[Federal Register: October 28, 2004 (Volume 69, Number 208)]
[Notices]
[Page 62902]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc04-67]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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: 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 December 2, 2004, from 8
a.m. to 5:30 p.m.
Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Teresa Watkins, 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: watkinst@cder.fda.gov or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512537. Please call the Information
Line for up-to-date information on this meeting.
Agenda: The committee will discuss new drug application (NDA) 21-
769, Testosterone Transdermal System (proposed tradename, Intrinsa) by
Procter and Gamble, indicated for the treatment of hypoactive sexual
desire disorder in surgically menopausal women receiving concomitant
estrogen therapy. Background materials for this meeting when available
will be posted on the Internet 1 business day before the meeting at:
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
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 November 17,
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 November 17, 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 Teresa Watkins 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 21, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-24068 Filed 10-27-04; 8:45 am]
BILLING CODE 4160-01-S