[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Rules and Regulations]
[Pages 41214-41224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14870]
[[Page 41213]]
Vol. 86
Friday,
No. 144
July 30, 2021
Part VIII
Department of Health and Human Services
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Semiannual Regulatory Agenda
Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / UA: Reg
Flex Agenda
[[Page 41214]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
21 CFR Ch. I
25 CFR Ch. V
42 CFR Chs. I-V
45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII
Regulatory Agenda
AGENCY: Office of the Secretary, HHS.
ACTION: Semiannual Regulatory Agenda.
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SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order
(E.O.) 12866 require the semiannual issuance of an inventory of
rulemaking actions under development throughout the Department,
offering for public review summarized information about forthcoming
regulatory actions.
FOR FURTHER INFORMATION CONTACT: Karuna Seshasai, Executive Secretary,
Department of Health and Human Services, 200 Independence Avenue SW,
Washington, DC 20201; (202) 690-5627.
SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) is the Federal government's lead agency for protecting the health
of all Americans and providing essential human services. HHS enhances
the health and well-being of Americans by promoting effective health
and human services and by fostering sound, sustained advances in the
sciences underlying medicine, public health, and social services.
This Agenda presents the regulatory activities that the Department
expects to undertake in the foreseeable future to advance this mission.
The purpose of the Agenda is to encourage more effective public
participation in the regulatory process. The regulatory actions
forecasted in this Agenda reflect the priorities of the Biden-Harris
Administration and HHS Secretary Xavier Becerra. Accordingly, this
Agenda contains rulemakings aimed at advancing equity and ensuring
nondiscrimination in health; ending the COVID-19 public health
emergency; enhancing access to quality, affordable health care;
addressing child welfare and maternal health; safeguarding the quality
of medical products; protecting the public health by reducing tobacco
use; revising prior actions that are inconsistent with the policy of
this Administration; and supporting other priority areas.
Please note that because the Department's most recent Statement of
Regulatory Priorities was published in Fall 2020 and under a previous
Administration, it no longer reflects the views of the Department or
this Administration. The Department will have the opportunity to issue
a new Statement of Regulatory Priorities reflecting its policy
direction alongside the Fall 2021 Agenda. At present, more information
about the policy priorities of the Biden-Harris Administration is
available through Executive Orders, Presidential Memoranda, other
Presidential Actions, regulatory actions, and sub-regulatory guidance
issued by the Biden-Harris Administration since January 20, 2021.
The rulemaking abstracts included in this paper issue of the
Federal Register cover, as required by the Regulatory Flexibility Act
of 1980, those prospective HHS rulemakings likely to have a significant
economic impact on a substantial number of small entities. The
Department's complete Regulatory Agenda is accessible online at http://www.RegInfo.gov.
Karuna Seshasai,
Executive Secretary to the Department.
Office of the Secretary--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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85........................ Limiting the Effect of 0991-AC11
Exclusions Implemented
Under the Social Security
Act (Rulemaking Resulting
From a Section 610
Review).
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Office for Civil Rights--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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86........................ Rulemaking on 0945-AA15
Discrimination on the
Basis of Disability in
Critical Health and Human
Services Programs or
Activities (Rulemaking
Resulting From a Section
610 Review).
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Office of the National Coordinator for Health Information Technology--
Completed Actions
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Regulation
Sequence No. Title Identifier No.
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87........................ Information Blocking and 0955-AA02
the ONC Health IT
Certification Program:
Extension of Compliance
Dates and Timeframes in
Response to the COVID-19
Public Health Emergency.
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Centers for Disease Control and Prevention--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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88........................ Control of Communicable 0920-AA75
Diseases; Foreign
Quarantine.
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[[Page 41215]]
Food and Drug Administration--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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89........................ National Standards for the 0910-AH11
Licensure of Wholesale
Drug Distributors and
Third-Party Logistics
Providers.
90........................ Certain Requirements 0910-AH56
Regarding Prescription
Drug Marketing (203
Amendment).
91........................ Medication Guide; Patient 0910-AH68
Medication Information.
92........................ Requirements for Tobacco 0910-AH91
Product Manufacturing
Practice.
93........................ Administrative Detention 0910-AI05
of Tobacco Products.
94........................ Nutrient Content Claims, 0910-AI13
Definition of Term:
Healthy.
95........................ Revocation of Uses of 0910-AI15
Partially Hydrogenated
Oils in Foods.
96........................ Tobacco Product Standard 0910-AI28
for Characterizing
Flavors in Cigars.
97........................ Conduct of Analytical and 0910-AI57
Clinical Pharmacology,
Bioavailability and
Bioequivalence Studies.
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Food and Drug Administration--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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98........................ Mammography Quality 0910-AH04
Standards Act.
99........................ Amendments to the List of 0910-AH81
Bulk Drug Substances That
Can Be Used To Compound
Drug Products in
Accordance With Section
503A of the Federal Food,
Drug, and Cosmetic Act.
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Food and Drug Administration--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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100....................... 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.
101....................... Sunlamp Products; 0910-AG30
Amendment to the
Performance Standard.
102....................... General and Plastic 0910-AH14
Surgery Devices:
Restricted Sale,
Distribution, and Use of
Sunlamp Products.
103....................... Nicotine Toxicity Warnings 0910-AH24
104....................... Requirements For 0910-AI44
Additional Traceability
Records for Certain Foods.
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Food and Drug Administration--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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105....................... Milk and Cream Product and 0910-AI40
Yogurt Products, Final
Rule to Revoke the
Standards for Lowfat
Yogurt and Nonfat Yogurt
and to Amend the Standard
for Yogurt.
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Centers for Medicare & Medicaid Services--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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106....................... Contract Year 2023 Policy 0938-AU30
and Technical Changes to
the Medicare Advantage
and Medicare Prescription
Drug Benefit Programs
(CMS-4192).
107....................... CY 2022 Revisions to 0938-AU42
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1751)
(Section 610 Review).
108....................... CY 2022 Hospital 0938-AU43
Outpatient PPS Policy
Changes and Payment Rates
and Ambulatory Surgical
Center Payment System
Policy Changes and
Payment Rates (CMS-1753)
(Section 610 Review).
109....................... Hospital Inpatient 0938-AU44
Prospective Payment
Systems for Acute Care
Hospitals; the Long-Term
Care Hospital Prospective
Payment System; and FY
2022 Rates (CMS-1752)
(Section 610 Review).
110....................... Medicare Advantage and 0938-AU59
Medicare Prescription
Drug Benefit Program
Payment Policy (CMS-4198).
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Centers for Medicare & Medicaid Services--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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111....................... Requirements Related to 0938-AU62
Surprise Billing; Part II
(CMS-9908).
112....................... Requirements Related to 0938-AU63
Surprise Billing; Part I
(CMS-9909).
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[[Page 41216]]
Centers for Medicare & Medicaid Services--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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113....................... Durable Medical Equipment 0938-AT21
Fee Schedule, Adjustments
to Resume the
Transitional 50/50
Blended Rates to Provide
Relief in Non-Competitive
Bidding Areas (CMS-1687)
(Section 610 Review).
114....................... Requirements for Long-Term 0938-AT36
Care Facilities:
Regulatory Provisions to
Promote Increased Safety
(CMS-3347) (Section 610
Review).
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Centers for Medicare & Medicaid Services--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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115....................... Most Favored Nation (MFN) 0938-AT91
Model (CMS-5528)
(Completion of a Section
610 Review).
116....................... Medicaid; Reducing 0938-AT99
Provider and Patient
Burden by Improving Prior
Authorization Processes
and Promoting Patients'
Electronic Access to
Health Information (CMS-
9123).
117....................... CY 2021 Revisions to 0938-AU10
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1734)
(Completion of a Section
610 Review).
118....................... CY 2021 Hospital 0938-AU12
Outpatient PPS Policy
Changes and Payment Rates
and Ambulatory Surgical
Center Payment System
Policy Changes and
Payment Rates (CMS-1736)
(Completion of a Section
610 Review).
119....................... Promoting Electronic 0938-AU53
Access to Health
Information for Patients
and for Medicare- and
Medicaid-Participating
Providers and Suppliers
(CMS-0057).
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Administration for Children and Families--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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120....................... Updating Native Employment 0970-AC83
Works Requirements
(Rulemaking Resulting
From a Section 610
Review).
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office of the Secretary (OS)
Proposed Rule Stage
85. Limiting the Effect of Exclusions Implemented Under the Social
Security Act (Rulemaking Resulting From a Section 610 Review)
Legal Authority: 5 U.S.C. 301; 31 U.S.C. 6101
Abstract: Exclusions implemented under the Social Security Act
prevent individuals convicted of certain crimes or individuals whose
health care licenses have been revoked from participating in Federal
health care programs. Instead of only being barred from participating
in all Federal healthcare programs, certain regulatory provisions have
resulted in these type of exclusion actions being given an overly broad
government-wide effect, and excluded parties have been barred from
participating in all Federal procurement and non-procurement actions.
However, because Social Security Act exclusions are not issued under an
agency's suspension and debarment authority, they do not stop
individuals from participating in all Federal procurement and non-
procurement actions. For an agency to bar individuals from
participating in all procurement and non-procurement activities, it
must exercise its suspension and debarment authority under the Federal
Acquisition Regulation or the Nonprocurement Common Rule. This
rulemaking would remove the regulatory provisions at issue, in order to
align the regulation with the intent of the Social Security Act and
current practice.
Timetable:
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Action Date FR Cite
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NPRM................................ 08/00/21 .......................
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Regulatory Flexibility Analysis Required: No.
Agency Contact: Tiffani Redding, Program Analyst, Department of
Health and Human Services, Office of the Secretary, 200 Independence
Avenue SW, Washington, DC 20201, Phone: 202 205-4321, Email:
[email protected].
RIN: 0991-AC11
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office for Civil Rights (OCR)
Proposed Rule Stage
86. Rulemaking on Discrimination on the Basis of Disability in Critical
Health and Human Services Programs or Activities (Rulemaking Resulting
From a Section 610 Review)
Legal Authority: Sec. 504 of the Rehabilitation Act of 19
Abstract: This proposed rule would revise regulations under, among
other statutes, section 504 of the Rehabilitation Act of 1973 to
address unlawful discrimination on the basis of disability in certain
vital HHS-funded health and human services programs. Covered topics
include non-discrimination in life-sustaining care, organ
transplantation, suicide prevention services, child welfare programs
and services, health care value assessment methodologies, accessible
medical equipment, auxiliary aids and services, Crisis Standards of
Care and other relevant health and human services activities.
Timetable:
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Action Date FR Cite
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NPRM................................ 09/00/21 .......................
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[[Page 41217]]
Regulatory Flexibility Analysis Required: No.
Agency Contact: Carla Carter, Supervisory Civil Rights Analyst,
Department of Health and Human Services, Office for Civil Rights, 200
Independence Avenue SW, Washington, DC 20201, Phone: 800 368-1019,
Email: [email protected].
RIN: 0945-AA15
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office of the National Coordinator for Health Information Technology
(ONC)
Completed Actions
87. Information Blocking and the ONC Health IT Certification Program:
Extension of Compliance Dates and Timeframes in Response to the COVID-
19 Public Health Emergency
Legal Authority: 42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; . . .
Abstract: In light of COVID-19, ONC issued an interim final rule
with comment period (IFC) that gives health IT developers and health
care providers flexibilities to effectively respond to the serious
public health threats posed by the spread of COVID-19. The IFC extends
certain applicability and compliance dates and timeframes in the 21st
Century Cures Act: Interoperability, Information Blocking, and the ONC
Health IT Certification Program Final Rule (ONC Cures Act Final Rule),
including applicability and compliance dates for the information
blocking provisions, certain 2015 Edition health IT certification
criteria, and Conditions and Maintenance of Certification requirements
under the ONC Health IT Certification Program. The IFC also updated
certain standards and made technical corrections and clarifications to
the ONC Cures Act Final Rule, which was published in the Federal
Register on May 1, 2020.
Completed:
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Reason Date FR Cite
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Interim Final Rule.................. 11/04/20 85 FR 70064
Interim Final Rule Comment Period 01/04/21 .......................
End.
Final Action--Agency Expects No 05/25/21 .......................
Further Action.
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michael Lipinski, Phone: 202 690-7151.
RIN: 0955-AA02
DEPARTMENT OF HEALTH AND HUUMAN SERVICES (HHS)
Centers for Disease Control and Prevention (CDC)
Final Rule Stage
88. Control of Communicable Diseases; Foreign Quarantine
Legal Authority: 42 U.S.C. 264; 42 U.S.C. 265
Abstract: This rulemaking amends current regulation to enable CDC
to require airlines to collect and provide to CDC certain data elements
regarding passengers and crew arriving from foreign countries under
certain circumstances.
Timetable:
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Action Date FR Cite
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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........................ 04/00/22 .......................
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ashley C. Altenburger JD, Public Health Analyst,
Department of Health and Human Services, Centers for Disease Control
and Prevention, 1600 Clifton Road NE, MS: H 16-4, Atlanta, GA 30307,
Phone: 800 232-4636, Email: [email protected].
RIN: 0920-AA75
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
89. National Standards for the Licensure of Wholesale Drug Distributors
and Third-Party Logistics Providers
Legal Authority: Pub. L. 113-54
Abstract: The rulemaking, once finalized, will establish standards
for State licensing of prescription drug wholesale distributors and
third-party logistics providers. The rulemaking will also establish a
Federal system for wholesale drug distributor and third-party logistics
provider licensing for use in the absence of a State licensure program.
Timetable:
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Action Date FR Cite
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NPRM................................ 09/00/21 .......................
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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:
[email protected].
RIN: 0910-AH11
90. Certain Requirements Regarding Prescription Drug Marketing (203
Amendment)
Legal Authority: Pub. L. 113-54
Abstract: The Food and Drug Administration (FDA) is amending the
regulations at 21 CFR 203 to remove provisions no longer in effect and
incorporate conforming changes following enactment of the Drug Supply
Chain Security Act (DSCSA). In this proposed rulemaking, the Agency is
amending the regulations to clarify provisions and avoid causing
confusion with the new standards for wholesale distribution established
by DSCSA.
Timetable:
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Action Date FR Cite
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NPRM................................ 09/00/21 .......................
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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:
[email protected].
RIN: 0910-AH56
91. Medication Guide; Patient Medication Information
Legal Authority: 21 U.S.C. 321 et seq.; 42 U.S.C. 262; 42 U.S.C.
264; 21 U.S.C. 371
Abstract: The proposed rule would amend FDA medication guide
regulations to require a new form of patient labeling, Patient
Medication Information, for submission to and review by the FDA for
human prescription drug products and certain blood products used,
dispensed, or administered on an outpatient basis. The proposed rule
would include requirements for Patient Medication Information
development and distribution. The proposed rule would require clear and
concisely written prescription drug product information presented in a
consistent and easily
[[Page 41218]]
understood format to help patients use their prescription drug products
safely and effectively.
Timetable:
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Action Date FR Cite
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NPRM................................ 10/00/21 .......................
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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
92. Requirements for Tobacco Product Manufacturing Practice
Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f
Abstract: The rule is proposing to establish tobacco product
manufacturing practice (TPMP) requirements for manufacturers of
finished and bulk tobacco products. This proposed rule, if finalized,
would 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:
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Action Date FR Cite
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NPRM................................ 10/00/21 .......................
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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, Building 71,
Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 240 276-
3904, Email: [email protected].
RIN: 0910-AH91
93. Administrative Detention of Tobacco Products
Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371
Abstract: The FDA is proposing regulations to establish
requirements for the administrative detention of tobacco products. This
action, if finalized, would allow FDA to administratively detain
tobacco products encountered during inspections that an officer or
employee conducting the inspection has reason to believe are
adulterated or misbranded. The intent of administrative detention is to
protect public health by preventing the distribution or use of tobacco
products encountered during inspections that are believed to be
adulterated or misbranded until FDA has had time to consider the
appropriate action to take and, where appropriate, to initiate a
regulatory legal action.
Timetable:
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Action Date FR Cite
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NPRM................................ 12/00/21 .......................
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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, WO 71, Room G335, Silver Spring, MD 20993, Phone: 877
287-1373, Email: [email protected].
Lauren Belcher, Regulatory Counsel, Department of Health and Human
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO
71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email:
[email protected].
RIN: 0910-AI05
94. Nutrient Content Claims, Definition of Term: Healthy
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 343; 21
U.S.C. 371
Abstract: The proposed rule would update the definition for the
implied nutrient content claim ``healthy'' to be consistent with
current nutrition science and federal dietary guidelines. The proposed
rule would revise the requirements for when the claim ``healthy'' can
be voluntarily used in the labeling of human food products so that the
claim reflects current science and dietary guidelines and helps
consumers maintain healthy dietary practices.
Timetable:
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Action Date FR Cite
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NPRM................................ 09/00/21 .......................
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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
95. Revocation of Uses of Partially Hydrogenated Oils in Foods
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 341; 21 U.S.C. 342; 21
U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379e
Abstract: In the Federal Register of June 17, 2015 (80 FR 34650),
we published a declaratory order announcing our final determination
that there is no longer a consensus among qualified experts that
partially hydrogenated oils (PHOs) are generally recognized as safe
(GRAS) for any use in human food. In the Federal Register of May 21,
2018 (83 FR 23382), we denied a food additive petition requesting that
the food additive regulations be amended to provide for the safe use of
PHOs in certain food applications. We are now proposing to update our
regulations to remove all mention of partially hydrogenated oils from
FDA's GRAS regulations and as an optional ingredient in standards of
identity. We are also proposing to revoke all prior sanctions for uses
of PHOs in food.
Timetable:
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Action Date FR Cite
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NPRM................................ 10/00/21 .......................
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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
96. Tobacco Product Standard for Characterizing Flavors in Cigars
Legal Authority: 21 U.S.C. 387g
Abstract: Evidence shows that flavored tobacco products, especially
those that are sweet, appeal to youth and also shows that youth may be
more likely to initiate tobacco use with such products. Characterizing
flavors in cigars, such as strawberry, grape, orange, and cocoa,
enhance taste and make them easier to use. Nearly one million youth in
the United States use flavored cigars, placing these youth at risk for
cigar-related disease and death. This proposed rule is a tobacco
product
[[Page 41219]]
standard that would ban characterizing flavors in all cigars. We are
taking this action to reduce the tobacco-related death associated with
cigars.
Timetable:
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Action Date FR Cite
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ANPRM............................... 03/21/18 83 FR 12294
ANPRM Comment Period End............ 07/19/18 .......................
NPRM................................ 08/00/21 .......................
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Samantha LohCollado, Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 71, Room G335, Silver Spring, MD 20993,
Phone: 877 287-1373, Fax: 877 287-1426, Email:
[email protected].
RIN: 0910-AI28
97. Conduct of Analytical and Clinical Pharmacology, Bioavailability
and Bioequivalence Studies
Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42
U.S.C. 262
Abstract: FDA is proposing to amend 21 CFR 320, in certain parts,
and establish a new 21 CFR 321 to clarify FDA's study conduct
expectations for analytical and clinical pharmacology, bioavailability
(BA) and bioequivalence (BE) studies that support human research and
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:
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Action Date FR Cite
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NPRM................................ 03/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Brian Joseph Folian, Regulatory Counsel, 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
98. Mammography Quality Standards Act
Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e);
42 U.S.C. 263b
Abstract: FDA is amending its regulations governing mammography.
The amendments will update the regulations issued under the Mammography
Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and
Cosmetic Act (FD&C Act). FDA is taking this action to address changes
in mammography technology and mammography processes that have occurred
since the regulations were published in 1997 and to address breast
density reporting to patient and healthcare providers.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/28/19 84 FR 11669
NPRM Comment Period End............. 06/26/19 .......................
Final Rule.......................... 09/00/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jean M. Olson, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 66, Room 5506, Silver Spring, MD 20993,
Phone: 301 796-6579, Email: [email protected].
RIN: 0910-AH04
99. Amendments to the List of Bulk Drug Substances That Can Be Used to
Compound Drug Products in Accordance With Section 503A of the Federal
Food, Drug, and Cosmetic Act
Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353a; 21
U.S.C. 355; 21 U.S.C. 371; . . .
Abstract: FDA has issued a regulation creating a list of bulk drug
substances (active pharmaceutical ingredients) that can be used to
compound drug products in accordance with section 503A of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the
subject of an applicable United States Pharmacopeia (USP) or National
Formulary (NF) monograph nor components of FDA-approved drugs (the 503A
Bulks List). FDA has proposed to amend the 503A Bulks List by placing
five additional bulk drug substances on the list. FDA has also
identified 26 bulk drug substances that FDA has considered and proposed
not to include on the 503A Bulks List. Additional substances nominated
by the public for inclusion on this list are currently under
consideration and will be the subject of a future rulemaking.
Timetable:
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Action Date FR Cite
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NPRM................................ 09/05/19 84 FR 46688
NPRM Comment Period End............. 12/04/19 .......................
Final Rule.......................... 12/00/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Rosilend Lawson, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993,
Phone: 240 402-6223, Email: [email protected].
RIN: 0910-AH81
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
100. Direct-to-Consumer Prescription Drug Advertisements: Presentation
of the Major Statement in a Clear, Conspicuous, Neutral Manner in
Advertisements in Television and Radio Format
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; . . .
Abstract: The Food and Drug Administration (FDA) is amending its
regulations concerning direct-to-consumer (DTC) advertisements of
prescription drugs. Prescription drug advertisements presented through
media such as TV and radio must disclose the product's major risks in
what is sometimes called the major statement. The rule would revise the
regulation to reflect the statutory requirement require that in DTC
advertisements for human drugs in television or radio format, the major
statement relating to the side effects and contraindications of an
advertised prescription drug 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
[[Page 41220]]
NPRM Comment Period End............. 06/28/10 .......................
NPRM Comment Period Reopened........ 01/27/12 77 FR 4273
NPRM Comment Period End............. 02/27/12 .......................
NPRM Comment Period Reopened........ 03/29/12 77 FR 16973
NPRM Comment Period Reopened End.... 04/09/12 .......................
Final Rule.......................... 05/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Suzanna Boyle, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, WO 51, Room 3214, Silver Spring, MD 20993, Phone: 240
402-4723, Email: [email protected].
RIN: 0910-AG27
101. Sunlamp Products; Amendment to the Performance Standard
Legal Authority: 21 U.S.C. 360ii; 21 U.S.C. 360kk; 21 U.S.C. 393;
21 U.S.C. 371
Abstract: FDA is updating the performance standard for sunlamp
products and ultraviolet lamps for use in these products to improve
safety, reflect new scientific information, and work towards
harmonization with international standards. By harmonizing with the
International Electrotechnical Commission, this rule will decrease the
regulatory burden on industry and allow the Agency to take advantage of
the expertise of the international committees, thereby also saving
resources.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/22/15 80 FR 79505
NPRM Comment Period End............. 03/21/16 .......................
Final Rule.......................... 05/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for
Devices and Radiological Health, Department of Health and Human
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO
66, Room 5454, Silver Spring, MD 20993, Phone: 301 796-5678, Email:
[email protected].
RIN: 0910-AG30
102. General and Plastic Surgery Devices: Restricted Sale,
Distribution, and Use of Sunlamp Products
Legal Authority: 21 U.S.C. 360j(e)
Abstract: This rule will apply device restrictions to sunlamp
products. Sunlamp products include ultraviolet (UV) lamps and UV
tanning beds and booths. The incidence of skin cancer, including
melanoma, has been increasing, and a large number of skin cancer cases
are attributable to the use of sunlamp products. The devices may cause
about 400,000 cases of skin cancer per year, and 6,000 of which are
melanoma. Beginning use of sunlamp products at young ages, as well as
frequently using sunlamp products, both increases the risk of
developing skin cancers and other illnesses, and sustaining other
injuries. Even infrequent use, particularly at younger ages, can
significantly increase these risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/22/15 80 FR 79493
NPRM Comment Period End............. 03/21/16 .......................
Final Rule.......................... 05/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ian Ostermiller, Regulatory Counsel, Center for
Devices and Radiological Health, Department of Health and Human
Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO
66, Room 5454, Silver Spring, MD 20993, Phone: 301 796-5678, Email:
[email protected].
RIN: 0910-AH14
103. Nicotine Toxicity Warnings
Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C.
371; 21 U.S.C. 387f; . . .
Abstract: This rule would establish acute nicotine toxicity warning
requirements for liquid nicotine and nicotine-containing e-liquid(s)
that are made or derived from tobacco and intended for human
consumption, and potentially for other tobacco products including, but
not limited to, novel tobacco products such as dissolvables, lotions,
gels, and drinks. This action is intended to increase consumer
awareness and knowledge of the risks of acute toxicity due to
accidental nicotine exposure from nicotine-containing e-liquids in
tobacco products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Samantha LohCollado, Regulatory Counsel, Department
of Health and Human Services, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 71, Room G335, Silver Spring, MD 20993,
Phone: 877 287-1373, Fax: 877 287-1426, Email:
[email protected].
RIN: 0910-AH24
104. Requirements for Additional Traceability Records for Certain Foods
Legal Authority: sec. 204 of the FDA Food Safety Modernization Act
(FSMA) (Pub. L. 111-353) (21 U.S.C. 2223(d)); sec. 701(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(a)); sec. 361 of
the Public Health Service Act (42 U.S.C. 264)
Abstract: This rule will establish additional recordkeeping
requirements for facilities that manufacture, process, pack, or hold
foods that are designated as high-risk foods.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/23/20 85 FR 59984
NPRM Comment Period End............. 01/21/21 .......................
NPRM Comment Period Extended........ 12/18/20 85 FR 82393
NPRM Comment Period End............. 02/22/21 .......................
Final Rule.......................... 11/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Katherine Vierk, Director, Division of Public
Health Informatics and Analytics, Department of Health and Human
Services, Food and Drug Administration, 5001 Campus Drive, CPK1, Room
2B014, HFS-005, College Park, MD 20740, Phone: 240 402-2122, Email:
[email protected].
RIN: 0910-AI44
[[Page 41221]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
105. Milk and Cream Product and Yogurt Products, Final Rule To Revoke
the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the
Standard for Yogurt
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 336; 21 U.S.C. 341; 21
U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371(e); 21 U.S.C. 379e
Abstract: This final rule amends the standard of identity for
yogurt and revokes the standards of identity for lowfat yogurt and
nonfat yogurt. It modernizes the standard for yogurt to allow for
technological advances, to preserve the basic nature and essential
characteristics of yogurt, and to promote honesty and fair dealing in
the interest of consumers. Section 701(e)(1), of the Federal Food,
Drug, and Cosmetic Act requires that the amendment or repeal of the
definition and standard of identity for a dairy product proceed under a
formal rulemaking process. Although, standard practice is not to
include formal rulemaking in the Unified Agenda, this rule is included
to highlight the de-regulatory work in this space.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Withdrawn From the Unified Agenda-- 06/01/21 .......................
This RIN is Being Pursued via
Formal Rulemaking Process.
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Terri Wenger, Phone: 240 402-2371, Email:
[email protected].
RIN: 0910-AI40
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
106. Contract Year 2023 Policy and Technical Changes to the Medicare
Advantage and Medicare Prescription Drug Benefit Programs (CMS-4192)
Legal Authority: 42 U.S.C. 1395w
Abstract: This proposed rule would strengthen and improve the
Medicare Advantage (MA or Part C) and Medicare Prescription Drug
Benefit (Part D) programs, codify existing sub regulatory guidance, and
implement any statutory changes (if necessary) for contract year 2023.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Christian Bauer, Director, Division of Part D
Policy, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C1-26-16, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6043, Email:
[email protected]
RIN: 0938-AU30
107. CY 2022 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1751) (Section 610
Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual proposed rule would revise payment polices
under the Medicare physician fee schedule, and make other policy
changes to payment under Medicare Part B. These changes would apply to
services furnished beginning January 1, 2022. Additionally, this rule
proposes updates to the Quality Payment Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gift Tee, Director, Division of Physician Services,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, 7500 Security Boulevard, MS:
C1-09-07, Baltimore, MD 21244, Phone: 410 786-9316, Email:
[email protected].
RIN: 0938-AU42
108. CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1753) (Section 610 Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual proposed rule would revise the Medicare
hospital outpatient prospective payment system to implement statutory
requirements and changes arising from our continuing experience with
this system. The proposed rule describes changes to the amounts and
factors used to determine payment rates for services. In addition, the
rule proposes changes to the ambulatory surgical center payment system
list of services and rates. This proposed rule would also update and
refine the requirements for the Hospital Outpatient Quality Reporting
(OQR) Program and the ASC Quality Reporting (ASCQR) Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Elise Barringer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-9222, Email:
[email protected].
RIN: 0938-AU43
109. Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals; the Long-Term Care Hospital Prospective Payment System; and
FY 2022 Rates (CMS-1752) (Section 610 Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual final rule revises the Medicare hospital
inpatient and long-term care hospital prospective payment systems for
operating and capital-related costs. This rule implements changes
arising from our continuing experience with these systems. In addition,
the rule establishes new requirements or revises existing requirements
for quality reporting by specific Medicare providers.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/10/21 86 FR 25070
NPRM Comment Period End............. 06/28/21 .......................
Final Action........................ 10/00/21 .......................
------------------------------------------------------------------------
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: C4-03-18, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email:
[email protected].
[[Page 41222]]
RIN: 0938-AU44
110. Medicare Advantage and Medicare Prescription Drug Benefit
Program Payment Policy (CMS-4198)
Legal Authority: 42 U.S.C. 1395w
Abstract: This proposed rule would codify long-established Medicare
Advantage and Part D payment policies that are outside the scope of the
annual Advance Notice/Rate Announcement.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jennifer Shapiro, Director, Medicare Plan Payment
Group, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C1-13-18, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-7407, Email:
[email protected].
RIN: 0938-AU59
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Final Rule Stage
111. Requirements Related to Surprise Billing; Part II (CMS-
9908)
Legal Authority: Pub. L. 116-260, Division BB, title I and title II
Abstract: This interim final rule with comment would implement
additional protections against surprise medical bills under the No
Surprises Act, including provisions related to the independent dispute
resolution processes.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 08/00/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Deborah Bryant, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Consumer Information and Insurance
Oversight, MS: W08-134, 7500 Security Boulevard, Baltimore, MD 21244,
Phone: 301 493-4293, Email: [email protected].
RIN: 0938-AU62
112. Requirements Related to Surprise Billing; Part I (CMS-
9909)
Legal Authority: Pub. L. 116-260, Division BB, title I and title II
Abstract: This interim final rule with comment would implement
certain protections against surprise medical bills under the No
Surprises Act.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule With Comment..... 07/00/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation
Division, Department of Health and Human Services, Centers for Medicare
& Medicaid Services, Center for Consumer Information and Insurance
Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301
492-4106, Email: [email protected].
RIN: 0938-AU63
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Long-Term Actions
113. Durable Medical Equipment Fee Schedule, Adjustments To Resume the
Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive
Bidding Areas (CMS-1687) (Section 610 Review)
Legal Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)); Pub. L.
114-255, sec. 5004(b), 16007(a) and 16008
Abstract: This final rule follows the interim final rule that
published May 11, 2018, and extended the end of the transition period
from June 30, 2016, to December 31, 2016 for phasing in adjustments to
the fee schedule amounts for certain durable medical equipment (DME)
and enteral nutrition paid in areas not subject to the Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive
Bidding Program (CBP). In addition, the interim rule amended the
regulation to resume the transition period for items furnished from
August 1, 2017, through December 31, 2018. The interim rule also made
technical amendments to existing regulations for DMEPOS items and
services to exclude infusion drugs used with DME from the DMEPOS CBP.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 05/11/18 83 FR 21912
Interim Final Rule Comment Period 07/09/18 .......................
End.
Continuation Notice................. 04/26/21 86 FR 21949
Final Action to be Merged With 0938- 05/00/22 .......................
AU17.
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Alexander Ullman, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C5-07-26, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-9671, Email:
[email protected].
RIN: 0938-AT21
114. Requirements for Long-Term Care Facilities: Regulatory Provisions
To Promote Increased Safety (CMS-3347) (Section 610 Review)
Legal Authority: Secs. 1819 and 1919 of the Social Security Act;
sec. 1819(d)(4)(B) and 1919(d)(4)(B) of the Social Security Act; sec.
1819(b)(1)(A) and 1919 (b)(1)(A) of the Social Security Act
Abstract: This final rule reforms the requirements that long-term
care facilities must meet to participate in the Medicare and Medicaid
programs in order to support the provision of safe care and preserve
access to care.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/18/19 84 FR 34737
NPRM Comment Period End............. 09/16/19 .......................
Final Action........................ 07/00/22 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Diane Corning, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Clinical Standards and Quality, MS: S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8486, Email: [email protected].
RIN: 0938-AT36
[[Page 41223]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
115. Most Favored Nation (MFN) Model (CMS-5528) (Completion of a
Section 610 Review)
Legal Authority: Social Security Act, sec. 1115A
Abstract: This interim final rule with comment period (IFC)
implements the Most Favored Nation (MFN) Model, a new Medicare payment
model under section 1115A of the Social Security Act (the Act). The MFN
Model tests whether more closely aligning payment for Medicare Part B
drugs and biologicals (hereafter, referred to as drugs) with
international prices and removing incentives to use higher-cost drugs
can control unsustainable growth in Medicare Part B spending without
adversely affecting quality of care for beneficiaries.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 10/30/18 83 FR 54546
ANPRM Comment Period End............ 12/31/18 .......................
Interim Final Rule.................. 11/27/20 85 FR 76180
Interim Final Rule Effective........ 11/27/20 .......................
Interim Final Rule Comment Period 01/26/21 .......................
End.
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Laura Strawbridge, Director, Division of Ambulatory
Payment Models, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Center for Medicare and Medicaid
Innovation, 7500 Security Boulevard, MS: WB-06-05, Baltimore, MD 21244,
Phone: 410 786-7400, Email: [email protected].
RIN: 0938-AT91
116. Medicaid; Reducing Provider and Patient Burden by Improving Prior
Authorization Processes and Promoting Patients' Electronic Access to
Health Information (CMS-9123)
Legal Authority: 42 U.S.C. 1302
Abstract: This final rule places new requirements on state Medicaid
and CHIP fee-for-service (FFS) programs, Medicaid managed care plans,
CHIP managed care entities, and Qualified Health Plan (QHP) issuers on
the Federally-facilitated Exchanges (FFEs) to improve the electronic
exchange of health care data, and streamline processes related to prior
authorization, while continuing CMS' drive toward interoperability, and
reducing burden in the health care market. In addition, on behalf of
the Department of Health and Human Service (HHS), the Office of the
National Coordinator for Health Information Technology (ONC) is
adopting certain specified implementation guides (IGs) needed to
support the Application Programming Interface (API) policies included
in this rule. Each of these elements plays a key role in reducing
overall payer and provider burden and improving patient access to
health information.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/18/20 85 FR 82586
Withdrawn........................... 03/17/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Alexandra Mugge, Phone: 410 786-4457, Email:
[email protected].
RIN: 0938-AT99
117. CY 2021 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1734) (Completion
of a Section 610 Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual final rule revises payment polices under the
Medicare physician fee schedule, and makes other policy changes to
payment under Medicare Part B. These changes apply to services
furnished beginning January 1, 2021. Additionally, this rule updates
the Quality Payment Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/17/20 85 FR 50074
NPRM Comment Period End............. 10/05/20 .......................
Final Action........................ 12/28/20 85 FR 84472
Final Action Effective.............. 01/01/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Marge Watchorn, Deputy Director, Division of
Practitioner Services, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-15,
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4361,
Email: [email protected].
RIN: 0938-AU10
118. CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1736) (Completion of a Section 610 Review)
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual final rule revises the Medicare hospital
outpatient prospective payment system to implement statutory
requirements and changes arising from our continuing experience with
this system. The rule describes changes to the amounts and factors used
to determine payment rates for services. In addition, the rule
implements changes to the ambulatory surgical center payment system
list of services and rates. This rule also updates and refines the
requirements for the Hospital Outpatient Quality Reporting (OQR)
Program and the ASC Quality Reporting (ASCQR) Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/12/20 85 FR 48772
NPRM Comment Period End............. 10/05/20 .......................
Final Action........................ 12/29/20 85 FR 85866
Final Action Effective.............. 01/01/21 .......................
------------------------------------------------------------------------
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-AU12
119. Promoting Electronic Access to Health Information for Patients and
for Medicare-and Medicaid-Participating Providers and Suppliers (CMS-
0057)
Legal Authority: 42 U.S.C. 1395hh
Abstract: The proposed rule would also revise requirements that
select Medicare- and Medicaid-participating providers and suppliers
must meet for continued participation in the Medicare and Medicaid
programs by requiring increased patient electronic access to their
health care information. This proposed rule would also improve the
electronic exchange of health information among the identified
providers and suppliers, and finally, this proposed rule would improve
patient safety by establishing patient identity management requirements
for the identified providers and suppliers.
Completed:
[[Page 41224]]
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Withdrawn........................... 03/17/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Alexandra Mugge, Phone: 410 786-4457, Email:
[email protected]
RIN: 0938-AU53
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Administration for Children and Families (ACF)
Proposed Rule Stage
120. Updating Native Employment Works Requirements (Rulemaking
Resulting From a Section 610 Review)
Legal Authority: 42 U.S.C. 612
Abstract: The rule would update NEW regulations at 45 CFR part 287
to avoid inconsistencies and reflect the changes that have been made to
the NEW statute and Administration for Children and Families (ACF)
grant policy and procedures since the current regulation's publication
on February 18, 2000. In particular, the regulations need to address
changes made in section 404(e) of the Social Security Act as amended in
1999, Uniform Administrative Requirements, Cost Principles, and Audit
Requirement for HHS Awards (45 CFR part 75)--Part 75 Uniform
Administrative Requirements, Cost Principles, and Audit Requirements
for HHS Awards, Public Law 106-107, the ``Federal Financial Assistance
Management, Improvement Act of 1999'' (Nov. 20, 1999), and various
minor technical changes. While some of these changes have been
addressed and communicated to the public and grantees via program
instructions and information memoranda, the regulations themselves are
now inconsistent with current law and policy.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: Tonya Ann Davis, Program Specialist, Department of
Health and Human Services, Administration for Children and Families,
330 C Street SW, Room 3020, Washington, DC 20201, Phone: 202 401-4851,
Email: [email protected].
RIN: 0970-AC83
[FR Doc. 2021-14870 Filed 7-29-21; 8:45 am]
BILLING CODE 4150-03-P