[Federal Register: July 23, 2003 (Volume 68, Number 141)]
[Page 43534-43535]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Neurological Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

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). At least one 
portion of the meeting will be closed to the public.
    Name of the Committee: Neurological Devices Panel of the Medical 
Devices 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 be held on August 5, 2003, from 10 
a.m. to 5:30 p.m.
    Location: Holiday Inn, Walker/Whetstone Ballroom, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact: Janet L. Scudiero, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-1184, ext. 176, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12513. Please call the Information Line for up-to-date 
information on this meeting.

[[Page 43535]]

    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for a neurological embolization 
device. Background information for the topic, including the agenda and 
questions for the committee, will be available to the public 1 business 
day before the meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panel/index.html.
 Material will be posted on August 4, 2003.
    Procedure: On August 5, 2003, from 10:30 a.m. to 5:30 p.m., the 
meeting is open to the public. 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 
August 1, 2003. Oral presentations from the public will be scheduled 
between approximately 10:45 a.m. and 11:15 a.m. and 3:30 p.m. and 4 
p.m. Time allotted for each presentation may be limited. Those desiring 
to make formal oral presentations should notify the contact person 
before August 1, 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.
    Closed Committee Deliberations: On August 5, 2003, from 10 a.m. to 
10:30 a.m., the meeting will be closed to the public to permit 
discussion of trade secret and/or confidential information regarding 
neurological device issues (5 U.S.C. 552b(c)(4)).
    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 Shirley Meeks, 
Conference Management Staff, at 301-594-1283, ext. 105, 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 17, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-18635 Filed 7-22-03; 8:45 am]