[Federal Register: January 6, 2006 (Volume 71, Number 4)]
[Page 943]
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 March 15, 2006, from 8 a.m. 
to 5 p.m.
    Location: Gaithersburg Hilton, The Ballrooms, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Johanna M. Clifford, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 
20857, 301-827-7001, FAX: 301-827-6776, e-mail: cliffordj@cder.fda.gov, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512542. Please call the 
Information Line for up-to-date information on this meeting. The 
background material will become available no later than the day before 
the meeting and will be posted on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
 under the heading ``Oncologic Drugs 

Advisory Committee'' (click on the year 2006 and scroll down to the 
above named committee meeting).
    Agenda: The committee will discuss the following: (1) Receive and 
discuss pediatric update from the October 20, 2005, meeting of the 
Pediatric Oncology Subcommittee; (2) discuss pre-clinical requirements 
and phase 1 trial design issues for the development of oncologic 
products; and (3) discuss new drug application (NDA) 20-509, S-039, 
GEMZAR (gemcitabine hydrochloride) for Injection, Eli Lilly & Co., 
proposed indication for use in combination with carboplatin for the 
treatment of patients with advanced ovarian cancer that has relapsed at 
least 6 months after completion of platinum-based therapy.
    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 March 7, 2006. 
Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. to 11 a.m. and 2:30 p.m. to 3 p.m. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before March 
7, 2006, 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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Johanna Clifford 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: December 27, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E5-8333 Filed 1-5-06; 8:45 am]