[Federal Register: May 7, 2007 (Volume 72, Number 87)]
[Notices]
[Page 25767-25768]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my07-46]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 is
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 June 27, 2007, from 8
a.m. to 4 p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers
Lane, Rockville, MD.
Contact Person: Mimi Phan, 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: Mimi.Phan@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.
Agenda: The subcommittee will do the following: (1) Discuss review
of
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oncology products granted pediatric exclusivity under the Best
Pharmaceuticals for Children Act (BPCA); and (2) discuss 13-cis
retinoic acid: summary of clinical experience, including access through
iPledge, and additional clinical studies for the treatment of patients
with neuroblastoma to be conducted under the BPCA.
FDA intends to make background material available to the public no
later than 1 business day 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and 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 June
13, 2007. Oral presentations from the public will be scheduled between
approximately 10 a.m. to 10:30 a.m., and 2 p.m. to 2:30 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 June 5, 2007. 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 June 6, 2007.
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 Mimi Phan at 301-
827-7001, 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: May 1, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-8656 Filed 5-4-07; 8:45 am]
BILLING CODE 4160-01-S