[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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