[Federal Register: January 25, 2002 (Volume 67, Number 17)]
[Notices]
[Page 3726-3727]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja02-89]
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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). The meeting will
be open 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 February 27, 2002, from
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, e-mail: SomersK@cder.fda.gov, 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: (1) Trial design considerations
and appropriate patient populations for studies of investigational
agents for adjuvant therapy of melanoma given the availability of an
approved agent for this indication; and (2) the appropriate study
design and control for the proposed phase 3 trial of investigational
new drug (IND) 2885, MELACINE (melanoma vaccine), Corixa Corp., for
adjuvant treatment of melanoma.
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 February 20,
2002. Oral presentations from the public will be scheduled between
approximately 8:15 a.m. and 8:45 a.m., and 1:15 p.m. and 1:45 p.m. Time
allotted for each
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presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before February 20,
2002, 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 30-minute open public session may be conducted for
interested persons who have submitted their request to speak by
February 20, 2002, to address issues specific to the topic before the
committee.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: January 18, 2002.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 02-1924 Filed 1-24-02; 8:45 am]
BILLING CODE 4160-01-S