[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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