Document ID: FDA-2005-N-0345-0006
Agency: fda
Document Type: Proposed Rule
Title: Semiannual Regulatory Agenda
Posted Date: 2014-01-25T05:00Z

[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Unknown Section]
[Pages 1158-1169]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29632]

[[Page 1157]]

Vol. 79

Tuesday,

No. 4

January 7, 2014

Part VIII

Department of Health and Human Services

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Semiannual Regulatory Agenda

  Federal Register / Vol. 79, No. 4 / Tuesday, January 7, 2014 / 
Unified Agenda  

[[Page 1158]]

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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 
12866 require the Department semiannually to issue an inventory of 
rulemaking actions under development to provide the public a summary of 
forthcoming regulatory actions. This information will help the public 
more effectively participate in the Department's regulatory activity, 
and the Department welcomes comments on any aspect of this agenda.

FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive 
Secretary, Department of Health and Human Services, Washington, DC 
20201.

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services 
(HHS) is the Federal Government's principal 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. The Department's Public Participation Task Force, which was 
created as part of the HHS Retrospective Review plan in response to 
Executive Order 13563 (Improving Regulation and Regulatory Review), 
regularly meets to identify ways to make the rulemaking process more 
accessible to the general public. For example, to encourage public 
participation, HHS regularly updates its main regulatory Web page 
(http://www.HHS.gov/regulations/), which includes links to HHS rules 
currently open for public comment and 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, including through a comment form on the HHS 
retrospective review Web page (http://www.HHS.gov/RetrospectiveReview). 
In addition, a cross-agency team at HHS is currently considering how to 
increase efficiency in rulemaking by organizing public comment on 
proposed rules.
    The rulemaking abstracts included in this paper issue of the 
Federal Register only 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: August 21, 2013.
Jennifer M. Cannistra,
Executive Secretary to the Department.

               Food and Drug Administration--Prerule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
274.......................  Over-the-Counter (OTC)             0910-AF43
                             Drug Review--Sunscreen
                             Products.
275.......................  Prescription Drug                  0910-AG14
                             Marketing Act of 1987;
                             Prescription Drug
                             Amendments of 1992;
                             Policies, Requirements,
                             and Administrative
                             Procedures (Section 610
                             Review).
------------------------------------------------------------------------

            Food and Drug Administration--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
276.......................  Food Labeling; Revision of         0910-AF22
                             the Nutrition and
                             Supplement Facts Labels
                             (Reg Plan Seq No. 49).
277.......................  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 (Reg Plan Seq No.
                             50).
278.......................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
279.......................  Over-the-Counter (OTC)             0910-AF36
                             Drug Review--Internal
                             Analgesic Products.
280.......................  Updated Standards for              0910-AG09
                             Labeling of Pet Food.
281.......................  Current Good Manufacturing         0910-AG10
                             Practice, Hazard
                             Analysis, and Risk-Based
                             Preventive Controls for
                             Food for Animals (Reg
                             Plan Seq No. 51).
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.......................  Produce Safety Regulation.         0910-AG35
285.......................  Hazard Analysis and Risk-          0910-AG36
                             Based Preventive Controls.
286.......................  ``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. 52).
287.......................  Requirements for the               0910-AG59
                             Testing and Reporting of
                             Tobacco Product
                             Constituents,
                             Ingredients, and
                             Additives.
288.......................  Foreign Supplier                   0910-AG64
                             Verification Program.
289.......................  Supplemental Applications          0910-AG94
                             Proposing Labeling
                             Changes for Approved
                             Drugs and Biological
                             Products (Reg Plan Seq
                             No. 55).

[[Page 1159]]

 
290.......................  Veterinary Feed Directive          0910-AG95
                             (Reg Plan Seq No. 56).
291.......................  Format and Content of              0910-AG96
                             Reports Intended to
                             Demonstrate Substantial
                             Equivalence.
292.......................  Radiology Devices;                 0910-AH03
                             Designation of Special
                             Controls for the Computed
                             Tomography X-Ray System.
293.......................  Mammography Quality                0910-AH04
                             Standards Act; Regulatory
                             Amendments.
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.

             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
294.......................  Content and Format of              0910-AF11
                             Labeling for Human
                             Prescription Drugs and
                             Biologics; Requirements
                             for Pregnancy and
                             Lactation Labeling.
295.......................  Infant Formula: Current            0910-AF27
                             Good Manufacturing
                             Practices; Quality
                             Control Procedures;
                             Notification
                             Requirements; Records and
                             Reports; and Quality
                             Factors.
296.......................  Combinations of                    0910-AF33
                             Bronchodilators With
                             Nasal Decongestants or
                             Expectorants; Cold,
                             Cough, Allergy,
                             Bronchodilator, and
                             Antiasthmatic Drug
                             Products for Over-the-
                             Counter Human Use.
297.......................  Laser Products; Proposed           0910-AF87
                             Amendment to Performance
                             Standard.
298.......................  Food Labeling: Calorie             0910-AG56
                             Labeling of Articles of
                             Food Sold in Vending
                             Machines (Reg Plan Seq
                             No. 57).
299.......................  Food Labeling: Nutrition           0910-AG57
                             Labeling of Standard Menu
                             Items in Restaurants and
                             Similar Retail Food
                             Establishments (Reg Plan
                             Seq No. 58).
300.......................  Use of Certain Symbols in          0910-AG74
                             Labeling.
301.......................  Requirements for the               0910-AG81
                             Submission of Data Needed
                             To Calculate User Fees
                             for Manufacturers and
                             Importers of Tobacco
                             Products.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
302.......................  Over-the-Counter (OTC)             0910-AF69
                             Drug Review--Topical
                             Antimicrobial Drug
                             Products.
303.......................  Amendment to the Current           0910-AG20
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Second Phase.
304.......................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Studies for
                             Medical Devices.
305.......................  Amendments to the Current          0910-AG70
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Components.
------------------------------------------------------------------------

             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
306.......................  Unique Device                      0910-AG31
                             Identification.
307.......................  Food Labeling: Serving             0910-AG82
                             Sizes; Reference Amount
                             and Serving Size
                             Declaration for Hard
                             Candies and Breath Mints.
308.......................  Food Labeling; Gluten-Free         0910-AG84
                             Labeling of Foods.
------------------------------------------------------------------------

      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
309.......................  Emergency Preparedness             0938-AO91
                             Requirements for Medicare
                             and Medicaid
                             Participating Providers
                             and Suppliers (CMS-3178-
                             P) (Section 610 Review).
310.......................  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-F) (Section 610
                             Review).
311.......................  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-P)
                             (Reg Plan Seq No. 62).
312.......................  CY 2015 Revisions to               0938-AS12
                             Payment Policies under
                             the Physician Fee
                             Schedule and Other
                             Revisions to Medicare
                             Part B (CMS-1612-P) (Reg
                             Plan Seq No. 63).
313.......................  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-
                             P) (Reg Plan Seq No. 64).
------------------------------------------------------------------------
References in boldface appear in The Regulatory Plan in part II of this
  issue of the Federal Register.

[[Page 1160]]

       Centers for Medicare & Medicaid Services--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
314.......................  Covered Outpatient Drugs           0938-AQ41
                             (CMS-2345-F) (Section 610
                             Review).
315.......................  CY 2014 Changes to the End-        0938-AR55
                             Stage Renal Disease
                             (ESRD) Prospective
                             Payment System, ESRD
                             Quality Incentive
                             Program, and Durable
                             Medical Equipment (CMS-
                             1526-F).
316.......................  Revisions to Payment               0938-AR56
                             Policies Under the
                             Physician Fee Schedule
                             and Medicare Part B for
                             CY 2014 (CMS-1600-F).
317.......................  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.
------------------------------------------------------------------------
318.......................  Changes to the Hospital            0938-AR53
                             Inpatient and Long-Term
                             Care Prospective Payment
                             System for FY 2014 (CMS-
                             1599-F).
319.......................  Changes to the Hospital            0938-AR54
                             Outpatient Prospective
                             Payment System and
                             Ambulatory Surgical
                             Center Payment System for
                             CY 2014 (CMS-1601-F).
------------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Prerule Stage

274. Over-the-Counter (OTC) Drug Review--Sunscreen 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. The first of 
the future actions will address the safety of sunscreen active 
ingredients.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM (Sunscreen and Insect            02/22/07  72 FR 7941
 Repellent).
ANPRM Comment Period End............   05/23/07
NPRM (UVA/UVB)......................   08/27/07  72 FR 49070
NPRM Comment Period End.............   12/26/07
Final Action (UVA/UVB)..............   06/17/11  76 FR 35620
NPRM (Effectiveness)................   06/17/11  76 FR 35672
NPRM (Effectiveness) Comment Period    09/15/11
 End.
ANPRM (Dosage Forms)................   06/17/11  76 FR 35669
ANPRM (Dosage Forms) Comment Period    09/15/11
 End.
ANPRM (Safety)......................   06/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Eng, Regulatory Project Manager, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-2773, Fax: 301 796-
9899, Email: david.eng@fda.hhs.gov.
    RIN: 0910-AF43

275. Prescription Drug Marketing Act of 1987; Prescription Drug 
Amendments of 1992; Policies, Requirements, and Administrative 
Procedures (Section 610 Review)

    Legal Authority: 21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 351 to 
353; 21 U.S.C. 360; 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381
    Abstract: FDA is currently reviewing regulations promulgated under 
the Prescription Drug Marketing Act (PDMA). FDA is undertaking this 
review to determine whether the regulations should be changed or 
rescinded to minimize adverse impacts on a substantial number of small 
entities. FDA has extended again the completion date by 1 year and will 
complete the review by November 2013.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
Begin Review of Current Regulation..   11/24/08
End Review of Current Regulation....   11/00/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Howard Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, 
Fax: 301 847-8440, Email: pdma610(c)review@fda.hhs.gov.
    RIN: 0910-AG14

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

276. Food Labeling; Revision of the Nutrition and Supplement Facts 
Labels

    Regulatory Plan: This entry is Seq. No. 49 in part II of this issue 
of the Federal Register.
    RIN: 0910-AF22

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

    Regulatory Plan: This entry is Seq. No. 50 in part II of this issue 
of the Federal Register.
    RIN: 0910-AF23

278. 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

[[Page 1161]]

    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)......   12/00/13
------------------------------------------------------------------------

    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: janice.adams-king@fda.hhs.gov.
    RIN: 0910-AF31

279. 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)........   07/00/14
NPRM (Amendment) (Acetaminophen)....   12/00/14
------------------------------------------------------------------------

    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: janice.adams-king@fda.hhs.gov.
    RIN: 0910-AF36

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 useful 
information about the nutrient content and ingredient composition of 
pet food products.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   06/00/14
------------------------------------------------------------------------

    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: 
william.burkholder@fda.hhs.gov.
    RIN: 0910-AG09

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

    Regulatory Plan: This entry is Seq. No. 51 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG10

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................................   06/00/14
------------------------------------------------------------------------

    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: janice.adams-king@fda.hhs.gov.
    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

[[Page 1162]]

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................................   01/00/14
------------------------------------------------------------------------

    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: megan.velez@fda.hhs.gov.
    RIN: 0910-AG18

284. Produce Safety Regulation

    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 Jan. 4, 2011)
    Abstract: FDA is proposing to 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 
proposed 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     11/18/13  78 FR 69006
 the Proposed Rule; Comment Period
 Extended.
Environmental Impact Statement for     03/14/14
 the Proposed Rule; Comment Period
 Extended End.
------------------------------------------------------------------------

    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: samir.assar@fda.hhs.gov.
    RIN: 0910-AG35

285. Hazard Analysis and Risk-Based Preventive Controls

    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 proposed 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
------------------------------------------------------------------------

    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: jenny.scott@fda.hhs.gov.
    RIN: 0910-AG36

286. ``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. 52 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG38

287. 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................................   12/00/13
------------------------------------------------------------------------

    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, 9200 Corporate Boulevard, Room 240 H, Rockville, MD 
20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: 
carol.drew@fda.hhs.gov.

[[Page 1163]]

    RIN: 0910-AG59

288. 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: FDA is proposing regulations that describe 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  .......................
------------------------------------------------------------------------

    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: 
brian.pendleton@fda.hhs.gov.
    RIN: 0910-AG64

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

    Regulatory Plan: This entry is Seq. No. 55 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG94

290. Veterinary Feed Directive

    Regulatory Plan: This entry is Seq. No. 56 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG95

291. 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 and compliance 
with the FD&C Act (sections 905(j) and 910(a) of the FD&C Act). This 
regulation also would provide information as to how the Agency will 
review and act on these submissions.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/00/14  .......................
------------------------------------------------------------------------

    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, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 
877 287-1373, Fax: 240 276-4193, Email: gerie.voss@fda.hhs.gov.
    RIN: 0910-AG96

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

    Legal Authority: 21 U.S.C. 360
    Abstract: The proposed rule would establish special controls for 
the computed tomography (CT) X-ray system, a class II device as defined 
in 21 CFR 892.1750. 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, or, in extremely high doses, radiation 
poisoning. Therefore, the design of a CT X-ray system needs to 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 special controls, combined 
with the general controls, to provide reasonable assurance of the 
safety and effectiveness of a class II CT X-ray system.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/00/14  .......................
------------------------------------------------------------------------

    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: erica.blake@fda.hhs.gov.
    RIN: 0910-AH03

293. 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................................   12/00/13  .......................
------------------------------------------------------------------------

    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: nancy.pirt@fda.hhs.gov.
    RIN: 0910-AH04

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administrtion (FDA)

Final Rule Stage

294. 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 (21 CFR 201.56 and 201.57) to better communicate 
risks.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   05/29/08  73 FR 30831

[[Page 1164]]

 
NPRM Comment Period End.............   08/27/08  .......................
Final Action........................   05/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Molly Flannery, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6246, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-3543, Email: 
molly.flannery@fda.hhs.gov.
    RIN: 0910-AF11

295. 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 in 21 CFR parts 106 and 107 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  .......................
Final Rule..........................   11/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Benson Silverman, Staff Director, Infant Formula 
and Medical Foods, 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 
402-1459, Email: benson.silverman@fda.hhs.gov
    RIN: 0910-AF27

296. Combinations of Bronchodilators With Nasal Decongestants or 
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. This action 
addresses cough/cold drug products containing an oral bronchodilator 
(ephedrine and its salts) in combination with any expectorant or 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........................   06/00/14  .......................
------------------------------------------------------------------------

    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: janice.adams-king@fda.hhs.gov.
    RIN: 0910-AF33

297. Laser Products; Proposed Amendment to Performance Standard

    Legal Authority: 21 U.S.C. 360hh to 360ss; 21 U.S.C. 371; 21 U.S.C. 
393
    Abstract: FDA is proposing to amend the 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 proposed 
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........................   06/00/14  .......................
------------------------------------------------------------------------

    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: nancy.pirt@fda.hhs.gov.
    RIN: 0910-AF87

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

    Regulatory Plan: This entry is Seq. No. 57 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG56

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

    Regulatory Plan: This entry is Seq. No. 58 in part II of this issue 
of the Federal Register.
    RIN: 0910-AG57

300. Use of Certain Sysmbols in Labeling

    Legal Authority: sec 502(c) of the Food Drug and Cosmetic Act (FD&C 
Act), 21 U.S.C. 352(c); sec 514(c) of FD&C Act, 21 U.S.C. 360d(c), 
enacted by the Food and Drug Modernization Act of 1997 (FDAMA)
    Abstract: The purpose of this rule is to allow for the inclusion of 
certain stand-alone symbols contained in a standard that FDA 
recognizes, provided that such symbols are explained in a symbols 
glossary that contemporaneously accompanies the medical device.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   04/19/13  78 FR 23508
NPRM Comment Period End.............   06/18/13  .......................
Final Action........................   04/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mary Follette Story, Human Factors and Accessible 
Medical Technology Specialist, Department of Health and Human Services, 
Food and Drug Administration, Center for Devices

[[Page 1165]]

and Radiological Health, Room 2553, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993, Phone: 301 796-1456, Email: molly.story@fda.hhs.gov.
    RIN: 0910-AG74

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

    Legal Authority: 21 U.S.C. 371; 21 U.S.C. 387s; Pub. L. 111-31
    Abstract: FDA is proposing to 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........................   06/00/14  .......................
------------------------------------------------------------------------

    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, Room 340K, 9200 Corporate Boulevard, 
Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: 
annette.marthaler@fda.hhs.gov.
    RIN: 0910-AG81

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

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

    Legal Authority: 21 U.S.C. 321p; 21 U.S.C. 331; 21 U.S.C. 351 to 
353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371
    Abstract: The OTC drug review establishes conditions under which 
OTC drugs are considered generally recognized as safe and effective and 
not misbranded. After a final monograph (i.e., final rule) is issued, 
only OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses antimicrobial agents in consumer hand wash 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)..   12/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: David Eng, Regulatory Project Manager, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, Phone: 301 796-2773, Fax: 301 796-
9899, Email: david.eng@fda.hhs.gov.
    RIN: 0910-AF69

303. Amendment to the Current Good Manufacturing Practice Regulations 
for Pharmaceuticals--Second Phase

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 
262; 42 U.S.C. 264
    Abstract: FDA will revise regulations for ``current good 
manufacturing practice'' for oversight and controls over the 
manufacture of drugs to ensure quality, including managing the risk of 
and establishing the safety of raw materials, materials used in the 
manufacturing of drugs, and finished drug products. This revision will 
update and harmonize requirements and improve detection and response to 
emerging product safety and quality signals.
    Timetable:

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Paula Katz, Regulatory Counsel, Office of 
Compliance, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, WO 51, Room 
4314, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 
796-6972, Fax: 301 847-8742, Email: paula.katz@fda.hhs.gov.
    RIN: 0910-AG20

304. Human Subject Protection; Acceptance of Data From Clinical Studies 
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 studies conducted in support of a premarket approval 
application, humanitarian device exemption application, an 
investigational device exemption application, or a premarket 
notification submission for a medical device.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   02/25/13  78 FR 12664
NPRM Comment Period End.............   05/28/13  .......................
Final Action........................   12/00/14  .......................
------------------------------------------------------------------------

    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: 
sheila.brown@fda.hhs.gov.
    RIN: 0910-AG48

305. Amendments to the Current Good Manufacturing Practice Regulations 
for Finished Pharmaceuticals--Components

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 351; 21 U.S.C. 352; 21 
U.S.C. 355; 21 U.S.C. 360b; 21 U.S.C. 360bbb-7; 21 U.S.C. 371; 21 
U.S.C. 374; 42 U.S.C. 262; 42 U.S.C. 264
    Abstract: FDA will revise regulations for ``current good 
manufacturing practice'' with regard to the control over components 
used in manufacturing finished pharmaceuticals.
    Timetable:

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

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Brian Hasselbalch, Consumer Safety Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, WO 51, Room 4364, 10903 New 
Hampshire Avenue,

[[Page 1166]]

Silver Spring, MD 20993, Phone: 301 796-3279, Email: 
brian.hasselbalch@fda.hhs.gov.
    Paula Katz, Consumer Safety Officer, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, WO 51, Room 1320, 10903 New Hampshire Avenue, Silver Spring, 
MD 20993, Phone: 301 796-6972, Email: paula.katz@fda.hhs.gov.
    RIN: 0910-AG70

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

306. Unique Device Identification

    Legal Authority: 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 360; 21 
U.S.C. 360h; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 U.S.C. 360l; 21 U.S.C. 
371
    Abstract: FDA is issuing a final rule establishing a unique device 
identification system for medical devices. A unique device 
identification system would allow healthcare professionals and others 
to rapidly and precisely identify a device and obtain important 
information concerning the device and would reduce medical errors.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/10/12  77 FR 40735
NPRM Comment Period End.............   11/07/12  .......................
Second NPRM.........................   11/19/12  77 FR 69393
Second NPRM Comment Period End......   12/19/13  .......................
Final Action........................   09/24/13  78 FR 58786
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: John J. Crowley, Senior Advisor for Patient Safety, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 980-1936, Email: 
jay.crowley@fda.hhs.gov.
    RIN: 0910-AG31

307. Food Labeling: Serving Sizes; Reference Amount and Serving Size 
Declaration for Hard Candies and Breath Mints

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
    Abstract: FDA is proposing to change the nutrition label serving 
size for breath mints to one unit. FDA is taking this action in 
response to a citizen petition that requested a serving size for breath 
mints that more accurately reflects the amount customarily consumed per 
eating occasion and comments received on an advance notice of proposed 
rulemaking published in 2005.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/30/97  62 FR 67775
NPRM Comment Period End.............   03/16/98  .......................
ANPRM...............................   04/05/05  70 FR 17010
ANPRM Comment Period End............   06/20/05  .......................
Withdrawn and Merged with 0910-AF23.   08/14/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Mark Kantor, Nutritionist, Department of Health and 
Human Services, Food and Drug Administration, HFS-830, 5100 Paint 
Branch Parkway, College Park, MD 20740, Phone: 240 402-1450, Fax: 301 
436-1191, Email: mark.kantor@fda.hhs.gov.
    RIN: 0910-AG82

308. Food Labeling; Gluten-Free Labeling of Foods

    Legal Authority: Title II of Pub. L. 108-282; 21 U.S.C. 321; 21 
U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371
    Abstract: FDA is amending its regulations to define the term 
``gluten-free'' for voluntary use in the labeling of foods. FDA is 
taking this action to assist persons who have celiac disease to more 
easily identify foods that they can eat while following a ``gluten-
free'' diet.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/23/07  72 FR 2795
NPRM Comment Period End.............   04/23/07  .......................
NPRM Comment Period Reopened........   08/03/11  76 FR 46671
NPRM Comment Period Reopened End....   10/03/11  .......................
Final Action........................   08/05/13  78 FR 47154
------------------------------------------------------------------------

    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: 
felicia.billingslea@fda.hhs.gov.
    RIN: 0910-AG84

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

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

    Legal Authority: 42 U.S.C. 1821; 42 U.S.C. 1861 (ff) (3)(B)(i)(ii); 
42 U.S.C. 1913 (c)(1) et al
    Abstract: This rule proposes 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 would ensure 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................................   11/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janice Graham, Health Insurance Specialist, Clincal 
Standards Group, 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: janice.graham@cms.hhs.gov.
    RIN: 0938-AO91

310. 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-F) 
(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)

[[Page 1167]]

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 Action........................   08/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sarah Harding, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop C4-01-26, 7500 Security Boulevard, Windsor 
Mill, MD 21244, Phone: 410 786-4001, Email: sarah.harding@cms.hhs.gov.
    RIN: 0938-AR62

311.  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-P)

    Regulatory Plan: This entry is Seq. No. 62 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS11

312.  CY 2015 Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P)

    Regulatory Plan: This entry is Seq. No. 63 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS12

313.  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-P)

    Regulatory Plan: This entry is Seq. No. 64 in part II of this issue 
of the Federal Register.
    RIN: 0938-AS15

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

314. 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........................   05/00/14  .......................
------------------------------------------------------------------------

    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: wendy.tuttle@cms.hhs.gov.
    RIN: 0938-AQ41

315. CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective 
Payment System, ESRD Quality Incentive Program, and Durable Medical 
Equipment (CMS-1526-F)

    Legal Authority: MIPPA sec 153(b); Pub. L. 111-148 sec 3401(h); 
ATRA sec 632(a)
    Abstract: This final rule updates the bundled payment system for 
End Stage Renal Disease (ESRD) facilities by 1/1/13. The rule also 
updates the Quality Incentives in the ESRD Program. In addition, this 
rule clarifies the grandfathering provision related to the 3-year 
minimum lifetime requirement for Durable Medical Equipment (DME). It 
also provides clarification of the definition of routinely purchased 
DME.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/08/13  78 FR 40835
NPRM Comment Period End.............   08/30/13  .......................
Final Action........................   11/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Michelle Cruse, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Mailstop C5-05-27, 
Baltimore, MD 21244, Phone: 410 786-7540, Email: 
michelle.cruse@cms.hhs.gov.
    RIN: 0938-AR55

316. Revisions to Payment Policies Under the Physician Fee Schedule and 
Medicare Part B for CY 2014 (CMS-1600-F)

    Legal Authority: Social Security Act secs 1102, 1871, 1848
    Abstract: This final rule revises payment polices under the 
Medicare physician fee schedule, and make other policy changes to 
payment under Medicare Part B. These changes are applicable to services 
furnished on or after January 1 annually.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/19/13  78 FR 43282
NPRM Comment Period End.............   09/06/13  .......................
Final Action........................   11/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kathy Bryant, Deputy 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: 
kathy.bryant@cms.hhs.gov.
    RIN: 0938-AR56

317.  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..................   06/00/14  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Christine Stahlecker, Acting Director, 
Administrative Simplification Group, Office of E-Health Standards and 
Services, Department of

[[Page 1168]]

Health and Human Services, Centers for Medicare & Medicaid Services, 
Mail Stop S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244, 
Phone: 410 786-6405, Email: christine.stahlecker@cms.hhs.gov.
    RIN: 0938-AS01

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

318. Changes to the Hospital Inpatient and Long-Term Care Prospective 
Payment System for FY 2014 (CMS-1599-F)

    Legal Authority: sec 1886(d) of the Social Security Act
    Abstract: This annual 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................................   05/10/13  78 FR 27485
NPRM Comment Period End.............   06/25/13  .......................
Final Action........................   08/19/13  78 FR 50419
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Roechel Kujawa, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop C4-07-07, 7500 Security Boulevard, 
Baltimore, MD 21244, Phone: 410 786-9111, Email: 
roechel.kujawa@cms.hhs.gov.
    RIN: 0938-AR53

319. Changes to the Hospital Outpatient Prospective Payment System and 
Ambulatory Surgical Center Payment System for CY 2014 (CMS-1601-F)

    Legal Authority: sec 1833 of the Social Security Act
    Abstract: This final rule revises the Medicare hospital outpatient 
prospective payment system to implement applicable statutory 
requirements and changes arising from our continuing experience with 
this system. The rule also describes changes to the amounts and factors 
used to determine payment rates for services. In addition, the rule 
finalizes changes to the Ambulatory Surgical Center Payment System list 
of services and rates.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/19/13  78 FR 43534
NPRM Comment Period End.............   09/06/13  .......................
Final Action........................   09/06/13  78 FR 54842
------------------------------------------------------------------------

    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 Management, Mail Stop C4-03-06, 
7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, 
Email: marjorie.baldo@cms.hhs.gov.
    RIN: 0938-AR54

[FR Doc. 2013-29632 Filed 1-6-14; 8:45 am]
BILLING CODE 4150-24-P