[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Pages 9419-9420]
From the Federal Register Online via the Government Publishing 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: [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. 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]
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