[Federal Register: October 29, 2004 (Volume 69, Number 209)]
[Page 63158]
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 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 November 30, 2004, from 
8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Janet L. Scudiero, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1184, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512513. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on premarket approval application for a device intended for use as an 
adjunct to sutured dural repair during cranial surgery to provide 
watertight closure. 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/panelmtg.html

    Procedure: On November 30, 2004, from 8:30 a.m. to 5 p.m., the 
meeting will be 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 November 9, 2004. Oral presentations from the public will be 
scheduled for approximately 30 minutes at the beginning of committee 
deliberations and for approximately 30 minutes near the end of the 
deliberations. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before November 9, 2004, 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 November 30, 2004, from 8 a.m. 
to 8:30 a.m., the meeting will be closed to permit FDA to present to 
the committee trade secret and/or confidential commercial information 
(5 U.S.C. 552b(c)(4)) relating to pending issues and applications.
    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 AnnMarie Williams, 
Conference Management Staff, at 301-594-1283, ext. 113 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: October 22, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-24191 Filed 10-28-04; 8:45 am]