Regulatory Agenda, 9578-9587 [2024-00453]

Download as PDF 9578 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Elizabeth J. Gramling, Executive Secretary, Department of Health and Office of the Secretary Human Services, 200 Independence Avenue SW, Washington, DC 20201; 21 CFR Ch. I (202) 690–5627. SUPPLEMENTARY INFORMATION: The 25 CFR Ch. V Department of Health and Human Services (HHS) is the Federal 42 CFR Chs. I–V government’s lead agency for protecting the health of all Americans and 45 CFR Subtitle A; Subtitle B, Chs. II, providing essential human services. III, and XIII HHS enhances the health and wellbeing of Americans by promoting Regulatory Agenda effective health and human services and by fostering sound, sustained advances AGENCY: Office of the Secretary, HHS. ACTION: Semiannual Regulatory Agenda. in the sciences underlying medicine, public health, and social services. This Agenda presents the regulatory SUMMARY: The Regulatory Flexibility Act activities that the Department expects to of 1980 and Executive Order (E.O.) undertake in the foreseeable future to 12866 require the semiannual issuance advance this mission. The purpose of of an inventory of rulemaking actions the Agenda is to encourage more under development throughout the effective public participation in the Department, offering for public review regulatory process. The regulatory summarized information about actions forecasted in this Agenda reflect forthcoming regulatory actions. 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 https:// www.RegInfo.gov. Elizabeth J. Gramling, HHS Executive Secretary. OFFICE FOR CIVIL RIGHTS—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 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 Regulation Identifier No. Sequence No. Title 314 .................... Medications for the Treatment of Opioid Use Disorder ................................................................................... 0930–AA39 CENTERS FOR DISEASE CONTROL AND PREVENTION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 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 ddrumheller on DSK120RN23PROD with PROPOSALS8 Sequence No. 316 317 318 319 .................... .................... .................... .................... 320 .................... 321 322 323 324 .................... .................... .................... .................... Regulation Identifier No. Title Medication Guide; Patient Medication Information .......................................................................................... Administrative Detention of Tobacco Products ................................................................................................ Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies .................... 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). Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (Section 610 Review). Tobacco Product Standard for Nicotine Level of Certain Tobacco Products (Reg Plan Seq No. 57) .......... Front-of-Package Nutrition Labeling (Reg Plan Seq No. 58) ......................................................................... Medical Devices; Laboratory Developed Tests (Reg Plan Seq No. 59) ........................................................ Registration of Commercial Importers of Drugs; Good Importing Practice ..................................................... References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. VerDate Sep<11>2014 20:53 Feb 08, 2024 Jkt 262001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\09FEP8.SGM 09FEP8 0910–AH68 0910–AI05 0910–AI57 0910–AI70 0910–AI71 0910–AI76 0910–AI80 0910–AI85 0910–AI87 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 9579 FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 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. Sunlamp Products; Amendment to the Performance Standard ...................................................................... General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products ............ 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. Requirements for Tobacco Product Manufacturing Practice ........................................................................... Nutrient Content Claims, Definition of Term: Healthy (Reg Plan Seq No. 61) .............................................. Tobacco Product Standard for Characterizing Flavors in Cigars (Reg Plan Seq No. 62) ............................. Tobacco Product Standard for Menthol in Cigarettes (Reg Plan Seq No. 64) .............................................. 326 .................... 327 .................... 328 .................... 329 330 331 332 .................... .................... .................... .................... 0910–AG27 0910–AG30 0910–AH14 0910–AH81 0910–AH91 0910–AI13 0910–AI28 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. 333 334 335 336 .................... .................... .................... .................... Regulation Identifier No. Title National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers .. Nicotine Toxicity Warnings ............................................................................................................................... Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) ........................................ Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products. 0910–AH11 0910–AH24 0910–AH56 0910–AI61 FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 337 .................... Revocation of Uses of Partially Hydrogenated Oils in Foods ......................................................................... 0910–AI15 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 338 .................... CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1807) (Section 610 Review). 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). 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). 339 .................... 340 .................... 0938–AV33 0938–AV34 0938–AV35 CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 341 .................... CY 2024 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1784) (Section 610 Review). 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). 342 .................... 0938–AV07 0938–AV09 ddrumheller on DSK120RN23PROD with PROPOSALS8 CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 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). CY 2024 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS–1780) (Completion of a Section 610 Review). FY 2024 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS–1783) (Completion of a Section 610 Review). 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). 344 .................... 345 .................... 346 .................... VerDate Sep<11>2014 20:53 Feb 08, 2024 Jkt 262001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\09FEP8.SGM 09FEP8 0938–AV02 0938–AV03 0938–AV06 0938–AV08 9580 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS—Continued Regulation Identifier No. Sequence No. Title 347 .................... FY 2024 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS–1787) (Completion of a Section 610 Review). 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). 348 .................... 0938–AV10 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 Regulation Identifier No. Sequence No. Title 349 .................... 350 .................... Supporting the Head Start Workforce and Other Quality Improvements (Reg Plan Seq No. 80) ................. Safe and Appropriate Foster Care Placement Requirements for Titles IV–E and IV–B (Section 610 Review) (Reg Plan Seq No. 81). 0970–AD01 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) Action Final Rule Stage ddrumheller on DSK120RN23PROD with PROPOSALS8 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 20:53 Feb 08, 2024 Jkt 262001 Date FR Cite 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) Substance Abuse and Mental Health Services Administration (SAMHSA) VerDate Sep<11>2014 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 2000Waiver) from 42 CFR part 8. Timetable: NPRM .................. Supplemental NPRM. NPRM Comment Period End. Supplemental NPRM Comment Period End. Final Action ......... 12/16/22 02/13/23 87 FR 77330 88 FR 9221 316. Medication Guide; Patient Medication Information [0910–AH68] 02/14/23 03/14/23 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 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 Proposed Rule Stage 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: E:\FR\FM\09FEP8.SGM 09FEP8 9581 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda Action Date NPRM .................. NPRM Comment Period End. Final Action ......... FR Cite 05/31/23 11/27/23 I 03/00/26 88 FR 35694 318. Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies [0910–AI57] I 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 ddrumheller on DSK120RN23PROD with PROPOSALS8 NPRM .................. FR Cite 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, VerDate Sep<11>2014 20:53 Feb 08, 2024 MD 20993, Phone: 877 287–1373, Email: ctpregulations@fda.hhs.gov. RIN: 0910–AI05 Jkt 262001 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 NPRM .................. FR Cite 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 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 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 NPRM .................. Date FR Cite 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 NPRM .................. Date FR Cite 12/00/23 Regulatory Flexibility Analysis Required: Yes. E:\FR\FM\09FEP8.SGM 09FEP8 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 Action Date FR Cite 322. Front-of-Package Nutrition Labeling [0910–AI80] NPRM .................. Regulatory Plan: This entry is Seq. No. 58 in part II of this issue of the Federal Register. RIN: 0910–AI80 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 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] ddrumheller on DSK120RN23PROD with PROPOSALS8 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: 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 VerDate Sep<11>2014 20:53 Feb 08, 2024 Jkt 262001 01/00/24 This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required. Timetable: Action Date NPRM .................. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period Reopened End. Final Rule ............ FR Cite 03/29/10 06/28/10 75 FR 15376 01/27/12 77 FR 4273 02/27/12 03/29/12 77 FR 16973 04/09/12 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 326. Sunlamp Products; Amendment to the Performance Standard [0910–AG30] Food and Drug Administration (FDA) 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: 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. PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 Action NPRM .................. NPRM Comment Period End. Final Rule ............ Date 12/22/15 03/21/16 I FR Cite 80 FR 79505 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 E:\FR\FM\09FEP8.SGM 09FEP8 9583 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 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 NPRM .................. NPRM Comment Period End. Final Rule ............ FR Cite 12/22/15 03/21/16 I 03/00/24 80 FR 79493 I ddrumheller on DSK120RN23PROD with PROPOSALS8 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 VerDate Sep<11>2014 20:53 Feb 08, 2024 Jkt 262001 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 NPRM .................. NPRM Comment Period End. Final Rule ............ FR Cite 09/05/19 12/04/19 I 10/00/24 84 FR 46688 I 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 NPRM .................. NPRM Comment Period End. NPRM Comment Period Extension to Oct. 06, 2023. PO 00000 Frm 00007 FR Cite 03/10/23 09/06/23 88 FR 15174 08/29/23 88 FR 59481 Fmt 4701 Sfmt 4702 Action Final Action ......... Date FR Cite 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. E:\FR\FM\09FEP8.SGM 09FEP8 9584 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda Timetable: Action Date NPRM .................. NPRM Comment Period End. NPRM Comment Period Extended. NPRM Comment Period Extended End. Final Rule ............ FR Cite 02/04/22 06/06/22 87 FR 6708 05/24/22 87 FR 31439 09/06/22 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 ddrumheller on DSK120RN23PROD with PROPOSALS8 NPRM .................. FR Cite 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 VerDate Sep<11>2014 20:53 Feb 08, 2024 Jkt 262001 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 NPRM .................. NPRM Comment Period End. Final Rule ............ FR Cite 02/04/22 04/05/22 I 04/00/25 87 FR 6443 I 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 PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 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 NPRM .................. Date FR Cite 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 NPRM .................. Direct Final Rule E:\FR\FM\09FEP8.SGM 09FEP8 Date 08/09/23 08/09/23 FR Cite 88 FR 53827 88 FR 53764 9585 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda Reason Date Direct Final Rule Effective. FR Cite 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 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 NPRM .................. 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 NPRM .................. FR Cite 06/00/24 ddrumheller on DSK120RN23PROD with PROPOSALS8 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 VerDate Sep<11>2014 20:53 Feb 08, 2024 Jkt 262001 Date FR Cite 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 NPRM .................. FR Cite 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 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 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 NPRM .................. NPRM Comment Period End. Final Action ......... Date 08/07/23 09/11/23 FR Cite 88 FR 52262 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) E:\FR\FM\09FEP8.SGM 09FEP8 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 NPRM .................. NPRM Comment Period End. Final Action ......... 07/31/23 09/11/23 FR Cite 88 FR 49552 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 ddrumheller on DSK120RN23PROD with PROPOSALS8 NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. FR Cite 04/10/23 06/05/23 88 FR 21316 08/07/23 10/01/23 88 FR 53200 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 VerDate Sep<11>2014 20:53 Feb 08, 2024 Jkt 262001 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 30day 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 NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. FR Cite 07/10/23 08/29/23 88 FR 43654 11/13/23 01/01/24 88 FR 77676 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 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 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 NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. Date FR Cite 04/10/23 06/05/23 88 FR 21238 08/02/23 10/01/23 88 FR 51054 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 NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. Date FR Cite 05/01/23 06/09/23 88 FR 26658 08/28/23 10/01/23 88 FR 58640 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Donald Thompson, Director, Division of Acute Care, E:\FR\FM\09FEP8.SGM 09FEP8 Federal Register / Vol. 89, No. 28 / Friday, February 9, 2024 / UA: Reg Flex Agenda 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 ddrumheller on DSK120RN23PROD with PROPOSALS8 NPRM .................. NPRM Comment Period End. VerDate Sep<11>2014 I 04/04/23 05/30/23 20:53 Feb 08, 2024 FR Cite 88 FR 20022 I Jkt 262001 Action Date Final Action ......... Final Action Effective. FR Cite 08/02/23 10/01/23 I 88 FR 51164 I 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 PO 00000 Frm 00011 Fmt 4701 Sfmt 9990 9587 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 E:\FR\FM\09FEP8.SGM 09FEP8

Agencies

[Federal Register Volume 89, Number 28 (Friday, February 9, 2024)]
[Unknown Section]
[Pages 9578-9587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00453]



[[Page 9577]]

Vol. 89

Friday,

No. 28

February 9, 2024

Part VIII





Department of Health and Human Services





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





Semiannual Regulatory Agenda

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

[[Page 9578]]


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

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 https://www.RegInfo.gov.

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: [email protected].
    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]]



------------------------------------------------------------------------
               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: [email protected].
    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: [email protected].
    Laura Chilaka, Regulatory Counsel, Department of Health and Human 
Services, Food and Drug Administration, Center for Tobacco Products, 
10903 New Hampshire Avenue, Document Control Center, Building 71, Room 
G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email: 
[email protected].
    RIN: 0910-AI05

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: [email protected].
    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: [email protected].
    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: 
[email protected].
    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: [email protected].
    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: [email protected].
    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

[[Page 9583]]

Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 5454, 
Silver Spring, MD 20993, Phone: 301 796-5678, Email: 
[email protected].
    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: 
[email protected].
    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: [email protected].
    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: [email protected].
    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: 
[email protected].
    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: [email protected].
    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: 
[email protected].
    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: [email protected].
    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: 
[email protected].
    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: 
[email protected].
    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: 
[email protected].
    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: 
[email protected].
    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: 
[email protected].
    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:

------------------------------------------------------------------------
               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: 
[email protected].
    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: [email protected].
    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: 
[email protected].
    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: 
[email protected].
    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: 
[email protected].
    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: 
[email protected].
    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.  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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