[Federal Register: January 2, 2002 (Volume 67, Number 1)]
[Notices]
[Page 82]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ja02-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Immunosuppressive Drugs 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: 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
presentation.
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]
BILLING CODE 4160-01-S