41214 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / 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: 

Karuna Seshasai, 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 the Biden-Harris 

Administration and HHS Secretary 

Xavier Becerra. Accordingly, this 

Agenda contains rulemakings aimed at 

advancing equity and ensuring 

nondiscrimination in health; ending the 

COVID–19 public health emergency; 

enhancing access to quality, affordable 

health care; addressing child welfare 

and maternal health; safeguarding the 

quality of medical products; protecting 

the public health by reducing tobacco 

use; revising prior actions that are 

inconsistent with the policy of this 

Administration; and supporting other 

priority areas. 

Please note that because the 

Department’s most recent Statement of 

Regulatory Priorities was published in 

Fall 2020 and under a previous 

Administration, it no longer reflects the 

views of the Department or this 

Administration. The Department will 

have the opportunity to issue a new 

Statement of Regulatory Priorities 

reflecting its policy direction alongside 

the Fall 2021 Agenda. At present, more 

information about the policy priorities 

of the Biden-Harris Administration is 

available through Executive Orders, 

Presidential Memoranda, other 

Presidential Actions, regulatory actions, 

and sub-regulatory guidance issued by 

the Biden-Harris Administration since 

January 20, 2021. 

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. 

Karuna Seshasai, 

Executive Secretary to the Department. 

OFFICE OF THE SECRETARY—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

85 ...................... Limiting the Effect of Exclusions Implemented Under the Social Security Act (Rulemaking Resulting 

From a Section 610 Review).

0991–AC11 

OFFICE FOR CIVIL RIGHTS—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

86 ...................... Rulemaking on Discrimination on the Basis of Disability in Critical Health and Human Services Programs 

or Activities (Rulemaking Resulting From a Section 610 Review).

0945–AA15 

OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

87 ...................... Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and 

Timeframes in Response to the COVID–19 Public Health Emergency.

0955–AA02 

CENTERS FOR DISEASE CONTROL AND PREVENTION—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

88 ...................... Control of Communicable Diseases; Foreign Quarantine ............................................................................... 0920–AA75 


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FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

89 ...................... National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers .. 0910–AH11 

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

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

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

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

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

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

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

97 ...................... Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies ..................... 0910–AI57 

FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

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 

FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS

Sequence No. Title Regulation 

Identifier No. 

100 .................... 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 

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

102 .................... General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products ............ 0910–AH14 

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

104 .................... Requirements For Additional Traceability Records for Certain Foods ............................................................ 0910–AI44 

FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

105 .................... Milk and Cream Product and Yogurt Products, Final Rule to Revoke the Standards for Lowfat Yogurt and 

Nonfat Yogurt and to Amend the Standard for Yogurt.

0910–AI40 

CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

106 .................... Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription 

Drug Benefit Programs (CMS–4192).

0938–AU30 

107 .................... CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1751) (Section 610 Review).0938–AU42 

108 .................... CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center 

Payment System Policy Changes and Payment Rates (CMS–1753) (Section 610 Review).

0938–AU43 

109 .................... Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital 

Prospective Payment System; and FY 2022 Rates (CMS–1752) (Section 610 Review).

0938–AU44 

110 .................... Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS–4198) ......... 0938–AU59 

CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

111 .................... Requirements Related to Surprise Billing; Part II (CMS–9908) ...................................................................... 0938–AU62 

112 .................... Requirements Related to Surprise Billing; Part I (CMS–9909) ....................................................................... 0938–AU63 


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CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS

Sequence No. Title Regulation 

Identifier No. 

113 .................... Durable Medical Equipment Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates 

to Provide Relief in Non-Competitive Bidding Areas (CMS–1687) (Section 610 Review).

0938–AT21 

114 .................... Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Increased Safety (CMS– 

3347) (Section 610 Review).

0938–AT36 

CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

115 .................... Most Favored Nation (MFN) Model (CMS–5528) (Completion of a Section 610 Review) ......................... 0938–AT91 

116 .................... Medicaid; Reducing Provider and Patient Burden by Improving Prior Authorization Processes and Promoting Patients’ Electronic Access to Health Information (CMS–9123).0938–AT99 

117 .................... CY 2021 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1734) (Completion of a Section 610 Review).0938–AU10 

118 .................... CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center 

Payment System Policy Changes and Payment Rates (CMS–1736) (Completion of a Section 610 Review).

0938–AU12 

119 .................... Promoting Electronic Access to Health Information for Patients and for Medicare- and Medicaid-Participating Providers and Suppliers (CMS–0057).0938–AU53 

ADMINISTRATION FOR CHILDREN AND FAMILIES—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

120 .................... Updating Native Employment Works Requirements (Rulemaking Resulting From a Section 610 Review).0970–AC83 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Office of the Secretary (OS) 

Proposed Rule Stage 

85. Limiting the Effect of Exclusions 

Implemented Under the Social Security 

Act (Rulemaking Resulting From a 

Section 610 Review) 

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 .................. 08/00/21 

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) 

Office for Civil Rights (OCR) 

Proposed Rule Stage 

86. Rulemaking on Discrimination on 

the Basis of Disability in Critical Health 

and Human Services Programs or 

Activities (Rulemaking Resulting From 

a Section 610 Review) 

Legal Authority: Sec. 504 of the 

Rehabilitation Act of 19 

Abstract: This proposed rule would 

revise regulations under, among other 

statutes, section 504 of the 

Rehabilitation Act of 1973 to address 

unlawful discrimination on the basis of 

disability in certain vital HHS-funded 

health and human services programs. 

Covered topics include nondiscrimination in life-sustaining care, 

organ transplantation, suicide 

prevention services, child welfare 

programs and services, health care value 

assessment methodologies, accessible 

medical equipment, auxiliary aids and 

services, Crisis Standards of Care and 

other relevant health and human 

services activities. 

Timetable: 

Action Date FR Cite 

NPRM .................. 09/00/21 


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Regulatory Flexibility Analysis 

Required: No. 

Agency Contact: Carla Carter, 

Supervisory Civil Rights Analyst, 

Department of Health and Human 

Services, Office for Civil Rights, 200 

Independence Avenue SW, Washington, 

DC 20201, Phone: 800 368–1019, Email: 

ocrmail@hhs.gov. 

RIN: 0945–AA15 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Office of the National Coordinator for 

Health Information Technology (ONC) 

Completed Actions 

87. Information Blocking and the ONC 

Health IT Certification Program: 

Extension of Compliance Dates and 

Timeframes in Response to the COVID– 

19 Public Health Emergency 

Legal Authority: 42 U.S.C. 300jj–11; 

42 U.S.C. 300jj–14; . . . 

Abstract: In light of COVID–19, ONC 

issued an interim final rule with 

comment period (IFC) that gives health 

IT developers and health care providers 

flexibilities to effectively respond to the 

serious public health threats posed by 

the spread of COVID–19. The IFC 

extends certain applicability and 

compliance dates and timeframes in the 

21st Century Cures Act: Interoperability, 

Information Blocking, and the ONC 

Health IT Certification Program Final 

Rule (ONC Cures Act Final Rule), 

including applicability and compliance 

dates for the information blocking 

provisions, certain 2015 Edition health 

IT certification criteria, and Conditions 

and Maintenance of Certification 

requirements under the ONC Health IT 

Certification Program. The IFC also 

updated certain standards and made 

technical corrections and clarifications 

to the ONC Cures Act Final Rule, which 

was published in the Federal Register 

on May 1, 2020. 

Completed: 

Reason Date FR Cite 

Interim Final Rule 11/04/20 85 FR 70064 

Interim Final Rule 

Comment Period End.

01/04/21 

Final Action— 

Agency Expects 

No Further Action.

05/25/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Michael Lipinski, 

Phone: 202 690–7151. 

RIN: 0955–AA02 

DEPARTMENT OF HEALTH AND 

HUUMAN SERVICES (HHS) 

Centers for Disease Control and 

Prevention (CDC) 

Final Rule Stage 

88. Control of Communicable Diseases; 

Foreign Quarantine 

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 ......... 04/00/22 

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 

89. National Standards for the 

Licensure of Wholesale Drug 

Distributors and Third–Party Logistics 

Providers 

Legal Authority: Pub. L. 113–54 

Abstract: The rulemaking, once 

finalized, will establish 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 thirdparty logistics provider licensing for use 

in the absence of a State licensure 

program. 

Timetable: 

Action Date FR Cite 

NPRM .................. 09/00/21 

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 

90. Certain Requirements Regarding 

Prescription Drug Marketing (203 

Amendment) 

Legal Authority: 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 .................. 09/00/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Aaron Weisbuch, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for Drug 

Evaluation and Research, Building 51, 

Room 4261, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993, 

Phone: 301 796–9362, Email: 

aaron.weisbuch@fda.hhs.gov. 

RIN: 0910–AH56 

91. Medication Guide; Patient 

Medication Information 

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 the 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 


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41218 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda 

understood format to help patients use 

their prescription drug products safely 

and effectively. 

Timetable: 

Action Date FR Cite 

NPRM .................. 10/00/21 

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 

92. Requirements for Tobacco Product 

Manufacturing Practice 

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 .................. 10/00/21 

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, Building 71, Room 

G335, Silver Spring, MD 20993, Phone: 

877 287–1373, Fax: 240 276–3904, 

Email: ctpregulations@fda.hhs.gov. 

RIN: 0910–AH91 

93. Administrative Detention of 

Tobacco Products 

Legal Authority: 21 U.S.C. 334; 21 

U.S.C. 371 

Abstract: The FDA is proposing 

regulations to establish requirements for 

the administrative detention of tobacco 

products. This action, if finalized, 

would allow FDA to administratively 

detain tobacco products encountered 

during inspections that an officer or 

employee 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 a 

regulatory legal action. 

Timetable: 

Action Date FR Cite 

NPRM .................. 12/00/21 

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, WO 71, Room 

G335, Silver Spring, MD 20993, Phone: 

877 287–1373, Email: ctpregulations@

fda.hhs.gov. 

Lauren Belcher, Regulatory Counsel, 

Department of Health and Human 

Services, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, WO 71, Room G335, Silver 

Spring, MD 20993, Phone: 877 287– 

1373, Email: ctpregulations@

fda.hhs.gov. 

RIN: 0910–AI05 

94. Nutrient Content Claims, Definition 

of Term: Healthy 

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 .................. 09/00/21 

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 

95. Revocation of Uses of Partially 

Hydrogenated Oils in Foods 

Legal Authority: 21 U.S.C. 321; 21 

U.S.C. 341; 21 U.S.C. 342; 21 U.S.C. 343; 

21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 

379e 

Abstract: In the Federal Register of 

June 17, 2015 (80 FR 34650), we 

published a declaratory order 

announcing our final determination that 

there is no longer a consensus among 

qualified experts that partially 

hydrogenated oils (PHOs) are generally 

recognized as safe (GRAS) for any use in 

human food. In the Federal Register of 

May 21, 2018 (83 FR 23382), we denied 

a food additive petition requesting that 

the food additive regulations be 

amended to provide for the safe use of 

PHOs in certain food applications. We 

are now proposing 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 proposing to revoke all prior 

sanctions for uses of PHOs in food. 

Timetable: 

Action Date FR Cite 

NPRM .................. 10/00/21 

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 

96. Tobacco Product Standard for 

Characterizing Flavors in Cigars 

Legal Authority: 21 U.S.C. 387g 

Abstract: Evidence shows that 

flavored tobacco products, especially 

those that are sweet, 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. Nearly one 

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 


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standard that would ban characterizing 

flavors in all cigars. We are taking this 

action to reduce the tobacco-related 

death associated with cigars. 

Timetable: 

Action Date FR Cite 

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

ANPRM Comment 

Period End.

07/19/18 

NPRM .................. 08/00/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Samantha 

LohCollado, Regulatory Counsel, 

Department of Health and Human 

Services, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Building 71, Room G335, Silver 

Spring, MD 20993, Phone: 877 287– 

1373, Fax: 877 287–1426, Email: 

ctpregulations@fda.hhs.gov. 

RIN: 0910–AI28 

97. Conduct of Analytical and Clinical 

Pharmacology, Bioavailability and 

Bioequivalence Studies 

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 human 

research and 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 .................. 03/00/22 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Brian Joseph Folian, 

Regulatory Counsel, 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Food and Drug Administration (FDA) 

Final Rule Stage 

98. Mammography Quality Standards 

Act 

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 ............ 09/00/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Jean M. Olson, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, 10903 New 

Hampshire Avenue, Building 66, Room 

5506, Silver Spring, MD 20993, Phone: 

301 796–6579, Email: jean.olson@

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 

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 ............ 12/00/21 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Food and Drug Administration (FDA) 

Long-Term Actions 

100. Direct-to-Consumer Prescription 

Drug Advertisements: Presentation of 

the Major Statement in a Clear, 

Conspicuous, Neutral Manner in 

Advertisements in Television and 

Radio Format 

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 risks in 

what is sometimes called the major 

statement. The rule would revise the 

regulation to reflect the statutory 

requirement require that in DTC 

advertisements for human drugs in 

television or radio format, the major 

statement relating to the side effects and 

contraindications of an advertised 

prescription drug 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 


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41220 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda 

Action Date FR Cite 

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 ............ 05/00/22 

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 

101. Sunlamp Products; Amendment to 

the Performance Standard 

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 ............ 05/00/22 

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 

102. General and Plastic Surgery 

Devices: Restricted Sale, Distribution, 

and Use of Sunlamp Products 

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 ............ 05/00/22 

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–AH14 

103. Nicotine Toxicity Warnings 

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 .................. 08/00/22 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Samantha 

LohCollado, Regulatory Counsel, 

Department of Health and Human 

Services, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Building 71, Room G335, Silver 

Spring, MD 20993, Phone: 877 287– 

1373, Fax: 877 287–1426, Email: 

ctpregulations@fda.hhs.gov. 

RIN: 0910–AH24 

104. Requirements for Additional 

Traceability Records for Certain Foods 

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 


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Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda 41221 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Food and Drug Administration (FDA) 

Completed Actions 

105. Milk and Cream Product and 

Yogurt Products, Final Rule To Revoke 

the Standards for Lowfat Yogurt and 

Nonfat Yogurt and To Amend the 

Standard for Yogurt 

Legal Authority: 21 U.S.C. 321; 21 

U.S.C. 336; 21 U.S.C. 341; 21 U.S.C. 343; 

21 U.S.C. 348; 21 U.S.C. 371(e); 21 

U.S.C. 379e 

Abstract: This final rule amends the 

standard of identity for yogurt and 

revokes the standards of identity for 

lowfat yogurt and nonfat yogurt. It 

modernizes the standard for yogurt to 

allow for technological advances, to 

preserve the basic nature and essential 

characteristics of yogurt, and to promote 

honesty and fair dealing in the interest 

of consumers. Section 701(e)(1), of the 

Federal Food, Drug, and Cosmetic Act 

requires that the amendment or repeal 

of the definition and standard of 

identity for a dairy product proceed 

under a formal rulemaking process. 

Although, standard practice is not to 

include formal rulemaking in the 

Unified Agenda, this rule is included to 

highlight the de-regulatory work in this 

space. 

Completed: 

Reason Date FR Cite 

Withdrawn From 

the Unified 

Agenda—This 

RIN is Being 

Pursued via 

Formal Rulemaking Process.

06/01/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Terri Wenger, Phone: 

240 402–2371, Email: terri.wenger@

fda.hhs.gov. 

RIN: 0910–AI40 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

Proposed Rule Stage 

106. Contract Year 2023 Policy and 

Technical Changes to the Medicare 

Advantage and Medicare Prescription 

Drug Benefit Programs (CMS–4192) 

Legal Authority: 42 U.S.C. 1395w 

Abstract: This proposed rule would 

strengthen and improve the Medicare 

Advantage (MA or Part C) and Medicare 

Prescription Drug Benefit (Part D) 

programs, codify existing sub regulatory 

guidance, and implement any statutory 

changes (if necessary) for contract year 

2023. 

Timetable: 

Action Date FR Cite 

NPRM .................. 09/00/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Christian Bauer, 

Director, Division of Part D Policy, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Center for Medicare, 

MS: C1–26–16, 7500 Security 

Boulevard, Baltimore, MD 21244, 

Phone: 410 786–6043, Email: 

christian.bauer@cms.hhs.gov 

RIN: 0938–AU30 

107. CY 2022 Revisions to Payment 

Policies Under the Physician Fee 

Schedule and Other Revisions to 

Medicare Part B (CMS–1751) (Section 

610 Review) 

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, 2022. Additionally, 

this rule proposes updates to the 

Quality Payment Program. 

Timetable: 

Action Date FR Cite 

NPRM .................. 06/00/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Gift Tee, Director, 

Division of Physician Services, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Center for Medicare, 

7500 Security Boulevard, MS: C1–09– 

07, Baltimore, MD 21244, Phone: 410 

786–9316, Email: gift.tee@cms.hhs.gov. 

RIN: 0938–AU42 

108. CY 2022 Hospital Outpatient PPS 

Policy Changes and Payment Rates and 

Ambulatory Surgical Center Payment 

System Policy Changes and Payment 

Rates (CMS–1753) (Section 610 Review) 

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 .................. 06/00/21 

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–AU43 

109. Hospital Inpatient Prospective 

Payment Systems for Acute Care 

Hospitals; the Long-Term Care Hospital 

Prospective Payment System; and FY 

2022 Rates (CMS–1752) (Section 610 

Review) 

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

NPRM Comment 

Period End.

06/28/21 

Final Action ......... 10/00/21 

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: C4–03–18, 7500 Security 

Boulevard, Baltimore, MD 21244, 

Phone: 410 786–6504, Email: 

donald.thompson@cms.hhs.gov. 


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41222 Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda 

RIN: 0938–AU44 

110. • Medicare Advantage and 

Medicare Prescription Drug Benefit 

Program Payment Policy (CMS–4198) 

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 .................. 01/00/22 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

Final Rule Stage 

111. • Requirements Related to Surprise 

Billing; Part II (CMS–9908) 

Legal Authority: Pub. L. 116–260, 

Division BB, title I and title II 

Abstract: This interim final rule with 

comment would implement additional 

protections against surprise medical 

bills under the No Surprises Act, 

including provisions related to the 

independent dispute resolution 

processes. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 08/00/21 

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: 301 493–4293, Email: 

deborah.bryant@cms.hhs.gov. 

RIN: 0938–AU62 

112. • Requirements Related to Surprise 

Billing; Part I (CMS–9909) 

Legal Authority: Pub. L. 116–260, 

Division BB, title I and title II 

Abstract: This interim final rule with 

comment would implement certain 

protections against surprise medical 

bills under the No Surprises Act. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 

With Comment.

07/00/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Lindsey Murtagh, 

Director, Market–Wide Regulation 

Division, Department of Health and 

Human Services, Centers for Medicare & 

Medicaid Services, Center for Consumer 

Information and Insurance Oversight, 

7500 Security Boulevard, Baltimore, MD 

21244, Phone: 301 492–4106, Email: 

lindsey.murtagh@cms.hhs.gov. 

RIN: 0938–AU63 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

Long-Term Actions 

113. Durable Medical Equipment Fee 

Schedule, Adjustments To Resume the 

Transitional 50/50 Blended Rates To 

Provide Relief in Non-Competitive 

Bidding Areas (CMS–1687) (Section 610 

Review) 

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 follows 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 to be 

Merged With 

0938–AU17.

05/00/22 

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 

114. Requirements for Long-Term Care 

Facilities: Regulatory Provisions To 

Promote Increased Safety (CMS–3347) 

(Section 610 Review) 

Legal Authority: Secs. 1819 and 1919 

of the Social Security Act; sec. 

1819(d)(4)(B) and 1919(d)(4)(B) of the 

Social Security Act; sec. 1819(b)(1)(A) 

and 1919 (b)(1)(A) of the Social Security 

Act 

Abstract: This final rule reforms the 

requirements that long-term care 

facilities must meet to participate in the 

Medicare and Medicaid programs in 

order to support the provision of safe 

care and preserve access to care. 

Timetable: 

Action Date FR Cite 

NPRM .................. 07/18/19 84 FR 34737 

NPRM Comment 

Period End.

09/16/19 

Final Action ......... 07/00/22 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Diane Corning, 

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: 

diane.corning@cms.hhs.gov. 

RIN: 0938–AT36 


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Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg Flex Agenda 41223 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

Completed Actions 

115. Most Favored Nation (MFN) Model 

(CMS–5528) (Completion of a Section 

610 Review) 

Legal Authority: Social Security Act, 

sec. 1115A 

Abstract: This interim final rule with 

comment period (IFC) implements the 

Most Favored Nation (MFN) Model, a 

new Medicare payment model under 

section 1115A of the Social Security Act 

(the Act). The MFN Model tests whether 

more closely aligning payment for 

Medicare Part B drugs and biologicals 

(hereafter, referred to as drugs) with 

international prices and removing 

incentives to use higher-cost drugs can 

control unsustainable growth in 

Medicare Part B spending without 

adversely affecting quality of care for 

beneficiaries. 

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 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Laura 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 

116. Medicaid; Reducing Provider and 

Patient Burden by Improving Prior 

Authorization Processes and Promoting 

Patients’ Electronic Access to Health 

Information (CMS–9123) 

Legal Authority: 42 U.S.C. 1302 

Abstract: This final rule places new 

requirements on state Medicaid and 

CHIP fee-for-service (FFS) programs, 

Medicaid managed care plans, CHIP 

managed care entities, and Qualified 

Health Plan (QHP) issuers on the 

Federally-facilitated Exchanges (FFEs) 

to improve the electronic exchange of 

health care data, and streamline 

processes related to prior authorization, 

while continuing CMS’ drive toward 

interoperability, and reducing burden in 

the health care market. In addition, on 

behalf of the Department of Health and 

Human Service (HHS), the Office of the 

National Coordinator for Health 

Information Technology (ONC) is 

adopting certain specified 

implementation guides (IGs) needed to 

support the Application Programming 

Interface (API) policies included in this 

rule. Each of these elements plays a key 

role in reducing overall payer and 

provider burden and improving patient 

access to health information. 

Completed: 

Reason Date FR Cite 

NPRM .................. 12/18/20 85 FR 82586 

Withdrawn ........... 03/17/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Alexandra Mugge, 

Phone: 410 786–4457, Email: 

alexandra.mugge@cms.hhs.gov. 

RIN: 0938–AT99 

117. CY 2021 Revisions to Payment 

Policies Under the Physician Fee 

Schedule and Other Revisions to 

Medicare Part B (CMS–1734) 

(Completion of a Section 610 Review) 

Legal Authority: 42 U.S.C. 1302; 42 

U.S.C. 1395hh 

Abstract: This annual final rule 

revises payment polices under the 

Medicare physician fee schedule, and 

makes other policy changes to payment 

under Medicare Part B. These changes 

apply to services furnished beginning 

January 1, 2021. Additionally, this rule 

updates the Quality Payment Program. 

Timetable: 

Action Date FR Cite 

NPRM .................. 08/17/20 85 FR 50074 

NPRM Comment 

Period End.

10/05/20 

Final Action ......... 12/28/20 85 FR 84472 

Final Action Effective.01/01/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Marge Watchorn, 

Deputy Director, Division of Practitioner 

Services, Department of Health and 

Human Services, Centers for Medicare & 

Medicaid Services, Center for Medicare, 

MS: C4–01–15, 7500 Security 

Boulevard, Baltimore, MD 21244, 

Phone: 410 786–4361, Email: 

marge.watchorn@cms.hhs.gov. 

RIN: 0938–AU10 

118. CY 2021 Hospital Outpatient PPS 

Policy Changes and Payment Rates and 

Ambulatory Surgical Center Payment 

System Policy Changes and Payment 

Rates (CMS–1736) (Completion of a 

Section 610 Review) 

Legal Authority: 42 U.S.C. 1302; 42 

U.S.C. 1395hh 

Abstract: This annual final rule 

revises the Medicare hospital outpatient 

prospective payment system to 

implement statutory requirements and 

changes arising from our continuing 

experience with this system. The rule 

describes changes to the amounts and 

factors used to determine payment rates 

for services. In addition, the rule 

implements changes to the ambulatory 

surgical center payment system list of 

services and rates. This rule also 

updates and refines the requirements for 

the Hospital Outpatient Quality 

Reporting (OQR) Program and the ASC 

Quality Reporting (ASCQR) Program. 

Timetable: 

Action Date FR Cite 

NPRM .................. 08/12/20 85 FR 48772 

NPRM Comment 

Period End.

10/05/20 

Final Action ......... 12/29/20 85 FR 85866 

Final Action Effective.01/01/21 

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–AU12 

119. Promoting Electronic Access to 

Health Information for Patients and for 

Medicare-and Medicaid-Participating 

Providers and Suppliers (CMS–0057) 

Legal Authority: 42 U.S.C. 1395hh 

Abstract: The proposed rule would 

also revise requirements that select 

Medicare- and Medicaid-participating 

providers and suppliers must meet for 

continued participation in the Medicare 

and Medicaid programs by requiring 

increased patient electronic access to 

their health care information. This 

proposed rule would also improve the 

electronic exchange of health 

information among the identified 

providers and suppliers, and finally, 

this proposed rule would improve 

patient safety by establishing patient 

identity management requirements for 

the identified providers and suppliers. 

Completed: 


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Reason Date FR Cite 

Withdrawn ........... 03/17/21 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Alexandra Mugge, 

Phone: 410 786–4457, Email: 

alexandra.mugge@cms.hhs.gov 

RIN: 0938–AU53 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Administration for Children and 

Families (ACF) 

Proposed Rule Stage 

120. Updating Native Employment 

Works Requirements (Rulemaking 

Resulting From a Section 610 Review) 

Legal Authority: 42 U.S.C. 612 

Abstract: The rule would update NEW 

regulations at 45 CFR part 287 to avoid 

inconsistencies and reflect the changes 

that have been made to the NEW statute 

and Administration for Children and 

Families (ACF) grant policy and 

procedures since the current 

regulation’s publication on February 18, 

2000. In particular, the regulations need 

to address changes made in section 

404(e) of the Social Security Act as 

amended in 1999, Uniform 

Administrative Requirements, Cost 

Principles, and Audit Requirement for 

HHS Awards (45 CFR part 75)—Part 75 

Uniform Administrative Requirements, 

Cost Principles, and Audit 

Requirements for HHS Awards, Public 

Law 106–107, the ‘‘Federal Financial 

Assistance Management, Improvement 

Act of 1999’’ (Nov. 20, 1999), and 

various minor technical changes. While 

some of these changes have been 

addressed and communicated to the 

public and grantees via program 

instructions and information 

memoranda, the regulations themselves 

are now inconsistent with current law 

and policy. 

Timetable: 

Action Date FR Cite 

NPRM .................. 12/00/21 

Regulatory Flexibility Analysis 

Required: No. 

Agency Contact: Tonya Ann Davis, 

Program Specialist, Department of 

Health and Human Services, 

Administration for Children and 

Families, 330 C Street SW, Room 3020, 

Washington, DC 20201, Phone: 202 401– 

4851, Email: tonya.davis@acf.hhs.gov. 

RIN: 0970–AC83 

[FR Doc. 2021–14870 Filed 7–29–21; 8:45 am] 

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