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Proposed Rule2022-14603

Regulatory Agenda

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Published

August 8, 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 151 (Monday, August 8, 2022)]
[Proposed Rules]
[Pages 48282-48291]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14603]

[[Page 48281]]

Vol. 87

Monday,

No. 151

August 8, 2022

Part VIII

Department of Health and Human Services

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Semiannual Regulatory Agenda

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

[[Page 48282]]

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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: Kashif Syed, Senior Advisor to the
Executive Secretary, Department of Health and Human Services, 200
Independence Avenue SW, Washington, DC 20201; (202) 690-5627.

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

Kashif Syed,
Senior Advisor to the HHS Executive Secretary.

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

Substance Abuse and Mental Health Services Administration--Proposed Rule
Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
85........................ Treatment of Opioid use 0930-AA39
Disorder With Extended
Take Home Doses of
Methadone.
------------------------------------------------------------------------

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

Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
87........................ National Standards for the 0910-AH11
Licensure of Wholesale
Drug Distributors and
Third-Party Logistics
Providers.
88........................ Medication Guide; Patient 0910-AH68
Medication Information.
89........................ Requirements for Tobacco 0910-AH91
Product Manufacturing
Practice.
90........................ Administrative Detention 0910-AI05
of Tobacco Products.
91........................ Nutrient Content Claims, 0910-AI13
Definition of Term:
Healthy.
92........................ Tobacco Product Standard 0910-AI28
for Characterizing
Flavors in Cigars.
93........................ Conduct of Analytical and 0910-AI57
Clinical Pharmacology,
Bioavailability and
Bioequivalence Studies.
94........................ Amendments to the Final 0910-AI70
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).
95........................ Distribution of Compounded 0910-AI71
Drug Products Under
Section 503A of the
Federal Food, Drug, and
Cosmetic Act (Section 610
Review).
------------------------------------------------------------------------

[[Page 48283]]

Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
96........................ 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.
97........................ Sunlamp Products; 0910-AG30
Amendment to the
Performance Standard.
98........................ Mammography Quality 0910-AH04
Standards Act.
99........................ 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.
100....................... Revocation of Uses of 0910-AI15
Partially Hydrogenated
Oils in Foods.
101....................... Requirements For 0910-AI44
Additional Traceability
Records For Certain Foods.
------------------------------------------------------------------------

Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
102....................... General and Plastic 0910-AH14
Surgery Devices:
Restricted Sale,
Distribution, and Use of
Sunlamp Products.
103....................... Nicotine Toxicity Warnings 0910-AH24
104....................... Certain Requirements 0910-AH56
Regarding Prescription
Drug Marketing (203
Amendment).
105....................... Postmarketing Safety 0910-AI61
Reporting Requirements,
Pharmacovigilance Plans,
and Pharmacovigilance
Quality Systems for Human
Drug and Biological
Products.
------------------------------------------------------------------------

Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
106....................... Laboratory Accreditation 0910-AH31
for Analyses of Foods.
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
107....................... Administrative 0938-AU19
Simplification:
Modifications to NCPDP
Retail Pharmacy Standards
(CMS-0056).
108....................... Medicare Advantage and 0938-AU59
Medicare Prescription
Drug Benefit Program
Payment Policy (CMS-4198).
109....................... 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).
110....................... 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).
111....................... 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)
(Section 610 Review).
112....................... Transitional Coverage for 0938-AU86
Emerging Technologies
(CMS-3421).
113....................... Conditions of 0938-AU92
Participation (CoPs) for
Rural Emergency Hospitals
(REHs) and Critical
Access Hospital (CAH) COP
Updates (CMS-3419)
(Section 610 Review).
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
114....................... Requirements Related to 0938-AU62
Surprise Billing; Part II
(CMS-9908).
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
115....................... Omnibus COVID-19 Health 0938-AU75
Care Staff Vaccination
(CMS-3415) (Section 610
Review).
------------------------------------------------------------------------

Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
116....................... 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)
(Completion of a Section
610 Review).

[[Page 48284]]

117....................... Most Favored Nation (MFN) 0938-AT91
Model (CMS-5528)
(Completion of a Section
610 Review).
118....................... 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)
(Completion of a Section
610 Review).
------------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the Secretary (OS)

Proposed Rule Stage

84. Limiting the Effect of Exclusions Implemented Under the Social
Security Act (Rulemaking Resulting From a Section 610 Review) [0991-
AC11]

Legal Authority: 5 U.S.C. 301; 31 U.S.C. 6101
Abstract: Exclusions implemented under the Social Security Act
prevent individuals convicted of certain crimes or individuals whose
health care licenses have been revoked from participating in Federal
health care programs. Instead of only being barred from participating
in all Federal healthcare programs, certain regulatory provisions have
resulted in these type of exclusion actions being given an overly broad
government-wide effect, and excluded parties have been barred from
participating in all Federal procurement and non-procurement actions.
However, because Social Security Act exclusions are not issued under an
agency's suspension and debarment authority, they do not stop
individuals from participating in all Federal procurement and non-
procurement actions. For an agency to bar individuals from
participating in all procurement and non-procurement activities, it
must exercise its suspension and debarment authority under the Federal
Acquisition Regulation or the Nonprocurement Common Rule. This
rulemaking would remove the regulatory provisions at issue, in order to
align the regulation with the intent of the Social Security Act and
current practice.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/22
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: No.
Agency Contact: Tiffani Redding, Program Analyst, Department of
Health and Human Services, Office of the Secretary, 200 Independence
Avenue SW, Washington, DC 20201, Phone: 202 205-4321, Email:
<a href="/cdn-cgi/l/email-protection#b0c4d9d6d6d1ded99ec2d5d4d4d9ded7f0d8d8c39ed7dfc6">[email&#160;protected]</a>.
RIN: 0991-AC11

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Proposed Rule Stage

85. Treatment of Opioid Use Disorder With Extended Take Home Doses of
Methadone [0930-AA39]

Legal Authority: 21 U.S.C. 823(g)(1)
Abstract: SAMHSA will propose to revise 42 CFR part 8 to make
permanent some regulatory flexibilities for opioid treatment programs
to provide extended take home doses of methadone. To facilitate this
new treatment paradigm, sections of 42 CFR part 8 would require
updating to reflect current treatment practice. SAMHSA's changes would
impact roughly 1800 opioid treatment programs and state opioid
treatment authorities.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/22
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Dr. Neeraj Gandotra, Chief Medical Officer,
Department of Health and Human Services, Substance Abuse and Mental
Health Services Administration, 5600 Fishers Lane, 18E67, Rockville, MD
20857, Phone: 202 823-1816, Email: <a href="/cdn-cgi/l/email-protection#5a343f3f283b30743d3b343e352e283b1a293b3732293b74323229743d352c">[email&#160;protected]</a>.
RIN: 0930-AA39

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Final Rule Stage

86. Control of Communicable Diseases; Foreign Quarantine [0920-AA75]

Legal Authority: 42 U.S.C. 264; 42 U.S.C. 265
Abstract: This rulemaking amends current regulation to enable CDC
to require airlines to collect and provide to CDC certain data elements
regarding passengers and crew arriving from foreign countries under
certain circumstances.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule Effective........ 02/07/20
Interim Final Rule.................. 02/12/20 85 FR 7874
Interim Final Rule Comment Period 03/13/20
End.
Final Action........................ 05/00/23
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ashley C. Altenburger JD, Public Health Analyst,
Department of Health and Human Services, Centers for Disease Control
and Prevention, 1600 Clifton Road NE, MS: H 16-4, Atlanta, GA 30307,
Phone: 800 232-4636, Email: <a href="/cdn-cgi/l/email-protection#3c585b514d4c5350555f45535a5a555f597c5f585f125b534a">[email&#160;protected]</a>.
RIN: 0920-AA75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

87. National Standards for the Licensure of Wholesale Drug Distributors
and Third-Party Logistics Providers [0910-AH11]

Legal Authority: secs. 583 and 584 of the FD&C Act, as added by the
DSCSA under Pub. L. 113-54, together with related FD&C Act authority
added by the DSCSA.
Abstract: The rulemaking, once finalized and effective, will
establish national standards for State licensing of prescription drug
wholesale distributors and third-party logistics providers. The
rulemaking will also establish a Federal system for wholesale drug
distributor and third-party logistics provider licensing for use in the
absence of a State licensure program.
Timetable:

[[Page 48285]]

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#543535263b3a7a23313d273621373c143230357a3c3c277a333b22">[email&#160;protected]</a>.
RIN: 0910-AH11

88. Medication Guide; Patient Medication Information [0910-AH68]

Legal Authority: 21 U.S.C. 321 et seq.; 42 U.S.C. 262; 42 U.S.C.
264; 21 U.S.C. 371
Abstract: The proposed rule would amend FDA medication guide
regulations to require a new form of patient labeling, Patient
Medication Information, for submission to and review by FDA for human
prescription drug products and certain blood products used, dispensed,
or administered on an outpatient basis. The proposed rule would include
requirements for Patient Medication Information development and
distribution. The proposed rule would require clear and concisely
written prescription drug product information presented in a consistent
and easily understood format to help patients use their prescription
drug products safely and effectively.
Timetable:

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

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Chris Wheeler, Supervisory Project Manager,
Department of Health and Human Services, Food and Drug Administration,
10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD
20993, Phone: 301 796-0151, Email: <a href="/cdn-cgi/l/email-protection#3d5e554f544e134a55585851584f7d5b595c1355554e135a524b">[email&#160;protected]</a>.
RIN: 0910-AH68

89. Requirements for Tobacco Product Manufacturing Practice [0910-AH91]

Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f
Abstract: The rule is proposing to establish tobacco product
manufacturing practice (TPMP) requirements for manufacturers of
finished and bulk tobacco products. This proposed rule, if finalized,
would set forth requirements for the manufacture, pre-production design
validation, packing, and storage of a tobacco product. This proposal
would help prevent the manufacture and distribution of contaminated and
otherwise nonconforming tobacco products. This proposed rule provides
manufacturers with flexibility in the manner in which they comply with
the proposed requirements while giving FDA the ability to enforce
regulatory requirements, thus helping to assure the protection of
public health.
Timetable:

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

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Matthew Brenner, Senior Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Tobacco Products, 10903 New Hampshire Avenue, Document
Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone:
877 287-1373, Email: <a href="/cdn-cgi/l/email-protection#42213632302725372e23362b2d2c31022426236c2a2a316c252d34">[email&#160;protected]</a>.
RIN: 0910-AH91

90. Administrative Detention of Tobacco Products [0910-AI05]

Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371
Abstract: FDA is proposing regulations to establish requirements
for the administrative detention of tobacco products. This proposal
would allow FDA to administratively detain tobacco products encountered
during inspections of manufacturers or other establishments that
manufacture, process, pack, or hold tobacco products that an authorized
FDA representative conducting the inspection has reason to believe are
adulterated or misbranded. The intent of administrative detention is to
protect public health by preventing the distribution or use of tobacco
products encountered during inspections that are believed to be
adulterated or misbranded until FDA has had time to consider the
appropriate action to take and, where appropriate, to initiate legal
action.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nathan Mease, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: <a href="/cdn-cgi/l/email-protection#51322521233436243d3025383e3f22113735307f3939227f363e27">[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#83e0f7f3f1e6e4f6efe2f7eaecedf0c3e5e7e2adebebf0ade4ecf5">[email&#160;protected]</a>.
RIN: 0910-AI05

91. Nutrient Content Claims, Definition of Term: Healthy [0910-AI13]

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 343; 21
U.S.C. 371
Abstract: The proposed rule would update the definition for the
implied nutrient content claim ``healthy'' to be consistent with
current nutrition science and federal dietary guidelines. The proposed
rule would revise the requirements for when the claim ``healthy'' can
be voluntarily used in the labeling of human food products so that the
claim reflects current science and dietary guidelines and helps
consumers maintain healthy dietary practices.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/22
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Vincent De Jesus, Nutritionist, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint
Branch Parkway, College Park, MD 20740, Phone: 240 402-1774, Fax: 301
436-1191, Email: <a href="/cdn-cgi/l/email-protection#55233c3b36303b217b31303f30262026153331347b3d3d267b323a23">[email&#160;protected]</a>.
RIN: 0910-AI13

92. Tobacco Product Standard for Characterizing Flavors in Cigars
[0910-AI28]

Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 371(a); 21
U.S.C. 387b and 387c; 21 U.S.C. 387f(d) and 387g; . . .

[[Page 48286]]

Abstract: Evidence shows that flavored tobacco products appeal to
youth and also shows that youth may be more likely to initiate tobacco
use with such products. Characterizing flavors in cigars, such as
strawberry, grape, orange, and cocoa, enhance taste and make them
easier to use. Over a half million youth in the United States use
flavored cigars, placing these youth at risk for cigar-related disease
and death. This proposed rule is a tobacco product standard that would
prohibit characterizing flavors (other than tobacco) in all cigars. We
are taking this action with the intention of reducing the tobacco-
related death and disease associated with cigar use.
Timetable:

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Nathan Mease, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Center for Tobacco Products, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: <a href="/cdn-cgi/l/email-protection#9efdeaeeecfbf9ebf2ffeaf7f1f0eddef8faffb0f6f6edb0f9f1e8">[email&#160;protected]</a>.
Courtney Smith, Senior Regulatory Counsel, Department of Health and
Human Services, Food and Drug Administration, Center for Tobacco
Products, Document Control Center, Building 71, Room G335, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax:
877 287-1426, Email: <a href="/cdn-cgi/l/email-protection#42213632302725372e23362b2d2c31022426236c2a2a316c252d34">[email&#160;protected]</a>.
RIN: 0910-AI28

93. Conduct of Analytical and Clinical Pharmacology, Bioavailability
and Bioequivalence Studies [0910-AI57]

Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42
U.S.C. 262
Abstract: FDA is proposing to amend 21 CFR 320, in certain parts,
and establish a new 21 CFR 321 to clarify FDA's study conduct
expectations for analytical and clinical pharmacology, bioavailability
(BA) and bioequivalence (BE) studies that support marketing
applications for human drug and biological products. The proposed rule
would specify needed basic study conduct requirements to enable FDA to
ensure those studies are conducted appropriately and to verify the
reliability of study data from those studies. This regulation would
align with FDA's other good practice regulations, would also be
consistent with current industry best practices, and would harmonize
the regulations more closely with related international regulatory
expectations.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Joseph Folian, Supervisory Biologist,
Department of Health and Human Services, Food and Drug Administration,
10903 New Hampshire Avenue, Building 51, Room 5215, Silver Spring, MD
20993-0002, Phone: 240 402-4089, Email: <a href="/cdn-cgi/l/email-protection#5d3f2f343c33733b3231343c331d3b393c7335352e733a322b">[email&#160;protected]</a>.
RIN: 0910-AI57

94. Amendments to the Final Rule Regarding the List of Bulk Substances
That Can Be Used to Compound Drug Products in Accordance With Section
503A of the Federal Food, Drug and Cosmetic Act (Section 610 Review)
[0910-AI70]

Legal Authority: 21 U.S.C. 353a; 21 U.S.C. 351; 21 U.S.C. 371(a);
21 U.S.C. 352; 21 U.S.C. 355; . . .
Abstract: FDA has issued a regulation creating a list of bulk drug
substances (active pharmaceutical ingredients) that can be used to
compound drug products in accordance with section 503A of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the
subject of an applicable United States Pharmacopeia (USP) or National
Formulary (NF) monograph nor components of FDA-approved drug products
(the 503A Bulks List). The proposed rule will identify certain bulk
drug substances that FDA has considered and is proposing to place on
the 503A Bulks List and certain bulk drug substances that FDA has
considered and is proposing not to include on the 503A Bulks List.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/23
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Alexandria Fujisaki, Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 51, Room 5169, Center for Drug Evaluation
and Research, Silver Spring, MD 20993, Phone: 240 402-4078.
RIN: 0910-AI70

95. <bullet> Distribution of Compounded Drug Products Under Section
503A of the Federal Food, Drug, and Cosmetic Act (Section 610 Review)
[0910-AI71]

Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21
U.S.C. 353a-1; 21 U.S.C. 353b; 21 U.S.C. 355; 21 U.S.C. 371
Abstract: The Food and Drug Administration is proposing rulemaking
regarding statutory requirements for certain distributions of
compounded human prescription drug products. The proposed rule, if
finalized, will include provisions regarding a standard memorandum of
understanding (MOU) that describes the responsibilities of a State
Board of Pharmacy or other appropriate State agency that chooses to
sign the standard MOU in investigating complaints related to drug
products compounded in such State and distributed outside such State
and in addressing the interstate distribution of inordinate amounts of
compounded human drug products. It will also, if finalized, include
provisions regarding the statutory 5 percent limit on distribution of
compounded human drug products out of the State in which they are
compounded in States that do not sign the standard MOU, and may address
adverse event reporting, product quality reporting, and communication
with State boards of pharmacy.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Undetermined.
Agency Contact: Alexandria Fujisaki, Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 51, Room 5169, Center for Drug Evaluation
and Research, Silver Spring, MD 20993, Phone: 240 402-4078, Email:
<a href="/cdn-cgi/l/email-protection#d3b2bfb6abb2bdb7a1bab2fdb5a6b9baa0b2b8ba93b5b7b2fdbbbba0fdb4bca5">[email&#160;protected]</a>.
RIN: 0910-AI71

[[Page 48287]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

96. Direct-to-Consumer Prescription Drug Advertisements: Presentation
of the Major Statement in a Clear, Conspicuous, Neutral Manner in
Advertisements in Television and Radio Format [0910-AG27]

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; . . .
Abstract: The Food and Drug Administration (FDA) is amending its
regulations concerning direct-to-consumer (DTC) advertisements of
prescription drugs. Prescription drug advertisements presented through
media such as TV and radio must disclose the product's major side
effects and contraindications in what is sometimes called the major
statement. The rule would revise the regulation to reflect the
statutory requirement that in DTC advertisements for human drugs in
television or radio format, the major statement relating to side
effects and contraindications of an advertised prescription drug must
be presented in a clear, conspicuous, and neutral manner. This rule
also establishes standards for determining whether the major statement
in these advertisements is presented in the manner required.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/29/10 75 FR 15376
NPRM Comment Period End............. 06/28/10
NPRM Comment Period Reopened........ 01/27/12 77 FR 4273
NPRM Comment Period End............. 02/27/12
NPRM Comment Period Reopened........ 03/29/12 77 FR 16973
NPRM Comment Period Reopened End.... 04/09/12
Final Rule.......................... 05/00/23
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Suzanna Boyle, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, WO 51, Room 3214, Silver Spring, MD 20993, Phone: 240
402-4723, Email: <a href="/cdn-cgi/l/email-protection#7f0c0a051e11111e511d1006131a3f191b1e5117170c51181009">[email&#160;protected]</a>.
RIN: 0910-AG27

97. Sunlamp Products; Amendment to the Performance Standard [0910-AG30]

Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393;
21 U.S.C. 371
Abstract: FDA is updating the performance standard for sunlamp
products and ultraviolet lamps for use in these products to improve
safety, reflect new scientific information, and work towards
harmonization with international standards. By harmonizing with the
International Electrotechnical Commission, this rule will decrease the
regulatory burden on industry and allow the Agency to take advantage of
the expertise of the international committees, thereby also saving
resources.
Timetable:

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#254c444b0b4a56514057484c49494057654341440b4d4d560b424a53">[email&#160;protected]</a>.
RIN: 0910-AG30

98. Mammography Quality Standards Act [0910-AH04]

Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e);
42 U.S.C. 263b
Abstract: FDA is amending its regulations governing mammography.
The amendments will update the regulations issued under the Mammography
Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and
Cosmetic Act (FD&C Act). FDA is taking this action to address changes
in mammography technology and mammography processes that have occurred
since the regulations were published in 1997 and to address breast
density reporting to patient and healthcare providers.
Timetable:

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Laurie Sternberg, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 66, Room 5517, Silver Spring, MD 20993,
Phone: 240 402-0425, Email: <a href="/cdn-cgi/l/email-protection#7a161b0f08131f54090e1f0814181f081d3a1c1e1b54121209541d150c">[email&#160;protected]</a>.
RIN: 0910-AH04

99. Amendments to the List of Bulk Drug Substances That Can Be Used to
Compound Drug Products in Accordance With Section 503A of the Federal
Food, Drug, and Cosmetic Act [0910-AH81]

Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21
U.S.C. 355; 21 U.S.C. 371; . . .
Abstract: FDA has issued a regulation creating a list of bulk drug
substances (active pharmaceutical ingredients) that can be used to
compound drug products in accordance with section 503A of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the
subject of an applicable United States Pharmacopeia (USP) or National
Formulary (NF) monograph nor components of FDA-approved drugs (the 503A
Bulks List). FDA has proposed to amend the 503A Bulks List by placing
five additional bulk drug substances on the list. FDA has also
identified 26 bulk drug substances that FDA has considered and proposed
not to include on the 503A Bulks List. Additional substances nominated
by the public for inclusion on this list are currently under
consideration and will be the subject of a future rulemaking.
Timetable:

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#5b29342832373e353f75373a2c2834351b3d3f3a75333328753c342d">[email&#160;protected]</a>.
RIN: 0910-AH81

100. Revocation of Uses of Partially Hydrogenated Oils in Foods [0910-
AI15]

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 341; 21 U.S.C. 342; 21
U.S.C. 343;

[[Page 48288]]

21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379e
Abstract: In the Federal Register of June 17, 2015 (80 FR 34650),
we published a declaratory order announcing our final determination
that there is no longer a consensus among qualified experts that
partially hydrogenated oils (PHOs) are generally recognized as safe
(GRAS) for any use in human food. In the Federal Register of May 21,
2018 (83 FR 23382), we denied a food additive petition requesting that
the food additive regulations be amended to provide for the safe use of
PHOs in certain food applications. We are now planning to issue a
direct final rule and companion proposed rule to update our regulations
to remove all mention of partially hydrogenated oils from FDA's GRAS
regulations and as an optional ingredient in standards of identity. We
are also revoking all prior sanctions for uses of PHOs in food.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Direct Final Rule................... 10/00/22 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ellen Anderson, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, HFS-265,
4300 River Road, College Park, MD 20740, Phone: 240 402-1309, Email:
<a href="/cdn-cgi/l/email-protection#a6c3cacac3c888c7c8c2c3d4d5c9c8e6c0c2c788ceced588c1c9d0">[email&#160;protected]</a>.
RIN: 0910-AI15

101. Requirements for Additional Traceability Records for Certain Foods
[0910-AI44]

Legal Authority: sec. 204 of the FDA Food Safety Modernization Act
(FSMA) (Pub. L. 111-353) (21 U.S.C. 2223(d)); sec. 701(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(a)); sec. 361 of
the Public Health Service Act (42 U.S.C. 264)
Abstract: This rule will establish additional recordkeeping
requirements for facilities that manufacture, process, pack, or hold
foods that are designated as high-risk foods.
Timetable:

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#711a1005191403181f145f071814031a311715105f1919025f161e07">[email&#160;protected]</a>
RIN: 0910-AI44

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

102. General and Plastic Surgery Devices: Restricted sale,
Distribution, and Use of Sunlamp Products [0910-AH14]

Legal Authority: 21 U.S.C. 360j(e)
Abstract: This rule will apply device restrictions to sunlamp
products. Sunlamp products include ultraviolet (UV) lamps and UV
tanning beds and booths. The incidence of skin cancer, including
melanoma, has been increasing, and a large number of skin cancer cases
are attributable to the use of sunlamp products. The devices may cause
about 400,000 cases of skin cancer per year, and 6,000 of which are
melanoma. Beginning use of sunlamp products at young ages, as well as
frequently using sunlamp products, both increases the risk of
developing skin cancers and other illnesses, and sustaining other
injuries. Even infrequent use, particularly at younger ages, can
significantly increase these risks.
Timetable:

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for
Devices and Radiological Health, Department of Health and Human
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO
66, Room 5454, Silver Spring, MD 20993, Phone: 301 796-567, Email:
<a href="/cdn-cgi/l/email-protection#9ef7fff0b0f1edeafbecf3f7f2f2fbecdef8faffb0f6f6edb0f9f1e8">[email&#160;protected]</a>.
RIN: 0910-AH14

103. Nicotine Toxicity Warnings [0910-AH24]

Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C.
371; 21 U.S.C. 387f; . . .
Abstract: This rule would establish acute nicotine toxicity warning
requirements for liquid nicotine and nicotine-containing e-liquid(s)
that are made or derived from tobacco and intended for human
consumption, and potentially for other tobacco products including, but
not limited to, novel tobacco products such as dissolvables, lotions,
gels, and drinks. This action is intended to increase consumer
awareness and knowledge of the risks of acute toxicity due to
accidental nicotine exposure from nicotine-containing e-liquids in
tobacco products.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/23 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Courtney Smith, Senior Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Tobacco Products, 10903 New Hampshire Avenue, Document
Control Center, Building 71, Room G3355, Silver Spring, MD 20993,
Phone: 877 287-1373, Email: <a href="/cdn-cgi/l/email-protection#bbd8cfcbc9dedcced7dacfd2d4d5c8fbdddfda95d3d3c895dcd4cd">[email&#160;protected]</a>.
RIN: 0910-AH24

104. Certain Requirements Regarding Prescription Drug Marketing (203
Amendment) [0910-AH56]

Legal Authority: Section 503 and related provisions of the FD&C
Act, as amended by Pub. L. 113-54
Abstract: The Food and Drug Administration (FDA) is amending the
regulations at 21 CFR 203 to remove provisions no longer in effect and
incorporate conforming changes following enactment of the Drug Supply
Chain Security Act (DSCSA). In this proposed rulemaking, the Agency is
amending the regulations to clarify provisions and avoid causing
confusion with the new standards for wholesale distribution established
by DSCSA.
Timetable:

Regulatory Flexibility Analysis Required: Yes.

[[Page 48289]]

Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, Building 51, Room 4261, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9362, Email:
<a href="/cdn-cgi/l/email-protection#1776766578793960727e647562747f57717376397f7f6439707861">[email&#160;protected]</a>.
RIN: 0910-AH56

105. Postmarketing Safety Reporting Requirements, Pharmacovigilance
Plans, and Pharmacovigilance Quality Systems for Human Drug and
Biological Products [0910-AI61]

Legal Authority: 42 U.S.C. 262; 42 U.S.C. 264; 42 U.S.C. 300aa-25;
21 U.S.C. 321; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21 U.S.C. 360; 21
U.S.C. 371; 21 U.S.C. 374; . . .
Abstract: The proposed rule would modernize FDA's regulations on
postmarketing safety reporting and pharmacovigilance for human drug and
biological products, including blood and blood components, by capturing
important new safety-related information, improving the quality and
utility of submitted reports, and supporting enhanced alignment with
internationally harmonized reporting guidelines. Among other things,
the proposed rule would require the submission of certain nonclinical
and clinical data to FDA in a periodic safety report, rather than the
annual report. The proposed rule also would require application holders
for drug products and certain biological products to establish and
maintain a pharmacovigilance quality system that reflects the
application holder's unique needs and that may support a more
streamlined, flexible approach to satisfying certain postmarketing
safety reporting requirements.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/23 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice L. Weiner, Principal Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue,
Building 51, Room 6270, Silver Spring, MD 20993-0002, Phone: 301 796-
3475, Fax: 301 847-8440, Email: <a href="/cdn-cgi/l/email-protection#bad0dbd4d3d9df94cddfd3d4dfc8fadcdedb94d2d2c994ddd5cc">[email&#160;protected]</a>.
RIN: 0910-AI61

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

106. Laboratory Accreditation for Analyses of Foods [0910-AH31]

Legal Authority: 21 U.S.C. 350k; 21 U.S.C. 371(a); . . .
Abstract: This rule will enable FDA to recognize accreditation
bodies that will accredit laboratories to perform analyses of food
under certain circumstances to help ensure appropriate use of
equipment, personnel, and procedures to conduct reliable analyses. A
program for accredited laboratories will increase the number of
qualified laboratories eligible to perform testing of food, which will
help FDA improve the safety of the U.S. food supply.
Completed:

------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Final Rule.......................... 12/03/21 86 FR 68728
Final Rule Effective................ 02/01/22 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Stacie Hammack, Phone: 301 796-5817, Email:
<a href="/cdn-cgi/l/email-protection#d7a4a3b6b4beb2f9bfb6babab6b4bc97b1b3b6f9bfbfa4f9b0b8a1">[email&#160;protected]</a>.
RIN: 0910-AH31

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

107. Administrative Simplification: Modifications to NCPDP Retail
Pharmacy Standards (CMS-0056) [0938-AU19]

Legal Authority: 42 U.S.C. 1320d to 1320d-9
Abstract: This proposed rule would require pharmacies and vendors
to modify the currently adopted National Council for Prescription Drug
Programs (NCPDP) standards to the Telecommunications Standard
Implementation Guide Version F6 (F6); Batch Standard Implementation
Guide version 15; and Batch Standard Subrogation Implementation Guide
version 10.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/22 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Geanelle Herring, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Office of Burden Reduction and Health Informatics,
MS: S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410
786-4466, Email: <a href="/cdn-cgi/l/email-protection#751210141b101919105b1d1007071c1b12351618065b1d1d065b121a03">[email&#160;protected]</a>.
RIN: 0938-AU19

108. Medicare Advantage and Medicare Prescription Drug Benefit Program
Payment Policy (CMS-4198) [0938-AU59]

Legal Authority: 42 U.S.C. 1395w
Abstract: This proposed rule would codify long-established Medicare
Advantage and Part D payment policies that are outside the scope of the
annual Advance Notice/Rate Announcement.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/22 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jennifer Shapiro, Director, Medicare Plan Payment
Group, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C1-13-18, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-7407, Email:
<a href="/cdn-cgi/l/email-protection#2f454a414146494a5d015c474e5f465d406f4c425c0147475c01484059">[email&#160;protected]</a>.
RIN: 0938-AU59

109. CY 2023 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1770) (Section 610
Review) [0938-AU81]

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual proposed rule would revise payment polices
under the Medicare physician fee schedule, and make other policy
changes to payment under Medicare Part B. These changes would apply to
services furnished beginning January 1, 2023. Additionally, this rule
proposes updates to the Quality Payment Program.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/22 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gift Tee, Director, Division of Physician Services,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS:
C1-09-

[[Page 48290]]

07, Baltimore, MD 21244, Phone: 410 786-9316, Email:
<a href="/cdn-cgi/l/email-protection#d0b7b9b6a4fea4b5b590b3bda3feb8b8a3feb7bfa6">[email&#160;protected]</a>.
RIN: 0938-AU81

110. CY 2023 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1772) (Section 610 Review) [0938-AU82]

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual proposed rule would revise the Medicare
hospital outpatient prospective payment system to implement statutory
requirements and changes arising from our continuing experience with
this system. The proposed rule describes changes to the amounts and
factors used to determine payment rates for services. In addition, the
rule proposes changes to the ambulatory surgical center payment system
list of services and rates. This proposed rule would also update and
refine the requirements for the Hospital Outpatient Quality Reporting
(OQR) Program and the ASC Quality Reporting (ASCQR) Program.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/22 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Elise Barringer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-9222, Email:
<a href="/cdn-cgi/l/email-protection#e0858c899385ce82819292898e878592a0838d93ce888893ce878f96">[email&#160;protected]</a>.
RIN: 0938-AU82

111. Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals; The Long-Term Care Hospital Prospective Payment System; and
FY 2023 Rates (CMS-1771) (Section 610 Review) [0938-AU84]

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual final rule revises the Medicare hospital
inpatient and long-term care hospital prospective payment systems for
operating and capital-related costs. This rule implements changes
arising from our continuing experience with these systems. In addition,
the rule establishes new requirements or revises existing requirements
for quality reporting by specific Medicare providers.
Timetable:

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#b3d7dcddd2dfd79dc7dbdcdec3c0dcddf3d0dec09ddbdbc09dd4dcc5">[email&#160;protected]</a>.
RIN: 0938-AU84

112. Transitional Coverage for Emerging Technologies (CMS-3421) [0938-
AU86]

Legal Authority: 42 U.S.C. 263a; 42 U.S.C. 405(a); 42 U.S.C. 1302;
42 U.S.C. 1320b-12; . . .
Abstract: This proposed rule would establish the criteria for an
expedited coverage pathway to provide Medicare beneficiaries with
faster access to innovative and beneficial technologies.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/23 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Lori Ashby, Senior Technical Advisor, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6322, Email:
<a href="/cdn-cgi/l/email-protection#2d41425f44034c5e454f546d4e405e0345455e034a425b">[email&#160;protected]</a>.
RIN: 0938-AU86

113. Conditions of Participation (COPS) for Rural Emergency Hospitals
(REHS) and Critical Access Hospital (CAH) COP Updates (CMS-3419)
(Section 610 Review) [0938-AU92]

Legal Authority: 42 U.S.C. 1395x
Abstract: This proposed rule would establish health and safety
requirements for a new provider type, Rural Emergency Hospitals, in
accordance with section 125 of the Consolidated Appropriations Act,
2021.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/22 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kianna Banks, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Clinical Standards and Quality, MS: S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8486, Email: <a href="/cdn-cgi/l/email-protection#462d2f27282827682427282d3506252b35682e2e3568212930">[email&#160;protected]</a>.
RIN: 0938-AU92

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

114. Requirements Related to Surprise Billing; Part II (CMS-9908)
[0938-AU62]

Legal Authority: Pub. L. 116-260, Division BB, title I and title II
Abstract: This final rule implements provisions related to the
independent dispute resolution processes included in the Public Health
Service Act sections 2799A-1(c) and 2799A-2(b), as added by sections
103 and 105 of the No Surprises Act.
Timetable:

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Deborah Bryant, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Consumer Information and Insurance
Oversight, MS: W08-134, 7500 Security Boulevard, Baltimore, MD 21244,
Phone: 301 492-4293, Email: <a href="/cdn-cgi/l/email-protection#e08485828f928188ce829299818e94a0838d93ce888893ce878f96">[email&#160;protected]</a>.
RIN: 0938-AU62

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

115. Omnibus Covid-19 Health Care Staff Vaccination (CMS-3415) (Section
610 Review) [0938-AU75]

Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This interim final rule with comment period revises the
infection

[[Page 48291]]

control requirements that most Medicare- and Medicaid-participating
providers and suppliers must meet to participate in the Medicare and
Medicaid programs. These changes are necessary to protect the health
and safety of residents, clients, patients, and staff and reflect
lessons learned as result of the COVID-19 public health emergency. The
revisions to the infection control requirements establish COVID-19
vaccination requirements for staff at the included Medicare- and
Medicaid-participating providers and suppliers.
Timetable:

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kim Roche, Nurse, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, Center for Clinical
Standards and Quality, MS: C2-21-16, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-3524, Email: <a href="/cdn-cgi/l/email-protection#7d161410530f121e15183d1e100e5315150e531a120b">[email&#160;protected]</a>.
RIN: 0938-AU75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

116. Durable Medical Equipment Fee Schedule, Adjustments To Resume the
Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive
Bidding Areas (CMS-1687) (Completion of a Section 610 Review) [0938-
AT21]

Legal Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)); Pub. L.
114-255, sec. 5004(b), 16007(a) and 16008
Abstract: This final rule responds to public comments on the
interim final rule that published May 11, 2018 and extended the end of
the transition period from June 30, 2016, to December 31, 2016 for
phasing in adjustments to the fee schedule amounts for certain durable
medical equipment (DME) and enteral nutrition paid in areas not subject
to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS) Competitive Bidding Program (CBP). In addition, the interim
rule amended the regulation to resume the transition period for items
furnished from August 1, 2017, through December 31, 2018. The interim
rule also made technical amendments to existing regulations for DMEPOS
items and services to exclude infusion drugs used with DME from the
DMEPOS CBP.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 05/11/18 83 FR 21912
Interim Final Rule Comment Period 07/09/18 .......................
End.
Continuation Notice................. 04/26/21 86 FR 21949
Final Action Merged With 0938-AU38 12/28/21 86 FR 73860
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#43222f263b222d2726316d362f2f2e222d03202e306d2b2b306d242c35">[email&#160;protected]</a>.
RIN: 0938-AT21

117. Most Favored Nation (MFN) Model (CMS-5528) (Completion of a
Section 610 Review) [0938-AT91]

Legal Authority: Social Security Act, sec. 1115A
Abstract: This final rule rescinds the Most Favored Nation Model
interim final rule with comment period that appeared in the November
27, 2020, Federal Register.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 10/30/18 83 FR 54546
ANPRM Comment Period End............ 12/31/18 .......................
Interim Final Rule.................. 11/27/20 85 FR 76180
Interim Final Rule Effective........ 11/27/20 .......................
Interim Final Rule Comment Period 01/26/21 .......................
End.
NPRM................................ 08/10/21 86 FR 43618
NPRM Comment Period End............. 10/12/21 .......................
Final Action........................ 12/29/21 86 FR 73986
Final Action Effective.............. 02/28/22 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Lara Strawbridge, Director, Division of Ambulatory
Payment Models, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Center for Medicare and Medicaid
Innovation, 7500 Security Boulevard, MS: WB-06-05, Baltimore, MD 21244,
Phone: 410 786-7400, Email: <a href="/cdn-cgi/l/email-protection#80ede6eec0e3edf3aee8e8f3aee7eff6">[email&#160;protected]</a>.
RIN: 0938-AT91

118. Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals; the Long-Term Care Hospital Prospective Payment System; and
FY 2022 Rates (CMS-1752) (Completion of a Section 610 Review) [0938-
AU44]

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This rule finalizes the remaining policies proposed for
the Medicare hospital inpatient and long-term care hospital prospective
payment systems for operating and capital-related costs. These policies
include implementation of sections 126, 127, and 131 of the
Consolidated Appropriations Act of 2020, and organ acquisition payment
policies.
Timetable:

------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/10/21 86 FR 25070
NPRM Comment Period End............. 06/28/21 .......................
Final Action........................ 08/13/21 86 FR 44774
Final Action Effective.............. 10/01/21 .......................
Final Action Correction............. 10/20/21 86 FR 58019
2nd Final Action.................... 12/27/21 86 FR 73416
2nd Final Action Effective.......... 02/25/22 .......................
------------------------------------------------------------------------

Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Donald Thompson, Director, Division of Acute Care,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email:
<a href="/cdn-cgi/l/email-protection#26424948474a4208524e494b5655494866454b55084e4e5508414950">[email&#160;protected]</a>.
RIN: 0938-AU44

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

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