[Federal Register Volume 75, Number 209 (Friday, October 29, 2010)]
[Notices]
[Page 66773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27322]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Pediatric Oncology Subcommittee of the 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: Pediatric Oncology Subcommittee of the 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 November 30, 2010, from
8 a.m. to 5:30 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31,
the Great Room, White Oak Conference Center (Rm. 1503), Silver Spring,
MD 20993-0002.
Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, 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: On November 30, 2010, information will be presented
regarding pediatric development plans for four products that were
either recently approved by FDA or, are in late stage development for
an adult oncology indication. The subcommittee will consider and
discuss issues relating to the development of each product for
pediatric use and provide guidance to facilitate the formulation of
Written Requests for pediatric studies, if appropriate. The four
products under consideration are: (1) Crizotinib, manufactured by
Pfizer, Inc.; (2) pralatrexate, manufactured by Allos Therapeutics,
Inc.; (3) denosumab, manufactured by Amgen, Inc.; and (4) eribulin,
manufactured by Eisai Inc.
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 subcommittee.
Written submissions may be made to the contact person on or before
November 15, 2010. Oral presentations from the public will be scheduled
between approximately 9:15 a.m. to 9:30 a.m., 11:15 a.m. to 11:30 a.m.,
2:05 p.m. to 2:20 p.m., and 4:10 p.m. to 4:25 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 November 4, 2010. 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 November 5, 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: October 25, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-27322 Filed 10-28-10; 8:45 am]
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