[Federal Register Volume 85, Number 166 (Wednesday, August 26, 2020)]
[Proposed Rules]
[Pages 52703-52714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16751]
[[Page 52703]]
Vol. 85
Wednesday,
No. 166
August 26, 2020
Part VII
Department of Health and Human Services
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Semiannual Regulatory Agenda
Federal Register / Vol. 85, No. 166 / Wednesday, August 26, 2020 /
UA: Reg Flex Agenda
[[Page 52704]]
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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: Ann C. Agnew, 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, especially for
those who are least able to help themselves. 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.
HHS has an agency-wide effort to support the Agenda's purpose of
encouraging more effective public participation in the regulatory
process. For example, to encourage public participation, we regularly
update our regulatory web page (http://www.HHS.gov/regulations) which
includes links to HHS rules currently open for public comment, and also
provides a ``regulations toolkit'' with background information on
regulations, the commenting process, how public comments influence the
development of a rule, and how the public can provide effective
comments. HHS also actively encourages meaningful public participation
in its retrospective review of regulations, through a comment form on
the HHS retrospective review web page (http://www.HHS.gov/RetrospectiveReview).
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.
Ann C. Agnew,
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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80........................ Limiting the Effect of 0991-AC11
Exclusions Implemented
Under the Social Security
Act (Rulemaking Resulting
From a Section 610
Review).
------------------------------------------------------------------------
Office for Civil Rights--Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
81........................ Nondiscrimination in 0945-AA11
Health and Health
Education Programs or
Activities.
------------------------------------------------------------------------
Office of the National Coordinator for Health Information Technology--
Final Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
------------------------------------------------------------------------
82........................ 21st Century Cures Act: 0955-AA01
Interoperability,
Information Blocking, and
the ONC Health IT
Certification Program.
------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
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83........................ Postmarketing Safety 0910-AA97
Reporting Requirements
for Human Drug and
Biological Products.
84........................ Over-the-Counter (OTC) 0910-AF31
Drug Review--Cough/Cold
(Antihistamine) Products.
85........................ Medication Guide; Patient 0910-AH68
Medication Information.
86........................ Requirements for Tobacco 0910-AH91
Product Manufacturing
Practice.
87........................ Nutrient Content Claims, 0910-AI13
Definition of Term:
Healthy.
88........................ Revocation of Uses of 0910-AI15
Partially Hydrogenated
Oils in Foods.
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[[Page 52705]]
Food and Drug Administration--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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89........................ Sunlamp Products; 0910-AG30
Amendment to the
Performance Standard.
90........................ Food Labeling; Gluten-Free 0910-AH00
Labeling of Fermented or
Hydrolyzed Foods.
91........................ Mammography Quality 0910-AH04
Standards Act.
92........................ General and Plastic 0910-AH14
Surgery Devices:
Restricted Sale,
Distribution, and Use of
Sunlamp Products.
93........................ 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.
94........................ 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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Food and Drug Administration--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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95........................ Acute Nicotine Toxicity 0910-AH24
Warnings for E-Liquids.
96........................ Testing Standards for 0910-AH90
Batteries and Battery
Management Systems in
Battery-Operated Tobacco
Products.
97........................ Administrative Detention 0910-AI05
of Tobacco Products.
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Food and Drug Administration--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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98........................ Over-the-Counter (OTC) 0910-AF35
Drug Review--External
Analgesic Products.
99........................ Over-the-Counter (OTC) 0910-AF36
Drug Review--Internal
Analgesic Products.
100....................... Sunscreen Drug Products 0910-AF43
For Over-The-Counter-
Human Use; Final
Monograph.
101....................... Over-the-Counter (OTC) 0910-AG12
Drug Review--Pediatric
Dosing for Cough/Cold
Products.
102....................... Required Warnings for 0910-AI39
Cigarette Packages and
Advertisements.
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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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103....................... Reporting of Crimes 0938-AT60
Occurring in Federally
Funded Long Term Care
Facilities and
Enforcement Under Section
1150B of the Social
Security Act (CMS-3359).
104....................... International Pricing 0938-AT91
Index Model For Medicare
Part B Drugs (CMS-5528)
(Section 610 Review).
105....................... FY 2021 Inpatient 0938-AU05
Rehabilitation Facility
(IRF) Prospective Payment
System Rate Update (CMS-
1729).
106....................... CY 2021 Revisions to 0938-AU10
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1734)
(Section 610 Review).
107....................... Hospital Inpatient 0938-AU11
Prospective Payment
Systems for Acute Care
Hospitals; the Long-Term
Care Hospital Prospective
Payment System; and FY
2021 Rates (CMS-1735)
(Section 610 Review).
108....................... 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)
(Section 610 Review).
109....................... Payment Policies for 0938-AU17
Durable Medical
Equipment, Prosthetics,
Orthotics and Supplies
(DMEPOS) (CMS-1738).
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Centers for Medicare & Medicaid Services--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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110....................... 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).
111....................... Requirements for Long-Term 0938-AT36
Care Facilities:
Regulatory Provisions to
Promote Program
Efficiency, Transparency,
and Burden Reduction (CMS-
3347) (Section 610
Review).
112....................... Organ Procurement 0938-AU02
Organizations (OPOs) (CMS-
3380) (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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113....................... CY 2020 Home Health 0938-AT68
Prospective Payment
System Rate Update and
Quality Reporting
Requirements (CMS-1711)
(Completion of a Section
610 Review).
114....................... CY 2020 Revisions to 0938-AT72
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1715)
(Completion of a Section
610 Review).
[[Page 52706]]
115....................... CY 2020 Hospital 0938-AT74
Outpatient PPS Policy
Changes and Payment Rates
and Ambulatory Surgical
Center Payment System
Policy Changes and
Payment Rates (CMS-1717)
(Completion of a Section
610 Review).
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office of the Secretary (OS)
Proposed Rule Stage
80. Limiting the Effect of Exclusions Implemented Under the Social
Security Act (Rulemaking Resulting From a Section 610 Review)
E.O. 13771 Designation: Deregulatory.
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................................ 06/00/20
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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:
tiffani.redding@hhs.gov.
RIN: 0991-AC11
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office for Civil Rights (OCR)
Final Rule Stage
81. Nondiscrimination in Health and Health Education Programs or
Activities
E.O. 13771 Designation: Deregulatory.
Legal Authority: Sec. 1557 of the Patient Protection and Affordable
Care Act (42 U.S.C. 18116)
Abstract: This rulemaking would finalize, with appropriate changes
in response to public comments, the proposed rule implementing section
1557 of the Patient Protection and Affordable Care Act (PPACA), and
conforming amendments to related HHS rules. Section 1557 of PPACA
prohibits discrimination on the basis of race, color, national origin,
sex, age, or disability under any health program or activity, any part
of which is receiving Federal financial assistance, including credits,
subsidies, or contracts of insurance, or under any program or activity
that is administered by an Executive Agency or any entity established
under title 1 of the PPACA.
Timetable:
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Action Date FR Cite
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NPRM................................ 06/14/19 84 FR 27846
NPRM Comment Period End............. 08/13/19
Final Action........................ 06/00/20
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Luben Montoya, Section Chief, Civil Rights
Division, Department of Health and Human Services, Office for Civil
Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 800
368-1019, TDD Phone: 800 537-7697, Email: ocrmail@hhs.gov.
RIN: 0945-AA11
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office of the National Coordinator for Health Information Technology
(ONC)
Final Rule Stage
82. 21st Century Cures Act: Interoperability, Information Blocking, and
the ONC Health IT Certification Program
E.O. 13771 Designation: Regulatory.
Legal Authority: Pub. L. 114-255
Abstract: The rulemaking would implement certain provisions of the
21st Century Cures Act, including conditions and maintenance of
certification requirements for health information technology (IT)
developers under the ONC Health IT Certification Program (Program), the
voluntary certification of health IT for use by pediatric healthcare
providers and reasonable and necessary activities that do not
constitute information blocking. The rulemaking would also modify the
2015 Edition health IT certification criteria and Program in additional
ways to advance interoperability, enhance health IT certification, and
reduce burden and costs.
Timetable:
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Action Date FR Cite
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NPRM................................ 03/04/19 84 FR 7424
NPRM Comment Period Extended........ 04/23/19 84 FR 16834
NPRM Comment Period End............. 05/03/19
NPRM Comment Period Extended End.... 06/03/19
Final Action........................ 06/00/20
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michael Lipinski, Director, Regulatory Affairs
Division, Department of Health and Human Services, Office of the
National Coordinator for Health Information Technology, Mary E. Switzer
Building, 330 C Street SW, Washington, DC 20201, Phone: 202 690-7151.
RIN: 0955-AA01
[[Page 52707]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
83. Postmarketing Safety Reporting Requirements for Human Drug and
Biological Products
E.O. 13771 Designation: Regulatory.
Legal Authority: 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 242a; 42
U.S.C. 262 and 263; 42 U.S.C. 263a; 42 U.S.C. 264; 42 U.S.C. 300aa-25;
21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 355; 21
U.S.C. 360; 21 U.S.C. 360b to 360f; 21 U.S.C. 360i to 360j; 21 U.S.C.
371; 21 U.S.C. 374; 21 U.S.C. 379
Abstract: The proposed rule would amend the postmarketing safety
reporting regulations for human drugs and biological products including
blood and blood products in order to better align FDA requirements with
guidelines of the International Council on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH),
and to update reporting requirements in light of current
pharmacovigilance practice and safety information sources and enhance
the quality of safety reports received by FDA. Revisions to the
postmarketing safety reporting requirements were proposed as part of a
single rulemaking (68 FR 12406) to clarify and revise both premarketing
and postmarketing safety reporting requirements for human drug and
biological products. FDA is reproposing the proposed postmarketing
requirements with revisions. Premarketing safety reporting requirements
were finalized in a separate final rule published on September 29, 2010
(75 FR 59961).
Timetable:
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Action Date FR Cite
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NPRM................................ 03/14/03 68 FR 12406
NPRM Comment Period Extended........ 06/18/03
NPRM Comment Period End............. 07/14/03
NPRM Comment Period Extension End... 10/14/03
Reproposing NPRM.................... 12/00/20
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6278, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3469, Fax: 301
847-8440, Email: jane.baluss@fda.hhs.gov.
RIN: 0910-AA97
84. Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine)
Products
E.O. 13771 Designation: Deregulatory.
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: FDA will be proposing a rule to add the common cold
indication to certain over-the-counter (OTC) antihistamine active
ingredients. This proposed rule is the result of collaboration under
the U.S. Canada Regulatory Cooperation Council as part of efforts to
reduce unnecessary duplication and differences. This pilot exercise
will help determine the feasibility of developing an ongoing mechanism
for alignment in review and adoption of certain aspects of the OTC Drug
Review.
Timetable:
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Action Date FR Cite
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Reopening of Administrative Record.. 08/25/00 65 FR 51780
Comment Period End.................. 11/24/00
NPRM (Amendment) (Common Cold)...... 12/00/20
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Regulatory Health Project
Manager, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 22, Room
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-3713, Fax: 301 796-9899, Email: janice.adams-king@fda.hhs.gov.
RIN: 0910-AF31
85. Medication Guide; Patient Medication Information
E.O. 13771 Designation: Regulatory.
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 understood format to help patients use their
prescription drug products safely and effectively.
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/00/20
------------------------------------------------------------------------
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
86. Requirements for Tobacco Product Manufacturing Practice
E.O. 13771 Designation: Regulatory.
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
------------------------------------------------------------------------
NPRM................................ 09/00/20
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Matthew Brenner, 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:
ctpregulations@fda.hhs.gov.
RIN: 0910-AH91
[[Page 52708]]
87. Nutrient Content Claims, Definition of Term: Healthy
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 343; 21
U.S.C. 371
Abstract: The proposed rule would update the definition for the
implied nutrient content claim ``healthy'' to be consistent with
current nutrition science and federal dietary guidelines. The proposed
rule would revise the requirements for when the claim ``healthy'' can
be voluntarily used in the labeling of human food products so that the
claim reflects current science and dietary guidelines and helps
consumers maintain healthy dietary practices.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/20
------------------------------------------------------------------------
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
88. Revocation of Uses of Partially Hydrogenated Oils in Foods
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 341; 21 U.S.C. 342; 21
U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379e
Abstract: In the Federal Register of June 17, 2015 (80 FR 34650),
we published a declaratory order announcing our final determination
that there is no longer a consensus among qualified experts that
partially hydrogenated oils (PHOs) are generally recognized as safe
(GRAS) for any use in human food. In the Federal Register of May 21,
2018 (83 FR 23382), we denied a food additive petition requesting that
the food additive regulations be amended to provide for the safe use of
PHOs in certain food applications. We are now proposing to update our
regulations to remove all mention of partially hydrogenated oils from
FDA's GRAS regulations and as an optional ingredient in standards of
identity. We are also proposing to revoke all prior sanctions for uses
of PHOs in food.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/20
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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:
ellen.anderson@fda.hhs.gov.
RIN: 0910-AI15
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
89. Sunlamp Products; Amendment to the Performance Standard
E.O. 13771 Designation: Fully or Partially Exempt.
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.......................... 09/00/20
------------------------------------------------------------------------
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
90. Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed
Foods
E.O. 13771 Designation: Regulatory.
Legal Authority: Sec. 206 of the Food Allergen Labeling and
Consumer Protection Act; 21 U.S.C. 343(a)(1); 21 U.S.C. 321(n); 21
U.S.C. 371(a)
Abstract: This final rule would establish requirements concerning
``gluten-free'' labeling for foods that are fermented or hydrolyzed or
that contain fermented or hydrolyzed ingredients. These additional
requirements for the ``gluten-free'' labeling rule are needed to help
ensure that individuals with celiac disease are not misled and receive
truthful and accurate information with respect to fermented or
hydrolyzed foods labeled as ``gluten-free.''
Timetable:
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Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/18/15 80 FR 71990
NPRM Comment Period Reopened........ 01/22/16 81 FR 3751
NPRM Comment Period End............. 02/16/16
NPRM Comment Period Reopened End.... 02/22/16
NPRM Comment Period Reopened........ 02/23/16 81 FR 8869
NPRM Comment Period Reopened End.... 04/25/16
Final Rule.......................... 06/00/20
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Carol D'Lima, Staff Fellow, Department of Health
and Human Services, Food and Drug Administration, Center for Food
Safety and Applied Nutrition, Room 4D022, HFS 820, 5001 Campus Drive,
College Park, MD 20740, Phone: 240 402-2371, Fax: 301 436-2636, Email:
carol.dlima@fda.hhs.gov.
RIN: 0910-AH00
91. Mammography Quality Standards Act
E.O. 13771 Designation: Regulatory.
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:
[[Page 52709]]
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/28/19 84 FR 11669
NPRM Comment Period End............. 06/26/19 .......................
Final Rule.......................... 09/00/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Erica Payne, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66,
Room 5517, Silver Spring, MD 20993, Phone: 301 796-3999, Fax: 301 847-
8145, Email: erica.payne@fda.hhs.gov.
RIN: 0910-AH04
92. General and Plastic Surgery Devices: Restricted Sale, Distribution,
and Use of Sunlamp Products
E.O. 13771 Designation: Regulatory.
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.......................... 04/00/21 .......................
------------------------------------------------------------------------
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-AH14
93. 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
E.O. 13771 Designation: Fully or Partially Exempt.
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). The final rule will amend the 503A Bulks List by placing
five additional bulk drug substances on the list. This rule will also
identify 26 bulk drug substances that FDA has considered and decided
not to include on the 503A Bulks List. Additional substances nominated
by the public for inclusion on this list are currently under
consideration and will be the subject of a future rulemaking.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/05/19 84 FR 46688
NPRM Comment Period End............. 12/04/19 .......................
Final Rule.......................... 12/00/20 .......................
------------------------------------------------------------------------
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
94. 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
E.O. 13771 Designation: Fully or Partially Exempt.
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. Such is consistent with the formal
rulemaking provisions of the Administrative Procedures Act (5 U.S.C.
556 and 557). 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.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 07/03/03 68 FR 39873
ANPRM Comment Period End............ 10/01/03 .......................
NPRM................................ 01/15/09 74 FR 2443
NPRM Comment Period End............. 04/29/09 .......................
Final Rule.......................... 08/00/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Terri Wenger, Food Technologist, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, 5001 Campus Drive, College Park, MD
20740, Phone: 240 402-2371, Email: terri.wenger@fda.hhs.gov.
RIN: 0910-AI40
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Long-Term Actions
95. Acute Nicotine Toxicity Warnings for E-Liquids
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 331; 21 U.S.C.
371; 21 U.S.C. 374; 21 U.S.C. 387
Abstract: This rule would establish nicotine exposure 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 protect users and non-
users from accidental exposures to nicotine-containing e-liquids in
tobacco products.
[[Page 52710]]
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/21 .......................
------------------------------------------------------------------------
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-AH24
96. Testing Standards for Batteries and Battery Management Systems in
Battery-Operated Tobacco Products
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 371; 21 U.S.C.
387b; 21 U.S.C. 387g; 21 U.S.C. 387i
Abstract: This rule would propose to establish a product standard
to require testing standards for batteries used in electronic nicotine
delivery systems (ENDS) and require design protections including a
battery management system for ENDS using batteries and protective
housing for replaceable batteries. This product standard would protect
the safety of users of battery-powered tobacco products and will help
to streamline the FDA premarket review process, ultimately reducing the
burden on both manufacturers and the Agency. The proposed rule would be
applicable to tobacco products that include a non-user replaceable
battery as well as products that include a user replaceable battery.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/21 .......................
------------------------------------------------------------------------
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: ctpregulations@fda.hhs.gov.
RIN: 0910-AH90
97. Administrative Detention of Tobacco Products
E.O. 13771 Designation: Other.
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
violative tobacco products until FDA has had time to consider the
appropriate action to take and, where appropriate, to initiate a
regulatory action.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/21 .......................
------------------------------------------------------------------------
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: ctpregulations@fda.hhs.gov.
RIN: 0910-AI05
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
98. Over-the-Counter (OTC) Drug Review--External Analgesic Products
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective and
not misbranded. After a final monograph (i.e., final rule) is issued,
only OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. The final
action addresses the 2003 proposed rule on patches, plasters, and
poultices. The proposed rule will address issues not addressed in
previous rulemakings.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Withdrawn........................... 04/13/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Phone: 301 796-3713, Email:
janice.adams-king@fda.hhs.gov.
RIN: 0910-AF35
99. Over-the-Counter (OTC) Drug Review--Internal Analgesic Products
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 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; 21
U.S.C. 379e
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective,
and not misbranded. After a final monograph (i.e., final rule) is
issued, only OTC drugs meeting the conditions of the monograph, or
having an approved new drug application, may be legally marketed. The
first action addresses acetaminophen safety. The second action
addresses products marketed for children under 2 years old and weight-
and age-based dosing for children's products.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Withdrawn........................... 04/10/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Phone: 301 796-3713, Fax: 301
796-9899, Email: janice.adams-king@fda.hhs.gov.
RIN: 0910-AF36
100. Sunscreen Drug Products for Over-the-Counter-Human-Use; Final
Monograph
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 360ff-5; 21 U.S.C. 371 to
374; 21 U.S.C. 379e
Abstract: The final rule will describe the conditions of use under
which OTC sunscreen products are generally recognized as safe and
effective (GRASE) and not misbranded. Consistent with the Sunscreen
Innovation Act, we expect that these conditions will include sunscreen
dosage forms and the effectiveness of various SPF values.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Withdrawn........................... 05/04/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
[[Page 52711]]
Agency Contact: Trang Tran, Phone: 240 402-7945, Email:
trang.tran@fda.hhs.gov.
RIN: 0910-AF43
101. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/
Cold Products
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; . . .
Abstract: The OTC drug review establishes conditions under which
OTC drugs are considered generally recognized as safe and effective,
and not misbranded. After a final monograph (i.e., final rule) is
issued, only OTC drugs meeting the conditions of the monograph, or
having an approved new drug application, may be legally marketed. This
action will propose changes to the final monograph for Cold, Cough,
Allergy, Bronchodilator, and Antiasthmatic Drug Products to address
safety and efficacy issues associated with pediatric cough and cold
products.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Withdrawn........................... 04/10/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Phone: 301 796-3713, Fax: 301
796-9899, Email: janice.adams-king@fda.hhs.gov.
RIN: 0910-AG12
102. Required Warnings for Cigarette Packages and Advertisements
E.O. 13771 Designation: Regulatory.
Legal Authority: 15 U.S.C. 1333; 21 U.S.C. 371; 21 U.S.C. 374; 21
U.S.C. 387c; 21 U.S.C. 387e; 21 U.S.C. 387i; Pub. L. 111-31, secs. 201
and 202, 123 Stat. 1776
Abstract: This rule will require color graphics depicting the
negative health consequences of smoking to accompany textual warning
statements on cigarette packages and in cigarette advertisements. As
directed by Congress in the Family Smoking Prevention and Tobacco
Control Act, which amends the Federal Cigarette Labeling and
Advertising Act, the rule will require these new cigarette health
warnings to occupy the top 50 percent of the area of the front and rear
panels of cigarette packages and at least 20 percent of the area of
cigarette advertisements. The original rule FDA issued in 2011 was
vacated by the U.S. Court of Appeals for the District of Columbia
Circuit in August 2012 (R.J. Reynolds Tobacco Co. v. United States Food
& Drug Admin., 696 F.3d 1205 D.C. Cir. 2012).
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
Final Rule.......................... 03/18/20 85 FR 15638
Final Action Effective.............. 06/18/21 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Courtney Smith, Phone: 877 287-1373, Fax: 877 287-
1426, Email: ctpregulations@fda.hhs.gov.
RIN: 0910-AI39
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
103. Reporting of Crimes Occurring in Federally Funded Long Term Care
Facilities and Enforcement Under Section 1150B of the Social Security
Act (CMS-3359)
E.O. 13771 Designation: Regulatory.
Legal Authority: 42 U.S.C. 1320b-25
Abstract: This proposed rule would implement federal requirements
requiring specific covered individuals in long-term care facilities to
report to the Secretary and law enforcement entities any reasonable
suspicion that a crime has been committed against a resident of or an
individual who is receiving care from such facility. It would also
implement requirements of these long-term care facilities to notify
such covered individuals of their reporting obligations, as well as
their rights under this reporting requirement, and prohibit retaliation
for making such reports. Additionally, this proposed rule would
establish procedures for imposing civil money penalties and exclusion
from participation in any federal health care program for violating the
obligations under these requirements. The rule would also provide for
hearings and appeals when those penalties and exclusions are imposed.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/00/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jessica Wright, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Clinical Standards and Quality, MS: C2-
21-16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
3838, Email: jessica.wright@cms.hhs.gov.
RIN: 0938-AT60
104. International Pricing Index Model for Medicare Part B Drugs (CMS-
5528) (Section 610 Review)
E.O. 13771 Designation: Regulatory.
Legal Authority: Social Security Act, sec. 1115A
Abstract: This proposed rule considers testing changes to payment
for certain separately payable Part B drugs and biologicals.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 10/30/18 83 FR 54546
ANPRM Comment Period End............ 12/31/18 .......................
NPRM................................ 06/00/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Andrew York, Social Science Research Analyst,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare and Medicaid Innovation, MS: WB-
06-05, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8945, Email: andrew.york1@cms.hhs.gov.
RIN: 0938-AT91
105. FY 2021 Inpatient Rehabilitation Facility (IRF) Prospective
Payment System Rate Update (CMS-1729)
E.O. 13771 Designation: Deregulatory.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual final rule updates the prospective payment
rates for inpatient rehabilitation facilities (IRFs) for fiscal year
2021.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/21/20 85 FR 22065
NPRM Comment Period End............. 06/15/20 .......................
Final Action........................ 08/00/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Gwendolyn Johnson, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C5-06-27, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6954, Email:
gwendolyn.johnson@cms.hhs.gov.
[[Page 52712]]
RIN: 0938-AU05
106. CY 2021 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1734) (Section 610
Review)
E.O. 13771 Designation: Other.
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, 2021. Additionally, this rule
proposes updates to the Quality Payment Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/20 .......................
------------------------------------------------------------------------
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: marge.watchorn@cms.hhs.gov.
RIN: 0938-AU10
107. Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals; The Long-Term Care Hospital Prospective Payment System; and
FY 2021 Rates (CMS-1735) (Section 610 Review)
E.O. 13771 Designation: Regulatory.
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................................ 05/29/20 85 FR 32460
NPRM Comment Period End............. 07/10/20 .......................
Final Action........................ 09/00/20 .......................
------------------------------------------------------------------------
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: C4-08-06, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email:
donald.thompson@cms.hhs.gov.
RIN: 0938-AU11
108. CY 2021 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1736) (Section 610 Review)
E.O. 13771 Designation: Other.
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................................ 06/00/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Marjorie Baldo, 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: 410 786-4617, Email:
marjorie.baldo@cms.hhs.gov.
RIN: 0938-AU12
109. Payment Policies for Durable Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS) (CMS-1738)
E.O. 13771 Designation: Other.
Legal Authority: 42 U.S.C. 1395l; 42 U.S.C. 1395m; 42 U.S.C. 1395u;
42 U.S.C. 1395w-3
Abstract: This rule includes proposed changes affecting Medicare
payment for DMEPOS items and services.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/20 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Joel Kaiser, Director, Division of DMEPOS Policy,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C5-07-26, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-6506, Email:
joel.kaiser@cms.hhs.gov.
RIN: 0938-AU17
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Long-Term Actions
110. 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)
E.O. 13771 Designation: Other.
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.
Final Action to be Merged With 0938- 05/00/21 .......................
AU17.
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Alexander Ullman, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services,
[[Page 52713]]
Center for Medicare, MS: C5-07-26, 7500 Security Boulevard, Baltimore,
MD 21244, Phone: 410 786-9671, Email: alexander.ullman@cms.hhs.gov.
RIN: 0938-AT21
111. Requirements for Long-Term Care Facilities: Regulatory Provisions
To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-
3347) (Section 610 Review)
E.O. 13771 Designation: Deregulatory.
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 that CMS has identified as unnecessary, obsolete, or
excessively burdensome on facilities. This rule increases the ability
of healthcare professionals to devote resources to improving resident
care by eliminating or reducing requirements that impede quality care
or that divert resources away from providing high-quality 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: Ronisha Blackstone, 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-
6882, Email: ronisha.blackstone@cms.hhs.gov.
RIN: 0938-AT36
112. Organ Procurement Organizations (OPOS) (CMS-3380) (Section 610
Review)
E.O. 13771 Designation: Regulatory.
Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302
Abstract: This final rule revises the Organ Procurement
Organization (OPO) Conditions for Coverage (CfCs) to increase donation
rates and organ transplantation rates by replacing the current measures
with new transparent, reliable, and objective measures.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/23/19 84 FR 70628
NPRM Comment Period End............. 02/21/20
Final Action........................ 12/00/22
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Alpha-Banu Wilson, 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-
8687, Email: alphabanu.wilson@cms.hhs.gov.
RIN: 0938-AU02
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
113. CY 2020 Home Health Prospective Payment System Rate Update and
Quality Reporting Requirements (CMS-1711) (Completion of a Section 610
Review)
E.O. 13771 Designation: Regulatory.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395(hh)
Abstract: This annual final rule updates the payment rates under
the Medicare prospective payment system for home health agencies. In
addition, this rule finalizes changes to the Home Health Value-Based
Purchasing (HHVBP) Model and to the Home Health Quality Reporting
Program (HH QRP).
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/18/19 84 FR 34598
NPRM Comment Period End............. 09/09/19
Final Action........................ 11/08/19 84 FR 60478
Final Action Effective.............. 01/01/20
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Hillary Loeffler, Director, Division of Home Health
and Hospice, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Center for Medicare, MS: C5-07-22, 7500
Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0456, Email:
hillary.loeffler@cms.hhs.gov.
RIN: 0938-AT68
114. CY 2020 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1715) (Completion
of a Section 610 Review)
E.O. 13771 Designation: Regulatory.
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, 2020. Additionally, this rule finalizes
updates to the Quality Payment Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/14/19 84 FR 40482
NPRM Comment Period End............. 09/27/19
Final Action........................ 11/15/19 84 FR 62568
Final Action Effective.............. 01/01/20
------------------------------------------------------------------------
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: marge.watchorn@cms.hhs.gov.
RIN: 0938-AT72
115. CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1717) (Completion of a Section 610 Review)
E.O. 13771 Designation: Regulatory.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
Abstract: This annual final rule revises the Medicare hospital
outpatient prospective payment system to implement statutory
requirements and changes arising from our continuing experience with
this system. The rule describes changes to the amounts and factors used
to determine payment rates for services. In addition, the rule
finalizes changes to the ambulatory surgical center payment system list
of services and rates. This rule also updates and refines the
requirements for the Hospital Outpatient Quality Reporting (OQR)
Program and the ASC Quality Reporting (ASCQR) Program.
Timetable:
[[Page 52714]]
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/09/19 84 FR 39398
NPRM Comment Period End............. 09/27/19
Final Action........................ 11/12/19 84 FR 61142
Final Action Effective.............. 01/01/20
------------------------------------------------------------------------
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-AT74
[FR Doc. 2020-16751 Filed 8-25-20; 8:45 am]
BILLING CODE 4150-03-P