[Federal Register Volume 89, Number 159 (Friday, August 16, 2024)]
[Unknown Section]
[Pages 66806-66819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16451]
[[Page 66805]]
Vol. 89
Friday,
No. 159
August 16, 2024
Part VII
Department of Health and Human Services
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Semiannual Regulatory Agenda
Federal Register / Vol. 89 , No. 159 / Friday, August 16, 2024 / UA:
Reg Flex Agenda
[[Page 66806]]
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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.
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SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order
(E.O.) 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: Elizabeth J. Gramling, 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
Xavier Becerra and the Biden-Harris Administration. Accordingly, this
Agenda contains rulemakings aimed at ensuring that the nation is well-
prepared to manage the long-term effects of COVID-19 going forward,
building and expanding access to affordable, quality health care,
addressing health disparities and promoting equity, lowering
prescription drug costs, and boosting the mental health and wellbeing
of 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 http://www.RegInfo.gov.
Elizabeth J. Gramling,
HHS Executive Secretary.
Office for Civil Rights--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
69........................ Rulemaking on 0945-AA15
Discrimination on the
Basis of Disability in
Health and Human Services
Programs or Activities.
------------------------------------------------------------------------
Substance Abuse and Mental Health Services Administration--Completed
Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
70........................ Medications for the 0930-AA39
Treatment of Opioid Use
Disorder.
------------------------------------------------------------------------
Centers for Disease Control and Prevention--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
71........................ Control of Communicable 0920-AA75
Diseases; Foreign
Quarantine.
------------------------------------------------------------------------
Centers for Disease Control and Prevention--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
72........................ Control of Communicable 0920-AA82
Diseases; Foreign
Quarantine Importation of
Dogs and Cats.
------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
73........................ Administrative Detention 0910-AI05
of Tobacco Products.
74........................ Conduct of Analytical and 0910-AI57
Clinical Pharmacology,
Bioavailability, and
Bioequivalence Studies.
75........................ Amendments to the Final 0910-AI70
Rule Regarding the List
of Bulk Substances That
Can Be Used to Compound
Drug Products in
Accordance With Section
503A of the Federal Food,
Drug, and Cosmetic Act
(Section 610 Review).
76........................ Distribution of Compounded 0910-AI71
Drug Products Under
Section 503A of the
Federal Food, Drug, and
Cosmetic Act (Section 610
Review).
77........................ Front-of-Package Nutrition 0910-AI80
Labeling.
[[Page 66807]]
78........................ Registration of Commercial 0910-AI87
Importers of Drugs; Good
Importing Practice.
79........................ Amendments to the Current 0910-AI88
Good Manufacturing
Practice Regulations for
Drug Products.
80........................ 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.
------------------------------------------------------------------------
81........................ Sunlamp Products; 0910-AG30
Amendment to the
Performance Standard.
82........................ General and Plastic 0910-AH14
Surgery Devices:
Restricted Sale,
Distribution, and Use of
Sunlamp Products.
83........................ Amendments to the List of 0910-AH81
Bulk Drug Substances That
Can Be Used To Compound
Drug Products in
Accordance With Section
503A of the Federal Food,
Drug, and Cosmetic Act.
84........................ Requirements for Tobacco 0910-AH91
Product Manufacturing
Practice.
85........................ Nutrient Content Claims, 0910-AI13
Definition of Term:
Healthy.
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Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
86........................ National Standards for the 0910-AH11
Licensure of Wholesale
Drug Distributors and
Third-Party Logistics
Providers.
87........................ Nicotine Toxicity Warnings 0910-AH24
88........................ Certain Requirements 0910-AH56
Regarding Prescription
Drug Marketing (203
Amendment).
89........................ Medication Guide; Patient 0910-AH68
Medication Information.
90........................ Tobacco Product Standard 0910-AI28
for Characterizing
Flavors in Cigars.
91........................ Tobacco Product Standard 0910-AI60
for Menthol in Cigarettes.
92........................ Postmarketing Safety 0910-AI61
Reporting Requirements,
Pharmacovigilance Plans,
and Pharmacovigilance
Quality Systems for Human
Drug and Biological
Products.
93........................ Tobacco Product Standard 0910-AI76
for Nicotine Level of
Certain Tobacco Products.
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Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
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94........................ Direct-to-Consumer 0910-AG27
Prescription Drug
Advertisements:
Presentation of the Major
Statement in a Clear,
Conspicuous, Neutral
Manner in Advertisements
in Television and Radio
Format.
95........................ Standards for the Growing, 0910-AI49
Harvesting, Packing, and
Holding of Produce for
Human Consumption
Relating to Agricultural
Water.
96........................ Medical Devices; 0910-AI85
Laboratory Developed
Tests.
------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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97........................ CY 2025 Revisions to 0938-AV33
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1807)
(Section 610 Review).
98........................ CY 2025 Hospital 0938-AV35
Outpatient PPS Policy
Changes and Payment Rates
and Ambulatory Surgical
Center Payment System
Policy Changes and
Payment Rates (CMS-1809)
(Section 610 Review).
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Centers for Medicare & Medicaid Services--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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99........................ Mental Health Parity and 0938-AU93
Addiction Equity Act and
the Consolidated
Appropriations Act, 2021
(CMS-9902).
100....................... Independent Dispute 0938-AV15
Resolution Operations
(CMS-9897).
101....................... FY 2025 Hospice Wage 0938-AV29
Index, Payment Rate
Update, and Quality
Reporting Requirements
(CMS-1810) (Section 610
Review).
102....................... FY 2025 Skilled Nursing 0938-AV30
Facility (SNFs)
Prospective Payment
System and Consolidated
Billing and Updates to
the Value-Based
Purchasing and Quality
Reporting Programs (CMS-
1802) (Section 610
Review).
103....................... FY 2025 Inpatient 0938-AV32
Psychiatric Facilities
Prospective Payment
System Rate and Quality
Reporting Updates (CMS-
1806) (Section 610
Review).
[[Page 66808]]
104....................... Hospital Inpatient 0938-AV34
Prospective Payment
Systems for Acute Care
Hospitals; the Long-Term
Care Hospital Prospective
Payment System; and FY
2025 Rates (CMS-1808)
(Section 610 Review).
------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
105....................... CY 2024 Revisions to 0938-AV07
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1784)
(Completion of a Section
610 Review).
106....................... CY 2024 Hospital 0938-AV09
Outpatient PPS Policy
Changes and Payment Rates
and Ambulatory Surgical
Center Payment System
Policy Changes and
Payment Rates (CMS-1786)
(Completion of a Section
610 Review).
------------------------------------------------------------------------
Administration for Children and Families--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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107....................... Native American Programs 0970-AD05
Financial and
Administrative
Requirements (Section 610
Review).
108....................... Name Change From Office of 0970-AD06
Child Support Enforcement
to Office of Child
Support Services (Section
610 Review).
109....................... Temporary Assistance for 0970-AD07
Needy Families Work
Participation Rate
Calculation Changes
(Section 610 Review).
110....................... Unaccompanied Children 0970-AD08
Program Prevention of
Sexual Abuse NPRM
(Section 610 Review).
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Administration for Children and Families--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
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111....................... Supporting the Head Start 0970-AD01
Workforce and Other
Quality Improvements.
112....................... Temporary Assistance for 0970-AD04
Needy Families Work
Outcomes Measures
(Section 610 Review).
113....................... Head Start Program CLASS 0970-AD09
Effective Date Delay
Direct Final Rule
(Section 610 Review).
114....................... ORR UC Program Child Abuse 0970-AD10
and Neglect (Section 610
Review).
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Administration for Children and Families--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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115....................... Safe and Appropriate, 0970-AD03
Affirming Foster Care
Placement Requirements
for Titles IV-E and IV-B
(Completion of a Section
610 Review).
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office for Civil Rights (OCR)
Completed Actions
69. Rulemaking on Discrimination on the Basis of Disability in Health
and Human Services Programs or Activities [0945-AA15]
Legal Authority: sec. 504 of the Rehabilitation Act of 1973; 29
U.S.C. 794
Abstract: This proposed rule would revise regulations under section
504 of the Rehabilitation Act of 1973 to address discrimination on the
basis of disability in HHS-funded programs and activities. Covered
topics include nondiscrimination in medical treatment; child welfare
programs and activities; value assessment methods; accessible medical
equipment; accessible web content, mobile apps, and kiosks; and other
relevant health and human services activities.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
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Final Action........................ 05/09/24 89 FR 40066
Final Action Effective.............. 07/08/24
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Molly Burgdorf, Phone: 800 368-1019, TDD Phone: 800
537-7697, Email: [email protected].
RIN: 0945-AA15
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Completed Actions
70. Medications for the Treatment of Opioid Use Disorder [0930-AA39]
Legal Authority: 21 U.S.C. 823(g)(1)
Abstract: The Substance Abuse and Mental Health Services
Administration (SAMHSA) will revise 42 CFR part 8 to make permanent
some regulatory flexibilities for Opioid Treatment Programs (OTPs)
granted under the COVID-19 Public Health Emergency (PHE), and to expand
access to care for people with Opioid Use Disorder (OUD). Specifically,
SAMHSA will
[[Page 66809]]
update criteria pertaining to unsupervised doses of methadone and also
initiation of buprenorphine via telemedicine. To expand access to care,
SAMHSA will also update admission criteria, particularly those rules
that may limit timely access to treatment in an OTP. To achieve this,
sections of 42 CFR part 8 will require updating. SAMHSA's changes will
impact roughly 1900 opioid treatment programs and state opioid
treatment authorities.
In response to the Consolidated Appropriations Act of 2023, which
removed the requirement to obtain a waiver in order to prescribe
certain schedule III-V medications for the treatment of OUD, SAMHSA
issued a supplemental notice of proposed rulemaking on Feb. 13, 2023,
(88 FR 9221) calling for additional public comment on SAMHSA's plans to
remove reference to the Drug Addiction Treatment Act of 2000 (DATA
2000-Waiver) from 42 CFR part 8.
Completed:
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Reason Date FR Cite
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Final Action........................ 02/02/24 89 FR 7528
Final Action Effective.............. 04/02/24
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Neeraj Gandotra, Phone: 202 823-1816, Email:
[email protected].
RIN: 0930-AA39
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Disease Control and Prevention (CDC)
Final Rule Stage
71. 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:
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Action Date FR Cite
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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........................ 10/00/24
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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: H 16-4, Atlanta, GA 30307,
Phone: 800 232-4636, Email: [email protected].
RIN: 0920-AA75
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Disease Control and Prevention (CDC)
Completed Actions
72. Control of Communicable Diseases; Foreign Quarantine Importation of
Dogs and Cats [0920-AA82]
Legal Authority: 42 U.S.C. 264
Abstract: HHS is amending its regulations concerning the
importation of dogs from high-risk rabies countries into the United
States (U.S.). The final rule will establish requirements regarding an
importation system that will reduce fraud and improve the U.S.
government's ability to verify U.S. entry requirements and mitigate the
introduction of dogs infected with rabies and other communicable
diseases of public health concern. Importation requirements for cats
will not change.
Completed:
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Reason Date FR Cite
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Final Rule.......................... 05/13/24 89 FR 41726
Final Rule Effective................ 08/01/24
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ashley C. Altenburger, Phone: 800 232-4636, Email:
[email protected].
RIN: 0920-AA82
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
73. 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
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NPRM................................ 12/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Quynh Nguyen, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
Laura Chilaka, Regulatory Counsel, Department of Health and Human
Services, Food and Drug Administration, Center for Tobacco Products,
10903 New Hampshire Avenue, Document Control Center, Building 71, Room
G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email:
[email protected].
RIN: 0910-AI05
74. 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
[[Page 66810]]
would harmonize the regulations more closely with related international
regulatory expectations.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/24
------------------------------------------------------------------------
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: [email protected].
RIN: 0910-AI57
75. Amendments to the Final Rule Regarding the List of Bulk Substances
That Can be Used To Compound Drug Products in Accordance With Section
503A of the Federal Food, Drug, and Cosmetic Act (Section 610 Review)
[0910-AI70]
Legal Authority: 21 U.S.C. 353a; 21 U.S.C. 351; 21 U.S.C. 371(a);
21 U.S.C. 352; 21 U.S.C. 355
Abstract: FDA has issued a regulation creating a list of bulk drug
substances (active pharmaceutical ingredients) that can be used to
compound drug products in accordance with section 503A of the Federal
Food, Drug, and Cosmetic Act, although they are neither the subject of
an applicable United States Pharmacopeia (USP) or National Formulary
(NF) monograph nor components of FDA-approved drug products (the 503A
Bulks List). The proposed rule will identify certain bulk drug
substances that FDA has considered and is proposing to place on the
503A Bulks List and certain bulk drug substances that FDA has
considered and is proposing not to include on the 503A Bulks List.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Rosilend Lawson, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993,
Phone: 240 402-6223, Email: [email protected].
RIN: 0910-AI70
76. Distribution of Compounded Drug Products Under Section 503A of the
Federal Food, Drug, and Cosmetic Act (Section 610 Review) [0910-AI71]
Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21
U.S.C. 353a-1; 21 U.S.C. 355; 21 U.S.C. 371
Abstract: The Food and Drug Administration is proposing rulemaking
regarding statutory requirements under section 503A of the Federal
Food, Drug, and Cosmetic Act for certain distributions of compounded
human drug products. The proposed rule, if finalized, will include
provisions regarding a standard memorandum of understanding (MOU) that
describes the responsibilities of a State Board of Pharmacy or other
appropriate State agency that chooses to sign the standard MOU in
investigating complaints related to drug products compounded in such
State and distributed outside such State and in addressing the
interstate distribution of inordinate amounts of compounded human drug
products. It will also, if finalized, include provisions regarding the
statutory 5 percent limit on distribution of compounded human drug
products out of the State in which they are compounded in States that
do not sign the standard MOU. The rule, will also, if finalized,
address communication with State boards of pharmacy.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Dominic Markwordt, 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 5104, Silver Spring, MD 20993, Phone: 301 796-9349, Email:
[email protected].
RIN: 0910-AI71
77. 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 proposed 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 proposed rule is being developed as part of a
broader, whole-of-government approach to help reduce the burden of
chronic disease and advance health equity by helping to improve dietary
patterns in the United States. Development of the proposed rule has
been informed by, among other things, research findings and extensive
public outreach and engagement, including a public meeting conducted by
the Reagan-Udall Foundation for the FDA and listening sessions with a
range of interested parties.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Mark Kantor, Nutritionist, Department of Health and
Human Services, Food and Drug Administration, CPK1 RM 3D034, HFS-830,
5001 Campus Drive, College Park, MD 20740, Phone: 240 402-2082, Email:
[email protected].
RIN: 0910-AI80
78. 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 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.
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
[[Page 66811]]
to register with FDA and for increased due diligence required by the
importer regarding the safety of the drugs. There would also be cost
savings to both FDA and industry from facilitating the review of
documentation that ensures compliance with our regulations prior to
being allowed to enter the United States. 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................................ 10/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: James Hanratty, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, WO 75, Rm.
1607A, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 240
402-4718, Email: [email protected].
RIN: 0910-AI87
79. Amendments to the Current Good Manufacturing Practice
Regulations for Drug Products [0910-AI88]
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21
U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 360bbb-7; 21
U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264
Abstract: FDA is proposing to amend the Current Good Manufacturing
Practice Regulations for Drug Products. The proposed amendment will
clarify and modernize the regulations by adding requirements for
quality management systems and controls over components and drug
product containers and closures.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/25
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ashley Boam, Health Science Administrator,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, Building 51, Room 4192, 10903
New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6341,
Email: [email protected].
RIN: 0910-AI88
80. 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................................ 10/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kristiana Brugger, Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 5252, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-3600, Email:
[email protected].
RIN: 0910-AI89
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
81. Sunlamp Products; Amendment to the Performance Standard [0910-AG30]
Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393;
21 U.S.C. 371
Abstract: FDA is updating the performance standard for sunlamp
products and ultraviolet lamps intended for use in these products to
improve safety, reflect new scientific information, and work towards
harmonization with international standards. By harmonizing with the
International Electrotechnical Commission, this rule will decrease the
regulatory burden on industry and allow the Agency to take advantage of
the expertise of the international committees, thereby also saving
resources.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/22/15 80 FR 79505
NPRM Comment Period End............. 03/21/16
Final Rule.......................... 12/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for
Devices and Radiological Health, Department of Health and Human
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO
66, Room 5454, Silver Spring, MD 20993, Phone: 301 796-5678, Email:
[email protected].
RIN: 0910-AG30
82. General and Plastic Surgery Devices: Restricted Sale, Distribution,
and Use of Sunlamp Products [0910-AH14]
Legal Authority: 21 U.S.C. 360j(e)
Abstract: This rule will apply device restrictions to sunlamp
products. Sunlamp products include ultraviolet (UV) lamps and UV
tanning beds and booths. A large number of skin cancer cases, including
cases of melanoma, are attributable to the use of sunlamp products.
Beginning use of sunlamp products at young ages, as well as frequently
using sunlamp products, both increases the risk of developing skin
cancers and other illnesses, and sustaining other injuries. Even
infrequent use, particularly at younger ages, can significantly
increase these risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/22/15 80 FR 79493
NPRM Comment Period End............. 03/21/16
Final Rule.......................... 11/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Daniel Schieffer, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66,
Silver Spring, MD 20993, Phone: 301 796-3350, Email:
[email protected].
RIN: 0910-AH14
[[Page 66812]]
83. Amendments to the List of Bulk Drug Substances That Can Be Used To
Compound Drug Products in Accordance With Section 503A of the Federal
Food, Drug, and Cosmetic Act [0910-AH81]
Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21
U.S.C. 355; 21 U.S.C. 371
Abstract: FDA has issued a regulation creating a list of bulk drug
substances (active pharmaceutical ingredients) that can be used to
compound drug products in accordance with section 503A of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the
subject of an applicable United States Pharmacopeia (USP) or National
Formulary (NF) monograph nor components of FDA-approved drugs (the 503A
Bulks List). FDA has proposed to amend the 503A Bulks List by placing
additional bulk drug substances on the list. FDA has also identified
bulk drug substances that FDA has considered and proposed not to
include on the 503A Bulks List. Additional substances nominated by the
public for inclusion on this list are currently under consideration and
will be the subject of future rulemaking.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/05/19 84 FR 46688
NPRM Comment Period End............. 12/04/19
Final Rule.......................... 10/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Oluwaseun ``Kemi'' Asante, Department of Health and
Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD
20993, Phone: 301 796-7425, Email: [email protected].
RIN: 0910-AH81
84. 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. This rule provides manufacturers with
flexibility in the manner in which they comply with the requirements
while giving FDA the ability to enforce regulatory requirements, thus
helping to assure the protection of public health. In April 2023, FDA
held an all tribes' call to provide an overview of the proposed rule,
answer questions, and receive tribal feedback. Additionally, in May
2023, FDA held an open session meeting of the Tobacco Products
Scientific Advisory Committee to enable the committee to discuss and
provide recommendations on the proposed rule. FDA made background
material available to members of the public and interested persons were
able to present data, information, and views on issues pending before
the committee.
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.......................... 04/00/25
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Matthew Brenner, Senior Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Tobacco Products, 10903 New Hampshire Avenue, Document
Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone:
877 287-1373, Email: [email protected].
RIN: 0910-AH91
85. 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.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/29/22 87 FR 59168
NPRM Comment Period End............. 12/28/22
NPRM Comment Period Extended........ 11/29/22 87 FR 73267
NPRM Comment Period Extended End.... 02/16/23
Final Rule.......................... 09/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Vincent De Jesus, Nutritionist, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint
Branch Parkway, College Park, MD 20740, Phone: 240 402-1774, Fax: 301
436-1191, Email: [email protected].
RIN: 0910-AI13
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
86. 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.......................... 05/00/26
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of
[[Page 66813]]
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:
[email protected].
RIN: 0910-AH11
87. Nicotine Toxicity Warnings [0910-AH24]
Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C.
371; 21 U.S.C. 387f; . . .
Abstract: This rule would establish acute nicotine toxicity warning
requirements for liquid nicotine and nicotine-containing e-liquid(s)
intended for human consumption, and potentially for other tobacco
products including, but not limited to, novel tobacco products such as
dissolvables, lotions, gels, and drinks. This action is intended to
increase consumer awareness and knowledge of the risks of acute
toxicity due to accidental nicotine exposure from nicotine-containing
e-liquids in tobacco products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/25
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Laura Chilaka, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center,
Building 71, Room G355, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
RIN: 0910-AH24
88. 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
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.......................... 05/00/26
------------------------------------------------------------------------
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:
[email protected].
RIN: 0910-AH56
89. 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, namely Patient Medication
Information, for submission to and review 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 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.......................... 05/00/26
------------------------------------------------------------------------
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: [email protected].
RIN: 0910-AH68
90. Tobacco Product Standard for Characterizing Flavors in Cigars
[0910-AI28]
Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 371(a); 21
U.S.C. 387b and 387c; 21 U.S.C. 387f(d) and 387g; . . .
Abstract: This rule is a tobacco product standard that would
prohibit characterizing flavors (other than tobacco) in all cigars. We
are taking this action with the intention of reducing the tobacco-
related death and disease associated with cigar use. Evidence shows
that flavored tobacco products appeal to youth and also shows that
youth may be more likely to initiate tobacco use with such products.
Characterizing flavors in cigars, such as strawberry, grape, orange,
and cocoa, enhance taste and make these products easier to use. Over a
half million youth in the United States use flavored cigars, placing
these youth at risk for cigar-related death and disease.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 03/21/18 83 FR 12294
ANPRM Comment Period End............ 07/19/18
NPRM................................ 05/04/22 87 FR 26396
NPRM Comment Period Extended........ 06/21/22 87 FR 36786
NPRM Comment Period End............. 07/05/22
NPRM Comment Period Extended End.... 08/02/22
-----------------------------------
Final Action........................ To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nathan Mease, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Center for Tobacco Products, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
RIN: 0910-AI28
91. 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.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 07/24/13 78 FR 44484
ANPRM Comment Period End............ 09/23/13
NPRM................................ 05/04/22 87 FR 26454
NPRM Comment Period Extended........ 06/21/22 87 FR 36786
NPRM Comment Period End............. 07/05/22
[[Page 66814]]
NPRM Comment Period Extended End.... 08/02/22
-----------------------------------
Final Action........................ To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Beth Buckler, Senior Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
RIN: 0910-AI60
92. 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, including blood and blood components, by capturing
important new safety-related information, improving the quality and
utility of submitted reports, and supporting enhanced alignment with
internationally harmonized reporting guidelines. Among other things,
the proposed rule would require the submission of certain nonclinical
and clinical data to FDA in a periodic safety report, rather than the
annual report. The proposed rule also would require application holders
for drug products and certain biological products to establish and
maintain a pharmacovigilance quality system that reflects the
application holder's unique needs and that may support a more
streamlined, flexible approach to satisfying certain postmarketing
safety reporting requirements.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/25
------------------------------------------------------------------------
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: [email protected].
RIN: 0910-AI61
93. Tobacco Product Standard for Nicotine Level of Certain Tobacco
Products [0910-AI76]
Legal Authority: 21 U.S.C. 387g
Abstract: The proposed rule is a tobacco product standard that
would establish a maximum nicotine level in cigarettes and certain
other finished tobacco products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nathan Mease, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Center for Tobacco Products, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
Dhanya John, Regulatory Counsel, Department of Health and Human
Services, Food and Drug Administration, Center for Tobacco Products,
Document Control Center, Building 71, Room G335, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 877 287-
1426, Email: [email protected].
RIN: 0910-AI76
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
94. Direct-to-Consumer Prescription Drug Advertisements: Presentation
of the Major Statement in a Clear, Conspicuous, Neutral Manner in
Advertisements in Television and Radio Format [0910-AG27]
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; . . .
Abstract: The Food and Drug Administration (FDA) is amending its
regulations concerning direct-to-consumer (DTC) advertisements of
prescription drugs. Prescription drug advertisements presented through
media such as TV and radio must disclose the product's major side
effects and contraindications in what is sometimes called the major
statement. The rule would revise the regulation to reflect the
statutory requirement that in DTC advertisements for human prescription
drugs presented in television or radio format and stating the name of
the drug and its conditions of use, the major statement relating to
side effects and contraindications of the advertised drug must be
presented in a clear, conspicuous, and neutral manner. This rule also
establishes standards for determining whether the major statement in
these advertisements is presented in the manner required.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Final Rule.......................... 11/21/23 88 FR 80958
Final Rule Effective................ 05/20/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Suzanna Boyle, Phone: 240 402-4723, Email:
[email protected].
RIN: 0910-AG27
95. Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption Relating to Agricultural Water [0910-
AI49]
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21
U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 243; 42 U.S.C. 264; 42 U.S.C.
271; . . .
Abstract: This rulemaking will revise certain requirements for
agricultural water for covered produce other than sprouts in the
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption (produce safety) regulation for covered produce
other than sprouts.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Final Rule.......................... 05/06/24 89 FR 37448
Final Rule Effective................ 07/05/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Samir Assar, Phone: 240 402-1636, Email:
[email protected].
RIN: 0910-AI49
96. Medical Devices; Laboratory Developed Tests [0910-AI85]
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21
U.S.C. 352; 21 U.S.C. 360c; . . .
[[Page 66815]]
Abstract: This rule would amend the Food and Drug Administration's
regulations to make explicit that laboratory developed tests (LDTs) are
devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act.)
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/03/23 88 FR 68006
Final Rule.......................... 05/06/24 89 FR 37286
Final Rule Effective................ 07/05/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Eitan Bernstein, Phone: 240 402-9812, Email:
[email protected].
RIN: 0910-AI85
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
97. CY 2025 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1807) (Section 610
Review) [0938-AV33]
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 117-169
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, 2025. Additionally, this rule
proposes updates to the Quality Payment Program. This proposed rule
would also codify the inflation rebate program for Medicare Part B and
Part D drugs established in the Inflation Reduction Act.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gift Tee, Director, Division of Physician Services,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS:
C1-09-07, Baltimore, MD 21244, Phone: 410 786-9316, Email:
[email protected].
RIN: 0938-AV33
98. CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1809) (Section 610 Review) [0938-AV35]
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
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................................ 07/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Elise Barringer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-9222, Email:
[email protected].
RIN: 0938-AV35
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Final Rule Stage
99. Mental Health Parity and Addiction Equity Act and the Consolidated
Appropriations Act, 2021 (CMS-9902) [0938-AU93]
Legal Authority: Pub. L. 116-260, Division BB, title II; Pub. L.
110-343, secs. 511 and 512
Abstract: This rule would finalize proposed amendments to the final
rules implementing the Mental Health Parity and Addiction Equity Act
(MHPAEA). The amendments clarify plans' and issuers' obligations under
the law, promote compliance with MHPAEA, and update requirements taking
into account experience with MHPAEA in the years since the rules were
finalized. The rule would also finalize new regulations implementing
amendments to MHPAEA recently enacted as part of the Consolidated
Appropriations Act, 2021 (CAA, 2021).
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/03/23 88 FR 51552
NPRM Comment Period Extended........ 09/28/23 88 FR 66728
NPRM Comment Period End............. 10/02/23
NPRM Comment Period Extended End.... 10/17/23
Final Action........................ 07/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation
Division, 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
492-4106, Email: [email protected].
RIN: 0938-AU93
100. Independent Dispute Resolution Operations (CMS-9897) [0938-AV15]
Legal Authority: Pub. L. 116-260, Division BB, title I & title II
Abstract: This final rule amends the Requirements Related to
Surprise Billing; Part I (July 2021 interim final rules), Requirements
Related to Surprise Billing Interim Final Rules; Part II (October 2021
interim final rules), and Requirements Related to Surprise Billing
Final Rules (August 2022 final rules), which set forth requirements
related to Title I (No Surprises Act (NSA)) and Title II (Transparency)
of Division BB of the Consolidated Appropriations Act, 2021.
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........................ 11/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Deborah Bryant, Senior Advisor, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center
[[Page 66816]]
for Consumer Information and Insurance Oversight, MS: W08-134, 7500
Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4293, Email:
[email protected].
RIN: 0938-AV15
101. FY 2025 Hospice Wage Index, Payment Rate Update, and Quality
Reporting Requirements (CMS-1810) (Section 610 Review) [0938-AV29]
Legal Authority: 42 U.S.C. 1302
Abstract: This annual proposed rule would update the hospice
payment rates and the wage index for fiscal year 2025. The rule also
proposes changes to the Hospice Quality Reporting program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/04/24 89 FR 23778
NPRM Comment Period End............. 05/28/24
Final Action........................ 10/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Slater, Director, Division of Home Health and
Hospice, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Center for Medicare, MS: C4-07-07, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-5229, Email:
[email protected].
RIN: 0938-AV29
102. FY 2025 Skilled Nursing Facility (SNFS) Prospective Payment System
and Consolidated Billing and Updates to the Value-Based Purchasing and
Quality Reporting Programs (CMS-1802) (Section 610 Review) [0938-AV30]
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C.
1395f(b); 42 U.S.C. 1395g; 42 U.S.C. 1395l(a); 42 U.S.C. 1395l(i); 42
U.S.C. 13951(n); 42 U.S.C. 1395m; 42 U.S.C. 1395x(v); 42 U.S.C.
1395x(kkk); 42 U.S.C. 1395hh; 42 U.S.C. 1395rr; 42 U.S.C. 1395tt; 42
U.S.C. 1395ww
Abstract: This annual rule updates the payment rates used under the
prospective payment system for SNFs for fiscal year 2025. The rule also
includes updates to the SNF Quality Reporting Program (QRP) and the
Skilled Nursing Facility Value-Based Purchasing (VBP) Program that will
affect Medicare payment to SNFs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/03/24 89 FR 23424
NPRM Comment Period End............. 05/28/24
Final Action........................ 10/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Tammy Luo, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicare, MS: C5-06-17, 7500 Security Boulevard, Baltimore,
MD 21244, Phone: 410 786-4325, Email: [email protected].
RIN: 0938-AV30
103. FY 2025 Inpatient Psychiatric Facilities Prospective Payment
System Rate and Quality Reporting Updates (CMS-1806) (Section 610
Review) [0938-AV32]
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g;
42 U.S.C. 1395hh; 42 U.S.C. 1395ww(s)
Abstract: This annual rule updates the prospective payment system
for inpatient psychiatric facilities (IPF) with discharges beginning on
October 1, 2024. The rule also includes updates to the IPF Quality
Reporting Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/03/24 89 FR 23146
NPRM Comment Period End............. 05/28/24
Final Action........................ 10/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Marissa Kellam, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C5-04-23, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-3012, Email:
[email protected].
RIN: 0938-AV32
104. Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals; the Long-Term Care Hospital Prospective Payment System; and
FY 2025 Rates (CMS-1808) (Section 610 Review) [0938-AV34]
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
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................................ 05/02/24 89 FR 35934
NPRM Comment Period End............. 06/10/24
Final Action........................ 10/00/24
------------------------------------------------------------------------
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, MS: C4-01-26, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email:
[email protected].
RIN: 0938-AV34
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
105. CY 2024 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1784) (Completion
of a Section 610 Review) [0938-AV07]
Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This annual final rule revises payment polices under the
Medicare physician fee schedule, and makes other policy changes to
payment under Medicare Part B including, but not limited to,
establishing payment policies for dental services prior to the
initiation of immunotherapy services. These changes apply to services
furnished beginning January 1, 2024. Additionally, this rule updates
the Quality Payment Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/07/23 88 FR 52262
NPRM Comment Period End............. 09/11/23
Final Action........................ 11/16/23 88 FR 78818
Final Action Effective.............. 01/01/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gift Tee, Director, Division of Physician Services,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS:
C1-09-
[[Page 66817]]
07, Baltimore, MD 21244, Phone: 410 786-9316, Email:
[email protected].
RIN: 0938-AV07
106. CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1786) (Completion of a Section 610 Review) [0938-
AV09]
Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This annual final rule revises the Medicare hospital
outpatient prospective payment system to implement statutory
requirements and changes arising from our continuing experience with
this system. The rule describes changes to the amounts and factors used
to determine payment rates for services. In addition, the rule makes
changes to the ambulatory surgical center payment system list of
services and rates. This rule also updates and refines the requirements
for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC
Quality Reporting (ASCQR) Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/31/23 88 FR 49552
NPRM Comment Period End............. 09/11/23
Final Action........................ 11/22/23 88 FR 81540
Final Action Effective.............. 01/01/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Elise Barringer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-9222, Email:
[email protected].
RIN: 0938-AV09
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Administration for Children and Families (ACF)
Proposed Rule Stage
107. 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). This is in response to Executive Order 14112
Reforming Federal Funding and Support for Tribal Nations to Better
Embrace Our Trust Responsibilities and Promote the Next Era of Tribal
Self-Determination which in part recognizes that federal programs were
administered in unduly burdensome ways that left Tribal Nations unduly
burdened and frustrated with bureaucracy. Elimination of the 20 percent
non-federal match for all ANA projects would have profound impact on
tribal communities with respect to improving equity and access to
federal programs intended for their benefit. Tribal leaders across
Indian Country have testified that nonfederal share requirement is a
significant barrier for applying and administering grant funds
especially for the smaller tribes that lack the resources to meet the
non-federal share.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: Amy Zukowski, Acting 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: 202 205-5606, Email:
[email protected].
RIN: 0970-AD05
108. Name Change From Office of Child Support Enforcement to
Office of Child Support Services (Section 610 Review) [0970-AD06]
Legal Authority: Not Yet Determined
Abstract: This Notice of Proposed Rulemaking would update 45 CFR
Chapter III to reflect that on June 5, 2023, the Office of Child
Support Enforcement became the Office of Child Support Services. This
name change reflects the program's commitment to serve the whole family
and provide services that promote family self-sufficiency so children
receive reliable support from both parents.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: Tavaughn McKenny, Program Specialist, Department of
Health and Human Services, Administration for Children and Families,
Office of Child Support Services, 330 C Street SW, Washington, DC
20201, Phone: 202 565-0129, Email: [email protected].
RIN: 0970-AD06
109. 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: To comply with requirements from the Fiscal
Responsibility Act of 2023 (FRA), this NPRM will propose changes to the
how Temporary Assistance for Needy Families (TANF) regulations describe
the federal work participation rate (WPR) calculation. As required by
Section 301 of the FRA, this NPRM will propose a recalibration of the
base year for the caseload reduction credit component of the WPR
calculation. The base year will change from 2005 to 2015. As required
by Section 303 of the FRA, this NPRM will propose that ACF only count a
case in a state's work participation rate calculation if the assistance
level for that case is at least $35 a month. Both changes will be
effective October 1, 2025.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: La Sherra Ayala, 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: 202 478-0714, Email: [email protected].
RIN: 0970-AD07
110. 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 public feedback and
ensure that the practices established in the IFR are
[[Page 66818]]
effectively tailored to the operational realities of the Office of
Refugee Resettlement's (ORR) Unaccompanied Children (UC) 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................................ 12/00/24
------------------------------------------------------------------------
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: [email protected].
RIN: 0970-AD08
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Administration for Children and Families (ACF)
Final Rule Stage
111. Supporting the Head Start Workforce and Other Quality Improvements
[0970-AD01]
Legal Authority: 42 U.S.C. 9801; 42 U.S.C. 9836a; 42 U.S.C. 9839
Abstract: This NPRM will propose changes to the Head Start Program
Performance Standards to better support the Head Start workforce and to
maintain the quality of comprehensive Head Start services. During the
public comment period, ACF engaged with the Head Start community
through listening sessions in multiple locations around the country and
virtually on the proposed rule to generate interest in submitting
public comments.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/20/23 88 FR 80818
NPRM Comment Period End............. 01/19/24
Final Action........................ 07/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jessica Bialecki, Policy and Planning Director,
Department of Health and Human Services, Administration for Children
and Families, Office of Head Start, 330 C Street SW, Washington, DC
20201, Phone: 202 283-1004, Email: [email protected].
RIN: 0970-AD01
112. Temporary Assistance for Needy Families Work Outcomes
Measures (Section 610 Review) [0970-AD04]
Legal Authority: Section 304 of the Fiscal Responsibility Act of
2023 (FRA, Pub. L. 118-5)
Abstract: This interim final rule modifies 45 CFR part 265 in order
to implement the statutory changes enacted by section 304 of the Fiscal
Responsibility Act of 2023 (FRA, Public Law 118-5) related to the
reporting of work outcomes under the Temporary Assistance for Needy
Families (TANF) program. ACF is promulgating this rule as an interim
final rule to ensure states and territories have sufficient time to
comply with data collection for fiscal year 2025.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 07/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: La Sherra Ayala, 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: 202 478-0714, Email: [email protected].
RIN: 0970-AD04
113. Head Start Program Class Effective Date Delay Direct
Final Rule (Section 610 Review) [0970-AD09]
Legal Authority: sec. 641 of the Act (42 U.S.C. 9836) as amended by
the Improving Head Start for School Readiness Act of 2007 (Pub. L. 110-
134)
Abstract: This Direct Final Rule describes how the Office of Head
Start officially delays the compliance date for programs to meet the
new competitive threshold for the Instructional Support domain of the
Classroom Assessment Scoring System (CLASS[supreg]) used to determine
whether a Head Start agency will be subject to an open competition
under the Designation Renewal System. The effective date in the Head
Start Program Performance Standards that raises the CLASS Instructional
Support competitive threshold from 2.3 to 2.5 was August 1, 2025. ACF
is pursuing this as a Direct Final Rule due to the time constraints of
when the threshold increase was scheduled to go into effect. This
Direct Final Rule officially delays this effective date to August 1,
2027.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Final Action........................ 09/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: Jessica Bialecki, Policy and Planning Director,
Department of Health and Human Services, Administration for Children
and Families, Office of Head Start, 330 C Street SW, Washington, DC
20201, Phone: 202 283-1004, Email: [email protected].
RIN: 0970-AD09
114. ORR UC Program Child Abuse and Neglect (Section 610
Review) [0970-AD10]
Legal Authority: 6 U.S.C. 279; 8 U.S.C. 1232(b)-(c)
Abstract: This Interim Final Rule on ORR child abuse and neglect
investigations describes how ORR shall investigate and substantiate
allegations of child abuse or neglect occurring in certain ORR care
facilities and maintain a registry of perpetrators relating to those
facilities where a State agency that would otherwise be responsible for
such investigations will not investigate allegations arising at
facilities housing unaccompanied children (e.g., because the State does
not license facilities on the basis that they serve unaccompanied
children). This interim final rule describes the obligations of care
provider facilities in the course of an investigation of allegations of
child abuse or neglect.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 08/00/24
------------------------------------------------------------------------
[[Page 66819]]
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: [email protected].
RIN: 0970-AD10
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Administration for Children and Families (ACF)
Completed Actions
115. Safe and Appropriate, Affirming Foster Care Placement Requirements
for Titles IV-E and IV-B (Completion of a Section 610 Review) [0970-
AD03]
Legal Authority: 42 U.S.C. 671(a)(16); 42 U.S.C. 622(b)(8)(A)(ii);
42 U.S.C. 675(1)(B); 42 U.S.C. 675(5))
Abstract: This rule clarifies that title IV-E/IV-B agencies are
required to offer safe and appropriate foster care placements,
including processes to ensure children can request such placements and
agencies must respond to concerns about those placements, for children
in foster care who identify as lesbian, gay, bisexual, transgender,
queer or questioning, intersex (LGBTQI+). The rule will not interfere
with faith-based child welfare providers that continue to partner with
title IV-E/IV-B agencies in a way that does not interfere with those
providers' sincerely held religious beliefs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/28/23 88 FR 66752
NPRM Comment Period End............. 11/27/23
Final Action........................ 04/30/24 89 FR 34818
Final Action Effective.............. 07/01/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: Kathleen McHugh, Director, Department of Health and
Human Services, Administration for Children and Families, Children's
Bureau, Division of Policy, 330 C Street SW, Washington, DC 20201,
Phone: 202 401-5789, Fax: 202 205-8221, Email: [email protected].
RIN: 0970-AD03
[FR Doc. 2024-16451 Filed 8-15-24; 8:45 am]
BILLING CODE 4150-03-P