[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
