[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.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


[[Page 52705]]


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
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).
------------------------------------------------------------------------

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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/20
------------------------------------------------------------------------

    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)

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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/14/19  84 FR 27846
NPRM Comment Period End.............   08/13/19
Final Action........................   06/00/20
------------------------------------------------------------------------

    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: [email protected].
    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
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
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
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
------------------------------------------------------------------------

    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: [email protected].
    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Reopening of Administrative Record..   08/25/00  65 FR 51780
Comment Period End..................   11/24/00
NPRM (Amendment) (Common Cold)......   12/00/20
------------------------------------------------------------------------

    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: [email protected].
    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:

------------------------------------------------------------------------
               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: [email protected].
    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/20
------------------------------------------------------------------------

    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: 
[email protected].
    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: [email protected].
    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
------------------------------------------------------------------------

    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

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: 
[email protected].
    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:

------------------------------------------------------------------------
               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: 
[email protected].
    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: [email protected].
    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: 
[email protected].
    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: [email protected].
    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: [email protected].
    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: [email protected].
    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: [email protected].
    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: [email protected].
    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: 
[email protected].
    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: [email protected].
    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: 
[email protected].
    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: [email protected].
    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: [email protected].
    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: [email protected].
    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: [email protected].
    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: 
[email protected].

[[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: [email protected].
    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: 
[email protected].
    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: 
[email protected].
    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: 
[email protected].
    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: [email protected].
    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: [email protected].
    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: [email protected].
    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: 
[email protected].
    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: [email protected].
    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: 
[email protected].
    RIN: 0938-AT74

[FR Doc. 2020-16751 Filed 8-25-20; 8:45 am]
BILLING CODE 4150-03-P