[Federal Register: December 18, 2001 (Volume 66, Number 243)]
[Page 65213-65214]
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 January 31, 2002, from 
8:30 a.m. to 3:30 p.m.
    Location: CDER Advisory Committee conference room 1066, 5630 
Fishers Lane, Rockville, MD.
    Contact: Karen M. Templeton-Somers, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,

[[Page 65214]]

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 supplemental new drug 
application (NDA) 21-386, ZOMETA (zoledronic acid for injection), 
Novartis Pharmaceuticals Corp., indicated for the treatment of bone 
metastases in patients with multiple myeloma, breast cancer, prostate 
cancer and other solid tumors.
    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 January 24, 
2002. Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:45 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before January 24, 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 January 24, 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: December 10, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-31025 Filed 12-17-01; 8:45 am]