Regulatory Agenda, 48550-48559 [2023-14544]
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Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / UA: Reg Flex Agenda
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Elizabeth J. Gramling, Executive
Secretary, Department of Health and
Human Services, 200 Independence
Avenue SW, Washington, DC 20201;
(202) 690–5627.
Office of the Secretary
21 CFR Ch. I
The
Department of Health and Human
Services (HHS) is the Federal
42 CFR Chs. I–V
government’s lead agency for protecting
the health of all Americans and
45 CFR Subtitle A; Subtitle B, Chs. II,
providing essential human services.
III, and XIII
HHS enhances the health and wellbeing of Americans by promoting
Regulatory Agenda
effective health and human services and
AGENCY: Office of the Secretary, HHS.
by fostering sound, sustained advances
ACTION: Semiannual Regulatory Agenda. in the sciences underlying medicine,
SUMMARY: The Regulatory Flexibility Act public health, and social services.
This Agenda presents the regulatory
of 1980 and Executive Order (E.O.)
activities that the Department expects to
12866 require the semiannual issuance
undertake in the foreseeable future to
of an inventory of rulemaking actions
advance this mission. The purpose of
under development throughout the
the Agenda is to encourage more
Department, offering for public review
effective public participation in the
summarized information about
regulatory process. The regulatory
forthcoming regulatory actions.
SUPPLEMENTARY INFORMATION:
25 CFR Ch. V
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, quality
health care, addressing health
disparities and promoting equity, and
boosting the mental health and
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 https://
www.RegInfo.gov.
Elizabeth J. Gramling,
HHS Executive Secretary.
OFFICE OF THE SECRETARY—PROPOSED RULE STAGE
Regulation
Identifier No.
Sequence No.
Title
68 ......................
Limiting the Effect of Exclusions Implemented Under the Social Security Act (Rulemaking Resulting
From a Section 610 Review).
0991–AC11
SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION—FINAL RULE STAGE
Regulation
Identifier No.
Sequence No.
Title
69 ......................
Medications for the Treatment of Opioid Use Disorder ...................................................................................
0930–AA39
CENTERS FOR DISEASE CONTROL AND PREVENTION—FINAL RULE STAGE
Regulation
Identifier No.
Sequence No.
Title
70 ......................
Control of Communicable Diseases; Foreign Quarantine ...............................................................................
0920–AA75
FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE
Sequence No.
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72
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74
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77 ......................
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Regulation
Identifier No.
Title
Medication Guide; Patient Medication Information ..........................................................................................
Requirements for Tobacco Product Manufacturing Practice ...........................................................................
Administrative Detention of Tobacco Products ................................................................................................
Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies ....................
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).
Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic
Act (Section 610 Review).
Tobacco Product Standard for Nicotine Level of Certain Tobacco Products .................................................
Registration of Commercial Importers of Drugs; Good Importing Practice .....................................................
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0910–AH68
0910–AH91
0910–AI05
0910–AI57
0910–AI70
0910–AI71
0910–AI76
0910–AI87
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FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE
Regulation
Identifier No.
Sequence No.
Title
79 ......................
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,
Conspicuous, Neutral Manner in Advertisements in Television and Radio Format.
Sunlamp Products; Amendment to the Performance Standard ......................................................................
General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products ............
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.
Nutrient Content Claims, Definition of Term: Healthy .....................................................................................
Revocation of Uses of Partially Hydrogenated Oils in Foods .........................................................................
Tobacco Product Standard for Characterizing Flavors in Cigars ....................................................................
Tobacco Product Standard for Menthol in Cigarettes .....................................................................................
80 ......................
81 ......................
82 ......................
83
84
85
86
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0910–AG27
0910–AG30
0910–AH14
0910–AH81
0910–AI13
0910–AI15
0910–AI28
0910–AI60
FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS
Sequence No.
87
88
89
90
......................
......................
......................
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Regulation
Identifier No.
Title
National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers ..
Nicotine Toxicity Warnings ...............................................................................................................................
Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) ........................................
Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality
Systems for Human Drug and Biological Products.
0910–AH11
0910–AH24
0910–AH56
0910–AI61
FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS
Regulation
Identifier No.
Sequence No.
Title
91 ......................
Mammography Quality Standards Act .............................................................................................................
0910–AH04
CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE
Regulation
Identifier No.
Sequence No.
Title
92 ......................
FY 2024 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS–1779) (Section 610 Review).
CY 2024 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1784) (Section 610 Review).
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital
Prospective Payment System; and FY 2024 Rates (CMS–1785) (Section 610 Review).
CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center
Payment System Policy Changes and Payment Rates (CMS–1786) (Section 610 Review).
93 ......................
94 ......................
95 ......................
0938–AV02
0938–AV07
0938–AV08
0938–AV09
CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE
Regulation
Identifier No.
Sequence No.
Title
96 ......................
FY 2024 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS–1787)
(Section 610 Review).
0938–AV10
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CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS
Regulation
Identifier No.
Sequence No.
Title
97 ......................
98 ......................
Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS–4198) .........
Omnibus COVID–19 Health Care Staff Vaccination (CMS–3415) (Section 610 Review) ............................
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0938–AU75
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ADMINISTRATION FOR CHILDREN AND FAMILIES—PROPOSED RULE STAGE
Title
99 ......................
Supporting the Head Start Workforce and Other Quality Improvements ........................................................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Office of the Secretary (OS)
Substance Abuse and Mental Health
Services Administration (SAMHSA)
Proposed Rule Stage
68. 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: HHS proposes to remove the
regulatory provisions at issue, in order
to align the regulation with the intent of
the Social Security Act and current
practice. 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 healthcare
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.
Timetable:
Action
Date
NPRM ..................
FR Cite
Final Rule Stage
69. Medications for the Treatment of
Opioid Use Disorder [0930–AA39]
Legal Authority: 21 U.S.C. 823(g)(1)
Abstract: The Substance Abuse and
Mental Health Services Administration
(SAMHSA) will revise 42 CFR part 8 to
make permanent some regulatory
flexibilities for Opioid Treatment
Programs (OTPs) granted under the
COVID–19 Public Health Emergency
(PHE), and to expand access to care for
people with Opioid Use Disorder
(OUD). Specifically, SAMHSA will
propose making permanent those
flexibilities pertaining to unsupervised
doses of methadone and also initiation
of buprenorphine via telemedicine. To
expand access to care, SAMHSA will
also review admission criteria,
particularly rules that may limit timely
access to treatment in an OTP. To
achieve this, sections of 42 CFR part 8
will require updating. SAMHSA’s
changes will impact roughly 1900
opioid treatment programs and state
opioid treatment authorities.
In response to the Consolidated
Appropriations Act of 2023, which
removed the requirement to obtain a
waiver in order to prescribe certain
schedule III–V medications for the
treatment of OUD, SAMHSA issued a
supplemental notice of proposed
rulemaking on Feb. 13, 2023, (88 FR
9221) calling for additional public
comment on SAMHSA’s plans to
remove reference to the Drug Addiction
Treatment Act of 2000 (DATA 2000Waiver) from 42 CFR part 8.
Timetable:
06/00/23
Action
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Regulation
Identifier No.
Sequence No.
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
768–0628, Email: tiffani.redding@
hhs.gov.
RIN: 0991–AC11
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Date
NPRM ..................
Supplemental
NPRM.
NPRM Comment
Period End.
Supplemental
NPRM Comment Period
End.
Final Action .........
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12/16/22
02/13/23
02/14/23
03/14/23
FR Cite
87 FR 77330
88 FR 9221
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: neeraj.gandotra@
samhsa.hhs.gov.
RIN: 0930–AA39
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Centers for Disease Control and
Prevention (CDC)
Final Rule Stage
70. 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
Interim Final Rule
Effective.
Interim Final Rule
Interim Final Rule
Comment Period End.
Final Action .........
Date
FR Cite
02/07/20
02/12/20
03/13/20
85 FR 7874
05/00/24
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Ashley C.
Altenburger JD, Regulatory Analyst,
Department of Health and Human
Services, Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
MS: H 16–4, Atlanta, GA 30307, Phone:
800 232–4636, Email:
dgmqpolicyoffice@cdc.gov.
RIN: 0920–AA75
01/00/24
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Federal Register / Vol. 88, No. 143 / Thursday, July 27, 2023 / UA: Reg Flex Agenda
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
71. 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, namely 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 the development and
distribution of Patient Medication
Information. 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
NPRM ..................
NPRM Comment
Period End.
05/31/23
11/27/23
FR Cite
88 FR 35694
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Chris Wheeler,
Supervisory Project Manager,
Department of Health and Human
Services, Food and Drug
Administration, 10903 New Hampshire
Avenue, Building 51, Room 3330, Silver
Spring, MD 20993, Phone: 301 796–
0151, Email: chris.wheeler@fda.hhs.gov.
RIN: 0910–AH68
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72. Requirements for Tobacco Product
Manufacturing Practice [0910–AH91]
Legal Authority: 21 U.S.C. 371; 21
U.S.C. 374; 21 U.S.C. 381(a); 21 U.S.C.
387b; 21 U.S.C. 387c; 21 U.S.C. 387f; 21
U.S.C. 387i; . . .
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
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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
NPRM ..................
NPRM Comment
Period End.
03/10/23
09/06/23
FR Cite
88 FR 15174
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: ctpregulations@
fda.hhs.gov.
RIN: 0910–AH91
73. Administrative Detention of
Tobacco Products [0910–AI05]
Legal Authority: 21 U.S.C. 334; 21
U.S.C. 371
Abstract: FDA is proposing a
regulation to establish requirements for
the administrative detention of tobacco
products. This proposed rule, when
finalized, 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
NPRM ..................
FR Cite
02/00/24
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Quynh Nguyen,
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
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Spring, MD 20993, Phone: 877 287–
1373, Email: ctpregulations@
fda.hhs.gov.
Laura Chilaka, 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:
ctpregulations@fda.hhs.gov.
RIN: 0910–AI05
74. 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
clinical pharmacology, and clinical and
analytical 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
NPRM ..................
Date
FR Cite
04/00/24
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:
brian.folian@fda.hhs.gov.
RIN: 0910–AI57
75. 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
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(active pharmaceutical ingredients) that
can be used to compound drug products
in accordance with section 503A of the
Federal Food, Drug, and Cosmetic 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
NPRM ..................
FR Cite
10/00/23
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: rosilend.lawson@
fda.hhs.gov.
RIN: 0910–AI70
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76. 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. 355; 21 U.S.C. 371
Abstract: The Food and Drug
Administration is proposing rulemaking
regarding statutory requirements under
section 503A of the Federal Food, Drug,
and Cosmetic Act for certain
distributions of compounded human
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. The rule,
will also, if finalized, address
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communication with State boards of
pharmacy.
Timetable:
Action
Date
NPRM ..................
FR Cite
10/00/23
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Dominic Markwordt,
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
5104, Silver Spring, MD 20993, Phone:
301 796–9349, Email:
dominic.markwordt@fda.hhs.gov.
RIN: 0910–AI71
77. Tobacco Product Standard for
Nicotine Level of Certain Tobacco
Products [0910–AI76]
Legal Authority: 21 U.S.C. 387g
Abstract: The proposed rule is a
tobacco product standard that would
establish a maximum nicotine level in
cigarettes and certain other finished
tobacco products.
Timetable:
Action
Date
NPRM ..................
FR Cite
Action
12/00/23
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, Document Control
Center, Building 71, Room G335, 10903
New Hampshire Avenue, Silver Spring,
MD 20993, Phone: 877 287–1373, Fax:
877 287–1426, Email: ctpregulations@
fda.hhs.gov.
RIN: 0910–AI76
78. • Registration of Commercial
Importers of Drugs; Good Importing
Practice [0910–AI87]
Legal Authority: Sec. 714 of the Food
and Drug Administrative Safety and
Innovation Act (FDASIA) of July 2012
Abstract: This proposed rulemaking
meets the mandate of section 714 of the
Food and Drug Administration Safety
and Innovation Act and will establish
registration and good importing practice
requirements for commercial importers
of drugs. Although manufacturers are
subject to regulatory requirements to
ensure such quality standards are met,
there are few clear responsibilities for
commercial importers of drugs to do the
same.
Cost estimates of the rule include
reading and understanding the rule,
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registering as a commercial importer
through the Food and Drug
Administration’s (FDA) electronic
importer registration system, annual
updating of registration, establishing a
quality management system, conducting
risk evaluations of drugs and suppliers,
shipment verifications, investigations,
corrective actions, and records
maintenance.
The unquantified benefits of the
proposed rule include improvement in
the safety of finished drugs allowed to
enter the United States from the
commercial drug importer’s requirement
to register with FDA and for increased
due diligence required by the importer
regarding the safety of the drugs. There
would also be cost savings to both FDA
and industry from facilitating the review
of documentation that ensures
compliance with our regulations prior to
being allowed to enter the United States.
This proposed rulemaking will also
enhance FDA’s ability to collect and
analyze data to enable risk-informed
decision-making while focusing on
protecting the integrity of the global
drug supply chain and ensuring safety,
effectiveness, and quality of imported
drugs.
Timetable:
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NPRM ..................
Date
FR Cite
11/00/23
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: James Hanratty,
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, WO 75, Rm.
1607A, 10903 New Hampshire Avenue,
Silver Spring, MD 20993, Phone: 240
402–4718, Email: james.hanratty@
fda.hhs.gov.
RIN: 0910–AI87
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
79. 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-toconsumer (DTC) advertisements of
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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
prescription drugs presented in
television or radio format and stating
the name of the drug and its conditions
of use, the major statement relating to
side effects and contraindications of the
advertised 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
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Reopened.
NPRM Comment
Period End.
NPRM Comment
Period Reopened.
NPRM Comment
Period Reopened End.
Final Rule ............
FR Cite
03/29/10
06/28/10
75 FR 15376
01/27/12
77 FR 4273
02/27/12
03/29/12
77 FR 16973
04/09/12
07/00/23
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: suzanna.boyle@
fda.hhs.gov.
RIN: 0910–AG27
committees, thereby also saving
resources.
Timetable:
Action
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
ddrumheller on DSK120RN23PROD with PROPOSALS8
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12/22/15
03/21/16
FR Cite
80 FR 79505
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
796–5678, Email: ian.ostermiller@
fda.hhs.gov.
RIN: 0910–AG30
81. 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:
80. 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 intended
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
Date
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
12/22/15
03/21/16
FR Cite
80 FR 79493
12/00/23
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Daniel Schieffer,
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, Center for Devices
and Radiological Health, 10903 New
Hampshire Avenue, WO 75, Room 7613,
Silver Spring, MD 20993, Phone: 301
796–3350, Email: daniel.schieffer@
fda.hhs.gov.
RIN: 0910–AH14
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48555
82. 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 additional bulk drug
substances on the list. FDA has also
identified 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 future rulemaking.
Timetable:
Action
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
Date
09/05/19
12/04/19
FR Cite
84 FR 46688
10/00/23
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: rosilend.lawson@
fda.hhs.gov.
RIN: 0910–AH81
83. 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 to
indicate that a food, because of its
nutrient content, may be useful in
achieving a total diet that conforms to
current dietary recommendations and
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helps consumers maintain healthy
dietary practices.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Comment
Period Extended End.
Final Action .........
FR Cite
09/29/22
12/28/22
87 FR 59168
11/29/22
87 FR 73267
02/16/23
04/00/24
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Vincent De Jesus,
Nutritionist, Department of Health and
Human Services, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition, (HFS–830),
Room 3D–031, 5100 Paint Branch
Parkway, College Park, MD 20740,
Phone: 240 402–1774, Fax: 301 436–
1191, Email: vincent.dejesus@
fda.hhs.gov.
RIN: 0910–AI13
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84. 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;
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
Direct Final Rule
FR Cite
06/00/23
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Ellen Anderson,
Consumer Safety Officer, Department of
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Health and Human Services, Food and
Drug Administration, HFS–265, 4300
River Road, College Park, MD 20740,
Phone: 240 402–1309, Email:
ellen.anderson@fda.hhs.gov.
RIN: 0910–AI15
85. 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; . . .
Abstract: This 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. 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 these products
easier to use. Over a half million youth
in the United States use flavored cigars,
placing these youth at risk for cigarrelated death and disease.
Timetable:
Action
Date
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
NPRM Comment
Period Extended.
NPRM Comment
Period End.
NPRM Comment
Period Extended End.
Final Rule ............
FR Cite
03/21/18
07/19/18
83 FR 12294
05/04/22
06/21/22
87 FR 26396
87 FR 36786
07/05/22
08/02/22
08/00/23
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:
ctpregulations@fda.hhs.gov.
RIN: 0910–AI28
86. Tobacco Product Standard for
Menthol in Cigarettes [0910–AI60]
Legal Authority: 21 U.S.C. 387g; 21
U.S.C 371; 21 U.S.C 387f
Abstract: This final rule is a tobacco
product standard to prohibit the use of
menthol as a characterizing flavor in
cigarettes.
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Timetable:
Action
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
NPRM Comment
Period Extended.
NPRM Comment
Period End.
NPRM Comment
Period Extended End.
Final Rule ............
Date
FR Cite
07/24/13
09/23/13
78 FR 44484
05/04/22
06/21/22
87 FR 26454
87 FR 36786
07/05/22
08/02/22
08/00/23
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Beth Buckler, 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: ctpregulations@
fda.hhs.gov.
RIN: 0910–AI60
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
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 final rule establishes
national standards for State licensing of
prescription drug wholesale distributors
and third-party logistics providers. The
rulemaking also establishes a Federal
system for wholesale drug distributor
and third-party logistics provider
licensing for use in the absence of a
State licensure program.
Timetable:
Action
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Extended.
NPRM Comment
Period Extended End.
Final Rule ............
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Date
FR Cite
02/04/22
06/06/22
87 FR 6708
05/24/22
87 FR 31439
09/06/22
04/00/25
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Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Aaron Weisbuch,
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, Center for Drug
Evaluation and Research, Building 51,
Room 4261, 10903 New Hampshire
Avenue, Silver Spring, MD 20993,
Phone: 301 796–9362, Email:
aaron.weisbuch@fda.hhs.gov.
RIN: 0910–AH11
88. 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) 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
NPRM ..................
FR Cite
10/00/24
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Laura Chilaka,
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 G355, Silver
Spring, MD 20993, Phone: 877 287–
1373, Email: ctpregulations@
fda.hhs.gov.
RIN: 0910–AH24
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89. 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 final rule amends Food
and Drug Administration (FDA)
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). The final
rule amends the regulations to clarify
provisions and avoid causing confusion
with the new standards for wholesale
distribution established by DSCSA.
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Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
02/04/22
04/05/22
FR Cite
87 FR 6443
04/00/25
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Aaron Weisbuch,
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, Center for Drug
Evaluation and Research, Building 51,
Room 4261, 10903 New Hampshire
Avenue, Silver Spring, MD 20993,
Phone: 301 796–9362, Email:
aaron.weisbuch@fda.hhs.gov.
RIN: 0910–AH56
90. 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
NPRM ..................
FR Cite
05/00/24
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Janice L. Weiner,
Principal Regulatory Counsel,
Department of Health and Human
Services, Food and Drug
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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: janice.weiner@fda.hhs.gov.
RIN: 0910–AI61
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
91. 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.
Completed:
Reason
Final Rule ............
Final Action Effective.
Date
03/10/23
09/10/24
FR Cite
88 FR 15126
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Laurie Sternberg,
Phone: 240 402–0425, Email:
laurie.sternberg@fda.hhs.gov.
RIN: 0910–AH04
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid
Services (CMS)
Proposed Rule Stage
92. FY 2024 Skilled Nursing Facility
(SNFS) Prospective Payment System
and Consolidated Billing and Updates
to the Value-Based Purchasing and
Quality Reporting Programs (CMS–
1779) (Section 610 Review) [0938–
AV02]
Legal Authority: 42 U.S.C. 1395hh; 42
U.S.C. 1302
Abstract: This annual final rule
updates the payment rates used under
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the prospective payment system for
SNFs for fiscal year 2024. The rule also
includes changes for the SNF Quality
Reporting Program (QRP) and for the
Skilled Nursing Facility Value-Based
Purchasing (VBP) Program that will
affect Medicare payment to SNFs.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
04/10/23
06/05/23
FR Cite
88 FR 21316
10/00/23
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Tammy Luo, Health
Insurance Specialist, Department of
Health and Human Services, Centers for
Medicare & Medicaid Services, Center
for Medicare, MS: C5–06–17, 7500
Security Boulevard, Baltimore, MD
21244, Phone: 410 786–4325, Email:
tammy.luo@cms.hhs.gov.
RIN: 0938–AV02
93. CY 2024 Revisions to Payment
Policies Under the Physician Fee
Schedule and Other Revisions to
Medicare Part B (CMS–1784) (Section
610 Review) [0938–AV07]
Legal Authority: 42 U.S.C. 1395hh; 42
U.S.C. 1302
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 including, but
not limited to, establishing payment
policies for dental services prior to the
initiation of immunotherapy services.
These changes would apply to services
furnished beginning January 1, 2024.
Additionally, this rule proposes updates
to the Quality Payment Program.
Timetable:
Action
Date
ddrumheller on DSK120RN23PROD with PROPOSALS8
NPRM ..................
FR Cite
06/00/23
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Gift Tee, Director,
Division of Physician Services,
Department of Health and Human
Services, Centers for Medicare &
Medicaid Services, Center for Medicare,
7500 Security Boulevard, MS: C1–09–
07, Baltimore, MD 21244, Phone: 410
786–9316, Email: gift.tee@cms.hhs.gov.
RIN: 0938–AV07
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94. Hospital Inpatient Prospective
Payment Systems for Acute Care
Hospitals; the Long-Term Care Hospital
Prospective Payment System; and FY
2024 Rates (CMS–1785) (Section 610
Review) [0938–AV08]
Legal Authority: 42 U.S.C. 1395hh; 42
U.S.C. 1302
Abstract: This annual proposed rule
would revise the Medicare hospital
inpatient and long-term care hospital
prospective payment systems for
operating and capital-related costs. This
proposed rule would implement
changes arising from our continuing
experience with these systems. In
addition, the rule proposes to establish
new requirements or revise existing
requirements for quality reporting by
specific Medicare providers.
Timetable:
Action
Date
NPRM ..................
FR Cite
06/00/23
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:
donald.thompson@cms.hhs.gov.
RIN: 0938–AV08
95. CY 2024 Hospital Outpatient PPS
Policy Changes and Payment Rates and
Ambulatory Surgical Center Payment
System Policy Changes and Payment
Rates (CMS–1786) (Section 610 Review)
[0938–AV09]
Legal Authority: 42 U.S.C. 1395hh; 42
U.S.C. 1302
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
NPRM ..................
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FR Cite
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Elise Barringer,
Health Insurance Specialist, Department
of Health and Human Services, Centers
for Medicare & Medicaid Services,
Center for Medicare, MS: C4–03–06,
7500 Security Boulevard, Baltimore, MD
21244, Phone: 410 786–9222, Email:
elise.barringer@cms.hhs.gov.
RIN: 0938–AV09
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid
Services (CMS)
Final Rule Stage
96. FY 2024 Hospice Wage Index,
Payment Rate Update, and Quality
Reporting Requirements (CMS–1787)
(Section 610 Review) [0938–AV10]
Legal Authority: 42 U.S.C. 1302; 42
U.S.C. 1395hh
Abstract: This annual final rule
updates the hospice payment rates and
the wage index for fiscal year 2024. The
rule also finalizes changes to the
Hospice Quality Reporting program.
Timetable:
Action
NPRM ..................
NPRM Comment
Period End.
Final Action .........
Date
04/04/23
05/30/23
FR Cite
88 FR 20022
10/00/23
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Brian Slater,
Director, Division of Home Health and
Hospice, Department of Health and
Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare,
MS: C4–07–07, 7500 Security
Boulevard, Baltimore, MD 21244,
Phone: 410 786–5229, Email:
brian.slater@cms.hhs.gov.
RIN: 0938–AV10
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid
Services (CMS)
Long-Term Actions
97. 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
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that are outside the scope of the annual
Advance Notice/Rate Announcement.
Timetable:
Action
Date
NPRM ..................
FR Cite
06/00/24
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Jennifer Shapiro,
Director, Medicare Plan Payment Group,
Department of Health and Human
Services, Centers for Medicare &
Medicaid Services, Center for Medicare,
MS: C1–13–18, 7500 Security
Boulevard, Baltimore, MD 21244,
Phone: 410 786–7407, Email:
jennifer.shapiro@cms.hhs.gov.
RIN: 0938–AU59
ddrumheller on DSK120RN23PROD with PROPOSALS8
98. 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
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
VerDate Sep<11>2014
18:41 Jul 26, 2023
Jkt 259001
infection control requirements establish
COVID–19 vaccination requirements for
staff at the included Medicare- and
Medicaid-participating providers and
suppliers.
Timetable:
Action
Date
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Reviewing Public
Comments.
11/05/21
11/05/21
FR Cite
86 FR 61555
01/04/22
To Be Determined
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Lauren Oviatt,
Acting Director, Division of NonInstitutional Standards and Quality,
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
21244–1850, Phone: 410 786–4683,
Email: lauren.oviatt@cms.hhs.gov.
RIN: 0938–AU75
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Administration for Children and
Families (ACF)
Proposed Rule Stage
99. • Supporting the Head Start
Workforce and Other Quality
Improvements [0970–AD01]
Legal Authority: 42 U.S.C. 9801; 42
U.S.C. 9836a; 42 U.S.C. 9839
Abstract: This NPRM will propose
changes to the Head Start Program
Performance Standards to better support
the Head Start workforce and to
maintain the quality of comprehensive
Head Start services.
Timetable:
Action
NPRM ..................
Date
FR Cite
07/00/23
Regulatory Flexibility Analysis
Required: Yes.
Agency Contact: Lindsey A
Hutchison, Senior Policy Analyst,
Department of Health and Human
Services, Administration for Children
and Families, 330 C Street SW, #4305B,
Washington, DC 20201, Phone: 904 860–
7032, Email: lindsey.hutchison@
acf.hhs.gov.
RIN: 0970–AD01
[FR Doc. 2023–14544 Filed 7–26–23; 8:45 am]
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]]>Agencies
[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Unknown Section]
[Pages 48550-48559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14544]
[[Page 48549]]
Vol. 88
Thursday,
No. 143
July 27, 2023
Part VIII
Department of Health and Human Services
-----------------------------------------------------------------------
Semiannual Regulatory Agenda
Federal Register / Vol. 88 , No. 143 / Thursday, July 27, 2023 / UA:
Reg Flex Agenda
[[Page 48550]]
-----------------------------------------------------------------------
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: Elizabeth J. Gramling, 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,
quality health care, addressing health disparities and promoting
equity, and boosting the mental health and 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 https://www.RegInfo.gov.
Elizabeth J. Gramling,
HHS Executive Secretary.
Office of the Secretary--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
68........................ 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--Final Rule
Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
69........................ Medications for the 0930-AA39
Treatment of Opioid Use
Disorder.
------------------------------------------------------------------------
Centers for Disease Control and Prevention--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
70........................ Control of Communicable 0920-AA75
Diseases; Foreign
Quarantine.
------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
71........................ Medication Guide; Patient 0910-AH68
Medication Information.
72........................ Requirements for Tobacco 0910-AH91
Product Manufacturing
Practice.
73........................ Administrative Detention 0910-AI05
of Tobacco Products.
74........................ Conduct of Analytical and 0910-AI57
Clinical Pharmacology,
Bioavailability, and
Bioequivalence Studies.
75........................ 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).
76........................ Distribution of Compounded 0910-AI71
Drug Products Under
Section 503A of the
Federal Food, Drug, and
Cosmetic Act (Section 610
Review).
77........................ Tobacco Product Standard 0910-AI76
for Nicotine Level of
Certain Tobacco Products.
78........................ Registration of Commercial 0910-AI87
Importers of Drugs; Good
Importing Practice.
------------------------------------------------------------------------
[[Page 48551]]
Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
79........................ 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.
80........................ Sunlamp Products; 0910-AG30
Amendment to the
Performance Standard.
81........................ General and Plastic 0910-AH14
Surgery Devices:
Restricted Sale,
Distribution, and Use of
Sunlamp Products.
82........................ 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.
83........................ Nutrient Content Claims, 0910-AI13
Definition of Term:
Healthy.
84........................ Revocation of Uses of 0910-AI15
Partially Hydrogenated
Oils in Foods.
85........................ Tobacco Product Standard 0910-AI28
for Characterizing
Flavors in Cigars.
86........................ Tobacco Product Standard 0910-AI60
for Menthol in Cigarettes.
------------------------------------------------------------------------
Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
87........................ National Standards for the 0910-AH11
Licensure of Wholesale
Drug Distributors and
Third-Party Logistics
Providers.
88........................ Nicotine Toxicity Warnings 0910-AH24
89........................ Certain Requirements 0910-AH56
Regarding Prescription
Drug Marketing (203
Amendment).
90........................ 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.
------------------------------------------------------------------------
91........................ Mammography Quality 0910-AH04
Standards Act.
------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
92........................ FY 2024 Skilled Nursing 0938-AV02
Facility (SNFs)
Prospective Payment
System and Consolidated
Billing and Updates to
the Value-Based
Purchasing and Quality
Reporting Programs (CMS-
1779) (Section 610
Review).
93........................ CY 2024 Revisions to 0938-AV07
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1784)
(Section 610 Review).
94........................ Hospital Inpatient 0938-AV08
Prospective Payment
Systems for Acute Care
Hospitals; the Long-Term
Care Hospital Prospective
Payment System; and FY
2024 Rates (CMS-1785)
(Section 610 Review).
95........................ CY 2024 Hospital 0938-AV09
Outpatient PPS Policy
Changes and Payment Rates
and Ambulatory Surgical
Center Payment System
Policy Changes and
Payment Rates (CMS-1786)
(Section 610 Review).
------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
96........................ FY 2024 Hospice Wage 0938-AV10
Index, Payment Rate
Update, and Quality
Reporting Requirements
(CMS-1787) (Section 610
Review).
------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
97........................ Medicare Advantage and 0938-AU59
Medicare Prescription
Drug Benefit Program
Payment Policy (CMS-4198).
98........................ Omnibus COVID-19 Health 0938-AU75
Care Staff Vaccination
(CMS-3415) (Section 610
Review).
------------------------------------------------------------------------
[[Page 48552]]
Administration for Children and Families--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
99........................ Supporting the Head Start 0970-AD01
Workforce and Other
Quality Improvements.
------------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office of the Secretary (OS)
Proposed Rule Stage
68. 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: HHS proposes to remove the regulatory provisions at
issue, in order to align the regulation with the intent of the Social
Security Act and current practice. 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 healthcare 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.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/23
------------------------------------------------------------------------
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: 202 768-0628, Email:
[email protected].
RIN: 0991-AC11
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Final Rule Stage
69. Medications for the Treatment of Opioid Use Disorder [0930-AA39]
Legal Authority: 21 U.S.C. 823(g)(1)
Abstract: The Substance Abuse and Mental Health Services
Administration (SAMHSA) will revise 42 CFR part 8 to make permanent
some regulatory flexibilities for Opioid Treatment Programs (OTPs)
granted under the COVID-19 Public Health Emergency (PHE), and to expand
access to care for people with Opioid Use Disorder (OUD). Specifically,
SAMHSA will propose making permanent those flexibilities pertaining to
unsupervised doses of methadone and also initiation of buprenorphine
via telemedicine. To expand access to care, SAMHSA will also review
admission criteria, particularly rules that may limit timely access to
treatment in an OTP. To achieve this, sections of 42 CFR part 8 will
require updating. SAMHSA's changes will impact roughly 1900 opioid
treatment programs and state opioid treatment authorities.
In response to the Consolidated Appropriations Act of 2023, which
removed the requirement to obtain a waiver in order to prescribe
certain schedule III-V medications for the treatment of OUD, SAMHSA
issued a supplemental notice of proposed rulemaking on Feb. 13, 2023,
(88 FR 9221) calling for additional public comment on SAMHSA's plans to
remove reference to the Drug Addiction Treatment Act of 2000 (DATA
2000-Waiver) from 42 CFR part 8.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/16/22 87 FR 77330
Supplemental NPRM................... 02/13/23 88 FR 9221
NPRM Comment Period End............. 02/14/23
Supplemental NPRM Comment Period End 03/14/23
Final Action........................ 01/00/24
------------------------------------------------------------------------
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: [email protected].
RIN: 0930-AA39
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Disease Control and Prevention (CDC)
Final Rule Stage
70. 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........................ 05/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ashley C. Altenburger JD, Regulatory Analyst,
Department of Health and Human Services, Centers for Disease Control
and Prevention, 1600 Clifton Road NE, MS: H 16-4, Atlanta, GA 30307,
Phone: 800 232-4636, Email: [email protected].
RIN: 0920-AA75
[[Page 48553]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
71. 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, namely 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 the development and distribution of Patient Medication
Information. 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................................ 05/31/23 88 FR 35694
NPRM Comment Period End............. 11/27/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Chris Wheeler, Supervisory Project Manager,
Department of Health and Human Services, Food and Drug Administration,
10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD
20993, Phone: 301 796-0151, Email: [email protected].
RIN: 0910-AH68
72. Requirements for Tobacco Product Manufacturing Practice [0910-AH91]
Legal Authority: 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381(a); 21
U.S.C. 387b; 21 U.S.C. 387c; 21 U.S.C. 387f; 21 U.S.C. 387i; . . .
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................................ 03/10/23 88 FR 15174
NPRM Comment Period End............. 09/06/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Matthew Brenner, Senior Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Tobacco Products, 10903 New Hampshire Avenue, Document
Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone:
877 287-1373, Email: [email protected].
RIN: 0910-AH91
73. Administrative Detention of Tobacco Products [0910-AI05]
Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371
Abstract: FDA is proposing a regulation to establish requirements
for the administrative detention of tobacco products. This proposed
rule, when finalized, 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................................ 02/00/24
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Quynh Nguyen, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
Laura Chilaka, Regulatory Counsel, Department of Health and Human
Services, Food and Drug Administration, Center for Tobacco Products,
10903 New Hampshire Avenue, Document Control Center, Building 71, Room
G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email:
[email protected].
RIN: 0910-AI05
74. 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 clinical pharmacology, and clinical and analytical
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................................ 04/00/24
------------------------------------------------------------------------
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: [email protected].
RIN: 0910-AI57
75. 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
[[Page 48554]]
(active pharmaceutical ingredients) that can be used to compound drug
products in accordance with section 503A of the Federal Food, Drug, and
Cosmetic 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................................ 10/00/23
------------------------------------------------------------------------
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: [email protected].
RIN: 0910-AI70
76. 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. 355; 21 U.S.C. 371
Abstract: The Food and Drug Administration is proposing rulemaking
regarding statutory requirements under section 503A of the Federal
Food, Drug, and Cosmetic Act for certain distributions of compounded
human 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. The rule, will also, if finalized,
address communication with State boards of pharmacy.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Dominic Markwordt, 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 5104, Silver Spring, MD 20993, Phone: 301 796-9349, Email:
[email protected].
RIN: 0910-AI71
77. Tobacco Product Standard for Nicotine Level of Certain Tobacco
Products [0910-AI76]
Legal Authority: 21 U.S.C. 387g
Abstract: The proposed rule is a tobacco product standard that
would establish a maximum nicotine level in cigarettes and certain
other finished tobacco products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/23
------------------------------------------------------------------------
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, Document Control Center, Building 71, Room
G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877
287-1373, Fax: 877 287-1426, Email: [email protected].
RIN: 0910-AI76
78. Registration of Commercial Importers of Drugs; Good
Importing Practice [0910-AI87]
Legal Authority: Sec. 714 of the Food and Drug Administrative
Safety and Innovation Act (FDASIA) of July 2012
Abstract: This proposed rulemaking meets the mandate of section 714
of the Food and Drug Administration Safety and Innovation Act and will
establish registration and good importing practice requirements for
commercial importers of drugs. Although manufacturers are subject to
regulatory requirements to ensure such quality standards are met, there
are few clear responsibilities for commercial importers of drugs to do
the same.
Cost estimates of the rule include reading and understanding the
rule, registering as a commercial importer through the Food and Drug
Administration's (FDA) electronic importer registration system, annual
updating of registration, establishing a quality management system,
conducting risk evaluations of drugs and suppliers, shipment
verifications, investigations, corrective actions, and records
maintenance.
The unquantified benefits of the proposed rule include improvement
in the safety of finished drugs allowed to enter the United States from
the commercial drug importer's requirement to register with FDA and for
increased due diligence required by the importer regarding the safety
of the drugs. There would also be cost savings to both FDA and industry
from facilitating the review of documentation that ensures compliance
with our regulations prior to being allowed to enter the United States.
This proposed rulemaking will also enhance FDA's ability to collect and
analyze data to enable risk-informed decision-making while focusing on
protecting the integrity of the global drug supply chain and ensuring
safety, effectiveness, and quality of imported drugs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: James Hanratty, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, WO 75, Rm.
1607A, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 240
402-4718, Email: [email protected].
RIN: 0910-AI87
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
79. 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
[[Page 48555]]
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 prescription
drugs presented in television or radio format and stating the name of
the drug and its conditions of use, the major statement relating to
side effects and contraindications of the advertised 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.......................... 07/00/23
------------------------------------------------------------------------
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: [email protected].
RIN: 0910-AG27
80. 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 intended 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.......................... 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: 301 796-5678, Email:
[email protected].
RIN: 0910-AG30
81. 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.......................... 12/00/23
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Daniel Schieffer, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, 10903 New Hampshire Avenue, WO 75,
Room 7613, Silver Spring, MD 20993, Phone: 301 796-3350, Email:
[email protected].
RIN: 0910-AH14
82. 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
additional bulk drug substances on the list. FDA has also identified
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 future rulemaking.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/05/19 84 FR 46688
NPRM Comment Period End............. 12/04/19 .......................
Final Rule.......................... 10/00/23 .......................
------------------------------------------------------------------------
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: [email protected].
RIN: 0910-AH81
83. 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 to indicate
that a food, because of its nutrient content, may be useful in
achieving a total diet that conforms to current dietary recommendations
and
[[Page 48556]]
helps consumers maintain healthy dietary practices.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/29/22 87 FR 59168
NPRM Comment Period End............. 12/28/22 .......................
NPRM Comment Period Extended........ 11/29/22 87 FR 73267
NPRM Comment Period Extended End.... 02/16/23 .......................
Final Action........................ 04/00/24 .......................
------------------------------------------------------------------------
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: [email protected].
RIN: 0910-AI13
84. 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; 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................... 06/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ellen Anderson, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, HFS-265,
4300 River Road, College Park, MD 20740, Phone: 240 402-1309, Email:
[email protected].
RIN: 0910-AI15
85. 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; . . .
Abstract: This 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. 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 these products easier to use. Over a
half million youth in the United States use flavored cigars, placing
these youth at risk for cigar-related death and disease.
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 Extended........ 06/21/22 87 FR 36786
NPRM Comment Period End............. 07/05/22 .......................
NPRM Comment Period Extended End.... 08/02/22 .......................
Final Rule.......................... 08/00/23 .......................
------------------------------------------------------------------------
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: [email protected].
RIN: 0910-AI28
86. Tobacco Product Standard for Menthol in Cigarettes [0910-AI60]
Legal Authority: 21 U.S.C. 387g; 21 U.S.C 371; 21 U.S.C 387f
Abstract: This final rule is a tobacco product standard to prohibit
the use of menthol as a characterizing flavor in cigarettes.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 07/24/13 78 FR 44484
ANPRM Comment Period End............ 09/23/13 .......................
NPRM................................ 05/04/22 87 FR 26454
NPRM Comment Period Extended........ 06/21/22 87 FR 36786
NPRM Comment Period End............. 07/05/22 .......................
NPRM Comment Period Extended End.... 08/02/22 .......................
Final Rule.......................... 08/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Beth Buckler, Senior Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
RIN: 0910-AI60
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
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 final rule establishes national standards for State
licensing of prescription drug wholesale distributors and third-party
logistics providers. The rulemaking also establishes a Federal system
for wholesale drug distributor and third-party logistics provider
licensing for use in the absence of a State licensure program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/04/22 87 FR 6708
NPRM Comment Period End............. 06/06/22 .......................
NPRM Comment Period Extended........ 05/24/22 87 FR 31439
NPRM Comment Period Extended End.... 09/06/22 .......................
Final Rule.......................... 04/00/25 .......................
------------------------------------------------------------------------
[[Page 48557]]
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, Building 51, Room 4261, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9362, Email:
[email protected].
RIN: 0910-AH11
88. 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)
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................................ 10/00/24 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Laura Chilaka, 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 G355, Silver Spring, MD 20993, Phone: 877 287-1373,
Email: [email protected].
RIN: 0910-AH24
89. 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 final rule amends Food and Drug Administration (FDA)
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). The final rule amends 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 .......................
Final Rule.......................... 04/00/25 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Aaron Weisbuch, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, Building 51, Room 4261, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-9362, Email:
[email protected].
RIN: 0910-AH56
90. 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................................ 05/00/24 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice L. Weiner, Principal Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue,
Building 51, Room 6270, Silver Spring, MD 20993-0002, Phone: 301 796-
3475, Fax: 301 847-8440, Email: [email protected].
RIN: 0910-AI61
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
91. 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.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Final Rule.......................... 03/10/23 88 FR 15126
Final Action Effective.............. 09/10/24 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Laurie Sternberg, Phone: 240 402-0425, Email:
[email protected].
RIN: 0910-AH04
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
92. FY 2024 Skilled Nursing Facility (SNFS) Prospective Payment System
and Consolidated Billing and Updates to the Value-Based Purchasing and
Quality Reporting Programs (CMS-1779) (Section 610 Review) [0938-AV02]
Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This annual final rule updates the payment rates used
under
[[Page 48558]]
the prospective payment system for SNFs for fiscal year 2024. The rule
also includes changes for the SNF Quality Reporting Program (QRP) and
for the Skilled Nursing Facility Value-Based Purchasing (VBP) Program
that will affect Medicare payment to SNFs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/10/23 88 FR 21316
NPRM Comment Period End............. 06/05/23 .......................
Final Action........................ 10/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Tammy Luo, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicare, MS: C5-06-17, 7500 Security Boulevard, Baltimore,
MD 21244, Phone: 410 786-4325, Email: [email protected].
RIN: 0938-AV02
93. CY 2024 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1784) (Section 610
Review) [0938-AV07]
Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
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 including, but not limited to,
establishing payment policies for dental services prior to the
initiation of immunotherapy services. These changes would apply to
services furnished beginning January 1, 2024. Additionally, this rule
proposes updates to the Quality Payment Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gift Tee, Director, Division of Physician Services,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS:
C1-09-07, Baltimore, MD 21244, Phone: 410 786-9316, Email:
[email protected].
RIN: 0938-AV07
94. Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals; the Long-Term Care Hospital Prospective Payment System; and
FY 2024 Rates (CMS-1785) (Section 610 Review) [0938-AV08]
Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This annual proposed rule would revise the Medicare
hospital inpatient and long-term care hospital prospective payment
systems for operating and capital-related costs. This proposed rule
would implement changes arising from our continuing experience with
these systems. In addition, the rule proposes to establish new
requirements or revise existing requirements for quality reporting by
specific Medicare providers.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Donald Thompson, Director, Division of Acute Care,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email:
[email protected].
RIN: 0938-AV08
95. CY 2024 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1786) (Section 610 Review) [0938-AV09]
Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
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................................ 06/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Elise Barringer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-9222, Email:
[email protected].
RIN: 0938-AV09
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Final Rule Stage
96. FY 2024 Hospice Wage Index, Payment Rate Update, and Quality
Reporting Requirements (CMS-1787) (Section 610 Review) [0938-AV10]
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual final rule updates the hospice payment rates
and the wage index for fiscal year 2024. The rule also finalizes
changes to the Hospice Quality Reporting program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/04/23 88 FR 20022
NPRM Comment Period End............. 05/30/23 .......................
Final Action........................ 10/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Slater, Director, Division of Home Health and
Hospice, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Center for Medicare, MS: C4-07-07, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-5229, Email:
[email protected].
RIN: 0938-AV10
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Long-Term Actions
97. 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
[[Page 48559]]
that are outside the scope of the annual Advance Notice/Rate
Announcement.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/24 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jennifer Shapiro, Director, Medicare Plan Payment
Group, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C1-13-18, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-7407, Email:
[email protected].
RIN: 0938-AU59
98. 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 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: Lauren Oviatt, Acting Director, Division of Non-
Institutional Standards and Quality, 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 21244-1850, Phone: 410 786-4683, Email:
[email protected].
RIN: 0938-AU75
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Administration for Children and Families (ACF)
Proposed Rule Stage
99. Supporting the Head Start Workforce and Other Quality
Improvements [0970-AD01]
Legal Authority: 42 U.S.C. 9801; 42 U.S.C. 9836a; 42 U.S.C. 9839
Abstract: This NPRM will propose changes to the Head Start Program
Performance Standards to better support the Head Start workforce and to
maintain the quality of comprehensive Head Start services.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/00/23 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Lindsey A Hutchison, Senior Policy Analyst,
Department of Health and Human Services, Administration for Children
and Families, 330 C Street SW, #4305B, Washington, DC 20201, Phone: 904
860-7032, Email: [email protected].
RIN: 0970-AD01
[FR Doc. 2023-14544 Filed 7-26-23; 8:45 am]
BILLING CODE 4150-03-P
