Revisions to Approval of Civil Consent Decrees With State and Local Governmental Entities

• Citation: 87 FR 12402
• Record Number: 2022-04509
• Published date: 04 March 2022
• Section: Rules and Regulations
• Court: Justice Department,The Attorney General Office

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

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received, go to https://

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heading of this document, into the

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Submit written requests for single

copies of the guidance to the Office of

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addressed 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/regulatory-

information/search-fda-guidance-

documents 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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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 non-

agency 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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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 (SO

2

) will contribute to

the attainment, maintenance, or both, of

the SO

2

and fine particulate matter

(PM

2.5

) 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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