[Federal Register: September 15, 2003 (Volume 68, Number 178)]
[Notices]               
[Page 53981-53982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se03-82]                         

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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 October 7, 2003, from 8 
a.m. to 5 p.m.
    Location: 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 12536. 
Please call the Information Line for up-to-date information on this 
meeting.
    Agenda: The committee will discuss the Women's Health Initiative 
study

[[Page 53982]]

results: Implications for the use of hormone therapy with estrogen/
progestin, as a second-line drug, in the prevention and treatment of 
postmenopausal osteoporosis in women.
    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 September 30, 
2003. Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. and 9:15 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before September 30, 
2003, 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: September 8, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-23334 Filed 9-12-03; 8:45 am]

BILLING CODE 4160-01-S