[Federal Register: May 13, 2004 (Volume 69, Number 93)]
[Notices]
[Page 26614]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my04-134]
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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 Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on June 9, 2004, from 8
a.m. to 5 p.m.
Location: Center for Drug Evaluation and Research 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 Committee 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: The subcommittee will meet between 8 a.m. and 1:30 p.m.,
and the agency will report to the committee 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
HYCAMTIN (topotecan), TEMODAR (temozolomide), EFFEXOR (venlafaxine),
MONOPRIL (fosinopril), ALLEGRA (fexofenadine), DURAGESIC (fentanyl),
CILOXAN (ciprofloxacin), and VIGAMOX (moxifloxacin). Following this,
from approximately 1:30 p.m. to 3:30 p.m., the agency will provide an
update on neonatal withdrawal syndrome and congenital eye malformations
reported in infants whose mothers used selective serotonin reuptake
inhibitors (SSRIs) during pregnancy. From approximately 3:30 p.m. to 4
p.m., the agency will provide an overview of the Pediatric Research
Equity Act, which was signed into law on December 3, 2003. From 4 p.m.
to 4:30 p.m., there will be an overview of the Institute of Medicine
report entitled ``Ethical Conduct in Pediatric Clinical Trials.''
Finally, from 4:30 p.m. to 4:45 p.m., the agency will provide an update
on the subpart D, institutional review board referral process.
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/acmenu.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 1, 2004.
Oral presentations from the public will be scheduled between
approximately 11:15 a.m. and 11:45 a.m., for issues related to the
section 17 adverse event reports. Also, oral presentations from the
public will be scheduled between approximately 3 p.m. and 3:30 p.m.,
for issues related to neonatal withdrawal syndrome and congenital eye
malformations seen in infants. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person by June 1, 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 contact 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 5, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-10830 Filed 5-12-04; 8:45 am]
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