[Federal Register: October 21, 2002 (Volume 67, Number 203)]
[Notices]
[Page 64651]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21oc02-53]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: PETERSONJ@CDER.FDA.GOV, 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