[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.

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

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.
------------------------------------------------------------------------
64........................  Nondiscrimination in               0945-AA11
                             Health Programs or
                             Activities.
------------------------------------------------------------------------


 Office of the National Coordinator for Health Information Technology--
                           Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
65........................  21st Century Cures Act:            0955-AA01
                             Interoperability,
                             Information Blocking, and
                             the ONC Health IT
                             Certification Program.
------------------------------------------------------------------------


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


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


[[Page 29625]]


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


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


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


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


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


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

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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/19
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/04/19  84 FR 7424
NPRM Comment Period Extended........   04/23/19  84 FR 16834
NPRM Comment Period End.............   05/03/19
NPRM Comment Period Extended End....   06/03/19
Final Action........................   11/00/19
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Reopening of Administrative Record..   08/25/00  65 FR 51780
Comment Period End..................   11/24/00
NPRM (Amendment) (Common Cold)......   06/00/19
------------------------------------------------------------------------

    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:

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

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/28/19  84 FR 11669
NPRM Comment Period End.............   06/26/19
Final Action........................   10/00/20
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Erica Payne, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, 
Room 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/19
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/19
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/19
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/19
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/14/03  68 FR 12406
NPRM Comment Period Extended........   06/18/03
NPRM Comment Period End.............   07/14/03
NPRM Comment Period Extension End...   10/14/03
Final Rule..........................   09/00/19
------------------------------------------------------------------------

    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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/18/15  80 FR 71990
NPRM Comment Period Reopened........   01/22/16  81 FR 3751
NPRM Comment Period End.............   02/16/16
NPRM Comment Period Reopened End....   02/22/16
NPRM Comment Period Reopened........   02/23/16  81 FR 8869
NPRM Comment Period Reopened End....   04/25/16
Final Rule..........................   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
------------------------------------------------------------------------


[[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