Regulatory Agenda, 66806-66819 [2024-16451]

Download as PDF 66806 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 21 CFR Ch. I 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. The 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. SUPPLEMENTARY INFORMATION: 25 CFR Ch. V 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 the long-term effects of COVID–19 going forward, building and expanding access to affordable, quality health care, addressing health disparities and promoting equity, lowering prescription drug costs, and boosting the mental health and wellbeing of children and families, among other policy priorities. The rulemaking abstracts included in this paper issue of the Federal Register cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities. The Department’s complete Regulatory Agenda is accessible online at https:// www.RegInfo.gov. Elizabeth J. Gramling, HHS Executive Secretary. OFFICE FOR CIVIL RIGHTS—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 69 ...................... Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities. 0945–AA15 SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 70 ...................... 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 71 ...................... Control of Communicable Diseases; Foreign Quarantine ............................................................................... 0920–AA75 CENTERS FOR DISEASE CONTROL AND PREVENTION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 72 ...................... Control of Communicable Diseases; Foreign Quarantine Importation of Dogs and Cats .............................. 0920–AA82 lotter on DSK11XQN23PROD with PROPOSALS4 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 73 ...................... 74 ...................... 75 ...................... 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). Front-of-Package Nutrition Labeling ................................................................................................................ 76 ...................... 77 ...................... VerDate Sep<11>2014 22:05 Aug 15, 2024 Jkt 250001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP7.SGM 16AUP7 0910–AI05 0910–AI57 0910–AI70 0910–AI71 0910–AI80 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda 66807 FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE—Continued Regulation Identifier No. Sequence No. Title 78 ...................... 79 ...................... 80 ...................... Registration of Commercial Importers of Drugs; Good Importing Practice ..................................................... Amendments to the Current Good Manufacturing Practice Regulations for Drug Products .......................... Pediatric Study Plan Requirements for New Drug and Biologics License Applications ................................. 0910–AI87 0910–AI88 0910–AI89 FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 81 ...................... 82 ...................... 83 ...................... 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 ..................................................................................... 84 ...................... 85 ...................... 0910–AG30 0910–AH14 0910–AH81 0910–AH91 0910–AI13 FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS Sequence No. 86 87 88 89 90 91 92 ...................... ...................... ...................... ...................... ...................... ...................... ...................... 93 ...................... 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) ........................................ Medication Guide; Patient Medication Information .......................................................................................... Tobacco Product Standard for Characterizing Flavors in Cigars .................................................................... Tobacco Product Standard for Menthol in Cigarettes ..................................................................................... Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products. Tobacco Product Standard for Nicotine Level of Certain Tobacco Products ................................................. 0910–AH11 0910–AH24 0910–AH56 0910–AH68 0910–AI28 0910–AI60 0910–AI61 0910–AI76 FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 94 ...................... Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water. Medical Devices; Laboratory Developed Tests ............................................................................................... 95 ...................... 96 ...................... 0910–AG27 0910–AI49 0910–AI85 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 97 ...................... CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1807) (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). 98 ...................... 0938–AV33 0938–AV35 lotter on DSK11XQN23PROD with PROPOSALS4 CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 99 ...................... Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021 (CMS– 9902). Independent Dispute Resolution Operations (CMS–9897) ............................................................................. FY 2025 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS–1810) (Section 610 Review). FY 2025 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS–1802) (Section 610 Review). FY 2025 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS–1806) (Section 610 Review). 100 .................... 101 .................... 102 .................... 103 .................... VerDate Sep<11>2014 22:05 Aug 15, 2024 Jkt 250001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\16AUP7.SGM 16AUP7 0938–AU93 0938–AV15 0938–AV29 0938–AV30 0938–AV32 66808 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE—Continued Regulation Identifier No. Sequence No. Title 104 .................... Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS–1808) (Section 610 Review). 0938–AV34 CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 105 .................... CY 2024 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1784) (Completion of a Section 610 Review). CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1786) (Completion of a Section 610 Review). 106 .................... 0938–AV07 0938–AV09 ADMINISTRATION FOR CHILDREN AND FAMILIES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 107 .................... 108 .................... Native American Programs Financial and Administrative Requirements (Section 610 Review) .................. Name Change From Office of Child Support Enforcement to Office of Child Support Services (Section 610 Review). Temporary Assistance for Needy Families Work Participation Rate Calculation Changes (Section 610 Review). Unaccompanied Children Program Prevention of Sexual Abuse NPRM (Section 610 Review) .................. 109 .................... 110 .................... 0970–AD05 0970–AD06 0970–AD07 0970–AD08 ADMINISTRATION FOR CHILDREN AND FAMILIES—FINAL RULE STAGE Sequence No. 111 112 113 114 .................... .................... .................... .................... Regulation Identifier No. Title Supporting the Head Start Workforce and Other Quality Improvements ........................................................ Temporary Assistance for Needy Families Work Outcomes Measures (Section 610 Review) .................... Head Start Program CLASS Effective Date Delay Direct Final Rule (Section 610 Review) ........................ ORR UC Program Child Abuse and Neglect (Section 610 Review) ............................................................. 0970–AD01 0970–AD04 0970–AD09 0970–AD10 ADMINISTRATION FOR CHILDREN AND FAMILIES—COMPLETED ACTIONS Title 115 .................... Safe and Appropriate, Affirming Foster Care Placement Requirements for Titles IV–E and IV–B (Completion of a Section 610 Review). DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office for Civil Rights (OCR) Completed Actions lotter on DSK11XQN23PROD with PROPOSALS4 Regulation Identifier No. Sequence No. 69. Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities [0945–AA15] Legal Authority: sec. 504 of the Rehabilitation Act of 1973; 29 U.S.C. 794 Abstract: This proposed rule would revise regulations under section 504 of the Rehabilitation Act of 1973 to address discrimination on the basis of disability in HHS-funded programs and activities. Covered topics include nondiscrimination in medical treatment; VerDate Sep<11>2014 22:05 Aug 15, 2024 Jkt 250001 child welfare programs and activities; value assessment methods; accessible medical equipment; accessible web content, mobile apps, and kiosks; and other relevant health and human services activities. Completed: Reason Date Final Action ......... Final Action Effective. 05/09/24 07/08/24 FR Cite 89 FR 40066 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Molly Burgdorf, Phone: 800 368–1019, TDD Phone: 800 537–7697, Email: 504@hhs.gov. RIN: 0945–AA15 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 0970–AD03 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Completed Actions 70. Medications for the Treatment of Opioid Use Disorder [0930–AA39] Legal Authority: 21 U.S.C. 823(g)(1) Abstract: The Substance Abuse and Mental Health Services Administration (SAMHSA) will revise 42 CFR part 8 to make permanent some regulatory flexibilities for Opioid Treatment Programs (OTPs) granted under the COVID–19 Public Health Emergency (PHE), and to expand access to care for people with Opioid Use Disorder (OUD). Specifically, SAMHSA will E:\FR\FM\16AUP7.SGM 16AUP7 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda 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 2000Waiver) from 42 CFR part 8. Completed: Reason Date Final Action ......... Final Action Effective. 02/02/24 04/02/24 FR Cite 89 FR 7528 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Neeraj Gandotra, Phone: 202 823–1816, Email: neeraj.gandotra@samhsa.hhs.gov. RIN: 0930–AA39 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ashley C. Altenburger JD, Regulatory Analyst, Department of Health and Human Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS: H 16–4, Atlanta, GA 30307, Phone: 800 232–4636, Email: dgmqpolicyoffice@cdc.gov. RIN: 0920–AA75 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Disease Control and Prevention (CDC) Action Legal Authority: 42 U.S.C. 264 Abstract: HHS is amending its regulations concerning the importation of dogs from high-risk rabies countries into the United States (U.S.). The final rule will establish requirements regarding an importation system that will reduce fraud and improve the U.S. government’s ability to verify U.S. entry requirements and mitigate the introduction of dogs infected with rabies and other communicable diseases of public health concern. Importation requirements for cats will not change. Completed: Reason DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage lotter on DSK11XQN23PROD with PROPOSALS4 71. Control of Communicable Diseases; Foreign Quarantine [0920–AA75] Legal Authority: 42 U.S.C. 264; 42 U.S.C. 265 Abstract: This rulemaking amends current regulation to enable CDC to require airlines to collect and provide to CDC certain data elements regarding passengers and crew arriving from foreign countries under certain circumstances. Timetable: Action Date Interim Final Rule Effective. Interim Final Rule Interim Final Rule Comment Period End. Final Action ......... VerDate Sep<11>2014 85 FR 7874 10/00/24 22:05 Aug 15, 2024 Jkt 250001 05/13/24 08/01/24 FR Cite 89 FR 41726 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ashley C. Altenburger, Phone: 800 232–4636, Email: dgmqpolicyoffice@cdc.gov. RIN: 0920–AA82 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 73. Administrative Detention of Tobacco Products [0910–AI05] FR Cite 02/07/20 02/12/20 03/13/20 Date Final Rule ............ Final Rule Effective. Centers for Disease Control and Prevention (CDC) 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: Completed Actions 72. Control of Communicable Diseases; Foreign Quarantine Importation of Dogs and Cats [0920–AA82] 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 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 66809 NPRM .................. Date FR Cite 12/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Quynh Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287– 1373, Email: ctpregulations@ fda.hhs.gov. Laura Chilaka, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287–1373, Email: ctpregulations@fda.hhs.gov. RIN: 0910–AI05 74. Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies [0910–AI57] Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262 Abstract: FDA is proposing to amend 21 CFR 320, in certain parts, and establish a new 21 CFR 321 to clarify FDA’s study conduct expectations for clinical pharmacology, and clinical and analytical bioavailability (BA) and bioequivalence (BE) studies that support marketing applications for human drug and biological products. The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies. This regulation would align with FDA’s other good practice regulations, would also be consistent with current industry best practices, and E:\FR\FM\16AUP7.SGM 16AUP7 66810 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda would harmonize the regulations more closely with related international regulatory expectations. Timetable: Action Date NPRM .................. FR Cite 10/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Brian Joseph Folian, Supervisory Biologist, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 22, Room 1440, Silver Spring, MD 20993–0002, Phone: 240 402–4089, Email: brian.folian@fda.hhs.gov. RIN: 0910–AI57 75. Amendments to the Final Rule Regarding the List of Bulk Substances That Can be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Section 610 Review) [0910–AI70] Legal Authority: 21 U.S.C. 353a; 21 U.S.C. 351; 21 U.S.C. 371(a); 21 U.S.C. 352; 21 U.S.C. 355 Abstract: FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act, although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drug products (the 503A Bulks List). The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. Timetable: Action Date lotter on DSK11XQN23PROD with PROPOSALS4 NPRM .................. 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 VerDate Sep<11>2014 22:05 Aug 15, 2024 Jkt 250001 76. Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (Section 610 Review) [0910–AI71] Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21 U.S.C. 353a–1; 21 U.S.C. 355; 21 U.S.C. 371 Abstract: The Food and Drug Administration is proposing rulemaking regarding statutory requirements under section 503A of the Federal Food, Drug, and Cosmetic Act for certain distributions of compounded human drug products. The proposed rule, if finalized, will include provisions regarding a standard memorandum of understanding (MOU) that describes the responsibilities of a State Board of Pharmacy or other appropriate State agency that chooses to sign the standard MOU in investigating complaints related to drug products compounded in such State and distributed outside such State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. It will also, if finalized, include provisions regarding the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the standard MOU. The rule, will also, if finalized, address communication with State boards of pharmacy. Timetable: Action Date NPRM .................. FR Cite 12/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Dominic Markwordt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 5104, Silver Spring, MD 20993, Phone: 301 796–9349, Email: dominic.markwordt@fda.hhs.gov. RIN: 0910–AI71 77. Front-of-Package Nutrition Labeling [0910–AI80] Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 343 note; 21 U.S.C. 371 Abstract: This proposed rule, if finalized, would require the front of food labels to display certain nutrition information to help consumers, including those who are busy and those with lower nutrition knowledge, make more informed dietary choices. Front-ofpackage nutrition labeling is intended to complement the Nutrition Facts label on packaged foods by giving consumers PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 additional context to help them quickly and easily identify foods that can help them build a healthy eating pattern. This proposed rule is being developed as part of a broader, whole-ofgovernment approach to help reduce the burden of chronic disease and advance health equity by helping to improve dietary patterns in the United States. Development of the proposed rule has been informed by, among other things, research findings and extensive public outreach and engagement, including a public meeting conducted by the Reagan-Udall Foundation for the FDA and listening sessions with a range of interested parties. Timetable: Action NPRM .................. Date FR Cite 10/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Mark Kantor, Nutritionist, Department of Health and Human Services, Food and Drug Administration, CPK1 RM 3D034, HFS– 830, 5001 Campus Drive, College Park, MD 20740, Phone: 240 402–2082, Email: mark.kantor@fda.hhs.gov. RIN: 0910–AI80 78. Registration of Commercial Importers of Drugs; Good Importing Practice [0910–AI87] Legal Authority: sec. 714 of the Food and Drug Administrative Safety and Innovation Act (FDASIA) of July 2012 Abstract: This proposed rulemaking meets the mandate of section 714 of the Food and Drug Administration Safety and Innovation Act and will establish registration and good importing practice requirements for commercial importers of drugs. Although manufacturers are subject to regulatory requirements to ensure such quality standards are met, there are few clear responsibilities for commercial importers of drugs to do the same. Cost estimates of the rule include reading and understanding the rule, registering as a commercial importer through the Food and Drug Administration’s (FDA) electronic importer registration system, annual updating of registration, establishing a quality management system, conducting risk evaluations of drugs and suppliers, shipment verifications, investigations, corrective actions, and records maintenance. The unquantified benefits of the proposed rule include improvement in the safety of finished drugs allowed to enter the United States from the commercial drug importer’s requirement E:\FR\FM\16AUP7.SGM 16AUP7 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda 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 NPRM .................. FR Cite 10/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: James Hanratty, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, WO 75, Rm. 1607A, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 240 402–4718, Email: james.hanratty@ fda.hhs.gov. RIN: 0910–AI87 79. • Amendments to the Current Good Manufacturing Practice Regulations for Drug Products [0910–AI88] Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 360bbb–7; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264 Abstract: FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products. The proposed amendment will clarify and modernize the regulations by adding requirements for quality management systems and controls over components and drug product containers and closures. Timetable: Action Date lotter on DSK11XQN23PROD with PROPOSALS4 NPRM .................. FR Cite 02/00/25 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ashley Boam, Health Science Administrator, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–6341, Email: ashley.boam@fda.hhs.gov. RIN: 0910–AI88 VerDate Sep<11>2014 22:05 Aug 15, 2024 Jkt 250001 80. • Pediatric Study Plan Requirements for New Drug and Biologics License Applications [0910– AI89] Legal Authority: 21 U.S.C. 355c(e)(7); 21 U.S.C. 355c(k)(1); 21 U.S.C. 371(a) Abstract: FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This proposed rule, if finalized, would implement the pediatric study plans provisions of the FD&C Act, and exercise the authority granted to the Secretary in the provisions of the FD&C Act governing exemptions from pediatric study requirements. Timetable: Action Date NPRM .................. FR Cite 10/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Kristiana Brugger, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 5252, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–3600, Email: kristiana.brugger@ fda.hhs.gov. RIN: 0910–AI89 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 81. Sunlamp Products; Amendment to the Performance Standard [0910–AG30] Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393; 21 U.S.C. 371 Abstract: FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards. By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources. Timetable: PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 Action NPRM .................. NPRM Comment Period End. Final Rule ............ Date 12/22/15 03/21/16 66811 FR Cite 80 FR 79505 12/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for Devices and Radiological Health, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring, MD 20993, Phone: 301 796–5678, Email: ian.ostermiller@ fda.hhs.gov. RIN: 0910–AG30 82. General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products [0910– AH14] Legal Authority: 21 U.S.C. 360j(e) Abstract: This rule will apply device restrictions to sunlamp products. Sunlamp products include ultraviolet (UV) lamps and UV tanning beds and booths. A large number of skin cancer cases, including cases of melanoma, are attributable to the use of sunlamp products. Beginning use of sunlamp products at young ages, as well as frequently using sunlamp products, both increases the risk of developing skin cancers and other illnesses, and sustaining other injuries. Even infrequent use, particularly at younger ages, can significantly increase these risks. Timetable: Action NPRM .................. NPRM Comment Period End. Final Rule ............ Date 12/22/15 03/21/16 FR Cite 80 FR 79493 11/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Daniel Schieffer, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Silver Spring, MD 20993, Phone: 301 796– 3350, Email: daniel.schieffer@ fda.hhs.gov. RIN: 0910–AH14 E:\FR\FM\16AUP7.SGM 16AUP7 66812 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda 83. Amendments to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act [0910–AH81] Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21 U.S.C. 355; 21 U.S.C. 371 Abstract: FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs (the 503A Bulks List). FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list. FDA has also identified bulk drug substances that FDA has considered and proposed not to include on the 503A Bulks List. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future rulemaking. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Rule ............ 09/05/19 12/04/19 FR Cite 84 FR 46688 10/00/24 lotter on DSK11XQN23PROD with PROPOSALS4 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Oluwaseun ‘‘Kemi’’ Asante, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–7425, Email: kemi.asante@fda.hhs.gov. RIN: 0910–AH81 84. Requirements for Tobacco Product Manufacturing Practice [0910–AH91] Legal Authority: 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381(a); 21 U.S.C. 387b; 21 U.S.C. 387c; 21 U.S.C. 387f; 21 U.S.C. 387i; . . . Abstract: The rule would establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This rule, if finalized, would set forth requirements for the manufacture, preproduction design validation, packing, and storage of a tobacco product. This rule would help prevent the manufacture and distribution of contaminated and otherwise VerDate Sep<11>2014 22:05 Aug 15, 2024 Jkt 250001 nonconforming tobacco products. This rule provides manufacturers with flexibility in the manner in which they comply with the requirements while giving FDA the ability to enforce regulatory requirements, thus helping to assure the protection of public health. In April 2023, FDA held an all tribes’ call to provide an overview of the proposed rule, answer questions, and receive tribal feedback. Additionally, in May 2023, FDA held an open session meeting of the Tobacco Products Scientific Advisory Committee to enable the committee to discuss and provide recommendations on the proposed rule. FDA made background material available to members of the public and interested persons were able to present data, information, and views on issues pending before the committee. Timetable: Action Date NPRM .................. NPRM Comment Period End. NPRM Comment Period Extension to Oct. 06, 2023. Final Rule ............ FR Cite 03/10/23 09/06/23 88 FR 15174 08/29/23 88 FR 59481 FR Cite 09/29/22 12/28/22 87 FR 59168 11/29/22 87 FR 73267 02/16/23 09/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Vincent De Jesus, Nutritionist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS–830), Room 3D–031, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402–1774, Fax: 301 436– 1191, Email: vincent.dejesus@ fda.hhs.gov. RIN: 0910–AI13 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions 04/00/25 85. Nutrient Content Claims, Definition of Term: Healthy [0910–AI13] Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 343; 21 U.S.C. 371 Abstract: The rule would update the definition for the implied nutrient content claim ‘‘healthy’’ to be consistent with current nutrition science and federal dietary guidelines. The rule would revise the requirements for when the claim ‘‘healthy’’ can be voluntarily used in the labeling of human food products to indicate that a food, because of its nutrient content, may be useful in achieving a total diet that conforms to current dietary recommendations and helps consumers maintain healthy dietary practices. Timetable: Frm 00008 NPRM .................. NPRM Comment Period End. NPRM Comment Period Extended. NPRM Comment Period Extended End. Final Rule ............ Date Food and Drug Administration (FDA) 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 PO 00000 Action Fmt 4701 Sfmt 4702 86. National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers [0910–AH11] Legal Authority: secs. 583 and 584 of the FD&C Act, as added by the DSCSA under Pub. L. 113–54, together with related FD&C Act authority added by the DSCSA Abstract: The final rule establishes national standards for State licensing of prescription drug wholesale distributors and third-party logistics providers. The rulemaking also establishes a Federal system for wholesale drug distributor and third-party logistics provider licensing for use in the absence of a State licensure program. Timetable: Action NPRM .................. NPRM Comment Period End. NPRM Comment Period Extended. NPRM Comment Period Extended End. Final Rule ............ Date FR Cite 02/04/22 06/06/22 87 FR 6708 05/24/22 87 FR 31439 09/06/22 05/00/26 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of E:\FR\FM\16AUP7.SGM 16AUP7 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda 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 87. Nicotine Toxicity Warnings [0910– AH24] Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C. 371; 21 U.S.C. 387f; . . . Abstract: This rule would establish acute nicotine toxicity warning requirements for liquid nicotine and nicotine-containing e-liquid(s) intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks. This action is intended to increase consumer awareness and knowledge of the risks of acute toxicity due to accidental nicotine exposure from nicotine-containing e-liquids in tobacco products. Timetable: Action Date NPRM .................. FR Cite 10/00/25 lotter on DSK11XQN23PROD with PROPOSALS4 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 88. Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) [0910–AH56] Legal Authority: Section 503 and related provisions of the FD&C Act, as amended by Pub. L. 113–54 Abstract: The final rule amends Food and Drug Administration (FDA) regulations at 21 CFR 203 to remove provisions no longer in effect and incorporate conforming changes following enactment of the Drug Supply Chain Security Act (DSCSA). The final rule amends the regulations to clarify provisions and avoid causing confusion with the new standards for wholesale distribution established by DSCSA. Timetable: Action Date NPRM .................. VerDate Sep<11>2014 02/04/22 22:05 Aug 15, 2024 FR Cite 87 FR 6443 Jkt 250001 Action Date NPRM Comment Period End. Final Rule ............ FR Cite 04/05/22 05/00/26 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Building 51, Room 4261, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796–9362, Email: aaron.weisbuch@fda.hhs.gov. RIN: 0910–AH56 89. Medication Guide; Patient Medication Information [0910–AH68] Legal Authority: 21 U.S.C. 321 et seq.; 42 U.S.C. 262; 42 U.S.C. 264; 21 U.S.C. 371 Abstract: The rule will amend FDA medication guide regulations to require a new form of patient labeling, namely Patient Medication Information, for submission to and review by FDA for human prescription drug products and certain blood products used, dispensed, or administered on an outpatient basis. The rule will include requirements for the development and distribution of Patient Medication Information. The rule will require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Rule ............ 05/31/23 11/27/23 FR Cite 88 FR 35694 05/00/26 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Chris Wheeler, Supervisory Project Manager, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD 20993, Phone: 301 796– 0151, Email: cderomp@fda.hhs.gov. RIN: 0910–AH68 90. Tobacco Product Standard for Characterizing Flavors in Cigars [0910– AI28] Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 371(a); 21 U.S.C. 387b and 387c; 21 U.S.C. 387f(d) and 387g; . . . PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 66813 Abstract: This rule is a tobacco product standard that would prohibit characterizing flavors (other than tobacco) in all cigars. We are taking this action with the intention of reducing the tobacco-related death and disease associated with cigar use. Evidence shows that flavored tobacco products appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Characterizing flavors in cigars, such as strawberry, grape, orange, and cocoa, enhance taste and make these products easier to use. Over a half million youth in the United States use flavored cigars, placing these youth at risk for cigarrelated death and disease. Timetable: Action ANPRM ............... ANPRM Comment Period End. NPRM .................. NPRM Comment Period Extended. NPRM Comment Period End. NPRM Comment Period Extended End. Final Action ......... Date FR Cite 03/21/18 07/19/18 83 FR 12294 05/04/22 06/21/22 87 FR 26396 87 FR 36786 07/05/22 08/02/22 To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Nathan Mease, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Center for Tobacco Products, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287–1373, Email: ctpregulations@fda.hhs.gov. RIN: 0910–AI28 91. Tobacco Product Standard for Menthol in Cigarettes [0910–AI60] Legal Authority: 21 U.S.C. 387g; 21 U.S.C 371; 21 U.S.C 387f Abstract: This rule is a tobacco product standard to prohibit the use of menthol as a characterizing flavor in cigarettes. Timetable: Action ANPRM ............... ANPRM Comment Period End. NPRM .................. NPRM Comment Period Extended. NPRM Comment Period End. E:\FR\FM\16AUP7.SGM 16AUP7 Date FR Cite 07/24/13 09/23/13 78 FR 44484 05/04/22 06/21/22 87 FR 26454 87 FR 36786 07/05/22 66814 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda Action Date NPRM Comment Period Extended End. Final Action ......... 08/02/22 To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Beth Buckler, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287– 1373, Email: ctpregulations@ fda.hhs.gov. RIN: 0910–AI60 93. Tobacco Product Standard for Nicotine Level of Certain Tobacco Products [0910–AI76] Legal Authority: 21 U.S.C. 387g Abstract: The proposed rule is a tobacco product standard that would establish a maximum nicotine level in cigarettes and certain other finished tobacco products. Timetable: 92. Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products [0910–AI61] Legal Authority: 42 U.S.C. 262; 42 U.S.C. 264; 42 U.S.C. 300aa–25; 21 U.S.C. 321; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; . . . Abstract: The proposed rule would modernize FDA’s regulations on postmarketing safety reporting and pharmacovigilance for human drug and biological products, including blood and blood components, by capturing important new safety-related information, improving the quality and utility of submitted reports, and supporting enhanced alignment with internationally harmonized reporting guidelines. Among other things, the proposed rule would require the submission of certain nonclinical and clinical data to FDA in a periodic safety report, rather than the annual report. The proposed rule also would require application holders for drug products and certain biological products to establish and maintain a pharmacovigilance quality system that reflects the application holder’s unique needs and that may support a more streamlined, flexible approach to satisfying certain postmarketing safety reporting requirements. Timetable: NPRM .................. Action lotter on DSK11XQN23PROD with PROPOSALS4 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 FR Cite Date NPRM .................. 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 VerDate Sep<11>2014 22:05 Aug 15, 2024 Jkt 250001 Action Date FR Cite To Be Determined Regulatory Flexibility Analysis Required: Yes. Agency Contact: Nathan Mease, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Center for Tobacco Products, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287–1373, Email: ctpregulations@fda.hhs.gov. Dhanya John, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287–1373, Fax: 877 287–1426, Email: ctpregulations@ fda.hhs.gov. RIN: 0910–AI76 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions Frm 00010 Fmt 4701 Reason Final Rule ............ Final Rule Effective. Sfmt 4702 Date 11/21/23 05/20/24 FR Cite 88 FR 80958 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Suzanna Boyle, Phone: 240 402–4723, Email: suzanna.boyle@fda.hhs.gov. RIN: 0910–AG27 95. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water [0910– AI49] Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 243; 42 U.S.C. 264; 42 U.S.C. 271; . . . Abstract: This rulemaking will revise certain requirements for agricultural water for covered produce other than sprouts in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (produce safety) regulation for covered produce other than sprouts. Completed: Reason 94. Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format [0910–AG27] Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; . . . Abstract: The Food and Drug Administration (FDA) is amending its regulations concerning direct-toconsumer (DTC) advertisements of prescription drugs. Prescription drug advertisements presented through media such as TV and radio must PO 00000 disclose the product’s major side effects and contraindications in what is sometimes called the major statement. The rule would revise the regulation to reflect the statutory requirement that in DTC advertisements for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications of the advertised drug must be presented in a clear, conspicuous, and neutral manner. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required. Completed: Final Rule ............ Final Rule Effective. Date 05/06/24 07/05/24 FR Cite 89 FR 37448 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Samir Assar, Phone: 240 402–1636, Email: samir.assar@ fda.hhs.gov. RIN: 0910–AI49 96. Medical Devices; Laboratory Developed Tests [0910–AI85] Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360c; . . . E:\FR\FM\16AUP7.SGM 16AUP7 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda Abstract: This rule would amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act.) Completed: Reason Date NPRM .................. Final Rule ............ Final Rule Effective. 10/03/23 05/06/24 07/05/24 FR Cite 88 FR 68006 89 FR 37286 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Eitan Bernstein, Phone: 240 402–9812, Email: eitan.bernstein@fda.hhs.gov. RIN: 0910–AI85 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) 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: Date lotter on DSK11XQN23PROD with PROPOSALS4 FR Cite 07/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gift Tee, Director, Division of Physician Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS: C1–09– 07, Baltimore, MD 21244, Phone: 410 786–9316, Email: gift.tee@cms.hhs.gov. RIN: 0938–AV33 VerDate Sep<11>2014 Date NPRM .................. 97. CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1807) (Section 610 Review) [0938–AV33] NPRM .................. 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 Proposed Rule Stage Action 98. CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1809) (Section 610 Review) [0938–AV35] 22:05 Aug 15, 2024 Jkt 250001 FR Cite 07/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Elise Barringer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4–03–06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–9222, Email: elise.barringer@cms.hhs.gov. RIN: 0938–AV35 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage 99. Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021 (CMS–9902) [0938–AU93] Legal Authority: Pub. L. 116–260, Division BB, title II; Pub. L. 110–343, secs. 511 and 512 Abstract: This rule would finalize proposed amendments to the final rules implementing the Mental Health Parity and Addiction Equity Act (MHPAEA). The amendments clarify plans’ and issuers’ obligations under the law, promote compliance with MHPAEA, and update requirements taking into account experience with MHPAEA in the years since the rules were finalized. PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 66815 The rule would also finalize new regulations implementing amendments to MHPAEA recently enacted as part of the Consolidated Appropriations Act, 2021 (CAA, 2021). Timetable: Action NPRM .................. NPRM Comment Period Extended. NPRM Comment Period End. NPRM Comment Period Extended End. Final Action ......... Date 08/03/23 09/28/23 FR Cite 88 FR 51552 88 FR 66728 10/02/23 10/17/23 07/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation Division, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492–4106, Email: lindsey.murtagh@cms.hhs.gov. RIN: 0938–AU93 100. Independent Dispute Resolution Operations (CMS–9897) [0938–AV15] Legal Authority: Pub. L. 116–260, Division BB, title I & title II Abstract: This final rule amends the Requirements Related to Surprise Billing; Part I (July 2021 interim final rules), Requirements Related to Surprise Billing Interim Final Rules; Part II (October 2021 interim final rules), and Requirements Related to Surprise Billing Final Rules (August 2022 final rules), which set forth requirements related to Title I (No Surprises Act (NSA)) and Title II (Transparency) of Division BB of the Consolidated Appropriations Act, 2021. Timetable: Action NPRM .................. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period Reopened End. Final Action ......... Date FR Cite 11/03/23 01/02/24 88 FR 75744 01/22/24 89 FR 3896 02/05/24 11/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Deborah Bryant, Senior Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center E:\FR\FM\16AUP7.SGM 16AUP7 66816 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda for Consumer Information and Insurance Oversight, MS: W08–134, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492–4293, Email: deborah.bryant@cms.hhs.gov. RIN: 0938–AV15 101. FY 2025 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS–1810) (Section 610 Review) [0938–AV29] Legal Authority: 42 U.S.C. 1302 Abstract: This annual proposed rule would update the hospice payment rates and the wage index for fiscal year 2025. The rule also proposes changes to the Hospice Quality Reporting program. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Action ......... 04/04/24 05/28/24 FR Cite 89 FR 23778 10/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Brian Slater, Director, Division of Home Health and Hospice, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4–07–07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–5229, Email: brian.slater@cms.hhs.gov. RIN: 0938–AV29 lotter on DSK11XQN23PROD with PROPOSALS4 102. FY 2025 Skilled Nursing Facility (SNFS) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS– 1802) (Section 610 Review) [0938– AV30] Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C. 1395f(b); 42 U.S.C. 1395g; 42 U.S.C. 1395l(a); 42 U.S.C. 1395l(i); 42 U.S.C. 13951(n); 42 U.S.C. 1395m; 42 U.S.C. 1395x(v); 42 U.S.C. 1395x(kkk); 42 U.S.C. 1395hh; 42 U.S.C. 1395rr; 42 U.S.C. 1395tt; 42 U.S.C. 1395ww Abstract: This annual rule updates the payment rates used under the prospective payment system for SNFs for fiscal year 2025. The rule also includes updates to the SNF Quality Reporting Program (QRP) and the Skilled Nursing Facility Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs. Timetable: Action Date NPRM .................. NPRM Comment Period End. VerDate Sep<11>2014 04/03/24 05/28/24 22:05 Aug 15, 2024 FR Cite 89 FR 23424 Jkt 250001 Action Date Final Action ......... FR Cite Action 10/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Tammy Luo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5–06–17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–4325, Email: tammy.luo@cms.hhs.gov. RIN: 0938–AV30 103. FY 2025 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS–1806) (Section 610 Review) [0938–AV32] Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g; 42 U.S.C. 1395hh; 42 U.S.C. 1395ww(s) Abstract: This annual rule updates the prospective payment system for inpatient psychiatric facilities (IPF) with discharges beginning on October 1, 2024. The rule also includes updates to the IPF Quality Reporting Program. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Action ......... 04/03/24 05/28/24 FR Cite 89 FR 23146 10/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Marissa Kellam, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5–04–23, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–3012, Email: marissa.kellam@cms.hhs.gov. RIN: 0938–AV32 104. Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS–1808) (Section 610 Review) [0938–AV34] Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual final rule revises the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This rule implements changes arising from our continuing experience with these systems. In addition, the rule establishes new requirements or revises existing requirements for quality reporting by specific Medicare providers. PO 00000 Frm 00012 Timetable: Fmt 4701 Sfmt 4702 NPRM .................. NPRM Comment Period End. Final Action ......... Date 05/02/24 06/10/24 FR Cite 89 FR 35934 10/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Donald Thompson, Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4–01–26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786–6504, Email: donald.thompson@cms.hhs.gov. RIN: 0938–AV34 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Completed Actions 105. CY 2024 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1784) (Completion of a Section 610 Review) [0938–AV07] Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302 Abstract: This annual final rule revises payment polices under the Medicare physician fee schedule, and makes other policy changes to payment under Medicare Part B including, but not limited to, establishing payment policies for dental services prior to the initiation of immunotherapy services. These changes apply to services furnished beginning January 1, 2024. Additionally, this rule updates the Quality Payment Program. Timetable: Action NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. Date FR Cite 08/07/23 09/11/23 88 FR 52262 11/16/23 01/01/24 88 FR 78818 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– E:\FR\FM\16AUP7.SGM 16AUP7 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda 07, Baltimore, MD 21244, Phone: 410 786–9316, Email: gift.tee@cms.hhs.gov. RIN: 0938–AV07 106. CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1786) (Completion of a Section 610 Review) [0938–AV09] Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302 Abstract: This annual final rule revises the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from our continuing experience with this system. The rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule makes changes to the ambulatory surgical center payment system list of services and rates. This rule also updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. FR Cite 07/31/23 09/11/23 88 FR 49552 11/22/23 01/01/24 88 FR 81540 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) Administration for Children and Families (ACF) lotter on DSK11XQN23PROD with PROPOSALS4 Proposed Rule Stage 107. • Native American Programs Financial and Administrative Requirements (Section 610 Review) [0970–AD05] 22:05 Aug 15, 2024 Jkt 250001 Action Date NPRM .................. FR Cite 11/00/24 Regulatory Flexibility Analysis Required: No. Agency Contact: Amy Zukowski, Acting Director Policy, Department of Health and Human Services, Administration for Children and Families, Administration for Native Americans, 330 C Street SW, Mail Stop 4126, Washington, DC 20201, Phone: 202 205–5606, Email: amy.zukowski@ acf.hhs.gov. RIN: 0970–AD05 108. • Name Change From Office of Child Support Enforcement to Office of Child Support Services (Section 610 Review) [0970–AD06] Legal Authority: Not Yet Determined Abstract: This Notice of Proposed Rulemaking would update 45 CFR Chapter III to reflect that on June 5, 2023, the Office of Child Support Enforcement became the Office of Child Support Services. This name change reflects the program’s commitment to serve the whole family and provide services that promote family selfsufficiency so children receive reliable support from both parents. Timetable: Action Date NPRM .................. Legal Authority: 42 U.S.C. 2991b (b) Abstract: This rule would remove the 20 percent non-federal contribution requirement for all grant awards under the Native American Programs Act (NAPA). This is in response to VerDate Sep<11>2014 Executive Order 14112 Reforming Federal Funding and Support for Tribal Nations to Better Embrace Our Trust Responsibilities and Promote the Next Era of Tribal Self-Determination which in part recognizes that federal programs were administered in unduly burdensome ways that left Tribal Nations unduly burdened and frustrated with bureaucracy. Elimination of the 20 percent non-federal match for all ANA projects would have profound impact on tribal communities with respect to improving equity and access to federal programs intended for their benefit. Tribal leaders across Indian Country have testified that nonfederal share requirement is a significant barrier for applying and administering grant funds especially for the smaller tribes that lack the resources to meet the non-federal share. Timetable: FR Cite 12/00/24 Regulatory Flexibility Analysis Required: No. Agency Contact: Tavaughn McKenny, Program Specialist, Department of Health and Human Services, Administration for Children and Families, Office of Child Support PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 66817 Services, 330 C Street SW, Washington, DC 20201, Phone: 202 565–0129, Email: tavaughn.mckenny@acf.hhs.gov. RIN: 0970–AD06 109. • Temporary Assistance for Needy Families Work Participation Rate Calculation Changes (Section 610 Review) [0970–AD07] Legal Authority: secs. 301 and 303 of the Fiscal Responsibility Act of 2023 (FRA, Public Law 118–5) Abstract: To comply with requirements from the Fiscal Responsibility Act of 2023 (FRA), this NPRM will propose changes to the how Temporary Assistance for Needy Families (TANF) regulations describe the federal work participation rate (WPR) calculation. As required by Section 301 of the FRA, this NPRM will propose a recalibration of the base year for the caseload reduction credit component of the WPR calculation. The base year will change from 2005 to 2015. As required by Section 303 of the FRA, this NPRM will propose that ACF only count a case in a state’s work participation rate calculation if the assistance level for that case is at least $35 a month. Both changes will be effective October 1, 2025. Timetable: Action NPRM .................. Date FR Cite 11/00/24 Regulatory Flexibility Analysis Required: No. Agency Contact: La Sherra Ayala, Deputy Director, Department of Health and Human Services, Administration for Children and Families, Office of Family Assistance, 330 C Street SW, Washington, DC 20201, Phone: 202 478– 0714, Email: lasherra.ayala@ acf.hhs.gov. RIN: 0970–AD07 110. • Unaccompanied Children Program Prevention of Sexual Abuse NPRM (Section 610 Review) [0970– AD08] Legal Authority: sec. 1101(c) of the Violence Against Women Reauthorization Act of 2013, Pub. L. 113–4 (VAWA 2013); Amendment to the Prison Rape Elimination Act (PREA) Pub. L. 108–79 Abstract: This Notice of Proposed Rulemaking would update the Standards To Prevent, Detect, and Respond to Sexual Abuse and Sexual Harassment Involving Unaccompanied Children Interim Final Rule published on December 24, 2014, to incorporate public feedback and ensure that the practices established in the IFR are E:\FR\FM\16AUP7.SGM 16AUP7 66818 Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda effectively tailored to the operational realities of the Office of Refugee Resettlement’s (ORR) Unaccompanied Children (UC) Program. The Violence Against Women Reauthorization Act of 2013 (VAWA 2013), Public Law 1134, contained a provision applying PREA to custodial facilities operated by HHS. VAWA 2013 requires HHS to publish a final rule adopting national standards to prevent, detect, and respond to rape and sexual assault. These national standards are to apply to all care provider facilities that maintain custody of UCs as defined in the Homeland Security Act of 2002 (6 U.S.C. 279(g)) and give due consideration to the recommended national standards provided by the NPREC report. Additionally, HHS is required to regularly assess compliance with the standards adopted and include the results of the assessments in performance evaluations of care provider facilities. As a result, HHS published the IFR to establish standards for the prevention, detection, and response to sexual abuse and sexual harassment of unaccompanied children in all ORR care provider facilities, except secure care providers and traditional foster care homes as described in the rule. Timetable: Action Date NPRM .................. FR Cite 12/00/24 Regulatory Flexibility Analysis Required: No. Agency Contact: Toby Robert McFarren Biswas, Director of Policy, Department of Health and Human Services, Administration for Children and Families, Office of Refugee Resettlement, Unaccompanied Children Bureau, 330 C Street SW, Washington, DC 20201, Phone: 202 555–4440, Email: ucpolicy-regulatoryaffairs@acf.hhs.gov. RIN: 0970–AD08 Head Start services. During the public comment period, ACF engaged with the Head Start community through listening sessions in multiple locations around the country and virtually on the proposed rule to generate interest in submitting public comments. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Action ......... Administration for Children and Families (ACF) lotter on DSK11XQN23PROD with PROPOSALS4 Final Rule Stage 111. Supporting the Head Start Workforce and Other Quality Improvements [0970–AD01] Legal Authority: 42 U.S.C. 9801; 42 U.S.C. 9836a; 42 U.S.C. 9839 Abstract: This NPRM will propose changes to the Head Start Program Performance Standards to better support the Head Start workforce and to maintain the quality of comprehensive VerDate Sep<11>2014 22:05 Aug 15, 2024 Jkt 250001 88 FR 80818 07/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jessica Bialecki, Policy and Planning Director, Department of Health and Human Services, Administration for Children and Families, Office of Head Start, 330 C Street SW, Washington, DC 20201, Phone: 202 283–1004, Email: jessica.bialecki@acf.hhs.gov. RIN: 0970–AD01 112. • Temporary Assistance for Needy Families Work Outcomes Measures (Section 610 Review) [0970–AD04] Legal Authority: Section 304 of the Fiscal Responsibility Act of 2023 (FRA, Pub. L. 118–5) Abstract: This interim final rule modifies 45 CFR part 265 in order to implement the statutory changes enacted by section 304 of the Fiscal Responsibility Act of 2023 (FRA, Public Law 118–5) related to the reporting of work outcomes under the Temporary Assistance for Needy Families (TANF) program. ACF is promulgating this rule as an interim final rule to ensure states and territories have sufficient time to comply with data collection for fiscal year 2025. Timetable: Action Date Interim Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 11/20/23 01/19/24 FR Cite FR Cite 07/00/24 Regulatory Flexibility Analysis Required: No. Agency Contact: La Sherra Ayala, Deputy Director, Department of Health and Human Services, Administration for Children and Families, Office of Family Assistance, 330 C Street SW, Washington, DC 20201, Phone: 202 478– 0714, Email: lasherra.ayala@ acf.hhs.gov. RIN: 0970–AD04 113. • Head Start Program Class Effective Date Delay Direct Final Rule (Section 610 Review) [0970–AD09] Legal Authority: sec. 641 of the Act (42 U.S.C. 9836) as amended by the PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 Improving Head Start for School Readiness Act of 2007 (Pub. L. 110–134) Abstract: This Direct Final Rule describes how the Office of Head Start officially delays the compliance date for programs to meet the new competitive threshold for the Instructional Support domain of the Classroom Assessment Scoring System (CLASS®) used to determine whether a Head Start agency will be subject to an open competition under the Designation Renewal System. The effective date in the Head Start Program Performance Standards that raises the CLASS Instructional Support competitive threshold from 2.3 to 2.5 was August 1, 2025. ACF is pursuing this as a Direct Final Rule due to the time constraints of when the threshold increase was scheduled to go into effect. This Direct Final Rule officially delays this effective date to August 1, 2027. Timetable: Action Final Action ......... Date FR Cite 09/00/24 Regulatory Flexibility Analysis Required: No. Agency Contact: Jessica Bialecki, Policy and Planning Director, Department of Health and Human Services, Administration for Children and Families, Office of Head Start, 330 C Street SW, Washington, DC 20201, Phone: 202 283–1004, Email: jessica.bialecki@acf.hhs.gov. RIN: 0970–AD09 114. • ORR UC Program Child Abuse and Neglect (Section 610 Review) [0970–AD10] Legal Authority: 6 U.S.C. 279; 8 U.S.C. 1232(b)–(c) Abstract: This Interim Final Rule on ORR child abuse and neglect investigations describes how ORR shall investigate and substantiate allegations of child abuse or neglect occurring in certain ORR care facilities and maintain a registry of perpetrators relating to those facilities where a State agency that would otherwise be responsible for such investigations will not investigate allegations arising at facilities housing unaccompanied children (e.g., because the State does not license facilities on the basis that they serve unaccompanied children). This interim final rule describes the obligations of care provider facilities in the course of an investigation of allegations of child abuse or neglect. Timetable: Action Interim Final Rule E:\FR\FM\16AUP7.SGM 16AUP7 Date 08/00/24 FR Cite Federal Register / Vol. 89, No. 159 / Friday, August 16, 2024 / UA: Reg Flex Agenda lotter on DSK11XQN23PROD with PROPOSALS4 Regulatory Flexibility Analysis Required: No. Agency Contact: Toby Robert McFarren Biswas, Director of Policy, Department of Health and Human Services, Administration for Children and Families, Office of Refugee Resettlement, Unaccompanied Children Bureau, 330 C Street SW, Washington, DC 20201, Phone: 202 555–4440, Email: ucpolicy-regulatoryaffairs@acf.hhs.gov. RIN: 0970–AD10 VerDate Sep<11>2014 22:05 Aug 15, 2024 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Administration for Children and Families (ACF) IV–B agencies in a way that does not interfere with those providers’ sincerely held religious beliefs. Timetable: Completed Actions Action 115. Safe and Appropriate, Affirming Foster Care Placement Requirements for Titles IV–E and IV–B (Completion of a Section 610 Review) [0970–AD03] Legal Authority: 42 U.S.C. 671(a)(16); 42 U.S.C. 622(b)(8)(A)(ii); 42 U.S.C. 675(1)(B); 42 U.S.C. 675(5)) Abstract: This rule clarifies that title IV–E/IV–B agencies are required to offer safe and appropriate foster care placements, including processes to ensure children can request such placements and agencies must respond to concerns about those placements, for children in foster care who identify as lesbian, gay, bisexual, transgender, queer or questioning, intersex (LGBTQI+). The rule will not interfere with faith-based child welfare providers that continue to partner with title IV–E/ PO 00000 Frm 00015 Fmt 4701 Sfmt 9990 66819 NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. Date FR Cite 09/28/23 11/27/23 88 FR 66752 04/30/24 07/01/24 89 FR 34818 Regulatory Flexibility Analysis Required: No. Agency Contact: Kathleen McHugh, Director, Department of Health and Human Services, Administration for Children and Families, Children’s Bureau, Division of Policy, 330 C Street SW, Washington, DC 20201, Phone: 202 401–5789, Fax: 202 205–8221, Email: kmchugh@acf.hhs.gov. RIN: 0970–AD03 [FR Doc. 2024–16451 Filed 8–15–24; 8:45 am] BILLING CODE 4150–03–P E:\FR\FM\16AUP7.SGM 16AUP7

Agencies

[Federal Register Volume 89, Number 159 (Friday, August 16, 2024)]
[Unknown Section]
[Pages 66806-66819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16451]



[[Page 66805]]

Vol. 89

Friday,

No. 159

August 16, 2024

Part VII





Department of Health and Human Services





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





Semiannual Regulatory Agenda

Federal Register / Vol. 89 , No. 159 / Friday, August 16, 2024 / UA: 
Reg Flex Agenda

[[Page 66806]]


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

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 the long-term effects of COVID-19 going forward, 
building and expanding access to affordable, quality health care, 
addressing health disparities and promoting equity, lowering 
prescription drug costs, and boosting the mental health and wellbeing 
of children and families, among other policy priorities.
    The rulemaking abstracts included in this paper issue of the 
Federal Register cover, as required by the Regulatory Flexibility Act 
of 1980, those prospective HHS rulemakings likely to have a significant 
economic impact on a substantial number of small entities. The 
Department's complete Regulatory Agenda is accessible online at https://www.RegInfo.gov.

Elizabeth J. Gramling,
HHS Executive Secretary.

               Office for Civil Rights--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
69........................  Rulemaking on                      0945-AA15
                             Discrimination on the
                             Basis of Disability in
                             Health and Human Services
                             Programs or Activities.
------------------------------------------------------------------------


  Substance Abuse and Mental Health Services Administration--Completed
                                 Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
70........................  Medications for the                0930-AA39
                             Treatment of Opioid Use
                             Disorder.
------------------------------------------------------------------------


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


      Centers for Disease Control and Prevention--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
72........................  Control of Communicable            0920-AA82
                             Diseases; Foreign
                             Quarantine Importation of
                             Dogs and Cats.
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
73........................  Administrative Detention           0910-AI05
                             of Tobacco Products.
74........................  Conduct of Analytical and          0910-AI57
                             Clinical Pharmacology,
                             Bioavailability, and
                             Bioequivalence Studies.
75........................  Amendments to the Final            0910-AI70
                             Rule Regarding the List
                             of Bulk Substances That
                             Can Be Used to Compound
                             Drug Products in
                             Accordance With Section
                             503A of the Federal Food,
                             Drug, and Cosmetic Act
                             (Section 610 Review).
76........................  Distribution of Compounded         0910-AI71
                             Drug Products Under
                             Section 503A of the
                             Federal Food, Drug, and
                             Cosmetic Act (Section 610
                             Review).
77........................  Front-of-Package Nutrition         0910-AI80
                             Labeling.

[[Page 66807]]

 
78........................  Registration of Commercial         0910-AI87
                             Importers of Drugs; Good
                             Importing Practice.
79........................  Amendments to the Current          0910-AI88
                             Good Manufacturing
                             Practice Regulations for
                             Drug Products.
80........................  Pediatric Study Plan               0910-AI89
                             Requirements for New Drug
                             and Biologics License
                             Applications.
------------------------------------------------------------------------


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
81........................  Sunlamp Products;                  0910-AG30
                             Amendment to the
                             Performance Standard.
82........................  General and Plastic                0910-AH14
                             Surgery Devices:
                             Restricted Sale,
                             Distribution, and Use of
                             Sunlamp Products.
83........................  Amendments to the List of          0910-AH81
                             Bulk Drug Substances That
                             Can Be Used To Compound
                             Drug Products in
                             Accordance With Section
                             503A of the Federal Food,
                             Drug, and Cosmetic Act.
84........................  Requirements for Tobacco           0910-AH91
                             Product Manufacturing
                             Practice.
85........................  Nutrient Content Claims,           0910-AI13
                             Definition of Term:
                             Healthy.
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
86........................  National Standards for the         0910-AH11
                             Licensure of Wholesale
                             Drug Distributors and
                             Third-Party Logistics
                             Providers.
87........................  Nicotine Toxicity Warnings         0910-AH24
88........................  Certain Requirements               0910-AH56
                             Regarding Prescription
                             Drug Marketing (203
                             Amendment).
89........................  Medication Guide; Patient          0910-AH68
                             Medication Information.
90........................  Tobacco Product Standard           0910-AI28
                             for Characterizing
                             Flavors in Cigars.
91........................  Tobacco Product Standard           0910-AI60
                             for Menthol in Cigarettes.
92........................  Postmarketing Safety               0910-AI61
                             Reporting Requirements,
                             Pharmacovigilance Plans,
                             and Pharmacovigilance
                             Quality Systems for Human
                             Drug and Biological
                             Products.
93........................  Tobacco Product Standard           0910-AI76
                             for Nicotine Level of
                             Certain Tobacco Products.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
94........................  Direct-to-Consumer                 0910-AG27
                             Prescription Drug
                             Advertisements:
                             Presentation of the Major
                             Statement in a Clear,
                             Conspicuous, Neutral
                             Manner in Advertisements
                             in Television and Radio
                             Format.
95........................  Standards for the Growing,         0910-AI49
                             Harvesting, Packing, and
                             Holding of Produce for
                             Human Consumption
                             Relating to Agricultural
                             Water.
96........................  Medical Devices;                   0910-AI85
                             Laboratory Developed
                             Tests.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
97........................  CY 2025 Revisions to               0938-AV33
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1807)
                             (Section 610 Review).
98........................  CY 2025 Hospital                   0938-AV35
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1809)
                             (Section 610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
99........................  Mental Health Parity and           0938-AU93
                             Addiction Equity Act and
                             the Consolidated
                             Appropriations Act, 2021
                             (CMS-9902).
100.......................  Independent Dispute                0938-AV15
                             Resolution Operations
                             (CMS-9897).
101.......................  FY 2025 Hospice Wage               0938-AV29
                             Index, Payment Rate
                             Update, and Quality
                             Reporting Requirements
                             (CMS-1810) (Section 610
                             Review).
102.......................  FY 2025 Skilled Nursing            0938-AV30
                             Facility (SNFs)
                             Prospective Payment
                             System and Consolidated
                             Billing and Updates to
                             the Value-Based
                             Purchasing and Quality
                             Reporting Programs (CMS-
                             1802) (Section 610
                             Review).
103.......................  FY 2025 Inpatient                  0938-AV32
                             Psychiatric Facilities
                             Prospective Payment
                             System Rate and Quality
                             Reporting Updates (CMS-
                             1806) (Section 610
                             Review).

[[Page 66808]]

 
104.......................  Hospital Inpatient                 0938-AV34
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals; the Long-Term
                             Care Hospital Prospective
                             Payment System; and FY
                             2025 Rates (CMS-1808)
                             (Section 610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
105.......................  CY 2024 Revisions to               0938-AV07
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1784)
                             (Completion of a Section
                             610 Review).
106.......................  CY 2024 Hospital                   0938-AV09
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1786)
                             (Completion of a Section
                             610 Review).
------------------------------------------------------------------------


      Administration for Children and Families--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
107.......................  Native American Programs           0970-AD05
                             Financial and
                             Administrative
                             Requirements (Section 610
                             Review).
108.......................  Name Change From Office of         0970-AD06
                             Child Support Enforcement
                             to Office of Child
                             Support Services (Section
                             610 Review).
109.......................  Temporary Assistance for           0970-AD07
                             Needy Families Work
                             Participation Rate
                             Calculation Changes
                             (Section 610 Review).
110.......................  Unaccompanied Children             0970-AD08
                             Program Prevention of
                             Sexual Abuse NPRM
                             (Section 610 Review).
------------------------------------------------------------------------


       Administration for Children and Families--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
111.......................  Supporting the Head Start          0970-AD01
                             Workforce and Other
                             Quality Improvements.
112.......................  Temporary Assistance for           0970-AD04
                             Needy Families Work
                             Outcomes Measures
                             (Section 610 Review).
113.......................  Head Start Program CLASS           0970-AD09
                             Effective Date Delay
                             Direct Final Rule
                             (Section 610 Review).
114.......................  ORR UC Program Child Abuse         0970-AD10
                             and Neglect (Section 610
                             Review).
------------------------------------------------------------------------


       Administration for Children and Families--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
115.......................  Safe and Appropriate,              0970-AD03
                             Affirming Foster Care
                             Placement Requirements
                             for Titles IV-E and IV-B
                             (Completion of a Section
                             610 Review).
------------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Completed Actions

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

    Legal Authority: sec. 504 of the Rehabilitation Act of 1973; 29 
U.S.C. 794
    Abstract: This proposed rule would revise regulations under section 
504 of the Rehabilitation Act of 1973 to address discrimination on the 
basis of disability in HHS-funded programs and activities. Covered 
topics include nondiscrimination in medical treatment; child welfare 
programs and activities; value assessment methods; accessible medical 
equipment; accessible web content, mobile apps, and kiosks; and other 
relevant health and human services activities.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Action........................   05/09/24  89 FR 40066
Final Action Effective..............   07/08/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Molly Burgdorf, Phone: 800 368-1019, TDD Phone: 800 
537-7697, Email: [email protected].
    RIN: 0945-AA15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Completed Actions

70. Medications for the Treatment of Opioid Use Disorder [0930-AA39]

    Legal Authority: 21 U.S.C. 823(g)(1)
    Abstract: The Substance Abuse and Mental Health Services 
Administration (SAMHSA) will revise 42 CFR part 8 to make permanent 
some regulatory flexibilities for Opioid Treatment Programs (OTPs) 
granted under the COVID-19 Public Health Emergency (PHE), and to expand 
access to care for people with Opioid Use Disorder (OUD). Specifically, 
SAMHSA will

[[Page 66809]]

update criteria pertaining to unsupervised doses of methadone and also 
initiation of buprenorphine via telemedicine. To expand access to care, 
SAMHSA will also update admission criteria, particularly those rules 
that may limit timely access to treatment in an OTP. To achieve this, 
sections of 42 CFR part 8 will require updating. SAMHSA's changes will 
impact roughly 1900 opioid treatment programs and state opioid 
treatment authorities.
    In response to the Consolidated Appropriations Act of 2023, which 
removed the requirement to obtain a waiver in order to prescribe 
certain schedule III-V medications for the treatment of OUD, SAMHSA 
issued a supplemental notice of proposed rulemaking on Feb. 13, 2023, 
(88 FR 9221) calling for additional public comment on SAMHSA's plans to 
remove reference to the Drug Addiction Treatment Act of 2000 (DATA 
2000-Waiver) from 42 CFR part 8.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Action........................   02/02/24  89 FR 7528
Final Action Effective..............   04/02/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Neeraj Gandotra, Phone: 202 823-1816, Email: 
[email protected].
    RIN: 0930-AA39

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Final Rule Stage

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule Effective........   02/07/20
Interim Final Rule..................   02/12/20  85 FR 7874
Interim Final Rule Comment Period      03/13/20
 End.
Final Action........................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ashley C. Altenburger JD, Regulatory Analyst, 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, 1600 Clifton Road NE, MS: H 16-4, Atlanta, GA 30307, 
Phone: 800 232-4636, Email: [email protected].
    RIN: 0920-AA75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Completed Actions

72. Control of Communicable Diseases; Foreign Quarantine Importation of 
Dogs and Cats [0920-AA82]

    Legal Authority: 42 U.S.C. 264
    Abstract: HHS is amending its regulations concerning the 
importation of dogs from high-risk rabies countries into the United 
States (U.S.). The final rule will establish requirements regarding an 
importation system that will reduce fraud and improve the U.S. 
government's ability to verify U.S. entry requirements and mitigate the 
introduction of dogs infected with rabies and other communicable 
diseases of public health concern. Importation requirements for cats 
will not change.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   05/13/24  89 FR 41726
Final Rule Effective................   08/01/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ashley C. Altenburger, Phone: 800 232-4636, Email: 
[email protected].
    RIN: 0920-AA82

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

73. Administrative Detention of Tobacco Products [0910-AI05]

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/24
------------------------------------------------------------------------

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

74. Conduct of Analytical and Clinical Pharmacology, Bioavailability, 
and Bioequivalence Studies [0910-AI57]

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

[[Page 66810]]

would harmonize the regulations more closely with related international 
regulatory expectations.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Joseph Folian, Supervisory Biologist, 
Department of Health and Human Services, Food and Drug Administration, 
10903 New Hampshire Avenue, Building 22, Room 1440, Silver Spring, MD 
20993-0002, Phone: 240 402-4089, Email: [email protected].
    RIN: 0910-AI57

75. Amendments to the Final Rule Regarding the List of Bulk Substances 
That Can be Used To Compound Drug Products in Accordance With Section 
503A of the Federal Food, Drug, and Cosmetic Act (Section 610 Review) 
[0910-AI70]

    Legal Authority: 21 U.S.C. 353a; 21 U.S.C. 351; 21 U.S.C. 371(a); 
21 U.S.C. 352; 21 U.S.C. 355
    Abstract: FDA has issued a regulation creating a list of bulk drug 
substances (active pharmaceutical ingredients) that can be used to 
compound drug products in accordance with section 503A of the Federal 
Food, Drug, and Cosmetic Act, although they are neither the subject of 
an applicable United States Pharmacopeia (USP) or National Formulary 
(NF) monograph nor components of FDA-approved drug products (the 503A 
Bulks List). The proposed rule will identify certain bulk drug 
substances that FDA has considered and is proposing to place on the 
503A Bulks List and certain bulk drug substances that FDA has 
considered and is proposing not to include on the 503A Bulks List.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Rosilend Lawson, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993, 
Phone: 240 402-6223, Email: [email protected].
    RIN: 0910-AI70

76. Distribution of Compounded Drug Products Under Section 503A of the 
Federal Food, Drug, and Cosmetic Act (Section 610 Review) [0910-AI71]

    Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21 
U.S.C. 353a-1; 21 U.S.C. 355; 21 U.S.C. 371
    Abstract: The Food and Drug Administration is proposing rulemaking 
regarding statutory requirements under section 503A of the Federal 
Food, Drug, and Cosmetic Act for certain distributions of compounded 
human drug products. The proposed rule, if finalized, will include 
provisions regarding a standard memorandum of understanding (MOU) that 
describes the responsibilities of a State Board of Pharmacy or other 
appropriate State agency that chooses to sign the standard MOU in 
investigating complaints related to drug products compounded in such 
State and distributed outside such State and in addressing the 
interstate distribution of inordinate amounts of compounded human drug 
products. It will also, if finalized, include provisions regarding the 
statutory 5 percent limit on distribution of compounded human drug 
products out of the State in which they are compounded in States that 
do not sign the standard MOU. The rule, will also, if finalized, 
address communication with State boards of pharmacy.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Dominic Markwordt, Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, 
Room 5104, Silver Spring, MD 20993, Phone: 301 796-9349, Email: 
[email protected].
    RIN: 0910-AI71

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

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 343 note; 
21 U.S.C. 371
    Abstract: This proposed rule, if finalized, would require the front 
of food labels to display certain nutrition information to help 
consumers, including those who are busy and those with lower nutrition 
knowledge, make more informed dietary choices. Front-of-package 
nutrition labeling is intended to complement the Nutrition Facts label 
on packaged foods by giving consumers additional context to help them 
quickly and easily identify foods that can help them build a healthy 
eating pattern. This proposed rule is being developed as part of a 
broader, whole-of-government approach to help reduce the burden of 
chronic disease and advance health equity by helping to improve dietary 
patterns in the United States. Development of the proposed rule has 
been informed by, among other things, research findings and extensive 
public outreach and engagement, including a public meeting conducted by 
the Reagan-Udall Foundation for the FDA and listening sessions with a 
range of interested parties.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mark Kantor, Nutritionist, Department of Health and 
Human Services, Food and Drug Administration, CPK1 RM 3D034, HFS-830, 
5001 Campus Drive, College Park, MD 20740, Phone: 240 402-2082, Email: 
[email protected].
    RIN: 0910-AI80

78. Registration of Commercial Importers of Drugs; Good Importing 
Practice [0910-AI87]

    Legal Authority: sec. 714 of the Food and Drug Administrative 
Safety and Innovation Act (FDASIA) of July 2012
    Abstract: This proposed rulemaking meets the mandate of section 714 
of the Food and Drug Administration Safety and Innovation Act and will 
establish registration and good importing practice requirements for 
commercial importers of drugs. Although manufacturers are subject to 
regulatory requirements to ensure such quality standards are met, there 
are few clear responsibilities for commercial importers of drugs to do 
the same.
    Cost estimates of the rule include reading and understanding the 
rule, registering as a commercial importer through the Food and Drug 
Administration's (FDA) electronic importer registration system, annual 
updating of registration, establishing a quality management system, 
conducting risk evaluations of drugs and suppliers, shipment 
verifications, investigations, corrective actions, and records 
maintenance.
    The unquantified benefits of the proposed rule include improvement 
in the safety of finished drugs allowed to enter the United States from 
the commercial drug importer's requirement

[[Page 66811]]

to register with FDA and for increased due diligence required by the 
importer regarding the safety of the drugs. There would also be cost 
savings to both FDA and industry from facilitating the review of 
documentation that ensures compliance with our regulations prior to 
being allowed to enter the United States. This proposed rulemaking will 
also enhance FDA's ability to collect and analyze data to enable risk-
informed decision-making while focusing on protecting the integrity of 
the global drug supply chain and ensuring safety, effectiveness, and 
quality of imported drugs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: James Hanratty, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, WO 75, Rm. 
1607A, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 240 
402-4718, Email: [email protected].
    RIN: 0910-AI87

79.  Amendments to the Current Good Manufacturing Practice 
Regulations for Drug Products [0910-AI88]

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 
U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 360bbb-7; 21 
U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264
    Abstract: FDA is proposing to amend the Current Good Manufacturing 
Practice Regulations for Drug Products. The proposed amendment will 
clarify and modernize the regulations by adding requirements for 
quality management systems and controls over components and drug 
product containers and closures.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/00/25
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ashley Boam, Health Science Administrator, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 
New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6341, 
Email: [email protected].
    RIN: 0910-AI88

80.  Pediatric Study Plan Requirements for New Drug and 
Biologics License Applications [0910-AI89]

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kristiana Brugger, Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 5252, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-3600, Email: 
[email protected].
    RIN: 0910-AI89

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

81. Sunlamp Products; Amendment to the Performance Standard [0910-AG30]

    Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393; 
21 U.S.C. 371
    Abstract: FDA is updating the performance standard for sunlamp 
products and ultraviolet lamps intended for use in these products to 
improve safety, reflect new scientific information, and work towards 
harmonization with international standards. By harmonizing with the 
International Electrotechnical Commission, this rule will decrease the 
regulatory burden on industry and allow the Agency to take advantage of 
the expertise of the international committees, thereby also saving 
resources.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/22/15  80 FR 79505
NPRM Comment Period End.............   03/21/16
Final Rule..........................   12/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for 
Devices and Radiological Health, Department of Health and Human 
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 
66, Room 5454, Silver Spring, MD 20993, Phone: 301 796-5678, Email: 
[email protected].
    RIN: 0910-AG30

82. General and Plastic Surgery Devices: Restricted Sale, Distribution, 
and Use of Sunlamp Products [0910-AH14]

    Legal Authority: 21 U.S.C. 360j(e)
    Abstract: This rule will apply device restrictions to sunlamp 
products. Sunlamp products include ultraviolet (UV) lamps and UV 
tanning beds and booths. A large number of skin cancer cases, including 
cases of melanoma, are attributable to the use of sunlamp products. 
Beginning use of sunlamp products at young ages, as well as frequently 
using sunlamp products, both increases the risk of developing skin 
cancers and other illnesses, and sustaining other injuries. Even 
infrequent use, particularly at younger ages, can significantly 
increase these risks.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/22/15  80 FR 79493
NPRM Comment Period End.............   03/21/16
Final Rule..........................   11/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Daniel Schieffer, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, 
Silver Spring, MD 20993, Phone: 301 796-3350, Email: 
[email protected].
    RIN: 0910-AH14

[[Page 66812]]

83. Amendments to the List of Bulk Drug Substances That Can Be Used To 
Compound Drug Products in Accordance With Section 503A of the Federal 
Food, Drug, and Cosmetic Act [0910-AH81]

    Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21 
U.S.C. 355; 21 U.S.C. 371
    Abstract: FDA has issued a regulation creating a list of bulk drug 
substances (active pharmaceutical ingredients) that can be used to 
compound drug products in accordance with section 503A of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the 
subject of an applicable United States Pharmacopeia (USP) or National 
Formulary (NF) monograph nor components of FDA-approved drugs (the 503A 
Bulks List). FDA has proposed to amend the 503A Bulks List by placing 
additional bulk drug substances on the list. FDA has also identified 
bulk drug substances that FDA has considered and proposed not to 
include on the 503A Bulks List. Additional substances nominated by the 
public for inclusion on this list are currently under consideration and 
will be the subject of future rulemaking.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/05/19  84 FR 46688
NPRM Comment Period End.............   12/04/19
Final Rule..........................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Oluwaseun ``Kemi'' Asante, Department of Health and 
Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD 
20993, Phone: 301 796-7425, Email: [email protected].
    RIN: 0910-AH81

84. Requirements for Tobacco Product Manufacturing Practice [0910-AH91]

    Legal Authority: 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381(a); 21 
U.S.C. 387b; 21 U.S.C. 387c; 21 U.S.C. 387f; 21 U.S.C. 387i; . . .
    Abstract: The rule would establish tobacco product manufacturing 
practice (TPMP) requirements for manufacturers of finished and bulk 
tobacco products. This rule, if finalized, would set forth requirements 
for the manufacture, pre-production design validation, packing, and 
storage of a tobacco product. This rule would help prevent the 
manufacture and distribution of contaminated and otherwise 
nonconforming tobacco products. This rule provides manufacturers with 
flexibility in the manner in which they comply with the requirements 
while giving FDA the ability to enforce regulatory requirements, thus 
helping to assure the protection of public health. In April 2023, FDA 
held an all tribes' call to provide an overview of the proposed rule, 
answer questions, and receive tribal feedback. Additionally, in May 
2023, FDA held an open session meeting of the Tobacco Products 
Scientific Advisory Committee to enable the committee to discuss and 
provide recommendations on the proposed rule. FDA made background 
material available to members of the public and interested persons were 
able to present data, information, and views on issues pending before 
the committee.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/10/23  88 FR 15174
NPRM Comment Period End.............   09/06/23
NPRM Comment Period Extension to       08/29/23  88 FR 59481
 Oct. 06, 2023.
Final Rule..........................   04/00/25
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Matthew Brenner, Senior Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Tobacco Products, 10903 New Hampshire Avenue, Document 
Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 
877 287-1373, Email: [email protected].
    RIN: 0910-AH91

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/29/22  87 FR 59168
NPRM Comment Period End.............   12/28/22
NPRM Comment Period Extended........   11/29/22  87 FR 73267
NPRM Comment Period Extended End....   02/16/23
Final Rule..........................   09/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Vincent De Jesus, Nutritionist, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint 
Branch Parkway, College Park, MD 20740, Phone: 240 402-1774, Fax: 301 
436-1191, Email: [email protected].
    RIN: 0910-AI13

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

86. National Standards for the Licensure of Wholesale Drug Distributors 
and Third-Party Logistics Providers [0910-AH11]

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/04/22  87 FR 6708
NPRM Comment Period End.............   06/06/22
NPRM Comment Period Extended........   05/24/22  87 FR 31439
NPRM Comment Period Extended End....   09/06/22
Final Rule..........................   05/00/26
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of

[[Page 66813]]

Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Building 51, Room 4261, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9362, Email: 
[email protected].
    RIN: 0910-AH11

87. Nicotine Toxicity Warnings [0910-AH24]

    Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C. 
371; 21 U.S.C. 387f; . . .
    Abstract: This rule would establish acute nicotine toxicity warning 
requirements for liquid nicotine and nicotine-containing e-liquid(s) 
intended for human consumption, and potentially for other tobacco 
products including, but not limited to, novel tobacco products such as 
dissolvables, lotions, gels, and drinks. This action is intended to 
increase consumer awareness and knowledge of the risks of acute 
toxicity due to accidental nicotine exposure from nicotine-containing 
e-liquids in tobacco products.
    Timetable:

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Laura Chilaka, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, 
Building 71, Room G355, Silver Spring, MD 20993, Phone: 877 287-1373, 
Email: [email protected].
    RIN: 0910-AH24

88. Certain Requirements Regarding Prescription Drug Marketing (203 
Amendment) [0910-AH56]

    Legal Authority: Section 503 and related provisions of the FD&C 
Act, as amended by Pub. L. 113-54
    Abstract: The final rule amends Food and Drug Administration (FDA) 
regulations at 21 CFR 203 to remove provisions no longer in effect and 
incorporate conforming changes following enactment of the Drug Supply 
Chain Security Act (DSCSA). The final rule amends the regulations to 
clarify provisions and avoid causing confusion with the new standards 
for wholesale distribution established by DSCSA.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/04/22  87 FR 6443
NPRM Comment Period End.............   04/05/22
Final Rule..........................   05/00/26
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Building 51, Room 4261, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9362, Email: 
[email protected].
    RIN: 0910-AH56

89. Medication Guide; Patient Medication Information [0910-AH68]

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

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Chris Wheeler, Supervisory Project Manager, 
Department of Health and Human Services, Food and Drug Administration, 
10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD 
20993, Phone: 301 796-0151, Email: [email protected].
    RIN: 0910-AH68

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

    Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 371(a); 21 
U.S.C. 387b and 387c; 21 U.S.C. 387f(d) and 387g; . . .
    Abstract: This rule is a tobacco product standard that would 
prohibit characterizing flavors (other than tobacco) in all cigars. We 
are taking this action with the intention of reducing the tobacco-
related death and disease associated with cigar use. Evidence shows 
that flavored tobacco products appeal to youth and also shows that 
youth may be more likely to initiate tobacco use with such products. 
Characterizing flavors in cigars, such as strawberry, grape, orange, 
and cocoa, enhance taste and make these products easier to use. Over a 
half million youth in the United States use flavored cigars, placing 
these youth at risk for cigar-related death and disease.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   03/21/18  83 FR 12294
ANPRM Comment Period End............   07/19/18
NPRM................................   05/04/22  87 FR 26396
NPRM Comment Period Extended........   06/21/22  87 FR 36786
NPRM Comment Period End.............   07/05/22
NPRM Comment Period Extended End....   08/02/22
                                     -----------------------------------
Final Action........................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nathan Mease, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Center for Tobacco Products, Document Control Center, 
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, 
Email: [email protected].
    RIN: 0910-AI28

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   07/24/13  78 FR 44484
ANPRM Comment Period End............   09/23/13
NPRM................................   05/04/22  87 FR 26454
NPRM Comment Period Extended........   06/21/22  87 FR 36786
NPRM Comment Period End.............   07/05/22

[[Page 66814]]

 
NPRM Comment Period Extended End....   08/02/22
                                     -----------------------------------
Final Action........................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Beth Buckler, Senior Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, 
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, 
Email: [email protected].
    RIN: 0910-AI60

92. Postmarketing Safety Reporting Requirements, Pharmacovigilance 
Plans, and Pharmacovigilance Quality Systems for Human Drug and 
Biological Products [0910-AI61]

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

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice L. Weiner, Principal Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, 
Building 51, Room 6270, Silver Spring, MD 20993-0002, Phone: 301 796-
3475, Fax: 301 847-8440, Email: [email protected].
    RIN: 0910-AI61

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

    Legal Authority: 21 U.S.C. 387g
    Abstract: The proposed rule is a tobacco product standard that 
would establish a maximum nicotine level in cigarettes and certain 
other finished tobacco products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nathan Mease, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Center for Tobacco Products, Document Control Center, 
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, 
Email: [email protected].
    Dhanya John, Regulatory Counsel, Department of Health and Human 
Services, Food and Drug Administration, Center for Tobacco Products, 
Document Control Center, Building 71, Room G335, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 877 287-
1426, Email: [email protected].
    RIN: 0910-AI76

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

94. Direct-to-Consumer Prescription Drug Advertisements: Presentation 
of the Major Statement in a Clear, Conspicuous, Neutral Manner in 
Advertisements in Television and Radio Format [0910-AG27]

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; . . .
    Abstract: The Food and Drug Administration (FDA) is amending its 
regulations concerning direct-to-consumer (DTC) advertisements of 
prescription drugs. Prescription drug advertisements presented through 
media such as TV and radio must disclose the product's major side 
effects and contraindications in what is sometimes called the major 
statement. The rule would revise the regulation to reflect the 
statutory requirement that in DTC advertisements for human prescription 
drugs presented in television or radio format and stating the name of 
the drug and its conditions of use, the major statement relating to 
side effects and contraindications of the advertised drug must be 
presented in a clear, conspicuous, and neutral manner. This rule also 
establishes standards for determining whether the major statement in 
these advertisements is presented in the manner required.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   11/21/23  88 FR 80958
Final Rule Effective................   05/20/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Suzanna Boyle, Phone: 240 402-4723, Email: 
[email protected].
    RIN: 0910-AG27

95. Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption Relating to Agricultural Water [0910-
AI49]

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 
U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 243; 42 U.S.C. 264; 42 U.S.C. 
271; . . .
    Abstract: This rulemaking will revise certain requirements for 
agricultural water for covered produce other than sprouts in the 
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
for Human Consumption (produce safety) regulation for covered produce 
other than sprouts.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   05/06/24  89 FR 37448
Final Rule Effective................   07/05/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Samir Assar, Phone: 240 402-1636, Email: 
[email protected].
    RIN: 0910-AI49

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

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 
U.S.C. 352; 21 U.S.C. 360c; . . .

[[Page 66815]]

    Abstract: This rule would amend the Food and Drug Administration's 
regulations to make explicit that laboratory developed tests (LDTs) are 
devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act.)
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/03/23  88 FR 68006
Final Rule..........................   05/06/24  89 FR 37286
Final Rule Effective................   07/05/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Eitan Bernstein, Phone: 240 402-9812, Email: 
[email protected].
    RIN: 0910-AI85

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

97. CY 2025 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1807) (Section 610 
Review) [0938-AV33]

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 117-169
    Abstract: This annual proposed rule would revise payment polices 
under the Medicare physician fee schedule, and make other policy 
changes to payment under Medicare Part B. These changes would apply to 
services furnished beginning January 1, 2025. Additionally, this rule 
proposes updates to the Quality Payment Program. This proposed rule 
would also codify the inflation rebate program for Medicare Part B and 
Part D drugs established in the Inflation Reduction Act.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gift Tee, Director, Division of Physician Services, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS: 
C1-09-07, Baltimore, MD 21244, Phone: 410 786-9316, Email: 
[email protected].
    RIN: 0938-AV33

98. CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1809) (Section 610 Review) [0938-AV35]

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elise Barringer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-9222, Email: 
[email protected].
    RIN: 0938-AV35

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

99. Mental Health Parity and Addiction Equity Act and the Consolidated 
Appropriations Act, 2021 (CMS-9902) [0938-AU93]

    Legal Authority: Pub. L. 116-260, Division BB, title II; Pub. L. 
110-343, secs. 511 and 512
    Abstract: This rule would finalize proposed amendments to the final 
rules implementing the Mental Health Parity and Addiction Equity Act 
(MHPAEA). The amendments clarify plans' and issuers' obligations under 
the law, promote compliance with MHPAEA, and update requirements taking 
into account experience with MHPAEA in the years since the rules were 
finalized. The rule would also finalize new regulations implementing 
amendments to MHPAEA recently enacted as part of the Consolidated 
Appropriations Act, 2021 (CAA, 2021).
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/03/23  88 FR 51552
NPRM Comment Period Extended........   09/28/23  88 FR 66728
NPRM Comment Period End.............   10/02/23
NPRM Comment Period Extended End....   10/17/23
Final Action........................   07/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation 
Division, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Center for Consumer Information and Insurance 
Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 
492-4106, Email: [email protected].
    RIN: 0938-AU93

100. Independent Dispute Resolution Operations (CMS-9897) [0938-AV15]

    Legal Authority: Pub. L. 116-260, Division BB, title I & title II
    Abstract: This final rule amends the Requirements Related to 
Surprise Billing; Part I (July 2021 interim final rules), Requirements 
Related to Surprise Billing Interim Final Rules; Part II (October 2021 
interim final rules), and Requirements Related to Surprise Billing 
Final Rules (August 2022 final rules), which set forth requirements 
related to Title I (No Surprises Act (NSA)) and Title II (Transparency) 
of Division BB of the Consolidated Appropriations Act, 2021.
    Timetable:

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Deborah Bryant, Senior Advisor, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center

[[Page 66816]]

for Consumer Information and Insurance Oversight, MS: W08-134, 7500 
Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4293, Email: 
[email protected].
    RIN: 0938-AV15

101. FY 2025 Hospice Wage Index, Payment Rate Update, and Quality 
Reporting Requirements (CMS-1810) (Section 610 Review) [0938-AV29]

    Legal Authority: 42 U.S.C. 1302
    Abstract: This annual proposed rule would update the hospice 
payment rates and the wage index for fiscal year 2025. The rule also 
proposes changes to the Hospice Quality Reporting program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/04/24  89 FR 23778
NPRM Comment Period End.............   05/28/24
Final Action........................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Slater, Director, Division of Home Health and 
Hospice, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Center for Medicare, MS: C4-07-07, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-5229, Email: 
[email protected].
    RIN: 0938-AV29

102. FY 2025 Skilled Nursing Facility (SNFS) Prospective Payment System 
and Consolidated Billing and Updates to the Value-Based Purchasing and 
Quality Reporting Programs (CMS-1802) (Section 610 Review) [0938-AV30]

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C. 
1395f(b); 42 U.S.C. 1395g; 42 U.S.C. 1395l(a); 42 U.S.C. 1395l(i); 42 
U.S.C. 13951(n); 42 U.S.C. 1395m; 42 U.S.C. 1395x(v); 42 U.S.C. 
1395x(kkk); 42 U.S.C. 1395hh; 42 U.S.C. 1395rr; 42 U.S.C. 1395tt; 42 
U.S.C. 1395ww
    Abstract: This annual rule updates the payment rates used under the 
prospective payment system for SNFs for fiscal year 2025. The rule also 
includes updates to the SNF Quality Reporting Program (QRP) and the 
Skilled Nursing Facility Value-Based Purchasing (VBP) Program that will 
affect Medicare payment to SNFs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/03/24  89 FR 23424
NPRM Comment Period End.............   05/28/24
Final Action........................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Tammy Luo, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare, MS: C5-06-17, 7500 Security Boulevard, Baltimore, 
MD 21244, Phone: 410 786-4325, Email: [email protected].
    RIN: 0938-AV30

103. FY 2025 Inpatient Psychiatric Facilities Prospective Payment 
System Rate and Quality Reporting Updates (CMS-1806) (Section 610 
Review) [0938-AV32]

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g; 
42 U.S.C. 1395hh; 42 U.S.C. 1395ww(s)
    Abstract: This annual rule updates the prospective payment system 
for inpatient psychiatric facilities (IPF) with discharges beginning on 
October 1, 2024. The rule also includes updates to the IPF Quality 
Reporting Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/03/24  89 FR 23146
NPRM Comment Period End.............   05/28/24
Final Action........................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Marissa Kellam, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-04-23, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-3012, Email: 
[email protected].
    RIN: 0938-AV32

104. Hospital Inpatient Prospective Payment Systems for Acute Care 
Hospitals; the Long-Term Care Hospital Prospective Payment System; and 
FY 2025 Rates (CMS-1808) (Section 610 Review) [0938-AV34]

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/02/24  89 FR 35934
NPRM Comment Period End.............   06/10/24
Final Action........................   10/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Director, Division of Acute Care, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: 
[email protected].
    RIN: 0938-AV34

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

105. CY 2024 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1784) (Completion 
of a Section 610 Review) [0938-AV07]

    Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
    Abstract: This annual final rule revises payment polices under the 
Medicare physician fee schedule, and makes other policy changes to 
payment under Medicare Part B including, but not limited to, 
establishing payment policies for dental services prior to the 
initiation of immunotherapy services. These changes apply to services 
furnished beginning January 1, 2024. Additionally, this rule updates 
the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/07/23  88 FR 52262
NPRM Comment Period End.............   09/11/23
Final Action........................   11/16/23  88 FR 78818
Final Action Effective..............   01/01/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gift Tee, Director, Division of Physician Services, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS: 
C1-09-

[[Page 66817]]

07, Baltimore, MD 21244, Phone: 410 786-9316, Email: 
[email protected].
    RIN: 0938-AV07

106. CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1786) (Completion of a Section 610 Review) [0938-
AV09]

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/31/23  88 FR 49552
NPRM Comment Period End.............   09/11/23
Final Action........................   11/22/23  88 FR 81540
Final Action Effective..............   01/01/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elise Barringer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-9222, Email: 
[email protected].
    RIN: 0938-AV09

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Administration for Children and Families (ACF)

Proposed Rule Stage

107.  Native American Programs Financial and Administrative 
Requirements (Section 610 Review) [0970-AD05]

    Legal Authority: 42 U.S.C. 2991b (b)
    Abstract: This rule would remove the 20 percent non-federal 
contribution requirement for all grant awards under the Native American 
Programs Act (NAPA). This is in response to Executive Order 14112 
Reforming Federal Funding and Support for Tribal Nations to Better 
Embrace Our Trust Responsibilities and Promote the Next Era of Tribal 
Self-Determination which in part recognizes that federal programs were 
administered in unduly burdensome ways that left Tribal Nations unduly 
burdened and frustrated with bureaucracy. Elimination of the 20 percent 
non-federal match for all ANA projects would have profound impact on 
tribal communities with respect to improving equity and access to 
federal programs intended for their benefit. Tribal leaders across 
Indian Country have testified that nonfederal share requirement is a 
significant barrier for applying and administering grant funds 
especially for the smaller tribes that lack the resources to meet the 
non-federal share.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Amy Zukowski, Acting Director Policy, Department of 
Health and Human Services, Administration for Children and Families, 
Administration for Native Americans, 330 C Street SW, Mail Stop 4126, 
Washington, DC 20201, Phone: 202 205-5606, Email: 
[email protected].
    RIN: 0970-AD05

108.  Name Change From Office of Child Support Enforcement to 
Office of Child Support Services (Section 610 Review) [0970-AD06]

    Legal Authority: Not Yet Determined
    Abstract: This Notice of Proposed Rulemaking would update 45 CFR 
Chapter III to reflect that on June 5, 2023, the Office of Child 
Support Enforcement became the Office of Child Support Services. This 
name change reflects the program's commitment to serve the whole family 
and provide services that promote family self-sufficiency so children 
receive reliable support from both parents.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Tavaughn McKenny, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
Office of Child Support Services, 330 C Street SW, Washington, DC 
20201, Phone: 202 565-0129, Email: [email protected].
    RIN: 0970-AD06

109.  Temporary Assistance for Needy Families Work 
Participation Rate Calculation Changes (Section 610 Review) [0970-AD07]

    Legal Authority: secs. 301 and 303 of the Fiscal Responsibility Act 
of 2023 (FRA, Public Law 118-5)
    Abstract: To comply with requirements from the Fiscal 
Responsibility Act of 2023 (FRA), this NPRM will propose changes to the 
how Temporary Assistance for Needy Families (TANF) regulations describe 
the federal work participation rate (WPR) calculation. As required by 
Section 301 of the FRA, this NPRM will propose a recalibration of the 
base year for the caseload reduction credit component of the WPR 
calculation. The base year will change from 2005 to 2015. As required 
by Section 303 of the FRA, this NPRM will propose that ACF only count a 
case in a state's work participation rate calculation if the assistance 
level for that case is at least $35 a month. Both changes will be 
effective October 1, 2025.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: La Sherra Ayala, Deputy Director, Department of 
Health and Human Services, Administration for Children and Families, 
Office of Family Assistance, 330 C Street SW, Washington, DC 20201, 
Phone: 202 478-0714, Email: [email protected].
    RIN: 0970-AD07

110.  Unaccompanied Children Program Prevention of Sexual Abuse 
NPRM (Section 610 Review) [0970-AD08]

    Legal Authority: sec. 1101(c) of the Violence Against Women 
Reauthorization Act of 2013, Pub. L. 113-4 (VAWA 2013); Amendment to 
the Prison Rape Elimination Act (PREA) Pub. L. 108-79
    Abstract: This Notice of Proposed Rulemaking would update the 
Standards To Prevent, Detect, and Respond to Sexual Abuse and Sexual 
Harassment Involving Unaccompanied Children Interim Final Rule 
published on December 24, 2014, to incorporate public feedback and 
ensure that the practices established in the IFR are

[[Page 66818]]

effectively tailored to the operational realities of the Office of 
Refugee Resettlement's (ORR) Unaccompanied Children (UC) Program. The 
Violence Against Women Reauthorization Act of 2013 (VAWA 2013), Public 
Law 1134, contained a provision applying PREA to custodial facilities 
operated by HHS. VAWA 2013 requires HHS to publish a final rule 
adopting national standards to prevent, detect, and respond to rape and 
sexual assault. These national standards are to apply to all care 
provider facilities that maintain custody of UCs as defined in the 
Homeland Security Act of 2002 (6 U.S.C. 279(g)) and give due 
consideration to the recommended national standards provided by the 
NPREC report. Additionally, HHS is required to regularly assess 
compliance with the standards adopted and include the results of the 
assessments in performance evaluations of care provider facilities. As 
a result, HHS published the IFR to establish standards for the 
prevention, detection, and response to sexual abuse and sexual 
harassment of unaccompanied children in all ORR care provider 
facilities, except secure care providers and traditional foster care 
homes as described in the rule.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Toby Robert McFarren Biswas, Director of Policy, 
Department of Health and Human Services, Administration for Children 
and Families, Office of Refugee Resettlement, Unaccompanied Children 
Bureau, 330 C Street SW, Washington, DC 20201, Phone: 202 555-4440, 
Email: [email protected].
    RIN: 0970-AD08

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Administration for Children and Families (ACF)

Final Rule Stage

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

    Legal Authority: 42 U.S.C. 9801; 42 U.S.C. 9836a; 42 U.S.C. 9839
    Abstract: This NPRM will propose changes to the Head Start Program 
Performance Standards to better support the Head Start workforce and to 
maintain the quality of comprehensive Head Start services. During the 
public comment period, ACF engaged with the Head Start community 
through listening sessions in multiple locations around the country and 
virtually on the proposed rule to generate interest in submitting 
public comments.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/20/23  88 FR 80818
NPRM Comment Period End.............   01/19/24
Final Action........................   07/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jessica Bialecki, Policy and Planning Director, 
Department of Health and Human Services, Administration for Children 
and Families, Office of Head Start, 330 C Street SW, Washington, DC 
20201, Phone: 202 283-1004, Email: [email protected].
    RIN: 0970-AD01

112.  Temporary Assistance for Needy Families Work Outcomes 
Measures (Section 610 Review) [0970-AD04]

    Legal Authority: Section 304 of the Fiscal Responsibility Act of 
2023 (FRA, Pub. L. 118-5)
    Abstract: This interim final rule modifies 45 CFR part 265 in order 
to implement the statutory changes enacted by section 304 of the Fiscal 
Responsibility Act of 2023 (FRA, Public Law 118-5) related to the 
reporting of work outcomes under the Temporary Assistance for Needy 
Families (TANF) program. ACF is promulgating this rule as an interim 
final rule to ensure states and territories have sufficient time to 
comply with data collection for fiscal year 2025.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   07/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: La Sherra Ayala, Deputy Director, Department of 
Health and Human Services, Administration for Children and Families, 
Office of Family Assistance, 330 C Street SW, Washington, DC 20201, 
Phone: 202 478-0714, Email: [email protected].
    RIN: 0970-AD04

113.  Head Start Program Class Effective Date Delay Direct 
Final Rule (Section 610 Review) [0970-AD09]

    Legal Authority: sec. 641 of the Act (42 U.S.C. 9836) as amended by 
the Improving Head Start for School Readiness Act of 2007 (Pub. L. 110-
134)
    Abstract: This Direct Final Rule describes how the Office of Head 
Start officially delays the compliance date for programs to meet the 
new competitive threshold for the Instructional Support domain of the 
Classroom Assessment Scoring System (CLASS[supreg]) used to determine 
whether a Head Start agency will be subject to an open competition 
under the Designation Renewal System. The effective date in the Head 
Start Program Performance Standards that raises the CLASS Instructional 
Support competitive threshold from 2.3 to 2.5 was August 1, 2025. ACF 
is pursuing this as a Direct Final Rule due to the time constraints of 
when the threshold increase was scheduled to go into effect. This 
Direct Final Rule officially delays this effective date to August 1, 
2027.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Final Action........................   09/00/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Jessica Bialecki, Policy and Planning Director, 
Department of Health and Human Services, Administration for Children 
and Families, Office of Head Start, 330 C Street SW, Washington, DC 
20201, Phone: 202 283-1004, Email: [email protected].
    RIN: 0970-AD09

114.  ORR UC Program Child Abuse and Neglect (Section 610 
Review) [0970-AD10]

    Legal Authority: 6 U.S.C. 279; 8 U.S.C. 1232(b)-(c)
    Abstract: This Interim Final Rule on ORR child abuse and neglect 
investigations describes how ORR shall investigate and substantiate 
allegations of child abuse or neglect occurring in certain ORR care 
facilities and maintain a registry of perpetrators relating to those 
facilities where a State agency that would otherwise be responsible for 
such investigations will not investigate allegations arising at 
facilities housing unaccompanied children (e.g., because the State does 
not license facilities on the basis that they serve unaccompanied 
children). This interim final rule describes the obligations of care 
provider facilities in the course of an investigation of allegations of 
child abuse or neglect.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   08/00/24
------------------------------------------------------------------------


[[Page 66819]]

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Toby Robert McFarren Biswas, Director of Policy, 
Department of Health and Human Services, Administration for Children 
and Families, Office of Refugee Resettlement, Unaccompanied Children 
Bureau, 330 C Street SW, Washington, DC 20201, Phone: 202 555-4440, 
Email: [email protected].
    RIN: 0970-AD10

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Administration for Children and Families (ACF)

Completed Actions

115. Safe and Appropriate, Affirming Foster Care Placement Requirements 
for Titles IV-E and IV-B (Completion of a Section 610 Review) [0970-
AD03]

    Legal Authority: 42 U.S.C. 671(a)(16); 42 U.S.C. 622(b)(8)(A)(ii); 
42 U.S.C. 675(1)(B); 42 U.S.C. 675(5))
    Abstract: This rule clarifies that title IV-E/IV-B agencies are 
required to offer safe and appropriate foster care placements, 
including processes to ensure children can request such placements and 
agencies must respond to concerns about those placements, for children 
in foster care who identify as lesbian, gay, bisexual, transgender, 
queer or questioning, intersex (LGBTQI+). The rule will not interfere 
with faith-based child welfare providers that continue to partner with 
title IV-E/IV-B agencies in a way that does not interfere with those 
providers' sincerely held religious beliefs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/28/23  88 FR 66752
NPRM Comment Period End.............   11/27/23
Final Action........................   04/30/24  89 FR 34818
Final Action Effective..............   07/01/24
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Kathleen McHugh, Director, Department of Health and 
Human Services, Administration for Children and Families, Children's 
Bureau, Division of Policy, 330 C Street SW, Washington, DC 20201, 
Phone: 202 401-5789, Fax: 202 205-8221, Email: [email protected].
    RIN: 0970-AD03

[FR Doc. 2024-16451 Filed 8-15-24; 8:45 am]
BILLING CODE 4150-03-P

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