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Proposed Rule2024-00453

Regulatory Agenda

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Published

February 9, 2024

Issuing agencies

Health and Human Services Department

Abstract

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.

Full Text

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[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Proposed Rules]
[Pages 9578-9587]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00453]

[[Page 9577]]

Vol. 89

Friday,

No. 28

February 9, 2024

Part VIII

Department of Health and Human Services

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Semiannual Regulatory Agenda

Federal Register / Vol. 89 , No. 28 / Friday, February 9, 2024 / UA:
Reg Flex Agenda

[[Page 9578]]

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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
(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 COVID-19 going forward, building and expanding
access to affordable, quality health care, addressing health
disparities and promoting equity, 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 <a href="http://www.RegInfo.gov">http://www.RegInfo.gov</a>.

Elizabeth J. Gramling,
HHS Executive Secretary.

Office for Civil Rights--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
313....................... Rulemaking on 0945-AA15
Discrimination on the
Basis of Disability in
Health and Human Services
Programs or Activities
(Reg Plan Seq No. 48).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.

Substance Abuse and Mental Health Services Administration--Final Rule
Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
314....................... 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.
------------------------------------------------------------------------
315....................... Control of Communicable 0920-AA75
Diseases; Foreign
Quarantine (Reg Plan Seq
No. 56).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.

Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
316....................... Medication Guide; Patient 0910-AH68
Medication Information.
317....................... Administrative Detention 0910-AI05
of Tobacco Products.
318....................... Conduct of Analytical and 0910-AI57
Clinical Pharmacology,
Bioavailability, and
Bioequivalence Studies.
319....................... 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).
320....................... Distribution of Compounded 0910-AI71
Drug Products Under
Section 503A of the
Federal Food, Drug, and
Cosmetic Act (Section 610
Review).
321....................... Tobacco Product Standard 0910-AI76
for Nicotine Level of
Certain Tobacco Products
(Reg Plan Seq No. 57).
322....................... Front-of-Package Nutrition 0910-AI80
Labeling (Reg Plan Seq
No. 58).
323....................... Medical Devices; 0910-AI85
Laboratory Developed
Tests (Reg Plan Seq No.
59).
324....................... Registration of Commercial 0910-AI87
Importers of Drugs; Good
Importing Practice.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.

[[Page 9579]]

Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
325....................... 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.
326....................... Sunlamp Products; 0910-AG30
Amendment to the
Performance Standard.
327....................... General and Plastic 0910-AH14
Surgery Devices:
Restricted Sale,
Distribution, and Use of
Sunlamp Products.
328....................... 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.
329....................... Requirements for Tobacco 0910-AH91
Product Manufacturing
Practice.
330....................... Nutrient Content Claims, 0910-AI13
Definition of Term:
Healthy (Reg Plan Seq No.
61).
331....................... Tobacco Product Standard 0910-AI28
for Characterizing
Flavors in Cigars (Reg
Plan Seq No. 62).
332....................... Tobacco Product Standard 0910-AI60
for Menthol in Cigarettes
(Reg Plan Seq No. 64).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.

Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
333....................... National Standards for the 0910-AH11
Licensure of Wholesale
Drug Distributors and
Third-Party Logistics
Providers.
334....................... Nicotine Toxicity Warnings 0910-AH24
335....................... Certain Requirements 0910-AH56
Regarding Prescription
Drug Marketing (203
Amendment).
336....................... Postmarketing Safety 0910-AI61
Reporting Requirements,
Pharmacovigilance Plans,
and Pharmacovigilance
Quality Systems for Human
Drug and Biological
Products.
------------------------------------------------------------------------

Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
337....................... Revocation of Uses of 0910-AI15
Partially Hydrogenated
Oils in Foods.
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
338....................... 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).
339....................... 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).
340....................... 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).
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
341....................... CY 2024 Revisions to 0938-AV07
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1784)
(Section 610 Review).
342....................... 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)
(Section 610 Review).
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
343....................... FY 2024 Skilled Nursing 0938-AV02
Facility (SNF) PPS and
Consolidated Billing and
Updates to the Value-
Based Purchasing and
Quality Reporting
Programs (CMS-1779)
(Completion of a Section
610 Review).
344....................... CY 2024 Home Health 0938-AV03
Prospective Payment
System Rate Update and
Home Infusion Therapy
Services Payment Update
(CMS-1780) (Completion of
a Section 610 Review).
345....................... FY 2024 Inpatient 0938-AV06
Psychiatric Facilities
Prospective Payment
System Rate and Quality
Reporting Updates (CMS-
1783) (Completion of a
Section 610 Review).
346....................... Hospital Inpatient 0938-AV08
Prospective Payment
Systems for Acute Care
Hospitals; the Long-Term
Care Hospital Prospective
Payment System; and FY
2024 Rates (CMS-1785)
(Completion of a Section
610 Review).

[[Page 9580]]

347....................... FY 2024 Hospice Wage 0938-AV10
Index, Payment Rate
Update, and Quality
Reporting Requirements
(CMS-1787) (Completion of
a Section 610 Review).
348....................... Hospital Outpatient 0938-AV18
Prospective Payment
System: Remedy for 340B-
Acquired Drugs Purchased
in Cost Years 2018-2022
(CMS-1793) (Section 610
Review) (Reg Plan Seq No.
77).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.

Administration for Children and Families--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
349....................... Supporting the Head Start 0970-AD01
Workforce and Other
Quality Improvements (Reg
Plan Seq No. 80).
350....................... Safe and Appropriate 0970-AD03
Foster Care Placement
Requirements for Titles
IV-E and IV-B (Section
610 Review) (Reg Plan Seq
No. 81).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
issue of the Federal Register.

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Proposed Rule Stage

313. Rulemaking on Discrimination on the Basis of Disability in Health
and Human Services Programs or Activities [0945-AA15]

Regulatory Plan: This entry is Seq. No. 48 in part II of this issue
of the Federal Register.
RIN: 0945-AA15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Final Rule Stage

314. 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 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.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/16/22 87 FR 77330
Supplemental NPRM................... 02/13/23 88 FR 9221
NPRM Comment Period End............. 02/14/23
Supplemental NPRM Comment Period End 03/14/23
Final Action........................ 01/00/24
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Dr. Neeraj Gandotra, Chief Medical Officer,
Department of Health and Human Services, Substance Abuse and Mental
Health Services Administration, 5600 Fishers Lane, 18E67, Rockville, MD
20857, Phone: 202 823-1816, Email: <a href="/cdn-cgi/l/email-protection#c3ada6a6b1a2a9eda4a2ada7acb7b1a283b0a2aeabb0a2edababb0eda4acb5">[email&#160;protected]</a>.
RIN: 0930-AA39

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Final Rule Stage

315. Control of Communicable Diseases; Foreign Quarantine [0920-AA75]

Regulatory Plan: This entry is Seq. No. 56 in part II of this issue
of the Federal Register.
RIN: 0920-AA75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

316. 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:

[[Page 9581]]

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#2043485249530e574845454c4552604644410e4848530e474f56">[email&#160;protected]</a>.
RIN: 0910-AH68

317. 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................................ 10/00/24
------------------------------------------------------------------------

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: <a href="/cdn-cgi/l/email-protection#34574044465153415855405d5b5a47745250551a5c5c471a535b42">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#5f3c2b2f2d3a382a333e2b3630312c1f393b3e7137372c71383029">[email&#160;protected]</a>.
RIN: 0910-AI05

318. 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................................ 04/00/24
------------------------------------------------------------------------

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 51, Room 5215, Silver Spring, MD
20993-0002, Phone: 240 402-4089, Email: <a href="/cdn-cgi/l/email-protection#b9dbcbd0d8d797dfd6d5d0d8d7f9dfddd897d1d1ca97ded6cf">[email&#160;protected]</a>.
RIN: 0910-AI57

319. 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: <a href="/cdn-cgi/l/email-protection#54263b273d38313a307a383523273b3a143230357a3c3c277a333b22">[email&#160;protected]</a>.
RIN: 0910-AI70

320. 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................................ 12/00/23
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.

[[Page 9582]]

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:
<a href="/cdn-cgi/l/email-protection#3a5e55575354535914575b48514d55485e4e7a5c5e5b14525249145d554c">[email&#160;protected]</a>.
RIN: 0910-AI71

321. Tobacco Product Standard for Nicotine Level of Certain Tobacco
Products [0910-AI76]

Regulatory Plan: This entry is Seq. No. 57 in part II of this issue
of the Federal Register.
RIN: 0910-AI76

322. Front-of-Package Nutrition Labeling [0910-AI80]

Regulatory Plan: This entry is Seq. No. 58 in part II of this issue
of the Federal Register.
RIN: 0910-AI80

323. Medical Devices; Laboratory Developed Tests [0910-AI85]

Regulatory Plan: This entry is Seq. No. 59 in part II of this issue
of the Federal Register.
RIN: 0910-AI85

324. 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 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................................ 01/00/24
------------------------------------------------------------------------

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: <a href="/cdn-cgi/l/email-protection#f59f94989086db9d949b879481818cb5939194db9d9d86db929a83">[email&#160;protected]</a>.
RIN: 0910-AI87

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

325. 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.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/29/10 75 FR 15376
NPRM Comment Period End............. 06/28/10
NPRM Comment Period Reopened........ 01/27/12 77 FR 4273
NPRM Comment Period End............. 02/27/12
NPRM Comment Period Reopened........ 03/29/12 77 FR 16973
NPRM Comment Period Reopened End.... 04/09/12
Final Rule.......................... 11/00/23
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Suzanna Boyle, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, WO 51, Room 3214, Silver Spring, MD 20993, Phone: 240
402-4723, Email: <a href="/cdn-cgi/l/email-protection#a6d5d3dcc7c8c8c788c4c9dfcac3e6c0c2c788ceced588c1c9d0">[email&#160;protected]</a>.
RIN: 0910-AG27

326. 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:

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

[[Page 9583]]

Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 5454,
Silver Spring, MD 20993, Phone: 301 796-5678, Email:
<a href="/cdn-cgi/l/email-protection#93faf2fdbdfce0e7f6e1fefafffff6e1d3f5f7f2bdfbfbe0bdf4fce5">[email&#160;protected]</a>.
RIN: 0910-AG30

327. 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. The incidence of skin cancer, including
melanoma, has been increasing, and a large number of skin cancer cases
are attributable to the use of sunlamp products. The devices may cause
about 400,000 cases of skin cancer per year, and 6,000 of which are
melanoma. 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:

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 75,
Room 7613, Silver Spring, MD 20993, Phone: 301 796-3350, Email:
<a href="/cdn-cgi/l/email-protection#5337323d3a363f7d20303b3a3635353621133537327d3b3b207d343c25">[email&#160;protected]</a>.
RIN: 0910-AH14

328. 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:

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: <a href="/cdn-cgi/l/email-protection#70021f03191c151e145e1c1107031f1e301614115e1818035e171f06">[email&#160;protected]</a>.
RIN: 0910-AH81

329. 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.
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 Action........................ 10/00/24
------------------------------------------------------------------------

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: <a href="/cdn-cgi/l/email-protection#fa998e8a889f9d8f969b8e93959489ba9c9e9bd4929289d49d958c">[email&#160;protected]</a>.
RIN: 0910-AH91

330. Nutrient Content Claims, Definition of Term: Healthy [0910-AI13]

Regulatory Plan: This entry is Seq. No. 61 in part II of this issue
of the Federal Register.
RIN: 0910-AI13

331. Tobacco Product Standard for Characterizing Flavors in Cigars
[0910-AI28]

Regulatory Plan: This entry is Seq. No. 62 in part II of this issue
of the Federal Register.
RIN: 0910-AI28

332. Tobacco Product Standard for Menthol in Cigarettes [0910-AI60]

Regulatory Plan: This entry is Seq. No. 64 in part II of this issue
of the Federal Register.
RIN: 0910-AI60

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

333. 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.

[[Page 9584]]

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.......................... 04/00/25
------------------------------------------------------------------------

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#3b5a5a495455154c5e5248594e58537b5d5f5a15535348155c544d">[email&#160;protected]</a>.
RIN: 0910-AH11

334. 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................................ 04/00/25
------------------------------------------------------------------------

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: <a href="/cdn-cgi/l/email-protection#c1a2b5b1b3a4a6b4ada0b5a8aeafb281a7a5a0efa9a9b2efa6aeb7">[email&#160;protected]</a>.
RIN: 0910-AH24

335. 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:

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#d4b5b5a6bbbafaa3b1bda7b6a1b7bc94b2b0b5fabcbca7fab3bba2">[email&#160;protected]</a>.
RIN: 0910-AH56

336. 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: <a href="/cdn-cgi/l/email-protection#4329222d2a20266d34262a2d2631032527226d2b2b306d242c35">[email&#160;protected]</a>.
RIN: 0910-AI61

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

337. Revocation of Uses of Partially Hydrogenated Oils in Foods [0910-
AI15]

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 341; 21 U.S.C. 342; 21
U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379e
Abstract: In the Federal Register of June 17, 2015 (80 FR 34650),
FDA published a declaratory order announcing our final determination
that there is no longer a consensus among qualified experts that
partially hydrogenated oils (PHOs) are generally recognized as safe
(GRAS) for any use in human food. In the Federal Register of May 21,
2018 (83 FR 23382), we denied a food additive petition requesting that
the food additive regulations be amended to provide for the safe use of
PHOs in certain food applications. Next, on August 9, 2023, we issued a
direct final rule and companion proposed rule that would update our
regulations to remove all mention of PHOs from FDA's GRAS regulations
and as an optional ingredient in standards of identity. This action
would also revoke all prior sanctions for uses of PHOs in food.
Completed:

------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/09/23 88 FR 53827
Direct Final Rule................... 08/09/23 88 FR 53764

[[Page 9585]]

Direct Final Rule Effective......... 12/22/23
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ellen Anderson, Phone: 240 402-1309, Email:
<a href="/cdn-cgi/l/email-protection#91f4fdfdf4ffbff0fff5f4e3e2feffd1f7f5f0bff9f9e2bff6fee7">[email&#160;protected]</a>.
RIN: 0910-AI15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

338. <bullet> 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................................ 06/00/24
------------------------------------------------------------------------

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:
<a href="/cdn-cgi/l/email-protection#9afdf3fceeb4eeffffdaf9f7e9b4f2f2e9b4fdf5ec">[email&#160;protected]</a>.
RIN: 0938-AV33

339. <bullet> 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 proposed rule would revise the Medicare
hospital inpatient and long-term care hospital prospective payment
systems for operating and capital-related costs. This proposed rule
would implement changes arising from our continuing experience with
these systems. In addition, the rule proposes to establish new
requirements or revise existing requirements for quality reporting by
specific Medicare providers.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/24
------------------------------------------------------------------------

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:
<a href="/cdn-cgi/l/email-protection#6f0b00010e030b411b0700021f1c00012f0c021c4107071c41080019">[email&#160;protected]</a>.
RIN: 0938-AV34

340. <bullet> 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................................ 06/00/24
------------------------------------------------------------------------

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:
<a href="/cdn-cgi/l/email-protection#dbbeb7b2a8bef5b9baa9a9b2b5bcbea99bb8b6a8f5b3b3a8f5bcb4ad">[email&#160;protected]</a>.
RIN: 0938-AV35

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

341. CY 2024 Revisions To Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1784) (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:

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:
<a href="/cdn-cgi/l/email-protection#05626c63712b716060456668762b6d6d762b626a73">[email&#160;protected]</a>.
RIN: 0938-AV07

342. CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1786) (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)

[[Page 9586]]

Program and the ASC Quality Reporting (ASCQR) Program.
Timetable:

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:
<a href="/cdn-cgi/l/email-protection#27424b4e544209454655554e4940425567444a54094f4f5409404851">[email&#160;protected]</a>.
RIN: 0938-AV09

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

343. FY 2024 Skilled Nursing Facility (SNF) PPS and Consolidated
Billing and Updates to the Value-Based Purchasing and Quality Reporting
Programs (CMS-1779) (Completion of a Section 610 Review) [0938-AV02]

Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This annual final rule updates the payment rates used
under the prospective payment system for SNFs for fiscal year 2024. The
rule also includes changes for the SNF Quality Reporting Program (QRP)
and for the Skilled Nursing Facility Value-Based Purchasing (VBP)
Program that will affect Medicare payment to SNFs.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/10/23 88 FR 21316
NPRM Comment Period End............. 06/05/23
Final Action........................ 08/07/23 88 FR 53200
Final Action Effective.............. 10/01/23
------------------------------------------------------------------------

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: <a href="/cdn-cgi/l/email-protection#4733262a2a3e692b322807242a34692f2f3469202831">[email&#160;protected]</a>.
RIN: 0938-AV02

344. CY 2024 Home Health Prospective Payment System Rate Update and
Home Infusion Therapy Services Payment Update (CMS-1780) (Completion of
a Section 610 Review) [0938-AV03]

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395(fff); 42 U.S.C.
1395(m)
Abstract: This annual final rule updates the national, standardized
30-day period payment rate, national per-visit rates used to calculate
low utilization payment adjustments (LUPAs) and outlier payments under
the Medicare prospective payment system for home health agencies based
on the applicable home health payment update percentage. Additionally,
this rule updates payment rates for home infusion therapy services and
makes changes to the Medicare enrollment requirements for hospices.
These changes apply to services furnished on or after January 1, 2024.
This rule also makes changes to how the separate payment for negative
pressure wound therapy using a disposable device is made as required by
section 4136 of the Consolidated Appropriations Act of 2023 (CAA,
2023), and implements the permanent home intravenous immune globulin
services (IVIG) benefit as required by section 4134 of the CAA, 2023.
This rule addresses the scope of the Medicare Part B benefit for leg,
arm, back, and neck braces under section 1861(s)(9) of the Social
Security Act, and newer technology devices, as well as the
implementation of the Medicare Part B benefit for lymphedema
compression treatment items under section 1861(s)(2) of the Social
Security Act.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/10/23 88 FR 43654
NPRM Comment Period End............. 08/29/23
Final Action........................ 11/13/23 88 FR 77676
Final Action Effective.............. 01/01/24
------------------------------------------------------------------------

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:
<a href="/cdn-cgi/l/email-protection#c9abbba0a8a7e7baa5a8bdacbb89aaa4bae7a1a1bae7aea6bf">[email&#160;protected]</a>.
RIN: 0938-AV03

345. FY 2024 Inpatient Psychiatric Facilities Prospective Payment
System Rate and Quality Reporting Updates (CMS-1783) (Completion of a
Section 610 Review) [0938-AV06]

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g;
42 U.S.C. 1395hh; . . .
Abstract: This annual final rule updates the prospective payment
system for inpatient psychiatric facilities (IPF) with discharges
beginning on October 1, 2023. The rule also includes updates to the IPF
Quality Reporting Program.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/10/23 88 FR 21238
NPRM Comment Period End............. 06/05/23
Final Action........................ 08/02/23 88 FR 51054
Final Action Effective.............. 10/01/23
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nicolas Brock, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C5-05-27, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-5148, Email:
<a href="/cdn-cgi/l/email-protection#751b1c161a1914065b17071a161e351618065b1d1d065b121a03">[email&#160;protected]</a>.
RIN: 0938-AV06

346. Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals; the Long-Term Care Hospital Prospective Payment System; and
FY 2024 Rates (CMS-1785) (Completion of a Section 610 Review) [0938-
AV08]

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................................ 05/01/23 88 FR 26658
NPRM Comment Period End............. 06/09/23
Final Action........................ 08/28/23 88 FR 58640
Final Action Effective.............. 10/01/23
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Donald Thompson, Director, Division of Acute Care,

[[Page 9587]]

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:
<a href="/cdn-cgi/l/email-protection#01656e6f606d652f75696e6c71726e6f41626c722f6969722f666e77">[email&#160;protected]</a>.
RIN: 0938-AV08

347. FY 2024 Hospice Wage Index, Payment Rate Update, and Quality
Reporting Requirements (CMS-1787) (Completion of a Section 610 Review)
[0938-AV10]

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual final rule updates the hospice payment rates
and the wage index for fiscal year 2024. The rule also finalizes
changes to the Hospice Quality Reporting program.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/04/23 88 FR 20022
NPRM Comment Period End............. 05/30/23
Final Action........................ 08/02/23 88 FR 51164
Final Action Effective.............. 10/01/23
------------------------------------------------------------------------

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:
<a href="/cdn-cgi/l/email-protection#96f4e4fff7f8b8e5faf7e2f3e4d6f5fbe5b8fefee5b8f1f9e0">[email&#160;protected]</a>.
RIN: 0938-AV10

348. Hospital Outpatient Prospective Payment System: Remedy for 340B-
Acquired Drugs Purchased in Cost Years 2018-2022 (CMS-1793) (Section
610 Review) [0938-AV18]

Regulatory Plan: This entry is Seq. No. 77 in part II of this issue
of the Federal Register.
RIN: 0938-AV18

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Administration for Children and Families (ACF)

Proposed Rule Stage

349. Supporting the Head Start Workforce and Other Quality Improvements
[0970-AD01]

Regulatory Plan: This entry is Seq. No. 80 in part II of this issue
of the Federal Register.
RIN: 0970-AD01

350. <bullet> Safe and Appropriate Foster Care Placement Requirements
for Titles IV-E and IV-B (Section 610 Review) [0970-AD03]

Regulatory Plan: This entry is Seq. No. 81 in part II of this issue
of the Federal Register.
RIN: 0970-AD03

[FR Doc. 2024-00453 Filed 2-8-24; 8:45 am]
BILLING CODE 4150-03-P

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