[Federal Register: January 12, 2004 (Volume 69, Number 7)]
[Notices]               
[Page 1748]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja04-91]                         

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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). The meeting will 
be open 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 February 3, 2004, from 9 
a.m. to 4:45 p.m., and February 4, 2004, from 8 a.m. to 12 noon.
    Location: CDER Advisory Committee Conference Room, rm. 1066, 5630 
Fishers Lane, Rockville, 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 by e-mail: perezt@cder.fda.gov. Please call the 
FDA Advisory Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512530, for up-to-date information on 
this meeting.
    Agenda: On February 3, 2004, the subcommittee will meet between 9 
a.m. and 10:15 a.m., and the agency will report to the subcommittee on 
Adverse Event Reporting as mandated in Section 17 of the Best 
Pharmaceuticals for Children Act (BPCA). The products to be reported 
during this portion of the meeting include: Paxil (paroxetine), Celexa 
(citalopram), Pravachol (pravastatin), and Navelbine (vinorelbine). 
Following this, from approximately 10:30 a.m. to 4:45 p.m., the 
subcommittee will discuss the use of imaging drugs in conjunction with 
cardiac imaging procedures in the pediatric population.
    On February 4, 2004, the subcommittee will meet between 8 a.m. and 
12 noon to continue the discussion on the use of imaging drugs in 
conjunction with cardiac imaging procedures in the pediatric 
population.
    The background material for this meeting will be posted on the 
Internet when available or 1 working day before the meeting 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 January 23, 
2004. On February 3, 2004, oral presentations from the public will be 
scheduled between approximately 9:45 a.m. and 10:15 a.m. for issues 
related to the Section 17 adverse event reports. Also, on February 3, 
2004, oral presentations from the public will be scheduled between 
approximately 3:45 p.m. and 4:45 p.m. for issues related to cardiac 
imaging in pediatric patients. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person by January 23, 2004, 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 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: January 5, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-503 Filed 1-9-04; 8:45 am]

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