[Federal Register Volume 79, Number 245 (Monday, December 22, 2014)]
[Proposed Rules]
[Pages 76718-76731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28964]



[[Page 76717]]

Vol. 79

Monday,

No. 245

December 22, 2014

Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

Federal Register / Vol. 79 , No. 245 / Monday, December 22, 2014 / 
Unified Agenda

[[Page 76718]]


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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: C'Reda J. Weeden, 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.

    Dated: September 22, 2014.
 C'Reda J. Weeden,
Executive Secretary to the Department.

Substance Abuse and Mental Health Services Administration--Proposed Rule
                                  Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
275.......................  SAMHSA User Fees for               0930-AA18
                             Publications.
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
276.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review_Cough/Cold
                             (Antihistamine) Products.
277.......................  Over-the-Counter (OTC)             0910-AF36
                             Drug Review_Internal
                             Analgesic Products.
278.......................  Over-the-Counter (OTC)             0910-AF69
                             Drug Review_Topical
                             Antimicrobial Drug
                             Products.
279.......................  Abbreviated New Drug               0910-AF97
                             Applications and
                             505(b)(2).
280.......................  Updated Standards for              0910-AG09
                             Labeling of Pet Food.
281.......................  Current Good Manufacturing         0910-AG10
                             Practice and Hazard
                             Analysis and Risk-Based
                             Preventive Controls for
                             Food for Animals (Reg
                             Plan Seq No. 48).
282.......................  Over-the-Counter (OTC)             0910-AG12
                             Drug Review_Pediatric
                             Dosing for Cough/Cold
                             Products.
283.......................  Electronic Distribution of         0910-AG18
                             Prescribing Information
                             for Human Prescription
                             Drugs Including
                             Biological Products.
284.......................  Standards for the Growing,         0910-AG35
                             Harvesting, Packing, and
                             Holding of Produce for
                             Human Consumption (Reg
                             Plan Seq No. 49).
285.......................  Current Good Manufacturing         0910-AG36
                             and Hazard Analysis, and
                             Risk-Based Preventive
                             Controls for Human Food
                             (Reg Plan Seq No. 50).
286.......................  Requirements for the               0910-AG59
                             Testing and Reporting of
                             Tobacco Product
                             Constituents,
                             Ingredients, and
                             Additives.
287.......................  Foreign Supplier                   0910-AG64
                             Verification Program (Reg
                             Plan Seq No. 52).
288.......................  Format and Content of              0910-AG96
                             Reports Intended to
                             Demonstrate Substantial
                             Equivalence.
289.......................  Food Labeling; Gluten-Free         0910-AH00
                             Labeling of Fermented,
                             Hydrolyzed, or Distilled
                             Foods.
290.......................  Radiology Devices;                 0910-AH03
                             Designation of Special
                             Controls for the Computed
                             Tomography X-Ray System.
291.......................  Mammography Quality                0910-AH04
                             Standards Act; Regulatory
                             Amendments.
292.......................  Investigational New Drug           0910-AH07
                             Application Annual
                             Reporting.
293.......................  General and Plastic                0910-AH14
                             Surgery Devices: Sunlamp
                             Products.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


[[Page 76719]]


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
294.......................  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.
295.......................  Content and Format of              0910-AF11
                             Labeling for Human
                             Prescription Drugs and
                             Biologics; Requirements
                             for Pregnancy and
                             Lactation Labeling.
296.......................  Combinations of                    0910-AF33
                             Bronchodilators With
                             Nasal Decongestant; Cold,
                             Cough, Allergy,
                             Bronchodilator, and
                             Antiasthmatic Drug
                             Products for Over-the-
                             Counter Human Use.
297.......................  Over-the-Counter (OTC)             0910-AF38
                             Drug Review_Laxative Drug
                             Products.
298.......................  Laser Products; Amendment          0910-AF87
                             to Performance Standard.
299.......................  ``Tobacco Products''               0910-AG38
                             Subject to the Federal
                             Food, Drug, and Cosmetic
                             Act, as Amended by the
                             Family Smoking Prevention
                             and Tobacco Control Act
                             (Reg Plan Seq No. 53).
300.......................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Investigations
                             for Medical Devices.
301.......................  Food Labeling: Calorie             0910-AG56
                             Labeling of Articles of
                             Food Sold in Vending
                             Machines (Reg Plan Seq
                             No. 54).
302.......................  Food Labeling: Nutrition           0910-AG57
                             Labeling of Standard Menu
                             Items in Restaurants and
                             Similar Retail Food
                             Establishments (Reg Plan
                             Seq No. 55).
303.......................  Supplemental Applications          0910-AG94
                             Proposing Labeling
                             Changes for Approved
                             Drugs and Biological
                             Products (Reg Plan Seq
                             No. 58).
304.......................  Veterinary Feed Directive          0910-AG95
                             (Reg Plan Seq No. 59).
305.......................  Combinations of                    0910-AH16
                             Bronchodilators With
                             Expectorants; Cold,
                             Cough, Allergy,
                             Bronchodilator, and
                             Antiasthmatic Drug
                             Products for Over-the-
                             Counter Human Use.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
306.......................  Food Labeling; Revision of         0910-AF22
                             the Nutrition and
                             Supplement Facts Labels.
307.......................  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.
308.......................  Focused Mitigation                 0910-AG63
                             Strategies To Protect
                             Food Against Intentional
                             Adulteration.
309.......................  Sanitary Transportation of         0910-AG98
                             Human and Animal Food.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
310.......................  Infant Formula: Current            0910-AF27
                             Good Manufacturing
                             Practices; Quality
                             Control Procedures;
                             Notification
                             Requirements; Records and
                             Reports; and Quality
                             Factors.
311.......................  Postmarketing Safety               0910-AF96
                             Reports for Human Drug
                             and Biological Products:
                             Electronic Submission
                             Requirements.
312.......................  Requirements for the               0910-AG81
                             Submission of Data Needed
                             to Calculate User Fees
                             for Domestic
                             Manufacturers and
                             Importers of Tobacco
                             Products.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
313.......................  Home Health Agency                 0938-AG81
                             Conditions of
                             Participation (CMS-3819-
                             F) (Rulemaking Resulting
                             From a Section 610
                             Review).
314.......................  Reform of Requirements for         0938-AR61
                             Long-Term Care Facilities
                             (CMS-3260-P) (Rulemaking
                             Resulting From a Section
                             610 Review) (Reg Plan Seq
                             No. 60).
315.......................  Medicare Shared Savings            0938-AS06
                             Program; Accountable Care
                             Organizations (CMS-1461-
                             P) (Section 610 Review).
316.......................  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).
317.......................  Medicare Clinical                  0938-AS33
                             Diagnostic Laboratory
                             Test Payment System (CMS-
                             1621-P).
318.......................  CY 2016 Revisions to               0938-AS40
                             Payment Policies under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1631-P) (Reg
                             Plan Seq No. 63).
319.......................  Hospital Inpatient                 0938-AS41
                             Prospective Payment
                             System for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and FY 2016 Rates
                             (CMS-1632-P) (Reg Plan
                             Seq No. 64).
320.......................  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-
                             P) (Reg Plan Seq No. 65).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.


[[Page 76720]]


       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
321.......................  Covered Outpatient Drugs           0938-AQ41
                             (CMS-2345-F) (Section 610
                             Review).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
322.......................  Emergency Preparedness             0938-AO91
                             Requirements for Medicare
                             and Medicaid
                             Participating Providers
                             and Suppliers (CMS-3178-
                             F).
323.......................  Adoption of Operating              0938-AS01
                             Rules for HIPAA
                             Transactions (CMS-0036-
                             IFC).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
324.......................  Prospective Payment System         0938-AR62
                             for Federally Qualified
                             Health Centers; Changes
                             to Contracting Policies
                             for Rural Health Clinics
                             and CLIA Enforcement
                             Actions for Proficiency
                             Testing Referral (CMS-
                             1443-FC) (Completion of a
                             Section 610 Review).
325.......................  Hospital Inpatient                 0938-AS11
                             Prospective Payment
                             System for Acute Care
                             Hospitals and the Long-
                             Term Care Hospital
                             Prospective Payment
                             System and Fiscal Year
                             2015 Rates (CMS-1607-F)
                             (Completion of a Section
                             610 Review).
326.......................  CY 2015 Revisions to               0938-AS12
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1612-FC)
                             (Section 610 Review).
327.......................  CY 2015 End-Stage Renal            0938-AS13
                             Disease Prospective
                             Payment System, Quality
                             Incentive Program, and
                             Durable Medical
                             Equipment, Prosthetics,
                             Orthotics, and Supplies
                             (CMS-1614-F) (Section 610
                             Review).
328.......................  CY 2015 Hospital                   0938-AS15
                             Outpatient Prospective
                             Payment System (PPS)
                             Policy Changes and
                             Payment Rates, and CY
                             2015 Ambulatory Surgical
                             Center Payment System
                             Policy Changes and
                             Payment Rates (CMS-1613-
                             FC) (Section 610 Review).
329.......................  Extension of Payment               0938-AS18
                             Adjustment for Low-Volume
                             Hospitals and the
                             Medicare-Dependent
                             Hospital Program Under
                             the FY 2014 Hospital
                             Inpatient Prospective
                             Payment System (CMS-1599-
                             IFC2) (Completion of a
                             Section 610 Review).
------------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Proposed Rule Stage

275. SAMHSA User Fees for Publications

    Legal Authority: 31 U.S.C. 9701; 31 U.S.C. 1111; EO 8284; EO 11541; 
Pub. L. 113-76
    Abstract: SAMSHA is proposing to implement a modest cost recovery 
program to partially offset the high costs of distributing its 
materials to the public. This user fee would apply only to ``over-the-
limit'' non-governmental orders. An ``over the limit'' order is defined 
as an order that exceeds either the average weight value (3.75 lbs) or 
the average number of copies (8). The ``non-governmental orders'' do 
not include: SAMHSA's Recovery Month bulk orders; orders by SAMHSA 
staff for meetings or conferences; and orders from ``.gov'' and 
``.mil'' addresses. Therefore, it is assumed that SAMHSA would not 
charge shipping for orders by other Federal, State, and local 
government agencies. The proposed rule would implement recent 
legislation allowing the funds collected as part of a user fee for 
publications and data requests to be available to SAMHSA until 
expended.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Altman, Legislative Director, Department of 
Health and Human Services, Substance Abuse and Mental Health Services 
Administration, 1 Choke Cherry Road, Rockville, MD 02857, Phone: 240 
276-2009, Email: <a href="/cdn-cgi/l/email-protection#b4d6c6ddd5da9ad5d8c0d9d5daf4c7d5d9dcc7d59ad3dbc2"><span class="__cf_email__" data-cfemail="0466766d656a2a65687069656a447765696c77652a636b72">[email protected]</span></a>.
    RIN: 0930-AA18

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

276. 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:

[[Page 76721]]



------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Reopening of Administrative Record..   08/25/00  65 FR 51780
Comment Period End..................   11/24/00  .......................
NPRM (Amendment) (Common Cold)......   09/00/15  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#f69c97989f9593d89792979b85db9d9f9891b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="600a010e0903054e0104010d134d0b090e07200604014e0808134e070f16">[email protected]</span></a>.
    RIN: 0910-AF31

277. Over-the-Counter (OTC) Drug Review--Internal Analgesic 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; 21 U.S.C. 374; 21 
U.S.C. 379e
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective, 
and not misbranded. After a final monograph (i.e., final rule) is 
issued, only OTC drugs meeting the conditions of the monograph, or 
having an approved new drug application, may be legally marketed. The 
first action addresses acetaminophen safety. The second action 
addresses products marketed for children under 2 years old and weight- 
and age-based dosing for children's products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Amendment) (Required Warnings    12/26/06  71 FR 77314
 and Other Labeling).
NPRM Comment Period End.............   05/25/07  .......................
Final Action (Required Warnings and    04/29/09  74 FR 19385
 Other Labeling).
Final Action (Correction)...........   06/30/09  74 FR 31177
Final Action (Technical Amendment)..   11/25/09  74 FR 61512
NPRM (Amendment) (Pediatric)........   10/00/15  .......................
NPRM (Amendment) (Acetaminophen)....   12/00/15  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#aac0cbc4c3c9cf84cbcecbc7d987c1c3c4cdeacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="e8828986818b8dc6898c89859bc58381868fa88e8c89c680809bc68f879e">[email protected]</span></a>.
    RIN: 0910-AF36

278. 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 healthcare antiseptic 
products.
    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 (Healthcare Antiseptic)........   04/00/15  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#6d070c03040e08430c090c001e400604030a2d0b090c4305051e430a021b"><span class="__cf_email__" data-cfemail="563c37383f3533783732373b257b3d3f383116303237783e3e2578313920">[email protected]</span></a>.
    RIN: 0910-AF69

279. 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................................   11/00/14  .......................
------------------------------------------------------------------------

    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, WO 51, Room 6268, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, 
Fax: 301 847-8440, Email: <a href="/cdn-cgi/l/email-protection#f69c97989f9593d881939f989384b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="85efe4ebece6e0abf2e0ecebe0f7c5e3e1e4abededf6abe2eaf3">[email protected]</span></a>.
    RIN: 0910-AF97

280. 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................................   04/00/15  .......................
------------------------------------------------------------------------

    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, Room 2642 (MPN-4, HFV-228), 7519 
Standish Place, Rockville, MD 20855, Phone: 240 453-6865, Email: 
<a href="/cdn-cgi/l/email-protection#3a4d535656535b5714584f48515255565e5f487a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="b9ced0d5d5d0d8d497dbcccbd2d1d6d5dddccbf9dfddd897d1d1ca97ded6cf">[email protected]</span></a>.
    RIN: 0910-AG09

281. Current Good Manufacturing Practice and Hazard Analysis and R-
Based Preventive Controls for Food for Animals

    Regulatory Plan: This entry is Seq. No. 48 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG10

[[Page 76722]]

282. Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/
Cold Products

    Legal Authority: 21 U.S.C. 331; 21 U.S.C. 351 to 353; 21 U.S.C. 
355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective, 
and not misbranded. After a final monograph (i.e., final rule) is 
issued, only OTC drugs meeting the conditions of the monograph, or 
having an approved new drug application, may be legally marketed. This 
action will propose changes to the final monograph to address safety 
and efficacy issues associated with pediatric cough and cold products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/00/15  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#0b616a6562686e256a6f6a6678266062656c4b6d6f6a25636378256c647d"><span class="__cf_email__" data-cfemail="dfb5beb1b6bcbaf1bebbbeb2acf2b4b6b1b89fb9bbbef1b7b7acf1b8b0a9">[email protected]</span></a>.
    RIN: 0910-AG12

283. Electronic Distribution of Prescribing Information for Human 
Prescription Drugs Including Biological Products

    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; 21 U.S.C. 358; 21 U.S.C. 360; 
21 U.S.C. 360b; 21 U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 
21 U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 
264
    Abstract: This rule would require electronic package inserts for 
human drug and biological prescription products with limited 
exceptions, in lieu of paper, which is currently used. These inserts 
contain prescribing information intended for healthcare practitioners. 
This would ensure that the information accompanying the product is the 
most up-to-date information regarding important safety and efficacy 
issues about these products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Megan Velez, Policy Analyst, Department of Health 
and Human Services, Food and Drug Administration, Office of Policy, WO 
32, Room 4249, 10903 New Hampshire Avenue, Silver Spring, MD 20993, 
Phone: 301 796-9301, Email: <a href="/cdn-cgi/l/email-protection#dbb6bebcbab5f5adbeb7bea19bbdbfbaf5b3b3a8f5bcb4ad"><span class="__cf_email__" data-cfemail="a3cec6c4c2cd8dd5c6cfc6d9e3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></a>.
    RIN: 0910-AG18

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

    Regulatory Plan: This entry is Seq. No. 49 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG35

285. Current Good Manufacturing and Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food

    Regulatory Plan: This entry is Seq. No. 50 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG36

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Carol Drew, 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: <a href="/cdn-cgi/l/email-protection#2f4c5b5f5d4a485a434e5b4640415c6f494b4e0147475c01484059"><span class="__cf_email__" data-cfemail="9ffcebefedfaf8eaf3feebf6f0f1ecdff9fbfeb1f7f7ecb1f8f0e9">[email protected]</span></a>.
    RIN: 0910-AG59

287. Foreign Supplier Verification Program

    Regulatory Plan: This entry is Seq. No. 52 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG64

288. 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................................   07/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gerie Voss, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Tobacco Products, Document Control Center, Bldg. 71, Rm. G335, 10903 
New Hampshire Ave., Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 
301 595-1426, Email: <a href="/cdn-cgi/l/email-protection#d5b6a1a5a7b0b2a0b9b4a1bcbabba695b3b1b4fbbdbda6fbb2baa3"><span class="__cf_email__" data-cfemail="a6c5d2d6d4c3c1d3cac7d2cfc9c8d5e6c0c2c788ceced588c1c9d0">[email protected]</span></a>.
    RIN: 0910-AG96

289. 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................................   01/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Felicia Billingslea, Director, Food Labeling and 
Standard Staff, Department of Health and Human Services, Food and Drug

[[Page 76723]]

Administration, Room 4D045, HFS 820, 5100 Paint Branch Parkway, College 
Park, MD 20740, Phone: 240 402-1803, Fax: 301 436-2636, Email: 
<a href="/cdn-cgi/l/email-protection#8ceae9e0e5efe5eda2eee5e0e0e5e2ebffe0e9edcceae8eda2e4e4ffa2ebe3fa"><span class="__cf_email__" data-cfemail="6d0b0801040e040c430f04010104030a1e01080c2d0b090c4305051e430a021b">[email protected]</span></a>.
    RIN: 0910-AH00

290. 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, when combined with the general controls, would 
provide reasonable assurance of the safety and effectiveness of a class 
II CT X-ray system.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/15  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#81e4f3e8e2e0afe3ede0eae4c1e7e5e0afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="fe9b8c979d9fd09c929f959bbe989a9fd096968dd0999188">[email protected]</span></a>.
    RIN: 0910-AH03

291. 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, such as breast density reporting, that have 
occurred since the regulations were published in 1997.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/00/15  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#026c636c617b2c726b7076426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="17797679746e39677e656357717376397f7f6439707861">[email protected]</span></a>.
    RIN: 0910-AH04

292. Investigational New Drug Application Annual Reporting

    Legal Authority: 21 U.S.C. 355(i); 21 U.S.C. 371(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 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................................   09/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Peter A. Taschenberger, Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
10903 New Hampshire Avenue, Building 51, Room 6312, Silver Spring, MD 
20993, Phone: 301 796-0018, Fax: 301 847-3529, Email: 
<a href="/cdn-cgi/l/email-protection#17677263726539637664747f727975726570726557717376397f7f6439707861"><span class="__cf_email__" data-cfemail="7101140514035f0510021219141f131403161403311715105f1919025f161e07">[email protected]</span></a>.
    RIN: 0910-AH07

293. 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................................   03/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Paul Gadiock, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, 10903 New 
Hampshire Avenue, W0-66, Room 4432, Silver Spring, MD 20993-0002, 
Phone: 301 796-5736, Fax: 301 847-8145, Email: 
<a href="/cdn-cgi/l/email-protection#403021352c6e272124292f232b002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="e494859188ca8385808d8b878fa4828085ca8c8c97ca838b92">[email protected]</span></a>.
    RIN: 0910-AH14

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

294. 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
    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........................   10/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Joy, Senior Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, WO 51, Room 
6254, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 
796-2242, Email: <a href="/cdn-cgi/l/email-protection#4e2a2f38272a602421370e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="157174637c713b7f7a6c557371743b7d7d663b727a63">[email protected]</span></a>.
    RIN: 0910-AA49

[[Page 76724]]

295. Content and Format of Labeling for Human Prescription Drugs and 
Biologics; Requirements for Pregnancy and Lactation Labeling

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 
U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 379e; 42 
U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264
    Abstract: This final rule will amend the content and format of the 
``Pregnancy,'' ``Labor and delivery,'' and ``Nursing mothers'' 
subsections of the ``Use in Specific Populations'' section of 
regulations regarding the labeling for human prescription drug and 
biological products to better communicate risks.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/29/08  73 FR 30831
NPRM Comment Period End.............   08/27/08  .......................
Final Action........................   11/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kathy Schreier, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Ave., WO51, Rm. 6246, 
Silver Spring, MD 20993, Phone: 301 796-3432, Email: 
<a href="/cdn-cgi/l/email-protection#82e9e3f6eafbacf1e1eaf0e7ebe7f0c2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="dbb0baafb3a2f5a8b8b3a9beb2bea99bbdbfbaf5b3b3a8f5bcb4ad">[email protected]</span></a>.
    RIN: 0910-AF11

296. Combinations of Bronchodilators With Nasal Decongestant; Cold, 
Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for 
Over-the-Counter Human Use

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective, 
and not misbranded. After a final monograph (i.e., final rule) is 
issued, only OTC drugs meeting the conditions of the monograph, or 
having an approved new drug application, may be legally marketed. These 
actions address cough/cold drug products containing an oral 
bronchodilator (ephedrine and its salts) in combination with any oral 
nasal decongestant.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Amendment)....................   07/13/05  70 FR 40232
NPRM Comment Period End.............   11/10/05  .......................
Final Action (Technical Amendment)..   03/19/07  72 FR 12730
Final Action (Oral Bronchodilator &    07/00/15  .......................
 Oral Nasal Decongestant).
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#ef858e81868c8ac18e8b8e829cc284868188af898b8ec187879cc1888099"><span class="__cf_email__" data-cfemail="abc1cac5c2c8ce85cacfcac6d886c0c2c5ccebcdcfca85c3c3d885ccc4dd">[email protected]</span></a>.
    RIN: 0910-AF33

297. Over-the-Counter (OTC) Drug Review--Laxative 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 to 360a; 21 U.S.C. 371 to 371a
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective, 
and not misbranded. After a final monograph (i.e., final rule) is 
issued, only OTC drugs meeting the conditions of the monograph, or 
having an approved new drug application, may be legally marketed. The 
final rule listed will address the professional labeling for sodium 
phosphate drug products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Final Action (Granular Psyllium)....   03/29/07  72 FR 14669
NPRM (Professional Labeling_Sodium     02/11/11  76 FR 7743
 Phosphate).
NPRM Comment Period End.............   03/14/11  .......................
Final Action (Professional             10/00/15  .......................
 Labeling_Sodium Phosphate).
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#3f555e51565c5a115e5b5e524c12545651587f595b5e1157574c11585049"><span class="__cf_email__" data-cfemail="08626966616b6d26696c69657b256361666f486e6c692660607b266f677e">[email protected]</span></a>.
    RIN: 0910-AF38

298. 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: The regulation will amend the performance standard for 
laser products to achieve closer harmonization between the current 
standard and the 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  .......................
Final Action........................   10/00/15  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#5b353a353822752b32292f1b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="3f515e515c46114f564d4b7f595b5e1157574c11585049">[email protected]</span></a>.
    RIN: 0910-AF87

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

    Regulatory Plan: This entry is Seq. No. 53 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG38

300. 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 from clinical investigations for medical devices to require that 
clinical investigations conducted outside the United States in support 
of a premarket approval application, humanitarian device exemption 
application, an investigational device exemption

[[Page 76725]]

application, or a premarket notification submission be conducted in 
accordance with good clinical practice.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/25/13  78 FR 12664
NPRM Comment Period End.............   05/28/13  .......................
Final Action........................   01/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sheila Anne Brown, Policy Analyst, Investigational 
Device Exemptions Staff, Department of Health and Human Services, Food 
and Drug Administration, WO 66, Room 1651, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993, Phone: 301 796-6563, Fax: 301 847-8120, Email: 
<a href="/cdn-cgi/l/email-protection#70031815191c115e12021f071e301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="0d7e656864616c236f7f627a634d6b696c2365657e236a627b">[email protected]</span></a>.
    RIN: 0910-AG48

301. Food Labeling: Calorie Labeling of Articles of Food Sold in 
Vending Machines

    Regulatory Plan: This entry is Seq. No. 54 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG56

302. Food Labeling: Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments

    Regulatory Plan: This entry is Seq. No. 55 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG57

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

    Regulatory Plan: This entry is Seq. No. 58 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG94

304. Veterinary Feed Directive

    Regulatory Plan: This entry is Seq. No. 59 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG95

305. <bullet> Combinations of Bronchodilators With Expectorants; Cold, 
Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for 
Over-the-Counter Human Use

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective, 
and not misbranded. After a final monograph (i.e. final rule) is 
issued, only OTC drugs meeting the conditions of the monograph, or 
having an approved new drug application, may be legally marketed. These 
actions address cough/cold drug products containing an oral 
bronchodilator (ephedrine and its salts) in combination with any 
expectorant.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM (Amendment)....................   07/13/05  70 FR 40232
NPRM Comment Period End.............   11/10/05  .......................
Final Action (Technical Amendment)..   03/19/07  72 FR 12730
Final Action........................   07/00/15  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#afc5cec1c6ccca81cecbcec2dc82c4c6c1c8efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="771d16191e1412591613161a045a1c1e191037111316591f1f0459101801">[email protected]</span></a>.
    RIN: 0910-AH16

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

306. 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. This rule will modernize the nutrition information found on 
the Nutrition Facts label, as well as the format and appearance of the 
label.
    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  .......................
Final Action........................   03/00/16  .......................
------------------------------------------------------------------------

    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), HFS-830, 5100 
Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, 
Email: <a href="/cdn-cgi/l/email-protection#56382322243f223f39382624393124373b252237303016303237783e3e2578313920"><span class="__cf_email__" data-cfemail="355b4041475c415c5a5b45475a524754584641545353755351541b5d5d461b525a43">[email protected]</span></a>.
    RIN: 0910-AF22

307. 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
    Abstract: FDA is amending its labeling regulations for foods to 
provide updated Reference Amounts Customarily Consumed (RACCs) for 
certain food categories. This 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 certain RACCs, FDA is also amending 
the definition of single-serving containers; amending the label serving 
size for breath mints; and providing for dual-column labeling, which 
would provide nutrition information per serving and per container or 
unit, as applicable, under certain circumstances.
    Timetable:

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

    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: <a href="/cdn-cgi/l/email-protection#214f5455534855484e4f51534e4653404c5255404747614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="7c1209080e15081513120c0e131b0e1d110f081d1a1a3c1a181d5214140f521b130a">[email protected]</span></a>.
    RIN: 0910-AF23

[[Page 76726]]

308. 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.
    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..........................   05/00/16  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#c6a0a9a9a2a2a3a0a3a8b5a386a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="dbbdb4b4bfbfbebdbeb5a8be9bbdbfbaf5b3b3a8f5bcb4ad">[email protected]</span></a>.
    RIN: 0910-AG63

309. 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 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..........................   03/00/16  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#5d30343e353c383173363c2e3529323e361d3b393c7335352e733a322b"><span class="__cf_email__" data-cfemail="6904000a01080c054702081a011d060a02290f0d084701011a470e061f">[email protected]</span></a>.
    RIN: 0910-AG98

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

310. Infant Formula: Current Good Manufacturing Practices; Quality 
Control Procedures; Notification Requirements; Records And Reports; and 
Quality Factors

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 350a; 21 
U.S.C. 371
    Abstract: The Food and Drug Administration (FDA) is revising its 
infant formula regulations to establish requirements for current good 
manufacturing practices (CGMP), including audits; to establish 
requirements for quality factors; and to amend FDA's quality control 
procedures, notification, and record and reporting requirements for 
infant formula. FDA is taking this action to improve the protection of 
infants who consume infant formula products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/09/96  61 FR 36154
NPRM Comment Period End.............   12/06/96  .......................
NPRM Comment Period Reopened........   04/28/03  68 FR 22341
NPRM Comment Period Extended........   06/27/03  68 FR 38247
NPRM Comment Period End.............   08/26/03  .......................
NPRM Comment Period Reopened........   08/01/06  71 FR 43392
NPRM Comment Period End.............   09/15/06  .......................
Interim Final Rule..................   02/10/14  79 FR 7934
Interim Final Rule Comment Period      03/27/14  .......................
 End.
Final Action........................   06/10/14  79 FR 33057
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Leila Beker, Biologist, Department of Health and 
Human Services, Food and Drug Administration, Center for Food Safety 
and Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College 
Park, MD 20740, Phone: 240 402-1451, Email: <a href="/cdn-cgi/l/email-protection#bbd7ded2d7da95d9ded0dec9fbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="81ede4e8ede0afe3e4eae4f3c1e7e5e0afe9e9f2afe6eef7">[email protected]</span></a>.
    RIN: 0910-AF27

311. Postmarketing Safety Reports for Human Drug and Biological 
Products: Electronic Submission Requirements

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355 to 355a; 21 U.S.C. 356 to 356c; 21 U.S.C. 360; 21 
U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379k-l; 21 U.S.C. 
379aa; 21 U.S.C. 381; 42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 264; . . 
.
    Abstract: The final rule would amend FDA's postmarketing safety 
reporting regulations for human drug and biological products to require 
that mandatory safety reports submitted to the Agency be transmitted in 
an electronic format that FDA can process, review, and archive. The 
rule will allow the Agency to review safety reports more quickly, to 
identify emerging safety problems, and disseminate safety information 
more rapidly in support of FDA's public health mission. The amendments 
also would be a key element in harmonizing FDA's postmarketing safety 
reporting regulations with international and International 
Harmonization Standards standards for the electronic submission of 
safety information.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   11/05/98  63 FR 59746
ANPRM Comment Period End............   02/03/99  .......................
NPRM................................   08/21/09  74 FR 42184
NPRM Comment Period End.............   11/19/09  .......................
Final Action........................   06/10/14  79 FR 33072
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.

[[Page 76727]]

    Agency Contact: Reena Raman, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6238, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-7577, Fax: 301 
847-8440, Email: <a href="/cdn-cgi/l/email-protection#e79582828986c995868a8689a7818386c98f8f94c9808891"><span class="__cf_email__" data-cfemail="a0d2c5c5cec18ed2c1cdc1cee0c6c4c18ec8c8d38ec7cfd6">[email protected]</span></a>.
    RIN: 0910-AF96

312. Requirements for the Submission of Data Needed To Calculate User 
Fees for Domestic Manufacturers and Importers of Tobacco Products

    Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31
    Abstract: This rule will require manufacturers and importers of 
tobacco products to submit certain market share data to FDA. USDA 
currently collects such data, but its program sunsets at the end of 
September 2014, and USDA will cease collection of this information. FDA 
is taking this action so that it may continue to calculate market share 
percentages needed to compute user fees.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/31/13  78 FR 32581
NPRM Comment Period End.............   08/14/13  .......................
Final Action........................   07/10/14  79 FR 39302
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#0c6f787c7e696b79606d786563627f4c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="24475054564143514845504d4b4a57644240450a4c4c570a434b52">[email protected]</span></a>.
    RIN: 0910-AG81

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

313. Home Health Agency Conditions of Participation (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 existing Conditions of 
Participation that Home Health Agencies must meet to participate in the 
Medicare program. The new requirements focus on the actual care 
delivered to patients by HHAs, reflect an interdisciplinary view of 
patient care, allow HHAs greater flexibility in meeting quality 
standards, and eliminate unnecessary procedural requirements. These 
changes are an integral part of our efforts to improve patient safety 
and achieve broad-based improvements in the quality of care furnished 
through Federal programs, while at the same time reducing 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
Second NPRM Comment Period End......   12/08/14  .......................
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, MS: S3-02-
01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6617, 
Email: <a href="/cdn-cgi/l/email-protection#6501040b0c000909004b160d0004170017250608164b0d0d164b020a13"><span class="__cf_email__" data-cfemail="afcbcec1c6cac3c3ca81dcc7caceddcaddefccc2dc81c7c7dc81c8c0d9">[email protected]</span></a>.
    RIN: 0938-AG81

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

    Regulatory Plan: This entry is Seq. No. 60 in part II of this issue 
of the Federal Register.
    RIN: 0938-AR61

315. Medicare Shared Savings Program; Accountable Care Organizations 
(CMS-1461-P) (Section 610 Review)

    Legal Authority: PL-111-148, sec 3022
    Abstract: This proposed rule addresses changes to the Medicare 
Shared Savings Program (Shared Savings Program), including provisions 
relating to the payment of Accountable Care Organizations (ACOs) 
participating in the Shared Savings Program. Under the Shared Savings 
Program, providers of services and suppliers that participate in an ACO 
continue to receive traditional Medicare fee for service (FFS) payments 
under Parts A and B and are eligible for additional payments from the 
ACO if they meet specified quality and savings requirements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Terri Postma, Medical Officer, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Mail Stop 
C5-15-24, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
4169, Email: <a href="/cdn-cgi/l/email-protection#ee9a8b9c9c87c09e819d9a838fae8d839dc086869dc0898198"><span class="__cf_email__" data-cfemail="65110017170c4b150a16110804250608164b0d0d164b020a13">[email protected]</span></a>.
    RIN: 0938-AS06

316. 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 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 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................................   03/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    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: <a href="/cdn-cgi/l/email-protection#4b3828243f3f652824243b2e390b28263865232338652c243d"><span class="__cf_email__" data-cfemail="1360707c67673d707c7c63766153707e603d7b7b603d747c65">[email protected]</span></a>.
    RIN: 0938-AS21

317. <bullet> Medicare Clinical Diagnostic Laboratory Test Payment 
System (CMS-1621-P)

    Legal Authority: Pub. L. 113-93, sec 216
    Abstract: Under section 216 of the Protecting Access to Medicare 
Act of 2014, this proposed rule would require Medicare payment for 
clinical laboratory tests to be based on private payor rates beginning 
January 1, 2017. Beginning January 1, 2016, and every 3 years 
thereafter (or, annually, for certain laboratory tests), applicable 
laboratories must report to CMS the amount they are

[[Page 76728]]

paid by each private payor for a test, and the volume of such tests 
performed for each such payer for the period. The payment rate reported 
by a laboratory must reflect all discounts, rebates, coupons, and other 
price concessions.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Anne Hauswald, 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 Blvd., Baltimore, MD 21244, Phone: 410 786-4546, Email: <a href="/cdn-cgi/l/email-protection#395857575c145c144d584055565c1751584c4a4e58555d795a544a1751514a175e564f"><span class="__cf_email__" data-cfemail="13727d7d763e763e67726a7f7c763d7b72666064727f7753707e603d7b7b603d747c65">[email protected]</span></a>.
    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: 
<a href="/cdn-cgi/l/email-protection#daacbbb6bfa8b3bff4b7b3b6b6bfa89ab9b7a9f4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="1f697e737a6d767a31727673737a6d5f7c726c3177776c31787069">[email protected]</span></a>.
    RIN: 0938-AS33

318. <bullet> CY 2016 Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P)

    Regulatory Plan: This entry is Seq. No. 63 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS40

319. <bullet> Hospital Inpatient Prospective Payment System for Acute 
Care Hospitals and the Long-Term Care Hospital Prospective Payment 
System and FY 2016 Rates (CMS-1632-P)

    Regulatory Plan: This entry is Seq. No. 64 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS41

320. <bullet> CY 2016 Hospital Outpatient PPS Policy Changes and 
Payment Rates and Ambulatory Surgical Center Payment System Policy 
Changes and Payment Rates (CMS-1633-P)

    Regulatory Plan: This entry is Seq. No. 65 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS42

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

321. Covered Outpatient Drugs (CMS-2345-F) (Section 610 Review)

    Legal Authority: Pub. L. 111- 48, secs 2501, 2503, 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........................   04/00/15  .......................
------------------------------------------------------------------------

    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: <a href="/cdn-cgi/l/email-protection#a8dfcdc6ccd186dcdddcdcc4cde8cbc5db86c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="acdbc9c2c8d582d8d9d8d8c0c9eccfc1df82c4c4df82cbc3da">[email protected]</span></a>.
    RIN: 0938-AQ41

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

322. Emergency Preparedness Requirements for Medicare and Medicaid 
Participating Providers and Suppliers (CMS-3178-F)

    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: <a href="/cdn-cgi/l/email-protection#c8a2a9a6a1abade6afbaa9a0a9a588aba5bbe6a0a0bbe6afa7be"><span class="__cf_email__" data-cfemail="503a313e3933357e37223138313d10333d237e3838237e373f26">[email protected]</span></a>.
    RIN: 0938-AO91

323. Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC)

    Legal Authority: Pub. L. 104-191, sec 1104
    Abstract: Under the Affordable Care Act, this interim final rule 
adopts operating rules for HIPAA transactions for health care claims or 
equivalent encounter information, enrollment and disenrollment of a 
health plan, health plan premium payments, and referral certification 
and authorization.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   11/00/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Geanelle Herring, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Administrative Simplification Group, Office of E-
Health Standards and Services, Mail Stop S2-26-17, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-4466, Email: 
<a href="/cdn-cgi/l/email-protection#6a0d0f0b040f06060f44020f181803040d2a09071944020219440d051c"><span class="__cf_email__" data-cfemail="3f585a5e515a53535a11575a4d4d5651587f5c524c1157574c11585049">[email protected]</span></a>.
    RIN: 0938-AS01


[[Page 76729]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

324. Prospective Payment System for Federally Qualified Health Centers; 
Changes to Contracting Policies for Rural Health Clinics and CLIA 
Enforcement Actions for Proficiency Testing Referral (CMS-1443-FC) 
(Completion of a Section 610 Review)

    Legal Authority: Pub. L. 111-148, sec 10501
    Abstract: This final rule establishes methodology and payment rates 
for a prospective payment system (PPS) for Federally qualified health 
center (FQHC) services under Medicare Part B beginning on October 1, 
2014, in compliance with the statutory requirement of the Affordable 
Care Act. This rule also establishes a policy which would allow rural 
health clinics (RHCs) to contract with nonphysician practitioners when 
statutory requirements for employment of nurse practitioners and 
physician assistants are met, and makes other technical and conforming 
changes to the RHC and FQHC regulations. Finally, this rule makes 
changes to the Clinical Laboratory Improvement Amendments (CLIA) 
regulations regarding enforcement actions for proficiency testing 
referral.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/23/13  78 FR 58386
NPRM Comment Period End.............   11/18/13  .......................
Final Rule..........................   05/02/14  79 FR 25436
Comment Period End..................   07/01/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Corinne Axelrod, Health Insurance Specialist, 
Hospital and Ambulatory Policy Group, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop C5-14-03, 
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5620, 
Email: <a href="/cdn-cgi/l/email-protection#61020e13080f0f044f0019040d130e0521020c124f0909124f060e17"><span class="__cf_email__" data-cfemail="b1d2dec3d8dfdfd49fd0c9d4ddc3ded5f1d2dcc29fd9d9c29fd6dec7">[email protected]</span></a>.
    RIN: 0938-AR62

325. Hospital Inpatient Prospective Payment System for Acute Care 
Hospitals and the Long-Term Care Hospital Prospective Payment System 
and Fiscal Year 2015 Rates (CMS-1607-F) (Completion of a Section 610 
Review)

    Legal Authority: sec 1886(d) of the Social Security Act
    Abstract: This 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:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/14/14  79 FR 27977
NPRM Comment Period End.............   06/30/14  .......................
Final Action........................   08/22/14  79 FR 49853
------------------------------------------------------------------------

    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: 
<a href="/cdn-cgi/l/email-protection#e3878c8d828f87cd978b8c8e93908c8da3808e90cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="bedad1d0dfd2da90cad6d1d3cecdd1d0feddd3cd90d6d6cd90d9d1c8">[email protected]</span></a>.
    RIN: 0938-AS11

326. CY 2015 Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Medicare Part B (CMS-1612-FC) (Section 
610 Review)

    Legal Authority: Social Security Act, secs 1102, 1871 and 1848
    Abstract: This final rule addresses changes to the physician fee 
schedule, and other Medicare Part B payment policies to ensure that our 
payment systems are updated to reflect changes in medical practice and 
the relative value of services, as well as changes in the statute.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/11/14  79 FR 40318
NPRM Comment Period End.............   09/02/14  .......................
Final Action........................   11/13/14  79 FR 67548
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kathy Bryant, Director, Division of Practitioner 
Services, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-3448, Email: 
<a href="/cdn-cgi/l/email-protection#cca7adb8a4b5e2aebeb5ada2b88cafa1bfe2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="305b514458491e524249515e4470535d431e5858431e575f46">[email protected]</span></a>.
    RIN: 0938-AS12

327. CY 2015 End-Stage Renal Disease Prospective Payment System, 
Quality Incentive Program, and Durable Medical Equipment, Prosthetics, 
Orthotics, and Supplies (CMS-1614-F) (Section 610 Review)

    Legal Authority: Social Security Act, sec 1834(a)(1)(6); MIPPA, sec 
153(b)
    Abstract: This final rule updates and makes revisions to the End-
Stage Renal Disease (ESRD) prospective payment system (PPS) for 
calendar year (CY) 2015. This rule also sets forth requirements for the 
ESRD quality incentive program (QIP), including payment years (PYs) 
2017 and 2018. This rule also makes a technical correction to remove 
outdated terms and definitions. In addition, this rule sets forth the 
methodology for adjusting Durable Medical Equipment, Prosthetics, 
Orthotics, and Supplies (DMEPOS) fee schedule payment amounts using 
information from the Medicare DMEPOS Competitive Bidding Program (CBP); 
makes alternative payment rules for DME and enteral nutrition under the 
Medicare DMEPOS CBP; clarifies the statutory Medicare hearing aid 
coverage exclusion and specifies devices not subject to the hearing aid 
exclusion; updates the definition of minimal self-adjustment regarding 
what specialized training is needed by suppliers to provide custom 
fitting services if they are not certified orthotists; clarifies the 
Change of Ownership (CHOW) and provides for an exception to the current 
requirements; revises the appeal provisions for termination of a 
contract and notification to beneficiaries under the Medicare DMEPOS 
CBP, and adds a technical change related to submitting bids for 
infusion drugs under the Medicare DMEPOS CBP.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/11/14  79 FR 40208
NPRM Comment Period End.............   09/02/14  .......................
Final Action........................   11/06/14  79 FR 66120
Final Action Effective..............   01/01/15  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michelle Cruse, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, Mail Stop C5-05-27, 7500 
Security Boulevard, Baltimore,

[[Page 76730]]

MD 21244, Phone: 410 786-7540, Email: <a href="/cdn-cgi/l/email-protection#4d20242e2528212128632e3f383e280d2e203e6325253e632a223b"><span class="__cf_email__" data-cfemail="264b4f454e434a4a4308455453554366454b55084e4e5508414950">[email protected]</span></a>.
    RIN: 0938-AS13

328. CY 2015 Hospital Outpatient Prospective Payment System (PPS) 
Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical 
Center Payment System Policy Changes and Payment Rates (CMS-1613-FC) 
(Section 610 Review)

    Legal Authority: sec 1833 of the Social Security Act
    Abstract: This final rule revises the Medicare hospital outpatient 
prospective payment system (OPPS) and the Medicare ambulatory surgical 
center (ASC) payment system for CY 2015 to implement applicable 
statutory requirements and changes arising from our continuing 
experience with these systems. In this rule, we describe the changes to 
the amounts and factors used to determine the payment rates for 
Medicare services paid under the OPPS and those paid under the ASC 
payment system. In addition, this rule updates and refines the 
requirements for the Hospital Outpatient Quality Reporting (OQR) 
Program and the ASC Quality Reporting (ASCQR) Program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/14/14  79 FR 40916
NPRM Comment Period End.............   09/02/14  .......................
Final Action........................   11/13/14  79 FR 66770
Final Action Effective..............   01/01/15  .......................
------------------------------------------------------------------------

    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: 
<a href="/cdn-cgi/l/email-protection#701d11021a1f0219155e12111c141f30131d035e1818035e171f06"><span class="__cf_email__" data-cfemail="2c414d5e46435e4549024e4d4048436c4f415f0244445f024b435a">[email protected]</span></a>.
    RIN: 0938-AS15

329. Extension of Payment Adjustment for Low-Volume Hospitals and the 
Medicare-Dependent Hospital Program Under the FY 2014 Hospital 
Inpatient Prospective Payment System (CMS-1599-IFC2) (Completion of a 
Section 610 Review)

    Legal Authority: Pub. L. 113-67, secs 1105 and 1106
    Abstract: This interim final rule implements changes to the payment 
adjustment for low-volume hospitals and to the Medicare-dependent 
hospital program under the hospital inpatient prospective payment 
systems for FY 2014 (through March 31, 2014) in accordance with 
sections 1105 and 1106, respectively, of the Pathway for SGR Reform Act 
of 2013.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Interim Final Rule..................   03/18/14  79 FR 15022
Interim Final Rule Comment Period      05/12/14  .......................
 End.
Merged With 0938-AS11...............   06/01/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michele Hudson, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop C4-10-07, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-5490, Email: 
<a href="/cdn-cgi/l/email-protection#127f7b717a777e773c7a6776617d7c52717f613c7a7a613c757d64"><span class="__cf_email__" data-cfemail="ec81858f84898089c28499889f8382ac8f819fc284849fc28b839a">[email protected]</span></a>.
    RIN: 0938-AS18

[FR Doc. 2014-28964 Filed 12-19-14; 8:45 am]
BILLING CODE 4150-24-P


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