[Federal Register Volume 63, Number 189 (Wednesday, September 30, 1998)]
[Notices]
[Page 52276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


 Gastroenterology and Urology 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: Gastroenterology and Urology 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 October 29, 1998, 8:30 
a.m. to 5 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact Person: Mary J. Cornelius, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194, ext. 118, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 12523. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval supplement for a new indication for an 
extracorporeal immunoadsorption device intended for the treatment of 
rheumatoid arthritis.
    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 October 22, 
1998. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9 a.m. Near the end of the committee 
deliberations, a 30-minute open public session will be conducted for 
interested persons to address issues specific to the submission before 
the committee. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before October 22, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-26083 Filed 9-29-98; 8:45 am]
BILLING CODE 4160-01-F