[Federal Register: August 6, 2004 (Volume 69, Number 151)]
[Notices]
[Page 47936]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au04-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 8, 2004, from
8 a.m. to 5 p.m.
Location: On September 8, 2004, the meeting will be held at the
Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., Bethesda, MD.
Contact Person: Dornette Spell-LeSane, Center for Drug Evaluation
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD
20857, 301-827-7001, FAX: 301-827-6776, e-mail:
spelllesaned@cder.fda.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512536. Please call the Information Line for up-to-date information
on this meeting.
Agenda: On September 8, 2004, the committee will discuss the FDA
draft guidance document entitled ``Guidance for the Clinical Evaluation
of Weight-Control Drugs,'' issued September 24, 1996 (see 69 FR 3588,
January 26, 2004, including solicitation for comments [Docket No.
2003D-0570], see also the FDA Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov.cder/guidance/index.htm
under the heading ``Clinical/Medical (Draft)'').
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by August 31,
2004. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 noon. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before August 31, 2004, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their
presentation.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Dornette Spell-
LeSane, at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 30, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-17949 Filed 8-5-04; 8:45 am]
BILLING CODE 4160-01-S