[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Pages 49271-49272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19532]
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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Draft Guidance for Industry on Frequently Asked Questions About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.
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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availability of the draft guidance for industry entitled ``Frequently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 The draft
guidance, when finalized, will provide responses to additional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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 15, 2013.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Office of Nutrition, Labeling, and Dietary Supplements,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access to the draft guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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We are announcing the availability of a draft guidance for industry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 This draft guidance is being issued consistent with our good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 The draft guidance, when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