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Pediatric Advisory Committee

Agenda:
On Wednesday, June 29, 2005, the committee will hear and discuss the recommendation of the Pediatric Ethics Subcommittee from its meeting on June 28, 2005, regarding a referral by an Institution Review Board of a proposed clinical investigation involving children as subjects that is regulated by FDA and is conducted or supported by DHHS. The committee will also discuss a report by the agency on Adverse Event Reporting, as mandated in section 17 of the Best Pharmaceuticals for Children Act (BPCA), for ethinyl estradiol; norgestimate (ORTHO TRI-CYCLEN), ciprofloxacin (CIPRO), tolterodine (DETROL LA), leflunomide (ARAVE), paricalcitol (ZEMPLAR), zolmitriptan (ZOMIG), dorzolamide TRUSOPT

On Thursday, June 30, 2005, the committee will discuss a report by the agency on Adverse Event Reporting, as mandated in section 17 of the BPCA, for methylphendidate (CONCERTA and other methtylphenidates).

Background material and meeting information meeting dates will become available no later than one business day before each meeting day (simply scroll down to the appropriate committee heading).

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 June 17, 2005. Oral presentations from the public will be scheduled on Wednesday, June 29, 2005, between approximately 3:20 p.m. and 3:50 p.m., and Thursday, June 30, 2005 between approximately 1:30 p.m. and 2:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before June 17, 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 N. Johannessen, at least 7 days in advance of the meeting.

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: jjohannessen@fda.gov.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001.