[Federal Register: May 11, 2004 (Volume 69, Number 91)]
[Notices]
[Page 26169]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11my04-109]
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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 June 15, 2004, from 8
a.m. to 6 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., 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 supplement for a vagus nerve
stimulation therapy system. The system is indicated for the adjunctive
long-term treatment of chronic or recurrent depression for patients who
are experiencing a major depressive episode that has not had an
adequate response to two or more antidepressant treatments. 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. The
material will be posted on June 14, 2004.
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 June 1, 2004.
Oral presentations from the public will be scheduled for approximately
90 minutes at the beginning of committee deliberations and for
approximately 30 minutes near the end of committee deliberations. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before June
1, 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: May 3, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-10595 Filed 5-10-04; 8:45 am]
BILLING CODE 4160-01-S