[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Notices]
[Page 62323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30705]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Antiviral Drugs Advisory Committee; Notice of Subcommittee
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 meeting of the Antiviral Drugs
Advisory Committee on immunosuppressive drugs.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on January 14, 1998, 8:30
a.m. to 5 p.m.
Location: Quality Suites, Potomac Ballroom, Three Research Ct.,
Rockville, MD.
Contact Person: Rhonda W. Stover or John B. Schupp, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, 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: On January 14, 1998, the subcommittee will discuss new drug
application (NDA) 50-722, CellCept (mycophenolate mofetil),
Syntex, USA, Inc., for immunosuppression following cardiac
transplantation.
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 January 7,
1998. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before January 7, 1998, 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: November 14, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-30705 Filed 11-20-97; 8:45 am]
BILLING CODE 4160-01-F
