Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 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
 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: Kashif Syed, Senior Advisor to the 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 tackling the coronavirus disease 2019 (COVID-19) pandemic, building and expanding access to affordable health care, addressing health disparities and promoting equity, and boosting the wellbeing of children and families, among other policy priorities. The rulemaking abstracts included in this paper issue of the 
                        **Federal Register**
                         cover, as required by the Regulatory Flexibility Act of 1980, those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities. The Department's complete Regulatory Agenda is accessible online at 
                        *http://www.RegInfo.gov.* Kashif Syed, Senior Advisor to the HHS Executive Secretary.
 Office of the Secretary—Proposed Rule Stage
Sequence No.
Title
Regulation
                                 Identifier No.84
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
Sequence No.
Title
Regulation
                                 Identifier No.85
Treatment of Opioid use Disorder With Extended Take Home Doses of Methadone
0930-AA39
 Centers for Disease Control and Prevention—Final Rule Stage
Sequence No.
Title
Regulation
                                 Identifier No.86
Control of Communicable Diseases; Foreign Quarantine
0920-AA75
 Food and Drug Administration—Proposed Rule Stage
Sequence No.
Title
Regulation
                                 Identifier No.87
National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
0910-AH1188
Medication Guide; Patient Medication Information
0910-AH6889
Requirements for Tobacco Product Manufacturing Practice
0910-AH9190
Administrative Detention of Tobacco Products
0910-AI0591
Nutrient Content Claims, Definition of Term: Healthy
0910-AI1392
Tobacco Product Standard for Characterizing Flavors in Cigars
0910-AI2893
Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies
0910-AI5794
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-AI7095
Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (
                                **Section 610 Review**
                                )
0910-AI71
 
 
 Food and Drug Administration—Final Rule Stage
Sequence No.
Title
Regulation
                                 Identifier No.96
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-AG2797
Sunlamp Products; Amendment to the Performance Standard
0910-AG3098
Mammography Quality Standards Act
0910-AH0499
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-AH81100
Revocation of Uses of Partially Hydrogenated Oils in Foods
0910-AI15101
Requirements For Additional Traceability Records For Certain Foods
0910-AI44
 Food and Drug Administration—Long-Term Actions
Sequence No.
Title
Regulation
                                 Identifier No.102
General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products
0910-AH14103
Nicotine Toxicity Warnings
0910-AH24104
Certain Requirements Regarding Prescription Drug Marketing (203 Amendment)
0910-AH56105
Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products
0910-AI61
 Food and Drug Administration—Completed Actions
Sequence No.
Title
Regulation
                                 Identifier No.106
Laboratory Accreditation for Analyses of Foods
0910-AH31
 Centers for Medicare & Medicaid Services—Proposed Rule Stage
Sequence No.
Title
Regulation
                                 Identifier No.107
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056)
0938-AU19108
Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS-4198)
0938-AU59109
CY 2023 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1770) (
                                **Section 610 Review**
                                )
0938-AU81110
CY 2023 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1772) (
                                **Section 610 Review**
                                )
0938-AU82111
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2023 Rates (CMS-1771) (
                                **Section 610 Review**
                                )
0938-AU84112
Transitional Coverage for Emerging Technologies (CMS-3421)
0938-AU86113
Conditions of Participation (CoPs) for Rural Emergency Hospitals (REHs) and Critical Access Hospital (CAH) COP Updates (CMS-3419) (
                                **Section 610 Review**
                                )
0938-AU92
 Centers for Medicare & Medicaid Services—Final Rule Stage
Sequence No.
Title
Regulation
                                 Identifier No.114
Requirements Related to Surprise Billing; Part II (CMS-9908)
0938-AU62
 Centers for Medicare & Medicaid Services—Long-Term Actions
Sequence No.
Title
Regulation
                                 Identifier No.115
Omnibus COVID-19 Health Care Staff Vaccination (CMS-3415) (
                                **Section 610 Review**
                                )
0938-AU75
 Centers for Medicare & Medicaid Services—Completed Actions
Sequence No.
Title
Regulation
                                 Identifier No.116
Durable Medical Equipment Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Non-Competitive Bidding Areas (CMS-1687) (
                                **Completion of a Section 610 Review**
                                )
0938-AT21( print page 48284)117
Most Favored Nation (MFN) Model (CMS-5528) (
                                **Completion of a Section 610 Review**
                                )
0938-AT91118
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2022 Rates (CMS-1752) (
                                **Completion of a Section 610 Review**
                                )
0938-AU44
 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the Secretary (OS) Proposed Rule Stage 84. 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:*
                         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 health care 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. This rulemaking would remove the regulatory provisions at issue, in order to align the regulation with the intent of the Social Security Act and current practice. *Timetable:* Action
Date
FR CiteNPRM
08/00/22
 *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:*
                         202 205-4321, 
                        *Email: tiffani.redding@hhs.gov.* *RIN:*
                         0991-AC11 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) Proposed Rule Stage 85. Treatment of Opioid Use Disorder With Extended Take Home Doses of Methadone [0930-AA39] *Legal Authority:*21 U.S.C. 823(g)(1) *Abstract:*
                         SAMHSA will propose to revise 42 CFR part 8 to make permanent some regulatory flexibilities for opioid treatment programs to provide extended take home doses of methadone. To facilitate this new treatment paradigm, sections of 42 CFR part 8 would require updating to reflect current treatment practice. SAMHSA's changes would impact roughly 1800 opioid treatment programs and state opioid treatment authorities. *Timetable:* Action
Date
FR CiteNPRM
09/00/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Dr. Neeraj Gandotra, Chief Medical Officer, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, 18E67, Rockville, MD 20857, 
                        *Phone:*
                         202 823-1816, 
                        *Email: neeraj.gandotra@samhsa.hhs.gov.* *RIN:*
                         0930-AA39 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Disease Control and Prevention (CDC) Final Rule Stage 86. Control of Communicable Diseases; Foreign Quarantine [0920-AA75] *Legal Authority:*42 U.S.C. 264; 42 U.S.C. 265 *Abstract:*
                         This rulemaking amends current regulation to enable CDC to require airlines to collect and provide to CDC certain data elements regarding passengers and crew arriving from foreign countries under certain circumstances. *Timetable:* Action
Date
FR CiteInterim Final Rule Effective
02/07/20Interim Final Rule
02/12/20
85 FR 7874Interim Final Rule Comment Period End
03/13/20Final Action
05/00/23
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Ashley C. Altenburger JD, Public Health Analyst, Department of Health and Human Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS: H 16-4, Atlanta, GA 30307, 
                        *Phone:*
                         800 232-4636, 
                        *Email: dgmqpolicyoffice@cdc.gov.* *RIN:*
                         0920-AA75 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Proposed Rule Stage 87. 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 rulemaking, once finalized and effective, will establish national standards for State licensing of prescription drug wholesale distributors and third-party logistics providers. The rulemaking will also establish a Federal system for wholesale drug distributor and third-party logistics provider licensing for use in the absence of a State licensure program. *Timetable:*( print page 48285) Action
Date
FR CiteNPRM
02/04/22
87 FR 6708NPRM Comment Period Extended
05/24/22
87 FR 31439NPRM Comment Period End
06/06/22NPRM Comment Extended End
09/06/22
 *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 88. 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 CiteNPRM
10/00/22
 *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 89. 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 CiteNPRM
07/00/22
 *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:*
                         877 287-1373, 
                        *Email: ctpregulations@fda.hhs.gov.* *RIN:*
                         0910-AH91 90. Administrative Detention of Tobacco Products [0910-AI05] *Legal Authority:*21 U.S.C. 334; 21 U.S.C. 371 *Abstract:*
                         FDA is proposing regulations to establish requirements for the administrative detention of tobacco products. This proposal 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 CiteNPRM
12/00/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Nathan Mease, 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.* Matthew Brenner, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, 
                        *Phone:*
                         877 287-1373, 
                        *Email: ctpregulations@fda.hhs.gov.* *RIN:*
                         0910-AI05 91. 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 so that the claim reflects current science and dietary guidelines and helps consumers maintain healthy dietary practices. *Timetable:* Action
Date
FR CiteNPRM
06/00/22
 *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: vincent.dejesus@fda.hhs.gov.* *RIN:*
                         0910-AI13 92. Tobacco Product Standard for Characterizing Flavors in Cigars [0910-AI28] *Legal Authority:*21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 371(a); 21 U.S.C. 387b and 387c; 21 U.S.C. 387f(d) and 387g; . . .
                        ( print page 48286) *Abstract:*
                         Evidence shows that flavored tobacco products appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Characterizing flavors in cigars, such as strawberry, grape, orange, and cocoa, enhance taste and make them easier to use. Over a half million youth in the United States use flavored cigars, placing these youth at risk for cigar-related disease and death. This proposed rule is a tobacco product standard that would prohibit characterizing flavors (other than tobacco) in all cigars. We are taking this action with the intention of reducing the tobacco-related death and disease associated with cigar use. *Timetable:* Action
Date
FR CiteANPRM
03/21/18
83 FR 12294ANPRM Comment Period End
07/19/18NPRM
05/04/22
87 FR 26396NPRM Comment Period End
07/05/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Nathan Mease, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Center for Tobacco Products, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, 
                        *Phone:*
                         877 287-1373, 
                        *Email: ctpregulations@fda.hhs.gov.* Courtney Smith, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, 
                        *Phone:*
                         877 287-1373, 
                        *Fax:*
                         877 287-1426, 
                        *Email: ctpregulations@fda.hhs.gov.* *RIN:*
                         0910-AI28 93. 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 analytical and clinical pharmacology, 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 CiteNPRM
12/00/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Brian Joseph Folian, Supervisory Biologist, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 5215, Silver Spring, MD 20993-0002, 
                        *Phone:*
                         240 402-4089, 
                        *Email: brian.folian@fda.hhs.gov.* *RIN:*
                         0910-AI57 94. 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 CiteNPRM
03/00/23
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Alexandria Fujisaki, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 5169, Center for Drug Evaluation and Research, Silver Spring, MD 20993, 
                        *Phone:*
                         240 402-4078. *RIN:*
                         0910-AI70 95. • 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. 353b; 21 U.S.C. 355; 21 U.S.C. 371 *Abstract:*
                         The Food and Drug Administration is proposing rulemaking regarding statutory requirements for certain distributions of compounded human prescription drug products. The proposed rule, if finalized, will include provisions regarding a standard memorandum of understanding (MOU) that describes the responsibilities of a State Board of Pharmacy or other appropriate State agency that chooses to sign the standard MOU in investigating complaints related to drug products compounded in such State and distributed outside such State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. It will also, if finalized, include provisions regarding the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the standard MOU, and may address adverse event reporting, product quality reporting, and communication with State boards of pharmacy. *Timetable:* Action
Date
FR CiteNPRM
12/00/22
 *Regulatory Flexibility Analysis Required:*
                         Undetermined. *Agency Contact:*
                         Alexandria Fujisaki, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 5169, Center for Drug Evaluation and Research, Silver Spring, MD 20993, 
                        *Phone:*
                         240 402-4078, 
                        *Email: alexandria.fujisaki@fda.hhs.gov.* *RIN:*
                         0910-AI71 
 
 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Final Rule Stage 96. 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 CiteNPRM
03/29/10
75 FR 15376NPRM Comment Period End
06/28/10NPRM Comment Period Reopened
01/27/12
77 FR 4273NPRM Comment Period End
02/27/12NPRM Comment Period Reopened
03/29/12
77 FR 16973NPRM Comment Period Reopened End
04/09/12Final 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: suzanna.boyle@fda.hhs.gov.* *RIN:*
                         0910-AG27 97. 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 CiteNPRM
12/22/15
80 FR 79505NPRM Comment Period End
03/21/16Final Rule
12/00/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Ian Ostermiller, Regulatory Counsel, Center for Devices and Radiological Health, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring, MD 20993, 
                        *Phone:*
                         301 796-5678, 
                        *Email: ian.ostermiller@fda.hhs.gov.* *RIN:*
                         0910-AG30 98. Mammography Quality Standards Act [0910-AH04] *Legal Authority:*21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e); 42 U.S.C. 263b *Abstract:*
                         FDA is amending its regulations governing mammography. The amendments will update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and healthcare providers. *Timetable:* Action
Date
FR CiteNPRM
03/28/19
84 FR 11669NPRM Comment Period End
06/26/19Final Rule
09/00/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Laurie Sternberg, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 5517, Silver Spring, MD 20993, 
                        *Phone:*
                         240 402-0425, 
                        *Email: laurie.sternberg@fda.hhs.gov.* *RIN:*
                         0910-AH04 99. 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 CiteNPRM
09/05/19
84 FR 46688NPRM Comment Period End
12/04/19Final Rule
03/00/23
 *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-AH81 100. 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; 
                        ( print page 48288)
                        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 CiteDirect Final Rule
10/00/22
 *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 101. Requirements for Additional Traceability Records for Certain Foods [0910-AI44] *Legal Authority:*
                         sec. 204 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 facilities that manufacture, process, pack, or hold foods that are designated as high-risk foods. *Timetable:* Action
Date
FR CiteNPRM
09/23/20
85 FR 59984NPRM Comment Period End
01/21/21NPRM Comment Period Extended
12/18/20
85 FR 82393NPRM Comment Period End
02/22/21Final Rule
11/00/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Katherine Vierk, Director, Division of Public Health Informatics and Analytics, Department of Health and Human Services, Food and Drug Administration, 5001 Campus Drive, CPK1, Room 2B014, HFS-005, College Park, MD 20740, 
                        *Phone:*
                         240 402-2122, 
                        *Email: katherine.vierk@fda.hhs.gov* *RIN:*
                         0910-AI44 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Long-Term Actions 102. 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 CiteNPRM
12/22/15
80 FR 79493NPRM Comment Period End
03/21/16Final 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:*
                         301 796-567, 
                        *Email: ian.ostermiller@fda.hhs.gov.* *RIN:*
                         0910-AH14 103. 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) that are made or derived from tobacco and 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 CiteNPRM
10/00/23
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Courtney Smith, 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 G3355, Silver Spring, MD 20993, 
                        *Phone:*
                         877 287-1373, 
                        *Email: ctpregulations@fda.hhs.gov.* *RIN:*
                         0910-AH24 104. 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 Food and Drug Administration (FDA) is amending the 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). In this proposed rulemaking, the Agency is amending the regulations to clarify provisions and avoid causing confusion with the new standards for wholesale distribution established by DSCSA. *Timetable:* Action
Date
FR CiteNPRM
02/04/22
87 FR 6443NPRM Comment Period End
04/05/22Next Action Undetermined
 *Regulatory Flexibility Analysis Required:*
                         Yes.
                        ( print page 48289) *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 105. 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 CiteNPRM
11/00/23
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Janice L. Weiner, Principal Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring, MD 20993-0002, 
                        *Phone:*
                         301 796-3475, 
                        *Fax:*
                         301 847-8440, 
                        *Email: janice.weiner@fda.hhs.gov.* *RIN:*
                         0910-AI61 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Food and Drug Administration (FDA) Completed Actions 106. Laboratory Accreditation for Analyses of Foods [0910-AH31] *Legal Authority:*21 U.S.C. 350k; 21 U.S.C. 371(a); . . . *Abstract:*
                         This rule will enable FDA to recognize accreditation bodies that will accredit laboratories to perform analyses of food under certain circumstances to help ensure appropriate use of equipment, personnel, and procedures to conduct reliable analyses. A program for accredited laboratories will increase the number of qualified laboratories eligible to perform testing of food, which will help FDA improve the safety of the U.S. food supply. *Completed:* Reason
Date
FR CiteFinal Rule
12/03/21
86 FR 68728Final Rule Effective
02/01/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Stacie Hammack, 
                        *Phone:*
                         301 796-5817, 
                        *Email: stacie.hammack@fda.hhs.gov.* *RIN:*
                         0910-AH31 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Proposed Rule Stage 107. Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056) [0938-AU19] *Legal Authority:*42 U.S.C. 1320d to 1320d-9 *Abstract:*
                         This proposed rule would require pharmacies and vendors to modify the currently adopted National Council for Prescription Drug Programs (NCPDP) standards to the Telecommunications Standard Implementation Guide Version F6 (F6); Batch Standard Implementation Guide version 15; and Batch Standard Subrogation Implementation Guide version 10. *Timetable:* Action
Date
FR CiteNPRM
09/00/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Geanelle Herring, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Burden Reduction and Health Informatics, MS: S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, 
                        *Phone:*
                         410 786-4466, 
                        *Email: geanelle.herring@cms.hhs.gov.* *RIN:*
                         0938-AU19 108. 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 CiteNPRM
12/00/22
 *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 109. CY 2023 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1770) (Section 610 Review) [0938-AU81] *Legal Authority:*42 U.S.C. 1302; 42 U.S.C. 1395hh *Abstract:*
                         This annual proposed rule would revise payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2023. Additionally, this rule proposes updates to the Quality Payment Program. *Timetable:* Action
Date
FR CiteNPRM
06/00/22
 *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-
                        ( print page 48290)
                        07, Baltimore, MD 21244, 
                        *Phone:*
                         410 786-9316, 
                        *Email: gift.tee@cms.hhs.gov.* *RIN:*
                         0938-AU81 110. CY 2023 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1772) (Section 610 Review) [0938-AU82] *Legal Authority:*42 U.S.C. 1302; 42 U.S.C. 1395hh *Abstract:*
                         This annual proposed rule would revise the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from our continuing experience with this system. The proposed rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the ambulatory surgical center payment system list of services and rates. This proposed rule would also update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. *Timetable:* Action
Date
FR CiteNPRM
06/00/22
 *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-AU82 111. Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; The Long-Term Care Hospital Prospective Payment System; and FY 2023 Rates (CMS-1771) (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 CiteNPRM
05/10/22
87 FR 28108NPRM Comment Period End
06/17/22Final Action
10/00/22
 *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: donald.thompson@cms.hhs.gov.* *RIN:*
                         0938-AU84 112. Transitional Coverage for Emerging Technologies (CMS-3421) [0938-AU86] *Legal Authority:*42 U.S.C. 263a; 42 U.S.C. 405(a); 42 U.S.C. 1302; 42 U.S.C. 1320b-12; . . . *Abstract:*
                         This proposed rule would establish the criteria for an expedited coverage pathway to provide Medicare beneficiaries with faster access to innovative and beneficial technologies. *Timetable:* Action
Date
FR CiteNPRM
04/00/23
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Lori Ashby, Senior Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, 
                        *Phone:*
                         410 786-6322, 
                        *Email: lori.ashby@cms.hhs.gov.* *RIN:*
                         0938-AU86 113. Conditions of Participation (COPS) for Rural Emergency Hospitals (REHS) and Critical Access Hospital (CAH) COP Updates (CMS-3419) (Section 610 Review) [0938-AU92] *Legal Authority:*42 U.S.C. 1395x *Abstract:*
                         This proposed rule would establish health and safety requirements for a new provider type, Rural Emergency Hospitals, in accordance with section 125 of the Consolidated Appropriations Act, 2021. *Timetable:* Action
Date
FR CiteNPRM
06/00/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Kianna Banks, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, 
                        *Phone:*
                         410 786-8486, 
                        *Email: kianna.banks@cms.hhs.gov.* *RIN:*
                         0938-AU92 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Final Rule Stage 114. Requirements Related to Surprise Billing; Part II (CMS-9908) [0938-AU62] *Legal Authority:*Pub. L. 116-260, Division BB, title I and title II *Abstract:*
                         This final rule implements provisions related to the independent dispute resolution processes included in the Public Health Service Act sections 2799A-1(c) and 2799A-2(b), as added by sections 103 and 105 of the No Surprises Act. *Timetable:* Action
Date
FR CiteInterim Final Rule
10/07/21
86 FR 55980Interim Final Rule Effective
10/07/21Interim Final Rule Comment Period End
12/06/21Final Action
06/00/22
 *Regulatory Flexibility Analysis Required*: Yes. *Agency Contact:*
                         Deborah Bryant, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, MS: W08-134, 7500 Security Boulevard, Baltimore, MD 21244, 
                        *Phone:*
                         301 492-4293, 
                        *Email: deborah.bryant@cms.hhs.gov.* *RIN:*
                         0938-AU62 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Long-Term Actions 115. 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 
                        ( print page 48291)
                        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 CiteInterim Final Rule
11/05/21
86 FR 61555Interim Final Rule Effective
11/05/21Interim Final Rule Comment Period End
01/04/22Reviewing Public Comments
To Be Determined
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Kim Roche, Nurse, 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, 
                        *Phone:*
                         410 786-3524, 
                        *Email: kim.roche@cms.hhs.gov.* *RIN:*
                         0938-AU75 DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Centers for Medicare & Medicaid Services (CMS) Completed Actions 116. Durable Medical Equipment Fee Schedule, Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive Bidding Areas (CMS-1687) (Completion of a Section 610 Review) [0938-AT21] *Legal Authority:*42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)); Pub. L. 114-255, sec. 5004(b), 16007(a) and 16008 *Abstract:*
                         This final rule responds to public comments on the interim final rule that published May 11, 2018 and extended the end of the transition period from June 30, 2016, to December 31, 2016 for phasing in adjustments to the fee schedule amounts for certain durable medical equipment (DME) and enteral nutrition paid in areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). In addition, the interim rule amended the regulation to resume the transition period for items furnished from August 1, 2017, through December 31, 2018. The interim rule also made technical amendments to existing regulations for DMEPOS items and services to exclude infusion drugs used with DME from the DMEPOS CBP. *Timetable:* Action
Date
FR CiteInterim Final Rule
05/11/18
83 FR 21912Interim Final Rule Comment Period End
07/09/18Continuation Notice
04/26/21
86 FR 21949Final Action Merged With 0938-AU38 and 0938-AU17
12/28/21
86 FR 73860
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Alexander Ullman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5-07-26, 7500 Security Boulevard, Baltimore, MD 21244, 
                        *Phone*: 410 786-9671, 
                        *Email: alexander.ullman@cms.hhs.gov.* *RIN:*
                         0938-AT21 117. Most Favored Nation (MFN) Model (CMS-5528) (Completion of a Section 610 Review) [0938-AT91] *Legal Authority:*
                         Social Security Act, sec. 1115A *Abstract:*
                         This final rule rescinds the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020, 
                        **Federal Register**
                        . *Timetable:* Action
Date
FR CiteANPRM
10/30/18
83 FR 54546ANPRM Comment Period End
12/31/18Interim Final Rule
11/27/20
85 FR 76180Interim Final Rule Effective
11/27/20Interim Final Rule Comment Period End
01/26/21NPRM
08/10/21
86 FR 43618NPRM Comment Period End
10/12/21Final Action
12/29/21
86 FR 73986Final Action Effective
02/28/22
 *Regulatory Flexibility Analysis Required:*
                         Yes. *Agency Contact:*
                         Lara Strawbridge, Director, Division of Ambulatory Payment Models, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare and Medicaid Innovation, 7500 Security Boulevard, MS: WB-06-05, Baltimore, MD 21244, 
                        *Phone:*
                         410 786-7400, 
                        *Email: mfn@cms.hhs.gov.* *RIN:*
                         0938-AT91 118. Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2022 Rates (CMS-1752) (Completion of a Section 610 Review) [0938-AU44] *Legal Authority:*42 U.S.C. 1302; 42 U.S.C. 1395hh *Abstract:*
                         This rule finalizes the remaining policies proposed for the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. These policies include implementation of sections 126, 127, and 131 of the Consolidated Appropriations Act of 2020, and organ acquisition payment policies. *Timetable:* Action
Date
FR CiteNPRM
05/10/21
86 FR 25070NPRM Comment Period End
06/28/21Final Action
08/13/21
86 FR 44774Final Action Effective
10/01/21Final Action Correction
10/20/21
86 FR 580192nd Final Action
12/27/21
86 FR 734162nd Final Action Effective
02/25/22
 *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: donald.thompson@cms.hhs.gov.* *RIN:*
                         0938-AU44


[FR Doc. 2022-14603 Filed 8-5-22; 8:45 am] BILLING CODE 4150-03-P