Subcommittee of the Antiviral Drugs Advisory Committee; Notice of Meeting

[Federal Register Volume 64, Number 114 (Tuesday, June 15, 1999)]
[Notices]
[Page 32060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15058]



[[Page 32060]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Subcommittee of the Antiviral Drugs Advisory Committee; 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: Subcommittee of the Antiviral Drugs Advisory 
Committee on Immunosuppressive 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 July 27, 1999, 8:30 a.m. 
to 5 p.m.
    Location: Holiday Inn, Goshen/Walker/Whetstone Rooms, Two 
Montgomery Village Ave., Gaithersburg, MD.
    Contact Person: Rhonda W. Stover, or John Schupp, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12531. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: The subcommittee will discuss the new drug application 
(NDA) 21-083, Rapamune (sirolimus, Wyeth-Ayerst Laboratories) 
for the prophylaxis of organ rejection in patients receiving renal 
transplants.
    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 July 20, 1999. 
Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9:30 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 20, 1999, 
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: June 7, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-15058 Filed 6-14-99; 8:45 am]
BILLING CODE 4160-01-F