Food and Drug Administration, HHS.
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 Start Printed Page 25768oncology 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://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).Start Signature
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