[Federal Register Volume 67, Number 226 (Friday, November 22, 2002)]
[Notices]
[Pages 70445-70446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29689]


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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 December 17, 2002, from 
12:30 p.m. to 6 p.m. and December 18, 2002, from 8 a.m. to 3:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 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 20857, 301-827-7001, FAX 301-827-6776, e-
mail: [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: On December 17, 2002, the committee will discuss biologics 
licensing application BL STN 125011/0, BEXXAR, Tositumomab (Anti-B1) 
and Iodine-131-Tositumomab, Corixa Corp., indicated for the treatment 
of patients with relapsed or refractory low-grade, follicular or 
transformed low-grade, B-cell non-Hodgkin's lymphoma (NHL) including 
patients with rituximab

[[Page 70446]]

refractory follicular NHL. On December 18, 2002, the committee will 
discuss new drug application (NDA) 20-498, S012, CASODEX (150 
milligrams bicalutamide), AstraZeneca Pharmaceuticals LP, indicated as: 
(1) Adjuvant therapy to radical prostatectomy and radiotherapy of 
curative intent in patients with locally advanced nonmetastatic 
prostate cancer who have a high risk for disease recurrence, or (2) 
immediate treatment of localized nonmetastatic prostate cancer in 
patients for whom therapy of curative intent is not indicated.
    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 December 10, 
2002. Oral presentations from the public will be scheduled between 
approximately 1:15 p.m. and 1:45 p.m. on December 17, 2002, and between 
approximately 8:15 a.m. and 8:45 a.m. on December 18, 2002. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
December 10, 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 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 
December 10, 2002, to address issues specific to the topic before the 
committee.
    Background materials for this meeting will be posted at the 
Oncologic Drugs Advisory Committee Dockets Web site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2002 and 
scroll down to the Oncologic Drugs Advisory Committee meetings.) The 
background materials for BEXXAR will be posted on December 16, 2002, 
and the background materials for CASODEX will be posted on December 17, 
2002. The slides and transcripts from the meeting will be posted at 
this same web address about 3 weeks after the meeting.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Karen M. Templeton-
Somers at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 15, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-29689 Filed 11-21-02; 8:45 am]
BILLING CODE 4160-01-S