[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Proposed Rules]
[Pages 5226-5236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27956]



[[Page 5225]]

Vol. 87

Monday,

No. 20

January 31, 2022

Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

  Federal Register / Vol. 87 , No. 20 / Monday, January 31, 2022 / UA: 
Reg Flex Agenda  

[[Page 5226]]


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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 well-being of Americans by promoting effective health 
and human services and by fostering sound, sustained advances in the 
sciences underlying medicine, public health, and social services.
    This Agenda presents the regulatory activities that the Department 
expects to undertake in the foreseeable future to advance this mission. 
The purpose of the Agenda is to encourage more effective public 
participation in the regulatory process. The regulatory actions 
forecasted in this Agenda reflect the priorities of HHS Secretary 
Xavier Becerra and the Biden-Harris Administration. Accordingly, this 
Agenda contains rulemakings aimed at tackling the coronavirus disease 
2019 (COVID-19) pandemic, building and expanding access to affordable 
health care, addressing health disparities and promoting equity, and 
boosting the wellbeing of children and families, among other policy 
priorities.
    The rulemaking abstracts included in this paper issue of the 
Federal Register cover, as required by the Regulatory Flexibility Act 
of 1980, those prospective HHS rulemakings likely to have a significant 
economic impact on a substantial number of small entities. The 
Department's complete Regulatory Agenda is accessible online at http://www.RegInfo.gov.

Karuna Seshasai,
Executive Secretary to the Department.

              Office of the Secretary--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
260.......................  Limiting the Effect of             0991-AC11
                             Exclusions Implemented
                             Under the Social Security
                             Act (Rulemaking Resulting
                             From a Section 610
                             Review).
------------------------------------------------------------------------


              Office for Civil Rights--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
261.......................  Rulemaking on                      0945-AA15
                             Discrimination on the
                             Basis of Disability in
                             Critical Health and Human
                             Services Programs or
                             Activities (Rulemaking
                             Resulting From a Section
                             610 Review) (Reg Plan Seq
                             No. 45).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


Substance Abuse and Mental Health Services Administration--Proposed Rule
                                  Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
262.......................  Treatment of Opioid use            0930-AA39
                             Disorder With Extended
                             Take Home Doses of
                             Methadone (Reg Plan Seq
                             No. 50).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


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


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
264.......................  National Standards for the         0910-AH11
                             Licensure of Wholesale
                             Drug Distributors and
                             Third-Party Logistics
                             Providers.
265.......................  Nicotine Toxicity Warnings         0910-AH24
266.......................  Certain Requirements               0910-AH56
                             Regarding Prescription
                             Drug Marketing (203
                             Amendment).
267.......................  Medication Guide; Patient          0910-AH68
                             Medication Information.
268.......................  Requirements for Tobacco           0910-AH91
                             Product Manufacturing
                             Practice.

[[Page 5227]]

 
269.......................  Administrative Detention           0910-AI05
                             of Tobacco Products.
270.......................  Nutrient Content Claims,           0910-AI13
                             Definition of Term:
                             Healthy (Reg Plan Seq No.
                             53).
271.......................  Revocation of Uses of              0910-AI15
                             Partially Hydrogenated
                             Oils in Foods.
272.......................  Tobacco Product Standard           0910-AI28
                             for Characterizing
                             Flavors in Cigars (Reg
                             Plan Seq No. 56).
273.......................  Conduct of Analytical and          0910-AI57
                             Clinical Pharmacology,
                             Bioavailability and
                             Bioequivalence Studies
                             (Reg Plan Seq No. 57).
274.......................  Additional Amendments to           0910-AI70
                             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).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
275.......................  Direct-to-Consumer                 0910-AG27
                             Prescription Drug
                             Advertisements:
                             Presentation of the Major
                             Statement in a Clear,
                             Conspicuous, Neutral
                             Manner in Advertisements
                             in Television and Radio
                             Format.
276.......................  Sunlamp Products;                  0910-AG30
                             Amendment to the
                             Performance Standard.
277.......................  Mammography Quality                0910-AH04
                             Standards Act.
278.......................  General and Plastic                0910-AH14
                             Surgery Devices:
                             Restricted Sale,
                             Distribution, and Use of
                             Sunlamp Products.
279.......................  Laboratory Accreditation           0910-AH31
                             for Analyses of Foods.
280.......................  Amendments to the List of          0910-AH81
                             Bulk Drug Substances That
                             Can Be Used To Compound
                             Drug Products in
                             Accordance With Section
                             503A of the Federal Food,
                             Drug, and Cosmetic Act.
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
281.......................  Requirements For                   0910-AI44
                             Additional Traceability
                             Records For Certain Foods.
282.......................  Postmarketing Safety               0910-AI61
                             Reporting Requirements,
                             Pharmacovigilance Plans,
                             and Pharmacovigilance
                             Quality Systems for Human
                             Drug and Biological
                             Products.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
283.......................  Administrative                     0938-AU19
                             Simplification:
                             Modifications to NCPDP
                             Retail Pharmacy Standards
                             (CMS-0056).
284.......................  Medicare Advantage and             0938-AU59
                             Medicare Prescription
                             Drug Benefit Program
                             Payment Policy (CMS-4198).
285.......................  CY 2023 Revisions to               0938-AU81
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1770)
                             (Section 610 Review).
286.......................  CY 2023 Hospital                   0938-AU82
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1772)
                             (Section 610 Review).
287.......................  Hospital Inpatient                 0938-AU84
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals; the Long-Term
                             Care Hospital Prospective
                             Payment System; and FY
                             2023 Rates (CMS-1771-P)
                             (Section 610 Review).
288.......................  Transitional Coverage for          0938-AU86
                             Emerging Technologies
                             (CMS-3421).
289.......................  Requirements for Rural             0938-AU92
                             Emergency Hospitals (CMS-
                             3419) (Section 610
                             Review) (Reg Plan Seq No.
                             66).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
290.......................  Durable Medical Equipment          0938-AT21
                             Fee Schedule, Adjustments
                             to Resume the
                             Transitional 50/50
                             Blended Rates to Provide
                             Relief in Non-Competitive
                             Bidding Areas (CMS-1687)
                             (Section 610 Review).
291.......................  Requirements Related to            0938-AU62
                             Surprise Billing; Part II
                             (CMS-9908).
292.......................  Omnibus COVID-19 Health            0938-AU75
                             Care Staff Vaccination
                             (CMS-3415) (Section 610
                             Review) (Reg Plan Seq No.
                             69).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


[[Page 5228]]


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
293.......................  Most Favored Nation (MFN)          0938-AT91
                             Model (CMS-5528) (Section
                             610 Review).
294.......................  Durable Medical Equipment,         0938-AU17
                             Prosthetics, Orthotics
                             and Supplies (DMEPOS)
                             Policy Issues and Level
                             II of the Healthcare
                             Common Procedure Coding
                             System (HCPCS) (CMS-1738)
                             (Section 610 Review).
295.......................  Hospital Inpatient                 0938-AU44
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals; the Long-Term
                             Care Hospital Prospective
                             Payment System; and FY
                             2022 Rates (CMS-1752)
                             (Section 610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
296.......................  Requirements for Long-Term         0938-AT36
                             Care Facilities:
                             Regulatory Provisions to
                             Promote Increased Safety
                             (CMS-3347) (Completion of
                             a Section 610 Review).
297.......................  CY 2022 Home Health                0938-AU37
                             Prospective Payment
                             System Rate Update, Home
                             Infusion Therapy
                             Services, and Quality
                             Reporting Requirements
                             (CMS-1747) (Completion of
                             a Section 610 Review).
298.......................  FY 2022 Inpatient                  0938-AU40
                             Psychiatric Facilities
                             Prospective Payment
                             System Rate and Quality
                             Reporting Updates (CMS-
                             1750) (Completion of a
                             Section 610 Review).
299.......................  CY 2022 Revisions to               0938-AU42
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1751)
                             (Completion of a Section
                             610 Review).
300.......................  CY 2022 Hospital                   0938-AU43
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1753)
                             (Completion of a Section
                             610 Review).
301.......................  Requirements Related to            0938-AU63
                             Surprise Billing; Part I
                             (CMS-9909).
------------------------------------------------------------------------


      Administration for Children and Families--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
302.......................  Updating Native Employment         0970-AC83
                             Works Requirements
                             (Rulemaking Resulting
                             From a Section 610
                             Review).
------------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the Secretary (OS)

Proposed Rule Stage

260. 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................................   12/00/21
------------------------------------------------------------------------

    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,
    RIN: 0991-AC11

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Proposed Rule Stage

261. Rulemaking on Discrimination on the Basis of Disability in 
Critical Health and Human Services Programs or Activities (Rulemaking 
Resulting From a Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 45 in part II of this issue 
of the Federal Register.
    RIN: 0945-AA15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Proposed Rule Stage

262.  Treatment of Opioid Use Disorder With Extended Take Home 
Doses of Methadone

    Regulatory Plan: This entry is Seq. No. 50 in part II of this issue 
of the Federal Register.
    RIN: 0930-AA39


[[Page 5229]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Final Rule Stage

263. 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      03/13/20
 End.
Final Action........................   09/00/22
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0920-AA75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

264. 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 third-party logistics 
provider licensing for use in the absence of a State licensure program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/21
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AH11

265. 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 e-liquids in 
tobacco products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/22
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Samantha LohCollado, Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, 
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, 
Email: [email protected].
    RIN: 0910-AH24

266. 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................................   01/00/22
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AH56

267. 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 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................................   02/00/22
------------------------------------------------------------------------

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

268. 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

[[Page 5230]]

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................................   03/00/22
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AH91

269. Administrative Detention of Tobacco Products

    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 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.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/22
------------------------------------------------------------------------

    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: [email protected].
    Matthew Brenner, Senior Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Tobacco 
Products, 10903 New Hampshire Avenue, Document Control Center, Building 
71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email: 
[email protected].
    RIN: 0910-AI05

270. Nutrient Content Claims, Definition of Term: Healthy

    Regulatory Plan: This entry is Seq. No. 53 in part II of this issue 
of the Federal Register.
    RIN: 0910-AI13

271. 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................................   01/00/22
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AI15

272. Tobacco Product Standard for Characterizing Flavors in Cigars

    Regulatory Plan: This entry is Seq. No. 56 in part II of this issue 
of the Federal Register.
    RIN: 0910-AI28

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

    Regulatory Plan: This entry is Seq. No. 57 in part II of this issue 
of the Federal Register.
    RIN: 0910-AI57

274.  Additional 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)

    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................................   11/00/21
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Alexandria Fujsaki, 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


[[Page 5231]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

275. 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-to-consumer (DTC) advertisements of 
prescription drugs. Prescription drug advertisements presented through 
media such as TV and radio must disclose the product's major side 
effects and contraindications in what is sometimes called the major 
statement. The rule would revise the regulation to reflect the 
statutory requirement that in DTC advertisements for human drugs in 
television or radio format, the major statement relating to side 
effects and contraindications of an advertised prescription drug must 
be presented in a clear, conspicuous, and neutral manner. This rule 
also establishes standards for determining whether the major statement 
in these advertisements is presented in the manner required.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/29/10  75 FR 15376
NPRM Comment Period End.............   06/28/10
NPRM Comment Period Reopened........   01/27/12  77 FR 4273
NPRM Comment Period End.............   02/27/12
NPRM Comment Period Reopened........   03/29/12  77 FR 16973
NPRM Comment Period Reopened End....   04/09/12
Final Rule..........................   09/00/22
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG27

276. 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: 
[email protected].
    RIN: 0910-AG30

277. 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..........................   03/00/22
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AH04

278. 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: 
[email protected].
    RIN: 0910-AH14

279. Laboratory Accreditation for Analyses of Foods

    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

[[Page 5232]]

the number of qualified laboratories eligible to perform testing of 
food, which will help FDA improve the safety of the U.S. food supply.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/04/19  84 FR 59452
NPRM Comment Period End.............   03/03/20
NPRM Comment Period Extended........   02/28/20  85 FR 11893
NPRM Comment Period Extended........   04/06/20  85 FR 19114
NPRM Comment Period End.............   07/06/20
Final Rule..........................   02/00/22
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Stacie Hammack, Chemist, Department of Health and 
Human Services, Food and Drug Administration, Office of Regulatory 
Affairs, Food and Feed Laboratory Operations, 60 8th Street NE, 
Atlanta, GA 30309,  Phone: 301 796-5817, Email: 
[email protected].
    RIN: 0910-AH31

280. 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..........................   03/00/22  .......................
------------------------------------------------------------------------

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

281. 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: 
[email protected].
    RIN: 0910-AI44

282.  Postmarketing Safety Reporting Requirements, 
Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for 
Human Drug and Biological Products

    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................................   03/00/23  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AI61

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

283. Administrative Simplification: Modifications to NCPDP Retail 
Pharmacy Standards (CMS-0056)

    Legal Authority: 42 U.S.C. 1320d to 1320d-9
    Abstract: This proposed rule seeks 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.

[[Page 5233]]

    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/00/22  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AU19

284. 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................................   05/00/22  .......................
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AU59

285.  CY 2023 Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Medicare Part B (CMS-1770) (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, 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: 
C1-09-07, Baltimore, MD 21244, Phone: 410 786-9316, Email: 
[email protected].
    RIN: 0938-AU81

286.  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)

    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: 
[email protected].
    RIN: 0938-AU82

287.  Hospital Inpatient Prospective Payment Systems for Acute 
Care Hospitals; the Long-Term Care Hospital Prospective Payment System; 
and FY 2023 Rates (CMS-1771-P) (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 inpatient and long-term care hospital prospective payment 
systems for operating and capital-related costs. This proposed rule 
would implement changes arising from our continuing experience with 
these systems. In addition, the rule proposes to establish new 
requirements or revise existing requirements for quality reporting by 
specific Medicare providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Director, Division of Acute Care, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: 
[email protected].
    RIN: 0938-AU84

288.  Transitional Coverage for Emerging Technologies (CMS-
3421)

    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................................   10/00/22  .......................
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AU86

289.  Requirements for Rural Emergency Hospitals (CMS-3419) 
(Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 66 in part II of this issue 
of the Federal Register.
    RIN: 0938-AU92


[[Page 5234]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

290. 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 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      07/09/18  .......................
 End.
Continuation Notice.................   04/26/21  86 FR 21949
Final Action to be Merged With 0938-   05/00/22  .......................
 AU38 and 0938-AU17.
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AT21

291. 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..................   10/07/21  86 FR 55980
Interim Final Rule Effective........   10/07/21  .......................
Interim Final Rule Comment Period      12/06/21  .......................
 End.
                                     -----------------------------------
Reviewing Comments..................           To Be Determined
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AU62

292.  Omnibus COVID-19 Health Care Staff Vaccination (CMS-3415) 
(Section 610 Review)

    Regulatory Plan: This entry is Seq. No. 69 in part II of this issue 
of the Federal Register.
    RIN: 0938-AU75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

293. Most Favored Nation (MFN) Model (CMS-5528) (Section 610 Review)

    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      01/26/21  .......................
 End.
NPRM................................   08/10/21  86 FR 43618
NPRM Comment Period End.............   10/12/21  .......................
Final Action........................   08/00/24  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AT91

294. Durable Medical Equipment, Prosthetics, Orthotics and Supplies 
(DMEPOS) Policy Issues and Level II of the Healthcare Common Procedure 
Coding System (HCPCS) (CMS-1738) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1395l; 42 U.S.C. 1395m; 42 U.S.C. 1395u; 
42 U.S.C. 1395w-3
    Abstract: This final rule responds to public comments on the 
proposed rule that published November 4, 2020, and establishes 
regulations for policy and program issues. Among the issues under 
consideration for this final rule are methodologies for adjusting the 
Medicare DMEPOS fee schedule amounts using information from the 
Medicare DMEPOS competitive bidding program for items furnished on the 
date immediately following the duration of the emergency period 
described in section 1135(g)(1)(B) of the Social Security Act; 
establishing procedures for making benefit category and payment 
determinations for new items and services that are durable medical 
equipment (DME), prosthetic devices, orthotics and prosthetics, 
therapeutic shoes and inserts, surgical dressings, or splints, casts, 
and other devices used for reductions of fractures and dislocations 
under Medicare Part B; classifying continuous glucose monitors (CGMs) 
as DME under Medicare Part B and establishing fee schedule amounts for 
these items and related supplies and accessories; and other issues in 
the proposed rule and interim final rules with comment period (IFC) 
that CMS issued on May 11, 2018 and May 8, 2020.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/04/20  85 FR 70358
NPRM Comment Period End.............   01/04/21  .......................
Final Action........................   11/00/23  .......................
------------------------------------------------------------------------


[[Page 5235]]

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Joel Kaiser, Director, Division of DMEPOS Policy, 
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: 410 786-6506, Email: 
[email protected].
    RIN: 0938-AU17

295. 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 rule finalizes the three remaining policies proposed 
for the Medicare hospital inpatient and long-term care hospital 
prospective payment systems for operating and capital-related costs. 
These policies include implementation of sections 126, 127, and 131 of 
the Consolidated Appropriations Act of 2020; changes in treatment of 
Medicaid Section 1115 waiver days for purposes of Medicare 
Disproportionate Share Hospital payments; 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....................   05/00/24  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Director, Division of Acute Care, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: 
[email protected].
    RIN: 0938-AU44

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

296. Requirements for Long-Term Care Facilities: Regulatory Provisions 
To Promote Increased Safety (CMS-3347) (Completion of a 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  .......................
Withdrawn...........................   08/04/21  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AT36

297. CY 2022 Home Health Prospective Payment System Rate Update, Home 
Infusion Therapy Services, and Quality Reporting Requirements (CMS-
1747) (Completion of a Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395(hh)
    Abstract: This annual final rule updates the home health 
prospective payment system payment rates and wage index. This rule also 
updates the home infusion therapy services payment rates. In addition, 
this rule implements changes to the Home Health Value-Based Purchasing 
Model and to the Home Health Quality Reporting Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/07/21  86 FR 35874
NPRM Comment Period End.............   08/27/21  .......................
Final Action........................   11/09/21  86 FR 62240
Final Action Effective..............   01/01/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Slater, Director, Division of Home Health and 
Hospice, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Center for Medicare, MS: C4-07-07, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-5229, Email: 
[email protected].
    RIN: 0938-AU37

298. FY 2022 Inpatient Psychiatric Facilities Prospective Payment 
System Rate and Quality Reporting Updates (CMS-1750) (Completion of a 
Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g; 
42 U.S.C. 1395hh; 42 U.S.C. 1395ww(s)
    Abstract: This annual final rule updates the prospective payment 
rates for inpatient psychiatric facilities (IPF) with discharges 
beginning on October 1, 2021. The rule also includes updates to the IPF 
Quality Reporting Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/13/21  86 FR 19480
NPRM Comment Period End.............   06/07/21  .......................
Final Action........................   08/04/21  86 FR 42608
Final Action Effective..............   10/01/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sherlene Jacques, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-04-27, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-0510, Email: 
[email protected].
    RIN: 0938-AU40

299. CY 2022 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1751) (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, 2022. Additionally, this rule

[[Page 5236]]

finalizes updates to the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/23/21  86 FR 39104
NPRM Comment Period End.............   09/13/21  .......................
Final Action........................   11/19/21  86 FR 64996
Final Action Effective..............   01/01/22  .......................
------------------------------------------------------------------------

    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: 
C1-09-07, Baltimore, MD 21244, Phone: 410 786-9316, Email: 
[email protected].
    RIN: 0938-AU42

300. CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1753) (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 
finalizes 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................................   08/04/21  86 FR 42018
NPRM Comment Period End.............   09/17/21  .......................
Final Action........................   11/16/21  86 FR 63458
Final Action Effective..............   01/01/22  .......................
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AU43

301. 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 implements certain 
protections against surprise medical bills under the No Surprises Act.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule With Comment.....   07/13/21  86 FR 36872
Interim Final Rule Comment Period      09/07/21  .......................
 End.
Interim Final Rule Effective........   09/13/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Lindsey Murtagh, Phone: 301 492-4106, Email: 
[email protected].
    RIN: 0938-AU63

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Administration for Children and Families (ACF)

Proposed Rule Stage

302. 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................................   06/00/22  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0970-AC83

[FR Doc. 2021-27956 Filed 1-28-22; 8:45 am]
BILLING CODE 4150-03-P