[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 [www.gpo.gov]
[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 http://www.RegInfo.gov.

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"><span class="__cf_email__" data-cfemail="64100d0202050a0d4a160100000d0a03240c0c174a030b12">[email protected]</span></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"><span class="__cf_email__" data-cfemail="3a545f5f485b50145d5b545e554e485b7a495b5752495b14525249145d554c">[email protected]</span></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"><span class="__cf_email__" data-cfemail="d5b1b2b8a4a5bab9bcb6acbab3b3bcb6b095b6b1b6fbb2baa3">[email protected]</span></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]]



------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/04/22  87 FR 6708
NPRM Comment Period Extended........   05/24/22  87 FR 31439
NPRM Comment Period End.............   06/06/22
NPRM Comment Extended End...........   09/06/22
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Building 51, Room 4261, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9362, Email: 
<a href="/cdn-cgi/l/email-protection#543535263b3a7a23313d273621373c143230357a3c3c277a333b22"><span class="__cf_email__" data-cfemail="1a7b7b687574346d7f7369786f79725a7c7e7b34727269347d756c">[email protected]</span></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"><span class="__cf_email__" data-cfemail="cdaea5bfa4bee3baa5a8a8a1a8bf8daba9ace3a5a5bee3aaa2bb">[email protected]</span></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"><span class="__cf_email__" data-cfemail="ef8c9b9f9d8a889a838e9b8680819caf898b8ec187879cc1888099">[email protected]</span></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"><span class="__cf_email__" data-cfemail="a7c4d3d7d5c2c0d2cbc6d3cec8c9d4e7c1c3c689cfcfd489c0c8d1">[email protected]</span></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"><span class="__cf_email__" data-cfemail="7c1f080c0e191b09101d081513120f3c1a181d5214140f521b130a">[email protected]</span></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"><span class="__cf_email__" data-cfemail="2d5b44434e48435903494847485e585e6d4b494c0345455e034a425b">[email protected]</span></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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   03/21/18  83 FR 12294
ANPRM Comment Period End............   07/19/18
NPRM................................   05/04/22  87 FR 26396
NPRM Comment Period End.............   07/05/22
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nathan Mease, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Center for Tobacco Products, Document Control Center, 
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, 
Email: <a href="/cdn-cgi/l/email-protection#9efdeaeeecfbf9ebf2ffeaf7f1f0eddef8faffb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="aecddadedccbc9dbc2cfdac7c1c0ddeec8cacf80c6c6dd80c9c1d8">[email protected]</span></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"><span class="__cf_email__" data-cfemail="83e0f7f3f1e6e4f6efe2f7eaecedf0c3e5e7e2adebebf0ade4ecf5">[email protected]</span></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"><span class="__cf_email__" data-cfemail="4f2d3d262e2161292023262e210f292b2e6127273c61282039">[email protected]</span></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"><span class="__cf_email__" data-cfemail="4f2e232a372e212b3d262e61293a25263c2e24260f292b2e6127273c61282039">[email protected]</span></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"><span class="__cf_email__" data-cfemail="0e7d7b746f60606f206c6177626b4e686a6f2066667d20696178">[email protected]</span></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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/22/15  80 FR 79505
NPRM Comment Period End.............   03/21/16
Final Rule..........................   12/00/22
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for 
Devices and Radiological Health, Department of Health and Human 
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 
66, Room 5454, Silver Spring, MD 20993, Phone: 301 796-5678, Email: 
<a href="/cdn-cgi/l/email-protection#254c444b0b4a56514057484c49494057654341440b4d4d560b424a53"><span class="__cf_email__" data-cfemail="82ebe3ecacedf1f6e7f0efebeeeee7f0c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/28/19  84 FR 11669
NPRM Comment Period End.............   06/26/19
Final Rule..........................   09/00/22
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Laurie Sternberg, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 66, Room 5517, Silver Spring, MD 20993, 
Phone: 240 402-0425, Email: <a href="/cdn-cgi/l/email-protection#7a161b0f08131f54090e1f0814181f081d3a1c1e1b54121209541d150c"><span class="__cf_email__" data-cfemail="6905081c1b000c471a1d0c1b070b0c1b0e290f0d084701011a470e061f">[email protected]</span></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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/05/19  84 FR 46688
NPRM Comment Period End.............   12/04/19
Final Rule..........................   03/00/23
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Rosilend Lawson, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993, 
Phone: 240 402-6223, Email: <a href="/cdn-cgi/l/email-protection#5b29342832373e353f75373a2c2834351b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="bdcfd2ced4d1d8d3d993d1dccaced2d3fddbd9dc93d5d5ce93dad2cb">[email protected]</span></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"><span class="__cf_email__" data-cfemail="f2979e9e979cdc939c969780819d9cb2949693dc9a9a81dc959d84">[email protected]</span></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:

------------------------------------------------------------------------
               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#711a1005191403181f145f071814031a311715105f1919025f161e07"><span class="__cf_email__" data-cfemail="cba0aabfa3aeb9a2a5aee5bda2aeb9a08badafaae5a3a3b8e5aca4bd">[email protected]</span></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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/22/15  80 FR 79493
NPRM Comment Period End.............   03/21/16  .......................
Final Rule..........................   06/00/23  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for 
Devices and Radiological Health, Department of Health and Human 
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO 
66, Room 5454, Silver Spring, MD 20993, Phone: 301 796-567, Email: 
<a href="/cdn-cgi/l/email-protection#9ef7fff0b0f1edeafbecf3f7f2f2fbecdef8faffb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="84ede5eaaaebf7f0e1f6e9ede8e8e1f6c4e2e0e5aaececf7aae3ebf2">[email protected]</span></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"><span class="__cf_email__" data-cfemail="2a495e5a584f4d5f464b5e434544596a4c4e4b04424259044d455c">[email protected]</span></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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/04/22  87 FR 6443
NPRM Comment Period End.............   04/05/22  .......................
Next Action Undetermined............
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.

[[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"><span class="__cf_email__" data-cfemail="701111021f1e5e0715190312051318301614115e1818035e171f06">[email protected]</span></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"><span class="__cf_email__" data-cfemail="90faf1fef9f3f5bee7f5f9fef5e2d0f6f4f1bef8f8e3bef7ffe6">[email protected]</span></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"><span class="__cf_email__" data-cfemail="dfacabbebcb6baf1b7beb2b2bebcb49fb9bbbef1b7b7acf1b8b0a9">[email protected]</span></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"><span class="__cf_email__" data-cfemail="751210141b101919105b1d1007071c1b12351618065b1d1d065b121a03">[email protected]</span></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"><span class="__cf_email__" data-cfemail="2b414e4545424d4e590558434a5b4259446b48465805434358054c445d">[email protected]</span></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"><span class="__cf_email__" data-cfemail="e2858b8496cc968787a2818f91cc8a8a91cc858d94">[email protected]</span></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"><span class="__cf_email__" data-cfemail="40252c2933256e22213232292e27253200232d336e2828336e272f36">[email protected]</span></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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/10/22  87 FR 28108
NPRM Comment Period End.............   06/17/22  .......................
Final Action........................   10/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Director, Division of Acute Care, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: 
<a href="/cdn-cgi/l/email-protection#b3d7dcddd2dfd79dc7dbdcdec3c0dcddf3d0dec09ddbdbc09dd4dcc5"><span class="__cf_email__" data-cfemail="20444f4e414c440e54484f4d50534f4e60434d530e4848530e474f56">[email protected]</span></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"><span class="__cf_email__" data-cfemail="573b38253e7936243f352e17343a24793f3f2479303821">[email protected]</span></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"><span class="__cf_email__" data-cfemail="80ebe9e1eeeee1aee2e1eeebf3c0e3edf3aee8e8f3aee7eff6">[email protected]</span></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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   10/07/21  86 FR 55980
Interim Final Rule Effective........   10/07/21  .......................
Interim Final Rule Comment Period      12/06/21  .......................
 End.
Final Action........................   06/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Deborah Bryant, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Consumer Information and Insurance 
Oversight, MS: W08-134, 7500 Security Boulevard, Baltimore, MD 21244, 
Phone: 301 492-4293, Email: <a href="/cdn-cgi/l/email-protection#e08485828f928188ce829299818e94a0838d93ce888893ce878f96"><span class="__cf_email__" data-cfemail="d4b0b1b6bba6b5bcfab6a6adb5baa094b7b9a7fabcbca7fab3bba2">[email protected]</span></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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   11/05/21  86 FR 61555
Interim Final Rule Effective........   11/05/21  .......................
Interim Final Rule Comment Period      01/04/22  .......................
 End.
                                     -----------------------------------
Reviewing Public Comments...........           To Be Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kim Roche, Nurse, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Center for Clinical 
Standards and Quality, MS: C2-21-16, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-3524, Email: <a href="/cdn-cgi/l/email-protection#7d161410530f121e15183d1e100e5315150e531a120b"><span class="__cf_email__" data-cfemail="89e2e0e4a7fbe6eae1ecc9eae4faa7e1e1faa7eee6ff">[email protected]</span></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"><span class="__cf_email__" data-cfemail="3a5b565f425b545e5f48144f5656575b547a59574914525249145d554c">[email protected]</span></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"><span class="__cf_email__" data-cfemail="f69b9098b6959b85d89e9e85d8919980">[email protected]</span></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"><span class="__cf_email__" data-cfemail="22464d4c434e460c564a4d4f52514d4c62414f510c4a4a510c454d54">[email protected]</span></a>.
    RIN: 0938-AU44

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


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