[Federal Register: August 1, 2006 (Volume 71, Number 147)]
[Page 43489]
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 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 
    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]