Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period, 68460 [2013-27213]

Download as PDF 68460 Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. To receive ‘‘Medical Device Development Tools,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1882 to identify the guidance you are requesting. This draft guidance contains information collection that is subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.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 part 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 807 subpart E have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 809 have been approved under OMB control number 0910–0485. V. Comments Interested persons may submit either electronic comments regarding this document 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. [FR Doc. 2013–27233 Filed 11–13–13; 8:45 am] TKELleY on DSK3SPTVN1PROD with NOTICES BILLING CODE 4160–01–P Food and Drug Administration [Docket No. FDA–2013–D–0880] Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance for industry entitled ‘‘Frequently Asked Questions About Medical Foods; Second Edition.’’ We are reopening the comment period in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit either electronic or written comments by December 16, 2013. SUMMARY: IV. Paperwork Reduction Act of 1995 Dated: November 4, 2013. Leslie Kux, Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES 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: ADDRESSES: I. Background In the Federal Register of August 13, 2013 (78 FR 49271), we published a notice announcing the availability of an updated draft guidance for industry entitled ‘‘Frequently Asked Questions About Medical Foods; Second Edition.’’ (We had published earlier versions of the guidance in May 1997 and May 2007.) The draft guidance, when finalized, will update some responses to questions that appeared in earlier versions of the guidance and add new questions and responses regarding the definition, labeling, and availability of medical foods. We invited comment on the draft guidance by October 15, 2013. explained that they needed more time to review the guidance, develop comments, and assemble data. If all of the guidance in the August 13, 2013, version were new, a reopening of the comment period for 60 additional days might be warranted. However, much of the draft guidance remains unchanged from our last revision in 2007. The additional content focuses on FDA’s thinking relating to use of medical foods under supervision by a physician, whether medical foods should be sold by prescription only, and types of diseases and conditions that a medical food could be used to manage. We are, therefore, reopening the comment period for the draft guidance for an additional 30 days, until December 16, 2013. We believe that this reopening allows adequate time for interested persons to submit comments without significantly delaying further FDA action on this draft guidance. (We initially intended to extend the comment period, but, due to the lapse in appropriations and resulting cessation of many government operations from October 1 through October 16, 2013, we were unable to issue a notice extending the comment period before October 15, 2013; consequently, we are reopening the comment period for an additional 30 days.) III. How To Submit Comments Interested persons may submit either electronic comments regarding the 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 may be posted to the docket at http:// www.regulations.gov. Dated: November 7, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–27213 Filed 11–13–13; 8:45 am] BILLING CODE 4160–01–P II. Request for Comments Following publication of the August 13, 2013, notice of availability, we received requests for a 60-day extension of the comment period. The requesters VerDate Mar<15>2010 19:20 Nov 13, 2013 Jkt 232001 PO 00000 Frm 00051 Fmt 4703 Sfmt 9990 E:\FR\FM\14NON1.SGM 14NON1

Agencies

[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Page 68460]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27213]


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

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; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the draft guidance for industry entitled 
``Frequently Asked Questions About Medical Foods; Second Edition.'' We 
are reopening the comment period in response to requests for an 
extension to allow interested persons additional time to submit 
comments.

DATES: Submit either electronic or written comments by December 16, 
2013.

ADDRESSES: 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

    In the Federal Register of August 13, 2013 (78 FR 49271), we 
published a notice announcing the availability of an updated draft 
guidance for industry entitled ``Frequently Asked Questions About 
Medical Foods; Second Edition.'' (We had published earlier versions of 
the guidance in May 1997 and May 2007.) The draft guidance, when 
finalized, will update some responses to questions that appeared in 
earlier versions of the guidance and add new questions and responses 
regarding the definition, labeling, and availability of medical foods. 
We invited comment on the draft guidance by October 15, 2013.

II. Request for Comments

    Following publication of the August 13, 2013, notice of 
availability, we received requests for a 60-day extension of the 
comment period. The requesters explained that they needed more time to 
review the guidance, develop comments, and assemble data.
    If all of the guidance in the August 13, 2013, version were new, a 
reopening of the comment period for 60 additional days might be 
warranted. However, much of the draft guidance remains unchanged from 
our last revision in 2007. The additional content focuses on FDA's 
thinking relating to use of medical foods under supervision by a 
physician, whether medical foods should be sold by prescription only, 
and types of diseases and conditions that a medical food could be used 
to manage. We are, therefore, reopening the comment period for the 
draft guidance for an additional 30 days, until December 16, 2013. We 
believe that this reopening allows adequate time for interested persons 
to submit comments without significantly delaying further FDA action on 
this draft guidance. (We initially intended to extend the comment 
period, but, due to the lapse in appropriations and resulting cessation 
of many government operations from October 1 through October 16, 2013, 
we were unable to issue a notice extending the comment period before 
October 15, 2013; consequently, we are reopening the comment period for 
an additional 30 days.)

III. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
the 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 may be posted to 
the docket at http://www.regulations.gov.

    Dated: November 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27213 Filed 11-13-13; 8:45 am]
BILLING CODE 4160-01-P