[Federal Register: March 10, 2006 (Volume 71, Number 47)]
[Notices]               
[Page 12364-12365]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr06-78]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Pediatric Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration.

ACTION: Notice.

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[[Page 12365]]

    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the Pediatric Advisory Committee. This 
meeting was announced in the Federal Register of February 1, 2006 (71 
FR 5343). The amendment is being made to reflect a change in the Date 
and Time and Agenda portions of the document. The starting time of the 
meeting has been moved to 7:30 a.m. and the committee will now also 
hear and discuss information on cardiovascular adverse events possibly 
related to ADHD medications. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Jan N. Johannessen, Office of Science 
and Health Coordination (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 the 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 1, 2006, 
FDA announced that a meeting of the Pediatric Advisory Committee would 
be held on March 22, 2006, from 8 a.m. to 6 p.m., and that the 
committee would receive an update on efforts to better understand 
cardiovascular adverse events possibly related to ADHD medications. On 
page 5343, in the first column, the Date and Time portion of the 
document is amended to read as follows:
    Date and Time: The meeting will be held on March 22, 2006, from 
7:30 a.m. to 6 p.m.
    On page 5343, in the second column, the Agenda portion of the 
document is amended to read as follows:
    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 hear 
and discuss information on 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.)
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: March 3, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-3435 Filed 3-9-06; 8:45 am]

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