[Federal Register: April 14, 2005 (Volume 70, Number 71)]
[Page 19763-19764]
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 held on May 18 and 19, 2005, from 
8:30 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballrooms, 8777 Georgia Ave., Silver 
Spring, MD.
    Contact Person: Shalini Jain, 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, e-mail: jains@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: This is the first in a series of meetings related to the 
issues in drug safety and FDA. This 2-day meeting will explore issues 
related to FDA's risk assessment program for marketed drugs. There are 
a number of methods that FDA uses in risk assessment of marketed drugs, 
including review and analysis of spontaneous reports of

[[Page 19764]]

adverse events, drug use data, healthcare administrative data, 
epidemiologic and observational studies, clinical trials, and active 
surveillance systems. Considerations will include the advantages and 
disadvantages of the current system for safety signal detection, and 
proposals for short-term and long-term ways to improve the current 
system. The background materials for this meeting will be posted 1 
business day before the meeting on the FDA Web site at http: //
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 2005 and 

scroll down to the 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 May 9, 2005. 
Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon on May 18, 2005, and between 
approximately 11:10 a.m. and 11:40 a.m. on May 19, 2005. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before May 9, 2005, 
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 Shalini Jain 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: April 7, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7458 Filed 4-13-05; 8:45 am]