[Federal Register Volume 65, Number 249 (Wednesday, December 27, 2000)]
[Notices]
[Page 81875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32890]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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: 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 10, 2001, 8:30
a.m. to 5:30 p.m.
Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave.,
Bethesda, MD.
Contact Person: 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: [email protected], 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 committee will discuss new drug application (NDA) 21-
227, CancidasTM (caspofungin) Injection, Merck Research
Laboratories, indicated for treatment of invasive aspergillosis in
patients who are refractory to or intolerant of other therapies.
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 4,
2001. 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 4, 2001, 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.
FDA regrets that it was unable to publish this notice 15 days prior
to the January 10, 2001, meeting. Because the agency believes there is
some urgency to bring these issues to public discussion and qualified
members of the Antiviral Drugs Advisory Committee were available at
this time, the Commissioner of Food and Drugs concluded that it was in
the public interest to hold this meeting even if there was not
sufficient time for the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: December 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-32890 Filed 12-26-00; 8:45 am]
BILLING CODE 4160-01-F