[Federal Register: November 18, 2003 (Volume 68, Number 222)]
[Notices]               
[Page 65075-65076]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no03-73]                         

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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.

[[Page 65076]]

    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 December 4, 2003, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, 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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 
the 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 November 24, 
2003. Oral presentations from the public will be scheduled between 
approximately 12:30 p.m. and 1:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 24, 
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 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: November 10, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-28685 Filed 11-17-03; 8:45 am]

BILLING CODE 4160-01-S