Contact Person: Jan N. Johannessen, Office of Science and Health Coordination of the Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14C-06), Rockville, MD 20857, 301-827-6687, or by e-mail:email@example.com FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up-to-date information on this meeting.
Agenda: The committee will discuss a report by the agency on Adverse Event Reporting, as mandated in Section 17 of the Best Pharmaceuticals for Children Act, for AGRYLIN (anagrelide), PARAPLATIN (carboplatin), DIFLUCAN (fluconazole), CAMPTOSAR (irinotecan), TAMIFLU (oseltamivir), VIOXX (rofecoxib), FERRLECIT (sodium ferric gluconate complex), and IMITREX (sumatriptan).
The background material will become available no later than the day before the meeting and will be posted under the Pediatric Advisory Committee Docket site athttp://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2005 and scroll down to Pediatric Advisory Committee meetings.)
Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by November 10, 2005. Oral presentations from the public will be scheduled on Friday, November 18, 2005, between approximately 8:30 a.m. and 9:30 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by November 10, 2005, 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.
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 Jan Johannessen 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).