[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Proposed Rules]
[Pages 35016-35029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14352]



[[Page 35015]]

Vol. 80

Thursday,

No. 117

June 18, 2015

Part VII





Department of Health and Human Services





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Unified Agenda

  Federal Register / Vol. 80 , No. 117 / Thursday, June 18, 2015 / 
Unified Agenda  

[[Page 35016]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

25 CFR Ch. V

42 CFR Chs. I-V

45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII


Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual Regulatory Agenda.

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

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
(E.O.) 12866 require the semiannual issuance of an inventory of 
rulemaking actions under development throughout the Department, 
offering for public review summarized information about forthcoming 
regulatory actions.

FOR FURTHER INFORMATION CONTACT: 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 this year 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.
    In the rules outlined for this Agenda, HHS continues its work to 
build a better, smarter, and stronger health care delivery system. Our 
aspiration is for patients to receive higher quality of care, for 
medical information to be easy to understand, and for health care 
dollars to be spent more wisely. We welcome the opportunity to build a 
more transparent health care delivery system and strengthen 
partnerships with patients, physicians, governments, and businesses. We 
continue our work by helping more people get and keep health insurance 
coverage and making health care more affordable for working families.
    In addition, HHS strives to lead in the advancement of scientific 
knowledge and innovation to enable our nation's scientists and 
researchers to continue making new and improved vaccines, cures, 
therapies, and rapid diagnostics. The accompanying regulations promote 
advancements in science, research, and innovation to attract the best 
experts to accelerate cures; reduce administrative burdens and 
duplication; and promote data sharing to protect the health of the 
American people.
    HHS has an agency-wide effort to support the Agenda's purpose of 
encouraging more effective public participation in the regulatory 
process and promote increase transparency to the public regarding our 
regulatory activity. 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.Reglnfo.gov.

C'Reda J. Weeden,
Executive Secretary to the Department.

  Substance Abuse and Mental Health Services Administration--Completed
                                 Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
99........................  SAMHSA User Fees for               0930-AA18
                             Publications.
------------------------------------------------------------------------


            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
100.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
101.......................  Over-the-Counter (OTC)             0910-AF69
                             Drug Review--Topical
                             Antimicrobial Drug
                             Products.
102.......................  Abbreviated New Drug               0910-AF97
                             Applications and
                             505(b)(2).
103.......................  Updated Standards for              0910-AG09
                             Labeling of Pet Food.
104.......................  Electronic Distribution of         0910-AG18
                             Prescribing Information
                             for Human Prescription
                             Drugs Including
                             Biological Products.
105.......................  Requirements for the               0910-AG59
                             Testing and Reporting of
                             Tobacco Product
                             Constituents,
                             Ingredients, and
                             Additives.
106.......................  Format and Content of              0910-AG96
                             Reports Intended to
                             Demonstrate Substantial
                             Equivalence.
107.......................  Food Labeling; Gluten-Free         0910-AH00
                             Labeling of Fermented,
                             Hydrolyzed, or Distilled
                             Foods.
108.......................  Radiology Devices;                 0910-AH03
                             Designation of Special
                             Controls for the Computed
                             Tomography X-Ray System.
109.......................  Mammography Quality                0910-AH04
                             Standards Act; Regulatory
                             Amendments.
110.......................  Investigational New Drug           0910-AH07
                             Application Annual
                             Reporting.
111.......................  General and Plastic                0910-AH14
                             Surgery Devices: Sunlamp
                             Products.
112.......................  Requirements for Tobacco           0910-AH22
                             Product Manufacturing
                             Practice.
------------------------------------------------------------------------


[[Page 35017]]


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier no.
------------------------------------------------------------------------
113.......................  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.
114.......................  Food Labeling; Revision of         0910-AF22
                             the Nutrition and
                             Supplement Facts Labels.
115.......................  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.
116.......................  Laser Products; Amendment          0910-AF87
                             to Performance Standard.
117.......................  Current Good Manufacturing         0910-AG10
                             Practice and Hazard
                             Analysis and Risk-Based
                             Preventive Controls for
                             Food for Animals.
118.......................  Standards for the Growing,         0910-AG35
                             Harvesting, Packing, and
                             Holding of Produce for
                             Human Consumption.
119.......................  Current Good Manufacturing         0910-AG36
                             and Hazard Analysis, and
                             Risk-Based Preventive
                             Controls for Human Food.
120.......................  ``Tobacco Products''               0910-AG38
                             Subject to the Federal
                             Food, Drug, and Cosmetic
                             Act, as Amended by the
                             Family Smoking Prevention
                             and Tobacco Control Act.
121.......................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Investigations
                             for Medical Devices.
122.......................  Foreign Supplier                   0910-AG64
                             Verification Program.
123.......................  Supplemental Applications          0910-AG94
                             Proposing Labeling
                             Changes for Approved
                             Drugs and Biological
                             Products.
124.......................  Veterinary Feed Directive.         0910-AG95
125.......................  Sanitary Transportation of         0910-AG98
                             Human and Animal Food.
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
126.......................  Focused Mitigation                 0910-AG63
                             Strategies To Protect
                             Food Against Intentional
                             Adulteration.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
127.......................  Content and Format of              0910-AF11
                             Labeling for Human
                             Prescription Drugs and
                             Biologics; Requirements
                             for Pregnancy and
                             Lactation Labeling.
128.......................  Food Labeling: Calorie             0910-AG56
                             Labeling of Articles of
                             Food Sold in Vending
                             Machines.
129.......................  Food Labeling: Nutrition           0910-AG57
                             Labeling of Standard Menu
                             Items in Restaurants and
                             Similar Retail Food
                             Establishments.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
130.......................  Reform of Requirements for         0938-AR61
                             Long-Term Care Facilities
                             (CMS-3260-P) (Rulemaking
                             Resulting From a Section
                             610 Review).
131.......................  Electronic Health Record           0938-AS26
                             (EHR) Incentive Programs--
                             Stage 3 (CMS-3310-F)
                             (Section 610 Review).
132.......................  Medicare Clinical                  0938-AS33
                             Diagnostic Laboratory
                             Test Payment System (CMS-
                             1621-P) (Section 610
                             Review).
133.......................  CY 2016 Revisions to               0938-AS40
                             Payment Policies Under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1631-P).
134.......................  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-F).
135.......................  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).
136.......................  FY 2016 Inpatient                  0938-AS45
                             Rehabilitation Facility
                             Prospective Payment
                             System (CMS-1624-F)
                             (Section 610 Review).
137.......................  Electronic Health Record           0938-AS58
                             Incentive Program--
                             Modifications to
                             Meaningful Use in 2015
                             through 2017 (CMS-3311-F)
                             (Section 610 Review).
------------------------------------------------------------------------


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


[[Page 35018]]


       Centers for Medicare & Medicaid Services--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             identifier No.
------------------------------------------------------------------------
139.......................  Home Health Agency                 0938-AG81
                             Conditions of
                             Participation (CMS-3819-
                             F) (Rulemaking Resulting
                             From a Section 610
                             Review).
140.......................  Emergency Preparedness             0938-AO91
                             Requirements for Medicare
                             and Medicaid
                             Participating Providers
                             and Suppliers (CMS-3178-
                             F) (Section 610 Review).
141.......................  Medicare Shared Savings            0938-AS06
                             Program; Accountable Care
                             Organizations (CMS-1461-
                             F) (Section 610 Review).
142.......................  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).
------------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Substance Abuse and Mental Health Services Administration (SAMHSA)

Completed Actions

99. SAMHSA USER FEES FOR PUBLICATIONS

    Legal Authority: 31 U.S.C. 9701; 31 U.S.C. 1111; E.O. 8284; E.O. 
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
------------------------------------------------------------------------
Withdrawn...........................   03/19/15  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0930-AA18

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

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

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: FDA will be proposing a rule to add the common cold 
indication to certain over-the-counter (OTC) antihistamine active 
ingredients. This proposed rule is the result of collaboration under 
the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts 
to reduce unnecessary duplication and differences. This pilot exercise 
will help determine the feasibility of developing an ongoing mechanism 
for alignment in review and adoption of OTC drug monograph elements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Reopening of Administrative Record..   08/25/00  65 FR 51780
Comment Period End..................   11/24/00  .......................
NPRM (Amendment) (Common Cold)......   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: [email protected].
    RIN: 0910-AF31

101. 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)........   05/01/15  80 FR 25166
NPRM Comment Period End.............   10/28/15  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AF69

102. 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

[[Page 35019]]

and related applications to patent certifications, notice to patent 
owners and application holders, the availability of a 30-month stay of 
approval, amendments and supplements, and the types of bioavailability 
and bioequivalence data that can be used to support these applications.
    Timetable:

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

    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: [email protected].
    RIN: 0910-AF97

103. 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................................   09/00/15  .......................
------------------------------------------------------------------------

    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, MPN-4, Room 2642, HFV-228, 7519 
Standish Place, Rockville, MD 20855, Phone: 240 402-5900, Email: 
[email protected].
    RIN: 0910-AG09

104. 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................................   12/18/14  79 FR 75506
NPRM Comment Period Extended........   03/09/15  80 FR 12364
NPRM Comment Period End.............   03/18/15  .......................
NPRM Comment Period Extended End....   05/18/15  .......................
Final Action........................   03/00/16  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Emily Gebbia, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, 
Room 6226, Silver Spring, MD 20993, Phone: 240 402-0980, Email: 
[email protected].
    RIN: 0910-AG18

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

    Legal Authority: 21 U.S.C. 301 et seq.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................................   02/00/16  .......................
------------------------------------------------------------------------

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

106. 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................................   11/00/15  .......................
------------------------------------------------------------------------

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

107. 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

[[Page 35020]]

20 parts per million (ppm) gluten in the food.
    Timetable:

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Felicia Billingslea, Director, Food Labeling and 
Standard Staff, Department of Health and Human Services, Food and Drug 
Administration, Room 4D045, HFS 820, 5100 Paint Branch Parkway, College 
Park, MD 20740, Phone: 240 402-1803, Fax: 301 436-2636, Email: 
[email protected].
    RIN: 0910-AH00

108. Radiaology 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................................   03/00/16  .......................
------------------------------------------------------------------------

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

109. 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................................   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: [email protected].
    RIN: 0910-AH04

110. Investigational New Drug Application Annual Reporting

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/00/15
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AH07

111. 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................................   05/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Paul Gadiock, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, 10903 New Hampshire Avenue, W0-66, 
Room 4432, Silver Spring, MD 20993-0002, Phone: 301 796-5736, Fax: 301 
847-8145, Email: [email protected].
    RIN: 0910-AH14

112.  Requirements for Tobacco Product Manufacturing Practice

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   03/19/13  78 FR 16824
ANPRM Comment Period End............   05/20/13
NPRM................................   02/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Darin Achilles, Senior Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
10903 New Hampshire Avenue, Document Control Center, Building 71, Room 
G335, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 301 595-1426, 
Email: [email protected].
    RIN: 0910-AH22


[[Page 35021]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

113. 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: [email protected].
    RIN: 0910-AA49

114. 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: [email protected].
    RIN: 0910-AF22

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

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371; Pub. 
L. 101-535, sec 2(b)(1)(A)
    Abstract: FDA is amending its labeling regulations for foods to 
provide 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: [email protected].
    RIN: 0910-AF23

116. 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........................   04/00/16
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Nancy Pirt, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: [email protected].
    RIN: 0910-AF87

117. Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 
U.S.C. 350c; 21 U.S.C. 350d note; 21 U.S.C. 350g; 21 U.S.C. 350g note; 
21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; 42 U.S.C. 243; 42 U.S.C. 
271; * * *
    Abstract: This rule establishes requirements for good manufacturing 
practice, and requires that certain facilities establish and implement 
hazard analysis and risk-based preventive controls for animal food, 
including ingredients and mixed animal feed. This action is intended to 
provide greater assurance that food for all animals, including pets, is 
safe.
    Timetable:

[[Page 35022]]



------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   10/29/13  78 FR 64736
NPRM Comment Period Extension.......   02/03/14  79 FR 6111
NPRM Comment Period End.............   02/26/14
NPRM Comment Period Extension End...   03/31/14
Supplemental NPRM...................   09/29/14  79 FR 58475
Supplemental NPRM Comment Period End   12/15/14
Final Rule..........................   08/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jeanette (Jenny) B. Murphy, Consumer Safety 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Veterinary Medicine, Room 2671 (MPN-4, HFV-
200), 7519 Standish Place, Rockville, MD 20855, Phone: 240 453-6845, 
Email: [email protected].
    RIN: 0910-AG10

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/16/13  78 FR 3503
NPRM Comment Period End.............   05/16/13
NPRM Comment Period Extended........   04/26/13  78 FR 24692
NPRM Comment Period Extended End....   09/16/13
NPRM Comment Period Extended........   08/09/13  78 FR 48637
NPRM Comment Period Extended End....   11/15/13
Notice of Intent To Prepare an         08/19/13  78 FR 50358
 Environmental Impact Statement for
 the Proposed Rule.
Notice of Intent To Prepare            11/15/13
 Environmental Impact Statement for
 the Proposed Rule Comment Period
 End.
NPRM Comment Period Extended........   11/20/13  78 FR 69605
NPRM Comment Period Extended End....   11/22/13
Environmental Impact Statement for     03/11/14  79 FR 13593
 the Proposed Rule; Comment Period
 Extended.
Environmental Impact Statement for     04/18/14  .......................
 the Proposed Rule; Comment Period
 Extended End.
Supplemental NPRM...................   09/29/14  79 FR 58433
Supplemental NPRM Comment Period End   12/15/14
Draft Environmental Impact Statement   01/14/15  80 FR 1852
Draft Environmental Impact Statement   03/13/15
 Comment Period End.
Final Rule..........................   10/00/15
------------------------------------------------------------------------

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

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

    Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub. 
L. 111-353 (signed on Jan. 4, 2011)
    Abstract: This rule would require a food facility to have and 
implement preventive controls to significantly minimize or prevent the 
occurrence of hazards that could affect food manufactured, processed, 
packed, or held by the facility. This action is intended to prevent or, 
at a minimum, quickly identify foodborne pathogens before they get into 
the food supply.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/16/13  78 FR 3646
NPRM Comment Period End.............   05/16/13
NPRM Comment Period Extended........   04/26/13  78 FR 24691
NPRM Comment Period Extended End....   09/16/13
NPRM Comment Period Extended........   08/09/13  78 FR 48636
NPRM Comment Period Extended End....   11/15/13
NPRM Comment Period Extended........   11/20/13  78 FR 69604
NPRM Comment Period Extended End....   11/22/13
Supplemental NPRM...................   09/29/14  79 FR 58523
Supplemental NPRM Comment Period End   12/15/14
Final Rule..........................   08/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Jenny Scott, Senior Advisor, Department of Health 
and Human Services, Food and Drug Administration, Office of Food 
Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 
402-1488, Email: [email protected].
    RIN: 0910-AG36

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

    Legal Authority: 21 U.S.C. 301 et seq.; The Federal Food, Drug, and 
Cosmetic Act; Pub. L. 111-31; The Family Smoking Prevention and Tobacco 
Control Act
    Abstract: The Family Smoking Prevention and Tobacco Control Act 
(Tobacco Control Act) provides the Food and Drug Administration (FDA) 
authority to regulate cigarettes, cigarette tobacco, roll-your-own 
tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic 
Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to 
issue regulations deeming other tobacco products to be

[[Page 35023]]

subject to the FD&C Act. This rule would deem additional products 
meeting the statutory definition of ``tobacco product'' to be subject 
to the FD&C Act, and would specify additional restrictions.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/25/14  79 FR 23142
NPRM Comment Period End.............   07/09/14
NPRM Comment Period Extended........   06/24/14  79 FR 35711
NPRM Comment Period End.............   08/08/14
Final Action........................   06/00/15
------------------------------------------------------------------------

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

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/25/13  78 FR 12664
NPRM Comment Period End.............   05/28/13
Final Action........................   12/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Aaliyah K. Eaves, Policy Advisor, Office of the 
Director, Department of Health and Human Services, Food and Drug 
Administration, Center for Devices and Radiological Health, WO 66, Room 
5422, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 
796-2948, Fax: 301 847-8120, Email: [email protected].
    RIN: 0910-AG48

122. Foreign Supplier Verification Program

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/29/13  78 FR 45729
NPRM Comment Period End.............   11/26/13
NPRM Comment Period Extended........   11/20/13  78 FR 69602
NPRM Comment Period Extended End....   01/27/14
Supplemental NPRM...................   09/29/14  79 FR 58573
Supplemental NPRM Comment Period End   12/15/14
Final Rule..........................   10/00/15
------------------------------------------------------------------------

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

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   11/13/13  78 FR 67985
NPRM Comment Period Extended........   12/27/13  78 FR 78796
NPRM Comment Period End.............   01/13/14
NPRM Comment Period Extended End....   03/13/14
NPRM Comment Period Reopened........   02/18/15  80 FR 8577
NPRM Comment Period Reopened End....   04/27/15
Final Rule..........................   02/00/16
------------------------------------------------------------------------

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

124. Veterinary Feed Directive

    Legal Authority: 21 U.S.C. 354; 21 U.S.C. 360b; 21 U.S.C. 360ccc; 
21 U.S.C. 360ccc-1; 21 U.S.C. 371
    Abstract: The Animal Drug Availability Act created a new category 
of products called veterinary feed directive (VFD) drugs. This 
rulemaking is intended to provide for the increased efficiency of the 
VFD program.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   03/29/10  75 FR 15387
ANPRM Comment Period End............   06/28/10
NPRM................................   12/12/13  78 FR 75515

[[Page 35024]]

 
NPRM Comment Period End.............   03/12/14
Final Rule..........................   05/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sharon Benz, Supervisory Animal Scientist, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, MPN-4, Room 2648, HFV-220, 7519 
Standish Place, Rockville, MD 20855, Phone: 240 402-5939, Email: 
[email protected].
    RIN: 0910-AG95

125. Sanitary Transportation of Human and Animal Food

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   04/30/10  75 FR 22713
ANPRM Comment Period End............   08/30/10
NPRM................................   02/05/14  79 FR 7005
NPRM Comment Period Extended........   05/23/14  79 FR 29699
NPRM Comment Period End.............   05/31/14
NPRM Comment Period Extended End....   07/30/14
Final Rule..........................   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: [email protected].
    RIN: 0910-AG98

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

126. 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: [email protected].
    RIN: 0910-AG63

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

127. 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........................   12/04/14  79 FR 72064
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AF11

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

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
    Abstract: FDA published a proposed rule to establish requirements 
for nutrition labeling of certain food items sold in certain vending 
machines. FDA also proposed the terms and conditions for vending 
machine operators registering to voluntarily be subject to the 
requirements. FDA is issuing a final rule, and taking this action to 
carry out section 4205 of the Patient Protection and Affordable Care 
Act.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/06/11  76 FR 19238
NPRM Comment Period End.............   07/05/11
Final Action........................   12/01/14  79 FR 71259
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Daniel Reese, Food Technologist, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, 
College Park, MD 20740, Phone: 240 402-2126, Email: 
[email protected].
    RIN: 0910-AG56

[[Page 35025]]

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

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
    Abstract: FDA published a proposed rule in the Federal Register to 
establish requirements for nutrition labeling of standard menu items in 
chain restaurants and similar retail food establishments. FDA also 
proposed the terms and conditions for restaurants and similar retail 
food establishments registering to voluntarily be subject to the 
Federal requirements. FDA is issuing a final rule, and taking this 
action to carry out section 4205 of the Patient Protection and 
Affordable Care Act.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/06/11  76 FR 19192
NPRM Comment Period End.............   07/05/11
Final Action........................   12/01/14  79 FR 71156
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Daniel Reese, Food Technologist, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, 
College Park, MD 20740, Phone: 240 402-2126, Email: 
[email protected].
    RIN: 0910-AG57

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

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

    Legal Authority: Pub. L. 111-148, sec 6102; 42 U.S.C. 263a; 42 
U.S.C. 1302; 42 U.S.C. 1395hh; 42 U.S.C. 1395rr
    Abstract: This proposed rule would revise the requirements that 
Long-Term Care facilities must meet to participate in the Medicare and 
Medicaid programs. These proposed changes are necessary to reflect the 
substantial advances that have been made over the past several years in 
the theory and practice of service delivery and safety. These proposals 
are also an integral part of our efforts to achieve broad-based 
improvements both in the quality of health care furnished through 
Federal programs, and in patient safety, while at the same time 
reducing procedural burdens on providers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Ronisha Davis, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Clinical Standards and Quality, Mail Stop 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
6882, Email: [email protected].
    RIN: 0938-AR61

131. Electronic Health Record (EHR) Incentive Programs--Stage 3 (CMS-
3310-F) (Section 610 Review)

    Legal Authority: Pub. L. 111-5, title IV of Division B
    Abstract: This final rule specifies the meaningful use criteria 
that eligible professionals (EPs), eligible hospitals, and critical 
access hospitals (CAHs) must meet in order to qualify for Medicare and/
or Medicaid electronic health record (EHR) incentive payments and avoid 
downward payment adjustments under Medicare for Stage 3 of the EHR 
Incentive Programs. This rule also establishes an EHR reporting period 
for all providers under a calendar year timeline except for providers 
in the first year of the Medicaid EHR Incentive Program where states 
may continue to allow an introductory 90-day period; requires the 
electronic submission of clinical quality measures (CQMs); creates a 
single set of meaningful use requirements for Stage 3 which will be 
optional for providers in 2017 and applicable for all providers 
beginning in 2018; and ensure privacy and security requirements 
continue to protect patient health information (PHI).
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/30/15  80 FR 16732
NPRM Comment Period End.............   05/29/15
Final Action........................   03/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elizabeth S. Holland, Director, Division of HIT 
Initiatives, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Clinical Standards and 
Quality, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 
21244, Phone: 410 786-1309, Email: [email protected].
    RIN: 0938-AS26

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

    Legal Authority: Pub. L. 113-93, sec 216
    Abstract: This proposed rule would require Medicare payment for 
clinical laboratory tests to be based on private payor rates beginning 
January 1, 2017, as required by section 216(a) of the Protecting Access 
to Medicare Act of 2014.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/15
------------------------------------------------------------------------

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

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

    Legal Authority: Social Security Act, secs 1102, 1871, 1848
    Abstract: This annual proposed rule would revise payment polices 
under the Medicare physician fee schedule, and make other policy 
changes to payment under Medicare Part B. These changes would apply to 
services furnished beginning January 1, 2016.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: John McInnes, Acting Director, Division of 
Practitioner Services, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-15, 
7500 Security

[[Page 35026]]

Boulevard, Baltimore, MD 21244, Phone: 410 786-0791, Email: 
[email protected].
    RIN: 0938-AS40

134. Hospital Inpatient Prospective Payment System for Acute Care 
Hospitals and the Long-Term Care Hospital Prospective Payment System 
and FY 2016 Rates (CMS-1632-F)

    Legal Authority: sec 1886(d) of the Social Security Act
    Abstract: This annual final rule revises the Medicare hospital 
inpatient and long-term care hospital prospective payment systems for 
operating and capital-related costs. This rule implements changes 
arising from our continuing experience with these systems.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/30/15  80 FR 24323
NPRM Comment Period End.............   06/16/15
Final Action........................   08/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Donald Thompson, Deputy Director, Division of Acute 
Care, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: 
[email protected].
    RIN: 0938-AS41

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

    Legal Authority: Sec 1833 of the Social Security Act
    Abstract: This annual proposed rule would revise the Medicare 
hospital outpatient prospective payment system to implement statutory 
requirements and changes arising from our continuing experience with 
this system. The proposed rule describes changes to the amounts and 
factors used to determine payment rates for services. In addition, the 
rule proposes changes to the ambulatory surgical center payment system 
list of services and rates.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/15
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AS42

136. FY 2016 Inpatient Rehabilitation Facility Prospective Payment 
System (CMS-1624-F) (Section 610 Review)

    Legal Authority: Social Security Act, sec 1886(j); Pub. L. 106-554; 
Pub. L. 106-113
    Abstract: This annual final rule updates the prospective payment 
rates for inpatient rehabilitation facilities (IRFs) for fiscal year 
2016.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/27/15  80 FR 23332
NPRM Comment Period End.............   06/22/15
Final Action........................   08/00/15
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Gwendolyn Johnson, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare, MS: C5-06-27, 7500 Security 
Boulevard, Baltimore, MD 21244, Phone: 410 786-6954, Email: 
[email protected].
    RIN: 0938-AS45

137.  Electronic Health Record Incentive Program--Modifications 
to Meaningful Use in 2015 Through 2017 (CMS-3311-F) (Section 610 
Review)

    Legal Authority: 42 U.S.C. 1302 and 1395hh; Pub. L. 111-5
    Abstract: This final rule changes the Medicare and Medicaid 
Electronic Health Record (EHR) Incentive Program EHR reporting period 
in 2015 to a 90-day period aligned with the calendar year, and also 
aligns the reporting period in 2016 with the calendar year. In 
addition, this rule modifies the patient action measures in the Stage 2 
objectives related to patient engagement. Finally, it streamlines the 
program by removing reporting requirements on measures which have 
become redundant, duplicative, or topped out through advancements in 
EHR function and provider performance for Stage 1 and Stage 2 of the 
Medicare and Medicaid EHR Incentive Programs.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/15/15  80 FR 20346
NPRM Comment Period End.............   06/15/15
Final Action........................   04/00/18
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Elizabeth S. Holland, Director, Division of HIT 
Initiatives, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Clinical Standards and 
Quality, Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 
21244, Phone: 410 786-1309, Email: [email protected].
    RIN: 0938-AS58

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

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

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

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/02/12  77 FR 5318
NPRM Comment Period End.............   04/02/12
Final Action........................   08/00/15
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AQ41


[[Page 35027]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Long-Term Actions

139. 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 (HHA) 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
NPRM Comment Period Extended........   12/01/14  79 FR 71081
Second NPRM Comment Period End......   01/07/15
Final Action........................   10/00/17
------------------------------------------------------------------------

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

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

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

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

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

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

    Legal Authority: Pub. L. 111-148, sec 3022
    Abstract: This rule finalizes 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................................   12/08/14  79 FR 72760
NPRM Comment Period End.............   02/06/15
Final Action........................   12/00/17
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AS06

142. 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................................   12/00/16
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AS21

[FR Doc. 2015-14352 Filed 6-17-15; 8:45 am]
 BILLING CODE 4150-03-P