[Federal Register Volume 69, Number 93 (Thursday, May 13, 2004)]
[Notices]
[Page 26614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10830]


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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: [email protected]. 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://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]
BILLING CODE 4160-01-S