48282 Federal Register / Vol. 87, No. 151 / Monday, August 8, 2022 / UA: Reg Flex Agenda 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

21 CFR Ch. I 

25 CFR Ch. V 

42 CFR Chs. I–V 

45 CFR Subtitle A; Subtitle B, Chs. II, 

III, and XIII 

Regulatory Agenda 

AGENCY: Office of the Secretary, HHS. 

ACTION: Semiannual Regulatory Agenda. 

SUMMARY: The Regulatory Flexibility Act 

of 1980 and Executive Order (E.O.) 

12866 require the semiannual issuance 

of an inventory of rulemaking actions 

under development throughout the 

Department, offering for public review 

summarized information about 

forthcoming regulatory actions. 

FOR FURTHER INFORMATION CONTACT: 

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 wellbeing of Americans by promoting 

effective health and human services and 

by fostering sound, sustained advances 

in the sciences underlying medicine, 

public health, and social services. 

This Agenda presents the regulatory 

activities that the Department expects to 

undertake in the foreseeable future to 

advance this mission. The purpose of 

the Agenda is to encourage more 

effective public participation in the 

regulatory process. The regulatory 

actions forecasted in this Agenda reflect 

the priorities of HHS Secretary Xavier 

Becerra and the Biden-Harris 

Administration. Accordingly, this 

Agenda contains rulemakings aimed at 

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–AH11 

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

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

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

91 ...................... Nutrient Content Claims, Definition of Term: Healthy ..................................................................................... 0910–AI13 

92 ...................... Tobacco Product Standard for Characterizing Flavors in Cigars .................................................................... 0910–AI28 

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

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

Act (Section 610 Review).

0910–AI71 


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Federal Register / Vol. 87, No. 151 / Monday, August 8, 2022 / UA: Reg Flex Agenda 48283 

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–AG27 

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

98 ...................... Mammography Quality Standards Act ............................................................................................................. 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 

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

101 .................... 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–AH14 

103 .................... Nicotine Toxicity Warnings ............................................................................................................................... 0910–AH24 

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

105 .................... 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–AU19 

108 .................... Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS–4198) ......... 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 

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 

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 

112 .................... Transitional Coverage for Emerging Technologies (CMS–3421) .................................................................... 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 

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 


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CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS—Continued 

Sequence No. Title Regulation 

Identifier No. 

117 .................... Most Favored Nation (MFN) Model (CMS–5528) (Completion of a Section 610 Review) ......................... 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 

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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 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 Cite 

Interim Final Rule 

Effective.

02/07/20 

Interim Final Rule 02/12/20 85 FR 7874 

Interim Final Rule 

Comment Period End.

03/13/20 

Final 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: 


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Action Date FR Cite 

NPRM .................. 02/04/22 87 FR 6708 

NPRM Comment 

Period Extended.

05/24/22 87 FR 31439 

NPRM Comment 

Period End.

06/06/22 

NPRM 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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 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; . . . 


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48286 Federal Register / Vol. 87, No. 151 / Monday, August 8, 2022 / UA: Reg Flex Agenda 

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 Cite 

ANPRM ............... 03/21/18 83 FR 12294 

ANPRM Comment 

Period End.

07/19/18 

NPRM .................. 05/04/22 87 FR 26396 

NPRM Comment 

Period 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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 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 


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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-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 

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: 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 Cite 

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

NPRM Comment 

Period End.

03/21/16 

Final 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 Cite 

NPRM .................. 03/28/19 84 FR 11669 

NPRM Comment 

Period End.

06/26/19 

Final 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 Cite 

NPRM .................. 09/05/19 84 FR 46688 

NPRM Comment 

Period End.

12/04/19 

Final 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; 


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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 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 Cite 

NPRM .................. 09/23/20 85 FR 59984 

NPRM Comment 

Period End.

01/21/21 

NPRM Comment 

Period Extended.

12/18/20 85 FR 82393 

NPRM Comment 

Period End.

02/22/21 

Final 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 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 

796–567, 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 eliquids in tobacco products. 

Timetable: 

Action Date FR Cite 

NPRM .................. 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 Cite 

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

NPRM Comment 

Period End.

04/05/22 

Next Action Undetermined.

Regulatory Flexibility Analysis 

Required: Yes. 


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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 Cite 

NPRM .................. 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 Cite 

Final Rule ............ 12/03/21 86 FR 68728 

Final 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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 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– 


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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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 05/10/22 87 FR 28108 

NPRM Comment 

Period End.

06/17/22 

Final 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 Cite 

NPRM .................. 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 Cite 

NPRM .................. 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 Cite 

Interim Final Rule 10/07/21 86 FR 55980 

Interim Final Rule 

Effective.

10/07/21 

Interim Final Rule 

Comment Period End.

12/06/21 

Final 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 


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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 End.

01/04/22 

Reviewing 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 Cite 

Interim Final Rule 05/11/18 83 FR 21912 

Interim Final Rule 

Comment Period End.

07/09/18 

Continuation Notice.04/26/21 86 FR 21949 

Final 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 Cite 

ANPRM ............... 10/30/18 83 FR 54546 

ANPRM Comment 

Period End.

12/31/18 

Interim Final Rule 11/27/20 85 FR 76180 

Interim Final Rule 

Effective.

11/27/20 

Interim Final Rule 

Comment Period End.

01/26/21 

NPRM .................. 08/10/21 86 FR 43618 

NPRM Comment 

Period End.

10/12/21 

Final Action ......... 12/29/21 86 FR 73986 

Action Date FR Cite 

Final 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 longterm 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 Cite 

NPRM .................. 05/10/21 86 FR 25070 

NPRM Comment 

Period End.

06/28/21 

Final Action ......... 08/13/21 86 FR 44774 

Final Action Effective.10/01/21 

Final Action Correction.10/20/21 86 FR 58019 

2nd Final Action .. 12/27/21 86 FR 73416 

2nd 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 


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