[Federal Register: January 6, 2006 (Volume 71, Number 4)]
[Notices]
[Page 943]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja06-62]
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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.
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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 March 15, 2006, from 8 a.m.
to 5 p.m.
Location: Gaithersburg Hilton, The Ballrooms, 620 Perry Pkwy.,
Gaithersburg, 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: cliffordj@cder.fda.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. The
background material will become available no later than the day before
the meeting and will be posted on FDA's Web site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
under the heading ``Oncologic Drugs
Advisory Committee'' (click on the year 2006 and scroll down to the
above named committee meeting).
Agenda: The committee will discuss the following: (1) Receive and
discuss pediatric update from the October 20, 2005, meeting of the
Pediatric Oncology Subcommittee; (2) discuss pre-clinical requirements
and phase 1 trial design issues for the development of oncologic
products; and (3) discuss new drug application (NDA) 20-509, S-039,
GEMZAR (gemcitabine hydrochloride) for Injection, Eli Lilly & Co.,
proposed indication for use in combination with carboplatin for the
treatment of patients with advanced ovarian cancer that has relapsed at
least 6 months after completion of platinum-based 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 March 7, 2006.
Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m. and 2:30 p.m. to 3 p.m. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before March
7, 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 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 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: December 27, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E5-8333 Filed 1-5-06; 8:45 am]
BILLING CODE 4160-01-S