Pediatric Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Pediatric Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. The committee also advises and makes recommendations to the Secretary of the Department of Health and Human Services (DHHS) under 45 CFR 46.407 on research involving children as subjects that is conducted or supported by DHHS, when that research is also regulated by FDA.

Date and Time: The meeting will be held on Wednesday, June 29, 2005, from 12:30 p.m. to 5 p.m. and on Thursday, June 30, 2005, from 8 a.m. to 5 p.m.

Location: The Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.

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 or 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: 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).

The background material will become available no later than the day before the meeting and will be posted under the Pediatric Advisory Committee (PAC) Docket site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm . (Click on the year 2005 and scroll down to PAC 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 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 by 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 notify 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).