[Federal Register: August 1, 2006 (Volume 71, Number 147)]
[Notices]
[Page 43489]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au06-62]
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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 September 6, 2006, from
8 a.m. to 5 p.m. and September 7, 2006, from 8 a.m. to 12 noon.
Location: Hilton, Washington DC/Silver Spring, Maryland Ballrooms,
8727 Colesville Rd., Silver Spring, 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, email: 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 September 6, 2006, the committee will discuss two new
drug applications (NDAs): (1) NDA 21-874, proposed trade name GENASENSE
(oblimersen sodium) Injection, Genta, Inc., proposed indication for the
treatment of patients with chronic lymphocytic leukemia in combination
with fludarabine and cyclophosphamide; and (2) NDA 020-287, FRAGMIN
(dalteparin sodium), Pfizer, Inc., proposed indication for the extended
treatment of symptomatic venous thromboembolism (VTE), proximal deep
vein thrombosis, and/or pulmonary embolism to reduce the recurrence of
VTE in patients with cancer. On September 7, 2006, the committee will
discuss NDA 21-660, ABRAXANNE (paclitaxel protein-bound particles for
injectible suspension) (albumin-bound), Abraxis Bioscience, Inc.,
including trial design issues for adjuvant treatment of node-positive
breast cancer.
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 on or before
August 22, 2006. Oral presentations from the public will be scheduled
between approximately 10 a.m. to 10:30 a.m., and 2:30 p.m. to 3 p.m. on
September 6, 2006, and between approximately 10 a.m. to 10:30 a.m. on
September 7, 2006. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person 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 before August 22, 2006.
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 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: July 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-12270 Filed 7-31-06; 8:45 am]
BILLING CODE 4160-01-S