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 


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Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Rules and Regulations 12403 

1 In addition to other changes made by the 

December 28, 2020, rule, that rule also corrected an 

existing drafting error by removing ‘‘or’’ at the end 

of 28 CFR 0.160(d)(1). That was a non-substantive 

change, and accordingly this final rule does not 

undo that technical correction. 

Agreements with State and Local 

Governmental Entities’’ (November 7, 

2018) (the ‘‘November 2018 

Memorandum’’). 

In addition, for consistency with the 

April 2021 Memorandum, the 

Department will revise the changes 

made to the Justice Manual in 2020 in 

response to the November 2018 

Memorandum. 

B. Background—Previous 

Administration 

The November 2018 Memorandum set 

forth principles to guide the 

development of consent decrees with 

State or local governmental entities, 

including limitations on the 

circumstances in which a consent 

decree with a State or local 

governmental entity may be appropriate, 

the substantive requirements for such 

consent decrees, internal notification 

requirements regarding the initiation of 

negotiations for consent decrees, and a 

requirement of review and approval of 

senior leadership of the Department 

before a consent decree is agreed to by 

the United States or submitted to the 

court for entry. Subsequently, 

conforming changes were made to the 

Justice Manual and to the Department’s 

regulations at 28 CFR 0.160. The 

revisions to § 0.160, codified at 

paragraphs (d)(6) and (e), were limited 

to amending the Department’s 

settlement authority regulations to 

require approval of the specified 

consent decrees by the Deputy Attorney 

General or the Associate Attorney 

General. See 85 FR 84229 (Dec. 28, 

2020). 

C. Current Administration 

Upon further consideration, the 

Attorney General has determined to 

restore longstanding regulations, 

protocols, and practices by authorizing 

the Assistant Attorneys General of the 

litigating components generally to 

handle such approvals because they are 

the Department officials most familiar 

with and best able to assess each 

particular case. 

Accordingly, this rule restores the 

regulatory provisions at 28 CFR 0.160 as 

they existed prior to the revisions 

adopted on December 28, 2020.1

The April 2021 Memorandum also 

noted that, pursuant to longstanding 

Department settlement authority 

regulations predating the changes 

discussed above, and still in effect, a 

settlement agreement or consent decree 

with a State or local governmental entity 

must be referred to the Deputy Attorney 

General or the Associate Attorney 

General for approval if the component 

head ‘‘is of the opinion that[,] because 

of a question of law or policy presented 

. . . or for any other reason, the 

proposed settlement should receive the 

personal attention of the Deputy 

Attorney General or the Associate 

Attorney General, as appropriate.’’ 28 

CFR 0.160(d)(2). 

II. Regulatory Certifications 

A. Administrative Procedure Act 

This rule relates to a matter of agency 

management or personnel and is a rule 

of agency organization, procedure, or 

practice. As such, this rule is exempt 

from the usual requirements of prior 

notice and comment and a 30-day delay 

in effective date. See 5 U.S.C. 553(a)(2), 

(b)(A), (d). 

B. Regulatory Flexibility Act 

A Regulatory Flexibility Analysis was 

not required for this final rule because 

the Department was not required to 

publish a general notice of proposed 

rulemaking for this matter. See 5 U.S.C. 

601(2), 604(a). 

C. Executive Orders 12866 and 13563— 

Regulatory Review 

This rule has been drafted and 

reviewed in accordance with Executive 

Order 12866, ‘‘Regulatory Planning and 

Review,’’ section 1(b), The Principles of 

Regulation, and Executive Order 13563, 

‘‘Improving Regulation and Regulatory 

Review,’’ section 1, General Principles 

of Regulation. 

This final rule is ‘‘limited to agency 

organization, management, or personnel 

matters’’ and thus is not a ‘‘rule’’ for 

purposes of review by the Office of 

Management and Budget. Executive 

Order 12866, sec. 3(d)(3). 

D. Executive Order 12988—Civil Justice 

Reform 

This regulation meets the applicable 

standards set forth in section 3(a) and 

3(b)(2) of Executive Order 12988, ‘‘Civil 

Justice Reform.’’ 

E. Executive Order 13132—Federalism 

This rule will not 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. This rule only 

pertains to the internal delegation of the 

Attorney General’s litigation authority, 

regarding the authority of the 

Department’s litigation components for 

approval of consent decrees entered into 

by the Department. Therefore, in 

accordance with Executive Order 13132, 

‘‘Federalism,’’ the Department has 

determined that this rule does not have 

sufficient federalism implications to 

warrant the preparation of a federalism 

summary impact statement. 

F. Unfunded Mandates Reform Act of 

1995 

This rule will not result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted for inflation) in any one year, 

and it will not significantly or uniquely 

affect small governments. Therefore, no 

actions are necessary under the 

provisions of the Unfunded Mandates 

Reform Act of 1995, 2 U.S.C. 1501 et 

seq. 

G. Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the 

Congressional Review Act (CRA), 5 

U.S.C. 804. This action pertains to 

agency management or personnel, and 

agency organization, procedure, or 

practice, and does not substantially 

affect the rights or obligations of nonagency parties. Accordingly, it is not a 

‘‘rule’’ as that term is used in the CRA, 

5 U.S.C. 804(3)(B), (C). Therefore, the 

reporting requirement of 5 U.S.C. 801 

does not apply. 

H. Paperwork Reduction Act of 1995 

This final rule does not impose any 

new reporting or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995, 44 U.S.C. 3501– 

3521. 

List of Subjects in 28 CFR Part 0 

Authority delegations (Government 

agencies), Government employees, 

Organization and functions 

(Government agencies), Privacy, 

Reporting and recordkeeping 

requirements, Whistleblowing. 

Accordingly, by virtue of the 

authority vested in me as Attorney 

General, including 5 U.S.C. 301 and 28 

U.S.C. 509, 510, part 0 of title 28 of the 

Code of Federal Regulations is amended 

as follows: 

PART 0—ORGANIZATION OF THE 

DEPARTMENT OF JUSTICE 

■ 1. The authority citation for part 0 

continues to read as follows: 

Authority: 5 U.S.C. 301; 28 U.S.C. 509, 

510, 515–519. 

■ 2. In § 0.160: 

■ a. Revise paragraphs (d)(4) and (5); 

and 


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12404 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Rules and Regulations 

1 62 FR 27968 (May 22, 1997). 

■ b. Remove paragraphs (d)(6) and (e). 

The revisions read as follows: 

§ 0.160 Offers that may be accepted by 

Assistant Attorneys General. 

* * * * * 

(d) * * * 

(4) When the proposed settlement 

commits a department or agency to 

expend funds that Congress has not 

appropriated and that have not been 

budgeted for the action in question, or 

commits a department or agency to seek 

particular appropriation or budget 

authorization; or 

(5) When the proposed settlement 

otherwise limits the discretion of a 

department or agency to make policy or 

managerial decisions committed to the 

department or agency by Congress or by 

the Constitution. 

Dated: February 18, 2022. 

Merrick B. Garland, 

Attorney General. 

[FR Doc. 2022–04509 Filed 3–3–22; 8:45 am] 

BILLING CODE 4410–BB–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2021–0482; FRL–9596–02– 

R3] 

Air Plan Approval; Pennsylvania; 

Revision of the Maximum Allowable 

Sulfur Content Limit for Number 2 and 

Lighter Commercial Fuel Oil 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a state 

implementation plan (SIP) revision 

submitted by the Commonwealth of 

Pennsylvania. The revision pertains to 

the reduction of the maximum 

allowable sulfur content limit for 

Number 2 (No. 2) and lighter 

commercial fuel oil, generally sold and 

used for residential and commercial 

furnaces and oil heat burners for home 

or space heating, water heating or both, 

from the current limit of 500 parts per 

million (ppm) to 15 ppm. EPA is 

approving this revision to the 

Pennsylvania SIP in accordance with 

the requirements of the Clean Air Act 

(CAA). 

DATES: This final rule is effective on 

April 4, 2022. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

Number EPA–R03–OAR–2021–0482. All 

documents in the docket are listed on 

the https://www.regulations.gov 

website. Although listed in the index, 

some information is not publicly 

available, e.g., confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available through https://

www.regulations.gov, or please contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section for 

additional availability information. 

FOR FURTHER INFORMATION CONTACT: 

Mallory Moser, Planning & 

Implementation Branch (3AD30), Air & 

Radiation Division, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. The telephone number is (215) 

814–215–814–2030. Ms. Moser can also 

be reached via electronic mail at 

moser.mallory@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 15, 2021 (86 FR 71213), 

EPA published a notice of proposed 

rulemaking (NPRM) that proposed 

approval of a SIP revision that 

incorporates the Commonwealth’s 

updated low-sulfur fuel oil provisions 

into the Pennsylvania SIP. The SIP 

revision was submitted by Pennsylvania 

on September 4, 2020, requesting that 

EPA incorporate the Pennsylvania 

Department of Environmental 

Protection’s (PADEP’s) revisions to 25 

Pennsylvania Code (Pa. Code) Chapters 

123 Section 22 into the Pennsylvania 

SIP. In response to the NPRM, EPA 

received one comment supporting the 

proposed action which can be found in 

the docket. EPA received no adverse 

comments. 

II. Summary of SIP Revision and EPA 

Analysis 

The SIP revision incorporates 

amendments to 25 Pa. Code Chapter 123 

section 22 which set the maximum 

allowable sulfur content limit for 

various fuel types into the Pennsylvania 

SIP. The amendments to 25 Pa. Code 

Chapter 123.22, reduce the SIP 

approved maximum allowable sulfur 

content limit for No. 2 and lighter 

commercial fuel oil, generally sold for 

and used in residential and commercial 

furnaces and oil heat burners for home 

or space heating, water heating, or both, 

from a limit of 500 ppm of sulfur to 15 

ppm. The amendments to 25 Pa. 123.22, 

became effective on September 1, 2020. 

The low-sulfur fuel oil provisions will 

aid in reducing regional haze and 

visibility impairment in Pennsylvania. 

Additionally, decreased emissions of 

sulfur dioxide (SO2) will contribute to 

the attainment, maintenance, or both, of 

the SO2 and fine particulate matter 

(PM2.5) National Ambient Air Quality 

Standards (NAAQS) in Pennsylvania 

and surrounding areas. Other specific 

requirements of the SIP revision and the 

rationale for EPA’s proposed action are 

explained in the NPRM and will not be 

restated here. Relevant support 

documents for this action are available 

online at https://www.regulations.gov, 

Docket number EPA–R03–OAR–2021– 

0482. 

III. EPA’s Response to Comments 

Received 

EPA received one comment, from the 

State of New Jersey, supporting our 

proposed action in the December 15, 

2021, NPRM. The comment received is 

in the docket for this rulemaking action. 

We received no adverse comments. 

IV. Final Action 

EPA is approving, as a SIP revision, 

the Commonwealth of Pennsylvania’s 

September 4, 2020, submittal revising 

the maximum allowable sulfur content 

limit for No. 2 and lighter commercial 

fuel oil. 

V. Incorporation by Reference 

In this document, EPA is finalizing 

regulatory text that includes 

incorporation by reference. In 

accordance with requirements of 1 CFR 

51.5, EPA is finalizing the incorporation 

by reference of Pennsylvania’s 

maximum allowable sulfur content limit 

for No. 2 and lighter commercial fuel oil 

regulation described in 25 Pa. Code 

Chapter 123. EPA has made, and will 

continue to make, these materials 

generally available through https://

www.regulations.gov and at the EPA 

Region III Office (please contact the 

person identified in the FOR FURTHER

INFORMATION CONTACT section of this 

preamble for more information). 

Therefore, these materials have been 

approved by EPA for inclusion in the 

SIP, have been incorporated by 

reference by EPA into that plan, are 

fully federally enforceable under 

sections 110 and 113 of the CAA as of 

the effective date of the final rulemaking 

of EPA’s approval, and will be 

incorporated by reference in the next 

update to the SIP compilation.1


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