[Federal Register: January 13, 2004 (Volume 69, Number 8)]
[Notices]
[Page 1987]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja04-52]
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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). The meeting will
be open 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 February 23, 2004, from
9:30 a.m. to 5 p.m.
Location: Hilton Washington, DC North/Gaithersburg, Ballroom Salons
A, B, C, and D, 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 and make recommendations on a
premarket notification submission for a thrombectomy 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/panelmtg.html.
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 February 9,
2004. Oral presentations from the public will be scheduled between
approximately 9:45 a.m. and 10:45 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before February 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.
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 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: January 5, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-600 Filed 1-12-04; 8:45 am]
BILLING CODE 4160-01-S