[Federal Register: March 30, 2004 (Volume 69, Number 61)]
[Notices]
[Page 16582-16583]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr04-80]
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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 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
Workshop.
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
outlets.
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]
BILLING CODE 4160-01-S