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Federal Register / Vol. 73, No.

39 / Wednesday, February 27, 2008 / Notices 10455

representative will serve as the recommendations to the agency on the contact person and submit a brief
nonvoting member to represent industry FDA’s regulatory issues. statement of the general nature of the
interests for the Pediatric Advisory Date and Time: The meeting will be evidence or arguments they wish to
Committee. The interested organizations held on April 16, 2008, from 8:30 a.m. present, the names and addresses of
are not bound by the list of nominees in to 3:30 p.m. proposed participants, and an
selecting a candidate. However, if no Location: Food and Drug indication of the approximate time
individual is selected within 60 days, Administration, Center for Drug requested to make their presentation on
the Commissioner will select the Evaluation and Research Advisory or before March 25, 2008. Time allotted
nonvoting member to represent industry Committee Conference Room, rm. 1066, for each presentation may be limited. If
interests. 5630 Fishers Lane, Rockville, MD. the number of registrants requesting to
Contact Person: Nicole Vesely, Center speak is greater than can be reasonably
III. Application Procedure for Drug Evaluation and Research (HFD– accommodated during the scheduled
Individuals may self nominate and/or 21), Food and Drug Administration, open public hearing session, FDA may
an organization may nominate one or 5600 Fishers Lane (for express delivery, conduct a lottery to determine the
more individuals to serve as a nonvoting 5630 Fishers Lane, rm. 1093), Rockville, speakers for the scheduled open public
industry representative. A current MD 20857, 301–827–6793, FAX: 301– hearing session. The contact person will
curriculum vitae and the name of the 827–6776, e-mail: notify interested persons regarding their
committee of interest should be sent to nicole.vesely@fda.hhs.gov, or FDA request to speak by March 26, 2008.
the FDA contact person (see FOR Advisory Committee Information Line, Persons attending FDA’s advisory
FURTHER INFORMATION CONTACT) within 1–800–741–8138 (301–443–0572 in the committee meetings are advised that the
30 days (see DATES). FDA will forward Washington, DC area), code agency is not responsible for providing
all nominations to the organizations 3014512542. Please call the Information access to electrical outlets.
expressing interest in participating in Line for up-to-date information on this FDA welcomes the attendance of the
the selection process for the committee meeting. A notice in the Federal public at its advisory committee
(persons who nominate themselves as Register about last minute modifications meetings and will make every effort to
nonvoting industry representatives will that impact a previously announced accommodate persons with physical
not participate in the selection process). advisory committee meeting cannot disabilities or special needs. If you
FDA has a special interest in ensuring always be published quickly enough o require special accommodations due to
that women, minority groups, provide timely notice. Therefore, you a disability, please contact Nicole
individuals with physical disabilities, should always check the agency’s Web Vesely at least 7 days in advance of the
and small businesses are adequately site and call the appropriate advisory meeting.
represented on its advisory committees, committee hot line/phone line to learn FDA is committed to the orderly
and therefore, encourages nominations about possible modifications before conduct of its advisory committee
for appropriately qualified candidates coming to the meeting. meetings. Please visit our Web site at
from these groups. Agenda: The subcommittee will http://www.fda.gov/oc/advisory/
This notice is issued under the consider and discuss opportunities for default.htm for procedures on public
Federal Advisory Committee Act (5 enhancing global pediatric oncology conduct during advisory committee
U.S.C. app. 2) and 21 CFR part 14, drug development and expanding meetings.
relating to advisory committees. international regulatory interactions Notice of this meeting is given under
given the January 2007 legislation the Federal Advisory Committee Act (5
Dated: February 19, 2008. introduced in the European Union that U.S.C. app. 2).
Randall W. Lutter, governs the development and
Deputy Commissioner for Policy. authorization of medicines for use in Dated: February 19, 2008.
[FR Doc. E8–3719 Filed 2–26–08; 8:45 am] children aged 0 to 17 years. Randall W. Lutter,
BILLING CODE 4160–01–S FDA intends to make background Deputy Commissioner for Policy.
material available to the public no later [FR Doc. E8–3676 Filed 2–26–08; 8:45 am]
than 2 business days before the meeting. BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND If FDA is unable to post the background
HUMAN SERVICES material on its Web site prior to the
meeting, the background material will DEPARTMENT OF HEALTH AND
Food and Drug Administration be made publicly available at the HUMAN SERVICES
location of the advisory committee
Pediatric Oncology Subcommittee of meeting, and the background material National Institutes of Health
the Oncologic Drugs Advisory will be posted on FDA’s Web site after
Committee; Notice of Meeting Center for Scientific Review; Notice of
the meeting. Background material is
Closed Meetings
AGENCY: Food and Drug Administration, available at http://www.fda.gov/ohrms/
HHS. dockets/ac/acmenu.htm, click on the Pursuant to section 10(d) of the
ACTION: Notice. year 2008 and scroll down to the Federal Advisory Committee Act, as
appropriate advisory committee link. amended (5 U.S.C. Appendix 2), notice
This notice announces a forthcoming Procedure: Interested persons may is hereby given of the following
meeting of a public advisory committee present data, information, or views, meetings.
of the Food and Drug Administration orally or in writing, on issues pending The meetings will be closed to the
(FDA). The meeting will be open to the before the subcommittee. Written public in accordance with the
public. submissions may be made to the contact provisions set forth in sections
jlentini on PROD1PC65 with NOTICES

Name of Committee: Pediatric person on or before April 2, 2008. Oral 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Oncology Subcommittee of the presentations from the public will be as amended. The grant applications and
Oncologic Drugs Advisory Committee. scheduled between approximately 1 the discussions could disclose
General Function of the Committee: p.m. and 2 p.m. Those desiring to make confidential trade secrets or commercial
To provide advice and formal oral presentations should notify property such as patentable material,

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