[Federal Register Volume 64, Number 169 (Wednesday, September 1, 1999)]
[Notices]
[Pages 47843-47844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22713]
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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 September 16, 1999, 11
a.m. to 6 p.m., and September 17, 1999, 8:30 a.m. to 3:30 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: Janet L. Scudiero, Center for Devices and
Radiological Health (CDRH) (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 World Wide Web at ``http://www.fda.gov/cdrh/
upadvmtg.html'' for up-to-date information on this meeting.
Agenda: On September 16, 1999, the committee will discuss and make
recommendations on: (1) The draft guidance entitled ``Guidance Document
for Dura Substitute Devices,'' and (2) the classification of processed
human dura mater. FDA notes that the guidance entitled ``Guidance for
the Preparation of a Premarket Notification Application for Processed
Human Dura Mater,'' which related to the classification of processed
human dura mater, became effective on July 31, 1999.
On September 17, 1999, the committee will discuss and make
recommendations on: (1) The draft guidance entitled ``Guidance Document
[[Page 47844]]
for Neurological Embolization Devices,'' and (2) the reclassification
of the totally implanted spinal cord stimulator. Single copies of the
guidance and the draft guidances are available to the public by calling
1-800-899-0381 or 301-827-0111 and requesting CDRH Facts-on-Demand by
assigned document number, or the documents may be obtained on the
Internet at the CDRH website as follows: ``Guidance Document for Dura
Substitute Devices,'' Facts-on-Demand document number 1152, or ``http:/
/www.fda.gov/cdrh/ode/1152.pdf''; ``Guidance for the Preparation of a
Premarket Notification Application for Processed Human Dura Mater,''
Facts-on-Demand document number 054, or ``http://www.fda.gov/cdrh/ode/
054.pdf''; and ``Guidance Document for Neurological Embolization
Devices,'' Facts-on-Demand document number 1151, or ``http://
www.fda.gov/cdrh/ode/1151.pdf''.
Procedure: On September 16, 1999, from 11 a.m. to 6 p.m., and on
September 17, 1999, from 8:30 a.m. to 3:30 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 September 8, 1999.
Oral presentations from the public will be scheduled on September 16,
1999, between approximately 12 noon and 12:30 p.m. for the discussion
of the draft guidance entitled ``Guidance Document for Dura Substitute
Devices'' and between approximately 3:45 p.m. and 4:15 p.m. and 5 p.m.
and 5:30 p.m. for the classification of processed human dura mater. On
September 17, 1999, oral presentations from the public will be
scheduled between approximately 9:45 a.m. and 10:15 a.m. for the
discussion of the draft guidance entitled ``Guidance Document for
Neurological Embolization Devices'' and between approximately 12:15
p.m. and 12:45 p.m. and 2:30 p.m. and 3 p.m. for the reclassification
of the totally implanted spinal cord stimulator. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before September 8,
1999, 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 September 17, 1999, from 8 a.m.
to 8:30 a.m., the meeting will be closed to permit discussion and
review of trade secret and/or confidential commercial information
regarding pending and future FDA issues. 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: August 25, 1999.
Linda Suydam,
Senior Associate Commissioner.
[FR Doc. 99-22713 Filed 8-27-99; 10:49 am]
BILLING CODE 4160-01-F
