[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