[Federal Register Volume 65, Number 215 (Monday, November 6, 2000)]
[Notices]
[Page 66547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28445]


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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 16, 2000, 9:30 
a.m. to 7 p.m.
    Location: Quality Suites Hotel, Potomac Rooms II and III, Three 
Research Ct., Rockville, 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, 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 
or access the Internet (http://www.fda.gov/cdrh/panelmtg.html for up-
to-date information on this meeting.
    Agenda: The committee will discuss and make recommendations on: (1) 
The design of clinical trials for devices to prevent stroke, to treat 
stroke, and to provide neurological protection after stroke; and (2) 
the design of clinical studies for temperature control devices to 
provide neurological protection.
    Procedure: On November 16, 2000, from 10 a.m. to 7 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 
November 9, 2000. On November 16, 2000, oral presentations from the 
public will be scheduled between approximately 11 a.m. and 11:30 a.m. 
for the discussion of the design of clinical studies for devices to 
prevent stroke, to treat stroke, and to provide neurological protection 
after stroke, and between approximately 4:30 p.m. and 5 p.m. for the 
discussion of the design of clinical studies for temperature control 
devices to provide neurological protection. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 9, 2000, 
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 16, 2000, from 9:30 
a.m. to 10 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)) regarding pending issues and applications.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the November 16, 2000, Neurological Devices Panel of the Medical 
Devices Advisory Committee meeting. Because the agency believes there 
is some urgency to bring these issues to public discussion and 
qualified members of the Neurological Devices Panel of the Medical 
Devices Advisory Committee were available at this time, the 
Commissioner of Food and Drugs concluded that it was in the public 
interest to hold this meeting even if there was not sufficient time for 
the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 31, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-28445 Filed 11-1-00; 4:34 pm]
BILLING CODE 4160-01-F