expire. Comments on the 

SUNSET proposed rule provided 

numerous additional examples related 

to HHS programs, as discussed in the 

Withdrawal NPRM. 86 FR 59915–59917. 

Response: We thank the commenters 

for illustrating the many ways 

participants across the health care 

system and other Department programs 

would be harmed if they could not 

depend on the integrity and reliability 

of HHS regulations. We agree that, 

beyond the harm of regulatory 

uncertainty, the damage from actual 

expiration of regulations could be 

severe. As explained in the Withdrawal 

NPRM and in Section III.B., we have 

determined that regulations are likely to 

expire under the SUNSET final rule. 

Expiration could cause serious harm to 

millions of stakeholders who rely on 

HHS programs, including underserved 

populations; upend established 

understandings across the public health 

spectrum as to how to comply with 

statutory requirements; and disrupt 

established industry standards that 

advance public health, create a level 

playing field for businesses, and boost 

consumer confidence. Because of these 

potential harms, we now conclude that 

the automatic expiration provision is 

contrary to the Department’s mission to 

protect the health of all Americans and 

provide essential human services, 

especially for those who are least able 

to help themselves. 

States, non-state government entities, 

hospitals and other health providers, 

insurers and managed care plans, and 

other key stakeholders in our country’s 

health care system structure their 

programmatic and business operations 

to satisfy the current Federal 

regulations. These rules help 

beneficiaries and potential applicants to 

understand the coverage they are or may 

be entitled to receive, patients to 

understand their rights in accessing and 

receiving care, and providers to 

understand their patients’ coverage. As 

discussed in the Withdrawal NPRM, the 

expiration of these regulations could 

mean that these and other regulated 

entities would be unsure how to comply 

with long-standing statutory 

requirements and may no longer be 

compelled to comply with long-standing 

safety standards. See 86 FR 59915– 

59917. Likewise, we now recognize, as 

discussed in Section V.D of this 

preamble, that the SUNSET final rule 

could result in rescinding rules in their 

entirety without a rule-specific 

justification or an opportunity for the 

public to comment on that justification, 

including identifying potential harms 

associated with the expiration. 

2. Impacts on State, Local, and Tribal 

Governments 

Comment: Several tribal organizations 

explained that the SUNSET final rule 

would undermine crucial regulatory 

protections for AI/ANs in accessing 

healthcare, including HHS regulations 

that are based in statute and developed 

through years of government-togovernment consultation between Tribal 

Leaders and HHS Leadership. Tribal 

commenters expressed support for 

HHS’s Withdrawal NPRM because the 

SUNSET final rule threatens the 

regulations intended to protect AI/ANs. 

These commenters also opposed the 

SUNSET final rule because they said the 

Department failed to abide by the HHS 

Tribal Consultation Policy and conduct 

tribal consultation to minimize the 

implications of this rule on tribal 

governments. One tribal commenter 


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13See Nicole Galloway, Missouri State Auditor 

Report No. 2019–126 (Dec. 19, 2019) (available at 

https://app.auditor.mo.gov/Repository/Press/ 

2019126349658.pdf); Nicole Galloway, Missouri 

State Auditor Report No. 2017–152 (Dec. 19, 2017) 

(available at https://app.auditor.mo.gov/Repository/ 

Press/2017152319255.pdf). 

expressed appreciation for the change of 

direction on the SUNSET final rule and 

hoped that the Department continues in 

this spirit of accounting for the impact 

of such decisions on Tribal Nations. 

Response: HHS respects and 

appreciates the leadership and 

partnership of Tribal Nations in 

protecting the health of AI/ANs. The 

Department is committed to 

strengthening the Nation-to-Nation 

relationship between the United States 

and federally recognized Indian Tribes. 

As discussed in the Withdrawal 

NPRM, HHS acknowledges that 

consultation with Tribal governments 

on the SUNSET proposed rule was not 

adequate. The Department also 

recognizes that it previously stated that 

the SUNSET final rule ‘‘would have no 

direct impact on Indian Tribes, beyond 

their costs of participation in the 

monitoring, Assessment, and Review 

processes,’’ based on an assumption that 

regulations would not expire. 86 FR 

5711. However, we have now 

determined, and explained in detail 

throughout this preamble, that the 

Department’s prior assumption that 

regulations would not expire was not 

well-founded. Therefore, HHS has 

revised its view of the impacts of the 

SUNSET final rule on Tribal Nations. 

The IHS serves over 2.6 million AI/ 

ANs and the Department recognizes that 

there are stark health disparities that 

persist in Tribal communities. The 

COVID–19 pandemic’s devastating 

impact on Tribal communities has 

demonstrated the real human toll of 

these disparities. HHS concludes that 

the SUNSET final rule would only make 

it harder to expand access to highquality health care across Indian 

Country, because it is likely to divert 

resources from HHS programs serving 

Tribes and introduce uncertainty and a 

threat of expiration for regulations that 

support HHS programs serving tribal 

communities. Likewise, the SUNSET 

final rule does not provide for advance 

notice of regulations that might 

automatically expire which would make 

it difficult for the Department or Tribes 

to initiate consultation. Moreover, even 

if these significant deficiencies could be 

improved, it would still not resolve 

more fundamental problems the 

SUNSET framework presents for tribal 

stakeholders, such as the burdens 

imposed on and uncertainties created 

for many stakeholders. 

As discussed in the Withdrawal 

NPRM, HHS now acknowledges the 

SUNSET final rule conflicts with the 

Department’s policy to engage in 

meaningful consultation. See 86 FR 

55911. HHS believes finalizing the 

Withdrawal NPRM is consistent with 

the objectives of the January 26, 2021, 

Presidential memorandum on ‘‘Tribal 

Consultation and Strengthening Nationto-Nation Relationships,’’ which 

reaffirmed the tribal consultation policy 

outlined in E.O. 13175, and announced 

that the Biden-Harris administration 

priority to make respect for Tribal 

sovereignty, self-governance, and 

regular, meaningful, and robust 

consultation with Tribal Nations 

cornerstones of Federal Indian policy. 

86 FR 7491. 

Comment: A number of states, 

municipalities, and State attorneys 

general expressed concern that the 

SUNSET final rule would pose a direct 

threat to state health care systems and 

the health and safety of their residents. 

The commenters indicated that states 

are directly threatened by the SUNSET 

final rule because they depend on HHS 

to administer trillions of dollars in 

Federal funding, governed by an 

intricate web of regulations and 

requirements. A comment from State 

attorneys general explained that, by 

permitting complex regulatory systems 

to automatically expire, the SUNSET 

final rule could have dire consequences 

for those who stand to lose health 

benefits or services but have no recourse 

to prevent that loss. One commenter 

stated that the SUNSET final rule stands 

to undermine the operations of state 

partners, such as state Medicaid 

agencies, and would impede their 

ability to provide services for Medicaid 

beneficiaries. 

Response: We agree that many diverse 

stakeholders throughout the country, 

including states, state Medicaid and 

other program agencies, and tribal 

governments, as well as health care 

providers, program beneficiaries, and 

others who rely on the legal framework 

established by the Department’s 

regulations and their implementation of 

the relevant statutes, could experience 

undue disruption as a result of the 

SUNSET final rule. As discussed in the 

Withdrawal NPRM, the automatic, 

potentially haphazard and 

unpredictable expiration of regulations 

could result in significant disruption, 

based on the sudden and unexamined 

removal of the prior regulatory 

framework without accompanying 

explanation or replacement. We 

appreciate the comments highlighting 

challenges that this scenario could 

present for many stakeholders, 

including state and tribal governments. 

3. Other Comments on Expiration 

Comment: A few commenters 

expressed doubt that accidental and 

unintended expiration of regulations 

would occur and pointed to the 

experience of North Carolina and 

Missouri. Each of those states has an 

established process for the review of 

state regulations that features a sunset 

mechanism. One commenter stated that 

North Carolina’s process resulted in no 

reports of accidental expirations. The 

commenter suggested that, because the 

quantity of HHS regulations is similar to 

the number of all regulations 

promulgated in North Carolina, the 

process should not be difficult for HHS 

to implement and avoid any expiration 

of a regulation. A second comment 

stated that Missouri connects a sunset 

provision to a five-year periodic review 

requirement in a manner similar to the 

SUNSET rule. The commenter shared a 

quote from the Missouri attorney 

general stating that they were not aware 

of any regulations that had expired as a 

result of Missouri’s sunset provision 

and that state agencies review every 

regulation under their control. 

Response: We address in greater detail 

in Section V.C the many significant 

differences between the SUNSET final 

rule and these and other state sunset 

laws—here we address only the specific 

points regarding the potential expiration 

of regulations. We disagree with these 

commenters in their assertions that we 

should extrapolate from these state 

examples to conclude that regulations 

would not expire under the SUNSET 

final rule because there are too many 

substantial differences to make a direct 

comparison helpful or appropriate. 

North Carolina’s reviews are less 

burdensome overall because North 

Carolina’s experience does not entail the 

multi-factor review and assessment 

required by the SUNSET final rule. We 

similarly find that Missouri’s experience 

does not match the scale and scope of 

the SUNSET final rule’s assessment and 

review scheme. For example, the most 

recent reports of the Missouri State 

Auditor responsible for assessing state 

agency compliance with periodic rule 

review found that the Missouri 

Department of Health and Human 

Services reviewed 759 rules and 

received no comments on its review and 

that the Department of Mental Health 

reviewed 156 rules and received 14 

comments.13 These rules represent a 

small fraction of the number of HHS 

regulations covering all of the HHS 

agencies and divisions, and the 

comment offers no analysis as to 

whether individual Missouri rules are 


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comparable to HHS regulations in terms 

of length and complexity. Furthermore, 

HHS regulations are national in scope, 

have an impact on a much greater 

number of programs and persons, and 

cover more diverse circumstances than 

state regulations. In issuing its 

regulations, HHS also follows Federal 

procedures and policies as set forth in 

statutes, EOs, and Department 

memoranda, which are not applicable to 

states. Accordingly, the review of HHS 

regulations is likely to entail greater 

complexities and the level of public 

interest in the HHS rules is likely to be 

much higher, which would result in 

significantly more comments. Thus, the 

pace and resources required to review 

North Carolina’s and Missouri’s 

inventory of regulations are not 

indicative of what HHS would 

experience under the SUNSET final 

rule, including the likelihood of 

expiring regulations. 

Moreover, as explained in Section 

III.B., implementation of the SUNSET 

final rule would require the Department 

to choose how to prioritize its resources 

as between (1) addressing existing and 

new priorities, including promulgating 

new congressionally directed 

regulations, and (2) preserving 

regulations from expiration. The fact 

that certain states with ‘‘sunset’’ 

programs can, and have chosen to, 

allocate resources in a way that 

preserves their regulations from 

expiration does not in any way imply 

that HHS would or could make the same 

choices in confronting this question. As 

explained above, we have considered 

the overall burdens and the ways in 

which full implementation of the 

SUNSET program would undermine 

other Department objectives, and we 

have concluded that prioritizing 

resources on SUNSET compliance, in 

order to avoid regulatory expiration, is 

not in the best interests of the public 

health and welfare. Therefore, we think 

regulations will expire. Whether states 

have made different choices does not 

determine the Department’s analysis 

regarding its obligations and priorities. 

C. Comments on the RFA and 

Retrospective Review 

In the Withdrawal NPRM, we 

tentatively concluded that the final rule 

may be harmful to small entities, 

inconsistent with Congress’s intent in 

enacting the RFA, and unnecessary to 

achieve the RFA’s objectives or to 

incentivize the Department to engage in 

retrospective review. 86 FR 59917. In 

this section, we respond to the 

comments submitted both on policy 

issues related to retrospective review 

and on compliance with the RFA. 

1. SUNSET Final Rule’s Degree of 

Consistency With the RFA 

Comment: Numerous commenters 

supported withdrawal of the SUNSET 

final rule as inconsistent with the RFA. 

Many of these commenters agreed with 

HHS’s assertion in the Withdrawal 

NPRM that the SUNSET final rule 

imposes requirements beyond the 

requirements of the RFA. Several of 

these commenters noted that the RFA 

focuses on review of only those rules 

that have or will have a ‘‘Significant 

Economic Impact Upon a Substantial 

Number of Small Entities’’ (SEISNOSE), 

and the SUNSET rule exceeds that 

scope because it requires assessment of 

all agency rules regardless of whether 

they have a SEISNOSE. One commenter 

noted that the majority of the 

regulations to which the SUNSET final 

rule applies do not actually fall within 

the scope of the RFA, citing the 

SUNSET final rule’s assumptions, 

which estimate that only 15% of the 

Department’s regulations have a 

SEISNOSE. Commenters also 

questioned HHS’s authority to impose 

the SUNSET rule’s requirements for the 

scale and speed of assessments and 

reviews in the absence of express 

authorization in the RFA. One 

commenter noted that courts have 

uniformly recognized the limited scope 

of the RFA and that the SUNSET final 

rule’s expansion of the RFA’s 

requirements finds no support in the 

text or purpose of the statute. Several 

commenters also noted that the RFA 

does not authorize agencies to 

retroactively impose a blanket 

expiration date to rescind regulations. 

Response: The Department agrees 

with these commenters that the 

SUNSET final rule’s requirements 

exceed the RFA’s requirements. 

Specifically, the Department agrees with 

the commenters who noted that the 

rule’s requirement that the Department 

‘‘assess’’ all HHS regulations within 

certain timeframes, to determine 

whether the regulations have or will 

have a SEISNOSE, exceeds the express 

requirements of section 610 of the RFA, 

which contemplates periodic review of 

only ‘‘rules . . . which have or will 

have a [SEISNOSE].’’ Nothing in the 

express language of that section requires 

agencies to identify such rules by 

conducting ‘‘assessments’’ of every rule 

issued by the agency and to comply 

with the SUNSET final rule’s notice and 

comment requirements for such 

assessments. Indeed, section 610 does 

not specify any means of identifying 

rules that have or will have a 

SEISNOSE. Section 610(a)’s silence with 

respect to identifying rules that have or 

will have a SEISNOSE, when contrasted 

with other provisions of that section 

explicitly imposing specific 

requirements on agencies’ retrospective 

reviews, see, e.g., 5 U.S.C. 610(b) 

(requiring agencies to consider specific 

enumerated factors when conducting 

reviews), indicates that Congress 

intended to leave such determinations 

to agencies’ discretion. See Fisher v. 

Pension Benefit Guar. Corp., 994 F.3d 

664, 671 (D.C. Cir. 2021) (‘‘In an 

administrative setting, . . . ‘the contrast 

between Congress’ mandate in one 

context with its silence in another 

suggests . . . a decision not to mandate 

any solution in the second context, i.e., 

to leave the question to agency 

discretion.’ ’’). 

Judicial decisions have reinforced 

agencies’ discretion under the RFA. As 

the D.C. Circuit has explained, ‘‘the Act 

in and of itself imposes no substantive 

constraint on agency decisionmaking,’’ 

Nat’l Tel. Co-op Ass’n v. FCC, 563 F.3d 

536, 540 (D.C. Cir. 2009), but instead is 

limited to ‘‘setting out precise, specific 

steps an agency must take,’’ 

Aeronautical Repair Station Ass’n, Inc. 

v. FAA, 494 F.3d 161, 178 (D.C. Cir. 

2007). Courts have therefore instructed 

that the RFA ‘‘requires nothing more 

than that the agency . . . demonstrate[e] 

a reasonable, good faith effort to carry 

out’’ those steps. U.S. Cellular Corp. v. 

FCC, 254 F.3d 78, 88 (D.C. Cir. 2001); 

Aeronautical Repair Station, 494 F.3d at 

178 (‘‘[Section 604 of] the Act requires 

agencies to publish analyses that 

address certain legally delineated 

topics. Because the analysis at issue 

here undoubtedly addressed all of the 

legally mandated subject areas, it 

complies with the Act.’’); see also 

Montgomery Cty., Maryland v. Fed. 

Commc’ns Comm’n, 863 F.3d 485, 495 

(6th Cir. 2017) (upholding agency’s final 

regulatory flexibility analysis as 

‘‘procedurally adequate’’); Zero Zone, 

Inc. v. United States Dep’t of Energy, 

832 F.3d 654, 683 (7th Cir. 2016) (citing 

U.S. Cellular Corp., 254 F.3d at 88); 

Alenco Commc’ns, Inc. v. FCC, 201 F.3d 

608, 625 (5th Cir. 2000) (citing Assoc. 

Fisheries of Me., Inc. v. Daley, 127 F.3d 

104, 114 (1st Cir. 1997)). 

In addition to not being mandated by 

the RFA, the assessment process in the 

SUNSET final rule is an overly 

burdensome and unnecessary means of 

identifying rules that have or will have 

a SEISNOSE. In fact, as discussed in 

more detail below, we now question 

whether the assessment process is a 

reasonable exercise of the Department’s 

discretion in light of the purpose and 

language of the RFA. As noted by one 

commenter, based on the Department’s 

assumptions in the RIA of the SUNSET 


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14See 5 U.S.C. 610(c) (requiring agencies to 

publish in the Federal Register a list of rules to be 

reviewed during the succeeding twelve months as 

well as invite public comment on rules to be 

reviewed). 15We note that, as discussed in Section V.D, 

expanding these timeframes would not resolve the 

myriad of problems with the SUNSET final rule 

discussed throughout this preamble, such as the 

burdens, confusion, and uncertainty imposed on 

stakeholders. 

final rule, which are adopted in the RIA 

of this final rule, only 530, or 

approximately 15%, of the Department’s 

rulemakings impose a SEISNOSE, 

whereas the SUNSET rule estimates the 

Department would need to assess a total 

of 3,574 rulemakings in order to identify 

those rules. The Department continues 

to believe that, had Congress intended 

for section 610 to mandate such a 

burdensome process for identifying a 

minority of rulemakings that have or 

will have a SEISNOSE, it would have 

said so explicitly. See Whitman v. Am. 

Trucking Ass’ns, 531 U.S. 457, 468 

(2001) (Congress ‘‘does not[ ] . . . hide 

elephants in mouse holes’’). Moreover, 

as explained in Section V.C.2 of this 

rule and the Withdrawal NPRM, 

conducting assessments of all HHS rules 

is not the only available means of 

identifying rules with a SEISNOSE, as 

commenters have identified numerous 

more targeted, efficient, and effective 

alternatives for identifying regulations 

that have or will have a SEISNOSE. We 

further note that, although the RFA 

applies across numerous government 

agencies, HHS is not aware of any 

department or agency issuing a similar 

sunset regulation or any litigation 

asserting that any department or agency, 

including HHS, has violated the RFA by 

failing to implement a rule like the 

SUNSET final rule. 

Moreover, as explained in the 

Withdrawal NPRM, principles of 

statutory construction do not support 

broadly interpreting section 610 to 

require agencies to simultaneously 

consider all regulations and do so on a 

recurring basis to determine whether 

they have or will have a SEISNOSE. 

Section 610(a) mandates that agencies 

publish a plan providing for a one-time 

simultaneous reexamination of 

regulations that have or will have a 

SEISNOSE. Had Congress intended for 

this plan to provide for simultaneous 

review that applies more broadly to all 

regulations and on a recurring basis, it 

would have said so. See, e.g., Salinas v. 

U.S. R.R. Retirement Bd., 141 S. Ct. 691, 

698 (2021) (quoting Russello v. United 

States, 464 U.S. 16, 23 (1983) (‘‘Where 

Congress includes particular language in 

one section of a statute but omits it in 

another section of the same Act, it is 

generally presumed that Congress acts 

intentionally and purposely in the 

disparate inclusion or exclusion.’’)). 

The Department also agrees with 

commenters that the SUNSET final 

rule’s automatic expiration provision— 

providing for the automatic expiration 

of any rule issued by the Department if 

it is not timely assessed or, as 

applicable, reviewed—exceeds the 

express requirements of the RFA. As 

explained in the Withdrawal NPRM, 

section 610 neither provides for 

automatic expiration of rules nor 

presumptively applies automatic 

expiration dates to regulations. Rather, 

it merely contemplates rescission or 

revision of rules, through the standard 

notice and comment rulemaking 

processes, only if they have or will have 

a SEISNOSE and if the Department has 

determined, based on its review of the 

factors set forth in section 610, that such 

rules should be rescinded or revised to 

minimize any SEISNOSE. We also note 

that section 608(b) of the RFA explicitly 

provides: ‘‘If the agency has not 

prepared a final regulatory analysis 

pursuant to section 604 of this title 

within one hundred and eighty days 

from the date of publication of the final, 

such rule shall lapse and have no 

effect.’’ The absence of any similar 

language in the RFA requiring rules to 

automatically lapse if an agency fails to 

comply with section 610 suggests that 

Congress did not intend for 

noncompliance with section 610 to have 

such an effect. See, e.g., Salinas, 141 S. 

Ct. at 698. 

The Department also notes that other 

requirements in the SUNSET final rule 

extend beyond the express requirements 

in the RFA. For example, the SUNSET 

final rule’s requirements for public 

notice and comment procedures with 

respect to assessments—such as 

publishing in the Federal Register a 

notice within a month of commencing 

an assessment as well as a notice of the 

results of all assessments—extend 

beyond section 610’s notice and 

comment requirements. Although 

section 610 requires notice and 

comment procedures for retrospective 

review of rules which have or will have 

SEISNOSE,14 it does not require notice 

and comment procedures for the 

Department’s determinations of which 

regulations have or will have a 

SEISNOSE. Additionally, the SUNSET 

final rule’s expedited five-year timeline 

for the completion of certain reviews 

and two-year timeline for amending or 

rescinding regulations following such 

reviews go beyond the express 

requirements of section 610(a), which 

contemplate only that reviews of rules 

under that section be conducted ‘‘within 

ten years’’ of specific dates.15

Additionally, the Department agrees 

with commenters that the automatic 

expiration provision and other 

requirements imposed by the SUNSET 

rule otherwise lack support in the 

language and purpose of the RFA. For 

the reasons already explained, the RFA 

does not explicitly impose or authorize 

these requirements. Moreover, as 

explained in the Withdrawal NPRM, 

these requirements appear to be 

inconsistent with the intent and 

purpose of the RFA as expressed in the 

statute’s language and legislative 

history. Specifically, the automatic 

expiration provision—by providing for 

the automatic expiration of rules 

without consideration of the impact of 

the rules on small entities or the 

statutory objectives the rule 

implements—appears to be inconsistent 

with the RFA’s intent to balance the 

objectives of the RFA with the 

objectives of statutes critical to public 

health. Congress expressed this intent in 

the language of section 610(a) itself, 

which contemplates the rescission of 

rules only if ‘‘consistent with the stated 

objectives of applicable statutes’’ and if 

the agency has determined that that the 

rule should be rescinded ‘‘to minimize 

any significant economic impact of the 

rules upon a substantial number of . . . 

small entities.’’ The RFA’s legislative 

history further expresses this intent, 

stating that Congress did not intend for 

the RFA’s requirements to ‘‘undermine 

. . . important [regulatory] 

achievements,’’ specifically those in the 

area of public health. 126 Cong. Rec. 

21,448, 21,451 (August 6, 1980) 

(statement of Sen. Culver, sponsor of S. 

299, which was ultimately enacted as 

amended as the RFA); see also S. Rep. 

96–878 (1980) (‘‘The Committee is 

emphatically opposed to any weakening 

of the legislatively mandated goals of 

federal regulation in the name of cost 

reduction. The bill clearly stipulates 

that there is to be no loss of regulatory 

goals. The language states that agencies 

shall seek and consider alternative 

proposals to the proposed rule 

‘consistent with the stated objectives of 

applicable statutes.’’). Rather, Congress 

intended that ‘‘agencies . . . continue to 

enforce [substantive] laws in a fully 

effective fashion,’’ id., and that 

‘‘environmental, health or safety 

catastrophes must never be made more 

likely because of flexible regulations,’’ 

id. at 21,455 (Description of Major 

Issues and Section-by-Section Analysis 

of Substitute for S. 299). 

In addition to the automatic 

expiration provision, other SUNSET 

final rule requirements exceeding the 

express requirements of section 610 


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appear inconsistent with the RFA’s 

intent. As explained previously in this 

preamble and in the Withdrawal NPRM, 

compliance with the SUNSET final 

rule’s requirement to assess thousands 

of regulations within certain timeframes 

would require the agency to divert 

resources from the Department’s 

significant public health objectives and 

potentially impair its ability to achieve 

those objectives. The RFA’s legislative 

history indicates that such a burden 

imposed by assessments would be 

contrary to Congress’s intent that 

‘‘regulatory flexibility legislation [not] 

undermine . . . important [regulatory] 

achievements.’’ 126 Cong. Rec. 21,451 

(statement of Sen. Culver); see also id. 

at 21,455 (Description of Major Issues 

and Section-by-Section Analysis of 

Substitute for S. 299) (addressing 

concerns that the RFA ‘‘might require 

agencies to significantly compromise 

the objectives of underlying statutes 

authorizing rulemaking’’). Such burdens 

on the Department’s ability to achieve 

important statutory objectives related to 

public health also appear inconsistent 

with the RFA’s intent to enhance 

administrative efficiency in the 

achievement of such objectives. See 126 

Cong. Rec. 21,456 (Description of Major 

Issues and Section-by-Section Analysis 

of Substitute for S. 299) (emphasizing 

that ‘‘regulatory flexibility should be 

considered a means of improving 

administrative effectiveness in enforcing 

the regulatory statutes which the 

Congress has enacted rather than an 

additional bureaucratic burden’’); see 

also S. Rep. 96–878 (stating that S. 299’s 

findings include ‘‘that reasonable 

alternative rules and regulations could 

be developed . . . without a significant 

loss of regulatory efficiency’’). 

Furthermore, the SUNSET final rule’s 

requirements exceeding the express 

requirements of section 610 also appear 

to be inconsistent with the RFA’s 

purpose of alleviating the regulatory 

burden on small entities. See, e.g., 126 

Cong. Rec. 21,449 (Description of Major 

Issues and Section-by-Section Analysis 

of Substitute for S. 299) (explaining that 

the RFA seeks to address the 

‘‘unnecessary and disproportionately 

burdensome demands . . . [of uniform 

regulatory requirements] upon small 

[entities] . . . with limited resources’’). 

As discussed in Section V.A and V.B of 

this preamble, the regulatory 

uncertainty created by the sudden 

expiration and threat of sudden 

expiration of regulations would 

disproportionately burden small entities 

who rely on regulations to level the 

playing field and lack the resources to 

successfully navigate a confusing 

regulatory landscape. See 126 Cong. 

Rec. 21,453 (Description of Major Issues 

and Section-by-Section Analysis of 

Substitute for S. 299) (finding that small 

entities often have limited access to 

regulatory expertise and capital as 

compared to larger businesses). 

Additionally, the scope of and 

compressed timelines for the 

assessments required by the SUNSET 

final rule would undermine small 

entities’ ability to provide input and 

data and otherwise participate in the 

assessment and review process, as well 

as undermine the Department’s ability 

to meaningfully consider such 

information. Such a result would be 

inconsistent with the RFA’s intent to 

‘‘give small businesses a greater 

opportunity to participate in shaping 

rules which would affect them.’’ 126 

Cong. Rec. 21,451 (statement of Sen. 

Culver). This result would also 

undermine the quality of the 

Department’s reviews and, therefore, the 

Department’s ability to accomplish the 

purpose of retrospective reviews as 

stated in section 610(a), which is ‘‘to 

minimize any significant economic 

impact of the rules upon a substantial 

number of such small entities.’’ 

For these reasons, the Department 

agrees with the commenters that the 

SUNSET final rule’s requirements 

exceed the express requirements of the 

RFA and appear to be inconsistent with 

the intent and purpose of the RFA as 

expressed in the statute’s language and 

legislative history, as well as case law 

interpreting the statute. We recognize 

that we previously took the position, in 

the SUNSET final rule, that the ‘‘rule 

does not impose any additional burden 

on the Department beyond what was 

already called for in the RFA,’’ 86 FR 

5705, but after further considering the 

RFA and its legislative history, we now 

consider that prior position erroneous. 

Comment: Several commenters 

asserted that the SUNSET final rule, 

including its automatic expiration 

provision, is consistent with section 610 

of the RFA. One commenter stated that 

the SUNSET rule accomplishes nothing 

new, different from, or contrary to the 

RFA because the RFA expressly 

contemplates rule rescission as one of 

the outcomes of retrospective review, 

and the SUNSET rule’s automatic 

expiration provision preserves rule 

rescission as one of the options 

available to HHS upon completion (or 

not) of retrospective review under the 

RFA. Another commenter claimed that 

a 10-year automatic expiration provision 

seems entirely appropriate and 

consistent with the RFA’s Congressional 

intent based on the view that the RFA 

already requires HHS to conduct 10-year 

reviews under section 610. Another 

commenter stated that the SUNSET rule 

is consistent with section 610 because it 

simply establishes an enforcement 

mechanism for that section. One 

commenter questioned the Department’s 

conclusion that the SUNSET final rule’s 

assessment requirement goes beyond the 

requirements of section 610 and states 

that the Department must assess rules to 

determine whether a rule has or will 

have a SEISNOSE under section 610. 

The commenter also noted that 

assessments of rules not previously 

identified as having a SEISNOSE would 

impose a ‘‘minimal burden’’ because 

‘‘[i]t is likely that most of th[ose] . . . 

regulations would remain’’ without a 

SEISNOSE and therefore ‘‘only a simple 

assessment of these rules would be 

necessary.’’ 

Response: The Department disagrees 

with the commenters that the SUNSET 

final rule, including the automatic 

expiration provision, is no different 

from and consistent with the RFA, for 

the reasons already explained in the 

prior comment response. 

Specifically, with respect to the 

automatic expiration provision, the RFA 

contains no explicit or implicit 

authority for an automatic expiration 

provision, and such a provision is 

inconsistent with the RFA’s intent and 

purpose. Thus, the Department 

disagrees with the commenter that the 

automatic expiration provision is not 

different from or inconsistent with the 

requirements in the RFA. Although 

section 610 of the RFA does 

contemplate rule rescission as a 

potential outcome of retrospective 

review, it contemplates rescission of 

rules only through the standard noticeand-comment process. Furthermore, 

that outcome would apply only to rules 

that have or will have a SEISNOSE and 

for which the agency has conducted a 

review considering the factors set forth 

in section 610 and has determined, in 

its discretion and based on the results 

of the review, whether the rule at issue 

‘‘should be amended or rescinded, 

consistent with the stated objectives of 

applicable statutes, to minimize any 

significant economic impact of the rules 

upon a substantial number of such small 

entities.’’ 5 U.S.C. 610(a). In contrast, 

the automatic expiration provision 

explicitly mandates automatic 

rescission of any rule, regardless of 

whether it has or will have a SEISNOSE, 

not based on the agency’s consideration 

of the relevant statutory factors or the 

potential for rescission to minimize 

SEISNOSE, but simply based on the 

agency’s failure to conduct an 

assessment or review of the rule within 

certain timeframes. Therefore, the 


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16See Notice of Plan for Periodic Review of Rules, 

46 FR 36332 (July 14, 1981). We note that FDA 

simultaneously published in the Federal Register 

its own plan for periodic review of its rules as a 

supplement to the Department’s plan. See Notice, 

46 FR 36333 (July 14, 1981) (‘‘This notice 

supplements the Department plan with additional 

information about FDA procedures for reviewing 

existing rules.’’). 

17See, e.g., 46 FR 36332 (‘‘[T]he Department and 

those staff divisions which administer rules will 

inventory and review all regulations for the purpose 

of selecting those regulations that should receive 

early, in depth review and revision, where 

necessary, to reduce regulatory burdens’’ and 

identifying principles to guide prioritization of 

review of existing regulations); id. (‘‘[A]gencies and 

offices of the Department will seek to identify for 

earliest review those regulations for which revision 

will most advance [certain] principles,’’ including 

‘‘[m]inimiz[ing] Federal, State, local, and private 

costs’’ and ‘‘[p]revent[ing] fraud, abuse, waste, and 

inefficiency’’); id. (‘‘The Department’s semiannual 

agenda will advise the public of regulations 

selected for review’’); id. at 36333 (‘‘[I]t is important 

that to the extent possible the more costly and 

burdensome rules by reviewed first’’). 

commenter is incorrect that the 

automatic expiration provision can be 

equated to or is consistent with the 

rescission of rules under the RFA. 

Furthermore, as explained above, 

section 608(b) of the RFA explicitly 

requires rules to automatically ‘‘lapse 

and have no effect’’ if the agency fails 

to timely prepare a final regulatory 

analysis pursuant to section 604, and 

the absence of any similar language in 

the RFA requiring rules to automatically 

lapse if an agency fails to comply with 

section 610 suggests that Congress did 

not intend for noncompliance with 

section 610 to have such an effect. See, 

e.g., Salinas, 141 S. Ct. at 698. 

The Department also disagrees with 

commenters that the SUNSET final 

rule’s automatic expiration provision is 

consistent with section 610 because that 

section already requires agencies to 

conduct 10-year reviews or because the 

rule simply provides an enforcement 

mechanism for section 610’s review 

requirements. As already explained in 

the prior comment response, the 

SUNSET final rule’s requirement that 

agencies assess thousands of rules 

without a SEISNOSE, in some cases 

within an expedited five-year 

timeframe, exceeds the express 

requirements of section 610. Therefore, 

by mandating automatic expiration of 

rules without a SEISNOSE when the 

Department fails to timely assess them, 

the rule’s automatic expiration 

provision does not seek to enforce only 

the requirements of section 610 but also 

requirements not expressly imposed by 

that section. Moreover, the Department 

notes that section 611(a) of the RFA 

already provides a remedy for agency 

noncompliance with section 610: 

Judicial review of such noncompliance 

and any relief deemed appropriate by 

the reviewing court. 

Additionally, the Department 

disagrees with the comment that the 

SUNSET final rule’s assessment 

requirement is necessary under or 

consistent with section 610. Indeed, 

HHS is not aware of any other Federal 

department or agency implementing a 

rule similar to the SUNSET final rule. 

As explained in the previous comment 

response, although section 610 

implicitly contemplates that agencies 

have some means of identifying rules 

with a SEISNOSE for retrospective 

review, it does not require agencies to 

conduct ‘‘assessments’’ of every rule 

and comply with the notice and 

comment requirements for such 

assessments. Rather, it is silent with 

respect to how agencies identify rules 

with SEISNOSE for review. This 

indicates that Congress intended to 

leave these determinations to agencies’ 

discretion, see Fisher, 994 F.3d at 671, 

and the Department, in its discretion, 

has now determined that the assessment 

process in the SUNSET final rule is 

overly burdensome and unnecessary for 

making such determinations. 

Moreover, the commenter’s suggestion 

that assessments would impose a 

‘‘minimal burden’’ is not persuasive. 

The only support the commenter cited 

for this assertion is its speculation that 

assessments of rules previously 

identified as not having a SEISNOSE 

would be ‘‘simple’’ because ‘‘[i]t is 

likely that most of th[ose] . . . 

regulations would remain’’ without a 

SEISNOSE. However, even if the 

commenter is correct that such rules are 

likely to remain without a SEISNOSE, 

the SUNSET final rule would still 

require the Department to assess them to 

determine whether that is the case, and 

in doing so, the Department would need 

to examine any relevant experience with 

the rule since its promulgation. 

Furthermore, the commenter failed to 

acknowledge that even assessments that 

are potentially more straightforward 

than others would still be subject to the 

extensive requirements the SUNSET 

final rule imposes on every assessment, 

including requirements for announcing 

the assessment on the website and in 

the Federal Register, opening a public 

docket, considering comments to the 

docket, and publishing the full results 

in the Federal Register. Given these 

requirements, the Department does not 

agree with the commenter that any 

assessment under the SUNSET final rule 

would be ‘‘simple’’ or that the 

assessment process as a whole would 

impose a ‘‘minimal burden.’’ 

2. HHS Compliance With the RFA 

Comment: Several commenters 

contended that withdrawal of the 

SUNSET final rule violates the RFA 

because, without the rule, the 

Department would not comply with 

section 610. These commenters asserted 

that HHS historically has not complied 

with section 610, and withdrawal of the 

rule would allow the Department to 

continue its noncompliance. Some of 

these commenters maintained that the 

SUNSET final rule is HHS’s current 

‘‘plan’’ for periodic review under 

section 610(a), and therefore repealing it 

will leave HHS without the required 

plan. One commenter asserted that HHS 

cannot repeal the SUNSET final rule 

because section 610 allows agencies 

only to ‘‘amend’’ their plans for 

retrospective review. Another 

commenter asserted that HHS has failed 

each year to ‘‘publish in the Federal 

Register a list of the rules . . . which 

are to be reviewed pursuant to . . . 

section [610] during the succeeding 

twelve months’’ under section 610(c). 

The commenters also claimed that the 

RFA requires (‘‘shall provide for’’) that 

HHS conduct the retrospective reviews 

identified in section 610 on the 

timelines provided for in that section, 

and that HHS has not adequately 

conducted such reviews. 

Response: We disagree with these 

commenters’ assessments of the history 

of the Department’s compliance with 

the RFA and predictions about the 

Department’s future plans with respect 

to the RFA. As noted by commenters, 

section 610 requires agencies to: Publish 

in the Federal Register a plan for the 

periodic review of the rules issued by 

the agency which have or will have a 

SEISNOSE; and each year publish in the 

Federal Register a list of the rules 

which have a SEISNOSE and are to be 

reviewed pursuant to section 610 during 

the succeeding twelve months. HHS has 

complied with these requirements. 

First, following the enactment of the 

RFA, on July 14, 1981, the Department 

published in the Federal Register its 

plan for periodic review as required by 

section 610(a).16 That plan provides for, 

among other things, the Department’s 

review of regulations that have or will 

have a SEISNOSE and identifies 

processes and principles that guide such 

reviews, including principles for 

prioritizing those reviews.17

Accordingly, the Department has had a 

plan in place since shortly after the 

enactment of the RFA. Second, in 

accordance with that plan and section 

610(c), the Department each year 

publishes in the Federal Register a list 

of the rules with a SEISNOSE that it is 

reviewing, has reviewed, or intends to 

review under section 610, along with a 

discussion of the Department’s 


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18See, e.g., Semiannual Regulatory Agenda, 86 

FR 16892 (Mar. 31, 2021) (publishing under the 

RFA and E.O. 12866 the Department’s ‘‘semiannual 

. . . inventory of rulemaking actions under 

development throughout,’’ including ‘‘as required 

by the [RFA] . . . , those prospective HHS 

rulemakings likely to have a [SEISNOSE],’’ 

‘‘offering for public review summarized information 

about forthcoming regulatory actions the 

Department,’’ and describing and identifying 

examples of the Department’s ‘‘agency-wide effort 

to support the [Regulatory] Agenda’s purpose of 

encouraging more effective public participation in 

the regulatory process’’). 

19See, e.g., id. The Department also submits this 

information regarding rules it has identified for 

periodic review under section 610 in its 

submissions to the Unified Agenda. One commenter 

maintained that these Unified Agenda submissions 

cannot satisfy section 610 because they are not 

published in the Federal Register and they are not 

contained in a single document. However, as 

explained above, the Department publishes 

information satisfying section 610 in the Federal 

Register as a single document. See, e.g., Regulatory 

Information Service Center, Introduction to the 

Unified Agenda of Regulatory and Deregulatory 

Actions—Fall 2021, 87 FR 5002, 5009 (Jan. 31. 

2022). 

20Congress considered and rejected a provision 

included in an earlier version of the bill that would 

have supported the commenter’s position. See 46 

FR 21449 (section 5(a) of S. 299, which was 

amended before being enacted as the RFA, included 

the following: ‘‘Each agency shall periodically 

review its rules and regulations in accordance with 

the schedule and criteria set forth in its published 

plan.’’). 

21See Medicare and Medicaid Programs; 

Regulatory Provisions to Promote Program 

Efficiency, Transparency, and Burden Reduction; 

Fire Safety Requirements for Certain Dialysis 

Facilities; Hospital and Critical Access Hospital 

(CAH) Changes to Promote Innovation, Flexibility, 

and Improvement in Patient Care, 84 FR 51732 

(Sept. 30, 2019) (RIN 0938–AT23); see also 

Semiannual Regulatory Agenda, 84 FR 29633 (June 

24, 2019) (merged with 0938–AT23). 

22See Medicare and Medicaid Programs; Reform 

of Requirements for Long-Term Care Facilities, 81 

FR 68688 (Oct. 4, 2016); see also Regulatory 

Agenda, 81 FR 94754 (Dec. 23, 2016) (0938–AR61). 

23See, e.g., Medicare and Medicaid Programs; 

Regulatory Provisions to Promote Program 

Efficiency, Transparency, and Burden Reduction; 

Fire Safety Requirements for Certain Dialysis 

Facilities; Hospital and Critical Access Hospital 

(CAH) Changes to Promote Innovation, Flexibility, 

andImprovement in Patient Care, 84 FR 51732 

(Sept. 30, 2019). 

24 Improving Regulation and Regulatory Review, 

76 FR 3821 (Jan. 21, 2011). 

25FY 2021 Annual Performance Plan and 

Report—Regulatory Reform, HHS, https://

www.hhs.gov/about/budget/fy2021/performance/ 

regulatory-reform/index.html. 

commitment to compliance with the 

requirements and intent of section 

610.18 As required by section 610(c), 

this document includes for each such 

rule a brief description of the rule, its 

legal basis, and the opportunity for 

public comment.19 Therefore, the 

commenters are incorrect that 

withdrawal of the SUNSET final rule 

would leave the Department without a 

plan for the periodic review of rules as 

required by section 610(a), or that HHS 

does not comply with section 610(c). 

The commenters have not cited any 

authority that either of these sections 

requires more.20

The Department also disagrees with 

the commenter that it cannot repeal the 

SUNSET final rule because section 610 

permits agencies to only ‘‘amend[]’’ 

their plans for retrospective review. 

However, the language the commenter 

cites—‘‘[s]uch plan may be amended by 

the agency at any time,’’ 5 U.S.C. 

610(a)—is a broad grant of authority to 

agencies with respect to amending their 

plans for retrospective review, not a 

limitation. See, e.g., Adirondack Med. 

Ctr. v. Sebelius, 740 F.3d 692, 698 (D.C. 

Cir. 2014) (‘‘Congress generally knows 

how to use the word ‘only’ when 

drafting laws.’’). This interpretation of 

section 610(a) is also consistent with 

Congress’s intent as expressed in the 

remaining language of that provision, 

which sets forth the general requirement 

that agencies publish plans for 

retrospective review but does not 

further specify how agencies develop 

and implement those plans. Such 

language stands in stark contrast to 

section 610(b), which explicitly imposes 

specific requirements on agencies’ 

retrospective reviews. See Fisher, 994 

F.3d at 671 (‘‘In an administrative 

setting, . . . ‘the contrast between 

Congress’ mandate in one context with 

its silence in another suggests not a 

prohibition but simply a decision not to 

mandate any solution in the second 

context, i.e., to leave the question to 

agency discretion.’ ’’). 

We also disagree with the assertion in 

the comments that the SUNSET final 

rule is HHS’s current ‘‘plan.’’ As 

described above, HHS has had a 

retrospective review plan in place since 

1981, which was unacknowledged in 

the SUNSET final rule. Under that plan, 

among other things, the Department 

reviews regulations that have or will 

have a SEISNOSE and identifies 

processes and principles that guide such 

reviews, including principles for 

prioritizing those reviews. Because the 

SUNSET final rule never became 

effective, the Department has never 

implemented the SUNSET final rule as 

its retrospective review plan. Instead, 

HHS’s longstanding plan remains 

operative. 

Furthermore, as discussed in the 

Withdrawal NPRM and as noted by the 

commenters to that proposal, the 

Department has a meaningful track 

record of retrospective regulatory 

review. HHS conducts retrospective 

reviews of its regulations with impacts 

on small entities and publishes notice of 

the reviews in the Federal Register. 

Additionally, as acknowledged in the 

SUNSET final rule, the Department in 

2016 and 2019 issued final rules 

resulting from section 610 reviews 

updating the requirements of 

participation in the Medicare and 

Medicaid programs for hospitals and 

critical access hospitals 21 and long-term 

care facilities.22 These rulemakings, 

among other things, allowed these 

entities greater flexibility in meeting the 

requirements and eliminated 

unnecessary, obsolete, or overly 

burdensome requirements.23

As described in the Withdrawal 

NPRM and as noted by commenters to 

that proposal, the Department also has 

undertaken several other recent and 

significant retrospective regulatory 

review efforts. Several commenters 

noted the 2015 CMS initiative to 

modernize Medicaid Managed Care 

regulations for Medicaid and CHIP 

beneficiaries, and we also noted in the 

Withdrawal NPRM that the CMS Office 

of Burden Reduction and Health 

Informatics works to eliminate overburdensome and unnecessary 

regulations. Commenters additionally 

noted that the Department’s 2011 Plan 

for Retrospective Review of Existing 

Rules,24 an initiative developed in 

accordance with E.O. 13563 and E.O. 

13610, and plans the Department 

subsequently published from Fiscal 

Year 2012 through 2016, have served as 

a framework for its retrospective review 

of existing regulations. Under these 

plans, the Department identified rules 

that could be potentially eliminated as 

obsolete, unnecessary, burdensome, or 

counterproductive or that could be 

modified to be more effective, efficient, 

flexible, and streamlined. Additionally, 

as noted in the Withdrawal NPRM, the 

Department, in response to E.O. 13771, 

‘‘Enforcing the Regulatory Reform 

Agenda,’’ established a Regulatory 

Reform Task Force that oversaw an 

effort to evaluate existing regulations 

and make recommendations to the 

Secretary regarding their repeal, 

replacement, or modification, consistent 

with applicable law. While this E.O. has 

since been revoked, the published 

summary reports of these reviews for 

Fiscal Years 2018–2020 are available on 

the HHS website.25

Also noted in the Withdrawal NPRM, 

numerous additional regulatory efforts 

by HHS routinely involve the review of 

regulations. The Department provides 

technical assistance to Congress on 

proposed legislation, which quite often 

requires an assessment of the proposal’s 

impact on current regulations. FDA also 

reviews regulations in responding to 

certain citizen petitions submitted 


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26For example, the regulations FDA issued to 

implement FSMA included both the addition of 

new sections of regulation and revisions and 

modifications to existing sections. See FSMA Rules 

& Guidance for Industry (available at https://

www.fda.gov/food/food-safety-modernization-actfsma/fsma-rules-guidance-industry#Rules). 

27See Notice of Plan for Periodic Review of Rules, 

46 FR 36332 (July 14, 1981). 

28Commenters to the SUNSET proposed rule also 

expressed concern that the methodology of the AI 

review was never made public, and the SUNSET 

final rule confirmed that the ‘‘Department did not 

notify the public about this research project.’’ 86 FR 

5710. 

under 21 CFR 10.30, requesting changes 

in FDA regulations. Additionally, it is 

common for new HHS regulations to 

amend, revise, or modify sections of 

regulations in order to update, replace, 

or rescind requirements, or to add new 

definitions or clarifications, which 

inherently entails review of these 

sections.26 As another example, 

regulations are reviewed to determine if 

guidance documents are needed to 

provide recommendations for 

complying with the regulation, which is 

particularly important when the 

regulation is necessarily general or 

broad to accommodate scientific and 

other innovation changes, and guidance 

is helpful to consider applicability of 

the regulatory provisions. 

All of these initiatives demonstrate 

HHS’s commitment to reviewing its 

regulations. Thus, the suggestion in the 

comments that HHS will not adequately 

conduct periodic review under section 

610 of the RFA moving forward absent 

the rule is groundless and speculative. 

HHS is committed to effective and 

appropriate retrospective review of its 

regulations and looks forward to 

exploring ways to improve its processes 

through means other than binding 

regulations. 

Accordingly, the Department believes 

that the SUNSET rule is not necessary 

to ensure its compliance with section 

610 and that its ability to undertake 

regulatory review efforts in the future 

would be undermined by complying 

with the unnecessary and burdensome 

requirements of the SUNSET final rule. 

Comment: Several comments asserted 

that HHS has essentially admitted in the 

SUNSET final rule that, absent the rule, 

it does not otherwise comply with the 

RFA. One comment asserted that HHS 

admitted in the SUNSET final rule that 

‘‘all prior plans’’ for retrospective 

review did not meet the requirement to 

publish a plan under section 610 

‘‘because each prior plan hopelessly 

failed to provide for any review of each 

regulation within ten years, if ever.’’ 

The comment also cited the following 

statements in the SUNSET final rule: 

HHS has had ‘‘limited success in 

performing retrospective regulatory 

review,’’ 86 FR 5738; ‘‘the Department’s 

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

at times been lacking,’’ id. at 5696; and 

‘‘The Department’s experience over the 

last forty years is that, absent a strong 

incentive such as the potential 

expiration of a regulation, the 

Department will not review an adequate 

number of its regulations,’’ id. at 5739. 

Another comment asserted that HHS 

admitted that many of its rules have 

remained untouched for years. Two of 

these comments questioned the 

Withdrawal NPRM’s assertion that 

many rules have remained untouched 

because they work as intended, 

asserting that the Withdrawal NPRM 

does not provide evidence to support 

this assertion. One comment asserted 

that if a rule finalized in the 1980s or 

1990s is working as intended, that 

means it is likely out of date because 

rule’s drafters could not have 

envisioned the technological and 

informational improvements that have 

taken place since the rule’s 

promulgation. 

Response: The Department disagrees 

with the comments that the SUNSET 

final rule concluded or demonstrated 

that HHS does not comply with the RFA 

absent that rule, but, to the extent that 

the SUNSET final rule is understood to 

convey that conclusion, we now think 

that conclusion is wrong. First, the 

SUNSET final rule does not state that 

‘‘all prior plans’’ for the Department’s 

retrospective review do not satisfy 

section 610(a), nor could it. For 

example, as explained in a prior 

comment response, the Department in 

1981 published in the Federal Register 

a plan for retrospective review that 

directly responds to the requirements 

under the RFA and provides for the 

Department’s periodic review of 

regulations that have or will have a 

SEISNOSE.27 Thus, HHS fulfilled 

section 610(a)’s ‘‘plan’’ requirement 

long before the promulgation of the 

SUNSET final rule. Notably, the 

SUNSET final rule does not even refer 

to this plan, let alone assert that it does 

not satisfy section 610(a)’s 

requirements. 

Second, neither the statements from 

the SUNSET final rule cited by the 

comments, nor the evidence cited for 

those statements, establish 

noncompliance or support the 

comments’ conclusion that HHS does 

not otherwise comply with the RFA. For 

example, the SUNSET final rule’s 

statement that the Department has had 

‘‘limited success in performing 

retrospective regulatory review’’ does 

not assert that the Department does not 

comply with section 610 specifically. As 

the SUNSET final rule shows, the 

Department under the previous 

administration expressed the policy 

position that extensive retrospective 

review, across the Department’s entire 

regulatory portfolio, was appropriate 

and should be prioritized above other 

Department priorities; its statements of 

‘‘limited success,’’ ‘‘lacking’’ efforts, and 

‘‘adequate’’ review must be understood 

in the context of these prior 

expectations and priorities rather than 

compliance with the RFA. Furthermore, 

the evidence the Department cited as 

support also does not specifically 

pertain to the Department’s section 610 

reviews or necessarily reveal anything 

about them. Specifically, this evidence 

includes: (1) An artificial intelligence 

(AI) data analysis of HHS regulations 

identifying that ‘‘85% of Department 

regulations created before 1990 have not 

been edited; the Department has nearly 

300 broken citation references in the 

CFR; and there are more than 50 

instances of HHS regulatory 

requirements to submit paper 

documents in triplicate or 

quadruplicate’’; and (2) a 2018 study 

estimating that 68% of Federal 

regulations have never been updated. 86 

FR 5710. The SUNSET final rule does 

not assert that the HHS regulations 

identified in this analysis are 

regulations with a SEISNOSE subject to 

section 610, and there appears to be no 

reason to assume that is the case. See 86 

FR 5710 (acknowledging that AI 

‘‘cannot at this time easily determine if 

a regulation satisfies the criteria listed 

in 5 U.S.C. 610’’). Indeed, based on the 

SUNSET final rule’s estimate that only 

15% of the Department’s regulations 

have or will have a SEISNOSE, it is 

possible that none of the regulations 

identified in either study are rules that 

have or will have a SEISNOSE. Thus, 

there appears to be no reason to 

conclude that the rules identified as 

unedited or flawed are rules with 

SEISNOSE that should be reviewed 

under section 610.28

Another HHS statement cited by the 

comment—that ‘‘the Department’s 

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

at times been lacking,’’ 86 FR 5696— 

also does not assert or establish that the 

Department does not comply with 

section 610. The statement merely 

suggests a belief that, ‘‘at times,’’ the 

Department could have improved its 

processes for retrospective review under 

section 610. It does not explicitly assert 

that the Department, then or now, fails 

to comply with the RFA. Additionally, 

like the data discussed above, the data 

the statement cites as support does not 


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29 ‘‘Medical Device Submissions: Amending 

Premarket Regulations That Require Multiple 

Copies and Specify that Paper Copies To Be 

Required in Electronic Format,’’ 84 FR 68334 (Dec. 

16, 2019). 

30OMB Memorandum M–11–10, ‘‘Executive 

Order 13563, ‘Improving Regulation and Regulatory 

Review’ ’’ (Feb. 2, 2011) (available at https://

www.whitehouse.gov/wp-content/uploads/legacy_

drupal_files/omb/memoranda/2011/m11-10.pdf). 

pertain specifically to reviews 

conducted under section 610. 

Specifically, the statement cites the 

number of retrospective analyses the 

Department has conducted in response 

to E.O. 13563. 86 FR 5696. However, 

E.O. 13563, unlike section 610, does not 

contemplate periodic review of only 

rules with a SEISNOSE for the purpose 

of minimizing SEISNOSE but instead 

applies to ‘‘existing significant 

regulations’’ for the purpose of assessing 

a far broader set of factors not focused 

on small entities, including ‘‘whether 

any such regulations should be 

modified, streamlined, expanded, or 

repealed . . . to make [an] agency’s 

regulatory program more effective or 

less burdensome in achieving the 

regulatory objectives.’’ See Improving 

Regulation and Regulatory Review, 76 

FR 3821, 3822 (Jan. 18, 2011). Therefore, 

the Department’s reviews conducted in 

response to that E.O. do not necessarily 

indicate anything about the number of 

reviews the Department has conducted 

or should consider conducting under 

section 610. The SUNSET final rule 

itself appears to recognize the limited 

value of these data by concluding only 

that ‘‘[t]hese findings are consistent with 

government assessments that the 

Department’s efforts to comply with 5 

U.S.C. 610 have at times been lacking.’’ 

86 FR 5696 (emphasis added). 

The final HHS statement cited by the 

commenter—‘‘The Department’s 

experience over the last forty years is 

that, absent a strong incentive such as 

the potential expiration of a regulation, 

the Department will not review an 

adequate number of its regulations’’—is 

equally flawed. Again, this statement 

does not explicitly address the adequacy 

of the Department’s reviews of 

regulations under section 610 but only 

generally refers to ‘‘review . . . of [ ] 

regulations.’’ Moreover, as explained 

above, the statement’s implication that 

the Department has not conducted an 

‘‘adequate’’ number of reviews must be 

understood in the context of the 

Department’s policy position under the 

previous administration that extensive 

retrospective review across its entire 

regulatory portfolio was appropriate and 

should be prioritized above other 

agency priorities. 

Third, the SUNSET final rule’s 

discussion of the Department’s section 

610 compliance and record of 

retrospective review contains errors and 

misstatements. In relying on studies 

purporting to demonstrate that HHS’s 

regulations have not been edited or are 

otherwise flawed, the SUNSET final 

rule appears to incorrectly assume that 

the age of a regulation and the fact that 

it has not been edited for some period 

of time suggests that the regulation 

should be and has not been reviewed 

under section 610 or pursuant to any of 

the Department’s numerous regulatory 

review efforts. See 86 FR 5710 

(concluding the AI data ‘‘suggested that 

large numbers of Department 

regulations would benefit from 

retrospective review’’); id. at 5738 

(‘‘These findings suggest regulations are 

not being updated to reflect evolving 

economic conditions and technology, 

even though this is a goal of the RFA.’’). 

As the Withdrawal NPRM explained, 

numerous agency efforts involving the 

review of regulations do not result in a 

change in the regulation. Moreover, 

section 610(a) explicitly contemplates 

unchanged regulations, stating that 

‘‘[t]he purpose of the review shall be to 

determine whether such rules should be 

continued without change, or should be 

amended or rescinded’’ (emphasis 

added). Also, as noted in the 

Withdrawal NPRM, the broken links 

and other typographical errors 

identified through the AI review were 

successfully addressed as part of the 

HHS ‘‘Regulatory Clean-Up Initiative,’’ a 

final rule published on November 16, 

2020, 85 FR 72899, that made 

miscellaneous corrections, including 

correcting references to other 

regulations, misspellings and other 

typographical errors in regulations 

issued by FDA, CMS, the Office of the 

Inspector General, and the ACF. In 

addition, FDA issued a final rule to 

amend regulations on medical device 

premarket submissions to remove 

requirements for paper and multiple 

copies and replace them with 

requirements for a single submission in 

electronic format.29

The assumption that unedited rules 

have not been reviewed is incorrect for 

the additional reason that many rules 

setting industry standards have 

remained untouched for years, not from 

neglect, but because they work as 

intended. The OMB memo offering 

guidance to heads of executive 

departments and agencies on 

implementation of E.O. 13563 explicitly 

states that, in conducting retrospective 

analysis of existing rules: ‘‘Agency plans 

should not, of course, call into question 

the value of longstanding agency rules 

simply because they are longstanding. 

Many important rules have been in 

place for some time.’’ 30 The Withdrawal 

NPRM points to numerous longstanding 

regulations that bring efficiencies to 

industry by clarifying applicable 

statutory obligations, such as food 

regulations involving nutrition, food 

labeling, standards of identity, food 

ingredients, and color additives. 

Furthermore, the Withdrawal NPRM 

cited comments to the SUNSET 

proposed rule confirming that these 

longstanding regulations create 

important efficiencies for regulated 

industry. By contrast, the commenter 

offered no support for its assumption 

that the age of a rule and the fact that 

it has not been edited must mean that 

it is out of date with respect to its 

technological and informational 

requirements. Moreover, even if certain 

of such requirements could be updated 

to reflect technological advances, the 

commenter does not explain why that 

would necessarily mean that the rule 

has or will have a SEISNOSE and 

should be reviewed under section 610. 

To have a SEISNOSE, a rule must have 

a significant economic impact on a 

substantial number of small entities, 

and the Department considers a rule to 

have a SEISNOSE if it has at least a 

three percent impact on revenue on at 

least five percent of small entities. See, 

e.g., 86 FR 5749. Again, based on the 

SUNSET final rule’s estimates, only 

15% of the Department’s regulations 

have a SEISNOSE, 86 FR 5737, which 

suggests that many, or potentially all, of 

the regulations the commenter claims 

have outdated technological 

requirements are not regulations with 

SEISNOSE subject to section 610 

review. 

The SUNSET final rule made similar 

errors with respect to other data it cited 

in its discussion of the Department’s 

RFA compliance and record of 

retrospective review. Specifically, the 

SUNSET final rule cited a review of 

HHS’s entries in the semiannual Unified 

Agenda over the last ten years, which 

identified three entries for final 

rulemakings resulting from section 610 

reviews. See 86 FR 5737. Based on these 

data, the SUNSET final rule suggested 

that, during that ten-year time period, 

the Department conducted section 610 

reviews of only 26 of its 370 

rulemakings previously determined to 

have a SEISNOSE. See id. at 5737–38 

(referring to ‘‘lax compliance with 

periodic review requirements under the 

. . . [ ]RFA[ ]’’). However, in drawing 

this conclusion, the SUNSET final rule 

appears to improperly assume that the 

three final rulemakings resulting in 

section 610 reviews (which it estimated 


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31See Protection of Human Subjects and 

Institutional Review Boards, RIN 0910–A107 (Fall 

2021) (available at https://www.reginfo.gov/public/ 

do/eAgendaViewRule?pubId=202110&RIN=0910- 

AI07). 

32See, e.g., Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based Preventive 

Controls for Food for Animals, RIN 0910–AI24 (Fall 

2021) (available at https://www.reginfo.gov/public/ 

do/eAgendaViewRule?pubId=202110&RIN=0910- 

AI24); Phased Review of New Animal Drug 

Applications, Electronic Submission, and Master 

Files, RIN 0910–A135 (Fall 2021) (available at 

https://www.reginfo.gov/public/do/ 

eAgendaViewRule?pubId=202110&RIN=0910- 

AI35); Revision of Requirements for the 

Establishment and Maintenance of Records Related 

to Medicated Animal Feed and Veterinary Feed 

Directive Drugs Office of Information and 

Regulatory Affairs, RIN: 0190–AI67 (Fall 2021) 

(available at https://www.reginfo.gov/public/do/ 

eAgendaViewRule?pubId=202110&RIN=0910- 

AI67). 

33See Medicare Beneficiary Policy Manual, 

Chapters 7 (Home Health), 8 (Skilled Nursing 

Facilities) and 15 (Outpatient Therapy) (available at 

https://www.cms.gov/Regulations-and-Guidance/ 

Guidance/Manuals/internet-Only-Manuals-IOMsItems/CMS012673). We note that the SUNSET final 

rule referred to a comment stating that regulations 

covering access to skilled therapy services had not 

been updated to reflect the national settlement in 

Jimmo v. Sebelius. See 86 FR 5696. However, the 

settlement agreement requires HHS to amend the 

Medicare Benefit Policy Manual to clarify the 

coverage standards, not to amend Medicare 

regulations. See ‘‘IX. Injunctive Provisions’’ in 

Settlement Agreement, at 8–14 (available at https:// 

www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/SNFPPS/Downloads/Jimmo-SettlementAgreement.pdf). 

34See, e.g., Curtis W. Copeland, Cong. Rsch. 

Serv., RL32801, Reexamining Rules: Section 610 of 

the Regulatory Flexibility Act 8 (2008) (‘‘[I]t would 

be reasonable to expect that, since [certain 

departments] indicated that they intended to issue 

a large number of rules each year with a significant 

effect on small entities, those same agencies would 

need to reexamine a large number of rules each year 

under Section 610.’’); U.S. Accountability Off., 

GAO/GGD–94–105, Regulatory Flexibility Act: 

Status of Agencies’ Compliance (1994) (citing an 

SBA report from 1983 suggesting potential for 

improving the Department’s review plan). 

amended CFR sections equivalent to 

approximately 26 rulemakings) 

represented the only section 610 

reviews conducted by the Department 

during this ten-year time period. See id. 

at 5737 n.213. In so concluding, the 

SUNSET final rule again relied on the 

flawed assumption that a section 610 

review must result in the amendment of 

a rule or a new rule, and thus excluded 

all other section 610 reviews indicated 

in the Unified Agenda during that time 

period. As a result of that exclusion, the 

Department incorrectly assessed the 

scope of rulemakings the Department 

reviewed under section 610 during the 

last ten years. 

The SUNSET final rule’s discussion of 

the Department’s RFA compliance also 

contains misstatements and other errors. 

The SUNSET final rule cited three 

‘‘examples of regulations that 

[commenters] and/or Congress have 

requested the Department to review, but 

that the commenters claimed were not 

reviewed.’’ 86 FR 5696. Although the 

SUNSET final rule did not take a firm 

position on the status of these examples, 

the implication that these matters are 

inactive is factually incorrect. For 

example, the Fall 2021 Unified Agenda 

includes planned action to harmonize 

the differences between the Basic HHS 

Policy for the Protection of Human 

Research Subjects (45 CFR part 46, 

subpart A) and the FDA regulations for 

the protection of human subjects (21 

CFR parts 50 and 56).31 The Fall 2021 

Unified Agenda also includes several 

planned regulatory actions by FDA’s 

Center for Veterinary Medicine (CVM) 

to revise 32 and in certain instances 

withdraw several regulations based, in 

part, on the comments received in 

dockets issued in 2017 seeking 

comments and information from 

interested parties to help FDA identify 

existing regulations and related 

paperwork requirements that could be 

modified, repealed, or replaced, 

consistent with the law, to achieve 

meaningful burden reduction while 

allowing us to achieve our public health 

mission and fulfill statutory obligations. 

In addition, CMS revised the Medicare 

Beneficiary Program Manual (MBPM), 

in accordance with the national 

settlement agreement in the Jimmo v. 

Sebelius litigation.33 Moreover, the 

SUNSET final rule did not assert that 

these regulations have or will have a 

SEISNOSE, or even that the commenters 

or Congress asserted that they do, and 

thus, the rule failed to demonstrate how, 

if at all, these examples implicate the 

Department’s retrospective review 

efforts under section 610. 

The remaining data cited in the 

SUNSET final rule’s discussion of the 

Department’s RFA compliance lacks 

relevance to that discussion. For 

example, the SUNSET final rule 

asserted that good governance 

stewardship actions were deprioritized 

and relegated to ‘‘rainy day’’ activities 

the Department operating divisions 

would get to when they could, citing a 

review conducted in 2019 that entailed 

an AI data analysis of HHS regulations. 

86 FR 5697. As already discussed in this 

response, the AI review results do not 

indicate whether any of the rules it 

identified as not updated or otherwise 

flawed have or will have a SEISNOSE, 

and thus the rule fails to demonstrate 

how, if at all, this review implicates the 

Department’s activities under section 

610. Furthermore, as noted above, the 

broken links and other typographical 

errors identified through the AI review 

process were successfully addressed as 

part of the HHS ‘‘Regulatory Clean-Up 

Initiative.’’ As another example, the 

SUNSET final rule also cited 

‘‘government assessments that the 

Department’s efforts to comply with 5 

U.S.C. 610 have at times been lacking,’’ 

86 FR 5696; however, these sources at 

most indicate at times in the past the 

Department could have reviewed more 

rules under section 610, and therefore, 

these sources do not demonstrate that 

the Department does not currently 

comply.34

The SUNSET final rule’s discussion of 

‘‘[m]achine-learning tools . . . [that] 

demonstrate the complexity of 

Department rules’’ similarly lacks 

relevance to the Department’s 

compliance with section 610. The rule 

cites data showing that the Department’s 

regulations in 2019, ‘‘based on the 

amount of information contained in 

text,’’ were ‘‘more complex than a 

typical Shakespeare play,’’ and notes 

that ‘‘reducing complexity is another 

goal of the RFA.’’ 86 FR 5738. However, 

as with much of the data already 

discussed, these data do not purport to 

relate specifically to rules that have or 

will have a SEISNOSE, and thus, again 

do not necessarily implicate the 

Department’s efforts under section 610. 

Moreover, even if these data were 

specific to regulations with a 

SEISNOSE, the Department does not 

agree with the SUNSET final rule that 

these data demonstrate that its 

regulations are overly complicated. As 

the SUNSET final rule itself 

acknowledges, complexity in the 

Department’s regulations ‘‘is not . . . 

surprising given that the regulations 

often involve science, engineering, or 

highly technical material.’’ 86 FR 5738. 

Moreover, the Department disagrees 

that ‘‘the amount of information in text’’ 

is a reliable proxy for complexity that is 

unnecessary or undesirable given that, 

in the Department’s experience, 

providing more information in a 

regulation can often enhance clarity. For 

example, in FDA’s experience, often in 

response to a proposed rule, 

commenters will request that the agency 

provide examples in the codified text 

which can lengthen the text but clarify 

the requirements. For example, a good 

manufacturing practices rule may 

require that ‘‘qualified personnel handle 

x.’’ So, to better explain what 

constitutes ‘‘qualified personnel,’’ the 

codified text may include examples 

such as education, years of work 

experience, etc. The examples are 

general and not prescriptive so that the 

regulated entity can exercise flexibility 

in determining what is applicable to 

their industry and their unique 


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35Ellig, Jerry, ‘‘Evaluating the Quality and Use of 

Regulatory Impact Analysis: The Mercatus Center’s 

Regulatory Report Card 2008–2013’’ Mercatus 

Center at George Mason University (July 2016) 

(available at https://www.mercatus.org/ 

publications/regulation/evaluating-quality-and-useregulatory-impact-analysis). 

36OMB, Validating Regulatory Analysis: 2005 

Report to Congress on the Costs and Benefits of 

Federal Regulations and Unfunded Mandates on 

State, Local, and Tribal Entities (2005), at 42 

(available at https://perma.cc/R8LX-BQMJ) 

(comparing pre- and post-regulation cost-benefit 

data for regulations promulgated by the 

Occupational Safety and Health Administration, the 

National Highway Traffic Safety Administration, 

the Environmental Protection Agency, the 

Department of Energy, and the Nuclear Regulatory 

Commission). 

37 Id. 

38See 86 FR5697 (citing Winston Harrington, 

Grading Estimates of the Benefits and Costs of 

Federal Regulation, Res. for the Future, Discussion 

Paper 06–39 (2006)). 

39See 86 FR 5698 (citing Richard Morgenstern, 

Retrospective Analysis of U.S. Federal 

Environmental Regulation, 9 J. of Benefit Cost 

Anal., no. 2., 285–304 (2018)). 

40See 86 FR 5698 (citing Cynthia Morgan & 

Nathalie B. Simon, National primary drinking water 

regulation for arsenic: A retrospective assessment of 

costs, 5 J. Benefit Cost Anal. no. 2 (2014)). 

manufacturing processes. Thus, while 

the codified text may be longer, it is not 

inherently more complex or 

burdensome. 

3. Policy Considerations Related to 

Retrospective Review 

Comment: Some commenters opposed 

finalizing the Withdrawal NPRM 

because, in their view, there is a need 

for HHS to conduct more retrospective 

review. Several commenters asserted 

that HHS regulations are outdated. One 

comment stated that greater 

retrospective review is needed because 

‘‘the costs of regulations frequently 

exceed what was projected at the time 

of promulgation,’’ citing information 

from the preamble to the SUNSET final 

rule. Another comment stated that there 

is an ‘‘overall lack of an evidentiary 

basis for many of [HHS’s] regulations’’ 

and cited a working paper 35 criticizing 

the Department’s retrospective review 

and HHS regulations’ identification of a 

problem that would be solved by the 

regulation. Several comments stated that 

widespread retrospective review is 

appropriate because, if the public must 

comply with HHS regulations, HHS 

should have to review them. 

Approximately ten identical anonymous 

comments stated that the Withdrawal 

NPRM should not be finalized because 

withdrawal or repeal of the SUNSET 

final rule would ensure Americans 

continue to be subject to costly, 

burdensome regulations and, before 

adding additional burdens on the 

American people, HHS should 

determine if its existing regulations are 

helping or harming them. 

Response: HHS does not agree that the 

SUNSET final rule should be retained 

for any of the reasons cited by 

commenters. First, even assuming that 

HHS would benefit from more 

retrospective review, none of these 

comments explain why the onerous 

procedures and compressed timeframes 

of the SUNSET final rule are necessary 

or desirable to achieve that goal. Upon 

review, HHS believes that the 

procedures set forth in the SUNSET 

final rule would be a poor method for 

achieving the goal of improved 

regulations through retrospective review 

because the pressure created by the 

SUNSET final rule process would 

undermine the quality of the 

Department’s reviews. The SUNSET 

final rule’s focus on small-entity 

impacts also does not seem directly 

responsive to these calls for large-scale 

reconsideration of HHS regulations. 

Second, HHS does not agree that the 

commenters have demonstrated a need 

for widespread retrospective review. For 

example, HHS disagrees with the 

general proposition that its regulations 

are outdated. The only evidence offered 

to support these assertions is the 

evidence presented in the SUNSET final 

rule, which is discussed in the previous 

comment response. For example, 

commenters cited the fact that many 

HHS regulations issued prior to 1990 

have not been edited. But that fact does 

not show that edits are needed, and it 

certainly does not show that the 

underlying policies of those regulations 

are flawed or that the regulations have 

impacts that should be reassessed. 

Similarly, the fact that broken links or 

typographical errors may exist in HHS 

regulations does not stand for a broader 

proposition that the underlying policies 

or impact analyses in the regulations are 

outdated. Nor is automatic expiration of 

a regulation an appropriate response to 

broken links or typographical errors in 

that regulation. Overall, HHS rejects the 

conclusion that our regulations are 

generally ‘‘outdated’’ because, as 

discussed throughout this preamble, we 

review regulations under many 

processes, regularly engage with 

stakeholders regarding the effects of our 

regulations, and craft regulations to be 

flexible and to account for technological 

advancement and changed 

circumstances over time. 

HHS has also reconsidered the 

evidence presented in the SUNSET final 

rule concerning cost-benefit projections 

at the time of promulgation, and we 

now determine that it is of limited, if 

any, relevance to HHS. In particular, in 

order to reach the conclusion that 

limitations in ‘‘government projections’’ 

counsel in favor of widespread 

retrospective regulatory review 

specifically for HHS, the SUNSET final 

rule relied on a 2005 OMB report that 

compared pre- and post-regulation costbenefit calculations for 47 regulations at 

five agencies. However, the report did 

not include HHS or any HHS 

regulations.36 Moreover, the 2005 OMB 

report looked at rules dating back from 

1975 to 1996.37 The SUNSET final rule 

also relied upon another study that 

evaluated OMB’s 2005 report to 

Congress on the benefits and costs of 

Federal regulations and a 2005 analysis 

sponsored by the SBA, but this study 

did not evaluate any HHS regulations.38

In addition, the SUNSET final rule 

presented, as evidence of inaccuracies 

in regulatory cost-benefit analysis, a 

publication that looked at eight 

regulations and included only one HHS 

regulation, an FDA rule related to food 

safety.39 One single FDA regulation is 

not a sufficiently representative sample 

from which any generalizable 

conclusions may be drawn regarding 

HHS regulations. Finally, another study 

relied upon in the SUNSET final rule 

pertained to only one regulation 

promulgated by the Environmental 

Protection Agency (EPA) to address 

arsenic in drinking water.40 It is not 

possible to draw any conclusions about 

HHS regulations from a study looking at 

just one EPA regulation. 

The Department also strongly 

disagrees that there is a lack of an 

evidentiary basis for many of its 

regulations. At the most basic level, the 

Department relies on evidence to guide 

it in its public health mission, including 

its rulemaking efforts. The economic 

analyses for rulemakings include 

qualitative and quantitative 

consideration of the impacts. Evidence, 

data, and analyses are considered to the 

extent available and are reflected in the 

RIAs for the regulations. The analyses 

and supporting data are included and 

made publicly available when the 

rulemaking is published. The same 

principles apply to the entire 

rulemaking. 

We are also not persuaded that the 

working paper cited by the commenter 

supports the proposition that HHS’s 

regulations lack an evidentiary basis. 

Critically, the paper limited its 

assessment to preliminary regulatory 

impact analyses accompanying 

proposed economically significant 

regulations. This approach discounts 

any additional evidence gathered 

between a notice of proposed 

rulemaking and publication of a final 

rule, including evidence from public 


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41https://www.mercatus.org/system/files/ElligReg-Report-Card-Eval-v1.pdf. Quotes are located on 

pages 14 and 94. 

42https://www.fda.gov/about-fda/reports/ 

economic-impact-analyses-fda-regulations. 

43https://www.federalregister.gov/. 

44Robinson, L.A., & Hammitt, J.K., ‘‘Valuing 

reductions in fatal illness risks: Implications of 

recent research,’’ 25(8) Health Economics 1039–52 

(2016). 

45Office of the Assistant Secretary for Planning 

and Evaluation, U.S. Department of Health and 

Human Services, ‘‘Appendix D: Updating Value per 

Statistical Life (VSL) Estimates for Inflation and 

Changes in Real Income’’ (June 2021) (available at 

https://aspe.hhs.gov/reports/updating-vslestimates). 

46Office of the Assistant Secretary for Planning 

and Evaluation, U.S. Department of Health and 

Human Services, ‘‘Valuing Time in U.S. Department 

of Health and Human Services Regulatory Impact 

Analyses: Conceptual Framework and Best 

Practices’’ (June 2017) (available at https://

aspe.hhs.gov/reports/valuing-time-us-departmenthealth-human-services-regulatory-impact-analysesconceptual-framework). 

47Office of the Assistant Secretary for Planning 

and Evaluation, U.S. Department of Health and 

Human Services, ‘‘Estimating Medical Costs for 

Regulatory Benefit-Cost Analysis: Conceptual 

Framework and Best Practices’’ (June 2017) 

(available at https://aspe.hhs.gov/reports/ 

estimating-medical-costs-regulatory-benefit-costanalysis-conceptual-framework-best-practices). 

48https://aspe.hhs.gov/reports/guidelinesregulatory-impact-analysis. 

comment incorporated into the final 

regulatory impact analysis. Thus, the 

commenter likely errs when transferring 

the findings of the report to finalized 

regulations, since HHS is more likely to 

publish final rules of actions that are 

justified. As an additional concern, the 

underlying report adopts several 

assessment criteria that do not speak to 

the quality of evidence presented in the 

preliminary regulatory impact analyses. 

For example, the paper awards points 

based on writing style, including 

whether the RIA is ‘‘written in plain 

English (light on technical jargon and 

acronyms, well organized, 

grammatically correct, direct language 

used),’’ and on how well a nonspecialist reader would understand the 

analysis, results, and conclusion. 

Although these factors may represent 

desirable practices, they do not relate to 

the evidentiary basis of a regulation. 

The commenter highlights the paper’s 

findings related to retrospective review; 

however, this score relates to whether a 

preliminary regulatory impact analysis 

discusses whether ‘‘the proposed rule 

establish[es] measures and goals that 

can be used to track the regulation’s 

results in the future’’ and whether it 

‘‘indicate[s] the data it will use to assess 

the regulation’s performance in the 

future and establish[es] provisions for 

doing so?’’ 41 Similarly, although these 

may represent desirable practices, they 

do not speak to the evidence contained 

in regulatory impact analysis of HHS 

regulations. Finally, we note that the 

paper covers proposed rules published 

between 2008 and 2013. It is quite likely 

that a more recent assessment would 

yield higher scores for HHS as regards 

some of the scoring criteria. For 

example, the paper assigned points 

based on accessibility, including 

whether an agency publishes proposed 

rules and RIAs on its website. FDA now 

maintains a website containing 

Economic Impact Analyses of FDA 

regulations, which contains links to at 

least 170 regulatory impact analyses the 

agency has developed since 2012.42

Other HHS agencies currently routinely 

publish preliminary RIAs in the same 

document as notices of proposed 

rulemaking in the Federal Register, 

which is also available online.43 Thus, 

we anticipate that a more recent 

assessment of the availability of RIAs 

online would yield higher scores in this 

category. The report also assigned 

points based on the verifiability of the 

models and assumptions used in the 

analysis, including whether the RIAs 

include citations to sources that justify 

the models or assumptions. Since the 

time of the paper, HHS has updated its 

approach to valuing reductions in 

mortality risks in benefit-cost analysis 

by commissioning a criteria-driven 

review of the empirical literature on the 

value per statistical life (VSL),44 and has 

published subsequent documentation of 

the Department’s approach to updating 

the VSL to account for income growth 

and inflation.45 HHS also commissioned 

research on the approaches used to 

value changes in time use and research 

on estimating impacts related to medical 

costs in RIAs, publishing conceptual 

frameworks and best practices on each 

of these topics.46 47 HHS also published 

Guidelines for Regulatory Impact 

Analysis in 2016, which includes best 

practices for conducting prospective 

and retrospective analysis.48 Since HHS 

RIAs routinely reference these 

documents, as well as the models and 

assumptions contained in these 

documents, we anticipate that a more 

recent assessment of the verifiability of 

the models and assumptions used in 

RIAs would also yield higher scores in 

this category. 

The Department also does not agree 

that the fact that regulated entities must 

comply with HHS regulations is a 

reason to retain the SUNSET final rule. 

The commenters appear to suggest that 

widespread review of regulations is 

needed as a sort of quid pro quo for 

regulated entities to comply with those 

regulations. But to the extent that these 

comments are purporting to protect the 

interests of regulated entities, HHS does 

not agree that the SUNSET final rule 

protects those interests. We have now 

determined, as discussed in Section VI, 

that the quantified costs of the rule far 

outstrip the quantified benefits, and the 

expiration provision threatens the basic 

regulatory frameworks on which 

regulated entities rely. Furthermore, the 

Department has finite resources, and we 

seriously doubt that deploying those 

resources for roving review under the 

SUNSET final rule, rather than other 

initiatives important to regulated 

entities, is in these entities’ interest. We 

note that almost no regulated entities 

submitted comments in support of the 

SUNSET final rule. 

Although some commenters stated 

that HHS regulations generally are 

burdensome, these commenters did not 

identify any specific regulations or offer 

support for their assertions. In any 

event, we disagree with the assertion. 

HHS regulations enhance public health, 

safety, and welfare and provide 

significant cost savings by, for example: 

Facilitating the implementation of 

programs to benefit millions of 

stakeholders, including underserved 

populations; preventing serious harm to 

the public; providing clarity and 

consistency across the public health 

spectrum to streamline compliance with 

statutory requirements; creating a level 

playing field for businesses; and 

boosting consumer confidence. 

In general, HHS agrees that there is 

value in retrospective review, but it 

must weigh that value against the value 

of other competing regulatory objectives 

that may be of equal or greater 

importance. Weighing those 

considerations, the Department has 

determined that the SUNSET final rule 

is not an appropriate way to achieve the 

goals of retrospective review. 

Comment: Some commenters stated 

that the SUNSET final rule should be 

retained because it provides benefits to 

the public. These commenters stated, for 

example, that the rule: allows HHS to 

consider new developments in science 

and medicine, better respect legal rights 

of conscience and religion, and perform 

more accurate cost-benefit analyses; 

gives ‘‘recurring departmental attention 

to the impact of HHS regulations on 

small and independent businesses;’’ 

increases accountability to real-world 

impacts; and makes sure that 

regulations ‘‘do not unnecessarily 

burden the American public through 

sheer inertia.’’ Some commenters stated 

that the rule would ‘‘eliminate red 

tape,’’ lead to ‘‘faster economic growth’’ 

and ‘‘significant economic benefits,’’ 

and ‘‘save lives.’’ Certain policy 

advocacy groups suggested that the 


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49More information about HHS’s actions, 

including HHS’s plan, progress on the plan, and 

public engagement, is available here: https://

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

index.html. 

SUNSET final rule benefits individuals 

because it provides a mechanism for 

every American to have their voice 

heard. 

Response: HHS does not agree that the 

SUNSET final rule should be retained 

based on these purported benefits. First, 

HHS considers matters of conscience 

and religion as relevant and appropriate 

as a matter of course, and has an Office 

for Civil Rights to address such issues 

as they arise. We do not see how 

conducting retrospective reviews under 

SUNSET final rule is necessary or even 

helpful to better respect legal rights of 

conscience and religion. 

Second, for the purported benefits of 

eliminating red tape, faster economic 

growth, significant cost savings and 

other types of broad economic benefits, 

and saved lives, HHS considers these 

speculative and not obviously 

attributable to the SUNSET final rule. 

The commenters make a number of 

leaps in their analysis to assert these 

benefits. For example, they assume that 

(1) regulations would be amended or 

rescinded following review under the 

SUNSET final rule; (2) these 

amendments and rescissions would 

have overall economic and/or lifesaving benefits; and (3) no other 

Department processes would result in 

these same amendments or rescissions. 

We disagree both with these 

assumptions and the chain of reasoning 

leading to the conclusion that the 

SUNSET final rule would necessarily 

have these benefits. As discussed in 

more detail in our preliminary and final 

regulatory impact analyses, see 86 FR 

59922 and Section VI, the benefit 

attributable to the SUNSET final rule is 

the benefit of any information learned 

from completing the assessments and 

reviews. We note that the SUNSET final 

rule’s regulatory impact analysis, 

similarly, contained very little 

discussion of benefits and did not 

quantify any benefits of the rule. 86 FR 

5749. 

Third, for the purported benefit of 

helping individuals—for example, by 

making it easier for them to participate 

in the process of regulatory review and 

have their voices heard—we do not 

agree that the SUNSET final rule would 

provide that benefit. Our view, which is 

informed by many comments on this 

subject as discussed in detail above, is 

that the SUNSET final rule generally 

harms individuals. The rule poses harm 

through, among other things, 

Department and stakeholder diversion 

of resources away from other important 

initiatives, uncertainty, and loss of 

regulatory programs through expiration. 

And, with respect to regulations that 

automatically expire, there will have 

been no notice and comment process for 

the expiration of those specific 

regulations. Even considering in a 

vacuum the purported benefit of 

increased stakeholder participation, our 

regulatory impact analysis recognizes 

that the approach of the SUNSET final 

rule creates greater costs for 

stakeholders. Furthermore, the sheer 

volume of rulemakings under 

assessment and review risks 

overwhelming individual commenters 

and preventing their participation. 

Fourth, for the remaining benefits 

asserted by commenters, such as 

incorporating new scientific information 

and updating impact analyses, HHS 

recognizes that these could be potential 

benefits of an appropriately targeted and 

manageable retrospective review 

scheme. Thus, the RIA notes that the 

final withdrawal rule will result in 

forgone information as a result of not 

performing the SUNSET final rule’s 

assessments and reviews. See Section VI 

below. However, we disagree that the 

SUNSET final rule would have 

generated significant benefits in these 

areas that outweigh the costs. Among 

other things, the pace and scope of 

assessments and reviews, combined 

with the threat of expiration, would 

likely curtail the careful and thorough 

deliberation needed to produce these 

types of benefits and could reduce the 

quality of regulatory reviews. Moreover, 

because HHS already undertakes 

regulatory review under the RFA and 

otherwise, benefits in these areas, if any, 

would only be incremental over the 

ones already produced. 

In light of the limited nature of the 

potential benefits, and balancing those 

potential benefits against the significant 

harms of the rule (which include, for 

example, resource diversion from other 

key programs, uncertainty, and the 

potential loss of regulations through the 

expiration mechanism), the Department 

has determined that the SUNSET final 

rule should be withdrawn. The 

Department recognizes that it previously 

concluded, in the SUNSET final rule, 

that the value of the rule’s retrospective 

review program outweighed any harms 

associated with the rule. However, the 

Department has since identified 

multiple flaws in its prior analysis that 

have led it to reconsider and reverse this 

conclusion. Among other things, 

finalization of the SUNSET final rule 

was premised on a miscalculation of the 

resources needed to comply with the 

rule. Because of that error, the analysis 

in the SUNSET final rule failed to 

recognize the effects the rule would 

have on other key programs and 

initiatives and the likelihood of 

expiration. The Department also 

previously miscalculated the substantial 

burdens the rule would place on 

stakeholders. Overall, HHS now 

recognizes that any informational 

benefits of the rule are greatly 

outweighed by its harms, and that the 

rule is irreconcilable with the 

Department’s public health mission. 

Thus, HHS is withdrawing this rule. 

Comment: Several commenters 

referred to various E.O.s issued over the 

years related to retrospective review. 

One of these commenters stated that 

HHS, in withdrawing the SUNSET final 

rule, must consider compliance with the 

E.O.s identified in the preamble to that 

rule. 

Response: First, we note that many of 

the E.O.s referred to in these comments 

or identified in the SUNSET final rule 

have been revoked, including E.O. 

12044, E.O. 12291, E.O. 12498, E.O. 

13771, and E.O. 13924. Thus, there is no 

requirement or expectation of 

‘‘compliance’’ with these E.O.s. 

Second, HHS has considered these 

E.O.s and does not agree that they 

provide support for retaining the 

SUNSET final rule. Most of these E.O.s 

direct agencies to develop plans for the 

periodic review of existing significant 

regulations to determine whether any 

such regulations should be modified or 

repealed so as to make the agency’s 

regulatory program more effective or 

less burdensome. One E.O. focuses on 

public engagement and OMB reporting 

with respect to the same scope of 

retrospective review. HHS already took 

various actions in response to these 

E.O.s, including publishing a plan and 

soliciting comments.49 Moreover, the 

E.O.s have a different purpose and focus 

than the SUNSET final rule, which 

purports to focus on minimizing the 

impacts of regulations on small entities. 

See, e.g., 86 FR 5751 (defining ‘‘Review’’ 

as ‘‘a process . . . the purpose of which 

shall be to determine whether Sections 

[of the CFR] . . . should be continued 

without change, or should be amended 

or rescinded, consistent with the stated 

objectives of applicable statutes, to 

minimize any significant economic 

impact of the Sections upon a 

substantial number of small entities.’’). 

Thus, we disagree that the E.O.s 

constitute a reason to retain the 

SUNSET final rule. 

Comment: In the Withdrawal NPRM, 

the Department invited comment on the 

experience of states and foreign 

governments implementing laws 

requiring ‘‘sunset reviews.’’ A few 


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50See, e.g., N.D. Cent. Code 28–32–18.1 

(permitting amendment or repeal of rules without 

complying with the other requirements of North 

Dakota’s Administrative Agencies Practice Act 

relating to adoption of rules); 75 OK Stat section 

75–307.1 (2014) (directing the Oklahoma House and 

Senate to conduct rule review); Tenn. Code Ann. 

section 4–56–102 (limiting review to procurement 

rules). One state cited had repealed its sunset 

provision. Rhode Island created an Office of 

Regulatory Reform to review proposed and existing 

rules and regulations, but the statutory provision 

requiring all agencies to conduct periodic review of 

rules was repealed. See R.I. Gen. Laws Ann. tit. 42, 

ch. 64.13; see also 2016 R.I. Pub. Laws 206 (June 

29, 2016) (repealing section 42–35–3.4 of Rhode 

Island’s Administrative Procedures Act). 

51N.C. Gen. Stat section 150B–21.3A, ‘‘Periodic 

Review and Expiration of Existing Rules.’’ 

52Sunset Advisory Commission, ‘‘Sunset in 

Texas 2022–2023,’’ 88th Legislature (Sept. 2021) 

(available at https://www.sunset.texas.gov/public/ 

uploads/files/reports/Sunset%20in%20Texas

%202022-23.pdf). 

commenters provided an assessment of 

the positive experience some states and 

foreign governments have had with 

implementing their own sunset laws. 

These commenters opposed the 

Withdrawal NPRM and pointed to the 

experience of North Carolina, Missouri, 

and Texas, whose state legislatures have 

each established a sunset law and a 

process for the review of state 

regulations that feature a sunset 

mechanism. One commenter stated that 

North Carolina’s process, under which 

all agency rules are slated for automatic 

repeal in 10 years unless reviewed, 

resulted in the repeal of about one state 

rule out of every ten reviewed. A second 

comment described the cost savings 

attributed to the Texas Sunset Advisory 

Commission. A third comment noted 

that Missouri connects a sunset 

provision to a five-year periodic review 

requirement in a manner very similar to 

the SUNSET final rule. In contrast, a 

comment submitted by the North 

Carolina attorney general, together with 

19 other State attorneys general, 

expressed support for withdrawing the 

SUNSET final rule, noting that the 

SUNSET final rule posed a direct threat 

to their states’ health care systems and 

the health and safety of their residents. 

Response: We appreciate that the 

commenters provided information in 

response to our request. The SUNSET 

final rule cited the experience of states 

and foreign governments as a 

justification for the rule, noting that the 

mechanism of retrospective review 

being implemented by the SUNSET 

final rule was informed by the 

experience of states and other 

jurisdictions that allow for the 

automatic expiration of regulations 

subject to review. See 86 FR 5700 

(‘‘experience in the States suggests that 

sunset provisions can be an important 

tool to ensure reviews take place’’). 

However, the SUNSET final rule did not 

account for myriad ways in which those 

state and international frameworks cited 

are considerably different from each 

other, nor did it account for their 

considerable differences with the 

SUNSET final rule.50

The Department has given further 

consideration to differences between 

state sunset laws, such as those of North 

Carolina, Missouri, and Texas, and the 

HHS SUNSET final rule. These 

differences include the legislative 

origins, implementation, operations, 

governing administrative law 

requirements, and the scope, breadth 

and volume of regulations. More 

specifically, the states’ experience with 

their sunset laws is of limited relevance 

to HHS because of the vastly greater 

scope of national regulations that 

impact tribal, state and local 

governments, and international 

stakeholders; the corresponding greater 

extent of the economic and public 

health impacts of the regulations; the 

amount of Department and stakeholder 

resources consumed by that larger 

scope; and differences in governing law, 

including the APA. We now conclude 

that the differences are so stark the 

states’ experiences have limited 

relevance for the Department and do not 

support retention of the SUNSET final 

rule. 

For example, with respect to North 

Carolina, the initial assessment outlined 

in its sunset law does not entail the 

multi-factor review and assessment 

required by the SUNSET final rule to 

evaluate whether a regulation has 

significant economic impact on a 

substantial number of small entities. 

Rather, the North Carolina law enacted 

by the General Assembly entails 

periodic review and expiration based on 

whether the rule is ‘‘necessary with 

substantive public interest,’’ ‘‘necessary 

without substantive public interest,’’ or 

‘‘unnecessary.’’ 51 Given that this 

framework is starkly different from the 

framework in the SUNSET final rule, 

and given the differences in the breadth 

and complexity of the underlying HHS 

regulations as compared to state 

regulations, the state experience 

implementing its own law does not shed 

much light on how implementation of 

the SUNSET final rule would impact the 

Department and its stakeholders. For 

example, the state experience does not 

inform the extent of Federal resources 

which would be diverted from 

addressing public health goals to 

undertake the scale and pace of reviews 

required by the SUNSET final rule, and 

potentially defend against challenges to 

each of those actions. 

The commenter also contended that 

continuing to create regulations without 

revisiting them is irresponsible because, 

with decades passing by without 

review, it is reasonable and likely to 

expect some portion, possibly sizeable, 

of HHS rules to be obsolete. The 

commenter asserted that North 

Carolina’s experience with regulatory 

review supports this assertion. We 

disagree. The commenter’s 

characterization of HHS regulations was 

conclusory and not grounded in any 

actual evaluation of current HHS 

regulations. In particular, it failed to 

take into account the regulatory reviews 

that have taken place and it assumes 

without evidence that the passage of 

time alone makes regulations obsolete. 

However, as discussed in greater detail 

elsewhere in this section, many 

regulations remain unchanged because 

they work as intended. For example, 

regulations that establish product 

standards or public service programs 

may not need periodic updates and their 

automatic expiration would cause 

public harm. 

Under the Texas Sunset Law, the 

Texas Legislature sets an expiration date 

in an agency’s authorizing statute and a 

review cycle to determine whether the 

Agency should be automatically 

abolished on this date or continued. As 

part of a review cycle, the Agency must 

submit a self-evaluation report, the 

public is invited to submit comments, 

and then the Texas Sunset Advisory 

Commission, a legislative advisory 

body, reviews the information and 

makes a recommendation whether to 

abolish or continue the agency. If the 

recommendation is for the Agency to 

continue, the Legislature must pass a 

bill to continue the Agency. As 

explained by Sunset Advisory 

Commission, in the self-evaluation 

report agencies describe their mission, 

functions, and programs, provide 

operational and performance data, and 

identify potential issues and 

opportunities for change through the 

Sunset process.52 Thus, the Texas 

agencies are not required to provide an 

assessment or review of their 

regulations. Because this scheme differs 

so vastly from the SUNSET final rule, 

Texas is not an appropriate model or 

comparator for the SUNSET final rule. 

With respect to Missouri, we already 

explained that the quantity of 

regulations subject to review in that 

state represents a small fraction of HHS 

regulations, and their substantive scope 

is far more limited. See Section V.B.3. 

We also note that it was the Missouri 

General Assembly that enacted 


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53Missouri Rev. Stat., Title XXXVI section 

536.175.5. 

54The OECD is forum where 37 democratic 

governments with market-based economies 

collaborate to develop policy standards to promote 

sustainable economic growth. See https://

www.state.gov/the-organization-for-economic-cooperation-and-development-oecd/. 

55For example, the SUNSET final rule amended 

an FDA regulation requiring an investigational 

medical device to disclose that it is ‘‘[l]imited . . . 

to investigational use.’’ 21 CFR 812.5(a). This 

regulation responds to a legislative directive to 

establish an investigational device program, the 

public-health need to establish safeguards for 

investigational use, and the specific circumstance 

that investigational devices could be diverted for 

ordinary patient use. Merely by introducing the 

possibility of expiration of this regulation without 

any replacement, the SUNSET final rule 

undermines these legislative objectives, threatens 

basic public-health protections, and creates 

uncertainty in the marketplace about the status of 

this requirement. But these factors were not 

considered when this regulation was amended by 

the SUNSET final rule. 

legislation directing State agencies to 

conduct periodic review of rules and 

rendering rules void if the agency fails 

to timely file a report on their review.53

Thus, the Missouri example does not 

show that the relevant agencies 

themselves view this type of sunset 

framework as advantageous or beneficial 

to their missions or that they would 

choose of their own volition to allocate 

their resources in this manner. In 

contrast, Congress has not directed the 

Department or any other agency, under 

the RFA or any other statute, to adopt 

a sunset mechanism for their 

regulations. 

One commenter also cited an 

Organisation for Economic Cooperation 

and Development (OECD) 54 report on 

the ex post review of laws and 

regulations and reiterated that the 

SUNSET final rule acknowledges that 

some countries have sunset provisions. 

However, no commenters provided 

substantive information about the 

experience of foreign governments 

adopting such laws. Thus, the 

Department concludes that the resource 

allocations of foreign governments, and 

approaches adopted in countries not 

bound by the U.S. APA, are not 

instructive for one department of the 

U.S. Government to adopt unilaterally. 

The comment submitted by the North 

Carolina attorney general and 19 other 

State attorneys general in favor of 

withdrawing the SUNSET final rule, 

reflects that these attorneys general do 

not share the views of the commenters 

discussed above. Despite a comment 

indicating the lack of reports of 

accidental expirations of regulations 

encountered, for example, in North 

Carolina’s regulatory reform process, the 

attorneys general stated that the 

considerably different process embodied 

by the SUNSET final rule would 

threatens their states’ health care 

systems and the health and safety of 

their residents. We agree with this 

comment and find it notable that an 

attorney general from a state with sunset 

provisions does not find their 

experience with the sunset law to be 

beneficial enough to encourage HHS to 

adopt its own. In sum, as discussed 

above, we conclude that the states’ 

experience with sunset laws do not 

support retention of the SUNSET final 

rule. 

D. Other Legal Comments 

In issuing the Withdrawal NPRM, the 

Department explained that questions 

had been raised in comments on the 

SUNSET proposed rule as to whether 

the SUNSET final rule is consistent with 

the procedural and substantive 

requirements of the APA. 86 FR 59921. 

Commenters on the Withdrawal NPRM 

discussed these and other legal issues. 

Below, we respond to the comments on 

(1) the legal issues with the SUNSET 

final rule, (2) legal arguments regarding 

this withdrawal proceeding, (3) 

proposed modifications to the SUNSET 

final rule, and (4) other legal issues 

raised in comments. 

1. Legal Objections to the SUNSET Final 

Rule 

Comment: Multiple comments stated 

that the expiration portion of the 

SUNSET final rule violates the APA 

because, to amend or repeal a rule under 

the APA, an agency must conduct a 

notice-and-comment process specific to 

the individual rule being amended or 

repealed. Various comments identified 

regulations subject to the expiration 

provision whose elimination would 

likely cause harm to the public, and 

stated that HHS was obligated to 

consider the seriousness of these 

potential harms. Other comments stated 

that the expiration provision was 

unlawful for other reasons, such as that 

it lacked or was contrary to statutory 

authority. 

One commenter disagreed, arguing 

that the expiration provision is 

consistent with the APA because HHS 

followed the APA’s rulemaking 

procedure in adopting the SUNSET rule 

and because ‘‘the Sunset Rule merely 

encoded what the RFA already 

contemplates.’’ Another commenter 

stated that HHS must ‘‘specifically 

address the inconsistency between its 

current view that the SUNSET Rule 

stands on a legally questionable footing, 

and its prior conclusion that it was 

legally sound under the RFA.’’ 

Response: The Department agrees 

with commenters who raised questions 

about lawfulness of the expiration 

provision. Specifically, we have serious 

concerns that the SUNSET final rule’s 

automatic expiration provision, as 

constructed, was not adequately 

justified under the APA. Similarly, we 

also question whether the SUNSET 

proposed rule was sufficiently detailed 

to provide adequate notice and an 

opportunity to comment on the 

potential expiration of each and every 

regulation covered under the SUNSET 

final rule. 

‘‘The APA’s arbitrary-and-capricious 

standard requires that agency action be 

reasonable and reasonably explained.’’ 

FCC v. Prometheus Radio Project, 141 S. 

Ct. 1150, 1158 (2021). An ‘‘agency must 

examine the relevant data and articulate 

a satisfactory explanation for its action 

including a ‘rational connection 

between the facts found and the choice 

made.’ ’’ State Farm, 463 U.S. at 43 

(quoting Burlington Truck Lines, Inc. v. 

United States, 371 U.S. 156, 168 (1962)). 

That explanation must show that ‘‘the 

decision was based on a consideration 

of the relevant factors.’’ Id. If the agency 

has ‘‘entirely failed to consider an 

important aspect of the problem,’’ the 

rule is ‘‘normally . . . arbitrary and 

capricious.’’ Id. These principles apply 

in full force to agency decisions to 

amend or repeal regulations. See 

generally id. In particular, when an 

agency changes course, including by 

amending a regulation, ‘‘a reasoned 

explanation is needed for disregarding 

facts and circumstances that underlay or 

were engendered by the prior policy.’’ 

FCC v. Fox TV Stations, Inc., 556 U.S. 

502, 515–16 (2009). 

As discussed, the SUNSET final rule 

would have amended thousands of 

regulations to schedule their expiration 

if the Department failed to conduct 

assessments and reviews on a certain 

timetable. In addressing this subject, the 

Department did not provide any 

particularized consideration of the 

regulations subject to expiration. It did 

not consider the specific ‘‘facts and 

circumstances that underlay’’ these 

regulations, such as the statutory 

directives and public health problems 

that these regulations address and that 

would be left unaddressed upon 

expiration.55 It also did not consider the 

specific ‘‘facts and circumstances that 

. . . were engendered’’ by these 

regulations, such as any reliance 

interests that may have developed based 

on the regulations. The Department did 

not even identify these specific facts and 

circumstances for the covered 

regulations, let alone treat them as 


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56The Department also previously justified the 

SUNSET final rule by comparing it to an 

amendment to a specific rule to add an expiration 

date, or an amendment to a defined term that is 

more widely applicable to a set of regulations. 

However, those comparisons do not address the 

underlying concern that the expiration provision 

lacked adequate justification. Because of the 

differences in scope, scale, and effect, it is far more 

likely that HHS could provide appropriate notice, 

consider the relevant factors, and produce the 

record needed to support those more targeted 

amendments, in contrast to the global amendment 

created by the SUNSET final rule. 

57The Department also continues to be concerned 

that the specific exemptions included in the 

SUNSET final rule were not the product of reasoned 

decision-making. The Department exempted certain 

FDA regulations, for example, because they ‘‘simply 

create product identities’’ and because, according to 

the Department, some subset of those regulations 

are being reviewed under other processes. 86 FR 

5731. However, these regulations do not simply 

create product identities; instead, they describe the 

conditions under which certain products can be 

marketed. The stated reasoning does not appear to 

support the exemption decision or their scope. In 

addition, the existing review processes cited by the 

Department only apply to a subset of the exempted 

regulations, and some of those review processes are 

limited to narrow issues, such as whether a device 

should be exempt from premarket review. See 86 

FR 5731 nn. 199, 200 (citing 21 U.S.C. 360(l), (m) 

relevant factors and weigh them against 

any perceived advantages of the 

SUNSET final rule. In addition, the 

Department did not address the various 

statutory purposes that would be 

undermined by expiration. Congress 

empowered the Department to act 

through its grants of authority, but there 

is no evidence that the Department 

considered those legislative goals or 

considered the expiration amendments 

in light of those goals. The expiration 

amendments were promulgated on a 

scale that made it nearly impossible to 

generate this type of particularized 

analysis or explanation. 

Instead, the Department offered the 

categorical rationale that ‘‘the benefits of 

retrospective review, and the need to 

strongly incentivize it, are so great that 

the risk of a regulation inadvertently 

expiring is justified by the benefit of 

institutionalizing retrospective review 

in this manner.’’ 86 FR 5723. One 

commenter asserted that this type of 

rationale, focusing solely on benefits 

and importance of retrospective review, 

meets the satisfactory explanation 

requirement in the APA. However, the 

Department now questions that 

assertion. We doubt that this one-sided 

explanation, which considers none of 

the facts, circumstances, or goals of the 

regulations subject to expiration, would 

enable a court to conclude that the 

expiration amendment was reasonable 

and reasonably explained. Ultimately, 

the Department failed to genuinely 

grapple with the potential harms of each 

amended regulation expiring, and the 

Department now acknowledges that 

those harms are unquestionably 

‘‘relevant factors.’’ 

The Department recognizes that it 

previously stated that it was 

‘‘considering the important factors’’ in 

the SUNSET final rule, but this bare 

assertion is belied by the fact that the 

rule did not elaborate on any factors 

other than the benefits of retrospective 

review. 86 FR 5716. The Department 

also stated that it had ‘‘provide[d] the 

reasoned explanation that would be 

required if it were a change in policy,’’ 

but, as previously noted, the 

Department did not provide any 

explanation addressing the relevant 

factors. Id. at 5702. In addition, in the 

final rule, HHS stated that it 

‘‘considered each individual 

Department regulation’’ in connection 

with deciding whether to exempt the 

regulation from the scope of the 

SUNSET final rule. Id. at 5703. 

However, courts have found that 

‘‘[s]tating that a factor was considered 

. . . is not a substitute for considering 

it,’’ Getty v. Fed. Sav. & Loan Ins. Corp., 

805 F.2d 1050, 1055 (D.C. Cir. 1986), 

and the record does not provide further 

evidence of Departmental consideration 

of the individual covered regulations. 

On the contrary, the SUNSET final rule 

contains a list of various regulations that 

commenters had proposed for 

exemption from the SUNSET final rule 

and then concludes, without 

explanation, that the regulations would 

not be exempt. 86 FR 5736. This bare 

conclusion appears to be directly at 

odds with the Department’s obligations 

under the APA to consider the relevant 

factors and adequately explain its 

decision.56

The legal defects described above 

concerning the SUNSET final rule’s 

amendments to regulations are the 

same, only magnified, in the 

circumstance that the SUNSET final 

rule results in the automatic expiration 

of a regulation. As reflected elsewhere 

in this preamble, the Department has 

determined that it is likely that at least 

some amended regulations would expire 

because of overburdened resources. 

Even if that were not immediately the 

case, this framework would allow a 

future administration with a 

deregulatory agenda to strategically 

repeal regulations through inaction. In 

the event of such expiration, the 

Department would be reversing course 

on a policy embodied in a regulation 

without any specific analysis of, or 

justification for—and without notice 

and an opportunity to comment on—the 

expiration, including the original 

motivating factors for issuing the 

regulation and potential relevant 

reliance interests. The Department 

likewise appears not to have examined 

whether expiration—without notice and 

comment—would be consistent with the 

HHS agency’s decision not to impose a 

termination date when it promulgated 

the rule in question. But, as noted 

above, when an agency changes course, 

such as by repealing a regulation, ‘‘a 

reasoned explanation is needed for 

disregarding facts and circumstances 

that underlay or were engendered by the 

prior policy.’’ Fox, 556 U.S. at 515–16. 

The failure to consider reliance 

interests, in particular, presents a 

substantial legal concern in light of the 

Supreme Court’s admonition that 

‘‘[w]hen an agency changes course, . . . 

it must be cognizant that longstanding 

policies may have engendered serious 

reliance interests that must be taken into 

account.’’ Dep’t of Homeland Sec. v. 

Regents of the Univ. of Cal., 140 S. Ct. 

1891, 1913 (2020) (internal quotations 

omitted). The Court held that agencies 

in the midst of policy change are 

‘‘required to assess whether there were 

reliance interests, determine whether 

they were significant, and weigh any 

such interests against competing policy 

concerns.’’ Id. at 377. The Department’s 

regulations, which affect a significant 

sector of the American economy, 

undoubtedly could have engendered 

varying degrees of reliance, and the 

expiration of those regulations could 

undermine any such reliance interests. 

At the time that a particular regulation 

expires under the SUNSET final rule, 

however, the Department would not 

have considered any of those regulationspecific interests. 

In the SUNSET final rule, HHS 

acknowledged the significant potential 

for there to be reliance interests in 

existing HHS regulations. For example, 

it stated that it had increased the length 

of time before the first expiration date 

from two years to five years in order to 

give ‘‘the regulated community . . . five 

years to adjust to the changes made by 

this final rule, so any reliance interests 

are significantly reduced as compared to 

the proposed rule.’’ 86 FR 5709. The 

Department has reconsidered this 

statement and has determined that this 

additional length of time is unlikely to 

significantly reduce reliance interests 

because the public would not know, 

likely for most of the five-year time 

period, whether a regulation would 

actually expire. In any event, the 

Department did not supply the 

particularized analysis regarding 

reliance interests contemplated by the 

Supreme Court, and the Department 

now doubts that this approach is lawful 

under the APA.57


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and 85 FR 21795). Finally, the exemptions are 

underinclusive: The Department failed to include 

other regulations that are similar, such as those 

codifying the standards for human blood and blood 

products or those codifying animal drug approvals. 

58See, e.g., Regulatory Agenda, 87 FR 5226 (Jan. 

31, 2022). 

HHS also disagrees with the 

commenter who stated that ‘‘the Sunset 

Rule merely encoded what the RFA 

already contemplates.’’ As explained 

elsewhere in this preamble, the RFA 

neither explicitly nor implicitly 

provides authority for automatic 

expiration dates. With respect to the 

comment that HHS must specifically 

address the inconsistency between its 

current view that the SUNSET final rule 

stands on a legally questionable footing, 

and its prior conclusion that it was 

legally sound under the RFA, the 

Department now has concluded that the 

SUNSET final rule exceeded the 

requirements of the RFA and did so in 

a manner that likely violates the APA. 

Comment: Multiple comments 

objected to the length of the comment 

period for the SUNSET proposed rule. 

One comment stated that ‘‘HHS did not 

provide . . . a meaningful opportunity 

for comment’’ under the APA. Another 

comment stated that the Department 

‘‘failed to provide any justification for 

the unusually short 30-day comment 

period’’ for portions of the proposed 

rule. The comment stated that the 

‘‘ability of the public to meaningfully 

and thoroughly comment on all aspects 

of the [SUNSET proposed rule] was 

compromised by the lack of prior notice 

and the shortened comment period.’’ 

Response: The Department shares the 

commenters’ concerns that the 30-day 

comment period on the SUNSET 

proposed rule did not provide a 

meaningful opportunity for comment in 

this particular rulemaking. The SUNSET 

final rule was indisputably complex and 

vast in scope and impact, affecting 

thousands of regulations. Given the 

complexity of this rule, we are no longer 

confident in the Department’s previous 

conclusion that the comment period 

during the initial SUNSET rulemaking 

was adequate. However, because the 

Withdrawal NPRM provided an 

opportunity for additional comment on 

the SUNSET final rule and because the 

SUNSET final rule is now being 

withdrawn, this procedural concern 

about the SUNSET proposed rule is now 

moot. 

2. Legal Objections to Withdrawal of the 

SUNSET Final Rule 

Comment: One comment asserted that 

the proposed withdrawal of the 

SUNSET final rule would be unlawful 

under the APA because HHS has not 

considered the ‘‘relevant factor’’ of 

compliance with the RFA. The comment 

stated that the SUNSET rule put HHS 

into compliance with the RFA, and that 

HHS ‘‘ignored important factors’’ when 

it ‘‘fail[ed] to explain how [it] will, in 

the alternative to the SUNSET Rule, 

comply with the RFA.’’ The comment 

also stated that HHS was obligated to 

explain how ‘‘its actions during the 

delay [of the SUNSET rule effective 

date] complied with its RFA 

obligations.’’ 

Response: HHS agrees that it must 

consider ‘‘relevant factors’’ in issuing 

this withdrawal decision, including the 

requirements of applicable statutes and 

the impact of the SUNSET final rule on 

stakeholders. Thus, the Department’s 

statutory obligations under the RFA is 

one of the factors we must consider. 

Elsewhere in this preamble, the 

Department has discussed in detail how 

it complies with the RFA’s requirements 

to publish a plan for periodic review 

and a list of the rules to be reviewed 

each year and how it completes regular 

reviews of its regulations under section 

610. All of these RFA activities 

continued during the delay of the 

effective date for the SUNSET final rule. 

HHS intends to continue its current 

practices under the RFA. Thus, HHS has 

considered the factor of compliance 

with the RFA and does not believe this 

factor requires the Department to retain 

the SUNSET final rule. 

Comment: One comment identified 

various factors that, in the commenter’s 

view, are ‘‘important aspects’’ that HHS 

needs to consider under the APA in 

order to withdraw the SUNSET final 

rule. The comment stated that these 

factors include (1) ‘‘the disruption that 

. . . this repeal rule would have on the 

agency and on public participation in 

the review process’’ and ‘‘the degree of 

regulatory uncertainty that [this rule] 

create[s]’’; (2) ‘‘the interests of doctors 

who would benefit from the on-time 

implementation of the SUNSET Rule to 

rules like the gender identity 

[nondiscrimination] mandate in HHS’s 

Section 1557 rule under the ACA, 

HHS’s gender identity 

[nondiscrimination] mandate in its 

grants rule 45 CFR 75.300(c) and (d), 

and HHS’s conscience rule at 45 CFR 

part 88’’; and (3) the public’s ‘‘interests 

in participating in notice and comment 

procedures to lift regulatory burdens on 

small entities.’’ 

Response: We disagree with this 

comment’s characterization of this 

rulemaking and its assessment of its 

impacts. With respect to the first factor 

identified in the comment, concerning 

disruption to the agency and the public, 

HHS has determined that it is the 

SUNSET final rule, and not withdrawal 

of the SUNSET final rule, that will 

disrupt the Department’s operations and 

create regulatory uncertainty. With 

elimination of the SUNSET final rule, 

HHS agencies and the public can have 

confidence that resources will continue 

to be allocated in the manner that best 

promotes the Department’s mission, and 

that HHS’s regulations will be amended 

or repealed through the well-established 

APA rulemaking processes. Because the 

SUNSET rule never took effect, the 

Department has not taken any 

implementation steps that would be 

disrupted by this withdrawal. 

Furthermore, because the rule never 

took effect, HHS has no reason to 

believe that the public has developed 

processes or expectations that would be 

disrupted by this withdrawal. This is 

particularly true given that the SUNSET 

final rule was issued on January 19, 

2021, and a new administration, with 

new policies and priorities, entered 

office on January 20, 2021. Even in the 

unanticipated circumstance that 

significant reliance interests have 

developed, we believe those interests 

would be outweighed by the important 

reasons for withdrawal identified in this 

preamble. 

With respect to the second factor, the 

suggestion that the expiration of 

regulations under the SUNSET final rule 

will benefit certain doctors who 

disagree in conscience with certain HHS 

rules is entirely speculative, and we do 

not agree that it is an ‘‘important aspect 

of the problem’’ that must be evaluated 

in connection with this withdrawal 

action. Even if this could be considered 

a relevant factor, the interests of this one 

subgroup do not outweigh the many 

important reasons for withdrawing this 

rule, including differing views on the 

same regulations as well as the risks the 

rule poses to a far larger sector of the 

U.S. population. 

With respect to the third factor, 

concerning the public’s interest in 

participating in a notice and comment 

process to lift regulatory burdens on 

small entities, HHS notes that under its 

current processes, the public already 

has an opportunity to participate in this 

type of notice and comment process 

when the Department conducts reviews 

under section 610. Indeed, section 

610(c) requires HHS to ‘‘invite public 

comment’’ on rules that are being 

reviewed under the RFA. Furthermore, 

the Department publishes its 

semiannual Regulatory Agenda for the 

express ‘‘purpose of . . . encourag[ing] 

more effective public participation in 

the regulatory process.’’ 58 In addition, 


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59See, e.g., Regulatory Agenda, 86 FR 16892 

(Mar. 31, 2021). 

HHS implements Department-wide 

initiatives to support that purpose, 

including the Department’s regulatory 

web page with resources such as links 

to HHS rules currently open for public 

comment and an ‘‘HHS Regulations 

Toolkit’’ providing background 

information on regulations, the 

commenting process, how public 

comments influence the development of 

a rule, and how the public can provide 

effective comments.59 Thus, to the 

extent that this is a relevant factor, HHS 

has considered this factor and does not 

agree it justifies retaining the SUNSET 

final rule. 

Comment: A few comments asserted 

that HHS has not adequately considered 

the benefits of the SUNSET final rule, in 

violation of the APA. One comment 

stated that the Withdrawal NPRM was 

‘‘inadequately supported’’ because HHS 

has not provided ‘‘any meaningful 

analysis or balance of the two sides of 

the issues.’’ Another comment asserted 

that the benefits of the SUNSET final 

rule were an ‘‘important aspect of the 

problem’’ that HHS had ignored. 

Response: In Section V.C.3 of this 

preamble, the Department has 

considered and addressed the various 

benefits asserted by commenters to be 

associated with the SUNSET final rule. 

Overall, we consider many of these 

benefits to be speculative, and we 

question whether they would transpire 

as a result of the SUNSET final rule. 

Furthermore, we have confirmed that 

the SUNSET final rule involves 

significant costs and legal 

vulnerabilities. In light of these 

considerations, we conclude that any 

benefits of the SUNSET final rule do not 

justify its costs and do not change the 

legal analysis of the expiration 

provision. Because HHS has considered 

the purported benefits and weighed 

them against the harms in determining 

that the rule should be withdrawn, we 

have fulfilled any applicable obligation 

under the APA. 

Comment: One comment asserted that 

‘‘HHS has not offered sufficient new 

reasons to change course’’ and withdraw 

the SUNSET final rule because ‘‘each 

reason [provided in the Withdrawal 

NPRM] had been considered and 

rejected in the SUNSET rule.’’ The 

comment also claimed that the 

Department did not give the public an 

adequate opportunity to comment 

because the Withdrawal NPRM did not 

‘‘disclos[e] to the public HHS’s reasons 

for changing its views.’’ 

Response: HHS disagrees with the 

commenter that its reasons for 

withdrawal, as stated in the Withdrawal 

NPRM and here, are inadequate or were 

inadequately communicated to the 

public. In both documents, HHS 

identified a number of reasons why this 

withdrawal is appropriate, and we 

explained in detail why these reasons 

are persuasive even in light of the 

Department’s prior analysis. We have 

been clear that the SUNSET final rule 

contained significant errors of fact and 

law and is contrary to the policies of the 

current Administration. 

For example, we explained that in the 

SUNSET final rule, HHS failed to give 

sufficient consideration and weight to 

the many comments opposing the 

SUNSET proposed rule and grossly 

miscalculated the resources required to 

comply with the rule and the manner in 

which the rule would affect the 

Department. Because of that, HHS 

improperly dismissed the many 

concerns raised about the diversion of 

HHS’s resources from other key 

initiatives and the harms of expired 

regulations, among other things. 

Although HHS may have previously 

‘‘considered and rejected’’ these 

considerations, HHS’s decision-making 

relied on a fundamentally flawed 

premise and therefore was unsound. 

In addition, we have explained that, 

upon review, we believe HHS 

previously overlooked key legal defects 

in the justification for the expiration 

provision, which we now must consider 

in the context of withdrawal. We have 

also cited the policy goals of the current 

Administration, which strongly support 

a change in course here. It is our view 

that burdens imposed by the SUNSET 

final rule could undermine the 

Department’s ability to fulfill its public 

health and human services missions, 

promote national priorities, and 

confront the challenges facing the 

nation. We have also further considered 

the evidence HHS previously cited to 

establish the purported need for or 

benefits of the SUNSET final rule, and 

we have explained why we no longer 

consider that evidence to justify the 

rule. In light of these and other reasons 

provided throughout this preamble and 

in the Withdrawal NPRM, HHS has 

adequately justified the change in 

course. 

Comment: One comment suggested 

that it is arbitrary and capricious for 

HHS to consider the harms of expiration 

in determining whether to withdraw the 

SUNSET final rule. The comment 

expressed the view that the SUNSET 

final rule does not exceed the 

requirements of the RFA, and because 

HHS must comply with the RFA, HHS 

should assume it can also comply with 

the SUNSET final rule and avoid 

expiration. The comment posited that, 

because letting anything expire under 

the SUNSET rule would violate the 

RFA, HHS should not consider 

expiration (and the resulting harms) 

within the realm of possibility. 

Response: We disagree. This comment 

is premised on the incorrect assumption 

that the RFA requires HHS to conduct 

assessments and reviews under the 

processes specified in the SUNSET final 

rule. As noted elsewhere in this 

preamble, that is not true: The 

requirements of the SUNSET final rule 

far exceed the requirements of the RFA. 

Because of that, it is entirely reasonable 

for HHS to predict that it will not be 

able to conduct the assessments and 

reviews in the timeframes required 

under the SUNSET final rule, such that 

regulations will expire, but that it can, 

at the same time, fully comply with the 

RFA. Moreover, HHS believes that the 

risk of expiration is exactly the type of 

relevant factor it is required to consider. 

HHS can and must consider whether its 

self-imposed retrospective review 

scheme will consume such resources, 

and creates such an existential threat, 

that duly promulgated regulations will 

disappear for reasons that have nothing 

to do with their regulatory value. 

Comment: One comment asserted that 

withdrawal of the SUNSET final rule 

will render HHS noncompliant with the 

RFA’s requirements, including the 

requirement to publish a plan for 

periodic review, such that withdrawal is 

unconstitutional under the Take Care 

Clause, the Supremacy Clause, and the 

separation-of-powers doctrine. The 

comment stated that ‘‘[n]either the 

President nor HHS can render optional 

a statutory directive that HHS publish a 

plan to periodically review its code of 

regulations.’’ 

Response: HHS disagrees that 

maintaining the SUNSET final rule is 

necessary to prevent non-compliance 

with the RFA. In Section V.C.2, the 

Department discussed its compliance 

with the RFA, including compliance 

with the ‘‘plan’’ requirement under 

section 610(a). In light of this 

compliance, to the extent that the Take 

Care Clause, Supremacy Clause, or 

separation-of-powers doctrine are 

implicated here, the President and the 

Department have fully discharged their 

responsibilities under those authorities. 

3. Proposed Modifications to the 

SUNSET Final Rule 

Comment: Some commenters stated 

that HHS should withdraw the SUNSET 

final rule in its entirety, citing, for 

example, the continuing uncertainty the 

rule would create. Other commenters 

identified modifications to the SUNSET 


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60As explained further in the regulatory impact 

analysis in Section VI, the Department conducted 

a quantitative analysis of four alternatives, 

including alternatives recommended by 

commenters. 

final rule, short of full withdrawal, that 

they believed could address the 

Department’s concerns as described in 

the Withdrawal NPRM. These proposed 

alternatives included providing a longer 

period for reviewing existing rules or 

forgoing the review of existing rules; 

providing a longer period for 

undertaking the reviews; reviewing only 

a subset of existing rules, such as those 

that have already been designated as 

having a SEISNOSE, are significant 

rules, are major rules, have unfunded 

mandates, or arise out of a particular 

section of the CFR, subagency, or 

statute; and narrowing or eliminating 

the expiration provision. Some of these 

commenters also suggested that the 

Withdrawal NPRM conceded that such 

targeted approaches are desirable. These 

commenters asserted that the 

Withdrawal NPRM failed to seriously 

consider alternatives and asserted that 

neither of the two alternatives 

considered in the Withdrawal NPRM’s 

economic analysis offers a targeted 

approach. 

Response: The Department agrees 

with the commenters who supported 

full withdrawal, but thanks the other 

commenters for offering these proposed 

modifications. In evaluating these 

proposals, we must balance the relevant 

factors and determine whether the 

various proposals advance the mission, 

policies, and priorities of the 

Department. We must take into account 

both competing statutory obligations 

and significant public health and 

welfare considerations, among other 

things. See Motor Vehicle Mfrs. Ass’n of 

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

Ins. Co., 463 U.S. 29, 43 (1983) (holding 

agencies must consider each ‘‘important 

aspect of the problem’’). After assessing 

the benefits and harms of the SUNSET 

final rule’s binding program of 

retrospective review, the statutory 

obligations for HHS to follow lawful 

regulatory processes and establish and 

maintain programs that serve the public 

health and welfare, and the 

Department’s basic public health 

mission, we have concluded that the 

relevant factors weigh heavily in favor 

of withdrawing the SUNSET final rule 

in its entirety. To the extent that there 

are any issues with HHS’s current 

retrospective review process, those 

issues should be addressed through 

other means than this rulemaking. Our 

reasoning is set forth below. 

First, the Department has determined 

that any version of a retrospective 

review program established through 

binding regulations could undermine 

our mission to advance public health 

and welfare. Legislative rules impose a 

legal duty on the Department to conduct 

retrospective review regardless of other 

urgent priorities, and they create an 

avenue for litigation based on noncompliance. While the Department 

acknowledges that there is value in 

retrospective review and has a plan for 

such review, the resources allocated for 

retrospective review can and should 

vary depending on the circumstances 

facing an agency. A prescriptive, 

binding review framework can 

improperly skew priorities, forcing the 

Department to elevate review above 

other public health initiatives that may 

be more important. The emergence of a 

global pandemic, for example, has 

shown how HHS must have the 

flexibility to adapt as new public health 

demands arise. 

In the RFA, Congress recognized the 

importance of this type of flexibility. 

Importantly, the RFA does not direct 

agencies to issue rules binding 

themselves to a prescriptive program of 

retrospective review. Instead, it directs 

agencies to ‘‘publish in the Federal 

Register a plan for the periodic review 

of [certain] rules.’’ 5 U.S.C. 610(a) 

(emphasis added). This plan can be 

‘‘amended by the agency at any time by 

publishing the revision in the Federal 

Register.’’ Id. (emphasis added). 

Congress could have required agencies 

to proceed through notice-and-comment 

rulemaking to bind themselves to a 

review program. It certainly 

demonstrated awareness of that 

procedural mechanism, given that the 

RFA is squarely focused on rules 

promulgated through notice-andcomment rulemaking. But instead, 

Congress tasked agencies with 

establishing a ‘‘plan’’ by Federal 

Register publication that can be 

amended ‘‘at any time’’—i.e., a plan that 

can be adjusted as circumstances arise 

to preserve and support underlying 

programs. The fact that Congress chose 

not to direct agencies to issue binding 

regulation to implement the RFA, and 

the fact that such binding regulations 

would by their nature place outsized 

importance on retrospective review, 

weigh heavily in favor of wholesale 

withdrawal (rather than modification) of 

the SUNSET final rule. 

Second, the Department must keep in 

mind its statutory obligations to follow 

lawful regulatory processes and to fulfill 

substantive statutory objectives. As 

explained earlier in this section, many 

comments asserted that the expiration 

provision in the SUNSET rule violates 

the APA. In the SUNSET final rule, HHS 

previously asserted that the expiration 

provision is a cornerstone of the 

SUNSET rule. It described the rule as 

not just creating a framework for 

retrospective review but also 

‘‘impos[ing] a strong incentive on [the 

Department] to perform retrospective 

review.’’ 86 FR 5697. It stated that 

‘‘absent such a forcing mechanism, the 

Department will not conduct as many 

retrospective reviews as desired’’ and 

that ‘‘it is nearly impossible to see how 

a satisfyingly comprehensive review 

could occur without a sunset 

mechanism.’’ 86 FR 5723, 5702. HHS 

even considered whether the expiration 

provision should be severable from 

other portions of the rule, but expressed 

doubt ‘‘that the proposed rule could 

properly function without the 

expiration dates.’’ 86 FR 5734. Thus, the 

expiration provision is a key animating 

feature of the SUNSET final rule. 

However, as explained above, HHS now 

agrees with the many commenters who 

asserted that the expiration provision is 

not adequately justified and is unlawful 

under the APA. Moreover, in Section 

V.C.1, we expressed doubt that the 

expiration provision is consistent with 

the intent and purpose of the RFA. And, 

where Congress has empowered the 

Department to promulgate specific 

substantive regulations, automatic 

expiration of those regulations could 

conflict with Congressional purpose, as 

well as violate the APA. In light of our 

new conclusions about a fundamental 

premise of the SUNSET final rule, the 

best course is for the rule to be retracted 

and for the Department to then take a 

fresh look at next steps. 

Third, even if the Department 

determined that a binding regulation for 

retrospective review were appropriate, 

and even if the legal issues with the 

automatic expiration provision did not 

fundamentally undermine the rule, HHS 

has considered alternatives within the 

ambit of the existing policy and has 

determined that they either are not 

viable or should not be adopted.60 Most 

of the alternate proposals presented by 

commenters retain the key animating 

feature of the SUNSET final rule— 

automatic expiration. But as explained 

in the Withdrawal NPRM and in this 

preamble, the automatic expiration 

provision is in our view unlawful and 

could lead to significant harm, 

including a significant burden on 

stakeholders such as small entities. The 

uncertainty resulting from the sudden 

expiration and threat of sudden 

expiration of regulations could create 

numerous negative repercussions for 

stakeholders and for the public health, 

including undermining the effective 


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61The Department notes that several comments 

suggest that extensively revising the rule would 

require a new rulemaking under the APA or at least 

an additional notice and comment period. 

implementation of Federal/State 

partnership programs such as Medicaid 

that rely on HHS rules establishing 

national standards for these programs, 

hindering the ability of programs that 

rely on Federal funding to apply for or 

receive that funding or engage in longterm planning, and impeding product 

development and innovation. Moreover, 

as explained in a prior comment 

response, regulatory uncertainty created 

by the SUNSET final rule, if effective, 

would disproportionately burden small 

entities who rely on regulations to level 

the playing field and lack resources to 

navigate the resulting confusing 

regulatory landscape. This result would 

be inconsistent with the RFA’s purpose 

of alleviating disproportionate burdens 

on small entities. Furthermore, the 

expiration of any regulations under the 

SUNSET final rule—which the 

Department now predicts would be 

unavoidable—means the public would 

lose any protections, entitlements, and 

other public health benefits those 

regulations provide. Leaving the 

automatic expiration provision intact in 

any form would not address the 

Department’s concerns that the 

provision is unlawful under the APA 

and inconsistent with the RFA and, in 

some cases, the Congressional purposes 

of the authorizing statutes for particular 

sets of regulations. 

Other commenters proposed 

modifying the SUNSET final rule to 

eliminate the automatic expiration 

provision. HHS has considered this 

alternative as well, and we have 

determined that a regulation that retains 

any of the other key features of the 

SUNSET final rule—such as widespread 

assessments or provisions imposing 

accelerated timelines for assessments 

and reviews—is not viable or 

appropriate because those provisions 

impose significant and unnecessary 

burdens on the Department and 

stakeholders. As explained in a prior 

comment response, the requirement to 

conduct thousands of assessments on a 

continuing basis, including the 

requirement to comply with notice and 

comment procedures for each 

assessment, are both onerous and 

unnecessary methods of identifying the 

minority of rules which have or will 

have a SEISNOSE and is inconsistent 

with the intent of section 610 and the 

RFA’s purpose. Even if the Department 

also limited the scope of rules subject to 

assessment, as some commenters 

suggested, those proposals raise the 

concerns that (1) the Department could 

miss rules that have or will have a 

SEISNOSE (because the scope would be 

limited based on criteria unrelated to 

SEISNOSE, such as imposing an 

unfunded mandate), and (2) the process 

for assessments under the SUNSET final 

rule, such as the inclusion of a comment 

period, is still unnecessarily 

burdensome. In addition, the five-year 

timeframe for assessing and reviewing 

existing regulations and the two-year 

timeframe for amending or rescinding 

regulations based on the results of a 

SUNSET final rule review impose 

additional unnecessary burdens on the 

Department. Proposals that do not 

eliminate these requirements are not 

viable or desirable because they fail to 

resolve the Department’s concerns with 

the drain on resources resulting from 

these provisions and force the 

Department to elevate retrospective 

review above other public health 

initiatives that may be more important. 

The Department has the discretion to 

‘‘prioritize regulatory actions in a way 

that best achieves the objectives’’ of the 

RFA, other applicable statutes, and its 

public health and welfare mission, see 

WildEarth Guardians v. EPA, 751 F.3d 

649, 656 (D.C. Cir. 2014), and the 

Department has determined that these 

proposals would not best achieve its 

objectives. 

The Department also considered 

alternatives that combine proposals 

from various commenters (even though 

these combinations were not 

specifically proposed), and we reject 

those alternatives for various reasons. 

As discussed, retaining any portion of 

the SUNSET final rule would run 

counter to HHS’s view that its section 

610 ‘‘plan’’ should not be codified in 

regulations, and it would not address 

the concern that elimination of the 

expiration provision fundamentally 

changes the nature and purpose of the 

SUNSET final rule such that wholesale 

reevaluation of the effort is required. We 

have also determined that lengthening 

the various timelines in the rule would 

not adequately address our concerns. 

The Regulatory Impact Analysis for this 

withdrawal rule considers the policy 

alternative of an initial ten-year period 

following the effective date to assess 

and review all regulations, for example, 

and while that policy alternative 

temporally shifts some of the burden on 

HHS, it does not meaningfully reduce 

the burdens. Indeed, even if HHS 

eliminated all of the most concerning 

provisions of the SUNSET final rule— 

such as the expiration provision, the 

assessment process, and the narrow 

timeframes—the remaining portions of 

the SUNSET final rule are still 

fundamentally flawed because they do 

not provide for a logical or reasonable 

approach to retrospective review under 

the RFA. For example, these provisions 

require recurring review of ‘‘Sections 

that were issued as part of the same 

rulemaking (and any amendments or 

additions that may have been issued 

thereafter).’’ See, e.g., 86 FR 5751. But 

such Sections are often themselves 

‘‘amendments or additions’’ to existing 

rulemakings, so this language suggests 

that these Sections would need to be 

reviewed multiple times in connection 

with each of those existing rulemakings 

and any future rulemakings amending 

such Sections. This methodology for 

implementing the RFA is unreasonable 

and should not be retained. As another 

example, the SUNSET final rule 

contains exceptions from the review 

processes, but upon review, these 

exceptions are not only ambiguous and 

difficult to implement, but also 

apparently inconsistent with the 

language in section 610 of the RFA that 

contemplates review of all regulations 

based on whether they have or will have 

a SEISNOSE. In sum, HHS has not 

identified any substantive portion of the 

SUNSET final rule that is worth 

retaining.61

As evidenced by the discussion in 

this preamble, the Department has 

considered numerous alternatives to 

withdrawal of the SUNSET final rule, 

including commenters’ proposed 

alternatives, and has explained its 

reasons for rejecting those alternatives. 

Contrary to one commenter’s suggestion, 

the alternatives considered by HHS 

were not limited to the alternatives 

identified in the Withdrawal NPRM’s 

economic analysis. Therefore, the 

Department has satisfied its obligation 

to ‘‘consider the ‘alternative[s]’ that are 

‘within the ambit of the existing 

[policy],’ ’’ Regents, 140 S. Ct. at 913 

(2020) (quoting State Farm, 463 U.S. at 

51), and give ‘‘adequate reasons for its 

abandonment’’ of any such alternatives, 

State Farm, 463 U.S. at 51. Moreover, 

the Department notes that those 

precedents make clear that an agency is 

‘‘not required to . . . ‘consider all 

policy alternatives in reaching [its] 

decision’ ’’ and is ‘‘not compelled to 

explore ‘every alternative device and 

thought conceivable by the mind of 

man.’ ’’ Regents, 140 S. Ct. at 1914 (first 

quoting State Farm, 463 U.S. at 51; then 

quoting Vt. Yankee Nuclear Power Corp. 

v. Natural Resources Defense Council, 

Inc., 425 U.S. 519, 551 (1978)); see State 

Farm, 463 U.S. at 51 (‘‘Nor do we 

broadly require an agency to consider 

all policy alternatives in reaching 


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62See 86 FR 15404 (extending SUNSET final rule 

effective date of until March 22, 2022); 87 FR 12399 

(further extending SUNSET final rule effective date 

until September 22, 2022). 63However, we note that, upon judicial review, 

a decision to withdraw a rule that is not yet 

effective may be accorded even more deference than 

a decision to repeal a rule in effect. Cf. Int’l Union, 

United Mine Workers of Am. v. U.S. Dep’t of Lab., 

358 F.3d 40, 43 (D.C. Cir. 2004) (courts ‘‘give more 

deference to an agency’s decision to withdraw a 

proposed rule than . . . to its decision to 

promulgate a new rule or to rescind an existing 

one’’); Williams Nat. Gas Co. v. F.E.R.C., 872 F.2d 

438, 444 (D.C. Cir. 1989) (noting that the 

‘‘application of the ‘arbitrary and capricious’ 

standard must be informed by [the court’s] 

recognition that an agency’s decision to retain the 

status quo may be more easily defensible than a 

shift in policy would be’’). 

decision. It is true that a rulemaking 

‘cannot be found wanting simply 

because the agency failed to include 

every alternative device and thought 

conceivable by the mind of man . . . 

regardless of how uncommon or 

unknown that alternative may have 

been . . . .’’). Therefore, HHS has 

satisfied any obligation to consider 

alternatives to withdrawal of the 

SUNSET final rule under State Farm 

and Regents. 

4. Other Legal Issues 

Comment: One comment alleged 

various legal defects associated with the 

Administrative Delay, which delayed 

the effective date of the SUNSET final 

rule under 5 U.S.C. 705. 86 FR 15404. 

The comment stated, for example, that 

the Administrative Delay was untimely, 

that HHS unlawfully skipped noticeand-comment processes under 5 U.S.C. 

553, and that the Administrative Delay 

was not lawfully issued under section 

705. The comment stated that because 

the Withdrawal NPRM ‘‘relies 

essentially on the purported legitimacy 

of the [Administrative Delay],’’ it ‘‘is 

part and parcel of an unlawful delay, 

and therefore is fruit of a poisonous tree 

that is arbitrary and capricious and 

abuse of discretion under the APA.’’ 

Response: HHS disagrees with the 

suggestion that the Administrative 

Delay suffers from any legal defect, and 

we are not aware of any legal basis for 

the commenter’s assertion regarding the 

applicability of a fruit-of-the-poisonoustree doctrine. 

In any event, criticisms of the 

Administrative Delay are outside the 

scope of this rulemaking proceeding. In 

this proceeding, HHS has proposed and 

has sought comment on withdrawal of 

the SUNSET final rule. That proposal is 

separate from the Administrative Delay. 

While the Department continues to 

believe that the Administrative Delay 

was lawful, we disagree with the 

commenter that the Administrative 

Delay—whether lawful or unlawful— 

affects or is otherwise relevant to this 

withdrawal action. 

Moreover, the Department is 

withdrawing the SUNSET final rule 

well before the first deadline for 

completing assessments and reviews of 

Department regulations would have 

occurred if the rule had taken effect 

absent the Administrative Delay. 

Accordingly, any question of the 

validity of the Administrative Delay is 

now moot. 

Comment: One comment noted that 

the Withdrawal NPRM proposed to 

‘‘withdraw or repeal’’ the rule and 

requested that the Department clarify 

whether it intends to withdraw vs. 

repeal the SUNSET final rule and 

identify any advantages and 

disadvantages associated with each 

action. Although the comment 

acknowledged that both withdrawal and 

repeal are methods to revoke a rule, it 

asserted that withdrawal of a rule from 

the Office of the Federal Register 

ordinarily takes place prior to a rule’s 

publication whereas a notice-andcomment rule that has become effective 

generally needs to be repealed through 

notice-and-comment rulemaking. 

Response: As used in this rulemaking, 

the terms ‘‘withdraw’’ and ‘‘repeal’’ 

refer to the timing of the issuance of this 

final rule relative to the effective date of 

the SUNSET final rule. When HHS 

issued the Withdrawal NPRM, it was 

not certain about future timing and 

therefore referred to both withdrawal 

and repeal in the alternative. Because 

the effective date of this final rule will 

occur before the effective date of the 

SUNSET final rule,62 HHS is 

withdrawing the SUNSET final rule 

before it ever becomes effective. 

Because the Department has engaged 

in notice and comment rulemaking, it 

need not address the question of 

whether it could have withdrawn the 

rule without notice and comment 

procedures. Whether this final rule is 

characterized as a ‘‘withdrawal,’’ 

‘‘repeal,’’ or ‘‘rescission’’ is ultimately of 

no consequence to the validity of this 

rulemaking,63 because HHS has engaged 

in notice and comment under the APA, 

and the revocation (under any label) of 

the SUNSET final rule is fully justified 

for all of the reasons we have set forth 

in this preamble. In addition, even if 

‘‘withdrawal’’ of the SUNSET final rule 

were not appropriate due to some 

alleged defect in the Administrative 

Delay (which HHS does not believe 

exists), the Department would have 

repealed the rule, through a process 

identical to this process, for the reasons 

explained throughout this preamble. 

Comment: One comment urged HHS 

to fully incorporate all public comments 

to the SUNSET proposed rule into the 

administrative record for its withdrawal 

of the SUNSET final rule. The 

commenter noted with approval that the 

Withdrawal NPRM discusses concerns 

raised in the comments to the SUNSET 

proposed rule. 

Response: The Department agrees 

with the comment that all public 

comments to the SUNSET proposed rule 

are properly part of the administrative 

record for this rulemaking proceeding. 

As the comment acknowledged, the 

Department considered the public 

comments to the SUNSET proposed rule 

before it issued the Withdrawal NPRM. 

See, e.g., 86 FR 59906 (‘‘After 

reconsideration of the comments 

submitted on the SUNSET proposed 

rule (85 FR 70096 (Nov. 4, 2020)), HHS 

is now issuing this notice of proposed 

rulemaking to withdraw or repeal the 

SUNSET final rule.’’). Therefore, those 

comments are properly part of the 

administrative record for this final rule. 

See, e.g., 21 CFR 10.3 (FDA regulation 

defining ‘‘Administrative record’’ as 

‘‘documents . . . on which the 

Commissioner relies to support the 

action’’); 42 CFR 405.1042 (Office of 

Medicare Hearings and Appeals 

regulation defining administrative 

record as ‘‘complete record of the 

evidence and administrative 

proceedings on the appealed matter’’). 

The Department notes that many of the 

comments to the Withdrawal NPRM 

discussed or attached copies of public 

comments to the SUNSET proposed rule 

and are therefore part of the 

administrative record for this 

rulemaking for that reason, as well. See, 

e.g., 21 CFR 10.40(g) (FDA regulation 

instructing that the record of the 

administrative proceeding for the 

promulgation of rules consists of ‘‘[a]ll 

comments received on the proposal, 

including all information submitted as 

part of the comments’’); 42 CFR 431.416 

(CMS regulation defining administrative 

record for State Medicaid and CHIP 

demonstration projects to include 

‘‘[w]ritten public comments sent to the 

CMS and any CMS responses’’ and ‘‘all 

documentation related’’ to a project 

application). 

E. Vague and Confusing Provisions 

In the Withdrawal NPRM, we 

explained that, upon reconsideration, 

the Department found many ambiguities 

in the SUNSET final rule that could 

impede the ability of the Department 

and the public to determine the scope 

and timing of the assessment and review 

process. 87 FR 59922. This confusion 

would have increased the burden on 

stakeholders trying to navigate the 

assessment and review process. Process 


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64The regulatory text of the SUNSET final rule 

consisted of one regulation, with multiple 

subsections, substantially replicated 10 times. 

Subsection (g) in the replicated regulatory text 

excluded (1) Sections that are prescribed by Federal 

law, such that the Department exercises no 

discretion as to whether to promulgate the Section 

and as to what is prescribed by the Section; (2) 

Sections whose expiration pursuant to this section 

would violate any other Federal law; (3) The 

SUNSET final rule; (4) Sections that involve a 

military or foreign affairs function of the United 

States; (5) Sections addressed solely to internal 

agency management or personnel matters; (6) 

Sections related solely to Federal Government 

procurement; and (7) Sections that were issued 

jointly with other Federal agencies, or that were 

issued in consultation with other agencies because 

of a legal requirement to consult with that other 

agency. Subsection (g) also excludes individual 

regulations specific to each HHS agency. 86 FR 

5729. 

ambiguities would also increase the risk 

of the automatic expiration of HHS 

regulations due to inadvertent 

noncompliance or misapplication of the 

requirements. We received the following 

additional comments on this topic. 

Comment: Many commenters agreed 

that the SUNSET final rule would create 

burdens, confusion, and uncertainty 

over which regulations are likely to 

remain in effect, and overall decrease 

predictability, transparency, and public 

engagement critical to the regulatory 

process. Ambiguities in the regulatory 

text would contribute to those problems. 

One comment, for example, stated that 

the SUNSET final rule contained many 

ambiguities that could impede the 

ability of HHS and the public to 

determine the scope and timing of the 

assessment and review process. Another 

comment criticized the SUNSET final 

rule for confusing definitions. Another 

comment opined that the rush to issue 

the SUNSET final rule, with the 

extremely short time for stakeholder 

comment and unprecedented 

acceleration of the timeline for 

completion of the rulemaking, resulted 

in an inadequately considered and 

drafted final rule, with provisions that 

are overly vague, lack needed details, 

and are impractical to implement. 

Response: We agree with these 

concerns. For example, as explained in 

Section V.D of this preamble, the 

SUNSET final rule requires recurring 

review of ‘‘Sections that were issued as 

part of the same rulemaking (and any 

amendments or additions that may have 

been issued thereafter).’’ But such 

Sections are often themselves 

‘‘amendments or additions’’ to existing 

rulemakings, so this language suggests 

that these Sections would need to be 

reviewed multiple times in connection 

with each of those existing rulemakings 

and any future rulemakings amending 

such Sections. This methodology for 

implementing the RFA is unreasonable 

and confusing. 

For example, the FDA rulemaking 

‘‘Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food’’ 

(Preventive Controls for Human Food) 

was published on September 17, 2015 

(80 FR 55907). However, in addition to 

new sections first promulgated in 2015, 

the rule also included revisions to 

sections of the CFR that were first 

promulgated in 1975, 1979, 1986, 1995, 

1997, 2001, 2004, and 2008. The 

SUNSET final rule suggests that, 

because these revised sections were 

issued as part of the 2015 rulemaking, 

the Department would need to review 

these revised sections multiple times— 

first, as part of a review of the 2015 

rulemaking, and then again as part of 

the Department’s reviews of the 

rulemakings in which those sections 

were first promulgated or previously 

revised. Moreover, the complexity of 

this process would be compounded by 

the fact that each of these sections of the 

CFR, because they were promulgated at 

different times, would have different 

expiration dates under the SUNSET 

final rule. 

Comment: The Withdrawal NPRM 

also expressed concern about ambiguity 

in the categories of exceptions described 

in the proposed rule and included in the 

final rule.64 Numerous commenters on 

the SUNSET proposed rule noted the 

lack of examples provided, and stated 

the lack of clarity for the categorical 

exceptions would leave the public 

unable to know which regulations 

would be eligible for the exceptions. 

Accordingly, some commenters stated 

that stakeholders would face a burden to 

conduct their own legal analysis. 

Response: In the Withdrawal NPRM, 

we agreed with these comments, and we 

continue to agree with them now. We 

explained that the SUNSET final rule 

failed to provide meaningful examples 

of these exceptions and recognized the 

possibility that this lack of clarity could 

delay the completion of the assessment 

process and place further strain on the 

resources and effort needed to avoid the 

expiration of regulations. Commenters 

on the Withdrawal NPRM confirmed 

this view. For example, one commenter 

explained that, rather than vaguely 

indicate that certain types of regulations 

may be subject to exceptions, the 

SUNSET final rule should have 

identified the regulations more 

specifically, so that commenters could 

engage in the comment process, and 

stakeholders could better understand 

the rule if implemented. Another 

commenter criticized the scope of the 

exceptions in the SUNSET final rule for 

their failure to ensure that these 

exceptions would avert the expiration of 

a regulation in the event of a pandemic 

or other declared national or public 

health emergency. 

In addition, many commenters on the 

original SUNSET proposed rule stated 

that it was improper for the final rule to 

exclude the SUNSET final rule itself 

from the requirements of Section (c) of 

each of the codified provisions, meaning 

that under the rule, the rule itself is not 

subject to assessment, review, or 

expiration. The SUNSET final rule 

based this exemption on an assumption 

that the SUNSET final rule would not 

‘‘directly impose on the public costs 

that exceed benefits’’ because no rules 

would expire due to lack of assessment 

or review. 86 FR 5730. The Department 

now concludes that this assumption was 

incorrect and therefore does not justify 

the double-standard inherent in this 

aspect of the SUNSET final rule. 

VI. Final Regulatory Impact Analysis 

A. Introduction, Summary, and 

Background 

1. Introduction 

We have examined the impacts of the 

final withdrawal rule under E.O. 12866, 

E.O. 13563, the Regulatory Flexibility 

Act (RFA) (5 U.S.C. 601–612), and the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4). E.O.s 12866 and 13563 

direct us to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). We 

believe that this final withdrawal rule is 

a significant regulatory action as defined 

by E.O. 12866. 

The RFA requires us to analyze 

regulatory options that would minimize 

any significant impact of a rule on small 

entities. Because the final withdrawal 

rule would result in cost savings to 

regulated entities, this analysis 

concludes, and the Secretary certifies, 

that the final withdrawal rule will not 

have a significant economic impact on 

a substantial number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $165 million, 


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using the most current (2021) Implicit 

Price Deflator for the Gross Domestic 

Product. This final withdrawal rule will 

result in an expenditure in at least one 

year that meets or exceeds this amount. 

2. Summary of Costs and Benefits 

The final withdrawal rule will 

withdraw the SUNSET final rule. This 

regulatory action will reduce the time 

spent by the Department performing 

retrospective assessments and reviews 

of its regulations, and time spent by the 

general public on comments related to 

these assessments and reviews 

anticipated under the SUNSET final 

rule. We monetize the likely reductions 

in time spent by the Department and the 

general public and report these impacts 

as cost savings. Our primary estimate of 

these cost savings in 2020 dollars, 

annualized over 10 years, using a 3% 

discount rate, totals $69.9 million. 

Using a 7% discount rate, we estimate 

$75.5 million in annualized cost 

savings. Table 1 reports these primary 

estimates alongside a range of estimates 

that capture uncertainty in the amount 

of time it will take the Department to 

perform each assessment and review, 

and uncertainty in the amount of time 

the public will spend on comments. 

In addition to these monetized effects, 

the final withdrawal rule will also 

reduce regulatory uncertainty and 

regulatory confusion anticipated under 

the SUNSET final rule. Given the scope 

of the SUNSET final rule, these impacts 

would have been experienced by small 

businesses but also the general public, 

larger businesses, Tribes, States, nongovernmental organizations, and other 

regulated entities and stakeholders 

across a wide range of industrial sectors. 

The final withdrawal rule will also 

reduce the time spent by the 

Department on other activities that we 

have not monetized or quantified, such 

as the time developing Small Entity 

Compliance Guides (SECGs), and it will 

reduce the time spent by the public 

monitoring regulations undergoing 

assessment or review and set to expire. 

The final withdrawal rule will also 

result in a disbenefit with respect to 

forgone information as a result of not 

performing the assessments and 

reviews. 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF THE FINAL WITHDRAWAL RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

Benefits: 

Annualized Monetized $millions/year ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Annualized Quantified ...................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ........................................ —Reduction in regulatory uncertainty 

and confusion. 

—Disbenefits from the information 

foregone from not performing 

assessments and reviews. 

Costs: 

Annualized Monetized $millions/year ¥$75.5 

¥69.9 

¥$40.1 

¥37.2 

¥$110.9 

¥102.7 

2020 

2020 

7 

3 

2022–2031 

2022–2031 

Cost savings from not performing assessments and reviews, and time 

spent by the public on comments. 

Annualized Quantified ...................... ..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative. 

Transfers: 

Federal Annualized Monetized 

$millions/year.

..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ............................................ From: To: 

Other Annualized Monetized 

$millions/year.

..................

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

From/To ............................................ From: To: 

Effects: 

State, Local or Tribal Government: 

Small Business: 

Wages: 

Growth: 

3. Summary of Changes 

Compared to the preliminary 

regulatory impact analysis, this final 

regulatory impact analysis expands the 

discussion of regulatory alternatives, 

including a quantitative analysis of two 

additional alternatives recommended in 

public comments. Specifically, we 

analyze a policy option that would 

maintain the general framework of the 

SUNSET final rule but limit its scope to 

regulations that the Department 

previously identified as having a 

significant economic impact on a 

substantial number of small entities. We 

also analyze a policy option that would 

maintain the SUNSET final rule’s 

requirements related to the timeline for 

assessing and reviewing all of the 

Department’s existing regulations, but 

without the automatic expiration 

provision contained in the SUNSET 

final rule. 

We have revised the discussion and 

estimates contained in this regulatory 

impact analysis to reflect regulatory 

action that administratively postponed 

the effective date of the SUNSET final 

rule. This analysis now states that the 

regulatory action will withdraw the 

SUNSET final rule, whereas the 

preliminary regulatory impact analysis 


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65 86 FR 5694. 

66 86 FR 15404; 87 FR 12399. 

67This approach allows for a more direct 

comparison with the estimates contained in the 

SUNSET final rule RIA and follows a common 

practice in regulatory impact analysis to assess 

costs assuming full compliance with the regulation. 

We supplement the full-compliance estimates by 

identifying the likely impacts associated with less 

than full compliance. The HHS Guidelines for 

Regulatory Impact Analysis (available at https://

aspe.hhs.gov/system/files/pdf/242926/HHS_

RIAGuidance.pdf.), Chapter 4 ‘‘Assess Costs,’’ 

contains a more complete discussion of this 

approach. 

covered regulatory actions to withdraw 

or repeal the SUNSET final rule. We 

have made minor edits for clarity 

throughout the document. Finally, we 

have read and considered public 

comments addressing the regulatory 

impact analysis and respond to these 

comments in Sections V.A.3, C.3, and 

D.3 of this preamble. 

4. Background 

On January 19, 2021, HHS issued the 

‘‘Securing Updated and Necessary 

Statutory Evaluations Timely’’ final 

rule. Under the SUNSET final rule, all 

HHS regulations less than ten years old, 

with certain exceptions, will expire ten 

years after issuance, unless HHS 

performs an assessment of the 

regulations and a more detailed review 

of those regulations that have a 

significant economic impact upon a 

substantial number of small entities. 

The SUNSET final rule also provides for 

regulations older than ten years to 

expire unless assessed and, if 

applicable, reviewed within an initial 

five-year period. After this initial 

assessment and review process, the 

SUNSET final rule requires continuing 

assessments and reviews every ten years 

under threat of expiration. HHS 

published a regulatory impact analysis 

(SUNSET RIA) alongside the final rule, 

providing estimates of the likely impact 

of the policy on Departmental resources 

and time spent by the general public 

related to these efforts. Following the 

initiation of litigation, HHS issued an 

administrative delay of effective date, 

effective as of March 19, 2021, which 

extended the effective date of the 

SUNSET final rule by one year to March 

22, 2022. HHS issued a second 

administrative delay of effective date, 

effective as of March 4, 2022, which 

further extended the effective date of the 

final rule by six months to September 

22, 2022. For the purposes of this 

analysis, we refer to the January 19, 

2021, final rule and the two 

administrative delays collectively as the 

SUNSET final rule. On October 19, 

2021, HHS published a proposed rule to 

withdraw or repeal the SUNSET final 

rule. 

B. Market Failure or Social Purpose 

Requiring Federal Regulatory Action 

The SUNSET final rule established 

automatic expiration dates for most of 

the Department’s regulations, and a 

recurring assessment and review 

process that it must follow to avoid such 

expirations. The SUNSET final rule’s 

RIA likely underestimated both the time 

commitment of a credible assessment 

and review process, and the time spent 

by the general public commenting on 

regulations undergoing assessment and 

review. Given the volume and 

heterogeneity of regulations affected, 

our current evaluation of the time 

commitment necessary to conduct 

credible assessments and reviews, the 

timeframes for completing these 

retrospective analyses, and subsequent 

regulatory actions anticipated as a result 

of these analyses, it is likely that 

regulations will automatically expire. 

The potential for regulations to 

automatically expire introduces 

regulatory uncertainty, with potential 

negative repercussions for stakeholders. 

The actuality of having regulations 

expire automatically could lead to 

regulatory confusion among 

stakeholders and harm the public health 

in numerous ways, as described in the 

preamble and this analysis. This final 

withdrawal rule is therefore needed to 

improve the functioning of government 

and to reduce the costs to the 

Department and the general public 

associated with the SUNSET final rule. 

C. Purpose of the Final Withdrawal Rule 

The purpose of the final withdrawal 

rule is to revoke the SUNSET final rule. 

This regulatory action will directly 

address the potential harm from the 

automatic expiration of the 

Department’s regulations. The final 

withdrawal rule will generate cost 

savings to the Department from 

reductions in staff time spent on 

assessments and reviews, and on related 

activities. It will also generate cost 

savings to the general public by 

reducing time spent on public 

comments related to these assessments 

and reviews, and on other activities, 

such as monitoring potentially expiring 

regulations. The final withdrawal rule 

will also reduce any regulatory 

uncertainty from the potential automatic 

expiration of rules. 

D. Baseline Conditions 

We adopt a baseline that assumes the 

requirements of the January 19, 2021, 

SUNSET final rule 65 remain in place 

over the period of our analysis, 

accounting for the administrative delays 

of the effective date.66 The SUNSET 

final rule RIA contains monetized 

estimates of the costs to the Department 

to perform retrospective analyses of 

existing regulations and the costs to the 

public to monitor and respond to 

anticipated regulatory actions taken by 

the Department following these 

retrospective analyses. For the purpose 

of estimating the time spent on 

retrospective analyses under the 

baseline of this analysis, we maintain 

the assumption in the SUNSET final 

rule RIA that the Department will satisfy 

the requirements of the SUNSET final 

rule and no regulations will 

automatically expire.67 We also 

maintain various assumptions in the 

SUNSET final rule RIA relating to the 

timing of the effects and treatment of the 

one-year waiver provision that allows 

the Secretary to make one-time, case-bycase exceptions to the automatic 

expiration of a rule. We also maintain 

the SUNSET final rule RIA’s choice of 

a 10-year time horizon for the analysis 

and adopt a base year of 2022 for 

discounting purposes. In this section, 

we reconsider several other assumptions 

underlying the cost estimates in the 

SUNSET final rule RIA, and discuss 

additional cost drivers not identified 

and monetized in the analysis. These 

revised estimates inform our baseline 

scenario of no further regulatory action. 

This analysis of the baseline scenario 

concludes that the SUNSET final rule 

likely underestimated to a significant 

degree the resources needed for the 

required undertaking. 

Regulations Subject to the SUNSET 

Final Rule 

We adopt the SUNSET final rule 

RIA’s estimate of 18,000 regulations 

potentially subject to the SUNSET final 

rule that will need to be assessed in the 

first ten years. For each of these 

regulations, the Department will need to 

perform an assessment to determine 

whether the regulation imposes a 

significant economic impact on a 

substantial number of small entities. 

The SUNSET final rule RIA estimates 

that roughly five regulations on average 

are part of the same rulemaking and 

could be assessed at one time. We 

maintain this assumption and 

terminology, which results in a total of 

3,600 assessments in the first ten years. 

Although we adopt the SUNSET final 

rule RIA’s estimate that the Department 

would perform 3,600 assessments, this 

estimate may understate the number of 

assessments performed under the 

SUNSET final rule, since certain 

regulations would need to be assessed 

multiple times as part of separate 


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68Available at https://cdn.advocacy.sba.gov/wpcontent/uploads/2019/06/21110349/How-toComply-with-the-RFA.pdf. 

assessments. The SUNSET final rule 

RIA assumes that 11% of these 

assessments, or 396, are for regulations 

previously determined to have a 

significant economic impact on a 

substantial number of small entities, but 

reduces this figure to 370 to account for 

rulemakings that are likely to be 

reviewed for reasons other than the 

SUNSET final rule. This adjustment 

similarly reduces the estimate of the 

number of rulemakings impacted by the 

SUNSET final rule to 3,574 

[=3600¥(396–370)]. 

For each of these 370 rulemakings, the 

Department will need to perform a 

review, which includes a retrospective 

regulatory flexibility analysis. The 

SUNSET final rule RIA distinguishes 

between the 44 rulemakings that predate 

the RFA and are unlikely to have an 

existing prospective regulatory 

flexibility analysis, and the remaining 

326 rulemakings that are assumed to 

have an existing prospective analysis. 

The SUNSET final rule RIA also 

estimates there will be an additional 160 

rulemakings assessed to have a 

significant impact on a substantial 

number of small entities that have not 

previously been identified as having a 

significant economic impact. The 

Department will need to perform a 

review of these rulemakings under the 

SUNSET final rule. 

The SUNSET final rule provides for 

an initial five-year period for the 

Department to address regulations older 

than ten years. We maintain the 

assumption in the SUNSET final rule 

RIA that assessments and reviews 

required in the first five years will be 

completed evenly across this time 

period, and that the remaining 

assessments and reviews will be 

completed evenly across the next fiveyear time period. Of the 3,574 total 

assessments anticipated under the 

SUNSET final rule, 3,415 would occur 

during the first five-year period, an 

average of 683.0 assessments per year; 

while 159 assessments would occur 

during the second five-year period, an 

average of 31.8 assessments per year. Of 

the total reviews anticipated under the 

SUNSET final rule, 506 would occur 

during the first five-year period, an 

average of 101.2 reviews per year; while 

24 assessments would occur during the 

second five-year period, an average of 

4.8 reviews per year. Table D1 presents 

yearly counts of assessments and 

reviews anticipated under the baseline 

scenario. These figures are broadly 

consistent with the figures contained in 

the SUNSET final rule RIA; however, 

unlike that analysis, we do not reduce 

the number of assessments under the 

SUNSET final rule by the number of 

reviews performed, since these 

assessments occur first and serve to 

identify those regulations requiring 

review. 

TABLE D1—BASELINE ASSESSMENTS AND REVIEWS UNDER THE SUNSET FINAL RULE

Year Total 

assessments 

Reviews 

Pre-RFA Post-RFA Not specified Total 

2022 ..................................................................................... 683.0 8.8 61.8 30.6 101.2 

2023 ..................................................................................... 683.0 8.8 61.8 30.6 101.2 

2024 ..................................................................................... 683.0 8.8 61.8 30.6 101.2 

2025 ..................................................................................... 683.0 8.8 61.8 30.6 101.2 

2026 ..................................................................................... 683.0 8.8 61.8 30.6 101.2 

2027 ..................................................................................... 31.8 0.0 3.4 1.4 4.8 

2028 ..................................................................................... 31.8 0.0 3.4 1.4 4.8 

2029 ..................................................................................... 31.8 0.0 3.4 1.4 4.8 

2030 ..................................................................................... 31.8 0.0 3.4 1.4 4.8 

2031 ..................................................................................... 31.8 0.0 3.4 1.4 4.8 

Total .............................................................................. 3574.0 44.0 326.0 160.0 530.0 

Time per Assessment and per Review 

The SUNSET final rule RIA contains 

estimates of the time per assessment and 

time per review performed under the 

SUNSET final rule. For each 

assessment, the SUNSET final rule RIA 

assumes that it will require between 3 

and 10 hours to assess a rulemaking. For 

each review, the SUNSET RIA assumes 

that it will require between 250 and 500 

hours to review rulemakings that 

predate the RFA, and between 40 and 

100 hours to review rulemakings that 

postdate the RFA. For the 160 

rulemakings newly found to have a 

significant impact, the SUNSET RIA 

assumes that it will take between 40 and 

100 hours to complete a review. 

The Department now concludes the 

SUNSET RIA likely underestimates the 

time necessary to credibly assess 

whether a regulation imposes a 

significant economic impact on a 

substantial number of small entities by 

a significant degree. The Small Business 

Administration (SBA) Office of 

Advocacy published ‘‘A Guide for 

Government Agencies: How to Comply 

with The Regulatory Flexibility Act,’’ 

detailing a step-by-step approach for 

analysts.68 For each of the 3,574 

rulemakings requiring an assessment 

under the SUNSET final rule, the 

Department will need to define the 

problem and describe the regulated 

entities, estimate economic impacts by 

size categories, and determine which 

size categories incur significant impacts. 

The SBA guide presents a two-page 

checklist containing the elements of an 

adequate certification. In practice, when 

performing a threshold analysis, 

analysts will face novel conceptual 

issues and data challenges, both of 

which require thoughtful consideration 

and professional judgement. The 

SUNSET final rule also requires HHS to 

open a docket and review public 

comments on each rulemaking being 

assessed. Furthermore, SBA indicates 

that it is not sufficient to rely on an 

assessment made at the time a 

regulation was published: 

In some cases, even if an agency was 

originally able to certify properly under 

section 605 of the RFA that a rule would not 

have a significant economic impact on a 

substantial number of small entities, changed 

conditions may mean that the rule now does 

have a significant impact and therefore 

should be reviewed under section 610. For 

example, many more small businesses may 

be subject to the rule now than when the rule 

was promulgated. The cost of compliance 

with a current rule may have increased 

sharply because of a required new 

technology. (SBA, pp. 80–81) 

We assume that, under the baseline 

scenario of the SUNSET final rule, the 

Department will follow the 


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recommendations in the SBA guidance, 

and will perform a credible threshold 

analysis for each rulemaking to assess 

whether it imposes a significant 

economic impact on a substantial 

number of small entities. Each 

assessment will likely require time by 

an economist or other analyst to perform 

and document the threshold analysis, 

with input from at least one subject 

matter expert on the area of the 

regulation. Recognizing the need to fully 

respond to all the requirements, we 

modify the assumption in the SUNSET 

final rule RIA and adopt an estimate of 

40 to 100 hours to complete a credible 

threshold analysis for each rulemaking 

requiring an assessment. 

As described earlier, the SUNSET 

final rule RIA contains two estimates for 

the time necessary to perform a 

retrospective analysis as part of a 

review. For rulemakings published 

before the RFA was enacted, the 

SUNSET final rule RIA assumes 

between 250 and 500 hours per review. 

For rulemakings published after the 

RFA was enacted, the SUNSET final 

rule RIA assumes that a prospective 

regulatory flexibility analysis is 

available and further assumes that this 

will reduce the time necessary to 

complete a review, adopting a range of 

40 and 100 hours per review. For the 

160 rulemakings newly found to have a 

significant impact, the SUNSET RIA 

assumes that it will take between 40 and 

100 hours to complete a review. The 

Sensitivity Analysis Section of the 

SUNSET final rule RIA acknowledges 

that ‘‘[o]ne commenter noted that 

conducting a retrospective analysis can 

be as time-consuming and expensive as 

a prospective regulatory analysis, 

suggesting the Department’s estimates of 

the time and expense of Reviews may be 

understated.’’ Upon further 

consideration, the Department agrees 

that the commenter is likely correct. 

For the analysis of this final 

withdrawal rule, we adopt the SUNSET 

final rule RIA estimate of 250 to 500 

hours for all retrospective analyses 

performed as part of a review, regardless 

of when the underlying rulemaking was 

published, and regardless of whether 

the rulemaking was previously found to 

have a significant impact on a 

substantial number of small entities. If 

previously published prospective or 

retrospective regulatory flexibility 

analyses are generally available, 

analysts may be able to build off of these 

previous analytic efforts when 

developing a retrospective analysis 

under the SUNSET final rule. All else 

equal, this would suggest the average 

time per retrospective analysis may be 

closer to the lower-bound estimate of 

250 hours. If these analyses are not 

generally available, this would suggest 

an average time per retrospective 

analysis closer to the upper-bound 

estimate of 500 hours. We do not 

address the assumption in the SUNSET 

final rule RIA that a prospective 

regulatory flexibility analysis is 

available for every rulemaking 

published after the RFA was enacted, 

because it does not impact the estimate 

of the overall time spent on reviews 

under the baseline scenario. Our 

approach also allows us to ignore the 

apparent internal inconsistency in the 

SUNSET final rule RIA underlying the 

time per review of the 160 rulemakings 

that are newly assessed to have a 

significant impact. 

The SUNSET final rule RIA is not 

clear on what activities are included in 

its estimates of the time per review 

other than the time spent developing a 

retrospective analysis. We interpret the 

magnitudes of these estimates to 

exclude consideration of time spent on 

activities other than drafting the 

retrospective analysis. For example, the 

Department may need to conduct a 

study or survey to gather data to inform 

its analyses. We therefore include an 

additional 250 hours to 500 hours per 

review to account for this omission. 

This estimate reflects time spent by 

Department subject matter experts, 

lawyers, and other reviewers informing 

the retrospective analysis and providing 

feedback on draft analyses. It also 

reflects time spent by economists and 

other analysts developing the 

retrospective analysis to respond to this 

feedback, and time spent reading and 

incorporating evidence from other 

sources, including public comments. 

Table D2 summarizes the assumptions 

in the SUNSET final rule RIA and our 

revised assumptions for the final 

withdrawal rule of the time per 

assessment and time per review 

performed under the baseline scenario 

of the SUNSET final rule. Combining 

the time spent on retrospective analysis 

and on other related activities, we 

estimate that each review will take 

between 500 and 1,000 hours to 

complete. 

TABLE D2—HOURS PER ASSESSMENT AND REVIEW

Baseline requirement 

SUNSET final rule RIA Final withdrawal rule 

Low High Low High 

Assessment ..................................................................................................... 3 10 40 100 

Review: Retrospective Analysis, pre-RFA regulation ...................................... 250 500 250 500 

Review: Retrospective Analysis, post-RFA regulation .................................... 40 100 250 500 

Review: Retrospective Analysis, Not Specified ............................................... 40 100 250 500 

Review: Other Activities ................................................................................... 0 0 250 500 

Time Spent by the Public To Monitor 

and Comment 

Under the SUNSET final rule, the 

Department would create a docket on 

www.Regulations.gov for each 

assessment or review that the 

Department is conducting. The public 

would then be able to submit comments 

to the dockets of each rulemaking being 

assessed or reviewed. The SUNSET final 

rule RIA includes a discussion of the 

costs to the stakeholders to monitor and 

comment on regulations as these are 

undergoing assessment and review; 

however, the analysis assigns no costs to 

the Department associated with setting 

up these dockets or engaging with the 

comments. The analysis also does not 

monetize any other costs associated 

with operationalization of the SUNSET 

final rule, which also requires 

developing a schedule for activities 

associated with the SUNSET final rule, 

publishing monthly updates on the 

commencement of assessments and 

reviews, publishing the results of 

assessments and review (‘‘including the 

full underlying analyses and data used 

to support the results’’) once a year, and 

establishing a website dashboard to help 

the public monitor the Department’s 

progress. 

When estimating the impact on the 

public, the SUNSET final rule RIA 

assumes the public will wait until the 

assessments and reviews are complete 

and the Department has announced it 

intends to rescind or amend a 

rulemaking before commenting. Thus, 


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69Available at https://cdn.advocacy.sba.gov/wpcontent/uploads/2019/06/21110349/How-toComply-with-the-RFA.pdf pg. 83. 

for example, the SUNSET final rule RIA 

first estimates that 53 rulemakings will 

be rescinded and another 159 

rulemakings amended as a result of the 

retrospective analyses initiated as a 

result of the SUNSET final rule, 

monetizing the time spent by the public 

responding to those 212 rulemakings. 

The SUNSET final rule RIA assumes 

that, for each of the 53 rulemakings 

rescinded following a review completed 

under the SUNSET final rule, the public 

will submit 243 comments; and for each 

of the 159 rulemakings amended, the 

public will submit 486 comments. This 

will result in an estimated 90,153 

comments, for which the SUNSET final 

rule RIA assumes will take between 5 

and 15 hours to prepare. Presumably, 

this estimate is inclusive of finding out 

that the rulemaking is likely to be 

rescinded or amended, reading and 

understanding the rulemaking, 

completing further research, 

communicating with other stakeholders, 

identifying concerns, and drafting and 

submitting comments. The preamble to 

the SUNSET final rule anticipates that 

the Department will create on its 

website a dashboard that shows its 

progress on its Assessments and 

Reviews. Therefore, we assume that any 

reduction in the time spent by the 

public attributable to this dashboard is 

accounted for in these time estimates. 

We have reconsidered the SUNSET 

final rule RIA’s assumption that the 

public will wait until the Department 

has announced it intends to rescind or 

amend a rulemaking before 

commenting. Upon further 

consideration, the Department finds it 

more likely that the public will 

comment on rulemakings undergoing 

assessment and review rather than wait 

until learning the specific rulemakings 

that will be rescinded or amended as a 

result of these assessments and reviews. 

The Department’s prior assumptions 

appear at odds with the decision to 

invite public comment during both the 

assessment and review processes. 

Furthermore, as discussed by the SBA, 

‘‘insights about an existing regulation 

received from regulated entities and 

other interested parties should be a key 

component of a retrospective rule 

review. By making the review process 

transparent and accessible, agencies are 

more likely to identify improvements 

that will benefit all parties at the 

conclusion of the review.’’ 69

This means that we assume that the 

public will comment on all 3,600 

rulemakings subject to the SUNSET 

final rule that will be available for 

public comment in connection with a 

Department assessment or review, in 

contrast with the SUNSET final rule 

RIA, which assumes the public will 

offer no comments. We adopt the 

SUNSET final rule RIA’s estimate of 486 

comments per rulemaking, but instead 

apply this to the 530 rulemakings that, 

following a threshold analysis in an 

assessment, the Department will begin 

to review. We believe that the public 

will submit fewer comments for 

rulemakings undergoing an assessment 

(rather than a review), and adopt an 

assumption of 25 comments per 

assessment. We also adopt the SUNSET 

final rule RIA’s assumption about the 

time spent per comment (between 5 and 

15 hours) and apply it in the context of 

assessments and reviews. Table D3 

summarizes a comparison of the 

assumptions in the SUNSET final rule 

RIA and in the baseline analysis of this 

final withdrawal rule of the comments 

per assessment and review, and for the 

subsequent regulatory actions to rescind 

or amend rulemakings. 

TABLE D3—BASELINE COMMENTS PER ACTION

Baseline requirement SUNSET 

final rule RIA 

Final 

withdrawal rule 

Assessment ................................................................................................................................................. 0 25 

Review ......................................................................................................................................................... 0 486 

Rescission .................................................................................................................................................... 486 N/A 

Amendment .................................................................................................................................................. 243 N/A 

Considerations Related to Rescissions 

and Amendments 

As described earlier, the SUNSET 

final rule RIA envisions the Department 

identifying and rescinding 53 

rulemakings and amending 159 

rulemakings following completed 

reviews under the SUNSET final rule. 

Upon further reflection and analysis, the 

Department no longer believes it was 

appropriate to unambiguously attribute 

subsequent regulatory actions of this 

nature to the SUNSET final rulemaking 

in the context of a regulatory impact 

analysis. Even if the challenging 

attribution questions could be resolved, 

we maintain that the SUNSET final rule 

RIA understates the impact of the 

SUNSET final rule since it implicitly 

assumes that the Department would not 

have to spend any time to develop and 

publish subsequent regulatory actions to 

rescind or amend existing regulations. 

This unstated assumption is difficult to 

justify given the resources required to 

undertake a full notice-and-comment 

rulemaking proceeding. Since these 

anticipated regulatory actions relate to 

regulations that have a significant 

economic impact on a substantial 

number of small entities, we expect that 

these actions will need to involve 

subject matter experts, legal review, 

policy coordination, Departmental 

clearance, and a communications 

strategy to bring transparency to the 

process. For certain regulatory actions, 

we anticipate review by the Office of 

Management and Budget. We have not 

attempted to estimate the time and 

resources associated with developing 

these regulatory actions or 

unambiguously attributed the costs of 

those actions to the SUNSET final rule. 

Baseline Effect of the SUNSET Final 

Rule 

To quantify the likely effect of the 

SUNSET final rule on the Department, 

we multiply the number of assessments 

and number of reviews from Table D1 

by the assumptions relating to the time 

per assessment and time per review 

described in Table D2. To quantify the 

likely effect of the SUNSET final rule on 

the public, we multiply the figures in 

Table D1 by the assumptions relating to 

the comments per assessment and 

comments per review described in Table 

D3. This gives us estimates for the 

number of comments, which we then 

multiply by the time estimates per 

comment (between 5 and 15 hours) to 

estimate the total time spent by the 

public. Table D4 presents yearly 

estimates of hours spent related to 

assessments performed under the 


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SUNSET final rule to the Department 

and the public. Table D5 presents 

comparable figures related to reviews. 

Table D6 presents the total time 

anticipated under the SUNSET final 

rule related to assessments and reviews. 

TABLE D4—HOURS RELATED TO ASSESSMENTS UNDER THE SUNSET FINAL RULE

Year Assessments 

Department Public 

Low High Low High 

2022 ..................................................................................... 683.0 27,320 68,300 85,375 256,125 

2023 ..................................................................................... 683.0 27,320 68,300 85,375 256,125 

2024 ..................................................................................... 683.0 27,320 68,300 85,375 256,125 

2025 ..................................................................................... 683.0 27,320 68,300 85,375 256,125 

2026 ..................................................................................... 683.0 27,320 68,300 85,375 256,125 

2027 ..................................................................................... 31.8 1,272 3,180 3,975 11,925 

2028 ..................................................................................... 31.8 1,272 3,180 3,975 11,925 

2029 ..................................................................................... 31.8 1,272 3,180 3,975 11,925 

2030 ..................................................................................... 31.8 1,272 3,180 3,975 11,925 

2031 ..................................................................................... 31.8 1,272 3,180 3,975 11,925 

TABLE D5—HOURS RELATED TO REVIEWS UNDER THE SUNSET FINAL RULE

Year Reviews 

Department Public 

Low High Low High 

2022 ..................................................................................... 101.2 50,600 101,200 245,916 737,748 

2023 ..................................................................................... 101.2 50,600 101,200 245,916 737,748 

2024 ..................................................................................... 101.2 50,600 101,200 245,916 737,748 

2025 ..................................................................................... 101.2 50,600 101,200 245,916 737,748 

2026 ..................................................................................... 101.2 50,600 101,200 245,916 737,748 

2027 ..................................................................................... 4.8 2,400 4,800 11,664 34,992 

2028 ..................................................................................... 4.8 2,400 4,800 11,664 34,992 

2029 ..................................................................................... 4.8 2,400 4,800 11,664 34,992 

2030 ..................................................................................... 4.8 2,400 4,800 11,664 34,992 

2031 ..................................................................................... 4.8 2,400 4,800 11,664 34,992 

TABLE D6—TOTAL HOURS RELATED TO THE SUNSET FINAL RULE

Year 

Department Public 

Low High Low High 

2022 ................................................................................................................. 77,920 169,500 331,291 993,873 

2023 ................................................................................................................. 77,920 169,500 331,291 993,873 

2024 ................................................................................................................. 77,920 169,500 331,291 993,873 

2025 ................................................................................................................. 77,920 169,500 331,291 993,873 

2026 ................................................................................................................. 77,920 169,500 331,291 993,873 

2027 ................................................................................................................. 3,672 7,980 15,639 46,917 

2028 ................................................................................................................. 3,672 7,980 15,639 46,917 

2029 ................................................................................................................. 3,672 7,980 15,639 46,917 

2030 ................................................................................................................. 3,672 7,980 15,639 46,917 

2031 ................................................................................................................. 3,672 7,980 15,639 46,917 

While these time estimates are 

significant, they are not inclusive of all 

costs expected under the SUNSET final 

rule. In addition to the quantified 

estimates above, we expect that the 

Department will experience other costs 

related to the requirements of the 

SUNSET final rule under the baseline 

scenario. For example, the estimates 

above do not include time spent 

reviewing guidance documents related 

to rulemaking undergoing assessment 

and review. They also do not include 

the time associated with developing 

SECGs for the 160 rulemakings newly 

found to have a significant impact on a 

substantial number of small entities, or 

the time associated with updating 

existing guidances for the same or 

related rulemakings. The figures above 

also omit the monetary costs to 

purchase data and data subscriptions 

that we anticipate will serve as critical 

inputs for the assessments and reviews, 

and costs associated with conducting 

formal evaluations to understand the 

impact of the rules. In addition, the 

estimates do not include the costs of 

resolving and communicating the 

meaning of ambiguous provisions in the 

SUNSET final rule. For example, HHS 

anticipates that it will take considerable 

work to determine when regulations 

must be assessed and reviewed as part 

of a particular rulemaking and when 

regulations fall within an exception. 

Even after that work is complete, 

additional resources are required to 

share those interpretations with the 

public. Furthermore, the figures do not 

account for the time and costs 

associated with HHS’s efforts to 

reevaluate and redirect resources to 

support assessments and reviews and 

thereby preserve regulations. 

As an additional consideration, we 

estimate that assessing and reviewing 

regulations will require the equivalent 

of 67 and 146 full-time employees in 

each of the first five years of the 

analysis, adopting the SUNSET final 


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70This 1,160-hour estimate corresponds to a 

measure of the ‘‘Net Supported Direct FDA Work 

Hours Available for Assignments’’ (86 FR 5743). 

71 86 FR 5743. 

72 86 FR 5745. 

rule RIA’s estimate of 1,160 hours of 

work per year per employee.70 Given 

current staffing and other Departmental 

needs and priorities, we anticipate the 

need to hire non-government experts to 

perform a share of the retrospective 

work. This approach will likely result in 

additional overhead costs that we have 

not quantified. We also anticipate the 

need to spend Departmental resources 

to find, hire, train, and transfer 

personnel with technical expertise to 

conduct the analyses, the costs of which 

have not been quantified in this 

analysis. 

E. Benefits of the Final Withdrawal Rule 

The monetized benefits of this 

regulatory action to withdraw the 

SUNSET final rule are the cost savings 

to the Department from not completing 

the assessments and reviews required 

under the baseline scenario, and the 

cost savings to the public from not 

commenting on these assessments and 

reviews. To monetize these cost savings, 

we multiply the hours related to the 

SUNSET final rule in Table D6 by the 

cost per hour of these activities. We 

adopt the SUNSET final rule RIA’s 

‘‘estimates that the fully-loaded cost per 

hour to the Department to employ a 

person to conduct a Review or 

Assessment is $244.98 per hour’’ 71 and 

‘‘fully loaded cost per hour of writing 

comments is $143.20.’’ 72 Table E1 

presents the yearly cost savings to the 

Department and the public expected 

under the final withdrawal rule 

compared to the baseline scenario. We 

combine the low estimates for the 

Department and the public to generate 

an overall low estimate, and similarly 

combine the high estimates for the 

Department and the public to generate 

an overall high estimate. We also report 

an overall primary estimate, which is 

the midpoint between the low and high 

estimates. Finally, we report the present 

discounted value (PDV) and annualized 

cost savings under the final withdrawal 

rule for both a 3% and 7% discount 

rate. All figures are reported in 2020 

dollars, in millions. 

TABLE E1—COST SAVINGS UNDER THE FINAL WITHDRAWAL RULE

[Millions of $] 

Year 

Department Public Overall 

Low High Low High Low Central High 

2022 ............................. $19.1 $41.5 $47.4 $142.3 $66.5 $125.2 $183.8 

2023 ............................. 19.1 41.5 47.4 142.3 66.5 125.2 183.8 

2024 ............................. 19.1 41.5 47.4 142.3 66.5 125.2 183.8 

2025 ............................. 19.1 41.5 47.4 142.3 66.5 125.2 183.8 

2026 ............................. 19.1 41.5 47.4 142.3 66.5 125.2 183.8 

2027 ............................. 0.9 2.0 2.2 6.7 3.1 5.9 8.7 

2028 ............................. 0.9 2.0 2.2 6.7 3.1 5.9 8.7 

2029 ............................. 0.9 2.0 2.2 6.7 3.1 5.9 8.7 

2030 ............................. 0.9 2.0 2.2 6.7 3.1 5.9 8.7 

2031 ............................. 0.9 2.0 2.2 6.7 3.1 5.9 8.7 

PDV, 3% ...................... 91.0 197.9 226.1 678.3 317.1 596.7 876.2 

PDV, 7% ...................... 80.9 176.0 201.1 603.2 282.0 530.6 779.2 

Annualized, 3% ............ 10.7 23.2 26.5 79.5 37.2 69.9 102.7 

Annualized, 7% ............ 11.5 25.1 28.6 85.9 40.1 75.5 110.9 

For comparison, in present value 

terms, these estimates of annualized 

cost savings are more than four times 

the size of the annualized cost estimates 

included in the SUNSET final rule RIA. 

This reflects what the Department has 

now concluded are more reasonable 

assumptions about the effect of the 

SUNSET final rule rather than a claim 

that the combination of these two 

regulatory actions will generate net cost 

savings. These cost savings estimates 

attributed to the final withdrawal rule 

are consistent with a scenario that the 

Department returns to its approach to 

Section 610 reviews that immediately 

predate the publication of the SUNSET 

final rule on January 19, 2021. We 

believe that this represents a credible 

and appropriate approach for estimating 

the likely cost savings that will be 

attributable to the final withdrawal rule. 

Other considerations relating to the 

appropriate frequency or nature of 

retrospective economic analyses of 

existing Departmental regulations are 

beyond the scope of this final rule RIA. 

In the previous section, we discussed 

concerns about potential costs of the 

SUNSET final rule that were overlooked 

in the SUNSET final rule RIA. To the 

extent that we are unable to quantify or 

monetize these costs, such as the 

purchase of data, conducting studies to 

evaluate the impacts of rules, additional 

overhead costs associated with 

contracting with non-government 

entities to perform a share of the 

retrospective work, and other personnel 

costs, the cost savings anticipated under 

the final withdrawal rule are equally 

underestimated. 

In addition to cost savings, the final 

withdrawal rule will generate nonquantified benefits from reduced 

regulatory uncertainty. Although we 

calculate the cost savings estimates in 

this analysis by adopting an assumption 

that the Department will fulfill the 

requirements of the SUNSET final rule 

rather than to let any regulation expire 

automatically, it is highly likely that 

some regulations will automatically 

expire. Withdrawing the SUNSET final 

rule will remove the expiration 

provisions, which will also remove the 

likelihood of any automatic expiration 

of regulatory requirements. The final 

withdrawal rule will also eliminate the 

potential for regulatory confusion 

among stakeholders, and harm to the 

public health related to the actuality of 

having regulations expire automatically. 

F. Costs of the Final Withdrawal Rule 

The costs of the final withdrawal rule 

will be the forgone benefits of the 

information learned from the 

assessments and reviews completed 

under the baseline scenario. We adopt 

the approach taken in the SUNSET final 


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73 85 FR 70096. 

rule RIA and make no attempt to 

quantify or monetize the value of this 

information. The SUNSET final rule RIA 

also describes potential benefits from 

subsequent regulatory actions to rescind 

or amend existing regulations as a result 

of the SUNSET final rule; however, the 

Department now believes that any 

effects associated with future regulatory 

actions raise challenging questions of 

attribution (entirely to those regulatory 

actions themselves, or at least partially 

to the SUNSET final rule). We therefore 

do not unambiguously identify these as 

a source of foregone benefits under the 

final withdrawal rule. 

G. Analysis of Regulatory Alternatives to 

the Final Withdrawal Rule 

We quantitatively analyze four 

alternative options to the final 

withdrawal rule. First, we consider an 

option to maintain the general approach 

of the SUNSET final rule, but adopt a 

two-year period following the effective 

date to assess and review all regulations 

older than ten years. This option, 

Alternative 1, follows the timeline 

envisioned under the November 4, 2020, 

proposed SUNSET rule.73 Second, we 

consider an option to maintain the 

general approach of the SUNSET final 

rule, but adopt an initial ten-year period 

following the effective date to assess 

and review all regulations, regardless of 

when these were first published. This 

option, Alternative 2, evenly distributes 

the time spent by the Department 

assessing and reviewing existing 

regulations. Third, we consider an 

option to maintain the general 

framework of the SUNSET final rule but 

limit its scope to regulations that the 

Department previously identified as 

having a significant economic impact on 

a substantial number of small entities. 

This option, Alternative 3, would 

include the 326 Reviews of Post-RFA 

rulemakings identified in Table D1. 

Fourth, we consider an option, 

Alternative 4, that would maintain the 

SUNSET final rule’s requirements 

related to the timeline for assessing and 

reviewing all of the Department’s 

existing regulations, but without the 

automatic expiration provision 

contained in the SUNSET final rule. 

Table G1 presents the primary 

estimates of yearly cost savings under 

the final withdrawal rule and under the 

four policy alternatives described above. 

Each of these policy options are 

compared to the common baseline 

scenario described in section D. We 

report the PDV and annualized cost 

savings under the final withdrawal rule 

and two policy alternatives for both a 

3% and 7% discount rate. All figures 

are reported in 2020 dollars, in millions. 

Negative cost-savings estimates indicate 

that a policy alternative would likely 

result in net cost increases compared to 

the baseline scenario. 

TABLE G1—PRIMARY ESTIMATE OF COST SAVINGS UNDER THE FINAL WITHDRAWAL RULE AND ALTERNATIVES

[$M] 

Year Final rule Alternative 1 Alternative 2 Alternative 3 Alternative 4 

2022 ..................................................................................... $125.2 ¥$187.8 $59.6 $70.8 $0.0 

2023 ..................................................................................... 125.2 ¥187.8 59.6 70.8 0.0 

2024 ..................................................................................... 125.2 121.5 59.6 70.8 0.0 

2025 ..................................................................................... 125.2 121.5 59.6 70.8 0.0 

2026 ..................................................................................... 125.2 121.5 59.6 70.8 0.0 

2027 ..................................................................................... 5.9 2.2 ¥59.6 2.9 0.0 

2028 ..................................................................................... 5.9 2.2 ¥59.6 2.9 0.0 

2029 ..................................................................................... 5.9 2.2 ¥59.6 2.9 0.0 

2030 ..................................................................................... 5.9 2.2 ¥59.6 2.9 0.0 

2031 ..................................................................................... 5.9 2.2 ¥59.6 2.9 0.0 

PDV, 3% .............................................................................. 596.7 ¥26.6 37.5 335.9 0.0 

PDV, 7% .............................................................................. 530.6 ¥54.5 70.2 298.9 0.0 

Annualized, 3% .................................................................... 69.9 ¥3.1 4.4 39.4 0.0 

Annualized, 7% .................................................................... 75.5 ¥7.8 10.0 42.6 0.0 

The cost savings reported for the 

Sunset final rule match the estimates 

contained in Table E1 of this analysis. 

For Alternative 1, we estimate 

annualized cost savings of ¥$3.1 

million using a 3% discount rate. This 

indicates that Alternative 1 would result 

in incremental annualized costs of $3.1 

million above the baseline scenario of 

the SUNSET final rule. In addition to 

this quantified impact on cost savings, 

Alternative 1 would increase the 

likelihood that the Department would 

need to hire non-government experts to 

perform a share of the retrospective 

work, resulting in additional overhead 

costs that we have not monetized. 

Alternative 1 would also result in 

additional unquantified benefits 

associated with earlier completion of 

some of the retrospectives, and therefore 

earlier access to information from these 

assessments and reviews. 

For Alternatives 2 and 3, we estimate 

annualized cost savings of $4.4 million 

and $335.9 million, respectively. 

Compared to the SUNSET final rule, 

Alternatives 2 and 3 would reduce the 

likelihood that the Department would 

need to hire non-government experts to 

perform a share of the retrospective 

work, and thus reduce the potential for 

additional overhead costs. Compared to 

the SUNSET final rule, Alternative 2 

would result in non-quantified forgone 

benefits associated with later 

completion of some of the retrospective 

analyses, and therefore later access to 

information from these assessments and 

reviews. Alternative 3 would reduce the 

number of retrospective analyses and 

result in more foregone information. 

For Alternative 4, we do not identify 

any incremental costs or cost savings 

compared to the baseline scenario of the 

SUNSET final rule, maintaining the 

assumption in the main analysis that the 

Department will fulfill the analytic 

requirements of the SUNSET final rule. 

However, compared to SUNSET final 

rule, Alternative 4 would generate nonquantified benefits from reduced 

regulatory uncertainty associated with 

the automatic expiration provision of 

the SUNSET final rule. Alternative 4 

would, therefore, result in nonquantified benefits from reduced 

regulatory confusion among 

stakeholders, and non-quantified 

benefits from reduced harm to the 

public health related to the actuality of 

having regulations expire automatically. 


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74U.S. Small Business Administration (2019). 

‘‘Table of Size Standards.’’ August 19, 2019. https:// 

www.sba.gov/document/support--table-sizestandards. 

75Robert Jay Dilger (2021). ‘‘Small Business Size 

Standards: A Historical Analysis of Contemporary 

Issues.’’ Congressional Research Service Report 

R40860. Updated May 28, 2021. Page 2. https://

crsreports.congress.gov/product/pdf/R/R40860. 

H. Final Small Entity Analysis 

The Department has examined the 

economic implications of this final 

withdrawal rule as required by the 

Regulatory Flexibility Act. This 

analysis, as well as other sections in this 

Regulatory Impact Analysis, serves as 

the Final Regulatory Flexibility 

Analysis, as required under the 

Regulatory Flexibility Act. 

1. Description and Number of Affected 

Small Entities 

The SBA maintains a Table of Small 

Business Size Standards Matched to 

North American Industry Classification 

System Codes (NAICS).74 We replicate 

the SBA’s description of this table: 

This table lists small business size 

standards matched to industries described in 

the North American Industry Classification 

System (NAICS), as modified by the Office of 

Management and Budget, effective January 1, 

2017. The latest NAICS codes are referred to 

as NAICS 2017. 

The size standards are for the most part 

expressed in either millions of dollars (those 

preceded by ‘‘$’’) or number of employees 

(those without the ‘‘$’’). A size standard is 

the largest that a concern can be and still 

qualify as a small business for Federal 

Government programs. For the most part, size 

standards are the average annual receipts or 

the average employment of a firm. 

The SUNSET final rule will 

potentially impact small entities across 

at least NAICS industry sectors 11 

(Agriculture, Forestry, Fishing and 

Hunting), 31–33 (Manufacturing), 42 

(Wholesale Trade), 44–45 (Retail Trade), 

48–49 (Transportation and 

Warehousing), 52 (Finance and 

Insurance), 54 (Professional, Scientific, 

and Technical Services), 62 (Health Care 

and Social Assistance), 81 (Other 

Services (except Public 

Administration)), and 92 (Public 

Administration). Given the wide range 

of entities affected, and various sources 

of uncertainty described in this section, 

it is not practical to directly estimate the 

number of small entities that will 

potentially be impacted under the 

baseline scenario of the SUNSET final 

rule. Similarly, it is impractical to 

identify the small entities that will be 

impacted by the final withdrawal rule. 

The Congressional Research Service 

observes that ‘‘about 97% of all 

employer firms qualify as small under 

the SBA’s size standards. These firms 

represent about 30% of industry 

receipts.’’ 75 For practicality, we assume 

that the bulk of the potential impacts of 

the final withdrawal rule to private 

sector regulated entities are small 

entities. 

2. Description of the Potential Impacts 

of the Rule on Small Entities 

Impacts to Small Entities Related to 

Rescissions and Amendments 

When estimating the impact on the 

public, the SUNSET final rule RIA first 

estimates that 53 regulations will be 

rescinded and another 159 regulations 

will be amended as a result of the 

retrospective analyses initiated as a 

result of the SUNSET final rule. Since 

the particular regulations impacted are 

unknowable prior to conducting the 

retrospective analyses, this results in 

uncertainty over the types of small 

entities that will be affected under the 

baseline scenario of the SUNSET final 

rule. The nature of this uncertainty 

means it is infeasible to estimate the 

number of small entities affected by 

these potential rescinded or amended 

regulations without first completing the 

retrospective analyses. 

As described earlier, the Department 

no longer believes it was appropriate to 

unambiguously attribute to the SUNSET 

final rulemaking subsequent regulatory 

actions of this nature in the context of 

a regulatory impact analysis. We 

therefore do not attribute any impacts of 

this nature to the final withdrawal rule, 

nor do we identify any impacts to small 

entities. 

Impacts to Small Entities Related to the 

Automatic Expiration of Regulations 

When identifying the potential 

benefits of the final withdrawal rule, we 

note that, while the Department would 

seek to fulfill the requirements of the 

SUNSET final rule rather than to let any 

regulation expire automatically, it is 

highly likely that some regulations will 

automatically expire without 

substantive review. This potential 

impact under the SUNSET final rule 

does not introduce similar questions of 

attribution; however, there remains 

uncertainty over the particular 

regulations that will be impacted. The 

nature of this uncertainty means we 

cannot identify the small entities that 

are most likely to be affected by 

regulations that automatically expire 

without substantive review. 

Revoking the SUNSET final rule will 

remove the expiration provisions, which 

will also remove the likelihood of any 

automatic expiration of regulatory 

requirements. The final withdrawal rule 

will also eliminate the potential for 

regulatory confusion among 

stakeholders, including small entities. 

We anticipate that a large share of these 

non-quantified benefits will accrue to 

small entities. 

Impacts to Small Entities Related to 

Commenting on Assessments and 

Reviews 

When identifying the potential 

benefits of the final withdrawal rule, we 

estimate the cost savings to the public 

from not commenting on these 

assessments and reviews that will be 

performed under the baseline scenario 

of the SUNSET final rule. Table E1 

summarizes these estimates, including a 

range of cost-savings to the public sector 

between $26.5 million and $79.5 

million in annualized terms under a 3% 

discount rate. Under a 7% discount rate, 

the comparable range of cost savings is 

$28.6 million and $85.9 million. 

Although these represent substantial 

cost savings in the aggregate, these 

include comments not just from small 

entities but also the general public, 

larger businesses, Tribes, States, nongovernmental organizations, and other 

regulated entities and stakeholders. 

To evaluate the likely magnitude of 

the impact to a single small entity, we 

consider an illustrative scenario of a 

full-time sole proprietor that submits 1 

or fewer comment per year. As 

described earlier, we estimate that each 

comment takes between 5 and 15 hours 

to prepare and submit. The final 

withdrawal rule will reduce the time 

spent on comments for this small entity 

by 5 to 15 hours per year. This 

represents between 0.2% to 0.7% of 

annual labor time saved, computed 

using an assumption that the individual 

works 2,087 hours per year. As an 

additional sensitivity analysis, we 

computed the number of comments that 

a sole proprietor will need to submit in 

one year such that the time spent on 

comments will exceed 3% of total time 

spent on labor. Assuming 2,087 hours of 

labor time per year, the total time spent 

on comments to meet this threshold is 

about 63 hours. Using a central estimate 

of 10 hours to prepare and submit each 

comment, the sole proprietor could 

prepare up to 6 comments per year 

without exceeding the 3% threshold. 

We expect that fewer than 5 percent of 

small entities would share more than 6 

comments per year on regulations 

undergoing a retrospective analysis 

under the SUNSET final rule. This 

indicates that the potential cost savings 

to small entities under the final 

withdrawal rule are unlikely to be 

significant for a substantial number of 

small entities. The Department 


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32288 Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Rules and Regulations 

considers a rule to have a significant 

impact on a substantial number of small 

entities if it has at least a three percent 

impact on revenue on at least five 

percent of small entities. This costsaving benefit is well below this 

threshold. 

XII. Federalism 

We have analyzed this final rule in 

accordance with the principles set forth 

in E.O. 13132, ‘‘Federalism.’’ The 

Department has determined that this 

final rule does not contain policies that 

have substantial direct effects on the 

States, on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. 

VIII. Consultation and Coordination 

With Indian Tribal Governments 

We have analyzed this final rule in 

accordance with the principles set forth 

in E.O. 13175, ‘‘Consultation and 

Coordination With Indian Tribal 

Governments.’’ As we acknowledged 

and agreed in the Withdrawal NPRM, 

multiple comments from representatives 

of several Tribes and related groups 

expressed concern that the SUNSET 

final rule would have significant tribal 

implications, if implemented, and that 

consultation with Tribal governments 

on the SUNSET proposed rule was not 

adequate. See 86 FR 59931. However, 

the Department further explained that 

tribal consultation on the Withdrawal 

NPRM was unnecessary because the 

withdrawal of the SUNSET final rule 

would continue the status quo, and 

because of the numerous comments 

already received from Tribal 

governments and representatives asking 

for the SUNSET final rule to be 

withdrawn. The Department 

nevertheless provided notice of the 

Withdrawal NPRM to Tribes, 

acknowledging tribal concerns with the 

lack of tribal consultation on the earlier 

rulemaking and encouraging them to 

share any additional feedback by 

providing written comments on the 

proposed withdrawal. The Department 

continues to conclude that the final 

withdrawal rule does not contain 

policies that would have a substantial 

direct effect on one or more Indian 

Tribes, on the relationship between the 

Federal Government and Indian Tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. 

IX. Analysis of Environmental Impacts 

HHS had determined that the final 

rule will not have a significant impact 

on the environment. 

X. Paperwork Reduction Act 

In accordance with the Paperwork 

Reduction Act of 1995 and its 

implementing regulations, 44 U.S.C. 

3501–3521; 5 CFR part 1320, appendix 

A.1, the Department has reviewed this 

final rule and has determined that it 

proposes no new collections of 

information. 

XI. References 

1. OIRA dashboard screenshot (Dec. 18, 

2020). 

2. Complaint, County of Santa Clara v. HHS, 

Case No. 5:21–cv–01655–BLF (N.D. Cal. 

Mar. 9, 2021). 

Dated: May 24, 2022. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2022–11477 Filed 5–26–22; 8:45 am] 

BILLING CODE 4150–26–P 


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