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 


lotter on DSK11XQN23PROD with RULES1
12402 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Rules and Regulations 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Strategic Planning and Operational 

Policy, Office of Regulatory Affairs, 

Food and Drug Administration, 12420 

Parklawn Dr., Element Bldg., Rm. 4141, 

Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Peter Fox, Office of Regulatory Affairs, 

Office of Strategic Planning and 

Operational Policy, Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg., Rm. 4146, Rockville, MD 

20857, 240–402–1857, Peter.Fox@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a 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. The guidance discusses what 

preparations firms in a distribution 

chain, including manufacturers and 

distributors, should consider making to 

establish recall initiation procedures; to 

ensure timely identification of, and 

response to, product problems that 

might lead to a recall; and to promptly 

issue recall communications and press 

releases or other public notices. It also 

discusses preparations that firms in a 

distribution chain should consider 

making to ensure timely responses to 

recall communications. 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 FD&C Act and other 

laws administered by FDA. 

This guidance finalizes the draft 

guidance of the same title issued on 

April 24, 2019 (84 FR 17112). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. In addition to editorial 

changes made to improve clarity, 

changes from the draft to the final 

guidance include the addition of the 

terms correction and market withdrawal 

to the terminology section, the addition 

of language encouraging the use of 

electronic communications for 

conveying voluntary recall 

communications about FDA-regulated 

products, and the deletion of section IV 

(‘‘References’’). 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR 7.46, 7.49, and 

7.59 have been approved under OMB 

control number 0910–0249; section 417 

of the FD&C Act (21 U.S.C. 350f) has 

been approved under OMB control 

number 0910–0643; section 761 of the 

FD&C Act (21 U.S.C. 379aa–1) has been 

approved under OMB control number 

0910–0291; 21 CFR 107.240 has been 

approved under OMB control number 

0910–0188; 21 CFR part 117 has been 

approved under OMB control number 

0910–0751; and 21 CFR part 507 has 

been approved under OMB control 

number 0910–0751. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https://

www.regulations.gov. 

Dated: February 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04704 Filed 3–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Office of the Attorney General 

28 CFR Part 0 

[Docket No. OAG 175; AG Order No. 5536– 

2022] 

Revisions to Approval of Civil Consent 

Decrees With State and Local 

Governmental Entities 

AGENCY: Office of the Attorney General, 

Department of Justice. 

ACTION: Final rule. 

SUMMARY: This final rule revises the 

regulations of the Department of Justice 

(‘‘Department’’) to restore the traditional 

process regarding the approval 

procedures to be used when a civil 

action against a State or local 

governmental entity is to be resolved by 

consent decree. 

DATES: This rule is effective March 4, 

2022. 

FOR FURTHER INFORMATION CONTACT: 

Robert Hinchman, Senior Counsel, 

Office of Legal Policy, U.S. Department 

of Justice, Room 4252 RFK Building, 

950 Pennsylvania Avenue NW, 

Washington, DC 20530, telephone (202) 

514–8059 (not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

I. Discussion 

A. Overview 

This rule implements the April 16, 

2021 Memorandum of Attorney General 

Merrick B. Garland titled ‘‘Civil 

Settlement Agreements and Consent 

Decrees with State and Local 

Governmental Entities’’ (the ‘‘April 2021 

Memorandum’’), available at https://

www.justice.gov/ag/page/file/1387481/ 

download. Specifically, this rule 

withdraws the changes made to the 

Department’s regulations by the rule 

‘‘Approval of Civil Consent Decrees 

With State and Local Governmental 

Entities’’ published on December 28, 

2020 (85 FR 84229). 

The April 2021 Memorandum also 

specifically rescinded the Memorandum 

issued by former Attorney General 

Jefferson B. Sessions III, entitled 

‘‘Principles and Procedures for Civil 

Consent Decrees and Settlement 


lotter on DSK11XQN23PROD with RULES1