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Proposed Rule2021-27956

Regulatory Agenda

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Published

January 31, 2022

Issuing agencies

Health and Human Services Department

Abstract

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.

Full Text

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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.RegInfo.gov">http://www.RegInfo.gov</a>.

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. <bullet> 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: <a href="/cdn-cgi/l/email-protection#fc989b918d8c9390959f85939a9a959f99bc9f989fd29b938a">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#8beaeaf9e4e5a5fceee2f8e9fee8e3cbedefeaa5e3e3f8a5ece4fd">[email&#160;protected]</a>.
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: <a href="/cdn-cgi/l/email-protection#25465155574042504944514c4a4b56654341440b4d4d560b424a53">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#0a6b6b786564247d6f6379687f69624a6c6e6b24626279246d657c">[email&#160;protected]</a>.
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: <a href="/cdn-cgi/l/email-protection#65060d170c164b120d0000090017250301044b0d0d164b020a13">[email&#160;protected]</a>.
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: <a href="/cdn-cgi/l/email-protection#c0a3b4b0b2a5a7b5aca1b4a9afaeb380a6a4a1eea8a8b3eea7afb6">[email&#160;protected]</a>.
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: <a href="/cdn-cgi/l/email-protection#41223531332426342d2035282e2f32012725206f2929326f262e37">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#75160105071012001914011c1a1b06351311145b1d1d065b121a03">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#6c0900000902420d0208091e1f03022c0a080d4204041f420b031a">[email&#160;protected]</a>.
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. <bullet> 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: <a href="/cdn-cgi/l/email-protection#dba8aea1bab5b5baf5b9b4a2b7be9bbdbfbaf5b3b3a8f5bcb4ad">[email&#160;protected]</a>.
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:

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:
<a href="/cdn-cgi/l/email-protection#5831393676372b2c3d2a353134343d2a183e3c397630302b763f372e">[email&#160;protected]</a>.
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:

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: <a href="/cdn-cgi/l/email-protection#9af0fffbf4b4f5f6e9f5f4dafcfefbb4f2f2e9b4fdf5ec">[email&#160;protected]</a>.
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:

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:
<a href="/cdn-cgi/l/email-protection#5b323a357534282f3e29363237373e291b3d3f3a75333328753c342d">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#ccbfb8adafa5a9e2a4ada1a1adafa78caaa8ade2a4a4bfe2aba3ba">[email&#160;protected]</a>.
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:

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: <a href="/cdn-cgi/l/email-protection#1c6e736f757079727832707d6b6f73725c7a787d3274746f327b736a">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#5b303a2f333e2932353e752d323e29301b3d3f3a75333328753c342d">[email&#160;protected]</a>.
RIN: 0910-AI44

282. <bullet> 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: <a href="/cdn-cgi/l/email-protection#503a313e3933357e2735393e3522103634317e3838237e373f26">[email&#160;protected]</a>.
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: <a href="/cdn-cgi/l/email-protection#0b6c6e6a656e67676e25636e797962656c4b68667825636378256c647d">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#6208070c0c0b0407104c110a03120b100d22010f114c0a0a114c050d14">[email&#160;protected]</a>.
RIN: 0938-AU59

285. <bullet> 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:
<a href="/cdn-cgi/l/email-protection#bfd8d6d9cb91cbdadaffdcd2cc91d7d7cc91d8d0c9">[email&#160;protected]</a>.
RIN: 0938-AU81

286. <bullet> 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:
<a href="/cdn-cgi/l/email-protection#1c7970756f79327e7d6e6e75727b796e5c7f716f3274746f327b736a">[email&#160;protected]</a>.
RIN: 0938-AU82

287. <bullet> 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:
<a href="/cdn-cgi/l/email-protection#395d565758555d174d515654494a5657795a544a1751514a175e564f">[email&#160;protected]</a>.
RIN: 0938-AU84

288. <bullet> 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:
<a href="/cdn-cgi/l/email-protection#f4989b869dda95879c968db4979987da9c9c87da939b82">[email&#160;protected]</a>.
RIN: 0938-AU86

289. <bullet> 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:
<a href="/cdn-cgi/l/email-protection#91f0fdf4e9f0fff5f4e3bfe4fdfdfcf0ffd1f2fce2bff9f9e2bff6fee7">[email&#160;protected]</a>.
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:

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: <a href="/cdn-cgi/l/email-protection#f39796919c81929bdd91818a929d87b3909e80dd9b9b80dd949c85">[email&#160;protected]</a>.
RIN: 0938-AU62

292. <bullet> 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: <a href="/cdn-cgi/l/email-protection#2a474c446a49475904424259044d455c">[email&#160;protected]</a>.
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:

[[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:
<a href="/cdn-cgi/l/email-protection#c8a2a7ada4e6a3a9a1bbadba88aba5bbe6a0a0bbe6afa7be">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#cca8a3a2ada0a8e2b8a4a3a1bcbfa3a28cafa1bfe2a4a4bfe2aba3ba">[email&#160;protected]</a>.
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:

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: <a href="/cdn-cgi/l/email-protection#e18588808f84cf828e938f888f86a1828c92cf898992cf868e97">[email&#160;protected]</a>.
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:

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:
<a href="/cdn-cgi/l/email-protection#3456465d555a1a475855405146745759471a5c5c471a535b42">[email&#160;protected]</a>.
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:

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:
<a href="/cdn-cgi/l/email-protection#16657e73647a737873387c77756763736556757b65387e7e6538717960">[email&#160;protected]</a>.
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:

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:
<a href="/cdn-cgi/l/email-protection#caada3acbee4beafaf8aa9a7b9e4a2a2b9e4ada5bc">[email&#160;protected]</a>.
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:

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:
<a href="/cdn-cgi/l/email-protection#f99c95908a9cd79b988b8b90979e9c8bb99a948ad791918ad79e968f">[email&#160;protected]</a>.
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:
<a href="/cdn-cgi/l/email-protection#b4d8dddad0c7d1cd9ad9c1c6c0d5d3dcf4d7d9c79adcdcc79ad3dbc2">[email&#160;protected]</a>.
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: <a href="/cdn-cgi/l/email-protection#d0a4bfbea9b1feb4b1a6b9a390b1b3b6feb8b8a3feb7bfa6">[email&#160;protected]</a>.
RIN: 0970-AC83

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

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