[Federal Register: May 24, 2002 (Volume 67, Number 101)]
[Page 36615]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Pediatric Subcommittee of the Anti-Infective Drugs 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 Subcommittee of the Anti-Infective 
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 11, 2002, from 8 
a.m. to 6 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Thomas H. Perez, 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, e-mail: perezt@cder.fda.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12530. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: Beginning at 8 a.m., the subcommittee will discuss and 
receive comments on the ``written request template'' for the proton 
pump inhibitors in the treatment of gastroesophageal reflux disease in 
pediatric patients. Starting at 1 p.m., the subcommittee will discuss a 
``preliminary priority list'' of drugs for which: (1) Additional 
studies are needed to assess the safety and effectiveness of the use of 
the drug in the pediatric population and (2) the drug has no remaining 
marketing exclusivity or patent protection. This list is mandated by 
the Best Pharmaceuticals for Children Act and the National Institutes 
of Health is the designated lead. At 4:30 p.m., representatives from 
Europe will provide information to the subcommittee on the ongoing 
pediatric initiatives in the European Union. Following this at 5 p.m., 
the agency will provide an update to the subcommittee on the pediatric 
labeling that has resulted from the exclusivity initiative under the 
FDA Modernization Act and the annual update on the pediatric rule, 
completed studies, deferrals, and waivers. The background material for 
this meeting will be posted on the Internet when available or one 
working day before the meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/menu.htm.
    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 by June 3, 2002. 
Oral presentations from the public will be scheduled between 
approximately 9:15 a.m. and 9:45 a.m. and 2 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 
3, 2002, 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 
    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 Thomas H. Perez 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).

    Dated: May 20, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent 
[FR Doc. 02-13106 Filed 5-23-02; 8:45 am]