[Federal Register: August 6, 2004 (Volume 69, Number 151)]
[Page 47936]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of 

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    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 
    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draft guidance document entitled ``Guidance for the Clinical Evaluation 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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]