[Federal Register Volume 86, Number 60 (Wednesday, March 31, 2021)]
[Proposed Rules]
[Pages 16892-16903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04943]



[[Page 16891]]

Vol. 86

Wednesday,

No. 60

March 31, 2021

Part VIII





 Department of Health and Human Services





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Semiannual Regulatory Agenda

  Federal Register / Vol. 86 , No. 60 / Wednesday, March 31, 2021 / UA: 
Reg Flex Agenda  

[[Page 16892]]


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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: The Executive Secretariat, 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.
    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.

Samuel A. Shipley,
Senior Regulations Coordinator.

              Office of the Secretary--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
205.......................  Limiting the Effect of             0991-AC11
                             Exclusions Implemented
                             Under the Social Security
                             Act (Rulemaking Resulting
                             From a Section 610
                             Review).
------------------------------------------------------------------------


              Office for Civil Rights--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
206.......................  Implementation of the              0945-AA13
                             Religious Freedom
                             Restoration Act (Section
                             610 Review).
207.......................  Special Responsibilities           0945-AA14
                             of Medicare Hospitals in
                             Emergency Cases, and
                             Discrimination on the
                             Basis of Disability in
                             Critical Health and Human
                             Services Programs or
                             Activities (Section 610
                             Review) (Reg Plan Seq No.
                             33).
208.......................  Rulemaking on                      0945-AA15
                             Discrimination on the
                             Basis of Disability in
                             Critical Health and Human
                             Services Programs or
                             Activities (Rulemaking
                             Resulting From a Section
                             610 Review).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


               Office for Civil Rights--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
209.......................  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.
------------------------------------------------------------------------
210.......................  Information Blocking and           0955-AA02
                             the ONC Health IT
                             Certification Program:
                             Extension of Compliance
                             Dates and Timeframes in
                             Response to the COVID-19
                             Public Health Emergency
                             (Reg Plan Seq No. 35).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


[[Page 16893]]


 Office of the National Coordinator for Health Information Technology--
                            Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
211.......................  21st Century Cures Act:            0955-AA01
                             Interoperability,
                             Information Blocking, and
                             the ONC Health IT
                             Certification Program.
------------------------------------------------------------------------


      Centers for Disease Control and Prevention--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
212.......................  Control of Communicable            0920-AA75
                             Diseases; Foreign
                             Quarantine.
------------------------------------------------------------------------


      Centers for Disease Control and Prevention--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
213.......................  Control of Communicable            0920-AA76
                             Diseases; Foreign
                             Quarantine: Suspension of
                             the Right to Introduction
                             and Prohibition of
                             Introduction of Persons
                             into United States from
                             Designated Foreign
                             Countries or Places.
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
214.......................  Medication Guide; Patient          0910-AH68
                             Medication Information.
215.......................  Requirements for Tobacco           0910-AH91
                             Product Manufacturing
                             Practice.
216.......................  Administrative Detention           0910-AI05
                             of Tobacco Products.
217.......................  Nutrient Content Claims,           0910-AI13
                             Definition of Term:
                             Healthy.
218.......................  Revocation of Uses of              0910-AI15
                             Partially Hydrogenated
                             Oils in Foods.
219.......................  Conduct of Analytical and          0910-AI57
                             Clinical Pharmacology,
                             Bioavailability and
                             Bioequivalence Studies.
------------------------------------------------------------------------


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
220.......................  Sunlamp Products;                  0910-AG30
                             Amendment to the
                             Performance Standard.
221.......................  Mammography Quality                0910-AH04
                             Standards Act (Reg Plan
                             Seq No. 37).
222.......................  General and Plastic                0910-AH14
                             Surgery Devices:
                             Restricted Sale,
                             Distribution, and Use of
                             Sunlamp Products.
223.......................  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.
224.......................  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.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
225.......................  Acute Nicotine Toxicity            0910-AH24
                             Warnings for E-Liquids.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
226.......................  Postmarketing Safety               0910-AA97
                             Reporting Requirements
                             for Human Drug and
                             Biological Products.
227.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
228.......................  Food Labeling; Gluten-Free         0910-AH00
                             Labeling of Fermented or
                             Hydrolyzed Foods.
229.......................  Testing Standards for              0910-AH90
                             Batteries and Battery
                             Management Systems in
                             Battery-Operated Tobacco
                             Products.
------------------------------------------------------------------------


[[Page 16894]]


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
230.......................  Medicaid Programs Reducing         0938-AT99
                             Provider and Patient
                             Burden, and Promoting
                             Patients' Electronic
                             Access to Health
                             Information (CMS-9123).
231.......................  CY 2022 Revisions to               0938-AU42
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1751)
                             (Section 610 Review).
232.......................  CY 2022 Hospital                   0938-AU43
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1753)
                             (Section 610 Review).
233.......................  Hospital Inpatient                 0938-AU44
                             Prospective Payment
                             Systems for Acute Care
                             Hospitals; the Long-Term
                             Care Hospital Prospective
                             Payment System; and FY
                             2022 Rates (CMS-1752)
                             (Section 610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
234.......................  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).
235.......................  International Pricing              0938-AT91
                             Index Model For Medicare
                             Part B Drugs (CMS-5528)
                             (Section 610 Review).
236.......................  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).
237.......................  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).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
238.......................  Requirements for Long-Term         0938-AT36
                             Care Facilities:
                             Regulatory Provisions to
                             Promote Increased Safety
                             (CMS-3347) (Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
239.......................  Organ Procurement                  0938-AU02
                             Organizations (OPOs) (CMS-
                             3380) (Completion of a
                             Section 610 Review).
240.......................  Transparency in Coverage           0938-AU04
                             (CMS-9915).
241.......................  FY 2021 Inpatient                  0938-AU05
                             Rehabilitation Facility
                             (IRF) Prospective Payment
                             System Rate Update (CMS-
                             1729) (Completion of a
                             Section 610 Review).
242.......................  FY 2021 Inpatient                  0938-AU07
                             Psychiatric Facilities
                             Prospective Payment
                             System Rate Updates (CMS-
                             1731) (Completion of a
                             Section 610 Review).
243.......................  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).
244.......................  Clinical Laboratory                0938-AU33
                             Improvement Amendments
                             and Patient Protection
                             and Affordable Care Act;
                             Additional Policy and
                             Regulatory Revisions in
                             Response to the COVID-19
                             Public Health Emergency
                             (CMS-3401) (Completion of
                             a Section 610 Review).
------------------------------------------------------------------------


      Administration for Children and Families--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
245.......................  Updating Native Employment         0970-AC83
                             Works Requirements
                             (Rulemaking Resulting
                             From a Section 610
                             Review).
------------------------------------------------------------------------


[[Page 16895]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the Secretary (OS)

Proposed Rule Stage

205. 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................................   11/00/20  .......................
------------------------------------------------------------------------

    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)

Proposed Rule Stage

206.  Implementation of the Religious Freedom Restoration Act 
(Section 610 Review)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: Not Yet Determined
    Abstract: This proposed rule would set forth substantive standards 
the Department will use in its interpretation and application of RFRA. 
These would include elaboration on how HHS will interpret terms in RFRA 
such as religious exercise, substantial burden, and compelling 
interest, based on the guidance issued by the Attorney General 
concerning those terms, as well as applicable case law. The rule's 
standards would guide both OCR and the Department's components in 
understanding how RFRA's requirements govern the Department's various 
activities. The rulemaking would rely upon, other authorities, 42 
U.S.C. 2000bb-1, and the statutes that provide legal authority to issue 
programmatic regulations with respect to HHS programs, as well as HHS's 
interpretive authority.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Undetermined.
    Agency Contact: Christine Pratt, Senior Advisor on Conscience and 
Religious Freedom, Department of Health and Human Services, Office for 
Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 
800 368-1019, Email: [email protected].
    RIN: 0945-AA13

207.  Special Responsibilities of Medicare Hospitals in 
Emergency Cases, and Discrimination on the Basis of Disability in 
Critical Health and Human Services Programs or Activities (Section 610 
Review)

    Regulatory Plan: This entry is Seq. No. 33 in part II of this issue 
of the Federal Register.
    RIN: 0945-AA14

208.  Rulemaking on Discrimination on the Basis of Disability 
in Critical Health and Human Services Programs or Activities 
(Rulemaking Resulting From a Section 610 Review)

    E.O. 13771 Designation: Fully or Partially Exempt.
    Legal Authority: Section 504 of the Rehabilitation Act of 19
    Abstract: This proposed rule would revise regulations under, among 
other statutes, section 504 of the Rehabilitation Act of 1973 to 
robustly address unlawful discrimination on the basis of disability in 
certain vital HHS-funded health and human services programs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Carla Carter, Supervisory Civil Rights Analyst, 
Department of Health and Human Services, Office for Civil Rights, 200 
Independence Avenue SW, Washington, DC 20201, Phone: 800 368-1019, 
Email: [email protected].
    RIN: 0945-AA15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Completed Actions

209. 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 l of the PPACA.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Action........................   06/19/20  85 FR 37160
Final Action Effective..............   08/18/20  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Luben Montoya, Phone: 800 368-1019, TDD Phone: 800 
537-7697, Email: [email protected].

[[Page 16896]]

    RIN: 0945-AA11

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the National Coordinator for Health Information Technology 
(ONC)

Final Rule Stage

210.  Information Blocking and the ONC Health IT Certification 
Program: Extension of Compliance Dates and Timeframes in Response to 
the Covid-19 Public Health Emergency

    Regulatory Plan: This entry is Seq. No. 35 in part II of this issue 
of the Federal Register.
    RIN: 0955-AA02

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office of the National Coordinator for Health Information Technology 
(ONC)

Completed Actions

211. 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 final rule implements certain provisions of the 21st 
Century Cures Act, including Conditions and Maintenance of 
Certification requirements for health information technology (health 
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 implementation of these 
provisions will advance interoperability and support the access, 
exchange, and use of electronic health information. The rule also 
finalizes certain modifications to the 2015 Edition health IT 
certification criteria and Program in additional ways to advance 
interoperability, enhance health IT certification, and reduce burden 
and costs.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Action........................   05/01/20  85 FR 25642
Final Action Effective..............   06/30/20  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michael Lipinski, Phone: 202 690-7151.
    RIN: 0955-AA01

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Final Rule Stage

212. Control of Communicable Diseases; Foreign Quarantine

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 264; 42 U.S.C. 265
    Abstract: This rulemaking amends current regulation to enable CDC 
to require airlines to collect and provide to CDC certain data elements 
regarding passengers and crew arriving from foreign countries under 
certain circumstances.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule Effective........   02/07/20  .......................
Interim Final Rule..................   02/12/20  85 FR 7874
Interim Final Rule Comment Period      03/13/20  .......................
 End.
Final Action........................   04/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ashley C. Altenburger JD, Public Health Analyst, 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, 1600 Clifton Road NE, MS: H 16-4, Atlanta, GA 30307, 
Phone: 800 232-4636, Email: [email protected].
    RIN: 0920-AA75

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Disease Control and Prevention (CDC)

Completed Actions

213. Control of Communicable Diseases; Foreign Quarantine: Suspension 
of the Right to Introduction and Prohibition of Introduction of Persons 
Into United States From Designated Foreign Countries or Places

    E.O. 13771 Designation: Fully or Partially Exempt.
    Legal Authority: 42 U.S.C. 265
    Abstract: HHS/CDC is amending its Foreign Quarantine regulations to 
provide a procedure for CDC to suspend the introduction of persons from 
designated countries or places, if required, in the interest of public 
health.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule Comment Period      04/23/20  .......................
 End.
Final Action........................   09/11/20  85 FR 56724
Final Action Effective..............   10/13/20  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nina Witkofsky, Phone: 404 498-7000, Email: 
[email protected].
    RIN: 0920-AA76

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

214. 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................................   02/00/21  .......................
------------------------------------------------------------------------

    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

[[Page 16897]]

215. 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................................   02/00/21  .......................
------------------------------------------------------------------------

    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

216. 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................................   08/00/21  .......................
------------------------------------------------------------------------

    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

217. 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................................   11/00/20  .......................
------------------------------------------------------------------------

    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

218. 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................................   07/00/21  .......................
------------------------------------------------------------------------

    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

219.  Conduct of Analytical and Clinical Pharmacology, 
Bioavailability and Bioequivalence Studies

    E.O. 13771 Designation: Deregulatory.
    Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42 
U.S.C. 262
    Abstract: FDA is proposing to amend 21 CFR 320, in certain parts, 
and establish a new 21 CFR 321 to clarify FDA's study conduct 
expectations for analytical and clinical pharmacology, bioavailability 
(BA) and bioequivalence (BE) studies that support human research and 
marketing applications for human drug and biological products. The 
proposed rule would specify needed basic study conduct requirements to 
enable FDA to ensure those studies are conducted appropriately and to 
verify the reliability of study data from those studies. This 
regulation would align with FDA's other good practice regulations, 
would also be consistent with current industry best practices, and 
would harmonize the regulations more closely with related international 
regulatory expectations.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Joseph Folian, Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, Building 51, Room

[[Page 16898]]

5215, Silver Spring, MD 20993-0002, Phone: 240 402-4089, Email: 
[email protected].
    RIN: 0910-AI57

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

220. 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..........................   05/00/21  .......................
------------------------------------------------------------------------

    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-AG30

221. Mammography Quality Standards Act

    Regulatory Plan: This entry is Seq. No. 37 in part II of this issue 
of the Federal Register.
    RIN: 0910-AH04

222. 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..........................   10/00/21  .......................
------------------------------------------------------------------------

    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

223. 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

224. 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..........................   11/00/20  .......................
------------------------------------------------------------------------


[[Page 16899]]

    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

225. 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 acute nicotine toxicity warning 
requirements for liquid nicotine and nicotine-containing e-liquid(s) 
that are made or derived from tobacco and intended for human 
consumption, and potentially for other tobacco products including, but 
not limited to, novel tobacco products such as dissolvables, lotions, 
gels, and drinks. This action is intended to increase consumer 
awareness and knowledge of the risks of acute toxicity due to 
accidental nicotine exposure from nicotine-containing e-liquids in 
tobacco products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/22
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Samantha LohCollado, Senior Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
10903 New Hampshire Ave., Building 71, Room G335, Silver Spring, MD 
20993, Phone: 877 287-1373, Fax: 877 287-1426, Email: 
[email protected].
    RIN: 0910-AH24

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

226. 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).
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   09/04/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jane E. Baluss, Phone: 301 796-3469, Fax: 301 847-
8440, Email: [email protected].
    RIN: 0910-AA97

227. 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.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   11/23/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Adams-King, Phone: 301 796-3713, Fax: 301 
796-9899, Email: [email protected].
    RIN: 0910-AF31

228. 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.''
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Rule..........................   08/13/20  85 FR 49240
Final Rule Effective................   10/13/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Carol D'Lima, Phone: 240 402-2371, Fax: 301 436-
2636, Email: [email protected].
    RIN: 0910-AH00

229. 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

[[Page 16900]]

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.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Withdrawn...........................   09/04/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nathan Mease, Phone: 877 287-1373, Email: 
[email protected].
    RIN: 0910-AH90

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

230. Medicaid Programs Reducing Provider and Patient Burden, and 
Promoting Patients' Electronic Access to Health Information (CMS-9123)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 1302
    Abstract: This proposed rule would place new requirements on state 
Medicaid and CHIP fee-for-service (FFS) programs, Medicaid managed care 
plans, CHIP managed care entities, and Qualified Health Plan (QHP) 
issuers on the Federally-facilitated Exchanges (FFEs) to improve the 
electronic exchange of health care data, and streamline processes 
related to prior authorization, while continuing CMS' drive toward 
interoperability, and reducing burden in the health care market. In 
addition, on behalf of the Department of Health and Human Service 
(HHS), the Office of the National Coordinator for Health Information 
Technology (ONC) is proposing the adoption of certain specified 
implementation guides (IGs) needed to support the proposed Application 
Programming Interface (API) policies included in this rule. Each of 
these elements plays a key role in reducing overall payer and provider 
burden and improving patient access to health information.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Alexandra Mugge, Deputy Chief Health Informatics 
Officer, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Office of the Administrator, MS: C5-02-00, 7500 
Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4457, Email: 
[email protected].
    RIN: 0938-AT99

231.  CY 2022 Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Medicare Part B (CMS-1751) (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, 2022. Additionally, this rule 
proposes updates to the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/21
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: 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-AU42

232.  CY 2022 Hospital Outpatient PPS Policy Changes and 
Payment Rates and Ambulatory Surgical Center Payment System Policy 
Changes and Payment Rates (CMS-1753) (Section 610 Review)

    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................................   06/00/21
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elise Barringer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-9222, Email: 
[email protected].
    RIN: 0938-AU43

233.  Hospital Inpatient Prospective Payment Systems for Acute 
Care Hospitals; the Long-Term Care Hospital Prospective Payment System; 
and FY 2022 Rates (CMS-1752) (Section 610 Review)

    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 inpatient and long-term care hospital prospective payment 
systems for operating and capital-related costs. This proposed rule 
would implement changes arising from our continuing experience with 
these systems. In addition, the rule proposes to establish new 
requirements or revise existing requirements for quality reporting by 
specific Medicare providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/00/21
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Director, Division of Acute Care, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-08-06, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: 
[email protected].
    RIN: 0938-AU44


[[Page 16901]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

234. 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, Center for Medicare, MS: C5-07-26, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-9671, Email: 
[email protected].
    RIN: 0938-AT21

235. 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 rule finalizes 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  .......................
Interim Final Rule..................   11/27/20  85 FR 76180
Interim Final Rule Effective........   11/27/20  .......................
Interim Final Rule Comment Period      01/26/21  .......................
 End.
Final Action........................   11/00/23  .......................
------------------------------------------------------------------------

    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

236. 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: 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, 2021. Additionally, this rule updates 
the Quality Payment Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/17/20  85 FR 50074
NPRM Comment Period End.............   10/05/20  .......................
Final Action........................   01/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Marge Watchorn, Deputy Director, Division of 
Practitioner Services, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-15, 
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4361, 
Email: [email protected].
    RIN: 0938-AU10

237. 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: 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 
implements changes to the ambulatory surgical center payment system 
list of services and rates. This rule also updates and refines the 
requirements for the Hospital Outpatient Quality Reporting (OQR) 
Program and the ASC Quality Reporting (ASCQR) Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/12/20  85 FR 48772
NPRM Comment Period End.............   10/05/20  .......................
Final Action........................   01/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elise Barringer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-9222, Email: 
[email protected].
    RIN: 0938-AU12

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

238. Requirements for Long-Term Care Facilities: Regulatory Provisions 
To Promote Increased Safety (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 in

[[Page 16902]]

order to support the provision of safe care and preserve access to 
care.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/18/19  84 FR 34737
NPRM Comment Period End.............   09/16/19  .......................
Final Action........................   07/00/22  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Diane Corning, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards and Quality, MS: S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8486, Email: [email protected].
    RIN: 0938-AT36

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

239. Organ Procurement Organizations (OPOS) (CMS-3380) (Completion of a 
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........................   12/02/20  85 FR 77898
Final Action Effective..............   02/01/21  .......................
------------------------------------------------------------------------

    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

240. Transparency in Coverage (CMS-9915)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 18031; 42 U.S.C. 300gg-15a
    Abstract: This final rule would implement portions of Executive 
Order 13877 (``Improving Price and Quality Transparency in American 
Healthcare to Put Patients First'', June 24, 2019), which provides that 
the Secretaries of Health and Human Services, the Treasury, and Labor 
will facilitate access to information about expected health care costs 
for patients before they receive care.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
Final Action........................   11/12/20  85 FR 72158
Final Action Effective..............   01/11/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Deborah Bryant, Phone: 301 493-4293, Email: 
[email protected].
    RIN: 0938-AU04

241. FY 2021 Inpatient Rehabilitation Facility (IRF) Prospective 
Payment System Rate Update (CMS-1729) (Completion of a Section 610 
Review)

    E.O. 13771 Designation: Other.
    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........................   08/10/20  85 FR 48424
Final Action Effective..............   10/01/20  .......................
------------------------------------------------------------------------

    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].
    RIN: 0938-AU05

242. FY 2021 Inpatient Psychiatric Facilities Prospective Payment 
System Rate Updates (CMS-1731) (Completion of a Section 610 Review)

    E.O. 13771 Designation: Other.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395f; 42 U.S.C. 1395g; 
42 U.S.C. 1395hh; . . .
    Abstract: This annual final rule updates the prospective payment 
rates for inpatient psychiatric facilities (IPF) with discharges 
beginning on October 1, 2020.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/14/20  85 FR 20625
NPRM Comment Period End.............   06/09/20  .......................
Final Action........................   08/04/20  85 FR 47042
Final Action Effective..............   10/01/20  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sherlene Jacques, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-04-27, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-0510, Email: 
[email protected].
    RIN: 0938-AU07

243. 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.
    Completed:

------------------------------------------------------------------------
               Reason                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/29/20  85 FR 32460
Final Action........................   09/18/20  85 FR 58342
Final Action Effective..............   10/01/20  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Phone: 410 786-6504, Email: 
[email protected].
    RIN: 0938-AU11

[[Page 16903]]

244.  Clinical Laboratory Improvement Amendments and Patient 
Protection and Affordable Care Act; Additional Policy and Regulatory 
Revisions in Response To The Covid-19 Public Health Emergency (CMS-
3401) (Completion of a Section 610 Review)

    E.O. 13771 Designation: Other.
    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; 42 U.S.C. 1395rr
    Abstract: This interim final rule with comment period (IFC) 
strengthens CMS' ability to enforce compliance with Medicare and 
Medicaid Requirements for Participation, improves Long-Term Care (LTC) 
Facilities for Infection Control including reporting on information 
related to COVID-19 by specifying penalty amounts, revises regulations 
for tracking the incidence and impact of COVID-19 in hospitals and CAHs 
to assist public health officials in detecting outbreaks and saving 
lives, and requires all CLIA laboratories to report SARS-CoV-2 test 
results in such form and manner, and at such timing and frequency, as 
the Secretary during the Secretary's Public Health Emergency (PHE) 
declaration with respect to COVID19.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   09/02/20  85 FR 54820
Interim Final Rule Effective........   09/02/20  .......................
Interim Final Rule Comment Period      11/02/20  .......................
 End.
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: CDR Scott J. Cooper, Health Insurance Specialist, 
Clinical Standards Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail 
Stop S3-02-01, Baltimore, MD 21244, Phone: 410 786-9465, Email: 
[email protected].
    RIN: 0938-AU33

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Administration for Children and Families (ACF)

Proposed Rule Stage

245.  Updating Native Employment Works Requirements (Rulemaking 
Resulting From a Section 610 Review)

    E.O. 13771 Designation: Regulatory.
    Legal Authority: 42 U.S.C. 612
    Abstract: The rule would update NEW regulations at 45 CFR part 287 
to avoid inconsistencies and reflect the changes that have been made to 
the NEW statute and Administration for Children and Families (ACF) 
grant policy and procedures since the current regulation's publication 
on February 18, 2000. In particular, the regulations need to address 
changes made in section 404(e) of the Social Security Act as amended in 
1999, Uniform Administrative Requirements, Cost Principles, and Audit 
Requirement for HHS Awards (45 CFR part 75)--Part 75 Uniform 
Administrative Requirements, Cost Principles, and Audit Requirements 
for HHS Awards, Public Law 106-107, the ``Federal Financial Assistance 
Management, Improvement Act of 1999'' (Nov. 20, 1999), and various 
minor technical changes. While some of these changes have been 
addressed and communicated to the public and grantees via program 
instructions and information memoranda, the regulations themselves are 
now inconsistent with current law and policy.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/21  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Tonya Ann Davis, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
330 C Street SW, Room 3020, Washington, DC 20201, Phone: 202 401-4851, 
Email: [email protected].
    RIN: 0970-AC83

[FR Doc. 2021-04943 Filed 3-30-21; 8:45 am]
BILLING CODE 4150-03-P