[Federal Register: October 29, 2004 (Volume 69, Number 209)]
[Notices]
[Page 63158]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc04-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Neurological Devices Panel of the Medical Devices 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). 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
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 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]
BILLING CODE 4160-01-S