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Notice2025-18328

Regulatory Agenda

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Published

September 22, 2025

Issuing agencies

Health and Human Services Department

Abstract

The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.

Full Text

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[Federal Register Volume 90, Number 181 (Monday, September 22, 2025)]
[Proposed Rules]
[Pages 45510-45518]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18328]

[[Page 45509]]

Vol. 90

Monday,

No. 181

September 22, 2025

Part VII

Department of Health and Human Services

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Semiannual Regulatory Agenda

Federal Register / Vol. 90 , No. 181 / Monday, September 22, 2025 /
Unified Agenda

[[Page 45510]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

25 CFR Ch. V

42 CFR Chs. I-V

45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

-----------------------------------------------------------------------

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order
12866 require the semiannual issuance of an inventory of rulemaking
actions under development throughout the Department, offering for
public review summarized information about forthcoming regulatory
actions.

FOR FURTHER INFORMATION CONTACT: Wilma M. Robinson, Deputy Executive
Secretary, Department of Health and Human Services, 200 Independence
Avenue SW, Washington, DC 20201; (202) 690- 5627.

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) is the Federal government's lead agency for protecting the health
of all Americans and providing essential human services. HHS enhances
the health and well-being of Americans by promoting effective health
and human services and by fostering sound, sustained advances in the
sciences underlying medicine, public health, and social services.
This Agenda presents the regulatory activities that the Department
expects to undertake in the foreseeable future to advance this mission.
The purpose of the Agenda is to encourage more effective public
participation in the regulatory process. The regulatory actions
forecasted in this Agenda reflect the priorities of HHS Secretary
Robert F. Kennedy Jr. and the Donald J. Trump Administration.
Accordingly, this Agenda contains rulemakings aimed at making America
healthy again! To achieve this goal, this Agenda shows a commitment to
managing chronic disease; eliminating unnecessary administrative
expenses and rent-seeking practices that increase healthcare costs;
battling obesity; ensuring the safety and efficacy of our vaccines;
protecting the religious liberty of our medical workforce; and standing
up for the health and well-being of biological women, children, and
families, among other policy priorities.
The rulemaking abstracts included in this paper issue of the
Federal Register cover, as required by the Regulatory Flexibility Act
of 1980, those prospective HHS rulemakings likely to have a significant
economic impact on a substantial number of small entities. The
Department's complete Regulatory Agenda is accessible online at <a href="http://www.RegInfo.gov">http://www.RegInfo.gov</a>.

Wilma M. Robinson,
HHS Deputy Executive Secretary.

Office for Civil Rights--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
1......................... Making Technical Changes 0945-AA24
And Clarifying How OCR
Addresses Conscience
Authorities In Health
Care; Delegation of
Authority (Rulemaking
Resulting From a Section
610 Review).
------------------------------------------------------------------------

Centers for Disease Control and Prevention--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
2......................... Control of Communicable 0920-AA75
Diseases; Foreign
Quarantine.
------------------------------------------------------------------------

Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
3......................... Conduct of Analytical and 0910-AI57
Clinical Pharmacology,
Bioavailability, and
Bioequivalence Studies.
4......................... Postmarketing Safety 0910-AI61
Reporting Requirements,
Pharmacovigilance Plans,
and Pharmacovigilance
Quality Systems for Human
Drug and Biological
Products.
5......................... Registration of Commercial 0910-AI87
Importers of Drugs; Good
Importing Practice.
6......................... Pediatric Study Plan 0910-AI89
Requirements for New Drug
and Biologics License
Applications.
------------------------------------------------------------------------

Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
7......................... Front-of-Package Nutrition 0910-AI80
Labeling.
------------------------------------------------------------------------

Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
8......................... National Standards for the 0910-AH11
Licensure of Wholesale
Drug Distributors and
Third-Party Logistics
Providers.
9......................... Certain Requirements 0910-AH56
Regarding Prescription
Drug Marketing (203
Amendment).
10........................ Medication Guide; Patient 0910-AH68
Medication Information.

[[Page 45511]]

11........................ Requirements for Tobacco 0910-AH91
Product Manufacturing
Practice.
12........................ Administrative Detention 0910-AI05
of Tobacco Products.
13........................ Good Laboratory Practice 0910-AJ01
for Nonclinical
Laboratory Studies.
------------------------------------------------------------------------

Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
14........................ Nutrient Content Claims, 0910-AI13
Definition of Term:
Healthy.
15........................ Tobacco Product Standard 0910-AI60
for Menthol in Cigarettes.
16........................ Tobacco Product Standard 0910-AI76
for Nicotine Yield of
Cigarettes and Certain
Other Combusted Tobacco
Products.
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
17........................ CY 2026 Revisions to 0938-AV50
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1832)
(Section 610 Review).
18........................ CY 2026 Hospital 0938-AV51
Outpatient PPS Policy
Changes and Payment Rates
and Ambulatory Surgical
Center Payment System
Policy Changes and
Payment Rates (CMS-1834)
(Section 610 Review).
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
19........................ Independent Dispute 0938-AV15
Resolution Operations
(CMS-9897).
20........................ Hospital Inpatient 0938-AV45
Prospective Payment
Systems for Acute Care
Hospitals; the Long-Term
Care Hospital Prospective
Payment System; and FY
2026 Rates (CMS-1833)
(Section 610 Review).
21........................ FY 2026 Hospice Wage 0938-AV49
Index, Payment Rate
Update, and Quality
Reporting Requirements
(CMS-1835) (Section 610
Review).
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
22........................ Enhancing Coverage of 0938-AV57
Preventive Services Under
the Affordable Care Act
(CMS-9887).
23........................ Patient Protection and 0938-AV61
Affordable Care Act;
Marketplace Integrity and
Affordability (CMS-9884).
------------------------------------------------------------------------

Administration for Children and Families--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
24........................ Native American Programs 0970-AD05
Financial and
Administrative
Requirements (Section 610
Review).
25........................ Temporary Assistance for 0970-AD07
Needy Families Work
Participation Rate
Calculation Changes
(Section 610 Review).
26........................ Unaccompanied Children 0970-AD08
Program Prevention of
Sexual Abuse NPRM
(Section 610 Review).
------------------------------------------------------------------------

Administration for Children and Families--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
27........................ Office of Refugee 0970-AD10
Resettlement Child Abuse
and Neglect
Investigations Rule
(Section 610 Review).
------------------------------------------------------------------------

[[Page 45512]]

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Proposed Rule Stage
Office for Civil Rights (OCR)
............................
------------------------------------------------------------------------

1. <bullet> MAKING TECHNICAL CHANGES AND CLARIFYING HOW OCR ADDRESSES
CONSCIENCE AUTHORITIES IN HEALTH CARE; DELEGATION OF AUTHORITY
(RULEMAKING RESULTING FROM A SECTION 610 REVIEW) [0945-AA24]

Legal Authority: 5 U.S.C. 301 and other federal authorities
Abstract: In keeping with Executive Orders 14202 and 14188, and
HHS' commitment to reevaluate its regulations and guidance pertaining
to Federal laws on conscience and religious exercise, the proposed
conscience rule would amend the 2024 rule to make technical corrections
and clarify how OCR addresses those federal authorities.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/26
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: No
Agency Contact: David Christensen, Supervisory Policy Advisor,
Department of Health and Human Services, Office for Civil Rights, 200
Independence Avenue SW, Washington, DC 20201
Phone: 202 795-7830
Email: <a href="/cdn-cgi/l/email-protection#fd9e92938e9e9498939e988f889198bd95958ed39a928b">[email&#160;protected]</a>
RIN: 0945-AA24

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Final Rule Stage
Centers for Disease Control and Prevention
(CDC)
............................
------------------------------------------------------------------------

2. CONTROL OF COMMUNICABLE DISEASES; FOREIGN QUARANTINE [0920-AA75]

Legal Authority: 42 U.S.C. 264; 42 U.S.C. 265
Abstract: This rulemaking amends current regulation to enable CDC
to require airlines to collect and provide to CDC certain data elements
regarding passengers and crew arriving from foreign countries under
certain circumstances.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule Effective........ 02/07/20
Interim Final Rule.................. 02/12/20 85 FR 7874
Interim Final Rule Comment Period 03/13/20
End.
Final Action........................ 10/00/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Ashley C. Altenburger JD, Regulatory Analyst,
Department of Health and Human Services, Centers for Disease Control
and Prevention, 1600 Clifton Road NE, MS: H16-4, Atlanta, GA 30307
Phone: 800 232-4636
Email: <a href="/cdn-cgi/l/email-protection#80e4e7edf1f0efece9e3f9efe6e6e9e3e5c0e3e4e3aee7eff6">[email&#160;protected]</a>
RIN: 0920-AA75

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Proposed Rule Stage
Food and Drug Administration (FDA)
............................
------------------------------------------------------------------------

3. CONDUCT OF ANALYTICAL AND CLINICAL PHARMACOLOGY, BIOAVAILABILITY,
AND BIOEQUIVALENCE STUDIES [0910-AI57]

Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42
U.S.C. 262
Abstract: FDA is proposing to amend 21 CFR 320, in certain parts,
and establish a new 21 CFR 321 to clarify FDA's study conduct
expectations for clinical pharmacology, and clinical and analytical
bioavailability (BA) and bioequivalence (BE) studies that support
marketing applications for human drug and biological products. The
proposed rule would specify needed basic study conduct requirements to
enable FDA to ensure those studies are conducted appropriately and to
verify the reliability of study data from those studies. This
regulation would align with FDA's other good practice regulations,
would also be consistent with current industry best practices, and
would harmonize the regulations more closely with related international
regulatory expectations.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/26
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Brian Joseph Folian, Supervisory Biologist,
Department of Health and Human Services, Food and Drug Administration,
10903 New Hampshire Avenue, Building 22, Room 1440, Silver Spring, MD
20993-0002
Phone: 240 402-4089
Email: <a href="/cdn-cgi/l/email-protection#9af8e8f3fbf4b4fcf5f6f3fbf4dafcfefbb4f2f2e9b4fdf5ec">[email&#160;protected]</a>
RIN: 0910-AI57

4. POSTMARKETING SAFETY REPORTING REQUIREMENTS, PHARMACOVIGILANCE
PLANS, AND PHARMACOVIGILANCE QUALITY SYSTEMS FOR HUMAN DRUG AND
BIOLOGICAL PRODUCTS [0910-AI61]

Legal Authority: 42 U.S.C. 262; 42 U.S.C. 264; 42 U.S.C. 300aa-25;
21 U.S.C. 321; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21
U.S.C. 371; 21 U.S.C. 374; . . .
Abstract: The proposed rule would modernize FDA's regulations on
postmarketing safety reporting and pharmacovigilance for human drug and
biological products by capturing important new safety-related
information, improving the quality and utility of submitted reports,
and supporting enhanced efficiency and alignment with internationally
harmonized reporting guidelines. The proposed rule also would require
application holders for drug products and biological products (other
than blood or blood components) to establish and maintain a
pharmacovigilance quality system that reflects the application holder's
unique needs and that would support the more streamlined, flexible
approach to fulfilling certain postmarketing safety reporting
requirements
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/26
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Janice L. Weiner, Principal Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue,
Building 51, Room 6270, Silver Spring, MD 20993-0002
Phone: 301 796-3475
Fax: 301 847-8440
Email: <a href="/cdn-cgi/l/email-protection#fb919a9592989ed58c9e92959e89bb9d9f9ad5939388d59c948d">[email&#160;protected]</a>
RIN: 0910-AI61

5. REGISTRATION OF COMMERCIAL IMPORTERS OF DRUGS; GOOD IMPORTING
PRACTICE [0910-AI87]

Legal Authority: sec. 714 of the Food and Drug Administrative
Safety and Innovation Act (FDASIA) of July 2012
Abstract: This proposed rulemaking meets the mandate of section 714
of the Food and Drug Administration Safety and Innovation Act and will
establish registration and good importing practice requirements for
commercial importers

[[Page 45513]]

of drugs. Although manufacturers are subject to regulatory requirements
to ensure such quality standards are met, there are few clear
responsibilities for commercial importers of drugs to do the same.
Cost estimates of the rule include reading and understanding the
rule, registering as a commercial importer through the Food and Drug
Administration's (FDA) electronic importer registration system, annual
updating of registration, establishing a quality management system,
conducting risk evaluations of drugs and suppliers, shipment
verifications, investigations, corrective actions, and records
maintenance. These incremental costs would be more than offset by cost
savings to FDA and industry from facilitating the review of
documentation that ensures compliance with our regulations prior to
being allowed to enter the United States.
The unquantified benefits of the proposed rule include improvement
in the safety of finished drugs allowed to enter the United States from
the commercial drug importer's requirement to register with FDA and for
increased due diligence required by the importer regarding the safety
of the drugs. This proposed rulemaking will also enhance FDA's ability
to collect and analyze data to enable risk-informed decision-making
while focusing on protecting the integrity of the global drug supply
chain and ensuring safety, effectiveness, and quality of imported
drugs.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: James Hanratty, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 12420 Parklawn
Dr, Room 4045, Rockville, MD 20852
Phone: 240 402-4718
Email: <a href="/cdn-cgi/l/email-protection#a8c2c9c5cddb86c0c9c6dac9dcdcd1e8ceccc986c0c0db86cfc7de">[email&#160;protected]</a>
RIN: 0910-AI87

6. PEDIATRIC STUDY PLAN REQUIREMENTS FOR NEW DRUG AND BIOLOGICS LICENSE
APPLICATIONS [0910-AI89]

Legal Authority: 21 U.S.C. 355c(e)(7); 21 U.S.C. 355c(k)(1); 21
U.S.C. 371(a)
Abstract: FDA is proposing to amend its existing regulations and
add new regulations pertaining to submission of required initial
pediatric study plans (iPSPs) under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). This proposed rule, if finalized, would
implement the pediatric study plans provisions of the FD&C Act, and
exercise the authority granted to the Secretary in the provisions of
the FD&C Act governing exemptions from pediatric study requirements.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/26
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Reena Raman, Senior Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO Bldg. 51, Room 6284, 10903 New
Hampshire Avenue, Silver Spring, MD 20993-0002
Phone: 301 796-7577
Fax: 301 847-8440
Email: <a href="/cdn-cgi/l/email-protection#3d4f5858535c134f5c505c537d5b595c1355554e135a524b">[email&#160;protected]</a>
RIN: 0910-AI89

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Final Rule Stage
Food and Drug Administration (FDA)
............................
------------------------------------------------------------------------

7. FRONT-OF-PACKAGE NUTRITION LABELING [0910-AI80]

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 343 note;
21 U.S.C. 371
Abstract: This rule, if finalized, would require the front of food
labels to display certain nutrition information to help consumers,
including those who are busy and those with lower nutrition knowledge,
make more informed dietary choices. Front-of-package nutrition labeling
is intended to complement the Nutrition Facts label on packaged foods
by giving consumers additional context to help them quickly and easily
identify foods that can help them build a healthy eating pattern. This
rule would also amend certain nutrient content claim regulations to
align with current nutrition science and ensure consistency in
labeling.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/16/25 90 FR 5426
NPRM Comment Period End............. 05/16/25
Final Rule.......................... 05/00/26
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Claudine Kavanaugh, Director, Office of Nutrition
and Food Labeling, Department of Health and Human Services, Food and
Drug Administration, Humans Foods Program, CPK1 RM 4C096, 5001 Campus
Drive, College Park, MD 20740
Phone: 240 402-1450
Email: <a href="/cdn-cgi/l/email-protection#8ae9e6ebffeee3e4efa4e1ebfcebe4ebffede2caeceeeba4e2e2f9a4ede5fc">[email&#160;protected]</a>
RIN: 0910-AI80

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Long-Term Actions
Food and Drug Administration (FDA)
............................
------------------------------------------------------------------------

8. NATIONAL STANDARDS FOR THE LICENSURE OF WHOLESALE DRUG DISTRIBUTORS
AND THIRD-PARTY LOGISTICS PROVIDERS [0910-AH11]

Legal Authority: secs. 583 and 584 of the FD&C Act, as added by the
DSCSA under Pub. L. 113-54, together with related FD&C Act authority
added by the DSCSA.
Abstract: The final rule establishes national standards for State
licensing of prescription drug wholesale distributors and third-party
logistics providers. The rulemaking also establishes a Federal system
for wholesale drug distributor and third-party logistics provider
licensing for use in the absence of a State licensure program.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/04/22 87 FR 6708
NPRM Comment Period End............. 06/06/22
NPRM Comment Period Extended........ 05/24/22 87 FR 31439
NPRM Comment Period Extended End.... 09/06/22
Final Rule.......................... 05/00/27
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, Building 51, Room 4261, 10903 New
Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-9362
Email: <a href="/cdn-cgi/l/email-protection#5736362538397920323e243522343f17313336793f3f2479303821">[email&#160;protected]</a>
RIN: 0910-AH11

9. CERTAIN REQUIREMENTS REGARDING PRESCRIPTION DRUG MARKETING (203
AMENDMENT) [0910-AH56]

Legal Authority: Section 503 and related provisions of the FD&C
Act, as amended by Pub. L. 113-54

[[Page 45514]]

Abstract: The final rule amends Food and Drug Administration (FDA)
regulations at 21 CFR 203 to remove provisions no longer in effect and
incorporate conforming changes following enactment of the Drug Supply
Chain Security Act (DSCSA). The final rule amends the regulations to
clarify provisions and avoid causing confusion with the new standards
for wholesale distribution established by DSCSA.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/04/22 87 FR 6443
NPRM Comment Period End............. 04/05/22
Final Rule.......................... 05/00/27
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, Building 51, Room 4261, 10903 New
Hampshire Avenue, Silver Spring, MD 20993
Phone: 301 796-9362
Email: <a href="/cdn-cgi/l/email-protection#a7c6c6d5c8c989d0c2ced4c5d2c4cfe7c1c3c689cfcfd489c0c8d1">[email&#160;protected]</a>
RIN: 0910-AH56

10. MEDICATION GUIDE; PATIENT MEDICATION INFORMATION [0910-AH68]

Legal Authority: 21 U.S.C. 321 et seq.; 42 U.S.C. 262; 42 U.S.C.
264; 21 U.S.C. 371
Abstract: The rule will amend FDA medication guide regulations to
require a new form of patient labeling, Patient Medication Information,
for submission to and for approval by FDA for human prescription drug
products and certain blood products used, dispensed, or administered on
an outpatient basis. The rule will include requirements for the
development and distribution of Patient Medication Information. The
rule will require clear and concisely written prescription drug product
information presented in a consistent and easily understood format and
is intended to help patients use their prescription drug products
safely and effectively.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/31/23 88 FR 35694
NPRM Comment Period End............. 11/27/23
Final Rule.......................... 07/00/26
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Chris Wheeler, Supervisory Project Manager,
Department of Health and Human Services, Food and Drug Administration,
10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD
20993
Phone: 301 796-0151
Email: <a href="/cdn-cgi/l/email-protection#3b585f5e4954564b7b5d5f5a15535348155c544d">[email&#160;protected]</a>
RIN: 0910-AH68

11. REQUIREMENTS FOR TOBACCO PRODUCT MANUFACTURING PRACTICE [0910-AH91]

Legal Authority: 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381(a); 21
U.S.C. 387b; 21 U.S.C. 387c; 21 U.S.C. 387f; 21 U.S.C. 387i; . . .
Abstract: The rule would establish tobacco product manufacturing
practice (TPMP) requirements for manufacturers of finished and bulk
tobacco products. This rule, if finalized, would set forth requirements
for the manufacture, pre-production design validation, packing, and
storage of a tobacco product. This rule would help prevent the
manufacture and distribution of contaminated and otherwise
nonconforming tobacco products.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/10/23 88 FR 15174
NPRM Comment Period End............. 09/06/23
NPRM Comment Period Extension to 08/29/23 88 FR 59481
Oct. 06, 2023.
Final Rule.......................... 05/00/27
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: May Nelson, Department of Health and Human
Services, Food and Drug Administration, Center for Tobacco Products,
10903 New Hampshire Avenue, Document Control Center, Bldg. 71, Room
G335, Silver Spring, MD 20993
Phone: 877 287-1373
Email: <a href="/cdn-cgi/l/email-protection#a7c6d4ccc4d3d7e7c1c3c689cfcfd489c0c8d1">[email&#160;protected]</a>
RIN: 0910-AH91

12. ADMINISTRATIVE DETENTION OF TOBACCO PRODUCTS [0910-AI05]

Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371
Abstract: FDA is proposing a regulation to establish requirements
for the administrative detention of tobacco products. This proposed
rule, when finalized, would allow FDA to administratively detain
tobacco products encountered during inspections of manufacturers or
other establishments that manufacture, process, pack, or hold tobacco
products that an authorized FDA representative conducting the
inspection has reason to believe are adulterated or misbranded. The
intent of administrative detention is to protect public health by
preventing the distribution or use of tobacco products encountered
during inspections that are believed to be adulterated or misbranded
until FDA has had time to consider the appropriate action to take and,
where appropriate, to initiate legal action.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/27
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: May Nelson, Department of Health and Human
Services, Food and Drug Administration, Center for Tobacco Products,
10903 New Hampshire Avenue, Document Control Center, Bldg. 71, Room
G335, Silver Spring, MD 20993
Phone: 877 287-1373
Email: <a href="/cdn-cgi/l/email-protection#3455475f574044745250551a5c5c471a535b42">[email&#160;protected]</a>
RIN: 0910-AI05

13. GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES [0910-
AJ01]

Legal Authority: 21 U.S.C. 371
Abstract: The Food and Drug Administration (FDA) is proposing to:
(1) Amend the regulations for Good Laboratory Practice (21 CFR part 58)
to require a modern quality system for conducting nonclinical
laboratory studies when safety and toxicity studies support or are
intended to support applications or submissions for products regulated
by FDA; (2) to provide an opportunity for a hearing prior to
disqualification of certain persons involved in the conduct of a
nonclinical laboratory study (21 CFR part 16); and (3) to
simultaneously withdraw the 2016 proposed rule.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/26
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Ann Marie Metayer, Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 32, Room 4375, Silver Spring, MD 20993
Phone: 301 796-3324
Email: <a href="/cdn-cgi/l/email-protection#83e2ededadeee6f7e2fae6f1c3e5e7e2adebebf0ade4ecf5">[email&#160;protected]</a>
RIN: 0910-AJ01

[[Page 45515]]

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Completed Actions
Food and Drug Administration (FDA)
............................
------------------------------------------------------------------------

14. NUTRIENT CONTENT CLAIMS, DEFINITION OF TERM: HEALTHY [0910-AI13]

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 343; 21
U.S.C. 371
Abstract: The rule would update the definition for the implied
nutrient content claim ``healthy'' to be consistent with current
nutrition science and federal dietary guidelines. The rule would revise
the requirements for when the claim ``healthy'' can be voluntarily used
in the labeling of human food products to indicate that a food, because
of its nutrient content, may be useful in achieving a total diet that
conforms to current dietary recommendations and helps consumers
maintain healthy dietary practices.
Completed:

------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Final Rule.......................... 12/27/24 89 FR 106064
Final Rule Effective Delay.......... 02/25/25 90 FR 10592
Final Rule Effective................ 04/28/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Vincent De Jesus
Phone: 240 402-1774
Fax: 301 436-1191
Email: <a href="/cdn-cgi/l/email-protection#bbcdd2d5d8ded5cf95dfded1dec8cec8fbdddfda95d3d3c895dcd4cd">[email&#160;protected]</a>
RIN: 0910-AI13

15. TOBACCO PRODUCT STANDARD FOR MENTHOL IN CIGARETTES [0910-AI60]

Legal Authority: 21 U.S.C. 387g; 21 U.S.C. 371; 21 U.S.C. 387f
Abstract: This rule is a tobacco product standard to prohibit the
use of menthol as a characterizing flavor in cigarettes.
Completed:

------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Withdrawn........................... 07/25/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: May Nelson
Phone: 877 287-1373
Email: <a href="/cdn-cgi/l/email-protection#83e2f0e8e0f7f3c3e5e7e2adebebf0ade4ecf5">[email&#160;protected]</a>
RIN: 0910-AI60

16. TOBACCO PRODUCT STANDARD FOR NICOTINE YIELD OF CIGARETTES AND
CERTAIN OTHER COMBUSTED TOBACCO PRODUCTS [0910-AI76]

Legal Authority: 21 U.S.C. 387g
Abstract: The rule is a tobacco product standard that would
regulate nicotine yield by establishing a maximum nicotine level in
cigarettes and certain other combusted tobacco products.
Completed:

------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/16/25 90 FR 5032
Withdrawn........................... 04/21/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: May Nelson
Phone: 877 287-1373
Email: <a href="/cdn-cgi/l/email-protection#eb8a9880889f9bab8d8f8ac5838398c58c849d">[email&#160;protected]</a>
RIN: 0910-AI76

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Proposed Rule Stage
Centers for Medicare & Medicaid Services
(CMS)
............................
------------------------------------------------------------------------

17. CY 2026 REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE
SCHEDULE AND OTHER REVISIONS TO MEDICARE PART B (CMS-1832) (SECTION 610
REVIEW) [0938-AV50]

Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This annual proposed rule would revise payment polices
under the Medicare physician fee schedule, and make other policy
changes to payment under Medicare Part B. These changes would apply to
services furnished beginning January 1, 2026. Additionally, this rule
proposes updates to the Quality Payment Program.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Lindsey Baldwin, Director, Division of Practitioner
Services, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Center for Medicare, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-1694
Email: <a href="/cdn-cgi/l/email-protection#4b2722252f382e3265292a272f3c22250b28263865232338652c243d">[email&#160;protected]</a>
RIN: 0938-AV50

18. CY 2026 HOSPITAL OUTPATIENT PPS POLICY CHANGES AND PAYMENT RATES
AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM POLICY CHANGES AND
PAYMENT RATES (CMS-1834) (SECTION 610 REVIEW) [0938-AV51]

Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This annual proposed rule would revise the Medicare
hospital outpatient prospective payment system to implement statutory
requirements and changes arising from our continuing experience with
this system. The proposed rule describes changes to the amounts and
factors used to determine payment rates for services. In addition, the
rule proposes changes to the ambulatory surgical center payment system
list of services and rates. This proposed rule would also update and
refine the requirements for the Hospital Outpatient Quality Reporting
(OQR) Program and the ASC Quality Reporting (ASCQR) Program.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: David Rice, Director, Division of Outpatient Care,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-6004
Email: <a href="/cdn-cgi/l/email-protection#8ce8edfae5e8a2fee5efe9bdccefe1ffa2e4e4ffa2ebe3fa">[email&#160;protected]</a>
RIN: 0938-AV51

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Final Rule Stage
Centers for Medicare & Medicaid Services
(CMS)
............................
------------------------------------------------------------------------

19. INDEPENDENT DISPUTE RESOLUTION OPERATIONS (CMS-9897) [0938-AV15]

Legal Authority: Pub. L. 116-260, Division BB, title I & title II
Abstract: This document finalizes rules related to certain
provisions of the No Surprises Act regarding the Federal independent
dispute resolution (IDR) process, which was established as part of the
Consolidated Appropriations Act, 2021 (CAA). This rule sets forth new
requirements relating to the disclosure of information that group
health plans and health insurance issuers offering group or individual
health insurance

[[Page 45516]]

coverage must include along with the initial payment or notice of
denial of payment for certain items and services subject to the
surprise billing protections in the No Surprises Act. This rule also
requires plans and issuers to communicate information by using claim
adjustment reason codes (CARCs) and remittance advice remark codes
(RARCs), as specified in guidance, when providing any paper or
electronic remittance advice to an entity that does not have a
contractual relationship with the plan or issuer. This document also
amends certain requirements related to the open negotiation period
preceding the Federal IDR process, the initiation of the Federal IDR
process, the Federal IDR dispute eligibility review, and the payment
and collection of administrative fees and certified IDR entity fees.
This document also defines bundled payment arrangements, amends
requirements related to batched items and services, and amends the
rules for extensions of timeframes due to extenuating circumstances.
Additionally, this document requires plans and issuers to register in
the Federal IDR portal.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/03/23 88 FR 75744
NPRM Comment Period End............. 01/02/24
NPRM Comment Period Reopened........ 01/22/24 89 FR 3896
NPRM Comment Period Reopened End.... 02/05/24
Final Action........................ 11/00/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Bryan Kirk, Deputy Director, Division of
Independent Dispute Resolution, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, Center for Consumer
Information and Insurance Oversight, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 301 492-4122
Email: <a href="/cdn-cgi/l/email-protection#1371616a727d3d787a617853707e603d7b7b603d747c65">[email&#160;protected]</a>
RIN: 0938-AV15

20. HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS FOR ACUTE CARE
HOSPITALS; THE LONG-TERM CARE HOSPITAL PROSPECTIVE PAYMENT SYSTEM; AND
FY 2026 RATES (CMS-1833) (SECTION 610 REVIEW) [0938-AV45]

Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This annual final rule revises the Medicare hospital
inpatient and long-term care hospital prospective payment systems for
operating and capital-related costs. This rule implements changes
arising from our continuing experience with these systems. In addition,
the rule establishes new requirements or revises existing requirements
for quality reporting by specific Medicare providers.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/30/25 90 FR 18002
NPRM Comment Period End............. 06/10/25
Final Action........................ 10/00/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Donald Thompson, Director, Division of Acute Care,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-6504
Email: <a href="/cdn-cgi/l/email-protection#8aeee5e4ebe6eea4fee2e5e7faf9e5e4cae9e7f9a4e2e2f9a4ede5fc">[email&#160;protected]</a>
RIN: 0938-AV45

21. FY 2026 HOSPICE WAGE INDEX, PAYMENT RATE UPDATE, AND QUALITY
REPORTING REQUIREMENTS (CMS-1835) (SECTION 610 REVIEW) [0938-AV49]

Legal Authority: 42 U.S.C. 1302
Abstract: This annual final rule updates the hospice payment rates,
the wage index, and the hospice aggrgate cap for fiscal year 2026. The
rule also finalizes changes to the Hospice Quality Reporting program.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/30/25 90 FR 18568
NPRM Comment Period End............. 06/10/25
Final Action........................ 10/00/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Kelly Vontran, Deputy Director, Division of Home
Health and Hospice, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Center for Medicare, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-0332
Email: <a href="/cdn-cgi/l/email-protection#e388868f8f9acd958c8d9791828da3808e90cd8b8b90cd848c95">[email&#160;protected]</a>
RIN: 0938-AV49

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Completed Actions
Centers for Medicare & Medicaid Services
(CMS)
............................
------------------------------------------------------------------------

22. ENHANCING COVERAGE OF PREVENTIVE SERVICES UNDER THE AFFORDABLE CARE
ACT (CMS-9887) [0938-AV57]

Legal Authority: Public Health Service Act, Sec. 2713
Abstract: The proposed rule was formally withdrawn on January 15,
2025. This rule would amend the regulations implementing the Affordable
Care Act's requirement that non-grandfathered group health plans and
health insurance issuers offering non-grandfathered group or individual
health insurance coverage cover recommended preventive services without
cost sharing. Among other actions, the rule would take steps to expand
access to certain recommended preventive items and services that are
available over-the-counter; require coverage of certain preventive
drugs and drug-led devices in a manner that minimizes barriers to
accessing the drug or drug-led device of one's choice; reduce the
likelihood that individuals face unexpected out-of-pocket costs when
they receive preventive services; and ensure medical management
techniques are reasonable and do not unduly prevent individuals from
accessing certain preventive services. Together, these actions would
make it easier for covered individuals to access certain preventive
services and improve health outcomes.
Completed:

------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/28/24 89 FR 85750
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Lindsey Murtagh
Phone: 301 492-4106
Email: <a href="/cdn-cgi/l/email-protection#dfb3b6b1bbacbaa6f1b2aaadabbeb8b79fbcb2acf1b7b7acf1b8b0a9">[email&#160;protected]</a>
RIN: 0938-AV57

23. <bullet> PATIENT PROTECTION AND AFFORDABLE CARE ACT; MARKETPLACE
INTEGRITY AND AFFORDABILITY (CMS-9884) [0938-AV61]

Legal Authority: Pub. L. 111-148, Title I
Abstract: This final rule revises certain standards relevant to
American Health Benefits Exchanges, including standards relating to
past-due premium payments for qualified health plans; the

[[Page 45517]]

impact of an Exchange enrollee's failure to file and reconcile advance
premium tax credits received during a tax year; income eligibility
verifications for premium tax credits and cost-sharing reductions;
annual eligibility redeterminations; the automatic reenrollment
hierarchy; the annual open enrollment period; verifications of
eligibility for special enrollment periods; and, the premium adjustment
percentage methodology.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/19/25 90 FR 12942
NPRM Comment Period End............. 04/11/25
Final Action........................ 06/25/25 90 FR 27074
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes
Agency Contact: Rogelyn McLean, Senior Policy Advisor, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Consumer Information and Insurance Oversight, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-1524
Email: <a href="/cdn-cgi/l/email-protection#582a373f3d34213676353b343d3936183b352b7630302b763f372e">[email&#160;protected]</a>
RIN: 0938-AV61

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Proposed Rule Stage
Administration for Children and Families
(ACF)
............................
------------------------------------------------------------------------

24. NATIVE AMERICAN PROGRAMS FINANCIAL AND ADMINISTRATIVE REQUIREMENTS
(SECTION 610 REVIEW) [0970-AD05]

Legal Authority: 42 U.S.C. 2991b (b)
Abstract: This rule would remove the 20 percent non-federal
contribution requirement for all grant awards under the Native American
Programs Act (NAPA). The proposed rule is informed by extensive tribal
consultation in which applicants shared experiences that the 20 percent
cost share waiver process is extensive and discouragingly burdensome;
particularly for tribes that have limited capacity and are otherwise
resource constrained. The NPRM will seek to additionally eliminate 20
percent non-federal match which should have a positive impact on tribal
communities by increasing access to critical federal programs intended
to improve overall health and well-being through the promotion of
physical, social, and economic self-sufficiency. This change is also in
fulfillment of the Administration's commitment to uphold the federal
government's trust and treaty obligations to American Indian and Alaska
Native tribes and responsive to Executive Order 14192 Unleashing
Prosperity Through Deregulation.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/26
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: No
Agency Contact: Michelle Sauve, Director Policy, Department of
Health and Human Services, Administration for Children and Families,
Administration for Native Americans, 330 C Street SW, Mail Stop 4126,
Washington, DC 20201
Phone: 202 260-6974
Email: <a href="/cdn-cgi/l/email-protection#b8d5d1dbd0ddd4d4dd96cbd9cdceddf8d9dbde96d0d0cb96dfd7ce">[email&#160;protected]</a>
RIN: 0970-AD05

25. TEMPORARY ASSISTANCE FOR NEEDY FAMILIES WORK PARTICIPATION RATE
CALCULATION CHANGES (SECTION 610 REVIEW) [0970-AD07]

Legal Authority: secs. 301 and 303 of the Fiscal Responsibility Act
of 2023 (FRA, Public Law 118-5)
Abstract: This NPRM will propose changes to how the Temporary
Assistance for Needy Families (TANF) regulations describe the Federal
work participation rate (WPR) calculation, consistent with requirements
in the Fiscal Responsibility Act of 2023 (FRA). Section 301 of the FRA
recalibrates the base year for the caseload reduction credit component
of the WPR calculation, changing it from 2005 to 2015. Section 303 of
the FRA requires that ACF only include in a state's work participation
rate calculation a case with a work-eligible individual if the
assistance level for that case is at least $35 a month. The FRA
requires states to make these changes starting October 1, 2025.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: No
Agency Contact: Deborah List, Associate Deputy Director, Department
of Health and Human Services, Administration for Children and Families,
Office of Family Assistance, 330 C Street SW, Washington, DC 20201
Phone: 202 401-5488
Email: <a href="/cdn-cgi/l/email-protection#adc9c8cfc2dfccc583c1c4ded9edcccecb83c5c5de83cac2db">[email&#160;protected]</a>
RIN: 0970-AD07

26. UNACCOMPANIED CHILDREN PROGRAM PREVENTION OF SEXUAL ABUSE NPRM
(SECTION 610 REVIEW) [0970-AD08]

Legal Authority: sec. 1101(c) of the Violence Against Women
Reauthorization Act of 2013, Pub. L. 113-4 (VAWA 2013); Amendment to
the Prison Rape Elimination Act (PREA) Pub. L. 108-79
Abstract: This Notice of Proposed Rulemaking would update the
Standards To Prevent, Detect, and Respond to Sexual Abuse and Sexual
Harassment Involving Unaccompanied Children Interim Final Rule
published on December 24, 2014, to incorporate more up to date public
feedback and ensure that the practices established in the IFR are
effectively tailored to the operational realities of the Office of
Refugee Resettlement's (ORR) Unaccompanied Alien Children (UAC)
Program. The Violence Against Women Reauthorization Act of 2013 (VAWA
2013), Public Law 1134, contained a provision applying PREA to
custodial facilities operated by HHS. VAWA 2013 requires HHS to publish
a final rule adopting national standards to prevent, detect, and
respond to rape and sexual assault. These national standards are to
apply to all care provider facilities that maintain custody of UCs as
defined in the Homeland Security Act of 2002 (6 U.S.C. 279(g)) and give
due consideration to the recommended national standards provided by the
NPREC report. Additionally, HHS is required to regularly assess
compliance with the standards adopted and include the results of the
assessments in performance evaluations of care provider facilities. As
a result, HHS published the IFR to establish standards for the
prevention, detection, and response to sexual abuse and sexual
harassment of unaccompanied children in all ORR care provider
facilities, except secure care providers and traditional foster care
homes as described in the rule.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/26
------------------------------------------------------------------------

[[Page 45518]]

Email: <a href="/cdn-cgi/l/email-protection#fc899f8c9390959f85d18e999b89909d88938e859d9a9a9d958e8fbc9d9f9ad294948fd29b938a">[email&#160;protected]</a>
RIN: 0970-AD08

------------------------------------------------------------------------
Department of Health and Human Services
(HHS)
------------------------------------------- Final Rule Stage
Administration for Children and Families
(ACF)
............................
------------------------------------------------------------------------

27. OFFICE OF REFUGEE RESETTLEMENT CHILD ABUSE AND NEGLECT
INVESTIGATIONS RULE (SECTION 610 REVIEW) [0970-AD10]

Legal Authority: 6 U.S.C. 279; 8 U.S.C. 1232(b)-(c)
Abstract: This Final Rule converts the previously issued
Investigations of Child Abuse and Neglect IFR, that was published on
November 27, 2024, with an effective date of December 27, 2024, and
public comment concluding on January 27, 2025. The purpose of the
Investigations rule is to outline ACF's procedures, in certain
applicable states, to investigate and substantiate child abuse and
neglect (CA/N) allegations involving staff employed by the
Unaccompanied Alien Children Bureau affiliated grantees and
contractors, and implement actions responsive to such investigations
(e.g., related to staff employment). The Final Rule would apply only to
situations in states that do not conduct CA/N investigations of
individuals who may be working in such facilities.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule With Comment 11/27/24 89 FR 93498
Period.
Interim Final Rule; Correction...... 12/27/24 89 FR 104890
Interim Final Rule Effective; 12/27/24
Correction.
Interim Final Rule With Comment 12/27/24
Period Effective.
Interim Final Rule Comment Period 01/27/25
End.
Final Action........................ 09/00/25
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: No
Agency Contact: Toby Robert McFarren Biswas, Director of Policy,
Department of Health and Human Services, Administration for Children
and Families, Office of Refugee Resettlement, Unaccompanied Children
Bureau, 330 C Street SW, Washington, DC 20201
Phone: 202 555-4440
Email: <a href="/cdn-cgi/l/email-protection#106573607f7c7973693d627577657c71647f626971767671796263507173763e7878633e777f66">[email&#160;protected]</a>
RIN: 0970-AD10
[FR Doc. Filed 08-18-25; 0:00 a.m.]

BILLING CODE 4150-03-P

[FR Doc. 2025-18328 Filed 9-19-25; 8:45 am]
BILLING CODE 4150-03-P

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