[Federal Register: January 2, 2002 (Volume 67, Number 1)]
[Page 82]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Immunosuppressive Drugs Subcommittee of the Antiviral Drugs 
Advisory Committee; 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: Immunosuppressive Drugs Subcommittee of the 
Antiviral Drugs Advisory Committee.
    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 January 24, 2002, from 
8:30 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact: Tara P. Turner, 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: TurnerT@cder.fda.gov, 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 new drug applications (NDAs) 
21-083/SE1-006 and 21-110/SE1-004, RAPAMUNE (sirolimus) oral solution 
and tablets, Wyeth-Ayerst Research, approved for prophylaxis of organ 
rejection in patients receiving renal transplants. As stated in the 
approved labeling, it is recommended that RAPAMUNE be used in a regimen 
with cyclosporine and corticosteroids. The discussion is for the 
proposed elimination of cyclosporine from the immunosuppressive regimen 
2 to 4 months after transplantation under certain conditions.
    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 January 16, 
2002. 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 January 16, 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 
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 19, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-32175 Filed 12-31-01; 8:45 am]