Document ID: FDA-2010-N-0001-0017
Agency: fda
Document Type: Notice
Title: Oncologic Drugs Advisory Committee; Notice of Meeting
Posted Date: 2010-03-02T05:00Z

[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Pages 9419-9420]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4261]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

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 March 22, 2010, from 8 
a.m. to 5 p.m. This meeting is a reschedule of a postponed meeting 
originally announced in the Federal Register of December 17, 2009 (74 
FR 66986) to take place on February 10, 2010.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
    Contact Person: Nicole Vesely, 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, 
301-827-6793, FAX: 301-827-6776, e-mail: nicole.vesely@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. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: During the morning session of March 22, 2010, the committee 
will discuss new drug application (NDA) 022-481, proposed trade name 
PIXUVRI (pixantrone dimaleate) injection, by Cell Therapeutics, Inc. 
The proposed indication (use) for this product is as a single agent 
treatment for patients with recurring or refractory (difficult to 
treat), aggressive Non-Hodgkin's Lymphoma who have received two or more 
prior lines of therapy.
    During the afternoon session, the committee will discuss NDA 022-
374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for 
injection, by ChemGenex Pharmaceuticals. The proposed indication (use) 
for this product is for the treatment of adults with chronic myeloid 
leukemia bearing a genetic alteration known as the Bcr-Abl T315I 
mutation, and who have failed prior therapy with the drug imatinib.
    Due to the postponement of the February 10, 2010, Oncologic Drugs 
Advisory Committee meeting because of severe weather conditions and the 
urgency to reschedule this meeting, FDA regrets that it was unable to 
publish this notice 15 days prior to the March 22, 2010, Oncologic 
Drugs Advisory Committee meeting. Because the agency believes there is 
some urgency to bring these issues to public discussion and qualified 
members of the Oncologic Drugs Advisory Committee were available at 
this time, the Commissioner of Food and Drugs concluded that it was in 
the public interest to hold this meeting even if there was not 
sufficient time for the customary 15-day public notice.
    Background materials from the originally scheduled February 10, 
2010, Oncologic Drugs Advisory Committee meeting are currently 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link. 
Should any additional background materials become available, they will 
be posted 2 days before the March 22, 2010, meeting at this same Web 
site.
    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 
March 17, 2010. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. 
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 on or before March 12, 2010. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to

[[Page 9420]]

speak is greater than can be reasonably accommodated during the 
scheduled open public hearing session, FDA may conduct a lottery to 
determine the speakers for the scheduled open public hearing session. 
The contact person will notify interested persons regarding their 
request to speak by March 15, 2010.
    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 Nicole Vesely at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 24, 2010.
Joanne Less,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-4261 Filed 3-1-10; 8:45 am]
BILLING CODE 4160-01-S