Rule2024-21231
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 20, 2024
Effective
February 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency in order to clarify when such hearings are available. We are revising the list of statutory provisions enumerated in the Scope section of the regulation by adding one statutory reference and removing a different statutory reference. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.
Full Text
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<title>Federal Register, Volume 89 Issue 183 (Friday, September 20, 2024)</title>
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[Federal Register Volume 89, Number 183 (Friday, September 20, 2024)]
[Rules and Regulations]
[Pages 77019-77023]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21231]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 16
[Docket No. FDA-2024-N-3654]
RIN 0910-AI97
Regulatory Hearing Before the Food and Drug Administration;
General Provisions; Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
issuing a direct final rule amending the Scope section of our
regulation that provides for a regulatory hearing before the Agency in
order to clarify when such hearings are available. We are revising the
list of statutory provisions enumerated in the Scope section of the
regulation by adding one statutory reference and removing a different
statutory reference. The Agency is issuing these amendments directly as
a final rule because we believe they are noncontroversial and FDA
anticipates no significant adverse comments.
DATES: This rule is effective February 3, 2025. Either electronic or
written comments on the direct final rule or its companion proposed
rule must be submitted by December 4, 2024. If FDA receives no
significant adverse comments within the specified comment period, the
Agency intends to publish a document confirming the effective date of
the final rule in the
[[Page 77020]]
Federal Register within 30 days after the comment period on this direct
final rule ends. If timely significant adverse comments are received,
the Agency will publish a document in the Federal Register withdrawing
this direct final rule within 30 days after the comment period on this
direct final rule ends.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 4, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2024-N-3654 for ``Regulatory Hearing Before the Food and Drug
Administration; General Provisions; Amendments.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Robert Schwartz, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 1-877-287-1373,
<a href="/cdn-cgi/l/email-protection#98dbccc8cafdffedf4f9ecf1f7f6ebd8fefcf9b6f0f0ebb6fff7ee"><span class="__cf_email__" data-cfemail="71322521231416041d1005181e1f02311715105f1919025f161e07">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Direct Final Rule
B. Summary of the Major Provisions of the Direct Final Rule
C. Legal Authority
D. Costs and Benefits
II. Direct Final Rulemaking Procedures
III. Background
IV. Legal Authority
V. Description of the Direct Final Rule
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
I. Executive Summary
A. Purpose of the Direct Final Rule
FDA is issuing this direct final rule to amend Sec. 16.1 (21 CFR
16.1) to revise the list of statutory provisions enumerated in the
Scope section of the regulation and thus clarify the circumstances
under which the Agency intends to use the procedures in part 16 (21 CFR
part 16) for regulatory hearings. This rule revises the list in Sec.
16.1 by removing one statutory reference and adding a different
statutory reference under the same section of the same statute. Because
we believe the rule contains noncontroversial changes and we do not
expect significant adverse comment on the rulemaking, we are using
direct final rulemaking procedures, as described in this document.
B. Summary of the Major Provisions of the Direct Final Rule
The direct final rule revises Sec. 16.1, Scope, in order to
clarify the circumstances under which the Agency intends to use the
procedures in part 16 for regulatory hearings. The rule amends the list
of statutory provisions enumerated in Sec. 16.1. Specifically, the
rule removes the reference to section 906(e)(1)(B) of the Federal Food,
Drug, & Cosmetic Act (FD&C Act) (21 U.S.C. 387f(e)(1)(B)) (the
statutory provision that requires FDA to afford an opportunity for an
oral hearing prior to promulgating a tobacco product manufacturing
practice (TPMP) requirements regulation) and adds a reference to
section 906(e)(2)(E) of the FD&C Act (the statutory provision that
provides a petitioner an opportunity for an informal hearing on an
order issued on the petitioner's request for temporary or permanent
exemption or variance from TPMP requirements).
C. Legal Authority
FDA is issuing this rule under provisions of the FD&C Act related
to
[[Page 77021]]
regulations and hearings (21 U.S.C. 371), and general provisions
respecting control of tobacco products, (21 U.S.C. 387f(e)).
D. Costs and Benefits
This direct final rule clarifies the circumstances under which the
Agency intends to use the procedures in part 16 for a regulatory
hearing. Potentially affected entities would include manufacturers of
finished and bulk tobacco products who choose to request an exemption
or variance from TPMP requirements and are afforded an opportunity for
a hearing on orders regarding such requests. Because this rule merely
clarifies which of its existing procedures FDA intends to use when
conducting certain types of hearings under the FD&C Act, costs and
benefits of this rule are expected to be minimal.
II. Direct Final Rulemaking Procedures
In the document titled ``Guidance for FDA and Industry: Direct
Final Rule Procedures,'' announced and provided in the Federal Register
of November 21, 1997 (62 FR 62466), FDA described its procedures on
when and how we will employ direct final rulemaking. The guidance may
be accessed at <a href="https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm">https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm</a>. We have determined that this rule is appropriate for
direct final rulemaking because we believe that it includes only
noncontroversial amendments and we anticipate no significant adverse
comments. Consistent with our procedures on direct final rulemaking,
FDA is also publishing elsewhere in this issue of the Federal Register
a companion proposed rule to clarify when the Agency intends to use the
procedures under the regulation for regulatory hearings before the Food
and Drug Administration. The companion proposed rule provides a
procedural framework within which the rule may be finalized in the
event that the direct final rule is withdrawn because of any
significant adverse comments. The comment period for the direct final
rule runs concurrently with the comment period for the companion
proposed rule. Any comments received in response to the companion
proposed rule will be considered as comments regarding the direct final
rule.
We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comments, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register. A significant adverse comment is defined as a
comment that explains why the rule would be inappropriate, including
challenges to the rule's underlying premise or approach, or would be
ineffective or unacceptable without a change. In determining whether an
adverse comment is significant and warrants terminating a direct final
rulemaking, we will consider whether the comment raises an issue
serious enough to warrant a substantive response in a notice-and-
comment process. Comments that are frivolous, insubstantial, or outside
the scope of the rule will not be considered significant or adverse
under this procedure. A comment recommending a regulation change in
addition to those in this direct final rule would not be considered a
significant adverse comment unless the comment states why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to part of this rule and that part
can be severed from the remainder of the rule, we may adopt as final
those provisions of the rule that are not subject to the significant
adverse comment.
If any significant adverse comments are received during the comment
period, FDA will publish, before the effective date of this direct
final rule, a notice of significant adverse comment and withdraw the
direct final rule. If we withdraw the direct final rule, any comments
received will be applied to the proposed rule and will be considered in
developing a final rule using the usual notice-and-comment procedures.
If FDA receives no significant adverse comments during the
specified comment period, FDA intends to publish a document confirming
the effective date within 30 days after the comment period ends.
III. Background
Part 16 provides procedures for regulatory hearings held before
FDA. The procedures in part 16 apply, among other circumstances, when a
statute or regulation provides a person an opportunity for a hearing on
a regulatory action. In 2012, FDA amended part 16 \1\ to add several
statutory and regulatory provisions throughout 21 CFR parts 1, 7, and
16, to include reference to tobacco products, where appropriate, so
that tobacco products would be subject to the same general requirements
that apply to other FDA-regulated products. The 2012 amendments revised
Sec. 16.1, which governs the scope of part 16, to include references
to certain sections of the FD&C Act that provide an opportunity for a
hearing. Among other changes, the 2012 amendments added a reference to
section 906(e)(1)(B) of the FD&C Act to Sec. 16.1. This rule further
amends Sec. 16.1, as described below.
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\1\ ``Further Amendments to General Regulations of the Food and
Drug Administration to Incorporate Tobacco Products,'' Food and Drug
Administration, 77 FR 5171, February 2, 2012.
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The Agency is amending the list of statutory provisions enumerated
in Sec. 16.1(b)(1) by removing the reference to section 906(e)(1)(B)
and adding a reference to section 906(e)(2)(E) of the FD&C Act. The
list of statutory provisions enumerated in Sec. 16.1(b)(1) included
section 906(e)(1)(B) of the FD&C Act, which requires FDA to afford the
public an opportunity for an oral hearing before issuing any TPMP
requirements regulation. The purpose of an oral hearing under section
906(e)(1)(B) of the FD&C Act is to allow the public to provide
viewpoints, opinions, and information on proposed TPMP rules. The
procedures under part 16 are not in alignment with the purpose and
goals of the oral hearing required under section 906(e)(1)(B) of the
FD&C Act. For example, part 16 includes procedures to resolve a
``genuine and substantial issue of fact'' that is in dispute and the
right to confront and cross-examine witnesses, which are not well
suited for allowing the public to provide viewpoints, opinions, and
information to FDA regarding TPMP rules. Accordingly, FDA is removing
the reference to section 906(e)(1)(B) of the FD&C Act from part 16 as
other available procedures are better suited to achieve its purposes.
The Agency is also adding a reference to section 906(e)(2)(E) of
the FD&C Act to Sec. 16.1(b)(1). Section 906(e)(2)(E) of the FD&C Act
provides an opportunity for an informal hearing after the issuance of
an order related to a petitioner's request for a temporary or permanent
exemption or variance from TPMP requirements. The list of statutory
provisions in Sec. 16.1(b)(1) that specifies the statutory and
regulatory provisions under which regulatory hearings under part 16 are
available did not previously include section 906(e)(2)(E) of the FD&C
Act. FDA is adding this reference to clarify that it intends to use the
procedures in part 16 when conducting such hearings.
FDA is amending Sec. 16.1 to clarify when it intends to use the
procedures in part 16 for regulatory hearings. The amended rule is more
consistent with the statute as it aligns the purposes of the two
hearings referenced above with more appropriate hearing procedures
[[Page 77022]]
under FDA's regulations. It also clarifies the availability of hearings
under part 16 to tobacco product manufacturers.
IV. Legal Authority
FDA is issuing this rule under provisions of the FD&C Act related
to regulations and hearings (21 U.S.C. 371), and general provisions
respecting control of tobacco products (21 U.S.C. 387f). Section 701
(21 U.S.C. 371) vests FDA with ``the authority to promulgate
regulations for the efficient enforcement of [the FD&C Act].'' Section
906(e) of the FD&C Act includes provisions regarding TPMP requirements
regulations and temporary and permanent exemptions and variances from
TPMP requirements.
V. Description of the Direct Final Rule
We are revising Sec. 16.1, Scope, to remove a reference to
``Section 906(e)(1)(B) of the FD&C Act relating to the establishment of
good manufacturing practice requirements for tobacco products'' and add
a reference to ``Section 906(e)(2)(E) of the FD&C Act relating to
exemptions or variances from tobacco product manufacturing practice
requirements.'' The amended rule clarifies the availability of the
procedures in part 16 for regulatory hearings to include situations
when a petitioner has requested a temporary or permanent exemption or
variance from TPMP requirements.
VI. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all
benefits, costs, and transfers of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an
annual effect on the economy of $200 million or more (adjusted every 3
years by the Administrator of [the Office of Information and Regulatory
Affairs (OIRA)] for changes in gross domestic product); or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities.'' OIRA has determined that this final rule is not a
significant regulatory action under Executive Order 12866 Section
3(f)(1).
Because this rule is not likely to result in an annual effect on
the economy of $100 million or more or meets other criteria specified
in the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does not fall within
the scope of 5 U.S.C. 804(2).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule merely clarifies which of its existing
procedures FDA intends to use when conducting certain types of hearings
under the FD&C Act, we certify that the final rule will not have a
significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes estimates of
anticipated impacts, before issuing ``any rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $183
million, using the most current (2023) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in an
expenditure in any year that meets or exceeds this amount.
This rule clarifies the procedures FDA intends to use when
conducting certain types of hearings under the FD&C Act. When the TPMP
rule becomes final and effective, potentially affected entities,
including manufacturers of finished and bulk tobacco products, who
choose to request an exemption or variance from TPMP requirements would
be afforded an opportunity for a hearing on orders regarding such
requests.
We do not know how many manufacturers would pursue petitioning for
an exemption or variance from TPMP requirements, once the Agency has
published a final TPMP rule to establish such requirements and that
rule is in effect, nor do we know how many requirements may be included
in each petition. We reason that a manufacturer would petition for an
exemption or variance from a TPMP requirement only if compliance with
said requirement is not a financially viable choice compared to the
cost of a filing a petition. Because this rule merely clarifies which
of its existing procedures FDA intends to use when conducting certain
types of hearings under the FD&C Act, costs and benefits of this rule
are expected to be minimal.
VII. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VIII. Paperwork Reduction Act of 1995
This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.
IX. Federalism
We have analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this direct final rule does not contain policies that 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. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.
X. Consultation and Coordination With Indian Tribal Governments
We have analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13175. We have determined that
the rule does not contain policies that have substantial direct effects
on one or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order and,
consequently, a tribal summary impact statement is not required.
List of Subjects in 21 CFR Part 16
Administrative practice and procedure.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
16 is amended as follows:
[[Page 77023]]
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
1. The authority citation for part 16 continues to read as follows:
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
0
2. Amend Sec. 16.1 by revising paragraph (b)(1) to read as follows:
Sec. 16.1 Scope.
* * * * *
(b) * * *
(1) The statutory provisions are as follows:
Table 1 to Paragraph (b)(1)
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Section 304(g) of the Federal Food, Drug, and Cosmetic Act relating to
the administrative detention of devices and drugs (see Sec. Sec.
800.55(g) and 1.980(g) of this chapter).
Section 304(h) of the Federal Food, Drug, and Cosmetic Act relating to
the administrative detention of food for human or animal consumption
(see part 1, subpart k of this chapter).
Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act
relating to the modification or revocation of a variance from the
requirements of section 419 (see part 112, subpart P of this chapter).
Section 515(e)(1) of the Federal Food, Drug, and Cosmetic Act relating
to the proposed withdrawal of approval of a device premarket approval
application.
Section 515(e)(3) of the Federal Food, Drug, and Cosmetic Act relating
to the temporary suspension of approval of a premarket approval
application.
Section 515(f)(6) of the Federal Food, Drug, and Cosmetic Act relating
to a proposed order revoking a device product development protocol or
declaring a protocol not completed.
Section 515(f)(7) of the Federal Food, Drug, and Cosmetic Act relating
to revocation of a notice of completion of a product development
protocol.
Section 516(b) of the Federal Food, Drug, and Cosmetic Act regarding a
proposed regulation to ban a medical device with a special effective
date.
Section 518(b) of the Federal Food, Drug, and Cosmetic Act relating to a
determination that a device is subject to a repair, replacement, or
refund order or that a correction plan, or revised correction plan,
submitted by a manufacturer, importer, or distributor is inadequate.
Section 518(e) of the Federal Food, Drug, and Cosmetic Act relating to a
cease distribution and notification order or mandatory recall order
concerning a medical device for human use.
Section 520(f)(2)(D) of the Federal Food, Drug, and Cosmetic Act
relating to exemptions or variances from device current good
manufacturing practice requirements (see Sec. 820.1(d)).
Section 520(g)(4) and (g)(5) of the Federal Food, Drug, and Cosmetic Act
relating to disapproval and withdrawal of approval of an application
from an investigational device exemption (see Sec. Sec. 812.19(c),
812.30(c), 813.30(d), and 813.35(c) of this chapter).
Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act
relating to the misbranding of tobacco products.
Section 906(e)(2)(E) of the Federal Food, Drug, and Cosmetic Act
relating to exemptions or variances from tobacco product manufacturing
practice requirements.
Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act relating
to the withdrawal of an order allowing a new tobacco product to be
introduced or delivered for introduction into interstate commerce.
Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating to
the withdrawal of an order allowing a modified risk tobacco product to
be introduced or delivered for introduction into interstate commerce.
------------------------------------------------------------------------
* * * * *
Sec. 16.1 [Amended]
0
3. Effective December 18, 2025, in Sec. 16.1, amend paragraph (b)(2)
by redesignating table 1 to paragraph (b)(2) as table 2 to paragraph
(b)(2).
Dated: September 6, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-21231 Filed 9-19-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 20, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.