[Federal Register: February 1, 2006 (Volume 71, Number 21)]
[Page 5343]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Pediatric Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    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 Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues. The committee 
also advises and makes recommendations to the Secretary of Health and 
Human Services under 45 CFR 46.407 on research involving children as 
subjects that is conducted or supported by the Department of Health and 
Human Services, when that research is also regulated by FDA.
    Date and Time: The meeting will be held on Wednesday, March 22, 
2006, from 8 a.m. to 6 p.m.
    Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Jan N. Johannessen, Office of Science and Health 
Coordination, Office of the Commissioner (HF-33), Food and Drug 
Administration, 5600 Fishers Lane, (for express delivery, rm. 14C-06) 
Rockville, MD 20857, 301-827-6687, e-mail: Jan.Johannessen@fda.hhs.gov 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 8732310001. Please call the 
Information Line for up to date information on this meeting.
    Agenda: The Pediatric Advisory Committee will hear and discuss a 
report by the agency, as mandated in Section 17 of the Best 
Pharmaceuticals for Children Act (BPCA), on adverse event reports 
possibly related to clofarabine (CLOLAR), irbesartan (AVAPRO), 
sibutramine (MERIDIA), and the mixed salts amphetamine product 
(ADDERALL). In continuation of a prior committee discussion of adverse 
events for the class of methylphenidate products used to treat 
attention deficit hyperactivity disorder (ADHD), the committee will 
hear and discuss neuropsychiatric adverse events possibly related to 
other approved ADHD medications. The presentations will focus on 
neuropsychiatric adverse event reports and clinical trial data from 
approved ADHD medications. The committee will also receive an update on 
efforts to better understand cardiovascular adverse events possibly 
related to ADHD medications.
    The background material will become available no later than the day 
before the meeting and will be posted under the Pediatric Advisory 
Committee Docket site 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.
 (Click on the year 2006 and scroll down to Pediatric 

Advisory Committee meetings.)
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by March 8, 2006. 
Oral presentations from the public will be scheduled on March 22, 2006, 
between approximately 1 p.m. and 2 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person by March 8, 2006, 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 
    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 Jan N. Johannessen 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 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-1223 Filed 1-31-06; 8:45 am]