Fibromyalgia Public Meeting on Patient-Focused Drug Development; Rescheduling of Public Meeting; Extension of Comment Period

This Notice document was issued by the Food and Drug Administration (FDA)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1041]

Fibromyalgia Public Meeting on Patient-Focused Drug Development; Rescheduling of Public Meeting; Extension of Comment Period

Agency

Food and Drug Administration, HHS.

Action

Notice; rescheduling of public meeting; extension of comment period.

Summary

The Food and Drug Administration (FDA) is rescheduling a December 10, 2013, public meeting on Patient-Focused Drug Development for fibromyalgia, announced in the Federal Register on September 23, 2013. Due to inclement weather, the Federal Government was closed on December 10, 2013. We are rescheduling the public meeting to March 26, 2014, and extending the comment period for the public docket.

Dates

The public meeting will be held on March 26, 2014, from 1 p.m. to 5 p.m. Registration to attend the meeting must be received by March 20, 2014. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Submit either electronic or written comments by May 27, 2014.

Addresses

The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, Sections B and C of the Great Room (rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants is through Building 1, where routine security check procedures will be performed. For more information on parking and security procedures, please refer to .

Submit electronic comments to . 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.

FDA will post the agenda approximately 5 days before the meeting at .

For Further Information Contact

Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 1199, Silver Spring, MD 20993, 301-796-5003, FAX: 301-847-8443, email: .

Supplementary Information

In the Federal Register of September 23, 2013 (78 FR 58313), FDA announced a public meeting on December 10, 2013, to obtain patients' perspectives on the impact of fibromyalgia on daily life as well as the available therapies for fibromyalgia. Due to the Government closure on December 10, 2013, the meeting was postponed. We are rescheduling the public meeting to March 26, 2014, and extending the comment period to May 27, 2014 (see DATES). For additional information about the purpose of the meeting, topics for discussion, and registration see the September 23, 2013, Federal Register notice.

Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03587 Filed 2-18-14; 8:45 am]
BILLING CODE 4160-01-P
 
 
Comment Period Closed
May 27 2014, at 11:59 PM ET
ID: FDA-2013-N-1041-0004
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Document Information

Date Posted: Feb 19, 2014
Federal Register Number: 2014-03587
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Comments

178
Comments Received*
Comments from the National Fibromyalgia & Chronic Pain Association Rae Marie Gleason, Medical Education & Research Director The National Fibromyalgia & Chronic...
On behalf of the PatientsLikeMe Fibromyalgia Community I am pleased to attach two documents for public comment on Patient-focused Drug Development in...

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