81_FR_37405 81 FR 37294 - Regulatory Agenda

81 FR 37294 - Regulatory Agenda

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 81, Issue 111 (June 9, 2016)

Page Range37294-37306
FR Document2016-12904

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.

Federal Register, Volume 81 Issue 111 (Thursday, June 9, 2016)
[Federal Register Volume 81, Number 111 (Thursday, June 9, 2016)]
[Unknown Section]
[Pages 37294-37306]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                  37294                           Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda

                                                  DEPARTMENT OF HEALTH AND                                               The
                                                                                                                      SUPPLEMENTARY INFORMATION:                                       For example, to encourage public
                                                  HUMAN SERVICES                          Department of Health and Human                                                               participation, we regularly update our
                                                                                          Services (HHS) is the Federal                                                                regulatory Web page (http://
                                                  Office of the Secretary                 Government’s lead agency for protecting                                                      www.HHS.gov/regulations) which
                                                                                          the health of all Americans and                                                              includes links to HHS rules currently
                                                  21 CFR Ch. I                            providing essential human services,                                                          open for public comment, and also
                                                                                          especially for those who are least able                                                      provides a ‘‘regulations toolkit’’ with
                                                  25 CFR Ch. V                            to help themselves. HHS enhances the                                                         background information on regulations,
                                                                                          health and well-being of Americans by                                                        the commenting process, how public
                                                  42 CFR Chs. I–V                         promoting effective health and human                                                         comments influence the development of
                                                                                          services and by fostering sound,                                                             a rule, and how the public can provide
                                                  45 CFR Subtitle A; Subtitle B, Chs. II, sustained advances in the sciences                                                           effective comments. HHS also actively
                                                  III, and XIII                           underlying medicine, public health, and                                                      encourages meaningful public
                                                                                          social services.                                                                             participation in its retrospective review
                                                  Regulatory Agenda                          This Agenda presents the rulemaking                                                       of regulations, through a comment form
                                                  AGENCY: Office of the Secretary, HHS.   activities that the Department expects to                                                    on the HHS retrospective review Web
                                                  ACTION: Semiannual Regulatory Agenda. undertake in the foreseeable future to                                                         page (http://www.HHS.gov/
                                                                                          advance this mission. The Agenda                                                             RetrospectiveReview).
                                                  SUMMARY: The Regulatory Flexibility Act furthers several Departmental goals,
                                                                                                                                                                                          The rulemaking abstracts included in
                                                  of 1980 and Executive Order (EO) 12866 including strengthening health care;
                                                                                                                                                                                       this paper issue of the Federal Register
                                                  require the semiannual issuance of an   advancing scientific knowledge and                                                           cover, as required by the Regulatory
                                                  inventory of rulemaking actions under   innovation; advancing the health, safety,                                                    Flexibility Act of 1980, those
                                                  development throughout the              and well-being of the American people;                                                       prospective HHS rulemakings likely to
                                                  Department, offering for public review  increasing efficiency, transparency, and                                                     have a significant economic impact on
                                                  summarized information about            accountability of HHS programs; and                                                          a substantial number of small entities.
                                                  forthcoming regulatory actions.         strengthening the nation’s health and                                                        The Department’s complete Regulatory
                                                  FOR FURTHER INFORMATION CONTACT:        human services infrastructure and                                                            Agenda is accessible online at http://
                                                  Wilma Robinson, Deputy Executive        workforce.                                                                                   www.RegInfo.gov.
                                                  Secretary, Department of Health and        HHS has an agency-wide effort to
                                                  Human Services, 200 Independence        support the Agenda’s purpose of                                                              Wilma Robinson,
                                                  Avenue SW., Washington, DC 20201;       encouraging more effective public                                                            Deputy Executive Secretary to the
                                                  (202) 690–5627.                         participation in the regulatory process.                                                     Department.

                                                                                                                OFFICE FOR CIVIL RIGHTS—FINAL RULE STAGE
                                                                                                                                                                                                                              Regulation
                                                    Sequence No.                                                                                  Title                                                                      Identifier No.

                                                  104 ....................     Nondiscrimination Under the Patient Protection and Affordable Care Act ......................................................                    0945–AA02


                                                            OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY—PROPOSED RULE STAGE
                                                                                                                                                                                                                              Regulation
                                                    Sequence No.                                                                                  Title                                                                      Identifier No.

                                                  105 ....................     ONC Health IT Certification Program: Enhanced Oversight and Accountability .............................................                         0955–AA00


                                                                                                     FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE
                                                                                                                                                                                                                         Regulation
                                                    Sequence No.                                                                               Title                                                                    Identifier No.

                                                  106   ....................   Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products ......................................                               0910–AF31
                                                  107   ....................   Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products ........................................                             0910–AF69
                                                  108   ....................   Updated Standards for Labeling of Pet Food ...........................................................................................      0910–AG09
                                                  109   ....................   Format and Content of Reports Intended to Demonstrate Substantial Equivalence ...............................                               0910–AG96
                                                  110   ....................   Mammography Quality Standards Act; Regulatory Amendments ............................................................                       0910–AH04
                                                  111   ....................   Investigational New Drug Application Annual Reporting ..........................................................................            0910–AH07
                                                  112   ....................   Requirements for Tobacco Product Manufacturing Practice ....................................................................                0910–AH22
                                                  113   ....................   Use of Ozone Depleting Substances (Section 610 Review) ..................................................................                   0910–AH36
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                                                                         FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE
                                                                                                                                                                                                                              Regulation
                                                    Sequence No.                                                                                  Title                                                                      Identifier No.

                                                  114 ....................     Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Includ-                                            0910–AA49
                                                                                 ing Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs.
                                                  115 ....................     Postmarketing Safety Reporting Requirements for Human Drug and Biological Products ............................                                  0910–AA97
                                                  116 ....................     Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ......................                                     0910–AC53



                                             VerDate Sep<11>2014         16:34 Jun 08, 2016     Jkt 238001    PO 00000      Frm 00002     Fmt 4701     Sfmt 4702    E:\FR\FM\09JNP8.SGM         09JNP8


                                                                                  Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda                                                                             37295

                                                                                               FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE—Continued
                                                                                                                                                                                                                                      Regulation
                                                    Sequence No.                                                                                     Title                                                                           Identifier No.

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


                                                                                                        FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS
                                                                                                                                                                                                                                      Regulation
                                                    Sequence No.                                                                                     Title                                                                           Identifier No.

                                                  126   ....................   Laser Products; Amendment to Performance Standard ..................................................................................                     0910–AF87
                                                  127   ....................   Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives                                                   0910–AG59
                                                  128   ....................   Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System ...........                                                  0910–AH03
                                                  129   ....................   Regulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug,                                                            0910–AH10
                                                                                 and Cosmetic Act.


                                                                                                        FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS
                                                                                                                                                                                                                                      Regulation
                                                    Sequence No.                                                                                     Title                                                                           Identifier No.

                                                  130 ....................     Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption ...........                                                 0910–AG35
                                                  131 ....................     Foreign Supplier Verification Program .............................................................................................................      0910–AG64
                                                  132 ....................     Sanitary Transportation of Human and Animal Food ......................................................................................                  0910–AG98


                                                                                          CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE
                                                                                                                                                                                                                                      Regulation
                                                    Sequence No.                                                                                     Title                                                                           Identifier No.

                                                  133 ....................     Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement                                                  0938–AS21
                                                                                 in Patient Care (CMS–3295–P) (Rulemaking Resulting From a Section 610 Review).
                                                  134 ....................     Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare                                                            0938–AS69
                                                                                 Fee-for-Service (CMS–5517–P) (Section 610 Review).
                                                  135 ....................     Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hos-                                                       0938–AS77
                                                                                 pital Prospective Payment System and FY 2017 Rates (CMS–1655–F) (Section 610 Review).
                                                  136 ....................     CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing                                                           0938–AS80
                                                                                 Model; and Home Health Quality Reporting Requirements (Section 610 Review).
                                                  137 ....................     CY 2017 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medi-                                                      0938–AS81
                                                                                 care Part B (CMS–1654–P) (Section 610 Review).
                                                  138 ....................     CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center                                                          0938–AS82
                                                                                 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 Requirements for Medicare and Medicaid Participating Providers and Suppliers                                                      0938–AO91
                                                                                 (CMS–3178–F) (Section 610 Review).
                                                  140 ....................     Reform of Requirements for Long-Term Care Facilities (CMS–3260–F) (Rulemaking Resulting From a                                                           0938–AR61
                                                                                 Section 610 Review).
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                                                             CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS
                                                                                                                                                                                                                                      Regulation
                                                    Sequence No.                                                                                     Title                                                                           Identifier No.

                                                  141 ....................     Conditions of Participation for Home Health Agencies (CMS–3819–F) (Rulemaking Resulting From a                                                           0938–AG81
                                                                                 Section 610 Review).



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                                                  37296                         Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda

                                                                                CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS—Continued
                                                                                                                                                                                                                  Regulation
                                                    Sequence No.                                                                          Title                                                                  Identifier No.

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


                                                                                         CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS
                                                                                                                                                                                                                  Regulation
                                                    Sequence No.                                                                          Title                                                                  Identifier No.

                                                  144 ....................   Covered Outpatient Drugs (CMS–2345–FC) (Completion of a Section 610 Review) .................................                          0938–AQ41
                                                  145 ....................   CY 2016 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medi-                                    0938–AS40
                                                                               care Part B (CMS–1631–FC) (Completion of a Section 610 Review).
                                                  146 ....................   CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center                                        0938–AS42
                                                                               Payment System Policy Changes and Payment Rates (CMS–1633–FC) (Completion of a Section 610
                                                                               Review).
                                                  147 ....................   Comprehensive Care for Joint Replacement (CMS–5516–F) (Completion of a Section 610 Review) .......                                     0938–AS64



                                                  DEPARTMENT OF HEALTH AND                                      DEPARTMENT OF HEALTH AND                                   National Coordinator for Health
                                                  HUMAN SERVICES (HHS)                                          HUMAN SERVICES (HHS)                                       Information Technology, Room 729D,
                                                                                                                                                                           Hubert H. Humphrey Building, 200
                                                  Office for Civil Rights (OCR)                                 Office of the National Coordinator for
                                                                                                                                                                           Independence Avenue SW.,
                                                                                                                Health Information Technology (ONC)
                                                  Final Rule Stage                                                                                                         Washington, DC 20201, Phone: 202 690–
                                                                                                                Proposed Rule Stage                                        7151.
                                                  104. Nondiscrimination Under the                                                                                           RIN: 0955–AA00
                                                  Patient Protection and Affordable Care                        105. • ONC Health IT Certification
                                                  Act                                                           Program: Enhanced Oversight and
                                                                                                                Accountability
                                                    Legal Authority: 42 U.S.C. 18116                               Legal Authority: Not Yet Determined                     DEPARTMENT OF HEALTH AND
                                                    Abstract: This final rule implements                           Abstract: The rulemaking introduces                     HUMAN SERVICES (HHS)
                                                  prohibitions against discrimination on                        modifications and new requirements                         Food and Drug Administration (FDA)
                                                  the basis of race, color, national origin,                    under the ONC Health IT Certification
                                                                                                                Program (‘‘Program’’), including                           Proposed Rule Stage
                                                  sex, age, and disability as provided in
                                                  section 1557 of the Affordable Care Act.                      provisions related to the Office of the                    106. Over-the-Counter (OTC) Drug
                                                  Section 1557 provides protection from                         National Coordinator for Health                            Review—Cough/Cold (Antihistamine)
                                                  discrimination in health programs and                         Information Technology (ONC)’s role in                     Products
                                                  activities of covered entities. This                          the Program. The proposed rule
                                                                                                                proposes to establish processes for ONC                      Legal Authority: 21 U.S.C. 321p; 21
                                                  section also identifies additional forms                                                                                 U.S.C. 331; 21 U.S.C. 351 to 353; 21
                                                  of Federal financial assistance to which                      to directly review health IT certified
                                                                                                                under the Program and take action when                     U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
                                                  the section will apply.                                                                                                    Abstract: FDA will be proposing a
                                                                                                                necessary, including requiring the
                                                    Timetable:                                                  correction of non-conformities found in                    rule to add the common cold indication
                                                                                                                health IT certified under the Program                      to certain over-the-counter (OTC)
                                                          Action                 Date           FR Cite         and suspending and terminating                             antihistamine active ingredients. This
                                                                                                                certifications issued to Complete EHRs                     proposed rule is the result of
                                                  NPRM ..................       09/08/15     80 FR 54172                                                                   collaboration under the U.S.-Canada
                                                                                                                and Health IT Modules. The proposed
                                                  NPRM Comment                  11/09/15                                                                                   Regulatory Cooperation Council (RCC)
                                                    Period End.
                                                                                                                rule includes processes for ONC to
                                                                                                                authorize and oversee accredited testing                   as part of efforts to reduce unnecessary
                                                  Final Action .........        05/00/16                                                                                   duplication and differences. This pilot
                                                                                                                laboratories under the Program. It also
                                                                                                                includes a provision for the increased                     exercise will help determine the
                                                     Regulatory Flexibility Analysis                            transparency and availability of                           feasibility of developing an ongoing
                                                  Required: Yes.                                                surveillance results.                                      mechanism for alignment in review and
                                                     Agency Contact: Eileen Hanrahan,                              Timetable:                                              adoption of OTC drug monograph
                                                  Senior Civil Rights Analyst, Department                                                                                  elements.
                                                  of Health and Human Services, Office                                  Action               Date           FR Cite          Timetable:
                                                  for Civil Rights, 200 Independence                            NPRM ..................    03/02/16       81 FR 11056              Action              Date          FR Cite
                                                  Avenue SW., Washington, DC 20201,
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                                                                                NPRM Comment               05/02/16
                                                  Phone: 202 205–4925, Email:                                     Period End.                                              Reopening of Ad-           08/25/00    65 FR 51780
                                                  eileen.hanrahan@hhs.gov.                                      Final Action .........     10/00/16                          ministrative
                                                                                                                                                                             Record.
                                                     RIN: 0945–AA02                                                                                                        Comment Period             11/24/00
                                                                                                                  Regulatory Flexibility Analysis
                                                                                                                Required: Yes.                                               End.
                                                                                                                  Agency Contact: Michael Lipinski,                        NPRM (Amend-               01/00/17
                                                                                                                                                                             ment) (Common
                                                                                                                Policy Analyst, Department of Health                         Cold).
                                                                                                                and Human Services, Office of the


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                                                                           Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda                                               37297

                                                    Regulatory Flexibility Analysis                       796–3713, Fax: 301 796–9899, Email:                       RIN: 0910–AG96
                                                  Required: Yes.                                          janice.adams-king@fda.hhs.gov.
                                                                                                            RIN: 0910–AF69                                       110. Mammography Quality Standards
                                                    Agency Contact: Janice Adams-King,                                                                           Act; Regulatory Amendments
                                                  Regulatory Health Project Manager,                      108. Updated Standards for Labeling of
                                                  Department of Health and Human                                                                                    Legal Authority: 21 U.S.C. 360i; 21
                                                                                                          Pet Food                                               U.S.C. 360nn; 21 U.S.C. 374(e); 42
                                                  Services, Food and Drug
                                                  Administration, Center for Drug                           Legal Authority: 21 U.S.C. 343; 21                   U.S.C. 263b
                                                  Evaluation and Research, WO 22, Room                    U.S.C. 371; Pub. L. 110–85, sec                           Abstract: FDA is proposing to amend
                                                  5416, 10903 New Hampshire Avenue,                       1002(a)(3)                                             its regulations governing
                                                  Silver Spring, MD 20993, Phone: 301                       Abstract: FDA is proposing updated                   mammography. The amendments would
                                                  796–3713, Fax: 301 796–9899, Email:                     standards for the labeling of pet food                 update the regulations issued under the
                                                  janice.adams-king@fda.hhs.gov.                          that include nutritional and ingredient                Mammography Quality Standards Act of
                                                                                                          information, as well as style and                      1992 (MQSA). FDA is taking this action
                                                    RIN: 0910–AF31                                        formatting standards. FDA is taking this               to address changes in mammography
                                                  107. Over-the-Counter (OTC) Drug                        action to provide pet owners and animal                technology and mammography
                                                  Review—Topical Antimicrobial Drug                       health professionals more complete and                 processes that have occurred since the
                                                  Products                                                consistent information about the                       regulations were published in 1997 and
                                                                                                          nutrient content and ingredient                        to address breast density reporting to
                                                     Legal Authority: 21 U.S.C. 321p; 21                  composition of pet food products.                      patient and health care providers.
                                                  U.S.C. 331; 21 U.S.C. 351 to 353; 21                      Timetable:                                              Timetable:
                                                  U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
                                                     Abstract: The OTC drug review                               Action                Date         FR Cite              Action             Date      FR Cite
                                                  establishes conditions under which
                                                  OTC drugs are considered generally                      NPRM ..................   10/00/16                     NPRM ..................   08/00/16
                                                  recognized as safe and effective, and not
                                                  misbranded. After a final monograph                       Regulatory Flexibility Analysis                        Regulatory Flexibility Analysis
                                                  (i.e., final rule) is issued, only OTC                  Required: Yes.                                         Required: Yes.
                                                  drugs meeting the conditions of the                       Agency Contact: William Burkholder,                    Agency Contact: Nancy Pirt,
                                                  monograph, or having an approved new                    Veterinary Medical Officer, Department                 Regulatory Counsel, Department of
                                                  drug application, may be legally                        of Health and Human Services, Food                     Health and Human Services, Food and
                                                  marketed. This action addresses                         and Drug Administration, Center for                    Drug Administration, Center for Devices
                                                  antimicrobial agents in consumer                        Veterinary Medicine, MPN–4, Room                       and Radiological Health, WO 66, Room
                                                  antiseptic hand wash.                                   2642, HFV–228, 7519 Standish Place,                    4438, 10903 New Hampshire Avenue,
                                                                                                          Rockville, MD 20855, Phone: 240 402–                   Silver Spring, MD 20993, Phone: 301
                                                     Timetable:
                                                                                                          5900, Email: william.burkholder@                       796–6248, Fax: 301 847–8145, Email:
                                                         Action             Date           FR Cite        fda.hhs.gov.                                           nancy.pirt@fda.hhs.gov.
                                                                                                            RIN: 0910–AG09                                         RIN: 0910–AH04
                                                  NPRM                     06/17/94     59 FR 31402       109. Format and Content of Reports                     111. Investigational New Drug
                                                    (Healthcare).
                                                                                                          Intended To Demonstrate Substantial                    Application Annual Reporting
                                                  Comment Period          12/15/95
                                                    End.                                                  Equivalence                                              Legal Authority: 21 U.S.C. 321; 21
                                                  NPRM (Consumer          12/17/13      78 FR 76443         Legal Authority: 21 U.S.C. 387e(j); 21               U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352;
                                                    Hand Wash                                             U.S.C. 387j(a); secs 905(j) and 910(a) of              21 U.S.C. 353; 21 U.S.C. 355(i); 21
                                                    Products).                                            the Federal Food, Drug, and Cosmetic                   U.S.C. 371(a); 42 U.S.C. 262(a)
                                                  NPRM (Consumer          06/16/14                        Act                                                      Abstract: This proposed rule would
                                                    Hand Wash)                                              Abstract: This regulation would                      revise the requirements concerning
                                                    Comment Pe-
                                                    riod End.
                                                                                                          establish the format and content of                    annual reports submitted to
                                                  NPRM                    05/01/15      80 FR 25166       reports intended to demonstrate                        investigational new drug applications
                                                    (Healthcare An-                                       substantial equivalence. This regulation               (INDs) by replacing the current annual
                                                    tiseptic).                                            also would provide information as to                   reporting requirement with a
                                                  NPRM Comment            10/28/15                        how the Agency will review and act on                  requirement that is generally consistent
                                                    Period End                                            these submissions.                                     with the format, content, and timing of
                                                    (Healthcare An-                                         Timetable:                                           submission of the development safety
                                                    tiseptic).                                                                                                   update report devised by the
                                                  NPRM (Consumer          06/00/16                               Action                Date         FR Cite      International Conference on
                                                    Hand Rub).
                                                  Final Rule (Con-        09/00/16
                                                                                                                                                                 Harmonization of Technical
                                                                                                          NPRM ..................   09/00/16
                                                    sumer Hand                                                                                                   Requirements for Registration of
                                                    Wash).                                                  Regulatory Flexibility Analysis                      Pharmaceuticals for Human Use (ICH).
                                                                                                                                                                   Timetable:
                                                                                                          Required: Yes.
                                                    Regulatory Flexibility Analysis                         Agency Contact: Annette L. Marthaler,                        Action             Date      FR Cite
                                                  Required: Yes.                                          Regulatory Counsel, Department of
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                    Agency Contact: Janice Adams-King,                    Health and Human Services, Food and                    NPRM ..................   10/00/16
                                                  Regulatory Health Project Manager,                      Drug Administration, Center for
                                                  Department of Health and Human                          Tobacco Products, Document Control                       Regulatory Flexibility Analysis
                                                  Services, Food and Drug                                 Center, Building 71, Room G335, 10903                  Required: Yes.
                                                  Administration, Center for Drug                         New Hampshire Avenue, Silver Spring,                     Agency Contact: Ebla Ali Ibrahim,
                                                  Evaluation and Research, WO 22, Room                    MD 20993, Phone: 877 287–1373, Fax:                    Project Manager, Department of Health
                                                  5416, 10903 New Hampshire Avenue,                       877 287–1426, Email: ctpregulations@                   and Human Services, Food and Drug
                                                  Silver Spring, MD 20993, Phone: 301                     fda.hhs.gov.                                           Administration, Center for Drug


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                                                  37298                      Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda

                                                  Evaluation and Research, Building 51,                     membranes of humans where a cannula                      Abstract: The rule will reorganize,
                                                  Room 6302, 10903 New Hampshire                            is used for application. FDA is                        consolidate, clarify, and modify current
                                                  Avenue, Silver Spring, MD 20993,                          proposing this action because                          regulations concerning who must
                                                  Phone: 301 796–3691, Email: ebla.ali-                     alternative products that do not use                   register establishments and list human
                                                  ibrahim@fda.hhs.gov.                                      ODSs are now available and because                     drugs, including certain biological
                                                    RIN: 0910–AH07                                          these products are no longer being                     drugs, and animal drugs. These
                                                  112. Requirements for Tobacco Product                     marketed in approved versions that                     regulations contain information on
                                                  Manufacturing Practice                                    contain ODSs. On June 29, 2015, FDA                    when, how, and where to register drug
                                                                                                            published a notice and request for                     establishments and list drugs, and what
                                                    Legal Authority: 21 U.S.C. 371; 21                      comment concerning its tentative                       information must be submitted. They
                                                  U.S.C. 387b; 21 U.S.C. 387f                               conclusion that these products are no                  also address National Drug Codes.
                                                    Abstract: FDA is proposing                              longer an essential use under the Clean                  Timetable:
                                                  requirements that govern the methods                      Air Act (80 FR 36937). The Agency
                                                  used in, and the facilities and controls                  received no comments concerning                                Action             Date        FR Cite
                                                  used for, the pre-production design                       removal of essential use designations for
                                                  validation, manufacture, packing, and                     sterile aerosol talc and metered-dose                  NPRM ..................   08/29/06   71 FR 51276
                                                  storage of tobacco products.                              atropine sulfate, and is proposing to                  NPRM Comment              02/26/07
                                                    Timetable:                                              remove these designations by direct                      Period End.
                                                                                                                                                                   Final Action .........    07/00/16
                                                                                                            final rule and a companion proposed
                                                         Action               Date           FR Cite
                                                                                                            rule in the event adverse comments are
                                                                                                                                                                     Regulatory Flexibility Analysis
                                                  ANPRM ...............      03/19/13     78 FR 16824       received. FDA received one comment
                                                                                                                                                                   Required: Yes.
                                                  ANPRM Comment              05/20/13                       concerning removal of anesthetic drugs
                                                                                                                                                                     Agency Contact: David Joy, Senior
                                                   Period End.                                              for topical use in response to its 2015
                                                                                                                                                                   Regulatory Counsel, Department of
                                                  NPRM ..................    12/00/16                       notice and request for comment, and is
                                                                                                                                                                   Health and Human Services, Food and
                                                                                                            proposing to remove this exemption
                                                    Regulatory Flexibility Analysis                                                                                Drug Administration, Center for Drug
                                                                                                            through a separate notice. Because these
                                                  Required: Yes.                                                                                                   Evaluation and Research, 10903 New
                                                                                                            products are not currently sold in the
                                                    Agency Contact: Darin Achilles,                                                                                Hampshire Avenue, Building 51, Room
                                                                                                            approved form, no significant economic
                                                  Regulatory Counsel, Department of                                                                                6254, Silver Spring, MD 20993, Phone:
                                                                                                            impact is anticipated.
                                                  Health and Human Services, Food and                          Timetable:                                          301 796–2242, Email: david.joy@
                                                  Drug Administration, 10903 New                                                                                   fda.hhs.gov.
                                                  Hampshire Avenue, Document Control                               Action                Date         FR Cite        RIN: 0910–AA49
                                                  Center, Building 71, Room G335, Silver                                                                           115. Postmarketing Safety Reporting
                                                  Spring, MD 20993, Phone: 877 287–                         NPRM ..................   08/00/16
                                                                                                                                                                   Requirements for Human Drug and
                                                  1373, Fax: 301 595–1426, Email:                                                                                  Biological Products
                                                  ctpregulations@fda.hhs.gov.                                 Regulatory Flexibility Analysis
                                                    RIN: 0910–AH22                                          Required: No.                                             Legal Authority: 42 U.S.C. 216; 42
                                                                                                              Agency Contact: Daniel Orr,                          U.S.C. 241; 42 U.S.C. 242a; 42 U.S.C.
                                                  113. • Use of Ozone Depleting                             Regulatory Counsel, Department of                      262 and 263; 42 U.S.C. 263a to 263n; 42
                                                  Substances (Section 610 Review)                           Health and Human Services, Food and                    U.S.C. 264; 42 U.S.C. 300aa; 21 U.S.C.
                                                    Legal Authority: 21 U.S.C. 321; 21                      Drug Administration, Building 51 Room                  321; 21 U.S.C. 331; 21 U.S.C. 351 to 353;
                                                  U.S.C. 331; 21 U.S.C. 335; 21 U.S.C. 342;                 5199, 10993 New Hampshire Avenue,                      21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C.
                                                  21 U.S.C. 346a; 21 U.S.C. 348; 21 U.S.C.                  Silver Spring, MD 20993, Phone: 240                    360b to 360j; 21 U.S.C. 361a; 21 U.S.C.
                                                  351; 21 U.S.C. 352; 21 U.S.C. 355; 21                     402–0979, Email: daniel.orr@                           371; 21 U.S.C. 374; 21 U.S.C. 375; 21
                                                  U.S.C. 360b; 21 U.S.C. 361; 21 U.S.C.                     fda.hhs.gov.                                           U.S.C. 379e; 21 U.S.C. 381
                                                  371; 21 U.S.C. 372; 21 U.S.C. 374; 15                       RIN: 0910–AH36                                          Abstract: The final rule would amend
                                                  U.S.C. 402; 15 U.S.C. 409                                                                                        the postmarketing expedited and
                                                    Abstract: The Food and Drug                                                                                    periodic safety reporting regulations for
                                                  Administration (FDA or the Agency) is                     DEPARTMENT OF HEALTH AND                               human drugs and biological products to
                                                  proposing to amend its regulation (21                     HUMAN SERVICES (HHS)                                   revise certain definitions and reporting
                                                  CFR 2.125) on uses of ozone-depleting                                                                            formats as recommended by the
                                                  substances (ODSs), including                              Food and Drug Administration (FDA)                     International Conference on
                                                  chlorofluorocarbons (CFCs), to remove                     Final Rule Stage                                       Harmonisation and to define new terms;
                                                  designations for certain products as                                                                             to add to or revise current reporting
                                                  essential uses under the Clean Air Act.                   114. Requirements for Foreign and                      requirements; to revise certain reporting
                                                  Essential-use products are exempt from                    Domestic Establishment Registration                    time frames; and to propose other
                                                  FDA’s ban on the use of CFC propellants                   and Listing for Human Drugs, Including                 revisions to these regulations to enhance
                                                  in FDA-regulated products and the                         Drugs That Are Regulated Under a                       the quality of safety reports received by
                                                  Environmental Protection Agency’s                         Biologics License Application, and                     FDA. These revisions were proposed as
                                                  (EPA’s) ban on the use of CFCs and                        Animal Drugs                                           part of a single rulemaking (68 FR
                                                  other ODSs in pressurized dispensers.                       Legal Authority: 21 U.S.C. 321 and                   12406) to clarify and revise both
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                  This action, if finalized, will remove                    331; 21 U.S.C. 351 to 353; 21 U.S.C. 355               premarketing and postmarketing safety
                                                  essential use exemptions for sterile                      to 356c; 21 U.S.C. 360 and 360b; 21                    reporting requirements for human drug
                                                  aerosol talc administered intrapleurally                  U.S.C. 360c to 360f; 21 U.S.C. 360h to                 and biological products. FDA plans to
                                                  by thoracoscopy for human use,                            360j; 21 U.S.C. 371 and 374; 21 U.S.C.                 finalize the premarket and postmarket
                                                  metered-dose atropine sulfate aerosol                     379e and 381; 21 U.S.C. 393; 15 U.S.C.                 safety reporting requirements in
                                                  human drugs administered by oral                          1451 to 1561; 42 U.S.C. 262 and 264; 42                separate final rules. Premarketing safety
                                                  inhalation, and anesthetic drugs for                      U.S.C. 271; and sec 122; Pub. L. 105–                  reporting requirements were finalized in
                                                  topical use on accessible mucous                          115, 11 Stat. 2322 (21 U.S.C. 355 note)                a separate final rule published on


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                                                                             Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda                                                  37299

                                                  September 29, 2010 (75 FR 59961). This                           Action                Date          FR Cite              Action            Date        FR Cite
                                                  final rule applies to postmarketing
                                                  safety reporting requirements.                            NPRM ..................   04/10/06       71 FR 18039    NPRM Comment             06/02/14
                                                     Timetable:                                             NPRM Comment              07/10/06                        Period End.
                                                                                                              Period End.                                           Reopening of             07/27/15   80 FR 44302
                                                         Action               Date           FR Cite        Final Action .........    07/00/16                        Comment Pe-
                                                                                                                                                                      riod as to Spe-
                                                  NPRM ..................    03/14/03     68 FR 12406         Regulatory Flexibility Analysis                         cific Documents.
                                                  NPRM Comment               06/18/03                       Required: Yes.                                          NPRM Comment             09/25/15
                                                    Period Ex-                                                Agency Contact: Patrick Raulerson,                      Period End as
                                                    tended.                                                 Regulatory Counsel, Department of                         to Specific Doc-
                                                  NPRM Comment               07/14/03                       Health and Human Services, Food and                       uments.
                                                    Period End.                                                                                                     Supplemental             07/27/15   80 FR 44303
                                                                                                            Drug Administration, Center for Drug
                                                  NPRM Comment               10/14/03                                                                                 NPRM to Solicit
                                                                                                            Evaluation and Research, WO 51, Room                      Comment on
                                                    Period Exten-
                                                                                                            6368, 10903 New Hampshire Avenue,                         Limited Addi-
                                                    sion End.
                                                  Final Action .........     03/00/17                       Silver Spring, MD 20993–0002, Phone:                      tional Provi-
                                                                                                            301 796–3522, Fax: 301 847–8440,                          sions.
                                                    Regulatory Flexibility Analysis                         Email: patrick.raulerson@fda.hhs.gov.                   Supplemental             10/13/15
                                                  Required: Yes.                                              RIN: 0910–AC53                                          NPRM to Solicit
                                                    Agency Contact: Jane E. Baluss,                                                                                   Comment on
                                                                                                            117. Food Labeling: Revision of the                       Limited Addi-
                                                  Regulatory Counsel, Department of                         Nutrition and Supplement Facts Labels                     tional Provi-
                                                  Health and Human Services, Food and                                                                                 sions Comment
                                                                                                              Legal Authority: 21 U.S.C. 321; 21
                                                  Drug Administration, Center for Drug                                                                                Period End.
                                                                                                            U.S.C. 343; 21 U.S.C. 371
                                                  Evaluation and Research, WO 51, Room                        Abstract: FDA is amending the                         Administrative           09/10/15   80 FR 54446
                                                  6362, 10903 New Hampshire Avenue,                         labeling regulations for conventional                     Docket Update;
                                                  Silver Spring, MD 20993–0002, Phone:                                                                                Extension of
                                                                                                            foods and dietary supplements to                          Comment Pe-
                                                  301 796–3469, Fax: 301 847–8440,                          provide updated nutrition information
                                                  Email: jane.baluss@fda.hhs.gov.                                                                                     riod.
                                                                                                            on the label to assist consumers in                     Administrative           10/13/15
                                                    RIN: 0910–AA97                                          maintaining healthy dietary practices.                    Docket Update;
                                                  116. Medical Gas Containers and                           The rule would modernize the nutrition                    Comment Pe-
                                                  Closures; Current Good Manufacturing                      information found on the Nutrition                        riod End.
                                                  Practice Requirements                                     Facts label, as well as the format and                  NPRM Reopening           10/20/15   80 FR 63477
                                                                                                            appearance of the label. On July 27,                      of Comment
                                                     Legal Authority: 21 U.S.C. 321; 21                                                                               Period for Cer-
                                                  U.S.C. 351 to 21 U.S.C. 353                               2015, FDA issued a supplemental notice
                                                                                                                                                                      tain Documents.
                                                     Abstract: The Food and Drug                            of proposed rulemaking accepting
                                                                                                                                                                    NPRM Reopening           10/23/15
                                                  Administration is amending its current                    comments on limited additional                            of Comment
                                                  good manufacturing practice regulations                   provisions until October 13, 2015. Also                   Period for Cer-
                                                  and other regulations to clarify and                      on July 27, 2015, FDA reopened the                        tain Documents
                                                  strengthen requirements for the label,                    comment period on the proposed rule as                    Comment Pe-
                                                  color, dedication, and design of medical                  to specific documents until September                     riod End.
                                                                                                            25, 2015. In addition, in response to                   Final Action .........   05/00/16
                                                  gas containers and closures. Despite
                                                  existing regulatory requirements and                      requests for the raw data related to
                                                                                                            FDA’s consumer studies on the                             Regulatory Flexibility Analysis
                                                  industry standards for medical gases,                                                                             Required: Yes.
                                                  there have been repeated incidents in                     nutrition label, FDA issued a notice on
                                                                                                            September 10, 2015 to make the raw                        Agency Contact: Blakeley Fitzpatrick,
                                                  which cryogenic containers of harmful                                                                             Interdisciplinary Scientist, Department
                                                  industrial gases have been connected to                   data available for comment until
                                                                                                            October 13, 2015 and extended the                       of Health and Human Services, Food
                                                  medical oxygen supply systems in                                                                                  and Drug Administration, Center for
                                                  hospitals and nursing homes and                           comment period for the July 27, 2015
                                                                                                            reopening as to specific documents to                   Food Safety and Applied Nutrition,
                                                  subsequently administered to patients.                                                                            HFS–830, 5100 Paint Branch Parkway,
                                                  These incidents have resulted in death                    October 13, 2015. On October 20, 2015,
                                                                                                            FDA extended the comment period for                     College Park, MD 20740, Phone: 240
                                                  and serious injury. There have also been                                                                          402–5429, Email:
                                                  several incidents involving high-                         the consumer studies and the
                                                                                                            supplemental proposal to October 23,                    nutritionprogramstaff@fda.hhs.gov.
                                                  pressure medical gas cylinders that have                                                                            RIN: 0910–AF22
                                                  resulted in death and injuries to                         2015.
                                                                                                              Timetable:                                            118. Food Labeling: Serving Sizes of
                                                  patients. These amendments, together
                                                  with existing regulations, are intended                                                                           Foods That Can Reasonably Be
                                                                                                                   Action                Date          FR Cite      Consumed at One Eating Occasion;
                                                  to ensure that the types of incidents that
                                                  have occurred in the past, as well as                     ANPRM ...............     07/11/03       68 FR 41507
                                                                                                                                                                    Dual—Column Labeling; Updating,
                                                  other types of foreseeable and                            ANPRM Comment             10/09/03                      Modifying, and Establishing Certain
                                                  potentially deadly medical gas                              Period End.                                           RACCS
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                  accidents, do not occur in the future.                    Second ANPRM ..           04/04/05       70 FR 17008      Legal Authority: 21 U.S.C. 321; 21
                                                  FDA has described a number of                             Second ANPRM              06/20/05                      U.S.C. 343; 21 U.S.C. 371; Pub. L. 101–
                                                                                                              Comment Pe-
                                                  proposals in the proposed rule                                                                                    535, sec 2(b)(1)(A)
                                                                                                              riod End.
                                                  including requiring that gas use outlet                   Third ANPRM ......        11/02/07       72 FR 62149
                                                                                                                                                                      Abstract: FDA is amending its
                                                  connections on portable cryogenic                         Third ANPRM               01/31/08                      labeling regulations for foods to provide
                                                  medical gas containers be securely                          Comment Pe-                                           update, modify, and establish Reference
                                                  attached to the valve body.                                 riod End.                                             Amounts Customarily Consumed
                                                     Timetable:                                             NPRM ..................   03/03/14       79 FR 11879    (RACCs) for certain food categories. This


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                                                  37300                      Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda

                                                  rule would provide consumers with                                Action                Date          FR Cite      Center, Building 71, Room G335, 10903
                                                  nutrition information based on the                                                                                New Hampshire Avenue, Silver Spring,
                                                  amount of food that is customarily                        NPRM Comment              04/24/15       80 FR 22953    MD 20993, Phone: 877 287–1373, Fax:
                                                  consumed, which would assist                                Period Ex-                                            301 595–1426, Email: ctpregulations@
                                                  consumers in maintaining healthy                            tended.                                               fda.hhs.gov.
                                                  dietary practices. In addition to                         NPRM Comment              06/08/15                        RIN: 0910–AG38
                                                                                                              Period Ex-
                                                  updating, modifying, and establishing                       tended End.                                           121. Human Subject Protection;
                                                  certain RACCs, FDA is amending the                        Final Action .........    08/00/16                      Acceptance of Data From Clinical
                                                  definition of a single-serving containers;                                                                        Investigations for Medical Devices
                                                  amending the label serving size for                         Regulatory Flexibility Analysis
                                                  breath mints; and providing for dual-                                                                               Legal Authority: 21 U.S.C. 321; 21
                                                                                                            Required: Yes.
                                                  column labeling under certain                               Agency Contact: Janice L. Weiner,                     U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352;
                                                  circumstances, which would provide                                                                                21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C.
                                                                                                            Senior Regulatory Counsel, Department
                                                  nutrition information per serving and                                                                             360e; 21 U.S.C. 360i; 21 U.S.C. 360j; 21
                                                                                                            of Health and Human Services, Food
                                                  per container or unit, as applicable; and                                                                         U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381;
                                                                                                            and Drug Administration, Center for
                                                  making technical amendments to                                                                                    21 U.S.C. 393; 42 U.S.C. 264; 42 U.S.C.
                                                                                                            Drug Evaluation and Research, Building
                                                  various aspects fo the serving size                                                                               271; . . .
                                                                                                            51, Room 6268, 10903 New Hampshire
                                                  regulations.                                                                                                        Abstract: This rule will amend FDA’s
                                                                                                            Avenue, Silver Spring, MD 20993–0002,
                                                    Timetable:                                                                                                      regulations on acceptance of data for
                                                                                                            Phone: 301 796–3601, Fax: 301 847–
                                                                                                                                                                    medical devices to require that clinical
                                                                                                            8440, Email: janice.weiner@fda.hhs.gov.
                                                         Action               Date           FR Cite                                                                investigations submitted in support of a
                                                                                                              RIN: 0910–AF97
                                                                                                                                                                    premarket approval application,
                                                  ANPRM ...............      04/04/05     70 FR 17010       120. ‘‘Tobacco Products’’ Subject to the                humanitarian device exemption
                                                  ANPRM Comment              06/20/05                       Federal Food, Drug, and Cosmetic Act,                   application, an investigational device
                                                    Period End.                                             as Amended by the Family Smoking                        exemption application, or a premarket
                                                  NPRM/Comment               03/03/14     79 FR 11989       Prevention and Tobacco Control Act                      notification submission be conducted in
                                                    Period Ex-
                                                                                                               Legal Authority: 21 U.S.C. 301 et seq.;              accordance with good clinical practice if
                                                    tended.
                                                  NPRM Comment               06/02/14                       The Federal Food, Drug, and Cosmetic                    conducted outside the United States.
                                                    Period End.                                             Act; Pub. L. 111–31; The Family                           Timetable:
                                                  NPRM Comment               05/27/14     79 FR 29699       Smoking Prevention and Tobacco
                                                    Period Ex-                                                                                                              Action             Date        FR Cite
                                                                                                            Control Act
                                                    tended.                                                    Abstract: The Family Smoking
                                                  NPRM Comment               08/01/14                                                                               NPRM ..................   02/25/13   78 FR 12664
                                                                                                            Prevention and Tobacco Control Act                      NPRM Comment              05/28/13
                                                    Period End.                                             (Tobacco Control Act) provides the                        Period End.
                                                  Final Action .........     05/00/16
                                                                                                            Food and Drug Administration (FDA)                      Final Action .........    05/00/16
                                                    Regulatory Flexibility Analysis                         authority to regulate cigarettes, cigarette
                                                                                                            tobacco, roll-your-own tobacco, and                       Regulatory Flexibility Analysis
                                                  Required: Yes.
                                                                                                            smokeless tobacco. The Federal Food,                    Required: Yes.
                                                    Agency Contact: Cherisa Henderson,
                                                                                                            Drug, and Cosmetic Act (FD&C Act), as                     Agency Contact: Soma Kalb,
                                                  Nutritionist, Department of Health and
                                                                                                            amended by the Tobacco Control Act,                     Biomedical Engineer, Department of
                                                  Human Services, Food and Drug
                                                                                                            permits FDA to issue regulations                        Health and Human Services, Food and
                                                  Administration, HFS–830, 5100 Paint
                                                                                                            deeming other tobacco products to be                    Drug Administration, Center for Devices
                                                  Branch Parkway, College Park, MD
                                                                                                            subject to the FD&C Act. This rule                      and Radiological Health, Building 66,
                                                  20740, Phone: 240 402–5429, Fax: 301
                                                                                                            would deem additional products                          Room 1534, 10903 New Hampshire
                                                  436–1191, Email:
                                                                                                            meeting the statutory definition of                     Avenue, Silver Spring, MD 20993,
                                                  nutritionprogramstaff@fda.hhs.gov.
                                                                                                            ‘‘tobacco product’’ to be subject to the                Phone: 301 796–6359, Email:
                                                    RIN: 0910–AF23
                                                                                                            FD&C Act, and would specify additional                  soma.kalb@fda.hhs.gov.
                                                  119. Abbreviated New Drug                                 restrictions.                                             RIN: 0910–AG48
                                                  Applications and 505(B)(2)                                   Timetable:                                           122. Focused Mitigation Strategies To
                                                    Legal Authority: Pub. L. 108–173, title                                                                         Protect Food Against Intentional
                                                  XI; 21 U.S.C. 355; 21 U.S.C. 371                                 Action                Date          FR Cite      Adulteration
                                                    Abstract: This proposed rule would
                                                                                                            NPRM ..................   04/25/14       79 FR 23142      Legal Authority: 21 U.S.C. 331; 21
                                                  make changes to certain procedures for                    NPRM Comment              07/09/14                      U.S.C. 342; 21 U.S.C. 350g; 21 U.S.C.
                                                  Abbreviated New Drug Applications                           Period End.                                           350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub.
                                                  and related applications to patent                        NPRM Comment              06/24/14       79 FR 35711    L. 111–353
                                                  certifications, notice to patent owners                     Period Ex-                                              Abstract: This rule would require
                                                  and application holders, the availability                   tended.
                                                                                                                                                                    domestic and foreign food facilities that
                                                  of a 30-month stay of approval,                           NPRM Comment              08/08/14
                                                                                                              Period Ex-                                            are required to register under the
                                                  amendments and supplements, and the                                                                               Federal Food, Drug, and Cosmetic Act to
                                                  types of bioavailability and                                tended End.
                                                                                                            Final Action .........    05/00/16                      address hazards that may be
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                  bioequivalence data that can be used to                                                                           intentionally introduced by acts of
                                                  support these applications.                                 Regulatory Flexibility Analysis                       terrorism. These food facilities would be
                                                    Timetable:
                                                                                                            Required: Yes.                                          required to identify and implement
                                                                                                              Agency Contact: Gerie Voss, Senior                    focused mitigation strategies to
                                                         Action               Date           FR Cite
                                                                                                            Regulatory Counsel, Department of                       significantly minimize or prevent
                                                  NPRM ..................    02/06/15     80 FR 6802        Health and Human Services, Food and                     significant vulnerabilities identified at
                                                  NPRM Comment               05/07/15                       Drug Administration, Center for                         actionable process steps in a food
                                                   Period End.                                              Tobacco Products, Document Control                      operation.


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                                                                             Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda                                                   37301

                                                     Timetable:                                             of Health and Human Services, Food                      5515, 10903 New Hampshire Avenue,
                                                                                                            and Drug Administration, Center for                     Silver Spring, MD 20993, Phone: 301
                                                         Action               Date           FR Cite        Drug Evaluation and Research, Building                  796–5678, Email: ian.ostermiller@
                                                                                                            51, Room 6268, 10903 New Hampshire                      fda.hhs.gov.
                                                  NPRM ..................   12/24/13      78 FR 78014       Avenue, Silver Spring, MD 20993–0002,                     RIN: 0910–AH14
                                                  NPRM Comment              03/25/14      79 FR 16251
                                                    Period Ex-
                                                                                                            Phone: 301 796–3601, Fax: 301 847–
                                                    tended.                                                 8440, Email: janice.weiner@fda.hhs.gov.
                                                  NPRM Comment              03/31/14                          RIN: 0910–AG94
                                                                                                                                                                    DEPARTMENT OF HEALTH AND
                                                    Period End.                                             124. Food Labeling; Gluten-Free                         HUMAN SERVICES (HHS)
                                                  NPRM Comment               06/30/14                       Labeling of Fermented, Hydrolyzed, or
                                                    Period Ex-                                                                                                      Food and Drug Administration (FDA)
                                                    tended End.
                                                                                                            Distilled Foods
                                                  Final Rule ............    06/00/16                         Legal Authority: sec 206 of the Food                  Long-Term Actions
                                                                                                            Allergen Labeling and Consumer                          126. Laser Products; Amendment to
                                                    Regulatory Flexibility Analysis                         Protection Act; 21 U.S.C. 343(a)(1); 21                 Performance Standard
                                                  Required: Yes.                                            U.S.C. 321(n); 21 U.S.C. 371(a)
                                                    Agency Contact: Jody Menikheim,                           Abstract: This proposed rule would                      Legal Authority: 21 U.S.C. 360hh to
                                                  Supervisory General Health Scientist,                     establish requirements concerning                       360ss; 21 U.S.C. 371; 21 U.S.C. 393
                                                  Department of Health and Human                            compliance for using a ‘‘gluten-free’’                    Abstract: FDA is proposing to amend
                                                  Services, Food and Drug                                   labeling claim for those foods for which                the 2013 proposed rule for the
                                                  Administration, Center for Food Safety                    there is no scientifically valid analytical             performance standard for laser products,
                                                  and Applied Nutrition (HFS–005), 5100                     method available that can reliably detect               which will amend the performance
                                                  Paint Branch Parkway, College Park, MD                    and accurately quantify the presence of                 standard for laser products to achieve
                                                  20740, Phone: 240 402–1864, Fax: 301                      20 parts per million (ppm) gluten in the                closer harmonization between the
                                                  436–2633, Email: fooddefense@                             food.                                                   current standard and the recently
                                                  fda.hhs.gov.                                                Timetable:                                            amended International Electrotechnical
                                                    RIN: 0910–AG63                                                                                                  Commission (IEC) standard for laser
                                                                                                                   Action                Date          FR Cite      products and medical laser products.
                                                  123. Supplemental Applications                                                                                    The amendment is intended to update
                                                  Proposing Labeling Changes for                            NPRM ..................   11/18/15       80 FR 71990    FDA’s performance standard to reflect
                                                  Approved Drugs and Biological                             NPRM Comment              02/16/16       81 FR 3751     advancements in technology.
                                                  Products                                                    Period Re-                                              Timetable:
                                                    Legal Authority: 21 U.S.C. 321; 21                        opened.
                                                                                                            Comment Period            02/22/16       81 FR 8869             Action             Date        FR Cite
                                                  U.S.C. 331; 21 U.S.C. 352; 21 U.S.C. 353;                   Extended.
                                                  21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C.                   Final Action .........    04/00/17                      NPRM ..................   06/24/13   78 FR 37723
                                                  262; . . .
                                                                                                                                                                    NPRM Comment              09/23/13
                                                    Abstract: This rule would amend the                       Regulatory Flexibility Analysis                        Period End.
                                                  regulations regarding new drug                            Required: Yes.                                          NPRM (Repro-              06/00/17
                                                  applications (NDAs), abbreviated new                        Agency Contact: Carol D’Lima, Staff                    posal).
                                                  drug applications (ANDAs), and                            Fellow, Department of Health and
                                                  biologics license application (BLAs) to                   Human Services, Food and Drug                             Regulatory Flexibility Analysis
                                                  revise and clarify procedures for                         Administration, Center for Food Safety                  Required: Yes.
                                                  changes to the labeling of an approved                    and Applied Nutrition, Room 4D022,                        Agency Contact: Erica Blake,
                                                  drug to reflect certain types of newly                    HFS 820, 5100 Paint Branch Parkway,                     Regulatory Counsel, Department of
                                                  acquired information in advance of                        College Park, MD 20740, Phone: 240                      Health and Human Services, Food and
                                                  FDA’s review of such change.                              402–2371, Fax: 301 436–2636, Email:                     Drug Administration, Center for Devices
                                                    Timetable:                                              carol.dlima@fda.hhs.gov.                                and Radiological Health, WO 66, Room
                                                                                                              RIN: 0910–AH00                                        4426, 10903 New Hampshire Avenue,
                                                         Action               Date           FR Cite                                                                Silver Spring, MD 20993, Phone: 301
                                                                                                            125. General and Plastic Surgery
                                                                                                                                                                    796–6248, Fax: 301 847–8145, Email:
                                                  NPRM ..................   11/13/13      78 FR 67985       Devices: Sunlamp Products
                                                  NPRM Comment              12/27/13      78 FR 78796                                                               erica.blake@fda.hhs.gov.
                                                    Period Ex-
                                                                                                              Legal Authority: 21 U.S.C. 360j(e)                      RIN: 0910–AF87
                                                    tended.
                                                                                                              Abstract: This proposed rule would
                                                                                                            apply device restrictions to sunlamp                    127. Requirements for the Testing and
                                                  NPRM Comment              01/13/14
                                                                                                            products.                                               Reporting of Tobacco Product
                                                    Period End.
                                                  NPRM Comment               03/13/14                         Timetable:                                            Constituents, Ingredients, and
                                                    Period Ex-                                                                                                      Additives
                                                    tended End.                                                    Action                Date          FR Cite        Legal Authority: 21 U.S.C. 301 et seq.;
                                                  NPRM Comment              02/18/15      80 FR 8577                                                                21 U.S.C. 387; The Family Smoking
                                                    Period Re-                                              NPRM ..................   12/22/15       80 FR 79493
                                                                                                            NPRM Comment              03/21/16                      Prevention and Tobacco Control Act
                                                    opened.
                                                                                                                                                                      Abstract: The Federal Food, Drug, and
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                  NPRM Comment              04/27/15                          Period End.
                                                    Period Re-                                              Final Action .........    11/00/16                      Cosmetic Act, as amended by the
                                                    opened End.                                                                                                     Family Smoking Prevention and
                                                  Final Rule ............    04/00/17                         Regulatory Flexibility Analysis                       Tobacco Control Act, requires the Food
                                                                                                            Required: Yes.                                          and Drug Administration to promulgate
                                                    Regulatory Flexibility Analysis                           Agency Contact: Ian Ostermiller,                      regulations that require the testing and
                                                  Required: Yes.                                            Regulatory Counsel, Department of                       reporting of tobacco product
                                                    Agency Contact: Janice L. Weiner,                       Health and Human Services, Food and                     constituents, ingredients, and additives,
                                                  Senior Regulatory Counsel, Department                     Drug Administration, Building 66 Room                   including smoke constituents, that the


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                                                  37302                      Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda

                                                  Agency determines should be tested to                     129. Regulations on Human Drug                                  Action             Date        FR Cite
                                                  protect the public health.                                Compounding Under Sections 503A
                                                    Timetable:                                              and 503B of the Federal Food, Drug,                     NPRM Comment              08/09/13   78 FR 48637
                                                                                                            and Cosmetic Act                                          Period Ex-
                                                         Action               Date           FR Cite                                                                  tended.
                                                                                                              Legal Authority: 21 U.S.C. 353a; 21                   NPRM Comment              11/15/13
                                                  NPRM ..................    06/00/17
                                                                                                            U.S.C. 353b; 21 U.S.C. 371                                Period Ex-
                                                                                                              Abstract: FDA will propose                              tended End.
                                                                                                            regulations to define and implement                     Notice of Intent          08/19/13   78 FR 50358
                                                    Regulatory Flexibility Analysis                         certain statutory conditions under                        To Prepare an
                                                  Required: Yes.                                            which compounded products may                             Environmental
                                                    Agency Contact: Laura Rich, Senior                      qualify for exemptions from certain                       Impact State-
                                                  Regulatory Counsel, Department of                                                                                   ment for the
                                                                                                            requirements.                                             Proposed Rule.
                                                  Health and Human Services, Food and                         Timetable:                                            Notice of Intent          11/15/13
                                                  Drug Administration, Center for                                                                                     To Prepare En-
                                                  Tobacco Products, Building 71, G335,                             Action                Date          FR Cite        vironmental Im-
                                                  10903 New Hampshire Avenue, Silver                                                                                  pact Statement
                                                  Spring, MD 20993, Phone: 877 287–                         NPRM ..................   12/00/17                        for the Pro-
                                                  1373, Email: ctpregulations@                                                                                        posed Rule
                                                  fda.hhs.gov.                                                Regulatory Flexibility Analysis                         Comment Pe-
                                                                                                            Required: Yes.                                            riod End.
                                                    RIN: 0910–AG59
                                                                                                              Agency Contact: Sarah Rothman,                        NPRM Comment              11/20/13   78 FR 69605
                                                  128. Radiology Devices; Designation of                    Consumer Safety Officer, Department of                    Period Ex-
                                                  Special Controls for the Computed                         Health and Human Services, Food and                       tended.
                                                  Tomography X-Ray System                                   Drug Administration, Center for Drug                    NPRM Comment              11/22/13
                                                                                                                                                                      Period Ex-
                                                                                                            Evaluation and Research, Building 51,
                                                    Legal Authority: 21 U.S.C. 360c                                                                                   tended End.
                                                                                                            Room 5197, 10903 New Hampshire                          Environmental Im-         03/11/14   79 FR 13593
                                                    Abstract: The proposed rule would                       Avenue, Silver Spring, MD 20993,                          pact Statement
                                                  establish special controls for the                        Phone: 301 796–3536, Email:                               for the Pro-
                                                  computed tomography (CT) X-ray                            sarah.rothman@fda.hhs.gov.                                posed Rule;
                                                  system. A CT X-ray system is a                              RIN: 0910–AH10                                          Comment Pe-
                                                  diagnostic X-ray imaging system                                                                                     riod Extended.
                                                  intended to produce cross-sectional                                                                               Environmental Im-         04/18/14
                                                  images of the body through use of a                                                                                 pact Statement
                                                  computer to reconstruct an image from                     DEPARTMENT OF HEALTH AND                                  for the Pro-
                                                  the same axial plane taken at different                   HUMAN SERVICES (HHS)                                      posed Rule;
                                                                                                                                                                      Comment Pe-
                                                  angles. High doses of ionizing radiation                  Food and Drug Administration (FDA)                        riod Extended
                                                  can cause acute (deterministic) effects                                                                             End.
                                                  such as burns, reddening of the skin,                     Completed Actions
                                                                                                                                                                    Supplemental              09/29/14   79 FR 58433
                                                  cataracts, hair loss, sterility, and, in                  130. Standards for the Growing,                           NPRM.
                                                  extremely high doses, radiation                           Harvesting, Packing, and Holding of                     Supplemental              12/15/14
                                                  poisoning. The design of a CT X-ray                       Produce for Human Consumption                             NPRM Com-
                                                  system should balance the benefits of                                                                               ment Period
                                                  the device (i.e., the ability of the device                  Legal Authority: 21 U.S.C. 342; 21                     End.
                                                  to produce a diagnostic quality image)                    U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C.                   Final Action—             01/14/15   80 FR 1852
                                                  with the known risks (e.g., exposure to                   264; Pub. L. 111–353 (signed on January                   Draft Environ-
                                                  ionizing radiation). FDA is establishing                  4, 2011)                                                  mental Impact
                                                                                                               Abstract: This rule will establish                     Statement.
                                                  proposed special controls, which are                                                                              Final Action—             03/13/15
                                                  necessary to provide reasonable                           science-based minimum standards for
                                                                                                            the safe production and harvesting of                     Draft Environ-
                                                  assurance of the safety and effectiveness                                                                           mental Impact
                                                  of a class II CT X-ray system.                            those types of fruits and vegetables that                 Statement
                                                                                                            are raw agricultural commodities for                      Comment Pe-
                                                    Timetable:                                              which the Secretary has determined that                   riod End.
                                                                                                            such standards minimize the risk of                     Final Action Effec-       01/26/16
                                                         Action               Date           FR Cite
                                                                                                            serious adverse health consequences or                    tive.
                                                  NPRM ..................    05/00/17                       death. The purpose of the rule is to                    Final Rule ............   11/27/15   80 FR 74353
                                                                                                            reduce the risk of illness associated with
                                                                                                            fresh produce.                                            Regulatory Flexibility Analysis
                                                    Regulatory Flexibility Analysis                                                                                 Required: Yes.
                                                  Required: Yes.                                               Timetable:
                                                                                                                                                                      Agency Contact: Samir Assar,
                                                    Agency Contact: Erica Blake,                                   Action                Date          FR Cite      Supervisory Consumer Safety Officer,
                                                  Regulatory Counsel, Department of                                                                                 Department of Health and Human
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                  Health and Human Services, Food and                       NPRM ..................   01/16/13       78 FR 3503     Services, Food and Drug
                                                  Drug Administration, Center for Devices                   NPRM Comment              05/16/13                      Administration, Center for Food Safety
                                                  and Radiological Health, WO 66, Room                       Period End.
                                                                                                                                                                    and Applied Nutrition, Office of Food
                                                  4426, 10903 New Hampshire Avenue,                         NPRM Comment              04/26/13       78 FR 24692
                                                                                                             Period Ex-                                             Safety, 5100 Paint Branch Parkway,
                                                  Silver Spring, MD 20993, Phone: 301                                                                               College Park, MD 20740, Phone: 240
                                                                                                             tended.
                                                  796–6248, Fax: 301 847–8145, Email:                       NPRM Comment              09/16/13                      402–1636, Email: samir.assar@
                                                  erica.blake@fda.hhs.gov.                                   Period Ex-                                             fda.hhs.gov.
                                                    RIN: 0910–AH03                                           tended End.                                              RIN: 0910–AG35


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                                                                             Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda                                                   37303

                                                  131. Foreign Supplier Verification                               Action                Date          FR Cite      Security Boulevard, Baltimore, MD
                                                  Program                                                                                                           21244, Phone: 410 786–9465, Email:
                                                     Legal Authority: 21 U.S.C. 384a; title                 NPRM ..................   02/05/14       79 FR 7005     scott.cooper@cms.hhs.gov.
                                                                                                            NPRM Comment              05/23/14       79 FR 29699      RIN: 0938–AS21
                                                  III, sec 301 of FDA Food Safety                             Period Ex-
                                                  Modernization Act; Pub. L. 111–353,                         tended.                                               134. Merit-Based Incentive Payment
                                                  establishing sec 805 of the Federal Food,                 NPRM Comment              05/31/14                      System (MIPS) and Alternative
                                                  Drug, and Cosmetic Act (FD&C Act)                           Period End.                                           Payment Models (APMS) in Medicare
                                                     Abstract: This rule describes what a                   NPRM Comment              07/30/14                      Fee-For-Service (CMS–5517–P) (Section
                                                  food importer must do to verify that its                    Period Ex-                                            610 Review)
                                                  foreign suppliers produce food that is as                   tended End.
                                                  safe as food produced in the United                       Final Rule ............   04/06/16       81 FR 20092      Legal Authority: Pub. L. 114–10, sec
                                                  States. FDA is taking this action to                      Final Rule Effec-         06/06/16                      101
                                                  improve the safety of food that is
                                                                                                              tive.                                                   Abstract: This proposed rule would
                                                  imported into the United States.                                                                                  implement provisions of the Medicare
                                                                                                              Regulatory Flexibility Analysis                       Access and CHIP Reauthorization Act
                                                     Timetable:
                                                                                                            Required: Yes.                                          (MACRA) related to MIPS and APMs.
                                                                                                              Agency Contact: Michael E. Kashtock,                  Section 101 of MACRA authorizes a
                                                         Action               Date           FR Cite
                                                                                                            Supervisory Consumer Safety Officer,                    new MIPS, which repeals the Medicare
                                                  NPRM ..................   07/29/13      78 FR 45729       Department of Health and Human                          sustainable growth rate and improves
                                                  NPRM Comment              11/26/13                        Services, Food and Drug                                 Medicare payments for physician
                                                    Period End.                                             Administration, Center for Food Safety                  services. MACRA consolidates the
                                                  NPRM Comment              11/20/13      78 FR 69602       and Applied Nutrition, Office of Food                   current programs of the Physician
                                                    Period Ex-                                              Safety, 5100 Paint Branch Parkway,                      Quality Reporting System, the Value-
                                                    tended.                                                 College Park, MD 20740, Phone: 240
                                                  NPRM Comment               01/27/14                                                                               Based Modifier, and the Electronic
                                                                                                            402–2022, Fax: 301 346–2632, Email:                     Health Records Incentive Program into
                                                    Period Ex-
                                                    tended End.
                                                                                                            michael.kashtock@fda.hhs.gov.                           one program, MIPS, that streamlines
                                                  Supplemental              09/29/14      79 FR 58573
                                                                                                              RIN: 0910–AG98                                        and improves on the three distinct
                                                    NPRM.                                                                                                           incentive programs. Additionally,
                                                  Supplemental              12/15/14                                                                                MACRA authorizes incentive payments
                                                    NPRM Com-                                               DEPARTMENT OF HEALTH AND                                for providers who participate in eligible
                                                    ment Period                                                                                                     APMs.
                                                    End.
                                                                                                            HUMAN SERVICES (HHS)
                                                                                                                                                                      Timetable:
                                                  Final Rule ............   11/27/15      80 FR 74225       Centers for Medicare & Medicaid
                                                  Final Rule Effec-         01/27/16                        Services (CMS)
                                                    tive.                                                                                                                   Action             Date        FR Cite
                                                                                                            Proposed Rule Stage
                                                                                                                                                                    NPRM ..................   05/09/16   81 FR 28161
                                                    Regulatory Flexibility Analysis                                                                                 NPRM Comment              06/27/16
                                                                                                            133. Hospital and Critical Access
                                                  Required: Yes.                                                                                                     Period End.
                                                                                                            Hospital (CAH) Changes to Promote
                                                    Agency Contact: Brian L. Pendleton,
                                                                                                            Innovation, Flexibility, and
                                                  Senior Policy Advisor, Department of                                                                                Regulatory Flexibility Analysis
                                                                                                            Improvement in Patient Care (CMS–
                                                  Health and Human Services, Food and                                                                               Required: Yes.
                                                                                                            3295–P) (Rulemaking Resulting From a
                                                  Drug Administration, Office of Policy,                                                                              Agency Contact: James Sharp, Health
                                                                                                            Section 610 Review)
                                                  WO 32, Room 4245, 10903 New                                                                                       Insurance Specialist, Department of
                                                  Hampshire Avenue, Silver Spring, MD                         Legal Authority: 42 U.S.C. 1302; 42                   Health and Human Services, Centers for
                                                  20993–0002, Phone: 301 796–4614, Fax:                     U.S.C. 1395hh and 1395rr                                Medicare & Medicaid Services, Center
                                                  301 847–8616, Email: brian.pendleton@                       Abstract: This proposed rule would
                                                                                                                                                                    for Medicare & Medicaid Innovation
                                                  fda.hhs.gov.                                              update the requirements that hospitals
                                                                                                                                                                    Center, MS: WB–06–05, 7500 Security
                                                    RIN: 0910–AG64                                          and Critical Access Hospitals (CAHs)
                                                                                                                                                                    Boulevard, Baltimore, MD 21244,
                                                                                                            must meet to participate in the Medicare
                                                  132. Sanitary Transportation of Human                                                                             Phone: 410 786–7388, Email:
                                                                                                            and Medicaid programs. These
                                                  and Animal Food                                                                                                   james.sharp@cms.hhs.gov.
                                                                                                            proposals are intended to conform the
                                                                                                                                                                      RIN: 0938–AS69
                                                     Legal Authority: 21 U.S.C. 350e; 21                    requirements to current standards of
                                                  U.S.C. 373; 21 U.S.C. 331; 21 U.S.C. 342;                 practice and to support improvements                    135. Hospital Inpatient Prospective
                                                  21 U.S.C. 371; . . .                                      in quality of care, reduce barriers to                  Payment System for Acute Care
                                                     Abstract: This rule would establish                    care, and reduce some issues that may                   Hospitals and the Long-Term Care
                                                  requirements for parties including                        exacerbate workforce shortage concerns.                 Hospital Prospective Payment System
                                                  shippers, carriers by motor vehicle or                      Timetable:                                            and FY 2017 Rates (CMS–1655–F)
                                                  rail vehicle, and receivers engaged in                                                                            (Section 610 Review)
                                                  the transportation of food, including                            Action                Date          FR Cite
                                                                                                                                                                      Legal Authority: 42 U.S.C. 1302; 42
                                                  food for animals, to use sanitary                                                                                 U.S.C. 1395hh
                                                                                                            NPRM ..................   05/00/16
                                                  transportation practices to ensure that                                                                             Abstract: This annual final rule
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                                                  food is not transported under conditions                                                                          revises the Medicare hospital inpatient
                                                                                                              Regulatory Flexibility Analysis
                                                  that may render the food adulterated.                                                                             and long-term care hospital prospective
                                                                                                            Required: No.
                                                     Timetable:                                               Agency Contact: CDR Scott Cooper,                     payment systems for operating and
                                                                                                            Senior Technical Advisor, Department                    capital-related costs. This rule
                                                         Action               Date           FR Cite
                                                                                                            of Health and Human Services, Centers                   implements changes arising from our
                                                  ANPRM ...............     04/30/10      75 FR 22713       for Medicare & Medicaid Services,                       continuing experience with these
                                                  ANPRM Comment             08/30/10                        Center for Clinical Standards and                       systems.
                                                   Period End.                                              Quality, Mail Stop S3–01–02, 7500                         Timetable:


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                                                  37304                      Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda

                                                         Action               Date           FR Cite        would apply to services furnished                      DEPARTMENT OF HEALTH AND
                                                                                                            beginning January 1, 2017.                             HUMAN SERVICES (HHS)
                                                  NPRM ..................   04/27/16      81 FR 24946
                                                                                                              Timetable:                                           Centers for Medicare & Medicaid
                                                  NPRM Comment              06/17/16
                                                    Period End.                                                                                                    Services (CMS)
                                                  Final Action .........     08/00/16                              Action                Date         FR Cite
                                                                                                                                                                   Final Rule Stage
                                                                                                            NPRM ..................   06/00/16                     139. Emergency Preparedness
                                                    Regulatory Flexibility Analysis
                                                  Required: Yes.                                                                                                   Requirements for Medicare and
                                                    Agency Contact: Donald Thompson,                          Regulatory Flexibility Analysis                      Medicaid Participating Providers and
                                                  Deputy Director, Division of Acute Care,                  Required: Yes.                                         Suppliers (CMS–3178–F) (Section 610
                                                  Department of Health and Human                              Agency Contact: Ryan Howe, Director,                 Review)
                                                  Services, Centers for Medicare &                          Division of Practitioner Services,                        Legal Authority: 42 U.S.C. 1821; 42
                                                  Medicaid Services, Center for Medicare,                   Department of Health and Human                         U.S.C. 1861ff (3)(B)(i)(ii); 42 U.S.C.
                                                  MS: C4–01–26, 7500 Security                               Services, Centers for Medicare &                       1913(c)(1) et al
                                                  Boulevard, Baltimore, MD 21244,                           Medicaid Services, Center for Medicare,                   Abstract: This rule finalizes
                                                  Phone: 410 786–6504, Email:                               MS: C4–01–15, 7500 Security                            emergency preparedness requirements
                                                  donald.thompson@cms.hhs.gov.                              Boulevard, Baltimore, MD 21244,                        for Medicare and Medicaid participating
                                                    RIN: 0938–AS77                                          Phone: 410 786–3355, Email:                            providers and suppliers to ensure that
                                                  136. CY 2017 Home Health Prospective                      ryan.howe@cms.hhs.gov.                                 they adequately plan for both natural
                                                  Payment System Rate Update; Home                                                                                 and man-made disasters and coordinate
                                                                                                              RIN: 0938–AS81                                       with Federal, State, tribal, regional, and
                                                  Health Value-Based Purchasing Model;
                                                  and Home Health Quality Reporting                         138. CY 2017 Hospital Outpatient PPS                   local emergency preparedness systems.
                                                  Requirements (Section 610 Review)                         Policy Changes and Payment Rates and                   This rule ensures providers and
                                                                                                            Ambulatory Surgical Center Payment                     suppliers are adequately prepared to
                                                    Legal Authority: 42 U.S.C. 1302; 42                                                                            meet the needs of patients, residents,
                                                  U.S.C. 1395hh                                             System Policy Changes and Payment
                                                                                                            Rates (CMS–1656–P) (Section 610                        clients, and participants during
                                                    Abstract: This annual proposed rule                                                                            disasters and emergency situations.
                                                  would update the 60-day national                          Review)
                                                                                                                                                                      Timetable:
                                                  episode rate, the national per-visit rates                  Legal Authority: 42 U.S.C. 1302; 42
                                                  used to calculate low utilization                         U.S.C. 1395hh                                                  Action             Date        FR Cite
                                                  payment adjustments (LUPAs), and
                                                  outlier payments under the Medicare                         Abstract: This annual proposed rule                  NPRM ..................   12/27/13   78 FR 79082
                                                  prospective payment system for home                       would revise the Medicare hospital                     NPRM Comment              02/21/14   79 FR 9872
                                                                                                            outpatient prospective payment system                    Period Ex-
                                                  health agencies. The rule would also                                                                               tended.
                                                  update the provisions of the Home                         to implement statutory requirements
                                                                                                                                                                   NPRM Comment              03/31/14
                                                  Health Value-Based Purchasing                             and changes arising from our continuing                  Period End.
                                                  (HHVBP) program.                                          experience with this system. The rule                  Final Action .........    12/00/16
                                                    Timetable:                                              describes changes to the amounts and
                                                                                                            factors used to determine payment rates                  Regulatory Flexibility Analysis
                                                         Action               Date           FR Cite        for services. In addition, the rule would              Required: Yes.
                                                                                                            change the ambulatory surgical center                    Agency Contact: Janice Graham,
                                                  NPRM ..................    06/00/16                                                                              Health Insurance Specialist, Department
                                                                                                            payment system list of services and
                                                                                                            rates.                                                 of Health and Human Services, Centers
                                                    Regulatory Flexibility Analysis                                                                                for Medicare & Medicaid Services,
                                                  Required: Yes.                                              Timetable:                                           Center for Clincial Standards and
                                                    Agency Contact: Hillary Loeffler,                                                                              Quality, Mail Stop S3–02–01, 7500
                                                  Deputy Director, Division of Home                                Action                Date         FR Cite
                                                                                                                                                                   Security Boulevard, Baltimore, MD
                                                  Health and Hospice, Department of                                                                                21244–1850, Phone: 410 786–8020,
                                                  Health and Human Services, Centers for                    NPRM ..................   07/00/16
                                                                                                                                                                   Email: janice.graham@cms.hhs.gov.
                                                  Medicare & Medicaid Services, Center                                                                               RIN: 0938–AO91
                                                  for Medicare, MS: C5–07–22, 7500                            Regulatory Flexibility Analysis
                                                  Security Boulevard, Baltimore, MD                         Required: Yes.                                         140. Reform of Requirements for Long–
                                                  21244, Phone: 410 786–0456, Email:                                                                               Term Care Facilities (CMS–3260–F)
                                                                                                              Agency Contact: Marjorie Baldo,                      (Rulemaking Resulting From a Section
                                                  hillary.loeffler@cms.hhs.gov.                             Health Insurance Specialist, Department
                                                    RIN: 0938–AS80                                                                                                 610 Review)
                                                                                                            of Health and Human Services, Centers
                                                                                                            for Medicare & Medicaid Services,                        Legal Authority: Pub. L. 111–148, sec
                                                  137. CY 2017 Revisions to Payment
                                                                                                            Center for Medicare, MS: C4–03–06,                     6102; 42 U.S.C. 263a; 42 U.S.C. 1302; 42
                                                  Policies Under the Physician Fee
                                                                                                            7500 Security Boulevard, Baltimore, MD                 U.S.C. 1395hh; 42 U.S.C. 1395rr
                                                  Schedule and Other Revisions to
                                                                                                                                                                     Abstract: This final rule revises the
                                                  Medicare Part B (CMS–1654–P) (Section                     21244, Phone: 410 786–4617, Email:
                                                                                                                                                                   requirements that long-term care
sradovich on DSK3TPTVN1PROD with PROPOSALS




                                                  610 Review)                                               marjorie.baldo@cms.hhs.gov.                            facilities must meet to participate in the
                                                    Legal Authority: 42 U.S.C. 1302; 42                       RIN: 0938–AS82                                       Medicare and Medicaid programs.
                                                  U.S.C. 1395hh; Pub. L. 114–10                                                                                    These changes are necessary to reflect
                                                    Abstract: This annual proposed rule                                                                            the substantial advances that have been
                                                  would revise payment polices under the                                                                           made over the past several years in the
                                                  Medicare physician fee schedule, and                                                                             theory and practice of service delivery
                                                  make other policy changes to payment                                                                             and safety. The rule is also an integral
                                                  under Medicare Part B. These changes                                                                             part of CMS efforts to achieve broad-


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                                                                             Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda                                                   37305

                                                  based improvements both in the quality                           Action                Date          FR Cite      143. Imaging Accreditation (CMS–
                                                  of health care furnished through federal                                                                          3309–P) (Section 610 Review)
                                                  programs, and in patient safety, while at                 NPRM ..................   03/10/97       62 FR 11005
                                                                                                                                                                      Legal Authority: 42 U.S.C. 1395hh; 42
                                                  the same time reducing procedural                         NPRM Comment              06/09/97
                                                                                                              Period End.                                           U.S.C. 1102
                                                  burdens on providers.                                                                                               Abstract: This proposed rule would
                                                                                                            Second NPRM ....          10/09/14       79 FR 61163
                                                    Timetable:                                              NPRM Comment              12/01/14       79 FR 71081    establish standards for Imaging
                                                                                                              Period Ex-                                            Accreditation. These proposed
                                                         Action               Date           FR Cite          tended.                                               standards would address qualifications
                                                                                                            NPRM Comment              12/08/14                      for clinical personnel, standards to
                                                  NPRM ..................   07/16/15      80 FR 42167         Period End.
                                                  NPRM Comment              09/15/15      80 FR 55284
                                                                                                                                                                    ensure that suppliers have established
                                                                                                            NPRM Comment              01/07/15                      policies and procedures governing the
                                                    Period Exten-                                             Period Ex-
                                                    sion.                                                                                                           use of equipment in furnishing the
                                                                                                              tended End.
                                                  NPRM Comment              09/14/15                                                                                technical component of advanced
                                                                                                            Final Action .........    10/00/17
                                                    Period End.                                                                                                     diagnostic imaging, and the
                                                  NPRM Comment               10/14/15                                                                               establishment and maintenance of a
                                                    Period Ex-                                                Regulatory Flexibility Analysis                       quality assurance and quality control
                                                    tended End.                                             Required: No.                                           program to ensure reliability, clarity,
                                                  Final Action .........     09/00/16                         Agency Contact: Danielle Shearer,                     and accuracy of the diagnostic images.
                                                                                                            Health Insurance Specialist, Department                   Timetable:
                                                    Regulatory Flexibility Analysis                         of Health and Human Services, Centers
                                                  Required: Yes.                                            for Medicare & Medicaid Services,                               Action             Date        FR Cite
                                                    Agency Contact: Ronisha Blackstone,                     Center for Clinical Standards & Quality,
                                                  Health Insurance Specialist, Department                   7500 Security Boulevard, MS: S3–02–                     NPRM ..................     To Be    Determined
                                                  of Health and Human Services, Centers                     01, Baltimore, MD 21244, Phone: 410
                                                                                                            786–6617, Email: danielle.shearer@                        Regulatory Flexibility Analysis
                                                  for Medicare & Medicaid Services,
                                                                                                            cms.hhs.gov.                                            Required: Yes.
                                                  Center for Clinical Standards and
                                                                                                              RIN: 0938–AG81                                          Agency Contact: Sonia Swancy,
                                                  Quality, MS: S3–02–01, 7500 Security
                                                                                                                                                                    Health Insurance Specialist, Department
                                                  Boulevard, Baltimore, MD 21244,                           142. Medicare Clinical Diagnostic                       of Health and Human Services, Centers
                                                  Phone: 410 786–6882, Email:                               Laboratory Test Payment System (CMS–                    for Medicare & Medicaid Services,
                                                  ronisha.blackstone@cms.hhs.gov.                           1621–F) (Section 610 Review)                            Center for Clinical Standards and
                                                    RIN: 0938–AR61                                                                                                  Quality, MS: S3–02–01, 7500 Security
                                                                                                              Legal Authority: Pub. L. 113–93, sec
                                                                                                                                                                    Boulevard, Baltimore, MD 21244,
                                                                                                            216
                                                                                                                                                                    Phone: 410 786–8445, Email:
                                                                                                              Abstract: This final rule revises the                 sonia.swancy@cms.hhs.gov.
                                                  DEPARTMENT OF HEALTH AND                                  Medicare payment system for clinical
                                                  HUMAN SERVICES (HHS)                                                                                                RIN: 0938–AS62
                                                                                                            diagnostic laboratory tests and
                                                  Long-Term Actions                                         implements other changes required by
                                                                                                            section 216 of the Protecting Access to
                                                  Centers for Medicare & Medicaid                           Medicare Act of 2014.                                   DEPARTMENT OF HEALTH AND
                                                  Services (CMS)                                                                                                    HUMAN SERVICES (HHS)
                                                                                                              Timetable:
                                                  141. Conditions of Participation for                                                                              Completed Actions
                                                  Home Health Agencies (CMS–3819–F)                                Action                Date          FR Cite
                                                  (Rulemaking Resulting From a Section                                                                              Centers for Medicare & Medicaid
                                                  610 Review)                                               NPRM ..................   10/01/15       80 FR 59385    Services (CMS)
                                                                                                            NPRM Comment              11/25/15
                                                     Legal Authority: 42 U.S.C. 1302; 42                      Period End.                                           144. Covered Outpatient Drugs (CMS–
                                                  U.S.C. 1395x; 42 U.S.C. 1395cc(a); 42                     Final Action .........    10/00/18                      2345–FC) (Completion of a Section 610
                                                  U.S.C. 1395hh; 42 U.S.C. 1395bb                                                                                   Review)
                                                     Abstract: This final rule revises the                    Regulatory Flexibility Analysis                         Legal Authority: Pub. L. 111–48, sec
                                                  conditions of participation (CoPs) that                   Required: Yes.                                          2501; Pub. L. 111–48, 2503; Pub. L. 111–
                                                  home health agencies (HHAs) must meet                       Agency Contact: Valerie Miller,                       48, 3301(d)(2); Pub. L. 111–152, sec
                                                  in order to participate in the Medicare                   Deputy Director, Division of                            1206; Pub. L. 111–8, sec 221
                                                  and Medicaid programs. The                                Ambulatory Services, Department of                        Abstract: This final rule revises
                                                  requirements focus on the care                            Health and Human Services, Centers for                  requirements pertaining to Medicaid
                                                  delivered to patients by HHAs, reflect                    Medicare & Medicaid Services, Center                    reimbursement for covered outpatient
                                                  an interdisciplinary view of patient                      for Medicare, Mail Stop C4–01–26, 7500                  drugs to implement provisions of the
                                                  care, allow HHAs greater flexibility in                   Security Boulevard, Baltimore, MD                       Affordable Care Act. This rule also
                                                  meeting quality care standards, and                       21244, Phone: 410 786–4535, Email:                      revises other requirements related to
                                                  eliminate unnecessary procedural                          valerie.miller@cms.hhs.gov.                             covered outpatient drugs, including key
                                                  requirements. These changes are an                          Sarah Harding, Health Insurance                       aspects of Medicaid coverage, payment,
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                                                  integral part of our overall effort to                    Specialist, Department of Health and                    and the drug rebate program.
                                                  achieve broad-based, measurable                           Human Services, Centers for Medicare &                    Timetable:
                                                  improvements in the quality of care                       Medicaid Services, Center for Medicare,
                                                  furnished through the Medicare and                        MS: C4–01–26, 7500 Security                                     Action             Date        FR Cite
                                                  Medicaid programs, while at the same                      Boulevard, Baltimore, MD 21244,                         NPRM ..................   02/02/12   77 FR 5318
                                                  time eliminating unnecessary                              Phone: 410 786–4535, Email:                             NPRM Comment              04/02/12
                                                  procedural burdens on providers.                          sarah.harding@cms.hhs.gov.                                Period End.
                                                     Timetable:                                               RIN: 0938–AS33                                        Final Action .........    02/01/16   81 FR 5170



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                                                  37306                      Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Unified Agenda

                                                         Action               Date           FR Cite        Department of Health and Human                          147. Comprehensive Care for Joint
                                                                                                            Services, Centers for Medicare &                        Replacement (CMS–5516–F)
                                                  Final Action Effec-       04/01/16                        Medicaid Services, Center for Medicare,                 (Completion of a Section 610 Review)
                                                    tive.                                                   MS: C4–01–15, 7500 Security
                                                                                                            Boulevard, Baltimore, MD 21244,                           Legal Authority: Social Security Act,
                                                    Regulatory Flexibility Analysis                         Phone: 410 786–3355, Email:                             sec 1115A
                                                  Required: Yes.                                            ryan.howe@cms.hhs.gov.                                    Abstract: This final rule implements a
                                                    Agency Contact: Wendy Tuttle,                             RIN: 0938–AS40                                        new Medicare Part A and B payment
                                                  Health Insurance Specialist, Department                                                                           model under section 1115A of the
                                                  of Health and Human Services, Centers                     146. CY 2016 Hospital Outpatient PPS
                                                                                                                                                                    Social Security Act, called the
                                                  for Medicare & Medicaid Services,                         Policy Changes and Payment Rates and
                                                                                                                                                                    Comprehensive Care Joint Replacement
                                                  Center for Medicaid and State                             Ambulatory Surgical Center Payment
                                                                                                                                                                    Model, in which acute care hospitals in
                                                  Operations, Mail Stop S2–14–26, 7500                      System Policy Changes and Payment
                                                                                                                                                                    certain selected geographic areas receive
                                                  Security Boulevard, Baltimore, MD                         Rates (CMS–1633–FC) (Completion of a
                                                                                                                                                                    retrospective bundled payments for
                                                  21244, Phone: 410 786–8690, Email:                        Section 610 Review)
                                                                                                                                                                    episodes of care for lower extremity
                                                  wendy.tuttle@cms.hhs.gov.                                   Legal Authority: 42 U.S.C. 1302,                      joint replacement or reattachment of a
                                                    RIN: 0938–AQ41                                          1395m, 1395hh, and 1395ddd                              lower extremity. All related care within
                                                                                                              Abstract: This annual final rule                      90 days of hospital discharge from the
                                                  145. CY 2016 Revisions to Payment
                                                                                                            revises the Medicare hospital outpatient                joint replacement procedures would be
                                                  Policies Under the Physician Fee
                                                                                                            prospective payment system to                           included in the episode of care. We
                                                  Schedule and Other Revisions to
                                                                                                            implement statutory requirements and                    believe this model furthers our goals in
                                                  Medicare Part B (CMS–1631–FC)
                                                                                                            changes arising from our continuing                     improving the efficiency and quality of
                                                  (Completion of a Section 610 Review)
                                                                                                            experience with this system. The rule                   care for Medicare beneficiaries for these
                                                    Legal Authority: 42 U.S.C. 405(a),                      describes changes to the amounts and                    common medical procedures.
                                                  1302, 1395x, 1395y(a), 1395ff, 1395kk,                    factors used to determine payment rates
                                                  1395rr and 1395ww(k); 42 U.S.C. 263a;                     for services. In addition, the rule                       Timetable:
                                                  42 U.S.C. 1395m, 1395hh, and 1395ddd;                     changes the ambulatory surgical center
                                                  42 U.S.C. 1395w–101 through 1395w–                                                                                        Action             Date        FR Cite
                                                                                                            payment system list of services and
                                                  152, and 1395nn; ...                                      rates.                                                  NPRM ..................   07/14/15   80 FR 41198
                                                    Abstract: This annual final rule                          Timetable:                                            NPRM Comment              09/08/15
                                                  revises payment polices under the                                                                                   Period End.
                                                  Medicare physician fee schedule, and                             Action                Date          FR Cite      Final Action .........    11/24/15   80 FR 73273
                                                  makes other policy changes to payment                                                                             Final Action Effec-       01/15/16
                                                  under Medicare Part B. These changes                      NPRM ..................   07/08/15       80 FR 39200      tive.
                                                                                                            NPRM Comment              08/31/15
                                                  apply to services furnished beginning
                                                                                                              Period End.
                                                  January 1, 2016.                                          Final Action .........    11/13/15       80 FR 70298      Regulatory Flexibility Analysis
                                                    Timetable:                                              Final Action Effec-       01/01/16                      Required: Yes.
                                                                                                              tive.                                                   Agency Contact: Claire Schreiber,
                                                         Action               Date           FR Cite
                                                                                                                                                                    Health Insurance Specialist, Department
                                                                                                              Regulatory Flexibility Analysis                       of Health and Human Services, Centers
                                                  NPRM ..................   07/15/15      80 FR 41686
                                                  NPRM Comment              09/08/15                        Required: Yes.                                          for Medicare & Medicaid Services,
                                                    Period End.                                               Agency Contact: Marjorie Baldo,                       Center for Medicare & Medicaid
                                                  Final Action .........    11/16/15      80 FR 70886       Health Insurance Specialist, Department                 Innovation, MS: WB–08–62, 7500
                                                  Final Action Effec-       01/01/16                        of Health and Human Services, Centers                   Security Boulevard, Baltimore, MD
                                                    tive.                                                   for Medicare & Medicaid Services,                       21244, Phone: 410 786–8939, Email:
                                                                                                            Center for Medicare, MS: C4–03–06,                      claire.schreiber@cms.hhs.gov.
                                                    Regulatory Flexibility Analysis                         7500 Security Boulevard, Baltimore, MD
                                                  Required: Yes.                                            21244, Phone: 410 786–4617, Email:                        RIN: 0938–AS64
                                                    Agency Contact: Ryan Howe, Director,                    marjorie.baldo@cms.hhs.gov.                             [FR Doc. 2016–12904 Filed 6–8–16; 8:45 am]
                                                  Division of Practitioner Services,                          RIN: 0938–AS42                                        BILLING CODE 4150–03–P
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Document Created: 2018-02-08 07:33:40
Document Modified: 2018-02-08 07:33:40
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionUnknown Section
ActionSemiannual Regulatory Agenda.
ContactWilma Robinson, Deputy Executive Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201; (202) 690-5627.
FR Citation81 FR 37294 
CFR Citation21
Title 21 CFR Chapter I
25
Title 25 CFR Chapter V

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