Document ID: FDA-2014-D-1264-0001
Agency: fda
Document Type: Notice
Title: Submission of a Proposed Draft Guidance for Industry on Developing
Drugs for Treatment of Duchenne Muscular Dystrophy; Establishment of
a Public Docket
Posted Date: 2014-09-04T04:00Z

[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Pages 52732-52733]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21051]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1264]

Submission of a Proposed Draft Guidance for Industry on 
Developing Drugs for Treatment of Duchenne Muscular Dystrophy; 
Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to discuss issues related to developing drugs for 
Duchenne muscular dystrophy (DMD). During a public-private policy forum 
for DMD on December 12, 2013, FDA agreed that Parent Project Muscular 
Dystrophy (PPMD) and other interested parties in the DMD community 
could submit for FDA consideration a proposal for a draft guidance for 
industry on developing drugs for DMD. That proposed draft guidance was 
submitted to FDA on June 25, 2014. FDA values the guidance provided by 
the DMD community and is posting the document to seek additional 
guidance and public comment.

DATES: Submit electronic or written comments by October 6, 2014.

ADDRESSES: Submit written requests for single copies of the proposed 
draft guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the proposed draft guidance document.
    Submit electronic comments 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. All comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Colleen LoCicero, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4242, Silver Spring, MD 20993-0002, 301-
796-1114, colleen.locicero@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

[[Page 52733]]

I. Comments

    FDA invites comment on all matters relating to topics for 
consideration regarding DMD drug development. This request is not 
limited to comments on the proposal described in the submission by 
PPMD.
    Interested persons may submit either electronic comments 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.

II. Electronic Access

    Persons with access to the Internet may obtain the proposed draft 
guidance document at http://www.regulations.gov.

    Dated: August 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21051 Filed 9-3-14; 8:45 am]
BILLING CODE 4164-01-P