Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Rules and Regulations 12399 

AIRAC date State City Airport FDC No. FDC date Subject 

24–Mar–22 ............ PA Wilkes-Barre ........ Wilkes-Barre Wyoming Valley.2/6226 2/7/22 RNAV (GPS) RWY 7, Orig-B. 

24–Mar–22 ............ WI Green Bay ........... Green Bay-Austin Straubel 

Intl.

2/7089 2/7/22 RADAR 1, Amdt 9E. 

24–Mar–22 ............ ND Mohall .................. Mohall Muni ....................... 2/7090 2/7/22 RNAV (GPS) RWY 31, Orig-A. 

24–Mar–22 ............ WA Toledo ................. Ed Carlson Meml Fld— 

South Lewis County.

2/7092 2/7/22 RNAV (GPS) RWY 6, Orig. 

24–Mar–22 ............ MN Granite Falls ........ Granite Falls Muni/LenzenRoe-Fagen Meml Fld.2/8599 2/8/22 RNAV (GPS) RWY 33, Orig-A. 

24–Mar–22 ............ MN Granite Falls ........ Granite Falls Muni/LenzenRoe-Fagen Meml Fld.2/8604 2/8/22 VOR/DME RWY 33, Orig-C. 

[FR Doc. 2022–04497 Filed 3–3–22; 8:45 am] 

BILLING CODE 4910–13–P 

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 

Securing Updated and Necessary 

Statutory Evaluations Timely; 

Administrative Delay of Effective Date 

AGENCY: Department of Health and 

Human Services (HHS). 

ACTION: Final rule; delay of effective 

date. 

SUMMARY: The Department of Health and 

Human Services (HHS or Department) is 

postponing, pending judicial review, the 

effective date of a final rule entitled 

‘‘Securing Updated and Necessary 

Statutory Evaluations Timely’’ (SUNSET 

final rule) and published in the Federal 

Register of January 19, 2021, and a final 

rule correction published in the Federal 

Register of March 23, 2021. 

DATES: As of March 4, 2022, the 

effective date of the SUNSET final rule 

published January 19, 2021 (86 FR 

5694), which was delayed until March 

22, 2022, by an order that took effect as 

of March 19, 2021 (86 FR 15404, March 

23, 2021), is further delayed pursuant to 

5 U.S.C. 705 for six months until 

September 22, 2022. 

As of March 4, 2022, the effective date 

of the correction published March 23, 

2021 (86 FR 15404), is delayed until 

September 22, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Daniel J. Barry, Acting General Counsel, 

200 Independence Avenue SW, 

Washington, DC 20201; or by email at 

reviewnprm@hhs.gov; or by telephone at 

1–877–696–6775. 

SUPPLEMENTARY INFORMATION: 

I. Overview 

The SUNSET final rule, if 

implemented, would establish a new 

process for regulatory review of HHS 

regulations, which includes the 

automatic expiration of regulations 

under certain circumstances. It was 

scheduled to take effect on March 22, 

2021. After a lawsuit was filed on March 

9, 2021, seeking to overturn the 

SUNSET final rule, HHS issued an 

Administrative Delay of Effective Date 

(First Administrative Delay), which took 

effect as of March 19, 2021, which 

postponed the effective date of the 

SUNSET final rule, pending judicial 

review, until March 22, 2022. 86 FR 

15404 (Mar. 23, 2021). 

After conducting a thorough review of 

the SUNSET final rule including the 

oral and written comments on its 

proposal and the allegations in the 

lawsuit, HHS published a notice of 

proposed rulemaking to withdraw or 

repeal the SUNSET final rule 

(Withdrawal NPRM). 86 FR 59906 (Oct. 

29, 2021). The comment period on the 

Withdrawal NPRM closed on December 

28, 2021. HHS received approximately 

80 comments. Some comments were 

submitted by Plaintiffs in the lawsuit 

seeking to overturn the SUNSET final 

rule, and their comments incorporated 

by reference the Complaint they had 

filed. 

HHS is currently in the process of 

reviewing the comments and developing 

a final rule. For the reasons described 

below, HHS finds that the interests of 

justice require that the SUNSET final 

rule’s effective date be postponed 

pending judicial review because: (1) A 

postponement will permit HHS to 

continue and complete its review of the 

SUNSET final rule in light of the claims 

raised in the litigation; (2) the resolution 

of the rulemaking will inform the 

government’s position in this lawsuit; 

and (3) based on HHS’s review of the 

Complaint, HHS believes that the Court 

may find that: (a) Some of Plaintiffs’ 

claims have merit; (b) Plaintiffs’ 

allegations of harm are credible; and (c) 

the balance of equities and the public 

interest warrant postponement of the 

effective date to preserve the status quo 

while the Court considers the challenge 

to the SUNSET final rule. 

II. Background 

A. The SUNSET Proposed and Final 

Rules 

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. The 

SUNSET proposed rule provided that 

comments could be submitted until 

December 4, 2020, except for comments 

on the portion of the rule amending 42 

CFR parts 400–429 and parts 475–499, 

which were due by January 4, 2021. 

HHS received 532 comments total 

throughout the 60-day comment period, 

and the commenters ‘‘generally opposed 

the proposed rule, although some 

commenters supported it.’’ 86 FR 5704. 

HHS also held a public hearing on 

November 23, 2020, to receive 

information and views on the proposed 

rule (Public Hearing). Over twenty 

interested parties provided oral 

comments at the Public Hearing. See 

Transcript, Public Hearing on the 


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12400 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Rules and Regulations 

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). 

HHS issued the SUNSET final rule on 

January 19, 2021. 86 FR 5694. The 

substance of the SUNSET proposed and 

final rules are more fully described in 

the First Administrative Delay, and that 

description is adopted by reference into 

this preamble. See 86 FR 15405. 

B. The Santa Clara Complaint 

On March 9, 2021, the County of 

Santa Clara, California Tribal Families 

Coalition, National Association of 

Pediatric Nurse Practitioners, American 

Lung Association, Center for Science in 

the Public Interest, and Natural 

Resources Defense Council sued the 

Department seeking to overturn the 

SUNSET final rule under the 

Administrative Procedure Act (APA). 

Complaint, County of Santa Clara v. 

HHS, Case No. 5:21–cv–01655–BLF 

(N.D. Cal.). The substance of the 

Complaint is more fully described in the 

First Administrative Delay, and that 

description is adopted by reference into 

this preamble. See 86 FR 15405. 

C. The Administrative Delay of Effective 

Date and Stay of Litigation. 

On March 9, 2021, HHS issued the 

First Administrative Delay, which took 

effect as of March 19, 2021, which 

postponed the effective date of the 

SUNSET final rule, pending judicial 

review, until March 22, 2022. HHS 

explained that it believed that the Court 

may find: (a) That some of Plaintiffs’ 

claims have merit; (b) that Plaintiffs’ 

allegations of harm are credible; and (c) 

that the balance of equities and the 

public interest warrant postponement of 

the effective date pending judicial 

review. Accordingly, the Department 

found that the interests of justice 

required a postponement in order to 

preserve the status quo, because, if the 

rule took effect while HHS was 

evaluating the rule in light of the claims 

raised in litigation, it could create 

significant obligations for HHS, cause 

confusion for the public, including 

Plaintiffs, and may lead to compliance 

costs as entities, including Plaintiffs, 

plan steps necessary to deal with the 

rule’s implementation. HHS also 

observed that it was unaware of any 

benefits from the implementation of the 

SUNSET final rule that would be 

significantly curtailed from a stay of its 

effective date. See 86 FR 15404–08. 

With respect to the Santa Clara 

litigation, the parties requested that the 

court stay the case on the ground that 

HHS was reviewing the SUNSET final 

rule in light of Plaintiffs’ claims raised 

in this litigation and needed additional 

time to evaluate the claims and its 

position before taking further steps in 

the litigation. The court granted the 

stay. Order, County of Santa Clara v. 

HHS, Case No. 5:21–cv–01655–BLF 

(N.D. Cal.) (Apr. 22, 2021). Since that 

time, the parties have periodically 

submitted joint status reports to the 

court and requested that the litigation 

stay be extended, and those requests 

have thus far, as of February 1, 2022, 

been granted. 

D. 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 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 comments 

submitted to the SUNSET proposed rule 

docket and raised at the Public Hearing, 

and the current Administration’s 

policies. 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 all 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. HHS is 

actively engaged in considering the 

comments and developing a final rule. 

III. Discussion 

Under 5 U.S.C. 705 of the APA, an 

agency ‘‘may postpone the effective date 

of action taken by it, pending judicial 

review,’’ when the ‘‘agency finds that 

justice so requires.’’ On March 9, 2021, 

HHS issued the First Administrative 

Delay after concluding that the interests 

of justice required that the SUNSET 

final rule be stayed pending judicial 

review. For the reasons described in the 

First Administrative Delay and as 

further discussed in this document, the 

Department has concluded that the 

considerations supporting the First 

Administrative Delay remain true today, 

and the interests of justice require that 

the effective date of the SUNSET final 

rule should be further stayed until 

September 22, 2022. 

In the First Administrative Delay, the 

Department explained that it was taking 

a fresh and critical look at the SUNSET 

final rule in light of the allegations in 

the Complaint. The Complaint alleged 

serious legal vulnerabilities of the rule, 

and, while HHS did not concede any of 

these claims at that time, HHS required 

additional time to complete its 

evaluation of the SUNSET final rule 

given the pending litigation. In addition, 

the Complaint raised the question as to 

whether the SUNSET final rule, issued 

in the final days of the last 

Administration, is consistent with the 

policies and goals of the current 

Administration, both in terms of the 

appropriate role of regulatory oversight 

of the health care industry and 

necessary engagement with the public, 

including tribal organizations. 

After further review of the SUNSET 

final rule, the allegations in the 

Complaint, and the comments on the 

SUNSET proposed rule, we issued the 

Withdrawal NPRM in October 2021, in 

which we discussed our tentative 

conclusions for further public comment. 

Our discussion included concerns 

regarding the procedural shortcomings 

of the SUNSET rulemaking process, the 

fundamental errors in its Regulatory 

Impact Analysis, and the attendant legal 

vulnerabilities of the SUNSET final rule. 

Our reanalysis of the regulatory impact 

of this rule, as set forth in the 

Withdrawal NPRM, has underscored our 

belief that the Santa Clara court could 

find merit in at least some of Plaintiffs’ 

claims. 

Our review of the approximately 80 

comments submitted on the Withdrawal 

NPRM is ongoing. A few substantive 

comments support the SUNSET final 

rule while many other substantive 

comments favor withdrawal or repeal. 

As noted, Plaintiffs in the Santa Clara 

litigation submitted comments on the 

Withdrawal NPRM that attached copies 

of the Complaint. Accordingly, HHS’s 

consideration of the Complaint’s 

critique of the SUNSET final rule are 

part of its ongoing review. 

The Complaint also alleges that 

Plaintiffs and others would be 

immediately harmed by the SUNSET 

final rule, if implemented. The 

Complaint alleges that the uncertainty 

resulting from its implementation 

impacts the entire healthcare sector, 

which accounts for nearly one-fifth of 

the U.S. economy and secures 

individual and community health for 


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Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Rules and Regulations 12401 

hundreds of millions of Americans, and 

that participants in every single 

industry the Department regulates, 

including Plaintiffs, must plan their 

futures and operations without knowing 

what regulations will govern their 

businesses in these notoriously complex 

regulatory arenas. See Complaint, ¶¶ 2, 

95–122. While HHS does not concede 

that Plaintiffs would establish 

irreparable harm in litigation, HHS 

agrees that it is appropriate to postpone 

the effective date of the SUNSET final 

rule to preserve the status quo and to 

ensure that HHS has time to evaluate 

the rule before it takes effect to avoid 

the possibility of confusion among the 

regulated community. All of these 

potential consequences would be 

detrimental to the public health, 

underscoring that justice requires a 

postponement of the SUNSET final 

rule’s effective date pursuant to 5 U.S.C. 

705. 

We further conclude that extending 

the effective date of the SUNSET final 

rule will create no countervailing harms 

because this delay merely continues the 

status quo. And because 

implementation of the regulatory review 

framework provided under the SUNSET 

final rule would be a complex and 

lengthy process, any purported benefits 

from the retirement of regulations under 

the new process would not accrue for 

several years. Accordingly, given the 

public health concerns and the harms 

from the implementation of the 

SUNSET final rule alleged by the 

Plaintiffs and echoed in the comments 

to the SUNSET proposed rule and the 

Withdrawal NPRM, and the dearth of 

countervailing harms from extending 

the effective date, the balance of equities 

and the public interest favor the 

extension of the stay of the effective 

date of the SUNSET final rule to 

preserve the status quo and allow for 

judicial review of its legality before any 

implementation. 

Accordingly, HHS is issuing this 

further stay of the effective date of this 

final rule pending judicial review. This 

postponement applies to all of the 

regulations established under the 

SUNSET final rule. As noted above, the 

Complaint alleges that the SUNSET 

final rule suffers from a variety of 

defects, including procedural defects 

related to its promulgation. The 

Department believes it is appropriate to 

review the entire rule in light of the 

claims raised in the litigation, which it 

continues to actively evaluate in 

conjunction with its consideration of 

the comments to the Withdrawal NPRM 

and its efforts to develop a final rule. 

Thus, this postponement reaches the 

full rule, consistent with the 

Complaint’s prayer for relief. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2022–04524 Filed 3–3–22; 8:45 am] 

BILLING CODE 4150–26–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 7 

[Docket No. FDA–2018–D–2074] 

Initiation of Voluntary Recalls; 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance for industry and FDA staff 

entitled ‘‘Initiation of Voluntary Recalls 

Under 21 CFR part 7, subpart C.’’ The 

guidance for industry and FDA staff 

provides guidance on timely initiation 

of voluntary recalls of FDA-regulated 

products. It also discusses preparations 

that firms in a distribution chain should 

consider making to ensure timely 

responses to a recall communication. In 

addition, the guidance discusses how 

FDA assists firms with carrying out their 

recall responsibilities to protect the 

public health from distributed products 

in violation of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) and other 

laws administered by FDA. This 

guidance finalizes the draft guidance of 

the same title issued on April 24, 2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on March 4, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–2074 for ‘‘Initiation of 

Voluntary Recalls Under 21 CFR part 7, 

subpart C.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 


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