[Federal Register: January 25, 2002 (Volume 67, Number 17)]
[Page 3726-3727]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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

[[Page 3727]]

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 
    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]