[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Page 18765-18766]
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 June 2, 2006, from 10 
a.m. to 2 p.m.
    Location: Omni Hotel at CNN Center, International Ballroom, 100 CNN 
Center, Atlanta, Georgia. The hotel phone number is 404-659-0000.
    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.hhs.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: The committee will discuss new drug application (NDA) 21-
986, proposed trade name SPRYCEL (dasatinib) tablets, Bristol-Myers 
Squibb Co., with proposed indications for the: (1) Treatment of adults 
with chronic, accelerated, or blast phase chronic myeloid leukemia with 
resistance or intolerance to prior therapy including imatinib and (2) 
treatment of adults with Philadelphia chromosome-positive acute 
lymphoblastic leukemia, and lymphoid blast chronic myeloid leukemia 
with resistance or intolerance to prior 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 May 18, 2006. 
Oral presentations from the public will be scheduled between 
approximately 12 noon and 1 p.m. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before May 18, 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 
    Persons attending FDA's advisory committee meetings are advised 
that the

[[Page 18766]]

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: April 5, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-5413 Filed 4-11-06; 8:45 am]