[Federal Register Volume 63, Number 107 (Thursday, June 4, 1998)]
[Notices]
[Pages 30498-30499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14913]


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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 regulatory issues.
    Date and Time: The meeting will be held on June 12, 1998, 10:30 
a.m. to 5 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., 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, 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 for 
up-to-date information on this meeting.
    Agenda: On June 12, 1998, the committee will discuss and make 
recommendations on reclassification of preamendment class III 
artificial embolism devices for neurological use based on information 
received from a call for safety and effectiveness information, under 
section 515(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360e), published in the Federal Register of August 14, 1995, and June 
13, 1997 (60 FR 41984 and 62 FR 32352, respectively).
    Procedure: On June 12, 1998, from 11 a.m. to 5 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 June 9, 1998. 
Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 m. and between approximately 3:45 p.m. and 
4:15 p.m. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before June 9, 1998, 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 June 12, 1998, from 10:30 a.m. 
to 11 a.m., the meeting will be closed to permit FDA to present to the 
committee

[[Page 30499]]

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 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 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: May 27, 1998.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 98-14913 Filed 6-2-98; 9:28 am]
BILLING CODE 4160-01-F