[Federal Register Volume 67, Number 203 (Monday, October 21, 2002)]
[Notices]
[Page 64651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26728]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Women's Health Initiative Subcommittee of the Advisory Committee 
for Reproductive Health Drugs; 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: Women's Health Initiative Subcommittee of the 
Advisory Committee for Reproductive Health Drugs.
    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 November 12, 2002, from 
8 a.m. to 6 p.m. and on November 13, 2002, from 8 a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Jayne E. Peterson, 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, e-mail: [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12537. Please call the Information Line for up-to-date 
information on this meeting. Current information may also be accessed 
on the Internet at the FDA Docket Web site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
    Agenda: On both days, presentations and subcommittee discussions 
will address the following issues related to the study results from the 
estrogen plus progestin component of the Women's Health Initiative 
(WHI): (1) Assessment of the known benefits for the approved 
indications and risk management considerations, (2) the extent to which 
these new data might be extrapolated to other combination estrogen/
progestin products and doses, and (3) the WHI's implications for future 
clinical trials of hormonal therapy.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the subcommittee. 
Written submissions may be made to the contact person by November 1, 
2002. Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2:30 p.m. on November 12, 2002, and between 
approximately 1 p.m. and 2 p.m. on November 13, 2002. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 1, 2002, 
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 Jayne Peterson (see 
Contact Person) 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: October 11, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-26728 Filed 10-18-02; 8:45 am]
BILLING CODE 4160-01-S