[Federal Register: August 5, 2003 (Volume 68, Number 150)]
[Page 46199]
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 September 19, 2003, from 
8 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 at: jains@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 site 1 business day before 
the meeting at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
    Agenda: The committee will discuss current screening methods to 
assess sound alike and look alike proprietary drug names, in order to 
reduce the incidence of medication errors resulting from look-alike and 
sound-alike names. This advisory committee meeting is in followup to 
FDA, Institute for Safe Medication Practices, and the Pharmaceutical 
Research and Manufacturers of America public meeting on the same 
subject, held on June 26, 2003.
    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: July 25, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-19807 Filed 8-4-03; 8:45 am]