Document ID: FDA-2013-D-0880-0043
Agency: fda
Document Type: Notice
Title: Frequently Asked Questions About Medical Foods; Second Edition; Guidance for Industry; Availability
Posted Date: 2016-05-13T04:00Z

[Federal Register Volume 81, Number 93 (Friday, May 13, 2016)]
[Notices]
[Pages 29866-29867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11268]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Frequently Asked 
Questions About Medical Foods; Second Edition.'' FDA published earlier 
versions of the guidance in May 1997 and May 2007. The second edition 
of the guidance provides responses to additional questions regarding 
the definition and labeling of medical foods and updates some prior 
responses.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-0880 for ``Frequently Asked Questions About Medical Foods; 
Second Edition.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to Office 
of Nutrition and Food Labeling, 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 guidance.

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, 240-402-1451.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry, 
entitled ``Frequently Asked Questions About Medical Foods; Second 
Edition.'' We are issuing this guidance consistent with our good 
guidance practices regulation

[[Page 29867]]

(21 CFR 10.115). The guidance represents the current thinking of FDA on 
this topic. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.
    In the Federal Register of August 13, 2013 (78 FR 49271), we 
announced the availability of a draft guidance for industry entitled 
``Frequently Asked Questions About Medical Foods; Second Edition.'' We 
invited comment on the draft guidance by October 15, 2013. On November 
14, 2013, we reopened the comment period giving interested parties an 
additional 30 days until December 16, 2013, to submit comments (78 FR 
68460).
    This guidance is intended to provide industry with a convenient 
place to find answers to frequently asked questions about medical 
foods. FDA published earlier versions of the guidance in May 1997 and 
May 2007. This guidance is a second edition of the May 2007 guidance 
entitled ``Guidance for Industry: Frequently Asked Questions About 
Medical Foods.'' The second edition of the guidance provides responses 
to additional questions regarding the definition and labeling of 
medical foods and updates some of the prior responses. The second 
edition also provides FDA's thinking relating to the labeling of 
medical foods to be used under supervision by a physician, whether 
medical foods can be labeled with ``Rx Only,'' and types of diseases 
and conditions that a medical food could be used to manage.
    We received numerous comments on the draft guidance and have 
modified the final guidance where appropriate. In addition, we made 
editorial changes to improve clarity. The guidance announced in this 
notice finalizes the draft guidance dated August 2013.

II. Paperwork Reduction Act of 1995

    This 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 
collections of information in 21 CFR 101.3, 101.4, 101.5, 101.15, and 
101.105 have been approved under OMB control number 0910-0381. The 
collection of information under 21 CFR 1, part 1 subpart H has been 
approved under OMB control number 0910-0502. The collections of 
information in 21 CFR 113.100 and 114.100 (a) through (d) have been 
approved under OMB control number 0910-0037.

III. Electronic Access

    Persons with access to the Internet may obtain the 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: May 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11268 Filed 5-12-16; 8:45 am]
 BILLING CODE 4164-01-P