[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Notices]
[Pages 53274-53275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24893]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


The 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 November 20, 2009, from 
8 a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Deborah Falls, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, 301-796-6459, 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. A notice in the Federal Register about last minute 
modifications that impact a previously announced advisory committee 
meeting cannot always be published quickly enough to provide timely 
notice. Therefore, you should always check the agency's Web site and 
call the appropriate advisory committee hot line/phone line to learn 
about possible modifications before coming to the meeting.
    Agenda: On November 20, 2009, the committee will discuss, make 
recommendations and vote on a premarket approval application for the 
Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc. 
This device is indicated as adjunctive therapy for reducing the 
frequency of seizures in individuals diagnosed with epilepsy. For this 
device, a patient's epilepsy should be characterized by partial-onset 
seizures (affecting only a part of the brain when they begin), with or 
without secondary generalization, that are refractory to antiepileptic 
medications. ``Secondary generalization'' is used to describe a 
partial-onset seizure that later spreads to the whole brain. 
``Refractory'' to antiepileptic medications means that the patient's 
epilepsy does not respond to approved medications.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after

[[Page 53275]]

the meeting. Background material is available on the FDA Internet under 
the appropriate date at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    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 on or before 
November 16, 2009. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those desiring to make formal 
oral presentations should notify the contact person 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 
on or before November 12, 2009. Time allotted for each presentation may 
be limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by November 
13, 2009.
    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, 
301-796-5966, at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24893 Filed 10-15-09; 8:45 am]
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