[Federal Register Volume 84, Number 121 (Monday, June 24, 2019)]
[Proposed Rules]
[Pages 29623-29634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12004]
[[Page 29623]]
Vol. 84
Monday,
No. 121
June 24, 2019
Part VI
Department of Health and Human Services
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Unified Agenda
Federal Register / Vol. 84 , No. 121 / Monday, June 24, 2019 /
Unified Agenda
[[Page 29624]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
21 CFR Ch. I
25 CFR Ch. V
42 CFR Chs. I-V
45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII
Regulatory Agenda
AGENCY: Office of the Secretary, HHS.
ACTION: Semiannual Regulatory Agenda.
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SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order
(E.O.) 12866 require the semiannual issuance of an inventory of
rulemaking actions under development throughout the Department,
offering for public review summarized information about forthcoming
regulatory actions.
FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary,
Department of Health and Human Services, 200 Independence Avenue SW,
Washington, DC 20201; (202) 690-5627.
SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) is the Federal government's lead agency for protecting the health
of all Americans and providing essential human services, especially for
those who are least able to help themselves. HHS enhances the health
and well-being of Americans by promoting effective health and human
services and by fostering sound, sustained advances in the sciences
underlying medicine, public health, and social services.
This Agenda presents the regulatory activities that the Department
expects to undertake in the foreseeable future to advance this mission.
HHS has an agency-wide effort to support the Agenda's purpose of
encouraging more effective public participation in the regulatory
process. For example, to encourage public participation, we regularly
update our regulatory web page (http://www.HHS.gov/regulations) which
includes links to HHS rules currently open for public comment, and also
provides a ``regulations toolkit'' with background information on
regulations, the commenting process, how public comments influence the
development of a rule, and how the public can provide effective
comments. HHS also actively encourages meaningful public participation
in its retrospective review of regulations, through a comment form on
the HHS retrospective review web page (http://www.HHS.gov/RetrospectiveReview).
The rulemaking abstracts included in this paper issue of the
Federal Register cover, as required by the Regulatory Flexibility Act
of 1980, those prospective HHS rulemakings likely to have a significant
economic impact on a substantial number of small entities. The
Department's complete Regulatory Agenda is accessible online at http://www.RegInfo.gov.
Ann C. Agnew,
Executive Secretary to the Department.
Office for Civil Rights--Proposed Rule Stage
------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No.
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64........................ Nondiscrimination in 0945-AA11
Health Programs or
Activities.
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Office of the National Coordinator for Health Information Technology--
Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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65........................ 21st Century Cures Act: 0955-AA01
Interoperability,
Information Blocking, and
the ONC Health IT
Certification Program.
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Food and Drug Administration--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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66........................ Over-the-Counter (OTC) 0910-AF31
Drug Review--Cough/Cold
(Antihistamine) Products.
67........................ Sunscreen Drug Products 0910-AF43
For Over-The-Counter-
Human Use; Tentative
Final Monograph.
68........................ Mammography Quality 0910-AH04
Standards Act; Amendments
to Part 900 Regulations.
69........................ Medication Guides; Patient 0910-AH68
Medication Information.
70........................ Nutrient Content Claims, 0910-AI13
Definition of Term:
Healthy.
71........................ Revocation of Uses of 0910-AI15
Partially Hydrogenated
Oils in Foods.
72........................ Required Warnings for 0910-AI39
Cigarette Packages and
Advertisements.
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Food and Drug Administration--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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73........................ Postmarketing Safety 0910-AA97
Reporting Requirements
for Human Drug and
Biological Products.
74........................ Food Labeling; Gluten-Free 0910-AH00
Labeling of Fermented,
Hydrolyzed, or Distilled
Foods.
75........................ Topical Antimicrobial Drug 0910-AH97
Products for Over-the-
Counter Human Use: Final
Monograph for Consumer
Antiseptic Rub Products.
76........................ Milk and Cream Product and 0910-AI40
Yogurt Products, Final
Rule to Revoke the
Standards for Lowfat
Yogurt and Nonfat and to
Amend the Standard for
Yogurt.
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[[Page 29625]]
Food and Drug Administration--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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77........................ Over-the-Counter (OTC) 0910-AF35
Drug Review--External
Analgesic Products.
78........................ Over-the-Counter (OTC) 0910-AF36
Drug Review--Internal
Analgesic Products.
79........................ Over-the-Counter (OTC) 0910-AF38
Drug Review--Laxative
Drug Products.
80........................ Over-the-Counter (OTC) 0910-AF45
Drug Review--Weight
Control Products.
81........................ Over-the-Counter (OTC) 0910-AG12
Drug Review--Pediatric
Dosing for Cough/Cold
Products.
82........................ Electronic Distribution of 0910-AG18
Prescribing Information
for Human Prescription
Drugs Including
Biological Products.
83........................ Sunlamp Products; 0910-AG30
Amendment to the
Performance Standard.
84........................ General and Plastic 0910-AH14
Surgery Devices: Sunlamp
Products.
85........................ Combinations of 0910-AH16
Bronchodilators With
Expectorants; Cold,
Cough, Allergy,
Bronchodilator, and
Antiasthmatic Drug
Products for Over-the-
Counter Human Use.
86........................ Acute Nicotine Toxicity 0910-AH24
Warnings for E-Liquids.
87........................ Testing Standards for 0910-AH90
Batteries and Battery
Management Systems in
Electronic Nicotine
Delivery Systems.
88........................ Administration Detention 0910-AI05
of Tobacco Products.
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Food and Drug Administration--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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89........................ Label Requirement for Food 0910-AF61
That Has Been Refused
Admission Into the United
States.
90........................ Laser Products; Amendment 0910-AF87
to Performance Standard.
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Centers for Medicare & Medicaid Services--Proposed Rule Stage
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Regulation
Sequence No. Title Identifier No.
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91........................ Requirements for Long-Term 0938-AT36
Care Facilities:
Regulatory Provisions to
Promote Program
Efficiency, Transparency,
and Burden Reduction (CMS-
3347-P) (Section 610
Review).
92........................ CY 2020 Revisions to 0938-AT72
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B (CMS-1715-P)
(Section 610 Review).
93........................ Hospital Inpatient 0938-AT73
Prospective Payment
Systems for Acute Care
Hospitals; the Long-Term
Care Hospital Prospective
Payment System; and FY
2020 Rates (CMS-1716-F)
(Section 610 Review).
94........................ 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-
P) (Section 610 Review).
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Centers for Medicare & Medicaid Services--Final Rule Stage
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Regulation
Sequence No. Title Identifier No.
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95........................ Hospital and Critical 0938-AS21
Access Hospital (CAH)
Changes to Promote
Innovation, Flexibility,
and Improvement in
Patient Care (CMS-3295-F)
(Rulemaking Resulting
From a Section 610
Review).
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Centers for Medicare & Medicaid Services--Long-Term Actions
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Regulation
Sequence No. Title Identifier No.
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96........................ 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-
F) (Section 610 Review).
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Centers for Medicare & Medicaid Services--Completed Actions
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Regulation
Sequence No. Title Identifier No.
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97........................ CY 2019 Changes to the End- 0938-AT28
Stage Renal Disease
(ESRD) Prospective
Payment System, Quality
Incentive Program,
Durable Medical
Equipment, Prosthetics,
Orthotics, and Supplies
(DMEPOS) (CMS-1691-F)
(Completion of a Section
610 Review).
98........................ CY 2019 Home Health 0938-AT29
Prospective Payment
System Rate Update and CY
2020 Case-Mix Adjustment
Methodology Refinements;
Value-Based Purchasing
Model; Quality Reporting
Requirements (CMS-1689-
FC) (Completion of a
Section 610 Review).
[[Page 29626]]
99........................ CY 2019 Hospital 0938-AT30
Outpatient PPS Policy
Changes and Payment Rates
and Ambulatory Surgical
Center Payment System
Policy Changes and
Payment Rates (CMS-1695-
FC) (Completion of a
Section 610 Review).
100....................... CY 2019 Revisions to 0938-AT31
Payment Policies Under
the Physician Fee
Schedule and Other
Revisions to Medicare
Part B and the Quality
Payment Program (CMS-1693-
F) (Completion of a
Section 610 Review).
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office for Civil Rights (OCR)
Proposed Rule Stage
64. Nondiscrimination in Health 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 proposed rule implements section 1557 of the Patient
Protection and Affordable Care Act (PPACA), which prohibits
discrimination on the basis of race, color, national origin, sex, age,
and 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.
Timetable:
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Action Date FR Cite
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NPRM................................ 05/00/19
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Luben Montoya, Section Chief, Civil Rights
Division, Department of Health and Human Services, Office for Civil
Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202
774-3041, 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)
Proposed Rule Stage
65. 21st Century Cures Act: Interoperability, Information Blocking, and
the ONC Health IT Certification Program
E.O. 13771 Designation: Regulatory.
Legal Authority: Pub. L. 114-255
Abstract: The rulemaking would implement certain provisions of the
21st Century Cures Act, including conditions and maintenance of
certification requirements for health information technology (IT)
developers under the ONC Health IT Certification Program (Program), the
voluntary certification of health IT for use by pediatric healthcare
providers and reasonable and necessary activities that do not
constitute information blocking. The rulemaking would also modify the
2015 Edition health IT certification criteria and Program in additional
ways to advance interoperability, enhance health IT certification, and
reduce burden and costs.
Timetable:
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Action Date FR Cite
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NPRM................................ 03/04/19 84 FR 7424
NPRM Comment Period Extended........ 04/23/19 84 FR 16834
NPRM Comment Period End............. 05/03/19
NPRM Comment Period Extended End.... 06/03/19
Final Action........................ 11/00/19
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michael Lipinski, Director, Regulatory Affairs
Division, Department of Health and Human Services, Office of the
National Coordinator for Health Information Technology, Mary E. Switzer
Building, 330 C Street SW, Washington, DC 20201, Phone: 202 690-7151.
RIN: 0955-AA01
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Proposed Rule Stage
66. 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 on a pilot basis. 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 OTC drug
monograph elements.
Timetable:
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Action Date FR Cite
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Reopening of Administrative Record.. 08/25/00 65 FR 51780
Comment Period End.................. 11/24/00
NPRM (Amendment) (Common Cold)...... 06/00/19
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Regulatory Health Project
Manager, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research, WO 22, Room
5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301
796-3713, Fax: 301 796-9899, Email: [email protected].
RIN: 0910-AF31
67. Sunscreen Drug Products for Over-the-Counter-Human Use; Tentative
Final Monograph
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 proposed rule will address the general recognition of
safety and effectiveness (GRASE) status of the 16 sunscreen monograph
ingredients and describe data gaps that FDA believes need to be filled
in order for FDA to permit the continued marketing
[[Page 29627]]
of these ingredients without submitting new drug applications for
premarket review. Consistent with the Sunscreen Innovation Act, we also
expect to address sunscreen dosage forms and maximum SPF values.
Timetable:
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Action Date FR Cite
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ANPRM (Sunscreen and Insect 02/22/07 72 FR 7941
Repellent).
ANPRM Comment Period End............ 05/23/07 .......................
NPRM (UVA/UVB)...................... 08/27/07 72 FR 49070
NPRM Comment Period End............. 12/26/07 .......................
Final Action (UVA/UVB).............. 06/17/11 76 FR 35620
NPRM (Effectiveness)................ 06/17/11 76 FR 35672
NPRM (Effectiveness) Comment Period 09/15/11 .......................
End.
ANPRM (Dosage Forms)................ 06/17/11 76 FR 35669
ANPRM (Dosage Forms) Comment Period 09/15/11 .......................
End.
NPRM................................ 02/26/19 84 FR 6204
NPRM Comment Period End............. 05/28/19 .......................
Final Action........................ 11/00/19 .......................
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Kristen Hardin, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, 10903 New Hampshire Avenue, WO 22, Room 5491, Silver Spring,
MD 20993, Phone: 240 402-4246, Fax: 301 796-9841, Email:
[email protected].
RIN: 0910-AF43
68. Mammography Quality Standards Act; Amendments to Part 900
Regulations
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 proposing to amend its regulations governing
mammography. The amendments would update the regulations issued under
the Mammography Quality Standards Act of 1992 (MQSA). 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 health care providers.
Timetable:
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Action Date FR Cite
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NPRM................................ 03/28/19 84 FR 11669
NPRM Comment Period End............. 06/26/19
Final Action........................ 10/00/20
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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 5522, Silver Spring, MD 20993, Phone: 301 796-3999, Fax: 301 847-
8145, Email: [email protected].
RIN: 0910-AH04
69. Medication Guides; Patient Medication Information
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 321 et seq.; 42 U.S.C. 262; 42 U.S.C.
264; 21 U.S.C. 371
Abstract: The proposed rule would amend FDA medication guide
regulations to require a new form of patient labeling, Patient
Medication Information, for submission to and review by the FDA for
human prescription drug products and certain blood products used,
dispensed, or administered on an outpatient basis. The proposed rule
would include requirements for Patient Medication Information
development and distribution. The proposed rule would require clear and
concisely written prescription drug product information presented in a
consistent and easily understood format to help patients use their
prescription drug products safely and effectively.
Timetable:
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Action Date FR Cite
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NPRM................................ 11/00/19
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Chris Wheeler, Supervisory Project Manager,
Department of Health and Human Services, Food and Drug Administration,
10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD
20993, Phone: 301 796-0151, Email: [email protected].
RIN: 0910-AH68
70. 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 help
consumers maintain healthy dietary practices.
Timetable:
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Action Date FR Cite
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NPRM................................ 05/00/19
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Vincent De Jesus, Nutritionist, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint
Branch Parkway, College Park, MD 20740, Phone: 240 402-1774, Fax: 301
436-1191, Email: [email protected].
RIN: 0910-AI13
71. 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. 343; 21
U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379(e)
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 and to
revoke all prior sanctioned uses. This rulemaking implements FDA's
findings that the available data demonstrate that PHOs used in food may
cause the food to be unsafe.
Timetable:
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Action Date FR Cite
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NPRM................................ 11/00/19
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Ellen Anderson, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, HFS-265,
4300
[[Page 29628]]
River Road, College Park, MD 20740, Phone: 240 402-1309, Email:
[email protected].
RIN: 0910-AI15
72. 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. 387c; 21
U.S.C. 387i; Secs 201 and 202, Pub. L. 111-31, 123 Stat. 1776; . . .
Abstract: This rule would 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 Tobacco Control Act, which amends the
Federal Cigarette Labeling and Advertising Act, the rule would 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).
Timetable:
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Action Date FR Cite
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NPRM................................ 08/00/19
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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: 301
796-3894, Fax: 301 595-1426, Email: [email protected].
RIN: 0910-AI39
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Final Rule Stage
73. 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 to 263n; 42 U.S.C. 264; 42 U.S.C.
300aa; 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 360j; 21 U.S.C. 361a; 21 U.S.C.
371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379e; 21 U.S.C. 381
Abstract: The final 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. These revisions 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. Premarketing
safety reporting requirements were finalized in a separate final rule
published on September 29, 2010 (75 FR 59961).
Timetable:
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Action Date FR Cite
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NPRM................................ 03/14/03 68 FR 12406
NPRM Comment Period Extended........ 06/18/03
NPRM Comment Period End............. 07/14/03
NPRM Comment Period Extension End... 10/14/03
Final Rule.......................... 09/00/19
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Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6278, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3469, Fax: 301
847-8440, Email: [email protected].
RIN: 0910-AA97
74. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or
Distilled Foods
E.O. 13771 Designation: Regulatory.
Legal Authority: Sec. 206 of the Food Allergen Labeling and
Consumer Protection Act; 21 U.S.C. 343(a)(1); 21 U.S.C. 321(n); 21
U.S.C. 371(a)
Abstract: This final rule would establish requirements concerning
``gluten-free'' labeling for foods that are fermented or hydrolyzed or
that contain fermented or hydrolyzed ingredients. These additional
requirements for the ``gluten-free'' labeling rule are needed to help
ensure that individuals with celiac disease are not misled and receive
truthful and accurate information with respect to fermented or
hydrolyzed foods labeled as ``gluten-free.''
Timetable:
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Action Date FR Cite
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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.......................... 09/00/19
------------------------------------------------------------------------
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
75. Topical Antimicrobial Drug Products for Over-the-Counter Human Use:
Final Monograph for Consumer Antiseptic Rub 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 and 361; 21 U.S.C. 371; 21 U.S.C. 374
and 375; 21 U.S.C. 379; 42 U.S.C. 216; 42 U.S.C. 241 and 242; 42 U.S.C.
262
Abstract: This final rule amends the 1994 tentative final monograph
(TFM) for over-the-counter (OTC) antiseptic drug products that
published in the Federal Register of June 17, 1994, (the 1994 TFM). The
final rule is part of the ongoing review of OTC drug products conducted
by FDA. In this final rule, we address whether certain active
ingredients used in OTC consumer antiseptic products intended for use
without water (referred to as consumer antiseptic rubs) are for
evaluation under the OTC Drug Review for use in consumer antiseptic rub
products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Final Rule.......................... 05/00/19
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[[Page 29629]]
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Anita Kumar, Biologist, Department of Health and
Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research, 10903 New Hampshire Avenue, Building 22, Room
5445, Silver Spring, MD 20993, Phone: 301 796-1032, Email:
[email protected].
RIN: 0910-AH97
76. Milk and Cream Product and Yogurt Products, Final Rule To
Revoke the Standards for Lowfat Yogurt and Nonfat and To Amend the
Standard for Yogurt
E.O. 13771 Designation: Deregulatory.
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 for yogurt and
revokes the standards for lowfat and nonfat yogurt. It modernizes the
standard 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
identifies that specific decisions such as the definitions and
standards of identity for dairy products are to be promulgated under
formal rulemaking provisions of 5 U.S.C. 556 and 557. Section 3(d) of
Executive Order 12866 defines regulation to exclude regulations or
rules issued in accordance with the formal rulemaking provisions of 5
U.S.C. 556 and 557; accordingly, this final rule is not subject to the
requirements of Executive Order 12866. Notwithstanding this exclusion,
and our standard practice not to include formal rulemaking in the
Unified Agenda, we have decided to include this particular rule in the
Unified Agenda in order to highlight our 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 Action........................ 09/00/19
------------------------------------------------------------------------
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
77. 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.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Regulatory 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, Email:
[email protected].
RIN: 0910-AF35
78. 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.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Amendment) (Required Warnings 12/26/06 71 FR 77314
and Other Labeling).
NPRM Comment Period End............. 05/25/07
Final Action (Required Warnings and 04/29/09 74 FR 19385
Other Labeling).
Final Action (Correction)........... 06/30/09 74 FR 31177
Final Action (Technical Amendment).. 11/25/09 74 FR 61512
-----------------------------------
NPRM (Amendment) (Acetaminophen).... To Be Determined
------------------------------------------------------------------------
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-AF36
79. Over-the-Counter (OTC) Drug Review--Laxative Drug 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. 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 rule listed will address the professional labeling for sodium
phosphate drug products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Final Action (Granular Psyllium).... 03/29/07 72 FR 14669
Final Action Effective (Granular 10/01/07
Psyllium).
[[Page 29630]]
NPRM (Professional Labeling--Sodium 02/11/11 76 FR 7743
Phosphate).
NPRM Comment Period End............. 03/14/11
-----------------------------------
Final Rule.......................... To Be Determined
------------------------------------------------------------------------
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-AF38
80. Over-the-Counter (OTC) Drug Review--Weight Control 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 finalizes the 2005 proposed rule for weight control products
containing phenylpropanolamine.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Phenylpropanolamine).......... 12/22/05 70 FR 75988
NPRM Comment Period End............. 03/22/06
NPRM (Benzocaine)................... 03/09/11 76 FR 12916
NPRM Comment Period End............. 06/07/11
-----------------------------------
Final Action (Phenylpropanolamine).. To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Janice Adams-King, Regulatory 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, Email:
[email protected].
RIN: 0910-AF45
81. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold
Products
E.O. 13771 Designation: Regulatory.
Legal Authority: 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 to address safety
and efficacy issues associated with pediatric cough and cold products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ To Be Determined
------------------------------------------------------------------------
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-AG12
82. Electronic Distribution of Prescribing Information for Human
Prescription Drugs Including Biological Products
E.O. 13771 Designation: Other.
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. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21
U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42
U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264
Abstract: This rule would require electronic package inserts for
human drug and biological prescription products with limited
exceptions, in lieu of paper, which is currently used. These inserts
contain prescribing information intended for healthcare practitioners.
This would ensure that the information accompanying the product is the
most up-to-date information regarding important safety and efficacy
issues about these products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/18/14 79 FR 75506
NPRM Comment Period Extended........ 03/09/15 80 FR 12364
NPRM Comment Period End............. 03/18/15
NPRM Comment Period Extended End.... 05/18/15
-----------------------------------
Final Rule.......................... To Be Determined
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Michael Bernstein, Supervisory Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, WO 51, Room 6240, 10903 New
Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3478,
Email: [email protected].
RIN: 0910-AG18
83. 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 to improve safety, reflect new scientific information, and
work towards harmonization with international standards. By harmonizing
with the International Electrotechnical Commission, this rule will
decrease the regulatory burden on industry and allow the Agency to take
advantage of the expertise of the international committees, thereby
also saving resources.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/22/15 80 FR 79505
NPRM Comment Period End............. 03/21/16
Final Rule.......................... 06/00/20
------------------------------------------------------------------------
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
[[Page 29631]]
84. General and Plastic Surgery Devices: Sunlamp Products
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 360j(e)
Abstract: This rule would 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.This rule would apply device
restrictions to sunlamp products.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/22/15 80 FR 79493
NPRM Comment Period End............. 03/21/16
Final Rule.......................... 06/00/20
------------------------------------------------------------------------
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-AH14
85. Combinations of Bronchodilators With Expectorants; Cold, Cough,
Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-
Counter Human Use
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. These
actions address cough/cold drug products containing an oral
bronchodilator (ephedrine and its salts) in combination with any
expectorant.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM (Amendment).................... 07/13/05 70 FR 40232
NPRM Comment Period End............. 11/10/05
Final Action (Technical Amendment).. 03/19/07 72 FR 12730
-----------------------------------
Final Rule.......................... To Be Determined
------------------------------------------------------------------------
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-AH16
86. 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.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/21
------------------------------------------------------------------------
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: 301
796-3894, Fax: 301 595-1426, Email: [email protected].
RIN: 0910-AH24
87. Testing Standards for Batteries and Battery Management Systems in
Electronic Nicotine Delivery Systems
E.O. 13771 Designation: Regulatory.
Legal Authority: 21 U.S.C. 301 et. seq.; 21 U.S.C. 371; 21 U.S.C.
387(b); 21 U.S.C. 387(g); 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................................ 05/00/20
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Darin Achilles, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Fax: 301 595-1426, Email: [email protected].
RIN: 0910-AH90
88. Administration Detention of Tobacco Products
E.O. 13771 Designation: Other.
Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371
Abstract: The Food and Drug Administration (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.
[[Page 29632]]
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/20
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Darin Achilles, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Tobacco Products, 10903 New Hampshire Avenue, Document Control Center,
Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373,
Fax: 301 595-1426, Email: [email protected].
RIN: 0910-AI05
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration (FDA)
Completed Actions
89. Label Requirement for Food That Has Been Refused Admission Into the
United States
E.O. 13771 Designation: Deregulatory.
Legal Authority: 15 U.S.C. 1453 to 1455; 21 U.S.C. 321; 21 U.S.C.
342 and 343; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 42 U.S.C.
216; 42 U.S.C. 264
Abstract: On September 18, 2008, FDA issued a proposed rule that
would have required owners or consignees to label imported food that
was refused entry into the United States. FDA does not plan to finalize
the rule.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
NPRM; Withdrawal.................... 09/28/18 83 FR 49022
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Anthony C. Taube, Phone: 240 420-4565, Fax: 703
261-8625, Email: [email protected].
RIN: 0910-AF61
90. Laser Products; Amendment to Performance Standard
E.O. 13771 Designation: Deregulatory.
Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C.
393
Abstract: On June 24, 2013, FDA issued a proposed rule that would
have amended the performance standard for laser products to achieve
closer harmonization between the current standard and the amended
International Electrotechnical Commission (IEC) standard for laser
products and medical laser products. FDA does not plan to finalize the
2013 proposal.
Completed:
------------------------------------------------------------------------
Reason Date FR Cite
------------------------------------------------------------------------
NPRM; Withdrawal.................... 11/01/18 83 FR 54891
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Erica Payne, Phone: 301 796-3999, Fax: 301 847-
8145, Email: [email protected].
RIN: 0910-AF87
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Proposed Rule Stage
91. Requirements for Long-Term Care Facilities: Regulatory Provisions
To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-
3347-P) (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 proposed rule would reform 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 would increase 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................................ 05/00/19
------------------------------------------------------------------------
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
92. CY 2020 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B (CMS-1715-P) (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, 2020. Additionally, this rule
proposes updates to the Quality Payment Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/19
------------------------------------------------------------------------
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
93. Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals; the Long-Term Care Hospital Prospective Payment System; and
FY 2020 Rates (CMS-1716-F) (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 revises the Medicare hospital
inpatient and long-term care hospital prospective payment systems for
operating and capital-related costs. This rule would 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................................ 05/03/19 84 FR 19158
NPRM Comment Period End............. 06/24/19
Final Action........................ 08/00/19
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Agency Contact: Donald Thompson, Director, Division of Acute Care,
[[Page 29633]]
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-AT73
94. CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1717-P) (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................................ 06/00/19
------------------------------------------------------------------------
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
Blvd., Baltimore, MD 21244, Phone: 410 786-9222, Email:
[email protected].
RIN: 0938-AT74
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Final Rule Stage
95. Hospital and Critical Access Hospital (CAH) Changes To Promote
Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-F)
(Rulemaking Resulting From a Section 610 Review)
E.O. 13771 Designation: Regulatory.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr
Abstract: This final rule updates the requirements that hospitals
and critical access hospitals (CAHs) must meet to participate in the
Medicare and Medicaid programs. These final requirements are intended
to conform the requirements to current standards of practice and
support improvements in quality of care, reduce barriers to care, and
reduce some issues that may exacerbate workforce shortage concerns.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/16/16 81 FR 39447
NPRM Comment Period End............. 08/15/16 .......................
Final Action--To Be Merged With 0938- 06/00/19 .......................
AS59 and 0938-AT23.
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Agency Contact: CAPT Scott Cooper, Senior Technical Advisor,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Clinical Standards and Quality, Mail Stop
S3-01-02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
9465, Email: [email protected].
RIN: 0938-AS21
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Long-Term Actions
96. Durable Medical Equipment Fee Schedule, Adjustments To Resume the
Transitional 50/50 Blended Rates To Provide Relief in Non-Competitive
Bidding Areas (CMS-1687-F) (Section 610 Review)
E.O. 13771 Designation: Fully or Partially Exempt.
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........................ 05/00/21 .......................
------------------------------------------------------------------------
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Centers for Medicare & Medicaid Services (CMS)
Completed Actions
97. CY 2019 Changes to the End-Stage Renal Disease (ESRD) Prospective
Payment System, Quality Incentive Program, Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS) (CMS-1691-F) (Completion
of a Section 610 Review)
E.O. 13771 Designation: Regulatory.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C.
1395f(b); 42 U.S.C 1395g
Abstract: This annual final rule updates the bundled payment system
for ESRD facilities by January 1, 2019. The rule also updates the
quality incentives in the ESRD program and implements changes to the
DMEPOS competitive bidding program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/19/18 83 FR 34304
NPRM Comment Period End............. 09/10/18 .......................
Final Action........................ 11/14/18 83 FR 56922
Final Action Effective.............. 01/01/19 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
[[Page 29634]]
Agency Contact: Janae James, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare, MS: C5-05-27, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-0801, Email:
[email protected].
RIN: 0938-AT28
98. CY 2019 Home Health Prospective Payment System Rate Update and CY
2020 Case-Mix Adjustment Methodology Refinements; Value-Based
Purchasing Model; Quality Reporting Requirements (CMS-1689-FC)
(Completion of a Section 610 Review)
E.O. 13771 Designation: Deregulatory.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1315a; 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................................ 07/12/18 83 FR 32340
NPRM Comment Period End............. 08/31/18 .......................
Final Action........................ 11/13/18 83 FR 56406
Comment Period End.................. 12/31/18 .......................
Final Action Effective.............. 01/01/19 .......................
------------------------------------------------------------------------
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: C5-08-28, 7500
Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0456, Email:
[email protected].
RIN: 0938-AT29
99. CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates
and Ambulatory Surgical Center Payment System Policy Changes and
Payment Rates (CMS-1695-FC) (Completion of a Section 610 Review)
E.O. 13771 Designation: Deregulatory.
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 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................................ 07/31/18 83 FR 37046
NPRM Comment Period End............. 09/24/18 .......................
Final Action........................ 11/21/18 83 FR 58818
Final Action Effective.............. 01/01/19 .......................
------------------------------------------------------------------------
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-AT30
100. CY 2019 Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Medicare Part B and the Quality Payment
Program (CMS-1693-F) (Completion of a Section 610 Review)
E.O. 13771 Designation: Deregulatory.
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, 2019. Additionally, this rule updates
the Quality Payment Program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/27/18 83 FR 35704
NPRM Comment Period End............. 09/10/18 .......................
Final Action........................ 11/23/18 83 FR 59836
Final Action Effective.............. 01/01/19 .......................
------------------------------------------------------------------------
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-AT31
[FR Doc. 2019-12004 Filed 6-21-19; 8:45 am]
BILLING CODE 4150-03-P