[Federal Register Volume 66, Number 102 (Friday, May 25, 2001)]
[Notices]
[Pages 28914-28915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13368]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Oncologic 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.

[[Page 28915]]

    Date and Time: The meeting will be held on June 7, 2001, 8 a.m. to 
5:30 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact: Karen M. Templeton-Somers, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7001, or by e-mail at 
[email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code 12542. 
Please call the Information Line for up-to-date information on this 
meeting.
    Agenda: The committee will discuss single patient use of 
nonapproved oncology drugs and biologics. This is a continuation of the 
discussion started at the December 13 and 14, 2000, meeting.
    Procedure: The meeting is open to the public from 8 a.m. to 1 p.m. 
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 May 31, 2001. Oral presentations 
from the public will be scheduled between approximately 8:15 a.m. and 
9:15 a.m. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before May 31, 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.
    Background materials for this meeting will be posted at the 
Oncologic Drugs Advisory Committee dockets Web site at www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2001 and scroll down to 
the Oncologic Drugs Advisory Committee meetings.) The slides and 
transcripts from the meeting will be posted at this same Web site about 
3 weeks after the meeting.
    Closed Committee Deliberations: The meeting will be closed from 1 
p.m. to 5:30 p.m. to permit discussion and review of trade secret and/
or confidential information (5 U.S.C. 552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).
    FDA regrets that it was unable to publish this notice 15 days prior 
to the May 23, 2001, Oncologic Drugs Advisory Committee meeting. 
Because there agency believes there is some urgency to bring these 
issues to public discussion and qualified members of the Oncologic 
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.

    Dated: May 22, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-13368 Filed 5-23-01; 4:15 pm]
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