[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Pages 52732-52733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-21051]
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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Submission of a Proposed Draft Guidance for Industry on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.
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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could submit for FDA consideration a proposal for a draft guidance for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 That proposed draft guidance was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draft guidance to the Division of Drug Information, Center for Drug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access to the proposed draft guidance document.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, [email protected].
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]
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