Regulatory Agenda, 11228-11236 [2023-02026]

Download as PDF 11228 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / UA: Reg Flex Agenda summarized information about forthcoming regulatory actions. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Office of the Secretary Elizabeth J. Gramling, Executive Secretary, Department of Health and 21 CFR Ch. I Human Services, 200 Independence Avenue SW, Washington, DC 20201; 25 CFR Ch. V (202) 690–5627. SUPPLEMENTARY INFORMATION: The 42 CFR Chs. I–V Department of Health and Human Services (HHS) is the Federal 45 CFR Subtitle A; Subtitle B, Chs. II, government’s lead agency for protecting III, and XIII the health of all Americans and providing essential human services. Regulatory Agenda HHS enhances the health and wellbeing of Americans by promoting AGENCY: Office of the Secretary, HHS. effective health and human services and ACTION: Semiannual Regulatory Agenda. by fostering sound, sustained advances in the sciences underlying medicine, SUMMARY: The Regulatory Flexibility Act public health, and social services. This Agenda presents the regulatory of 1980 and Executive Order (E.O.) activities that the Department expects to 12866 require the semiannual issuance undertake in the foreseeable future to of an inventory of rulemaking actions advance this mission. The purpose of under development throughout the the Agenda is to encourage more Department, offering for public review 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 expanding access to health care, tackling disparities and advancing equity, increasing the nation’s public health preparedness, and supporting the wellbeing of families and communities, 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 OF THE SECRETARY—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 301 .................... Limiting the Effect of Exclusions Implemented Under the Social Security Act (Rulemaking Resulting From a Section 610 Review). 0991–AC11 SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 302 .................... Medications for the Treatment of Opioid Use Disorder (Reg Plan Seq No. 56) ............................................ 0930–AA39 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. CENTERS FOR DISEASE CONTROL AND PREVENTION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 303 .................... Control of Communicable Diseases; Foreign Quarantine (Reg Plan Seq No. 57) ........................................ 0920–AA75 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE lotter on DSK11XQN23PROD with PROPOSALS4 Sequence No. 304 305 306 307 308 309 .................... .................... .................... .................... .................... .................... 310 .................... VerDate Sep<11>2014 Regulation Identifier No. Title Medication Guide; Patient Medication Information .......................................................................................... Requirements for Tobacco Product Manufacturing Practice ........................................................................... Administrative Detention of Tobacco Products ................................................................................................ Nutrient Content Claims, Definition of Term: Healthy ..................................................................................... 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). 21:04 Feb 21, 2023 Jkt 250001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\22FEP8.SGM 22FEP8 0910–AH68 0910–AH91 0910–AI05 0910–AI13 0910–AI57 0910–AI70 0910–AI71 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / UA: Reg Flex Agenda 11229 FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE Regulation Identifier No. Sequence No. Title 311 .................... Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format. Sunlamp Products; Amendment to the Performance Standard ...................................................................... Mammography Quality Standards Act (Reg Plan Seq No. 63) ...................................................................... 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. Revocation of Uses of Partially Hydrogenated Oils in Foods ......................................................................... Tobacco Product Standard for Characterizing Flavors in Cigars (Reg Plan Seq No. 65) ............................. Tobacco Product Standard for Menthol in Cigarettes (Reg Plan Seq No. 67) .............................................. 312 313 314 315 .................... .................... .................... .................... 316 .................... 317 .................... 318 .................... 0910–AG27 0910–AG30 0910–AH04 0910–AH14 0910–AH81 0910–AI15 0910–AI28 0910–AI60 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS Sequence No. 319 320 321 322 .................... .................... .................... .................... Regulation Identifier No. Title National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers .. Nicotine Toxicity Warnings ............................................................................................................................... Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) ........................................ Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products. 0910–AH11 0910–AH24 0910–AH56 0910–AI61 FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 323 .................... Requirements For Additional Traceability Records For Certain Foods ........................................................... 0910–AI44 CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE Regulation Identifier No. Sequence No. Title 324 .................... 325 .................... 326 .................... Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS–4198) ......... Transitional Coverage for Emerging Technologies (CMS–3421) (Reg Plan Seq No. 71) ............................. CY 2024 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1784) (Section 610 Review). Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2024 Rates (CMS–1785) (Section 610 Review). CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1786) (Section 610 Review). 327 .................... 328 .................... 0938–AU59 0938–AU86 0938–AV07 0938–AV08 0938–AV09 References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS Regulation Identifier No. Sequence No. Title 329 .................... Omnibus COVID–19 Health Care Staff Vaccination (CMS–3415) (Section 610 Review) ............................ 0938–AU75 lotter on DSK11XQN23PROD with PROPOSALS4 CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS Regulation Identifier No. Sequence No. Title 330 .................... CY 2023 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS–1766) (Completion of a Section 610 Review). CY 2023 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS–1768) (Completion of a Section 610 Review). FY 2023 Inpatient Psychiatric Facilities Prospective Payment System Rate (CMS–1769) (Completion of a Section 610 Review). CY 2023 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1770) (Completion of a Section 610 Review). 331 .................... 332 .................... 333 .................... VerDate Sep<11>2014 21:04 Feb 21, 2023 Jkt 250001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\22FEP8.SGM 22FEP8 0938–AU77 0938–AU79 0938–AU80 0938–AU81 11230 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / UA: Reg Flex Agenda CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS—Continued Title 334 .................... Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2023 Rates (CMS–1771) (Completion of a Section 610 Review). DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the Secretary (OS) Substance Abuse and Mental Health Services Administration (SAMHSA) Proposed Rule Stage 301. Limiting the Effect of Exclusions Implemented Under the Social Security Act (Rulemaking Resulting From a Section 610 Review) [0991–AC11] Legal Authority: 5 U.S.C. 301; 31 U.S.C. 6101 Abstract: HHS proposes to remove the regulatory provisions at issue, in order to align the regulation with the intent of the Social Security Act and current practice. Exclusions implemented under the Social Security Act prevent individuals convicted of certain crimes or individuals whose health care licenses have been revoked from participating in federal healthcare programs. Instead of only being barred from participating in all federal healthcare programs, certain regulatory provisions have resulted in these type of exclusion actions being given an overly broad government-wide effect, and excluded parties have been barred from participating in all Federal procurement and non-procurement actions. However, because Social Security Act exclusions are not issued under an agency’s suspension and debarment authority, they do not stop individuals from participating in all federal procurement and non-procurement actions. For an agency to bar individuals from participating in all procurement and non-procurement activities, it must exercise its suspension and debarment authority under the Federal Acquisition Regulation or the Nonprocurement Common Rule. Timetable: Action Date NPRM .................. lotter on DSK11XQN23PROD with PROPOSALS4 Regulation Identifier No. Sequence No. FR Cite 12/00/22 Regulatory Flexibility Analysis Required: No. Agency Contact: Tiffani Redding, Program Analyst, Department of Health and Human Services, Office of the Secretary, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202 768–0628, Email: tiffani.redding@ hhs.gov. RIN: 0991–AC11 VerDate Sep<11>2014 21:04 Feb 21, 2023 Jkt 250001 Proposed Rule Stage Regulatory Plan: This entry is Seq. No. 56 in part II of this issue of the Federal Register. RIN: 0930–AA39 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Disease Control and Prevention (CDC) Final Rule Stage 303. Control of Communicable Diseases; Foreign Quarantine [0920–AA75] Regulatory Plan: This entry is Seq. No. 57 in part II of this issue of the Federal Register. RIN: 0920–AA75 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 304. 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 proposed rule would amend FDA medication guide regulations to require a new form of patient labeling, 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 proposed rule would include requirements for Patient Medication Information development and distribution. The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use PO 00000 Frm 00004 Fmt 4701 their prescription drug products safely and effectively. Timetable: Action NPRM .................. 302. Medications for the Treatment of Opioid Use Disorder [0930–AA39] Sfmt 4702 0938–AU84 Date FR Cite 12/00/22 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Chris Wheeler, Supervisory Project Manager, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD 20993, Phone: 301 796– 0151, Email: chris.wheeler@fda.hhs.gov. RIN: 0910–AH68 305. Requirements for Tobacco Product Manufacturing Practice [0910–AH91] Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f Abstract: The rule is proposing to establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This proposal would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products. This proposed rule provides manufacturers with flexibility in the manner in which they comply with the proposed requirements while giving FDA the ability to enforce regulatory requirements, thus helping to assure the protection of public health. Timetable: Action NPRM .................. Date FR Cite 12/00/22 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– E:\FR\FM\22FEP8.SGM 22FEP8 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / UA: Reg Flex Agenda 1373, Email: ctpregulations@ fda.hhs.gov. RIN: 0910–AH91 306. 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 NPRM .................. FR Cite 06/00/23 lotter on DSK11XQN23PROD with PROPOSALS4 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 307. Nutrient Content Claims, Definition of Term: Healthy [0910– AI13] 21:04 Feb 21, 2023 Jkt 250001 Action Date NPRM .................. NPRM Comment Period End. 09/29/22 12/28/22 FR Cite 87 FR 59168 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 308. Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies [0910–AI57] Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262 Abstract: FDA is proposing to amend 21 CFR 320, in certain parts, and establish a new 21 CFR 321 to clarify FDA’s study conduct expectations for clinical pharmacology, and clinical and analytical bioavailability (BA) and bioequivalence (BE) studies that support marketing applications for human drug and biological products. The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies. This regulation would align with FDA’s other good practice regulations, would also be consistent with current industry best practices, and would harmonize the regulations more closely with related international regulatory expectations. Timetable: Action Date NPRM .................. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 343; 21 U.S.C. 371 Abstract: The proposed rule would update the definition for the implied nutrient content claim ‘‘healthy’’ to be consistent with current nutrition science and federal dietary guidelines. VerDate Sep<11>2014 The proposed 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: FR Cite 08/00/23 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Brian Joseph Folian, Supervisory Biologist, Department of Health and Human Services, Food and Drug Administration, 10903 New PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 11231 Hampshire Avenue, Building 51, Room 5215, Silver Spring, MD 20993–0002, Phone: 240 402–4089, Email: brian.folian@fda.hhs.gov. RIN: 0910–AI57 309. 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 (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 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 NPRM .................. Date FR Cite 10/00/23 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 310. 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 E:\FR\FM\22FEP8.SGM 22FEP8 11232 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / UA: Reg Flex Agenda 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 pharmacy. Timetable: Action Date NPRM .................. FR Cite 10/00/23 Regulatory Flexibility Analysis Required: Undetermined. 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 contraindications of an advertised prescription drug must be presented in a clear, conspicuous, and neutral manner. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required. Timetable: Action Date NPRM .................. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period End. NPRM Comment Period Reopened. NPRM Comment Period Reopened End. Final Rule ............ FR Cite 03/29/10 06/28/10 75 FR 15376 01/27/12 77 FR 4273 02/27/12 03/29/12 77 FR 16973 04/09/12 05/00/23 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Suzanna Boyle, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 51, Room 3214, Silver Spring, MD 20993, Phone: 240 402–4723, Email: suzanna.boyle@ fda.hhs.gov. RIN: 0910–AG27 312. Sunlamp Products; Amendment to the Performance Standard [0910–AG30] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) lotter on DSK11XQN23PROD with PROPOSALS4 Final Rule Stage 311. Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format [0910–AG27] Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; . . . Abstract: The Food and Drug Administration (FDA) is amending its regulations concerning direct-toconsumer (DTC) advertisements of prescription drugs. Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. The rule would revise the regulation to reflect the statutory requirement that in DTC advertisements for human drugs in television or radio format, the major statement relating to side effects and VerDate Sep<11>2014 21:04 Feb 21, 2023 Jkt 250001 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 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 NPRM .................. NPRM Comment Period End. Final Rule ............ 12/22/15 03/21/16 FR Cite 80 FR 79505 06/00/23 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for Devices PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 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 313. Mammography Quality Standards Act [0910–AH04] Regulatory Plan: This entry is Seq. No. 63 in part II of this issue of the Federal Register. RIN: 0910–AH04 314. General and Plastic Surgery Devices: Restricted Sale, Distribution, And Use of Sunlamp Products [0910– AH14] Legal Authority: 21 U.S.C. 360j(e) Abstract: This rule will apply device restrictions to sunlamp products. Sunlamp products include ultraviolet (UV) lamps and UV tanning beds and booths. The incidence of skin cancer, including melanoma, has been increasing, and a large number of skin cancer cases are attributable to the use of sunlamp products. The devices may cause about 400,000 cases of skin cancer per year, and 6,000 of which are melanoma. Beginning use of sunlamp products at young ages, as well as frequently using sunlamp products, both increases the risk of developing skin cancers and other illnesses, and sustaining other injuries. Even infrequent use, particularly at younger ages, can significantly increase these risks. Timetable: Action NPRM .................. NPRM Comment Period End. Final Rule ............ Date 12/22/15 03/21/16 FR Cite 80 FR 79493 06/00/23 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–AH14 E:\FR\FM\22FEP8.SGM 22FEP8 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / UA: Reg Flex Agenda 315. 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 five additional bulk drug substances on the list. FDA has also identified 26 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 a future rulemaking. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Rule ............ 09/05/19 12/04/19 FR Cite 84 FR 46688 10/00/23 lotter on DSK11XQN23PROD with PROPOSALS4 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Rosilend Lawson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993, Phone: 240–402–6223, Email: rosilend.lawson@ fda.hhs.gov. RIN: 0910–AH81 316. Revocation of Uses of Partially Hydrogenated Oils in Foods [0910– AI15] Legal Authority: 21 U.S.C. 321; 21 U.S.C. 341; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379e Abstract: In the Federal Register of June 17, 2015 (80 FR 34650), we published a declaratory order announcing our final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) for any use in human food. In the Federal Register of May 21, 2018 (83 FR 23382), we denied VerDate Sep<11>2014 21:04 Feb 21, 2023 Jkt 250001 a food additive petition requesting that the food additive regulations be amended to provide for the safe use of PHOs in certain food applications. We are now planning to issue a direct final rule and companion proposed rule to update our regulations to remove all mention of partially hydrogenated oils from FDA’s GRAS regulations and as an optional ingredient in standards of identity. We are also revoking all prior sanctions for uses of PHOs in food. Timetable: Action Date Direct Final Rule FR Cite 02/00/23 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Ellen Anderson, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS–265, 4300 River Road, College Park, MD 20740, Phone: 240–402–1309, Email: ellen.anderson@fda.hhs.gov. RIN: 0910–AI15 317. Tobacco Product Standard for Characterizing Flavors in Cigars [0910– AI28] Regulatory Plan: This entry is Seq. No. 65 in part II of this issue of the Federal Register. RIN: 0910–AI28 318. Tobacco Product Standard for Menthol in Cigarettes [0910–AI60] Regulatory Plan: This entry is Seq. No. 67 in part II of this issue of the Federal Register. RIN: 0910–AI60 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 319. 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. PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 11233 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 04/00/25 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Building 51, Room 4261, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301–796–9362, Email: aaron.weisbuch@fda.hhs.gov. RIN: 0910–AH11 320. 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 NPRM .................. Date FR Cite 04/00/24 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 E:\FR\FM\22FEP8.SGM 22FEP8 11234 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / UA: Reg Flex Agenda 321. Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) [0910–AH56] Legal Authority: Section 503 and related provisions of the FD&C Act, as amended by Pub. L. 113–54 Abstract: The final rule amends Food and Drug Administration (FDA) regulations at 21 CFR 203 to remove provisions no longer in effect and incorporate conforming changes following enactment of the Drug Supply Chain Security Act (DSCSA). The final rule amends the regulations to clarify provisions and avoid causing confusion with the new standards for wholesale distribution established by DSCSA. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Rule ............ 02/04/22 04/05/22 FR Cite 87 FR 6443 04/00/25 lotter on DSK11XQN23PROD with PROPOSALS4 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 322. 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 VerDate Sep<11>2014 21:04 Feb 21, 2023 Jkt 250001 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 NPRM .................. FR Cite 05/00/24 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Janice L. Weiner, Principal Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring, MD 20993–0002, Phone: 301–796–3475, Fax: 301–847– 8440, Email: janice.weiner@fda.hhs.gov. RIN: 0910–AI61 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 324. Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS–4198) [0938– AU59] Legal Authority: 42 U.S.C. 1395w Abstract: This proposed rule would codify long-established Medicare Advantage and Part D payment policies that are outside the scope of the annual Advance Notice/Rate Announcement. Timetable: Action NPRM .................. Date FR Cite 06/00/23 Completed Actions Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jennifer Shapiro, Director, Medicare Plan Payment Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C1–13–18, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410–786–7407, Email: jennifer.shapiro@cms.hhs.gov. RIN: 0938–AU59 323. Requirements for Additional Traceability Records for Certain Foods [0910–AI44] 325. Transitional Coverage for Emerging Technologies (CMS–3421) [0938–AU86] Legal Authority: sec. 204(d) of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111–353) (21 U.S.C. 2223(d)); sec. 701(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(a)); sec. 361 of the Public Health Service Act (42 U.S.C. 264) Abstract: This rule will establish additional recordkeeping requirements for entities that manufacture, process, pack, or hold foods that are designated as high-risk foods. Completed: Regulatory Plan: This entry is Seq. No. 71 in part II of this issue of the Federal Register. RIN: 0938–AU86 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Reason Date Final Rule ............ Final Action Effective. 11/21/22 01/20/23 FR Cite 87 FR 70910 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Katherine Vierk, Phone: 240–402–2122, Email: katherine.vierk@fda.hhs.gov. RIN: 0910–AI44 PO 00000 326. • CY 2024 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1784) (Section 610 Review) [0938–AV07] Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302 Abstract: This annual proposed rule would revise payment polices under the Medicare physician fee schedule, and make 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 would apply to services furnished beginning January 1, 2024. Additionally, this rule proposes updates to the Quality Payment Program. Timetable: Action NPRM .................. Frm 00008 Fmt 4701 Sfmt 4702 E:\FR\FM\22FEP8.SGM 22FEP8 Date 06/00/23 FR Cite 11235 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / UA: Reg Flex Agenda Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gift Tee, Director, Division of Physician Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS: C1–09– 07, Baltimore, MD 21244, Phone: 410– 786–9316, Email: gift.tee@cms.hhs.gov. RIN: 0938–AV07 327. • Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2024 Rates (CMS–1785) (Section 610 Review) [0938–AV08] Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302 Abstract: This annual proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems. In addition, the rule proposes to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers. Timetable: Action Date NPRM .................. FR Cite 04/00/23 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–AV08 lotter on DSK11XQN23PROD with PROPOSALS4 328. • CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS–1786) (Section 610 Review) [0938–AV09] Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302 Abstract: This annual 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 VerDate Sep<11>2014 21:04 Feb 21, 2023 Jkt 250001 ambulatory surgical center payment system list of services and rates. This proposed rule would also update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Timetable: Action Date NPRM .................. FR Cite 06/00/23 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Elise Barringer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4–03–06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410–786–9222, Email: elise.barringer@cms.hhs.gov. RIN: 0938–AV09 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions 329. Omnibus COVID–19 Health Care Staff Vaccination (CMS–3415) (Section 610 Review) [0938–AU75] Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302 Abstract: This interim final rule with comment period revises the infection control requirements that most Medicare- and Medicaid-participating providers and suppliers must meet to participate in the Medicare and Medicaid programs. These changes are necessary to protect the health and safety of residents, clients, patients, and staff and reflect lessons learned as result of the COVID–19 public health emergency. The revisions to the infection control requirements establish COVID–19 vaccination requirements for staff at the included Medicare- and Medicaid-participating providers and suppliers. Timetable: Action Date Interim Final Rule Interim Final Rule Effective. Interim Final Rule Comment Period End. 11/05/21 11/05/21 Frm 00009 86 FR 61555 01/04/22 Reviewing Public Comments. PO 00000 FR Cite Fmt 4701 To Be Determined Sfmt 4702 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Lauren Oviatt, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: C2–21–16, 7500 Security Boulevard, Baltimore, MD 21244–1850, Phone: 410–786–4683, Email: lauren.oviatt@cms.hhs.gov. RIN: 0938–AU75 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Completed Actions 330. CY 2023 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS–1766) (Completion of a Section 610 Review) [0938–AU77] Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual final rule updates the national standardized 30day period payment rate, national pervisit rates used to calculate low utilization payment adjustments (LUPAs), and outlier payments under the Medicare prospective payment system for home health agencies based on the applicable home health payment update percentage. This rule also updates the home infusion therapy services payment rate. These changes apply to services furnished on or after January 1, 2023. Timetable: Action NPRM .................. NPRM Comment Period End. Final Action ......... Final Rule Effective. Date FR Cite 06/23/22 08/16/22 87 FR 37600 11/04/22 01/01/23 87 FR 66790 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–AU77 E:\FR\FM\22FEP8.SGM 22FEP8 11236 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / UA: Reg Flex Agenda 331. CY 2023 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS–1768) (Completion of a Section 610 Review) [0938–AU79] Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C. 1395f(b); 42 U.S.C. 1395g; . . . Abstract: This annual final rule updates the bundled payment system for ESRD facilities by January 1, 2023. The rule also updates the quality incentives in the ESRD program. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. FR Cite 06/28/22 08/22/22 87 FR 38464 11/07/22 01/01/23 87 FR 67136 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Simone Dennis, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5–06–16, Baltimore, MD 21244, Phone: 410 786– 6041, Email: simone.dennis@ cms.hhs.gov. RIN: 0938–AU79 332. FY 2023 Inpatient Psychiatric Facilities Prospective Payment System Rate (CMS–1769) (Completion of a Section 610 Review) [0938–AU80] Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh Abstract: This annual final rule updates the prospective payment system for inpatient psychiatric facilities (IPF) with discharges beginning on October 1, 2022. Timetable: Action Date lotter on DSK11XQN23PROD with PROPOSALS4 NPRM .................. VerDate Sep<11>2014 04/04/22 21:04 Feb 21, 2023 FR Cite 87 FR 19415 Jkt 250001 Action Date NPRM Comment Period End. Final Action ......... Final Action Effective. FR Cite 05/31/22 07/29/22 10/01/22 87 FR 46846 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Nicolas Brock, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5–05–27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410–786–5148, Email: nicolas.brock@cms.hhs.gov. RIN: 0938–AU80 333. CY 2023 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1770) (Completion of a Section 610 Review) [0938–AU81] Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh 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. These changes apply to services furnished beginning January 1, 2023. Additionally, this rule updates the Quality Payment Program. Timetable: Action Date NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. FR Cite 07/29/22 09/06/22 87 FR 45860 11/18/22 01/01/23 87 FR 69404 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Gift Tee, Director, Division of Physician Services, Department of Health and Human PO 00000 Frm 00010 Fmt 4701 Sfmt 9990 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–AU81 334. Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2023 Rates (CMS–1771) (Completion of a Section 610 Review) [0938–AU84] 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 NPRM .................. NPRM Comment Period End. Final Action ......... Final Action Effective. Date FR Cite 05/10/22 06/17/22 87 FR 28108 08/10/22 10/01/22 87 FR 48780 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–AU84 [FR Doc. 2023–02026 Filed 2–21–23; 8:45 am] BILLING CODE 4150–03–P E:\FR\FM\22FEP8.SGM 22FEP8

Agencies

[Federal Register Volume 88, Number 35 (Wednesday, February 22, 2023)]
[Unknown Section]
[Pages 11228-11236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02026]



[[Page 11227]]

Vol. 88

Wednesday,

No. 35

February 22, 2023

Part VIII





 Department of Health and Human Services





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





Semiannual Regulatory Agenda

Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / 
UA: Reg Flex Agenda

[[Page 11228]]


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

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 expanding access to health care, 
tackling disparities and advancing equity, increasing the nation's 
public health preparedness, and supporting the wellbeing of families 
and communities, 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 of the Secretary--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
301.......................  Limiting the Effect of             0991-AC11
                             Exclusions Implemented
                             Under the Social Security
                             Act (Rulemaking Resulting
                             From a Section 610
                             Review).
------------------------------------------------------------------------


Substance Abuse and Mental Health Services Administration--Proposed Rule
                                  Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
302.......................  Medications for the                0930-AA39
                             Treatment of Opioid Use
                             Disorder (Reg Plan Seq
                             No. 56).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


      Centers for Disease Control and Prevention--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
303.......................  Control of Communicable            0920-AA75
                             Diseases; Foreign
                             Quarantine (Reg Plan Seq
                             No. 57).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
304.......................  Medication Guide; Patient          0910-AH68
                             Medication Information.
305.......................  Requirements for Tobacco           0910-AH91
                             Product Manufacturing
                             Practice.
306.......................  Administrative Detention           0910-AI05
                             of Tobacco Products.
307.......................  Nutrient Content Claims,           0910-AI13
                             Definition of Term:
                             Healthy.
308.......................  Conduct of Analytical and          0910-AI57
                             Clinical Pharmacology,
                             Bioavailability and
                             Bioequivalence Studies.
309.......................  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).
310.......................  Distribution of Compounded         0910-AI71
                             Drug Products Under
                             Section 503A of the
                             Federal Food, Drug, and
                             Cosmetic Act (Section 610
                             Review).
------------------------------------------------------------------------


[[Page 11229]]


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
311.......................  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.
312.......................  Sunlamp Products;                  0910-AG30
                             Amendment to the
                             Performance Standard.
313.......................  Mammography Quality                0910-AH04
                             Standards Act (Reg Plan
                             Seq No. 63).
314.......................  General and Plastic                0910-AH14
                             Surgery Devices:
                             Restricted Sale,
                             Distribution, and Use of
                             Sunlamp Products.
315.......................  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.
316.......................  Revocation of Uses of              0910-AI15
                             Partially Hydrogenated
                             Oils in Foods.
317.......................  Tobacco Product Standard           0910-AI28
                             for Characterizing
                             Flavors in Cigars (Reg
                             Plan Seq No. 65).
318.......................  Tobacco Product Standard           0910-AI60
                             for Menthol in Cigarettes
                             (Reg Plan Seq No. 67).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


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


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
323.......................  Requirements For                   0910-AI44
                             Additional Traceability
                             Records For Certain Foods.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
324.......................  Medicare Advantage and             0938-AU59
                             Medicare Prescription
                             Drug Benefit Program
                             Payment Policy (CMS-4198).
325.......................  Transitional Coverage for          0938-AU86
                             Emerging Technologies
                             (CMS-3421) (Reg Plan Seq
                             No. 71).
326.......................  CY 2024 Revisions to               0938-AV07
                             Payment Policies under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1784)
                             (Section 610 Review).
327.......................  Hospital Inpatient                 0938-AV08
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals; the Long-Term
                             Care Hospital Prospective
                             Payment System; and FY
                             2024 Rates (CMS-1785)
                             (Section 610 Review).
328.......................  CY 2024 Hospital                   0938-AV09
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1786)
                             (Section 610 Review).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
329.......................  Omnibus COVID-19 Health            0938-AU75
                             Care Staff Vaccination
                             (CMS-3415) (Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
330.......................  CY 2023 Home Health                0938-AU77
                             Prospective Payment
                             System Rate Update and
                             Home Infusion Therapy
                             Services Payment Update
                             (CMS-1766) (Completion of
                             a Section 610 Review).
331.......................  CY 2023 Changes to the End-        0938-AU79
                             Stage Renal Disease
                             (ESRD) Prospective
                             Payment System and
                             Quality Incentive Program
                             (CMS-1768) (Completion of
                             a Section 610 Review).
332.......................  FY 2023 Inpatient                  0938-AU80
                             Psychiatric Facilities
                             Prospective Payment
                             System Rate (CMS-1769)
                             (Completion of a Section
                             610 Review).
333.......................  CY 2023 Revisions to               0938-AU81
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1770)
                             (Completion of a Section
                             610 Review).

[[Page 11230]]

 
334.......................  Hospital Inpatient                 0938-AU84
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals; the Long-Term
                             Care Hospital Prospective
                             Payment System; and FY
                             2023 Rates (CMS-1771)
                             (Completion of a Section
                             610 Review).
------------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the Secretary (OS)

Proposed Rule Stage

301. Limiting the Effect of Exclusions Implemented Under the Social 
Security Act (Rulemaking Resulting From a Section 610 Review) [0991-
AC11]

    Legal Authority: 5 U.S.C. 301; 31 U.S.C. 6101
    Abstract: HHS proposes to remove the regulatory provisions at 
issue, in order to align the regulation with the intent of the Social 
Security Act and current practice. Exclusions implemented under the 
Social Security Act prevent individuals convicted of certain crimes or 
individuals whose health care licenses have been revoked from 
participating in federal healthcare programs. Instead of only being 
barred from participating in all federal healthcare programs, certain 
regulatory provisions have resulted in these type of exclusion actions 
being given an overly broad government-wide effect, and excluded 
parties have been barred from participating in all Federal procurement 
and non-procurement actions. However, because Social Security Act 
exclusions are not issued under an agency's suspension and debarment 
authority, they do not stop individuals from participating in all 
federal procurement and non-procurement actions. For an agency to bar 
individuals from participating in all procurement and non-procurement 
activities, it must exercise its suspension and debarment authority 
under the Federal Acquisition Regulation or the Nonprocurement Common 
Rule.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/22
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Tiffani Redding, Program Analyst, Department of 
Health and Human Services, Office of the Secretary, 200 Independence 
Avenue SW, Washington, DC 20201, Phone: 202 768-0628, Email: 
[email protected].
    RIN: 0991-AC11

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Proposed Rule Stage

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

    Regulatory Plan: This entry is Seq. No. 56 in part II of this issue 
of the Federal Register.
    RIN: 0930-AA39

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Final Rule Stage

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

    Regulatory Plan: This entry is Seq. No. 57 in part II of this issue 
of the Federal Register.
    RIN: 0920-AA75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

304. 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 proposed rule would amend FDA medication guide 
regulations to require a new form of patient labeling, 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 proposed rule would include 
requirements for Patient Medication Information development and 
distribution. The proposed rule would 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................................   12/00/22
------------------------------------------------------------------------

    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

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

    Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f
    Abstract: The rule is proposing to establish tobacco product 
manufacturing practice (TPMP) requirements for manufacturers of 
finished and bulk tobacco products. This proposed rule, if finalized, 
would set forth requirements for the manufacture, pre-production design 
validation, packing, and storage of a tobacco product. This proposal 
would help prevent the manufacture and distribution of contaminated and 
otherwise nonconforming tobacco products. This proposed rule provides 
manufacturers with flexibility in the manner in which they comply with 
the proposed requirements while giving FDA the ability to enforce 
regulatory requirements, thus helping to assure the protection of 
public health.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/22
------------------------------------------------------------------------

    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-

[[Page 11231]]

1373, Email: [email protected].
    RIN: 0910-AH91

306. 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................................   06/00/23
------------------------------------------------------------------------

    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

307. 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 proposed rule would update the definition for the 
implied nutrient content claim ``healthy'' to be consistent with 
current nutrition science and federal dietary guidelines. The proposed 
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
------------------------------------------------------------------------

    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

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/23
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Joseph Folian, Supervisory Biologist, 
Department of Health and Human Services, Food and Drug Administration, 
10903 New Hampshire Avenue, Building 51, Room 5215, Silver Spring, MD 
20993-0002, Phone: 240 402-4089, Email: [email protected].
    RIN: 0910-AI57

309. 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 (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 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................................   10/00/23
------------------------------------------------------------------------

    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

310. 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

[[Page 11232]]

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 pharmacy.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/23
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Undetermined.
    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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

311. 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 drugs in 
television or radio format, the major statement relating to side 
effects and contraindications of an advertised prescription drug must 
be presented in a clear, conspicuous, and neutral manner. This rule 
also establishes standards for determining whether the major statement 
in these advertisements is presented in the manner required.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/29/10  75 FR 15376
NPRM Comment Period End.............   06/28/10
NPRM Comment Period Reopened........   01/27/12  77 FR 4273
NPRM Comment Period End.............   02/27/12
NPRM Comment Period Reopened........   03/29/12  77 FR 16973
NPRM Comment Period Reopened End....   04/09/12
Final Rule..........................   05/00/23
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Suzanna Boyle, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, WO 51, Room 3214, Silver Spring, MD 20993, Phone: 240 
402-4723, Email: [email protected].
    RIN: 0910-AG27

312. 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 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..........................   06/00/23
------------------------------------------------------------------------

    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

313. Mammography Quality Standards Act [0910-AH04]

    Regulatory Plan: This entry is Seq. No. 63 in part II of this issue 
of the Federal Register.
    RIN: 0910-AH04

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

    Legal Authority: 21 U.S.C. 360j(e)
    Abstract: This rule will apply device restrictions to sunlamp 
products. Sunlamp products include ultraviolet (UV) lamps and UV 
tanning beds and booths. The incidence of skin cancer, including 
melanoma, has been increasing, and a large number of skin cancer cases 
are attributable to the use of sunlamp products. The devices may cause 
about 400,000 cases of skin cancer per year, and 6,000 of which are 
melanoma. Beginning use of sunlamp products at young ages, as well as 
frequently using sunlamp products, both increases the risk of 
developing skin cancers and other illnesses, and sustaining other 
injuries. Even infrequent use, particularly at younger ages, can 
significantly increase these risks.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/22/15  80 FR 79493
NPRM Comment Period End.............   03/21/16  .......................
Final Rule..........................   06/00/23  .......................
------------------------------------------------------------------------

    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-AH14

[[Page 11233]]

315. 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 
five additional bulk drug substances on the list. FDA has also 
identified 26 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 a future rulemaking.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/05/19  84 FR 46688
NPRM Comment Period End.............   12/04/19  .......................
Final Rule..........................   10/00/23  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Rosilend Lawson, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993, 
Phone: 240-402-6223, Email: [email protected].
    RIN: 0910-AH81

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Direct Final Rule...................   02/00/23  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ellen Anderson, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, HFS-265, 
4300 River Road, College Park, MD 20740, Phone: 240-402-1309, Email: 
[email protected].
    RIN: 0910-AI15

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

    Regulatory Plan: This entry is Seq. No. 65 in part II of this issue 
of the Federal Register.
    RIN: 0910-AI28

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

    Regulatory Plan: This entry is Seq. No. 67 in part II of this issue 
of the Federal Register.
    RIN: 0910-AI60

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

319. 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..........................   04/00/25  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Building 51, Room 4261, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301-796-9362, Email: 
[email protected].
    RIN: 0910-AH11

320. Nicotine Toxicity Warnings [0910-AH24]

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

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

    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

[[Page 11234]]

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/04/22  87 FR 6443
NPRM Comment Period End.............   04/05/22  .......................
Final Rule..........................   04/00/25  .......................
------------------------------------------------------------------------

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

322. 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................................   05/00/24  .......................
------------------------------------------------------------------------

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

323. Requirements for Additional Traceability Records for Certain Foods 
[0910-AI44]

    Legal Authority: sec. 204(d) of the FDA Food Safety Modernization 
Act (FSMA) (Pub. L. 111-353) (21 U.S.C. 2223(d)); sec. 701(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(a)); sec. 361 of 
the Public Health Service Act (42 U.S.C. 264)
    Abstract: This rule will establish additional recordkeeping 
requirements for entities that manufacture, process, pack, or hold 
foods that are designated as high-risk foods.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   11/21/22  87 FR 70910
Final Action Effective..............   01/20/23  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Katherine Vierk, Phone: 240-402-2122, Email: 
[email protected].
    RIN: 0910-AI44

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

324. Medicare Advantage and Medicare Prescription Drug Benefit Program 
Payment Policy (CMS-4198) [0938-AU59]

    Legal Authority: 42 U.S.C. 1395w
    Abstract: This proposed rule would codify long-established Medicare 
Advantage and Part D payment policies that are outside the scope of the 
annual Advance Notice/Rate Announcement.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/23  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jennifer Shapiro, Director, Medicare Plan Payment 
Group, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C1-13-18, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410-786-7407, Email: 
[email protected].
    RIN: 0938-AU59

325. Transitional Coverage for Emerging Technologies (CMS-3421) [0938-
AU86]

    Regulatory Plan: This entry is Seq. No. 71 in part II of this issue 
of the Federal Register.
    RIN: 0938-AU86

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

    Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
    Abstract: This annual proposed rule would revise payment polices 
under the Medicare physician fee schedule, and make 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 would apply to 
services furnished beginning January 1, 2024. Additionally, this rule 
proposes updates to the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/23  .......................
------------------------------------------------------------------------


[[Page 11235]]

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gift Tee, Director, Division of Physician Services, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS: 
C1-09-07, Baltimore, MD 21244, Phone: 410-786-9316, Email: 
[email protected].
    RIN: 0938-AV07

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/00/23  .......................
------------------------------------------------------------------------

    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-AV08

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/23  .......................
------------------------------------------------------------------------

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

329. Omnibus COVID-19 Health Care Staff Vaccination (CMS-3415) (Section 
610 Review) [0938-AU75]

    Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
    Abstract: This interim final rule with comment period revises the 
infection control requirements that most Medicare- and Medicaid-
participating providers and suppliers must meet to participate in the 
Medicare and Medicaid programs. These changes are necessary to protect 
the health and safety of residents, clients, patients, and staff and 
reflect lessons learned as result of the COVID-19 public health 
emergency. The revisions to the infection control requirements 
establish COVID-19 vaccination requirements for staff at the included 
Medicare- and Medicaid-participating providers and suppliers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   11/05/21  86 FR 61555
Interim Final Rule Effective........   11/05/21  .......................
Interim Final Rule Comment Period      01/04/22  .......................
 End.
                                     -----------------------------------
Reviewing Public Comments...........           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Lauren Oviatt, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards and Quality, MS: C2-
21-16, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410-
786-4683, Email: [email protected].
    RIN: 0938-AU75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

330. CY 2023 Home Health Prospective Payment System Rate Update and 
Home Infusion Therapy Services Payment Update (CMS-1766) (Completion of 
a Section 610 Review) [0938-AU77]

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual final rule updates the national standardized 
30-day period payment rate, national per-visit rates used to calculate 
low utilization payment adjustments (LUPAs), and outlier payments under 
the Medicare prospective payment system for home health agencies based 
on the applicable home health payment update percentage. This rule also 
updates the home infusion therapy services payment rate. These changes 
apply to services furnished on or after January 1, 2023.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/23/22  87 FR 37600
NPRM Comment Period End.............   08/16/22  .......................
Final Action........................   11/04/22  87 FR 66790
Final Rule Effective................   01/01/23  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Slater, Director, Division of Home Health and 
Hospice, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Center for Medicare, MS: C4-07-07, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410-786-5229, Email: 
[email protected].
    RIN: 0938-AU77

[[Page 11236]]

331. CY 2023 Changes to the End-Stage Renal Disease (ESRD) Prospective 
Payment System and Quality Incentive Program (CMS-1768) (Completion of 
a Section 610 Review) [0938-AU79]

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C. 
1395f(b); 42 U.S.C. 1395g; . . .
    Abstract: This annual final rule updates the bundled payment system 
for ESRD facilities by January 1, 2023. The rule also updates the 
quality incentives in the ESRD program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/28/22  87 FR 38464
NPRM Comment Period End.............   08/22/22  .......................
Final Action........................   11/07/22  87 FR 67136
Final Action Effective..............   01/01/23  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Simone Dennis, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-06-16, Baltimore, MD 
21244, Phone: 410 786-6041, Email: [email protected].
    RIN: 0938-AU79

332. FY 2023 Inpatient Psychiatric Facilities Prospective Payment 
System Rate (CMS-1769) (Completion of a Section 610 Review) [0938-AU80]

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual final rule updates the prospective payment 
system for inpatient psychiatric facilities (IPF) with discharges 
beginning on October 1, 2022.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/04/22  87 FR 19415
NPRM Comment Period End.............   05/31/22  .......................
Final Action........................   07/29/22  87 FR 46846
Final Action Effective..............   10/01/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nicolas Brock, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-05-27, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410-786-5148, Email: 
[email protected].
    RIN: 0938-AU80

333. CY 2023 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1770) (Completion 
of a Section 610 Review) [0938-AU81]

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    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. These changes apply to services 
furnished beginning January 1, 2023. Additionally, this rule updates 
the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/29/22  87 FR 45860
NPRM Comment Period End.............   09/06/22  .......................
Final Action........................   11/18/22  87 FR 69404
Final Action Effective..............   01/01/23  .......................
------------------------------------------------------------------------

    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-AU81

334. Hospital Inpatient Prospective Payment Systems for Acute Care 
Hospitals; the Long-Term Care Hospital Prospective Payment System; and 
FY 2023 Rates (CMS-1771) (Completion of a Section 610 Review) [0938-
AU84]

    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................................   05/10/22  87 FR 28108
NPRM Comment Period End.............   06/17/22  .......................
Final Action........................   08/10/22  87 FR 48780
Final Action Effective..............   10/01/22  .......................
------------------------------------------------------------------------

    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-AU84

[FR Doc. 2023-02026 Filed 2-21-23; 8:45 am]
BILLING CODE 4150-03-P

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