
[Federal Register: October 29, 2010 (Volume 75, Number 209)]
[Notices]               
[Page 66773]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc10-88]                         

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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: 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: 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]
BILLING CODE 4160-01-P

