[Federal Register Volume 68, Number 101 (Tuesday, May 27, 2003)]
[Notices]
[Pages 28828-28829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13054]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pediatric Subcommittee of the Anti-Infective Drugs Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Pediatric Subcommittee of the Anti-Infective 
Drugs Advisory Committee.
    General Function of the Subcommittee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 11, 2003, from 8:30 
a.m. to 5 p.m. and on June 12, 2003, from 8 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, 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, or e-mail: [email protected], or FDA Advisory 
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: On June 11, 2003, the subcommittee will discuss the current 
epidemiology and therapeutic interventions relevant to 
hyperbilirubinemia in the term and near-term newborn. On June 12, 2003, 
the subcommittee will begin with a closed session between 8 a.m. and 3 
p.m. Following the closed session, there will be an open subcommittee 
meeting from approximately 3:15 p.m. to 5 p.m., where the agency will 
report to the subcommittee on adverse event reporting as mandated in 
section 17 of the Best Pharmaceuticals for Children Act. The products 
to be discussed during this portion of the meeting include ZOLOFT 
(sertraline) Pfizer Inc., and DITROPAN (oxybutynin) Alza Corp., with an 
interim update to be provided on LIPITOR (atorvastatin) Pfizer Inc., 
and ZOCOR (simvastatin) Merck & Co. Inc. The background material for 
this meeting will be posted on the Internet when available or 1-

[[Page 28829]]

working day before the meeting at www.fda.gov/ohrms/dockets/ac/menu.htm.
    Procedure: On June 11, 2003, from 8 a.m. to 5 p.m., the meeting is 
open to the public. On June 12, 2003, from 3:15 p.m. to 5 p.m., the 
meeting is open to the public. 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 4, 2003. On June 11, 2003, oral presentations from the public 
will be scheduled between approximately 3 p.m. and 4 p.m. On June 12, 
2003, oral presentations from the public will be scheduled between 
approximately 4:15 p.m. and 4:45 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person by June 4, 2003, 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.
    Closed Subcommittee Deliberations: On June 12, 2003, from 8 a.m. to 
3 p.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
    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 Thomas 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 19, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-13054 Filed 5-23-03; 8:45 am]
BILLING CODE 4160-01-S