[Federal Register: June 30, 2003 (Volume 68, Number 125)]
[Page 38713-38714]
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.

[[Page 38714]]

    Date and Time: The meeting will be held on September 18, 2003, from 
8 a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Kimberly Littleton Topper, 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 at: topperk@cder.fda.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 12535. Please call the Information 
Line for up-to-date information on this meeting. Background materials 
for this meeting, when available, will be posted on the Web one 
business day before the meeting at: www.fda.gov/ohrms/dockets/ac/acmenu.htm
    Agenda: The committee will discuss medication errors relating to 
the labeling and packaging of various drug products in low-density 
polyethylene plastic vials.
    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 September 12, 
2003. Oral presentations from the public will be scheduled 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 before September 12, 2003, 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 
    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 Kimberly Topper 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: June 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16358 Filed 6-27-03; 8:45 am]