March 22, 2010: Meeting of the Pediatric Advisory Committee Meeting Announcement
|OC||March 22, 2010||8:00 a.m. - 6:00 p.m.||Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814|
The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Anthelios 40, Cardiolite (technetium Tc-99), Nasacort AQ (triamcinolone), Viramune (nevirapine), Valtrex (valacyclovir), Zmax (azithromycin), Rotarix (rotavirus vaccine, live, oral), Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine), Pentacel [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine], and Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed vaccine). The committee will also receive an update on Topical Calcineurin Inhibitors: Elidel (pimecrolimus) and Protopic (tacrolimus). Also, the committee will receive a brief follow-up on the FDA Early Communication about reports of liver-related adverse events in patients taking orlistat (marketed as Alli and Xenical).
FDA intends to make the complete set of 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, all efforts will be made to try and provide the background material 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 http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
Public Participation and Sponsor Information Interested persons and Sponsors (representatives from industry) 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 on or before March 8, 2010. Comments received on or before March 18, 2010, will be provided to the committee before the meeting.
- Oral presentations from the public (excluding Sponsors) will be scheduled between approximately 1 p.m. and 2 p.m on March 22, 2010. 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 February 29, 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 March 1, 2010.
- Doreen Kezer, MSN
Office of Science and Public Health
Office of the Commissioner (HF–33)
Food and Drug Administration
5600 Fishers Lane (for express delivery, rm. 14B–08)
Rockville, MD 20857
- 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.
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.
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.
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 Doreen Kezer, MSN at (301) 827-1249 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).