[Federal Register: November 22, 2002 (Volume 67, Number 226)]
[Notices]
[Page 70445-70446]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no02-89]
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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 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: 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: 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