[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Proposed Rules]
[Pages 44252-44263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17060]



[[Page 44251]]

Vol. 78

Tuesday,

No. 141

July 23, 2013

Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

  Federal Register / Vol. 78 , No. 141 / Tuesday, July 23, 2013 / 
Unified Agenda  

[[Page 44252]]


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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.
    The purpose of the agenda is to encourage more effective public 
participation in the regulatory process. HHS is currently furthering 
this goal by engaging in a Department-wide effort to identify ways to 
make the rulemaking process more accessible to the general public. This 
effort is in response to President Obama's January 18, 2011, Executive 
Order 13563, ``Improving Regulation and Regulatory Review,'' which 
requires ongoing retrospective review of current agency regulations and 
encourages federal agencies to develop balanced regulations through a 
process that ``allows for public participation and an open exchange of 
ideas.'' HHS's efforts include stakeholder outreach and continuing to 
update its main regulatory Web page (http://www.HHS.gov/Regulations) 
with information helpful to the public. For example, to encourage 
public participation, the Web page includes links to HHS rules 
currently open for public comment and provides a ``regulations 
toolkit'' with background information on regulations, the commenting 
process, and how the public can provide effective comments. HHS also 
actively encourages meaningful public participation in retrospective 
review and rulemaking through education and outreach (http://www.HHS.gov/RetrospectiveReview).
    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: April 22, 2013.
Jennifer M. Cannistra,
Executive Secretary to the Department.

               Food and Drug Administration--Prerule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
1.........................  Over-the-Counter (OTC)             0910-AF43
                             Drug Review--Sunscreen
                             Products.
2.........................  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.
------------------------------------------------------------------------
3.........................  Food Labeling; Revision of         0910-AF22
                             the Nutrition and
                             Supplement Facts Labels.
4.........................  Serving Sizes of Foods             0910-AF23
                             That Can Reasonably Be
                             Consumed in One Eating
                             Occasion; Dual Column
                             Labeling; Updating,
                             Modifying and
                             Establishing Certain
                             Reference Amounts
                             Customarily Consumed.
5.........................  Over-the-Counter (OTC)             0910-AF31
                             Drug Review--Cough/Cold
                             (Antihistamine) Products.
6.........................  Over-the-Counter (OTC)             0910-AF36
                             Drug Review--Internal
                             Analgesic Products.
7.........................  Over-the-Counter (OTC)             0910-AF69
                             Drug Review--Topical
                             Antimicrobial Drug
                             Products.
8.........................  Laser Products; Proposed           0910-AF87
                             Amendment to Performance
                             Standard.
9.........................  Updated Standards for              0910-AG09
                             Labeling of Pet Food.
10........................  Current Good Manufacturing         0910-AG10
                             Practice, Hazard
                             Analysis, and Risk-Based
                             Preventive Controls for
                             Food for Animals.
11........................  Over-the-Counter (OTC)             0910-AG12
                             Drug Review--Pediatric
                             Dosing for Cough/Cold
                             Products.
12........................  Electronic Distribution of         0910-AG18
                             Prescribing Information
                             for Human Prescription
                             Drugs Including
                             Biological Products.
13........................  Amendment to the Current           0910-AG20
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Second Phase.
14........................  Produce Safety Regulation.         0910-AG35
15........................  Hazard Analysis and Risk-          0910-AG36
                             Based Preventive Controls.

[[Page 44253]]

 
16........................  ``Tobacco Products''               0910-AG38
                             Subject to the Federal
                             Food, Drug, and Cosmetic
                             Act, as Amended by the
                             Family Smoking Prevention
                             and Tobacco Control Act.
17........................  Requirements for the               0910-AG59
                             Testing and Reporting of
                             Tobacco Product
                             Constituents,
                             Ingredients, and
                             Additives.
18........................  Foreign Supplier                   0910-AG64
                             Verification Program.
19........................  Amendments to the Current          0910-AG70
                             Good Manufacturing
                             Practice Regulations for
                             Finished Pharmaceuticals--
                             Components.
20........................  Requirements for the               0910-AG81
                             Submission of Data Needed
                             to Calculate User Fees
                             for Manufacturers and
                             Importers of Tobacco
                             Products.
21........................  Food Labeling: Serving             0910-AG82
                             Sizes; Reference Amount
                             and Serving Size
                             Declaration for Hard
                             Candies and Breath Mints.
22........................  Supplemental Applications          0910-AG94
                             Proposing Labeling
                             Changes for Approved
                             Drugs and Biological
                             Products.
23........................  Veterinary Feed Directive.         0910-AG95
24........................  Format and Content of              0910-AG96
                             Reports Intended to
                             Demonstrate Substantial
                             Equivalence.
25........................  Radiology Devices;                 0910-AH03
                             Designation of Special
                             Controls for the Computed
                             Tomography X-Ray System.
26........................  Mammography Quality                0910-AH04
                             Standards Act; Regulatory
                             Amendments.
------------------------------------------------------------------------


             Food and Drug Administration--Final Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
27........................  Content and Format of              0910-AF11
                             Labeling for Human
                             Prescription Drugs and
                             Biologics; Requirements
                             for Pregnancy and
                             Lactation Labeling.
28........................  Infant Formula: Current            0910-AF27
                             Good Manufacturing
                             Practices; Quality
                             Control Procedures;
                             Notification
                             Requirements; Records and
                             Reports; and Quality
                             Factors.
29........................  Over-the-Counter (OTC)             0910-AF33
                             Drug Review--Cough/Cold
                             (Combination) Products.
30........................  Unique Device                      0910-AG31
                             Identification.
31........................  Food Labeling: Calorie             0910-AG56
                             Labeling of Articles of
                             Food Sold in Vending
                             Machines.
32........................  Food Labeling: Nutrition           0910-AG57
                             Labeling of Standard Menu
                             Items in Restaurants and
                             Similar Retail Food
                             Establishments.
33........................  Use of Certain Symbols in          0910-AG74
                             Labeling.
34........................  Food Labeling; Gluten-Free         0910-AG84
                             Labeling of Foods.
------------------------------------------------------------------------


             Food and Drug Administration--Long-Term Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
35........................  Human Subject Protection;          0910-AG48
                             Acceptance of Data From
                             Clinical Studies for
                             Medical Devices.
------------------------------------------------------------------------


             Food and Drug Administration--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
36........................  Food Labeling: Serving             0910-AG83
                             Sizes; Reference Amounts
                             for Candies.
------------------------------------------------------------------------


      Centers for Medicare & Medicaid Services--Proposed Rule Stage
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
37........................  Emergency Preparedness             0938-AO91
                             Requirements for Medicare
                             and Medicaid
                             Participating Providers
                             and Suppliers (CMS-3178-
                             P) (Section 610 Review).
38........................  Changes to the Hospital            0938-AR54
                             Outpatient Prospective
                             Payment System and
                             Ambulatory Surgical
                             Center Payment System for
                             CY 2014 (CMS-1601-P).
39........................  Revisions to Payment               0938-AR56
                             Policies Under the
                             Physician Fee Schedule
                             and Medicare Part B for
                             CY 2014 (CMS-1600-P).
40........................  Prospective Payment System         0938-AR62
                             for Federally Qualified
                             Health Centers (FQHCs)
                             (CMS-1443-P) (Section 610
                             Review).
------------------------------------------------------------------------


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

[[Page 44254]]

 
42........................  Changes to the Hospital            0938-AR53
                             Inpatient and Long-Term
                             Care Prospective Payment
                             System for FY 2014 (CMS-
                             1599-F).
------------------------------------------------------------------------


       Centers for Medicare & Medicaid Services--Completed Actions
------------------------------------------------------------------------
                                                           Regulation
       Sequence No.                    Title             Identifier No.
------------------------------------------------------------------------
43........................  Transparency Reports and           0938-AR33
                             Reporting of Physician
                             Ownership of Investment
                             Interests (CMS-5060-F).
44........................  Part B Inpatients Billings         0938-AR73
                             in Hospitals (CMS-1455-F).
------------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Prerule Stage

1. 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)......................   11/00/13
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AF43

2. 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)[email protected].
    RIN: 0910-AG14

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Proposed Rule Stage

3. 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 proposing to amend 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. If finalized, 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................................   11/00/13
------------------------------------------------------------------------

    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: 240 402-1450, 
Email: [email protected].
    RIN: 0910-AF22

[[Page 44255]]

4. Serving Sizes of Foods That Can Reasonably Be Consumed in One Eating 
Occasion; Dual Column Labeling; Updating, Modifying and Establishing 
Certain Reference Amounts Customarily Consumed

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
    Abstract: FDA is proposing to amend its labeling regulations for 
foods to provide updated Reference Amounts Customarily Consumed (RACCs) 
for certain food categories. If finalized, 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 considering amending the definition of single-serving 
containers and providing for dual-column labeling, which would provide 
nutrition information per serving and per container, for certain 
containers.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
ANPRM...............................   04/04/05  70 FR 17010
ANPRM Comment Period End............   06/20/05
NPRM................................   11/00/13
------------------------------------------------------------------------

    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: 202 402-1450, Fax: 
301 436-1191, Email: [email protected].
    RIN: 0910-AF23

5. 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)......   11/00/13
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AF31

6. 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) (Acetaminophen)....   12/00/13
NPRM (Amendment) (Pediatric)........   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: [email protected].
    RIN: 0910-AF36

7. 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)..   09/00/13
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AF69

8. 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

[[Page 44256]]

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

    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

9. 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................................   04/00/14
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AG09

10. Current Good Manufacturing Practice, 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: FDA is proposing regulations for preventive controls for 
animal food, including ingredients and mixed animal feed. This action 
is intended to provide greater assurance that food marketed for all 
animals, including pets, is safe.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   08/00/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Kim Young, Deputy Director, Division of Compliance, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 
Standish Place, Rockville, MD 20855, Phone: 240 276-9207, Email: 
[email protected].
    RIN: 0910-AG10

11. 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................................   11/00/13
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG12

12. 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................................   10/00/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Janet Norden, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, WO 51, Room 6324, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-2500, Email: 
[email protected].
    RIN: 0910-AG18

13. Amendment to the Current Good Manufacturing Practice Regulations 
for Finished 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................................   01/00/14
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Paula Katz, Regulatory Counsel, Office of 
Compliance, Department of Health and Human Services, Food and Drug

[[Page 44257]]

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: [email protected].
    RIN: 0910-AG20

14. 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  .......................
------------------------------------------------------------------------

    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

15. 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 Extended........   04/26/13  78 FR 24691
NPRM Comment Period End.............   09/16/13  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG36

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

    Legal Authority: 21 U.S.C. 301 et seq., The Federal Food, Drug, and 
Cosmetic Act; Pub. L. 111-31, The Family Smoking Prevention and Tobacco 
Control Act
    Abstract: The Family Smoking Prevention and Tobacco Control Act 
(Tobacco Control Act) provides the Food and Drug Administration (FDA) 
authority to regulate cigarettes, cigarette tobacco, roll-your-own 
tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic 
Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to 
issue regulations deeming other tobacco products to be subject to the 
FD&C Act. This proposed rule would deem 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................................   10/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: May Nelson, 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: 240 276-3904, Email: [email protected].
    RIN: 0910-AG38

17. 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: 
[email protected].
    RIN: 0910-AG59

18. 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................................   07/00/13  .......................
------------------------------------------------------------------------

    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].

[[Page 44258]]

    RIN: 0910-AG64

19. 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................................   07/00/13  .......................
------------------------------------------------------------------------

    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, Silver Spring, MD 20993, Phone: 301 796-3279, Email: 
[email protected].
    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: [email protected].
    RIN: 0910-AG70

20. 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  .......................
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AG81

21. 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  .......................
NPRM................................   07/00/13  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG82

22.  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 proposed 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. The proposed rule would describe the process by 
which information regarding a ``changes being effected'' (CBE) labeling 
supplement submitted by an NDA or ANDA holder would be made publicly 
available during FDA's review of the labeling change. The proposed rule 
also would clarify requirements for the NDA holder for the reference 
listed drug and all ANDA holders to submit conforming labeling 
revisions after FDA has taken an action on the NDA and/or ANDA holder's 
CBE labeling supplement. These proposed revisions to FDA's regulations 
would create parity between NDA holders and ANDA holders with respect 
to submission of CBE labeling supplements.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/13  .......................
------------------------------------------------------------------------

    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 6304, 10903 New 
Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, 
Fax: 301 847-8440, Email: [email protected].
    RIN: 0910-AG94

23.  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 drugs (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................................   09/00/13  .......................
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Sharon Benz, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine, 
MPN-4, Room 2648, HFV-220, 7529 Standish Place, Rockville, MD 20855, 
Phone: 240 453-6864, Email: [email protected].
    RIN: 0910-AG95

[[Page 44259]]

24.  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................................   06/00/14  .......................
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG96

25.  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................................   12/00/13  .......................
------------------------------------------------------------------------

    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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Final Rule Stage

27. 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
NPRM Comment Period End.............   08/27/08  .......................
Final Action........................   01/00/14  .......................
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AF11

28. 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..........................   07/00/13  .......................
------------------------------------------------------------------------


[[Page 44260]]

    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: [email protected].
    RIN: 0910-AF27

29. Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) 
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 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........................   10/00/13
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AF33

30. 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........................   07/00/13
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AG31

31. 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........................   09/00/13
------------------------------------------------------------------------

    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

32. 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........................   09/00/13
------------------------------------------------------------------------

    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

33. Use of Certain Symbols 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

[[Page 44261]]

Drug Administration, Center for Devices and Radiological Health, Room 
2553, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 
796-1456, Email: [email protected].
    RIN: 0910-AG74

34. 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........................   07/00/13
------------------------------------------------------------------------

    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-AG84

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Long-Term Actions

35. 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........................   09/00/14
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0910-AG48

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Food and Drug Administration (FDA)

Completed Actions

36. Food Labeling: Serving Sizes; Reference Amounts for Candies

    Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
    Abstract: FDA is proposing to change its serving size regulations 
to provide updated Reference Amounts Customarily Consumed for candies. 
FDA is taking this action in response to comments received on an 
advance notice of proposed rulemaking published in 2005. This RIN is 
being withdrawn from the Unified Agenda and merged with RIN 0910-AG82.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   01/08/98  63 FR 1078
NPRM Comment Period End.............   02/09/98
ANPRM...............................   04/05/05  70 FR 17010
ANPRM Comment Period End............   06/20/05
Withdrawn...........................   03/11/13
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0910-AG83

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Proposed Rule Stage

37. 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................................   09/00/13
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AO91

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

    Legal Authority: sec 1833 of the Social Security Act
    Abstract: This proposed rule would revise the Medicare hospital 
outpatient prospective payment system to implement applicable statutory 
requirements and changes arising from our continuing experience with 
this system. The proposed rule also 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:

[[Page 44262]]



------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/13
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AR54

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

    Legal Authority: Social Security Act secs 1102, 1871, 1848
    Abstract: This 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 be applicable to 
services furnished on or after January 1 annually.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   07/00/13
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AR56

40. Prospective Payment System for Federally Qualified Health Centers 
(FQHCS) (CMS-1443-P) (Section 610 Review)

    Legal Authority: Pub. L. 111-148, sec 10501
    Abstract: The Affordable Care Act amends the current Medicare FQHC 
payment policy by requiring the establishment of a new payment system, 
effective with cost reporting periods beginning on or after October 1, 
2014. This rule proposes the establishment of the new prospective 
payment system.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   09/00/13
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AR62

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Final Rule Stage

41. 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........................   01/00/14
------------------------------------------------------------------------

    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: [email protected].
    RIN: 0938-AQ41

42. 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........................   08/00/13
------------------------------------------------------------------------

    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: 
[email protected].
    RIN: 0938-AR53

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Centers for Medicare & Medicaid Services (CMS)

Completed Actions

43. Transparency Reports and Reporting of Physician Ownership of 
Investment Interests (CMS-5060-F)

    Legal Authority: Pub. L. 111-148, sec 6002
    Abstract: This final rule requires applicable manufacturers of 
drugs, devices, biologicals, or medical supplies covered by Medicare, 
Medicaid, or CHIP to annually report to the Secretary certain payments 
or transfers of value provided to physicians or teaching hospitals 
(covered recipients). In addition, applicable manufacturers and 
applicable group purchasing organizations (GPOs) are required to 
annually report certain physician ownership or investment interests.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   12/19/11  76 FR 78742
NPRM Comment Period End.............   02/17/12
Final Action........................   02/08/13  78 FR 9457
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Niall Brennan, Director, Policy and Data Analysis 
Group, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 
202 690-6627, Email: [email protected].
    RIN: 0938-AR33

44. Part B Inpatients Billings in Hospitals (CMS-1455-F)

    Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; 42 U.S.C. 1395rr 
(b)(1)

[[Page 44263]]

    Abstract: This final rule revises Medicare Part B billings policies 
when a Part A claim for a hospital inpatient admission is denied as not 
medically reasonable and necessary.
    Timetable:

------------------------------------------------------------------------
               Action                    Date            FR Cite
------------------------------------------------------------------------
NPRM................................   03/18/13  78 FR 16632
NPRM Comment Period End.............   05/17/13
Merged With 0938-AR53...............   04/23/13
------------------------------------------------------------------------

    Regulatory Flexibility Analysis Required: Yes.
    Agency Contact: Twi Jackson, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 
410 786-1159, Email: [email protected].
    RIN: 0938-AR73

[FR Doc. 2013-17060 Filed 7-22-13; 8:45 am]
BILLING CODE 4150-24-P