[Federal Register Volume 69, Number 222 (Thursday, November 18, 2004)]
[Notices]
[Page 67592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25530]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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 December 1, 2004, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Kennedy/Adams Ballroom, 8777 Georgia Ave., 
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, e-mail: [email protected], 
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 these items: (1) New drug 
application (NDA) 21-673, proposed trade name CLOLAR (clofarabine) Ilex 
Products, Inc., proposed indication for the treatment of pediatric 
patients 1 to 21 years old with refractory or relapsed acute leukemias, 
and (2) NDA 21-600, proposed trade name MARQIBO (vincristine sulfate 
liposome injection) Inex Pharmaceuticals Corp., proposed indication for 
the treatment of patients with aggressive non-Hodgkin's lymphoma 
previously treated with at least two combination chemotherapy regimens.
    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 November 23, 
2004. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m., and between approximately 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 November 23, 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 
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: November 9, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-25530 Filed 11-17-04; 8:45 am]
BILLING CODE 4160-01-S