Document ID: FDA-2013-D-0880-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Availability
Posted Date: 2013-08-13T04:00Z

[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Pages 49271-49272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19532]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0880]

Draft Guidance for Industry on Frequently Asked Questions About 
Medical Foods; Second Edition; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of the draft guidance for industry entitled ``Frequently 
Asked Questions About Medical Foods; Second Edition.'' The draft 
guidance, when finalized, will provide responses to additional 
questions regarding the definition, labeling, and availability of 
medical foods and updates to some of the existing responses.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on the 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 15, 2013.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Office of Nutrition, Labeling, and Dietary Supplements, 
Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Shawne Suggs-Anderson, Center for Food 
Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1783.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Frequently Asked Questions About Medical Foods; Second 
Edition.'' This draft guidance is being issued consistent with our good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on medical foods. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternate approach may be used if 
such approach satisfies the requirements of the applicable statutes and 
regulations.
    We originally issued this guidance in May 2007. This draft guidance 
provides responses to additional questions regarding the definition, 
labeling, and availability of medical foods and updates to some of the 
existing responses.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the 
PRA). The collections of information in sections 101.3, 101.4, 101.5, 
101.15, and 101.105 of 21 CFR part 101 have been approved under OMB 
control number 0910-0381.
    The labeling provisions recommended in this draft guidance in 
response to Question 13 are not subject to review by OMB because they 
do not constitute a ``collection of information'' under the PRA. 
Rather, the recommended labeling is a ``public disclosure of 
information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

III. Comments

    Interested persons may submit either electronic comments regarding 
this draft guidance to http://www.regulations.gov or written comments 
to the Division of Dockets Management (see ADDRESSES). It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

[[Page 49272]]

IV. Electronic Access

    Persons with access to the Internet may obtain this draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: August 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19532 Filed 8-12-13; 8:45 am]
BILLING CODE 4160-01-P