[Federal Register: March 30, 2004 (Volume 69, Number 61)]
[Page 16582-16583]
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 May 3 and 4, 2004, from 
8 a.m. to 5 p.m.
    Location: 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 or 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.
    Agenda: On May 3, 2004, the committee will discuss these items: (1) 
New drug application (NDA) 21-649, GENASENSE (oblimersen sodium) Genta, 
Inc., proposed indication for use in combination with DTIC DOME 
(dacarbazine), Bayer Pharmaceuticals Corp., proposed for the treatment 
of patients with advanced malignant melanoma; and (2) NDA 21-661, RSR 
13 Injection (efaproxiral sodium) Allos Therapeutics, Inc., proposed 
indication for use as an adjunct to whole brain radiation therapy in 
the treatment of brain metastases from primary breast cancer. On May 4, 
2004, the committee will discuss these items: (1) Safety concerns 
associated with ARANESP (darbepoetin alfa) Amgen, Inc., and PROCRIT 
(epoetin alfa) Ortho Biotech, L.P., both of which are indicated for the 
treatment of anemia associated with cancer chemotherapy; and (2) colo-
rectal cancer endpoints as a followup to the November 2003 FDA 
    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 April 26, 2004 
. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m., and 2:30 p.m. and 3 p.m on May 3, 
2004. On May 4, 2004, oral presentations from the public will be 
scheduled between approximately 10:30 a.m. and 11 a.m., and 2:30 p.m. 
and 3 p.m. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before April 26, 2004, 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

[[Page 16583]]

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 Trevelin Prysock at 
301-827-7001, 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: March 22, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-6973 Filed 3-29-04; 8:45 am]