[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]

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