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

CourtJustice Department,The Attorney General Office
Citation87 FR 12402
Record Number2022-04509
Publication Date04 March 2022
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,
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Parklawn Dr., Element Bldg., Rm. 4141,
Rockville, MD 20857. Send two self-
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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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 (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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