[Federal Register Volume 65, Number 42 (Thursday, March 2, 2000)]
[Notices]
[Page 11320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4947]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Urology 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: Urology 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 April 10, 2000, 9 a.m. 
to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Sandra Titus or Jayne E. Peterson or Robin M. 
Spencer, Center for Drug Evaluation and Research (HFD-21), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
7001, or 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.
    Agenda: The subcommittee will consider the safety and efficacy of 
new drug application 21-118, UprimaTM (apomorphine HCl 
tablets, sublingual, TAP Holdings) proposed for use in the treatment of 
erectile dysfunction.
    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 April 5, 2000. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before April 5, 2000, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-4947 Filed 3-1-00; 8:45 am]
BILLING CODE 4160-01-F