[Federal Register Volume 65, Number 51 (Wednesday, March 15, 2000)]
[Notices]
[Page 13981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6282]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Neurological Devices Panel 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 March 31, 2000, 9:30 
a.m. to 5:30 p.m.
    Location: DoubleTree Hotel, Grand Ballroom, 1750 Rockville Pike, 
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 at http://www.fda.gov/cdrh/panelmtg.html for up-
to-date information on this meeting.
    Agenda: There will be a brief FDA presentation of the least 
burdensome provisions of the FDA Modernization Act of 1997. The 
committee will discuss, make recommendations, and vote on a premarket 
approval application for a deep brain stimulator for the treatment of 
Parkinson's disease.
    Procedure: On March 31, 2000, from 10 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 
March 13, 2000. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11:30 a.m. and between 
approximately 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 March 13, 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 March 31, 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 
regarding pending applications. This portion of the meeting will be 
closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 6, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-6282 Filed 3-14-00; 8:45 am]
BILLING CODE 4160-01-F