[Federal Register: January 6, 2006 (Volume 71, Number 4)]
[Page 942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Drug Safety and Risk Management Advisory Committee; Notice of 

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: Drug Safety and Risk Management Advisory 
    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 February 9, 2006, from 8 
a.m. to 5 p.m. and February 10, 2006, from 8 a.m. to 3 p.m.
    Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Victoria Ferretti-Aceto, Center for Drug Evaluation 
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: 
ferrettiv@cder.fda.gov, or FDA Advisory Committee Information Line, 1-

800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014512535. Please call the Information Line for up-to-date information 
on this meeting.
    Agenda: Cases of sudden death and serious adverse events including 
hypertension, myocardial infarction, and stroke have been reported to 
the agency in association with therapeutic doses of drugs used to treat 
Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and 
adult populations. The few controlled clinical studies of longer term 
drug treatment of ADHD provided little information on cardiovascular 
risks. On February 9, 2006, the committee will be asked to discuss 
approaches that could be used to study whether these products increase 
the risk of adverse cardiovascular outcomes. On February 10, 2006, the 
committee will be briefed on developments in the Office of Drug Safety 
and will receive updates on the Drug Safety Oversight Board and agency 
actions for the COX-2 selective Nonsteroidal Anti-Inflammatory Drugs 
(NSAIDs) and the risk management program for the isotretinoin products.
    Background materials for this meeting will be posted 1 business day 
before the meeting on FDA's Web 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 Drug 

Safety and Risk Management Advisory Committee).
    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 February 2, 
2006. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on February 9, 2006, and between 
approximately 8:15 a.m. and 9:15 a.m. on February 10, 2006. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
February 2, 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 contact Victoria Ferretti-
Aceto 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: December 27, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-6 Filed 1-5-06; 8:45 am]