[Federal Register Volume 64, Number 39 (Monday, March 1, 1999)]
[Notices]
[Page 10003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4876]



[[Page 10003]]

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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.
    Date and Time: The meeting will be held on March 23, 1999, 8 a.m. 
to 5:30 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Karen M. Templeton-Somers, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20057, 301-827-7001, 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 new drug application (NDA) 21-
051 Temodal (temozolomide) Capsules, Schering Corp., 
indicated for the treatment of patients with advanced metastatic 
malignant melanoma.
    Procedure: On March 23, 1999, from 8 a.m. to 12:15 p.m., the 
meeting is open to the public. 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 
March 8, 1999. 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 March 8, 1999, 
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. After the scientific presentations, a 15-
minute open public session will be conducted for interested persons who 
have submitted their request to speak by March 8, 1999, to address 
issues specific to the submission or topic before the committee.
    Closed Committee Deliberations: On March 23, 1999, from 1 p.m. to 
5:30 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
The investigational new drug application and Phase I and Phase II drug 
products in process will be presented, and recent action on selected 
NDA's will be discussed. This portion of the meeting will be closed to 
permit discussion of this information.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 22, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-4876 Filed 2-26-99; 8:45 am]
BILLING CODE 4160-01-F