[Federal Register Volume 81, Number 111 (Thursday, June 9, 2016)]
[Proposed Rules]
[Pages 37294-37306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12904]



[[Page 37293]]

Vol. 81

Thursday,

No. 111

June 9, 2016

Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

  Federal Register / Vol. 81 , No. 111 / Thursday, June 9, 2016 / 
Unified Agenda  

[[Page 37294]]


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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 
(EO) 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: Wilma Robinson, Deputy 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 rulemaking activities that the Department 
expects to undertake in the foreseeable future to advance this mission. 
The Agenda furthers several Departmental goals, including strengthening 
health care; advancing scientific knowledge and innovation; advancing 
the health, safety, and well-being of the American people; increasing 
efficiency, transparency, and accountability of HHS programs; and 
strengthening the nation's health and human services infrastructure and 
workforce.
    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.

 Wilma Robinson,
Deputy Executive Secretary to the Department.

                Office for Civil Rights--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
104.......................  Nondiscrimination Under            0945-AA02
                             the Patient Protection
                             and Affordable Care Act.
------------------------------------------------------------------------


 Office of the National Coordinator for Health Information Technology--
                           Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
105.......................  ONC Health IT                      0955-AA00
                             Certification Program:
                             Enhanced Oversight and
                             Accountability.
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                       Regulation
      Sequence No.                  Title            Identifier No.
---------------------------------------------------------------------
106.....................  Over-the-Counter (OTC)           0910-AF31
                           Drug Review--Cough/Cold
                           (Antihistamine)
                           Products.
107.....................  Over-the-Counter (OTC)           0910-AF69
                           Drug Review--Topical
                           Antimicrobial Drug
                           Products.
108.....................  Updated Standards for            0910-AG09
                           Labeling of Pet Food.
109.....................  Format and Content of            0910-AG96
                           Reports Intended to
                           Demonstrate Substantial
                           Equivalence.
110.....................  Mammography Quality              0910-AH04
                           Standards Act;
                           Regulatory Amendments.
111.....................  Investigational New Drug         0910-AH07
                           Application Annual
                           Reporting.
112.....................  Requirements for Tobacco         0910-AH22
                           Product Manufacturing
                           Practice.
113.....................  Use of Ozone Depleting           0910-AH36
                           Substances (Section 610
                           Review).
------------------------------------------------------------------------


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
114.......................  Requirements for Foreign           0910-AA49
                             and Domestic
                             Establishment
                             Registration and Listing
                             for Human Drugs,
                             Including Drugs That Are
                             Regulated Under a
                             Biologics License
                             Application, and Animal
                             Drugs.
115.......................  Postmarketing Safety               0910-AA97
                             Reporting Requirements
                             for Human Drug and
                             Biological Products.
116.......................  Medical Gas Containers and         0910-AC53
                             Closures; Current Good
                             Manufacturing Practice
                             Requirements.

[[Page 37295]]

 
117.......................  Food Labeling: Revision of         0910-AF22
                             the Nutrition and
                             Supplement Facts Labels.
118.......................  Food Labeling: Serving             0910-AF23
                             Sizes of Foods That Can
                             Reasonably Be Consumed At
                             One Eating Occasion; Dual-
                             Column Labeling;
                             Updating, Modifying, and
                             Establishing Certain
                             RACCs.
119.......................  Abbreviated New Drug               0910-AF97
                             Applications and
                             505(b)(2).
120.......................  ``Tobacco Products''               0910-AG38
                             Subject to the Federal
                             Food, Drug, and Cosmetic
                             Act, as Amended by the
                             Family Smoking Prevention
                             and Tobacco Control Act.
121.......................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Investigations
                             for Medical Devices.
122.......................  Focused Mitigation                 0910-AG63
                             Strategies To Protect
                             Food Against Intentional
                             Adulteration.
123.......................  Supplemental Applications          0910-AG94
                             Proposing Labeling
                             Changes for Approved
                             Drugs and Biological
                             Products.
124.......................  Food Labeling; Gluten-Free         0910-AH00
                             Labeling of Fermented,
                             Hydrolyzed, or Distilled
                             Foods.
125.......................  General and Plastic                0910-AH14
                             Surgery Devices: Sunlamp
                             Products.
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
126.......................  Laser Products; Amendment          0910-AF87
                             to Performance Standard.
127.......................  Requirements for the               0910-AG59
                             Testing and Reporting of
                             Tobacco Product
                             Constituents,
                             Ingredients, and
                             Additives.
128.......................  Radiology Devices;                 0910-AH03
                             Designation of Special
                             Controls for the Computed
                             Tomography X-Ray System.
129.......................  Regulations on Human Drug          0910-AH10
                             Compounding Under
                             Sections 503A and 503B of
                             the Federal Food, Drug,
                             and Cosmetic Act.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
130.......................  Standards for the Growing,         0910-AG35
                             Harvesting, Packing, and
                             Holding of Produce for
                             Human Consumption.
131.......................  Foreign Supplier                   0910-AG64
                             Verification Program.
132.......................  Sanitary Transportation of         0910-AG98
                             Human and Animal Food.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
133.......................  Hospital and Critical              0938-AS21
                             Access Hospital (CAH)
                             Changes to Promote
                             Innovation, Flexibility,
                             and Improvement in
                             Patient Care (CMS-3295-P)
                             (Rulemaking Resulting
                             From a Section 610
                             Review).
134.......................  Merit-Based Incentive              0938-AS69
                             Payment System (MIPS) and
                             Alternative Payment
                             Models (APMs) in Medicare
                             Fee-for-Service (CMS-5517-
                             P) (Section 610 Review).
135.......................  Hospital Inpatient                 0938-AS77
                             Prospective Payment
                             System for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and FY 2017 Rates
                             (CMS-1655-F) (Section 610
                             Review).
136.......................  CY 2017 Home Health                0938-AS80
                             Prospective Payment
                             System Rate Update; Home
                             Health Value-Based
                             Purchasing Model; and
                             Home Health Quality
                             Reporting Requirements
                             (Section 610 Review).
137.......................  CY 2017 Revisions to               0938-AS81
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1654-P)
                             (Section 610 Review).
138.......................  CY 2017 Hospital                   0938-AS82
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1656-
                             P) (Section 610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
139.......................  Emergency Preparedness             0938-AO91
                             Requirements for Medicare
                             and Medicaid
                             Participating Providers
                             and Suppliers (CMS-3178-
                             F) (Section 610 Review).
140.......................  Reform of Requirements for         0938-AR61
                             Long-Term Care Facilities
                             (CMS-3260-F) (Rulemaking
                             Resulting From a Section
                             610 Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
141.......................  Conditions of                      0938-AG81
                             Participation for Home
                             Health Agencies (CMS-3819-
                             F) (Rulemaking Resulting
                             From a Section 610
                             Review).

[[Page 37296]]

 
142.......................  Medicare Clinical                  0938-AS33
                             Diagnostic Laboratory
                             Test Payment System (CMS-
                             1621-F) (Section 610
                             Review).
143.......................  Imaging Accreditation (CMS-        0938-AS62
                             3309-P) (Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
144.......................  Covered Outpatient Drugs           0938-AQ41
                             (CMS-2345-FC) (Completion
                             of a Section 610 Review).
145.......................  CY 2016 Revisions to               0938-AS40
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1631-FC)
                             (Completion of a Section
                             610 Review).
146.......................  CY 2016 Hospital                   0938-AS42
                             Outpatient PPS Policy
                             Changes and Payment Rates
                             and Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1633-
                             FC) (Completion of a
                             Section 610 Review).
147.......................  Comprehensive Care for             0938-AS64
                             Joint Replacement (CMS-
                             5516-F) (Completion of a
                             Section 610 Review).
------------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Office for Civil Rights (OCR)

Final Rule Stage

104. Nondiscrimination Under the Patient Protection and Affordable Care 
Act

    Legal Authority: 42 U.S.C. 18116
    Abstract: This final rule implements prohibitions against 
discrimination on the basis of race, color, national origin, sex, age, 
and disability as provided in section 1557 of the Affordable Care Act. 
Section 1557 provides protection from discrimination in health programs 
and activities of covered entities. This section also identifies 
additional forms of Federal financial assistance to which the section 
will apply.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/08/15  80 FR 54172
NPRM Comment Period End.............   11/09/15
Final Action........................   05/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Eileen Hanrahan, Senior Civil Rights Analyst, 
Department of Health and Human Services, Office for Civil Rights, 200 
Independence Avenue SW., Washington, DC 20201, Phone: 202 205-4925, 
Email: [email protected].
    RIN: 0945-AA02

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

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

Proposed Rule Stage

105.  ONC Health IT Certification Program: Enhanced Oversight 
and Accountability

    Legal Authority: Not Yet Determined
    Abstract: The rulemaking introduces modifications and new 
requirements under the ONC Health IT Certification Program 
(``Program''), including provisions related to the Office of the 
National Coordinator for Health Information Technology (ONC)'s role in 
the Program. The proposed rule proposes to establish processes for ONC 
to directly review health IT certified under the Program and take 
action when necessary, including requiring the correction of non-
conformities found in health IT certified under the Program and 
suspending and terminating certifications issued to Complete EHRs and 
Health IT Modules. The proposed rule includes processes for ONC to 
authorize and oversee accredited testing laboratories under the 
Program. It also includes a provision for the increased transparency 
and availability of surveillance results.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/02/16  81 FR 11056
NPRM Comment Period End.............   05/02/16  .......................
Final Action........................   10/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michael Lipinski, Policy Analyst, Department of 
Health and Human Services, Office of the National Coordinator for 
Health Information Technology, Room 729D, Hubert H. Humphrey Building, 
200 Independence Avenue SW., Washington, DC 20201, Phone: 202 690-7151.
    RIN: 0955-AA00

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

106. Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) 
Products

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: FDA will be proposing a rule to add the common cold 
indication to certain over-the-counter (OTC) antihistamine active 
ingredients. This proposed rule is the result of collaboration under 
the U.S.-Canada Regulatory Cooperation Council (RCC) 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)......   01/00/17
------------------------------------------------------------------------


[[Page 37297]]

    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

107. Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug 
Products

    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. This 
action addresses antimicrobial agents in consumer antiseptic hand wash.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Healthcare)...................   06/17/94  59 FR 31402
Comment Period End..................   12/15/95
NPRM (Consumer Hand Wash Products)..   12/17/13  78 FR 76443
NPRM (Consumer Hand Wash) Comment      06/16/14
 Period End.
NPRM (Healthcare Antiseptic)........   05/01/15  80 FR 25166
NPRM Comment Period End (Healthcare    10/28/15
 Antiseptic).
NPRM (Consumer Hand Rub)............   06/00/16
Final Rule (Consumer Hand Wash).....   09/00/16
------------------------------------------------------------------------

    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-AF69

108. Updated Standards for Labeling of Pet Food

    Legal Authority: 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 110-85, sec 
1002(a)(3)
    Abstract: FDA is proposing updated standards for the labeling of 
pet food that include nutritional and ingredient information, as well 
as style and formatting standards. FDA is taking this action to provide 
pet owners and animal health professionals more complete and consistent 
information about the nutrient content and ingredient composition of 
pet food products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: William Burkholder, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, MPN-4, Room 2642, HFV-228, 7519 
Standish Place, Rockville, MD 20855, Phone: 240 402-5900, Email: 
[email protected].
    RIN: 0910-AG09

109. Format and Content of Reports Intended To Demonstrate Substantial 
Equivalence

    Legal Authority: 21 U.S.C. 387e(j); 21 U.S.C. 387j(a); secs 905(j) 
and 910(a) of the Federal Food, Drug, and Cosmetic Act
    Abstract: This regulation would establish the format and content of 
reports intended to demonstrate substantial equivalence. This 
regulation also would provide information as to how the Agency will 
review and act on these submissions.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Annette L. Marthaler, Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Tobacco Products, Document Control Center, Building 71, Room 
G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 
287-1373, Fax: 877 287-1426, Email: [email protected].
    RIN: 0910-AG96

110. Mammography Quality Standards Act; Regulatory Amendments

    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................................   08/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nancy Pirt, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: [email protected].
    RIN: 0910-AH04

111. Investigational New Drug Application Annual Reporting

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 
U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355(i); 21 U.S.C. 371(a); 42 
U.S.C. 262(a)
    Abstract: This proposed rule would revise the requirements 
concerning annual reports submitted to investigational new drug 
applications (INDs) by replacing the current annual reporting 
requirement with a requirement that is generally consistent with the 
format, content, and timing of submission of the development safety 
update report devised by the International Conference on Harmonization 
of Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH).
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ebla Ali Ibrahim, Project Manager, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug

[[Page 37298]]

Evaluation and Research, Building 51, Room 6302, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-3691, Email: [email protected].
    RIN: 0910-AH07

112. Requirements for Tobacco Product Manufacturing Practice

    Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387b; 21 U.S.C. 387f
    Abstract: FDA is proposing requirements that govern the methods 
used in, and the facilities and controls used for, the pre-production 
design validation, manufacture, packing, and storage of tobacco 
products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   03/19/13  78 FR 16824
ANPRM Comment Period End............   05/20/13  .......................
NPRM................................   12/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Darin Achilles, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 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-AH22

113.  Use of Ozone Depleting Substances (Section 610 Review)

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 335; 21 
U.S.C. 342; 21 U.S.C. 346a; 21 U.S.C. 348; 21 U.S.C. 351; 21 U.S.C. 
352; 21 U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 361; 21 U.S.C. 371; 21 
U.S.C. 372; 21 U.S.C. 374; 15 U.S.C. 402; 15 U.S.C. 409
    Abstract: The Food and Drug Administration (FDA or the Agency) is 
proposing to amend its regulation (21 CFR 2.125) on uses of ozone-
depleting substances (ODSs), including chlorofluorocarbons (CFCs), to 
remove designations for certain products as essential uses under the 
Clean Air Act. Essential-use products are exempt from FDA's ban on the 
use of CFC propellants in FDA-regulated products and the Environmental 
Protection Agency's (EPA's) ban on the use of CFCs and other ODSs in 
pressurized dispensers. This action, if finalized, will remove 
essential use exemptions for sterile aerosol talc administered 
intrapleurally by thoracoscopy for human use, metered-dose atropine 
sulfate aerosol human drugs administered by oral inhalation, and 
anesthetic drugs for topical use on accessible mucous membranes of 
humans where a cannula is used for application. FDA is proposing this 
action because alternative products that do not use ODSs are now 
available and because these products are no longer being marketed in 
approved versions that contain ODSs. On June 29, 2015, FDA published a 
notice and request for comment concerning its tentative conclusion that 
these products are no longer an essential use under the Clean Air Act 
(80 FR 36937). The Agency received no comments concerning removal of 
essential use designations for sterile aerosol talc and metered-dose 
atropine sulfate, and is proposing to remove these designations by 
direct final rule and a companion proposed rule in the event adverse 
comments are received. FDA received one comment concerning removal of 
anesthetic drugs for topical use in response to its 2015 notice and 
request for comment, and is proposing to remove this exemption through 
a separate notice. Because these products are not currently sold in the 
approved form, no significant economic impact is anticipated.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Daniel Orr, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Building 51 
Room 5199, 10993 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 
240 402-0979, Email: [email protected].
    RIN: 0910-AH36

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

114. Requirements for Foreign and Domestic Establishment Registration 
and Listing for Human Drugs, Including Drugs That Are Regulated Under a 
Biologics License Application, and Animal Drugs

    Legal Authority: 21 U.S.C. 321 and 331; 21 U.S.C. 351 to 353; 21 
U.S.C. 355 to 356c; 21 U.S.C. 360 and 360b; 21 U.S.C. 360c to 360f; 21 
U.S.C. 360h to 360j; 21 U.S.C. 371 and 374; 21 U.S.C. 379e and 381; 21 
U.S.C. 393; 15 U.S.C. 1451 to 1561; 42 U.S.C. 262 and 264; 42 U.S.C. 
271; and sec 122; Pub. L. 105-115, 11 Stat. 2322 (21 U.S.C. 355 note)
    Abstract: The rule will reorganize, consolidate, clarify, and 
modify current regulations concerning who must register establishments 
and list human drugs, including certain biological drugs, and animal 
drugs. These regulations contain information on when, how, and where to 
register drug establishments and list drugs, and what information must 
be submitted. They also address National Drug Codes.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/29/06  71 FR 51276
NPRM Comment Period End.............   02/26/07  .......................
Final Action........................   07/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Joy, Senior Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, 
Room 6254, Silver Spring, MD 20993, Phone: 301 796-2242, Email: 
[email protected].
    RIN: 0910-AA49

115. Postmarketing Safety Reporting Requirements for Human Drug and 
Biological Products

    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 expedited 
and periodic safety reporting regulations for human drugs and 
biological products to revise certain definitions and reporting formats 
as recommended by the International Conference on Harmonisation and to 
define new terms; to add to or revise current reporting requirements; 
to revise certain reporting time frames; and to propose other revisions 
to these regulations to 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. 
FDA plans to finalize the premarket and postmarket safety reporting 
requirements in separate final rules. Premarketing safety reporting 
requirements were finalized in a separate final rule published on

[[Page 37299]]

September 29, 2010 (75 FR 59961). This final rule applies to 
postmarketing safety reporting requirements.
    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 Action........................   03/00/17  .......................
------------------------------------------------------------------------

    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 6362, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3469, Fax: 301 
847-8440, Email: [email protected].
    RIN: 0910-AA97

116. Medical Gas Containers and Closures; Current Good Manufacturing 
Practice Requirements

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351 to 21 U.S.C. 353
    Abstract: The Food and Drug Administration is amending its current 
good manufacturing practice regulations and other regulations to 
clarify and strengthen requirements for the label, color, dedication, 
and design of medical gas containers and closures. Despite existing 
regulatory requirements and industry standards for medical gases, there 
have been repeated incidents in which cryogenic containers of harmful 
industrial gases have been connected to medical oxygen supply systems 
in hospitals and nursing homes and subsequently administered to 
patients. These incidents have resulted in death and serious injury. 
There have also been several incidents involving high-pressure medical 
gas cylinders that have resulted in death and injuries to patients. 
These amendments, together with existing regulations, are intended to 
ensure that the types of incidents that have occurred in the past, as 
well as other types of foreseeable and potentially deadly medical gas 
accidents, do not occur in the future. FDA has described a number of 
proposals in the proposed rule including requiring that gas use outlet 
connections on portable cryogenic medical gas containers be securely 
attached to the valve body.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/10/06  71 FR 18039
NPRM Comment Period End.............   07/10/06  .......................
Final Action........................   07/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Patrick Raulerson, Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3522, Fax: 301 
847-8440, Email: [email protected].
    RIN: 0910-AC53

117. Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
    Abstract: FDA is amending the labeling regulations for conventional 
foods and dietary supplements to provide updated nutrition information 
on the label to assist consumers in maintaining healthy dietary 
practices. The rule would modernize the nutrition information found on 
the Nutrition Facts label, as well as the format and appearance of the 
label. On July 27, 2015, FDA issued a supplemental notice of proposed 
rulemaking accepting comments on limited additional provisions until 
October 13, 2015. Also on July 27, 2015, FDA reopened the comment 
period on the proposed rule as to specific documents until September 
25, 2015. In addition, in response to requests for the raw data related 
to FDA's consumer studies on the nutrition label, FDA issued a notice 
on September 10, 2015 to make the raw data available for comment until 
October 13, 2015 and extended the comment period for the July 27, 2015 
reopening as to specific documents to October 13, 2015. On October 20, 
2015, FDA extended the comment period for the consumer studies and the 
supplemental proposal to October 23, 2015.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   07/11/03  68 FR 41507
ANPRM Comment Period End............   10/09/03  .......................
Second ANPRM........................   04/04/05  70 FR 17008
Second ANPRM Comment Period End.....   06/20/05  .......................
Third ANPRM.........................   11/02/07  72 FR 62149
Third ANPRM Comment Period End......   01/31/08  .......................
NPRM................................   03/03/14  79 FR 11879
NPRM Comment Period End.............   06/02/14  .......................
Reopening of Comment Period as to      07/27/15  80 FR 44302
 Specific Documents.
NPRM Comment Period End as to          09/25/15  .......................
 Specific Documents.
Supplemental NPRM to Solicit Comment   07/27/15  80 FR 44303
 on Limited Additional Provisions.
Supplemental NPRM to Solicit Comment   10/13/15  .......................
 on Limited Additional Provisions
 Comment Period End.
Administrative Docket Update;          09/10/15  80 FR 54446
 Extension of Comment Period.
Administrative Docket Update;          10/13/15  .......................
 Comment Period End.
NPRM Reopening of Comment Period for   10/20/15  80 FR 63477
 Certain Documents.
NPRM Reopening of Comment Period for   10/23/15  .......................
 Certain Documents Comment Period
 End.
Final Action........................   05/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Food Safety and Applied Nutrition, HFS-830, 5100 Paint 
Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Email: 
[email protected].
    RIN: 0910-AF22

118. Food Labeling: Serving Sizes of Foods That Can Reasonably Be 
Consumed at One Eating Occasion; Dual--Column Labeling; Updating, 
Modifying, and Establishing Certain RACCS

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371; Pub. 
L. 101-535, sec 2(b)(1)(A)
    Abstract: FDA is amending its labeling regulations for foods to 
provide update, modify, and establish Reference Amounts Customarily 
Consumed (RACCs) for certain food categories. This

[[Page 37300]]

rule would provide consumers with nutrition information based on the 
amount of food that is customarily consumed, which would assist 
consumers in maintaining healthy dietary practices. In addition to 
updating, modifying, and establishing certain RACCs, FDA is amending 
the definition of a single-serving containers; amending the label 
serving size for breath mints; and providing for dual-column labeling 
under certain circumstances, which would provide nutrition information 
per serving and per container or unit, as applicable; and making 
technical amendments to various aspects fo the serving size 
regulations.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   04/04/05  70 FR 17010
ANPRM Comment Period End............   06/20/05  .......................
NPRM/Comment Period Extended........   03/03/14  79 FR 11989
NPRM Comment Period End.............   06/02/14  .......................
NPRM Comment Period Extended........   05/27/14  79 FR 29699
NPRM Comment Period End.............   08/01/14  .......................
Final Action........................   05/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Cherisa Henderson, Nutritionist, Department of 
Health and Human Services, Food and Drug Administration, HFS-830, 5100 
Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Fax: 
301 436-1191, Email: [email protected].
    RIN: 0910-AF23

119. Abbreviated New Drug Applications and 505(B)(2)

    Legal Authority: Pub. L. 108-173, title XI; 21 U.S.C. 355; 21 
U.S.C. 371
    Abstract: This proposed rule would make changes to certain 
procedures for Abbreviated New Drug Applications and related 
applications to patent certifications, notice to patent owners and 
application holders, the availability of a 30-month stay of approval, 
amendments and supplements, and the types of bioavailability and 
bioequivalence data that can be used to support these applications.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/06/15  80 FR 6802
NPRM Comment Period End.............   05/07/15  .......................
NPRM Comment Period Extended........   04/24/15  80 FR 22953
NPRM Comment Period Extended End....   06/08/15  .......................
Final Action........................   08/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, Building 51, Room 6268, 10903 
New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-
3601, Fax: 301 847-8440, Email: [email protected].
    RIN: 0910-AF97

120. ``Tobacco Products'' Subject to the Federal Food, Drug, and 
Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco 
Control Act

    Legal Authority: 21 U.S.C. 301 et seq.; The Federal Food, Drug, and 
Cosmetic Act; Pub. L. 111-31; The Family Smoking Prevention and Tobacco 
Control Act
    Abstract: The Family Smoking Prevention and Tobacco Control Act 
(Tobacco Control Act) provides the Food and Drug Administration (FDA) 
authority to regulate cigarettes, cigarette tobacco, roll-your-own 
tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic 
Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to 
issue regulations deeming other tobacco products to be subject to the 
FD&C Act. This rule would deem additional products meeting the 
statutory definition of ``tobacco product'' to be subject to the FD&C 
Act, and would specify additional restrictions.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/25/14  79 FR 23142
NPRM Comment Period End.............   07/09/14  .......................
NPRM Comment Period Extended........   06/24/14  79 FR 35711
NPRM Comment Period Extended End....   08/08/14  .......................
Final Action........................   05/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gerie Voss, Senior Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Tobacco Products, Document Control Center, Building 71, Room G335, 
10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-
1373, Fax: 301 595-1426, Email: [email protected].
    RIN: 0910-AG38

121. Human Subject Protection; Acceptance of Data From Clinical 
Investigations for Medical Devices

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 
U.S.C. 352; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360e; 21 U.S.C. 
360i; 21 U.S.C. 360j; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 21 
U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 271; . . .
    Abstract: This rule will amend FDA's regulations on acceptance of 
data for medical devices to require that clinical investigations 
submitted in support of a premarket approval application, humanitarian 
device exemption application, an investigational device exemption 
application, or a premarket notification submission be conducted in 
accordance with good clinical practice if conducted outside the United 
States.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/25/13  78 FR 12664
NPRM Comment Period End.............   05/28/13  .......................
Final Action........................   05/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Soma Kalb, Biomedical Engineer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, Building 66, Room 1534, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-6359, Email: 
[email protected].
    RIN: 0910-AG48

122. Focused Mitigation Strategies To Protect Food Against Intentional 
Adulteration

    Legal Authority: 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350g; 21 
U.S.C. 350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub. L. 111-353
    Abstract: This rule would require domestic and foreign food 
facilities that are required to register under the Federal Food, Drug, 
and Cosmetic Act to address hazards that may be intentionally 
introduced by acts of terrorism. These food facilities would be 
required to identify and implement focused mitigation strategies to 
significantly minimize or prevent significant vulnerabilities 
identified at actionable process steps in a food operation.

[[Page 37301]]

    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/24/13  78 FR 78014
NPRM Comment Period Extended........   03/25/14  79 FR 16251
NPRM Comment Period End.............   03/31/14
NPRM Comment Period Extended End....   06/30/14
Final Rule..........................   06/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jody Menikheim, Supervisory General Health 
Scientist, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-005), 
5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1864, 
Fax: 301 436-2633, Email: [email protected].
    RIN: 0910-AG63

123. Supplemental Applications Proposing Labeling Changes for Approved 
Drugs and Biological Products

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 
U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; . . .
    Abstract: This rule would amend the regulations regarding new drug 
applications (NDAs), abbreviated new drug applications (ANDAs), and 
biologics license application (BLAs) to revise and clarify procedures 
for changes to the labeling of an approved drug to reflect certain 
types of newly acquired information in advance of FDA's review of such 
change.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/13/13  78 FR 67985
NPRM Comment Period Extended........   12/27/13  78 FR 78796
NPRM Comment Period End.............   01/13/14
NPRM Comment Period Extended End....   03/13/14
NPRM Comment Period Reopened........   02/18/15  80 FR 8577
NPRM Comment Period Reopened End....   04/27/15
Final Rule..........................   04/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, Building 51, Room 6268, 10903 
New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-
3601, Fax: 301 847-8440, Email: [email protected].
    RIN: 0910-AG94

124. Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or 
Distilled Foods

    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 proposed rule would establish requirements 
concerning compliance for using a ``gluten-free'' labeling claim for 
those foods for which there is no scientifically valid analytical 
method available that can reliably detect and accurately quantify the 
presence of 20 parts per million (ppm) gluten in the food.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/18/15  80 FR 71990
NPRM Comment Period Reopened........   02/16/16  81 FR 3751
Comment Period Extended.............   02/22/16  81 FR 8869
Final Action........................   04/00/17
------------------------------------------------------------------------

    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, 5100 Paint Branch 
Parkway, College Park, MD 20740, Phone: 240 402-2371, Fax: 301 436-
2636, Email: [email protected].
    RIN: 0910-AH00

125. General and Plastic Surgery Devices: Sunlamp Products

    Legal Authority: 21 U.S.C. 360j(e)
    Abstract: This proposed 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 Action........................   11/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ian Ostermiller, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Building 66 
Room 5515, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 
301 796-5678, Email: [email protected].
    RIN: 0910-AH14

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

126. Laser Products; Amendment to Performance Standard

    Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 
393
    Abstract: FDA is proposing to amend the 2013 proposed rule for the 
performance standard for laser products, which will amend the 
performance standard for laser products to achieve closer harmonization 
between the current standard and the recently amended International 
Electrotechnical Commission (IEC) standard for laser products and 
medical laser products. The amendment is intended to update FDA's 
performance standard to reflect advancements in technology.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/24/13  78 FR 37723
NPRM Comment Period End.............   09/23/13
NPRM (Reproposal)...................   06/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Erica Blake, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, WO 66, Room 4426, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: [email protected].
    RIN: 0910-AF87

127. Requirements for the Testing and Reporting of Tobacco Product 
Constituents, Ingredients, and Additives

    Legal Authority: 21 U.S.C. 301 et seq.; 21 U.S.C. 387; The Family 
Smoking Prevention and Tobacco Control Act
    Abstract: The Federal Food, Drug, and Cosmetic Act, as amended by 
the Family Smoking Prevention and Tobacco Control Act, requires the 
Food and Drug Administration to promulgate regulations that require the 
testing and reporting of tobacco product constituents, ingredients, and 
additives, including smoke constituents, that the

[[Page 37302]]

Agency determines should be tested to protect the public health.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Laura Rich, Senior Regulatory Counsel, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Tobacco Products, Building 71, G335, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993, Phone: 877 287-1373, Email: 
[email protected].
    RIN: 0910-AG59

128. Radiology Devices; Designation of Special Controls for the 
Computed Tomography X-Ray System

    Legal Authority: 21 U.S.C. 360c
    Abstract: The proposed rule would establish special controls for 
the computed tomography (CT) X-ray system. A CT X-ray system is a 
diagnostic X-ray imaging system intended to produce cross-sectional 
images of the body through use of a computer to reconstruct an image 
from the same axial plane taken at different angles. High doses of 
ionizing radiation can cause acute (deterministic) effects such as 
burns, reddening of the skin, cataracts, hair loss, sterility, and, in 
extremely high doses, radiation poisoning. The design of a CT X-ray 
system should balance the benefits of the device (i.e., the ability of 
the device to produce a diagnostic quality image) with the known risks 
(e.g., exposure to ionizing radiation). FDA is establishing proposed 
special controls, which are necessary to provide reasonable assurance 
of the safety and effectiveness of a class II CT X-ray system.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Erica Blake, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, WO 66, Room 4426, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: [email protected].
    RIN: 0910-AH03

129. Regulations on Human Drug Compounding Under Sections 503A and 503B 
of the Federal Food, Drug, and Cosmetic Act

    Legal Authority: 21 U.S.C. 353a; 21 U.S.C. 353b; 21 U.S.C. 371
    Abstract: FDA will propose regulations to define and implement 
certain statutory conditions under which compounded products may 
qualify for exemptions from certain requirements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/17
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sarah Rothman, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, Building 51, Room 5197, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 796-3536, Email: 
[email protected].
    RIN: 0910-AH10

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

130. Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption

    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42 
U.S.C. 264; Pub. L. 111-353 (signed on January 4, 2011)
    Abstract: This rule will establish science-based minimum standards 
for the safe production and harvesting of those types of fruits and 
vegetables that are raw agricultural commodities for which the 
Secretary has determined that such standards minimize the risk of 
serious adverse health consequences or death. The purpose of the rule 
is to reduce the risk of illness associated with fresh produce.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/16/13  78 FR 3503
NPRM Comment Period End.............   05/16/13
NPRM Comment Period Extended........   04/26/13  78 FR 24692
NPRM Comment Period Extended End....   09/16/13
NPRM Comment Period Extended........   08/09/13  78 FR 48637
NPRM Comment Period Extended End....   11/15/13
Notice of Intent To Prepare an         08/19/13  78 FR 50358
 Environmental Impact Statement for
 the Proposed Rule.
Notice of Intent To Prepare            11/15/13
 Environmental Impact Statement for
 the Proposed Rule Comment Period
 End.
NPRM Comment Period Extended........   11/20/13  78 FR 69605
NPRM Comment Period Extended End....   11/22/13
Environmental Impact Statement for     03/11/14  79 FR 13593
 the Proposed Rule; Comment Period
 Extended.
Environmental Impact Statement for     04/18/14
 the Proposed Rule; Comment Period
 Extended End.
Supplemental NPRM...................   09/29/14  79 FR 58433
Supplemental NPRM Comment Period End   12/15/14
Final Action--Draft Environmental      01/14/15  80 FR 1852
 Impact Statement.
Final Action--Draft Environmental      03/13/15
 Impact Statement Comment Period End.
Final Action Effective..............   01/26/16
Final Rule..........................   11/27/15  80 FR 74353
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Food Safety and Applied Nutrition, Office of Food Safety, 
5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636, 
Email: [email protected].
    RIN: 0910-AG35

[[Page 37303]]

131. Foreign Supplier Verification Program

    Legal Authority: 21 U.S.C. 384a; title III, sec 301 of FDA Food 
Safety Modernization Act; Pub. L. 111-353, establishing sec 805 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act)
    Abstract: This rule describes what a food importer must do to 
verify that its foreign suppliers produce food that is as safe as food 
produced in the United States. FDA is taking this action to improve the 
safety of food that is imported into the United States.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/29/13  78 FR 45729
NPRM Comment Period End.............   11/26/13
NPRM Comment Period Extended........   11/20/13  78 FR 69602
NPRM Comment Period Extended End....   01/27/14
Supplemental NPRM...................   09/29/14  79 FR 58573
Supplemental NPRM Comment Period End   12/15/14
Final Rule..........................   11/27/15  80 FR 74225
Final Rule Effective................   01/27/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian L. Pendleton, Senior Policy Advisor, 
Department of Health and Human Services, Food and Drug Administration, 
Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email: 
[email protected].
    RIN: 0910-AG64

132. Sanitary Transportation of Human and Animal Food

    Legal Authority: 21 U.S.C. 350e; 21 U.S.C. 373; 21 U.S.C. 331; 21 
U.S.C. 342; 21 U.S.C. 371; . . .
    Abstract: This rule would establish requirements for parties 
including shippers, carriers by motor vehicle or rail vehicle, and 
receivers engaged in the transportation of food, including food for 
animals, to use sanitary transportation practices to ensure that food 
is not transported under conditions that may render the food 
adulterated.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   04/30/10  75 FR 22713
ANPRM Comment Period End............   08/30/10
NPRM................................   02/05/14  79 FR 7005
NPRM Comment Period Extended........   05/23/14  79 FR 29699
NPRM Comment Period End.............   05/31/14
NPRM Comment Period Extended End....   07/30/14
Final Rule..........................   04/06/16  81 FR 20092
Final Rule Effective................   06/06/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, Office of 
Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 
240 402-2022, Fax: 301 346-2632, Email: [email protected].
    RIN: 0910-AG98

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

133. Hospital and Critical Access Hospital (CAH) Changes to Promote 
Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) 
(Rulemaking Resulting From a Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr
    Abstract: This proposed rule would update the requirements that 
hospitals and Critical Access Hospitals (CAHs) must meet to participate 
in the Medicare and Medicaid programs. These proposals are intended to 
conform the requirements to current standards of practice and to 
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................................   05/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: CDR 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

134. Merit-Based Incentive Payment System (MIPS) and Alternative 
Payment Models (APMS) in Medicare Fee-For-Service (CMS-5517-P) (Section 
610 Review)

    Legal Authority: Pub. L. 114-10, sec 101
    Abstract: This proposed rule would implement provisions of the 
Medicare Access and CHIP Reauthorization Act (MACRA) related to MIPS 
and APMs. Section 101 of MACRA authorizes a new MIPS, which repeals the 
Medicare sustainable growth rate and improves Medicare payments for 
physician services. MACRA consolidates the current programs of the 
Physician Quality Reporting System, the Value-Based Modifier, and the 
Electronic Health Records Incentive Program into one program, MIPS, 
that streamlines and improves on the three distinct incentive programs. 
Additionally, MACRA authorizes incentive payments for providers who 
participate in eligible APMs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/09/16  81 FR 28161
NPRM Comment Period End.............   06/27/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: James Sharp, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare & Medicaid Innovation Center, 
MS: WB-06-05, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 
786-7388, Email: [email protected].
    RIN: 0938-AS69

135. Hospital Inpatient Prospective Payment System for Acute Care 
Hospitals and the Long-Term Care Hospital Prospective Payment System 
and FY 2017 Rates (CMS-1655-F) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual final rule revises the Medicare hospital 
inpatient and long-term care hospital prospective payment systems for 
operating and capital-related costs. This rule implements changes 
arising from our continuing experience with these systems.
    Timetable:

[[Page 37304]]



------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/27/16  81 FR 24946
NPRM Comment Period End.............   06/17/16
Final Action........................   08/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Deputy Director, Division of Acute 
Care, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: 
[email protected].
    RIN: 0938-AS77

136. CY 2017 Home Health Prospective Payment System Rate Update; Home 
Health Value-Based Purchasing Model; and Home Health Quality Reporting 
Requirements (Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh
    Abstract: This annual proposed rule would update the 60-day 
national episode rate, the national per-visit rates used to calculate 
low utilization payment adjustments (LUPAs), and outlier payments under 
the Medicare prospective payment system for home health agencies. The 
rule would also update the provisions of the Home Health Value-Based 
Purchasing (HHVBP) program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Hillary Loeffler, Deputy Director, Division of Home 
Health and Hospice, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Center for Medicare, MS: C5-07-22, 
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0456, 
Email: [email protected].
    RIN: 0938-AS80

137. CY 2017 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1654-P) (Section 
610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 114-10
    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, 2017.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ryan Howe, 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: 410 786-3355, Email: 
[email protected].
    RIN: 0938-AS81

138. CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1656-P) (Section 610 Review)

    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 rule describes changes to the amounts and factors used 
to determine payment rates for services. In addition, the rule would 
change the ambulatory surgical center payment system list of services 
and rates.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/16  .......................
------------------------------------------------------------------------

    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-AS82

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

139. Emergency Preparedness Requirements for Medicare and Medicaid 
Participating Providers and Suppliers (CMS-3178-F) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1821; 42 U.S.C. 1861ff (3)(B)(i)(ii); 42 
U.S.C. 1913(c)(1) et al
    Abstract: This rule finalizes emergency preparedness requirements 
for Medicare and Medicaid participating providers and suppliers to 
ensure that they adequately plan for both natural and man-made 
disasters and coordinate with Federal, State, tribal, regional, and 
local emergency preparedness systems. This rule ensures providers and 
suppliers are adequately prepared to meet the needs of patients, 
residents, clients, and participants during disasters and emergency 
situations.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/27/13  78 FR 79082
NPRM Comment Period Extended........   02/21/14  79 FR 9872
NPRM Comment Period End.............   03/31/14  .......................
Final Action........................   12/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Graham, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clincial Standards and Quality, Mail Stop 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410 
786-8020, Email: [email protected].
    RIN: 0938-AO91

140. Reform of Requirements for Long-Term Care Facilities (CMS-3260-F) 
(Rulemaking Resulting From a Section 610 Review)

    Legal Authority: Pub. L. 111-148, sec 6102; 42 U.S.C. 263a; 42 
U.S.C. 1302; 42 U.S.C. 1395hh; 42 U.S.C. 1395rr
    Abstract: This final rule revises the requirements that long-term 
care facilities must meet to participate in the Medicare and Medicaid 
programs. These changes are necessary to reflect the substantial 
advances that have been made over the past several years in the theory 
and practice of service delivery and safety. The rule is also an 
integral part of CMS efforts to achieve broad-

[[Page 37305]]

based improvements both in the quality of health care furnished through 
federal programs, and in patient safety, while at the same time 
reducing procedural burdens on providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/16/15  80 FR 42167
NPRM Comment Period Extension.......   09/15/15  80 FR 55284
NPRM Comment Period End.............   09/14/15  .......................
NPRM Comment Period Extended End....   10/14/15  .......................
Final Action........................   09/00/16  .......................
------------------------------------------------------------------------

    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-AR61

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Long-Term Actions

Centers for Medicare & Medicaid Services (CMS)

141. Conditions of Participation for Home Health Agencies (CMS-3819-F) 
(Rulemaking Resulting From a Section 610 Review)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395x; 42 U.S.C. 
1395cc(a); 42 U.S.C. 1395hh; 42 U.S.C. 1395bb
    Abstract: This final rule revises the conditions of participation 
(CoPs) that home health agencies (HHAs) must meet in order to 
participate in the Medicare and Medicaid programs. The requirements 
focus on the care delivered to patients by HHAs, reflect an 
interdisciplinary view of patient care, allow HHAs greater flexibility 
in meeting quality care standards, and eliminate unnecessary procedural 
requirements. These changes are an integral part of our overall effort 
to achieve broad-based, measurable improvements in the quality of care 
furnished through the Medicare and Medicaid programs, while at the same 
time eliminating unnecessary procedural burdens on providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/10/97  62 FR 11005
NPRM Comment Period End.............   06/09/97  .......................
Second NPRM.........................   10/09/14  79 FR 61163
NPRM Comment Period Extended........   12/01/14  79 FR 71081
NPRM Comment Period End.............   12/08/14  .......................
NPRM Comment Period Extended End....   01/07/15  .......................
Final Action........................   10/00/17  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: No.
    Agency Contact: Danielle Shearer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards & Quality, 7500 
Security Boulevard, MS: S3-02-01, Baltimore, MD 21244, Phone: 410 786-
6617, Email: [email protected].
    RIN: 0938-AG81

142. Medicare Clinical Diagnostic Laboratory Test Payment System (CMS-
1621-F) (Section 610 Review)

    Legal Authority: Pub. L. 113-93, sec 216
    Abstract: This final rule revises the Medicare payment system for 
clinical diagnostic laboratory tests and implements other changes 
required by section 216 of the Protecting Access to Medicare Act of 
2014.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/01/15  80 FR 59385
NPRM Comment Period End.............   11/25/15  .......................
Final Action........................   10/00/18  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Valerie Miller, Deputy Director, Division of 
Ambulatory Services, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Center for Medicare, Mail Stop C4-01-
26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4535, 
Email: [email protected].
    Sarah Harding, Health Insurance Specialist, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Center 
for Medicare, MS: C4-01-26, 7500 Security Boulevard, Baltimore, MD 
21244, Phone: 410 786-4535, Email: [email protected].
    RIN: 0938-AS33

143. Imaging Accreditation (CMS-3309-P) (Section 610 Review)

    Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1102
    Abstract: This proposed rule would establish standards for Imaging 
Accreditation. These proposed standards would address qualifications 
for clinical personnel, standards to ensure that suppliers have 
established policies and procedures governing the use of equipment in 
furnishing the technical component of advanced diagnostic imaging, and 
the establishment and maintenance of a quality assurance and quality 
control program to ensure reliability, clarity, and accuracy of the 
diagnostic images.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................      To Be  Determined
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sonia Swancy, 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-
8445, Email: [email protected].
    RIN: 0938-AS62

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Completed Actions

Centers for Medicare & Medicaid Services (CMS)

144. Covered Outpatient Drugs (CMS-2345-FC) (Completion of a Section 
610 Review)

    Legal Authority: Pub. L. 111-48, sec 2501; Pub. L. 111-48, 2503; 
Pub. L. 111-48, 3301(d)(2); Pub. L. 111-152, sec 1206; Pub. L. 111-8, 
sec 221
    Abstract: This final rule revises requirements pertaining to 
Medicaid reimbursement for covered outpatient drugs to implement 
provisions of the Affordable Care Act. This rule also revises other 
requirements related to covered outpatient drugs, including key aspects 
of Medicaid coverage, payment, and the drug rebate program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/02/12  77 FR 5318
NPRM Comment Period End.............   04/02/12  .......................
Final Action........................   02/01/16  81 FR 5170

[[Page 37306]]

 
Final Action Effective..............   04/01/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Wendy Tuttle, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicaid and State Operations, Mail Stop 
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8690, Email: [email protected].
    RIN: 0938-AQ41

145. CY 2016 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1631-FC) 
(Completion of a Section 610 Review)

    Legal Authority: 42 U.S.C. 405(a), 1302, 1395x, 1395y(a), 1395ff, 
1395kk, 1395rr and 1395ww(k); 42 U.S.C. 263a; 42 U.S.C. 1395m, 1395hh, 
and 1395ddd; 42 U.S.C. 1395w-101 through 1395w-152, and 1395nn; ...
    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, 2016.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/15/15  80 FR 41686
NPRM Comment Period End.............   09/08/15  .......................
Final Action........................   11/16/15  80 FR 70886
Final Action Effective..............   01/01/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ryan Howe, 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: 410 786-3355, Email: 
[email protected].
    RIN: 0938-AS40

146. CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates 
and Ambulatory Surgical Center Payment System Policy Changes and 
Payment Rates (CMS-1633-FC) (Completion of a Section 610 Review)

    Legal Authority: 42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd
    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 changes 
the ambulatory surgical center payment system list of services and 
rates.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/08/15  80 FR 39200
NPRM Comment Period End.............   08/31/15  .......................
Final Action........................   11/13/15  80 FR 70298
Final Action Effective..............   01/01/16  .......................
------------------------------------------------------------------------

    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-AS42

147. Comprehensive Care for Joint Replacement (CMS-5516-F) (Completion 
of a Section 610 Review)

    Legal Authority: Social Security Act, sec 1115A
    Abstract: This final rule implements a new Medicare Part A and B 
payment model under section 1115A of the Social Security Act, called 
the Comprehensive Care Joint Replacement Model, in which acute care 
hospitals in certain selected geographic areas receive retrospective 
bundled payments for episodes of care for lower extremity joint 
replacement or reattachment of a lower extremity. All related care 
within 90 days of hospital discharge from the joint replacement 
procedures would be included in the episode of care. We believe this 
model furthers our goals in improving the efficiency and quality of 
care for Medicare beneficiaries for these common medical procedures.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/14/15  80 FR 41198
NPRM Comment Period End.............   09/08/15  .......................
Final Action........................   11/24/15  80 FR 73273
Final Action Effective..............   01/15/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Claire Schreiber, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare & Medicaid Innovation, MS: WB-
08-62, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
8939, Email: [email protected].
    RIN: 0938-AS64

[FR Doc. 2016-12904 Filed 6-8-16; 8:45 am]
 BILLING CODE 4150-03-P