[Federal Register: April 14, 2005 (Volume 70, Number 71)]
[Notices]
[Page 19763-19764]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap05-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Drug Safety and Risk Management 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: Drug Safety and Risk Management 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 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
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 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]
BILLING CODE 4160-01-S