[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Page 40209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19108]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


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 September 1, 2009, from 
8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
    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: The committee will discuss the following topics: (1) 
Supplemental new drug application (sNDA) 021-673[sol]S-009, CLOLAR 
(clofarabine) Injection for intravenous use, Genzyme Corp., proposed 
indication for the treatment of previously untreated adults aged 60 
years or older with acute myeloid leukemia with at least one 
unfavorable baseline prognostic factor and (2) new drug application 
(NDA) 022-489, proposed trade name ONRIGIN (laromustine) Injection, 
Vion Pharmaceuticals, Inc., proposed indication for remission induction 
therapy for patients 60 years or older with de novo poor-risk acute 
myeloid leukemia (AML).
    CLOLAR (clofarabine) Injection for intravenous use has a new 
proposed indication for treatment of AML in previously untreated adults 
aged 60 years or older with at least one medical or health factor that 
increases the risk of an unfavorable outcome. Laromustine Injection, 
with the proposed trade name ONRIGIN, has a proposed use for 
``remission induction therapy'' for AML. This is an initial approach to 
AML treatment designed to induce, or bring about, remission (reduction 
or disappearance) of leukemia in patients 60 years or older with de 
novo, or first occurrence, AML designated as ``poor-risk,'' or more 
likely to have a poor outcome.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    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 25, 2009. Oral presentations from the public will be scheduled 
between approximately 10:45 a.m. and 11:15 a.m. and between 
approximately 3:30 p.m. and 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 August 25, 2009. Time allotted for each presentation may 
be limited. If the number of registrants requesting to 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 August 
26, 2009.
    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: August 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-19108 Filed 8-10-09; 8:45 am]
BILLING CODE 4160-01-S