9578 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 

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 wellbeing 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 wellprepared 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 http://

www.RegInfo.gov. 

Elizabeth J. Gramling, 

HHS Executive Secretary. 

OFFICE FOR CIVIL RIGHTS—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

313 .................... Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities (Reg Plan Seq No. 48).0945–AA15 

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

Sequence No. Title Regulation 

Identifier No. 

314 .................... Medications for the Treatment of Opioid Use Disorder ................................................................................... 0930–AA39 

CENTERS FOR DISEASE CONTROL AND PREVENTION—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

315 .................... Control of Communicable Diseases; Foreign Quarantine (Reg Plan Seq No. 56) ........................................ 0920–AA75 

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

Sequence No. Title Regulation 

Identifier No. 

316 .................... Medication Guide; Patient Medication Information .......................................................................................... 0910–AH68 

317 .................... Administrative Detention of Tobacco Products ................................................................................................ 0910–AI05 

318 .................... Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies .................... 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 

320 .................... Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic 

Act (Section 610 Review).

0910–AI71 

321 .................... Tobacco Product Standard for Nicotine Level of Certain Tobacco Products (Reg Plan Seq No. 57) .......... 0910–AI76 

322 .................... Front-of-Package Nutrition Labeling (Reg Plan Seq No. 58) ......................................................................... 0910–AI80 

323 .................... Medical Devices; Laboratory Developed Tests (Reg Plan Seq No. 59) ........................................................ 0910–AI85 

324 .................... Registration of Commercial Importers of Drugs; Good Importing Practice ..................................................... 0910–AI87 

References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. 


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Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 9579 

FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

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 

326 .................... Sunlamp Products; Amendment to the Performance Standard ...................................................................... 0910–AG30 

327 .................... General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products ............ 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 

329 .................... Requirements for Tobacco Product Manufacturing Practice ........................................................................... 0910–AH91 

330 .................... Nutrient Content Claims, Definition of Term: Healthy (Reg Plan Seq No. 61) .............................................. 0910–AI13 

331 .................... Tobacco Product Standard for Characterizing Flavors in Cigars (Reg Plan Seq No. 62) ............................. 0910–AI28 

332 .................... Tobacco Product Standard for Menthol in Cigarettes (Reg Plan Seq No. 64) .............................................. 0910–AI60 

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

Sequence No. Title Regulation 

Identifier No. 

333 .................... National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers .. 0910–AH11 

334 .................... Nicotine Toxicity Warnings ............................................................................................................................... 0910–AH24 

335 .................... Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) ........................................ 0910–AH56 

336 .................... Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality 

Systems for Human Drug and Biological Products.

0910–AI61 

FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

337 .................... Revocation of Uses of Partially Hydrogenated Oils in Foods ......................................................................... 0910–AI15 

CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

338 .................... 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 

339 .................... 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 

340 .................... 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 

CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

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 

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 

CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

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 

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 

345 .................... FY 2024 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates 

(CMS–1783) (Completion of a Section 610 Review).

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 


ddrumheller on DSK120RN23PROD with PROPOSALS8
9580 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 

CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS—Continued 

Sequence No. Title Regulation 

Identifier No. 

347 .................... FY 2024 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS–1787) 

(Completion of a Section 610 Review).

0938–AV10 

348 .................... Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost 

Years 2018–2022 (CMS–1793) (Section 610 Review) (Reg Plan Seq No. 77).

0938–AV18 

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

Sequence No. Title Regulation 

Identifier No. 

349 .................... Supporting the Head Start Workforce and Other Quality Improvements (Reg Plan Seq No. 80) ................. 0970–AD01 

350 .................... Safe and Appropriate Foster Care Placement Requirements for Titles IV–E and IV–B (Section 610 Review) (Reg Plan Seq No. 81).0970–AD03 

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: neeraj.gandotra@

samhsa.hhs.gov. 

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: 


ddrumheller on DSK120RN23PROD with PROPOSALS8
Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 9581 

Action Date FR Cite 

NPRM .................. 05/31/23 88 FR 35694 

NPRM Comment 

Period End.

11/27/23 

Final Action ......... 03/00/26 

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: chris.wheeler@fda.hhs.gov. 

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: ctpregulations@

fda.hhs.gov. 

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: 

ctpregulations@fda.hhs.gov. 

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: 

brian.folian@fda.hhs.gov. 

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: rosilend.lawson@

fda.hhs.gov. 

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. 


ddrumheller on DSK120RN23PROD with PROPOSALS8

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9582 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 

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: 

dominic.markwordt@fda.hhs.gov. 

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: james.hanratty@

fda.hhs.gov. 

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-toconsumer (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: suzanna.boyle@

fda.hhs.gov. 

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: 

Action Date FR Cite 

NPRM .................. 12/22/15 80 FR 79505 

NPRM Comment 

Period End.

03/21/16 

Final Rule ............ 03/00/24 

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 


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I 
Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 9583 

Drug Administration, 10903 New 

Hampshire Avenue, WO 66, Room 5454, 

Silver Spring, MD 20993, Phone: 301 

796–5678, Email: ian.ostermiller@

fda.hhs.gov. 

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: 

Action Date FR Cite 

NPRM .................. 12/22/15 80 FR 79493 

NPRM Comment 

Period End.

03/21/16 

Final Rule ............ 03/00/24 

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 75, Room 7613, 

Silver Spring, MD 20993, Phone: 301 

796–3350, Email: daniel.schieffer@

fda.hhs.gov. 

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: 

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: 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: rosilend.lawson@

fda.hhs.gov. 

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, preproduction 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 Oct. 06, 

2023.

08/29/23 88 FR 59481 

Action Date FR Cite 

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: ctpregulations@

fda.hhs.gov. 

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. 


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9584 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 

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: 

aaron.weisbuch@fda.hhs.gov. 

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: ctpregulations@

fda.hhs.gov. 

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: 

Action Date FR Cite 

NPRM .................. 02/04/22 87 FR 6443 

NPRM Comment 

Period End.

04/05/22 

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: 

aaron.weisbuch@fda.hhs.gov. 

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: janice.weiner@fda.hhs.gov. 

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 


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Reason Date FR Cite 

Direct Final Rule 

Effective.

12/22/23 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Ellen Anderson, 

Phone: 240 402–1309, Email: 

ellen.anderson@fda.hhs.gov. 

RIN: 0910–AI15 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

Proposed Rule Stage 

338. • 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: gift.tee@cms.hhs.gov. 

RIN: 0938–AV33 

339. • 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: 

donald.thompson@cms.hhs.gov. 

RIN: 0938–AV34 

340. • 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: 

elise.barringer@cms.hhs.gov. 

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: 

Action Date FR Cite 

NPRM .................. 08/07/23 88 FR 52262 

NPRM Comment 

Period End.

09/11/23 

Final Action ......... 01/00/24 

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: gift.tee@cms.hhs.gov. 

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) 


ddrumheller on DSK120RN23PROD with PROPOSALS8
9586 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 

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 ......... 01/00/24 

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: 

elise.barringer@cms.hhs.gov. 

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: 

tammy.luo@cms.hhs.gov. 

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 pervisit 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: 

brian.slater@cms.hhs.gov. 

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: 

nicolas.brock@cms.hhs.gov. 

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, 


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

donald.thompson@cms.hhs.gov. 

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 

Action Date FR Cite 

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: 

brian.slater@cms.hhs.gov. 

RIN: 0938–AV10 

348. Hospital Outpatient Prospective 

Payment System: Remedy for 340BAcquired 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. • 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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