[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Notices]
[Page 5393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2409]


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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). At least one 
portion of the meeting will be closed 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 regulatory issues.
    Date and Time: The meeting will be held on February 12, 1998, 8:30 
a.m. to 5 p.m.
    Location: Parklawn Bldg., conference rooms G and H, 5600 Fishers 
Lane, 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, 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.
    Procedure: On February 12, 1998, from 9:30 a.m. to 10:30 a.m., the 
meeting will be 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 February 6, 1998. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before February 6, 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 February 12, 1998, from 10:30 
a.m. to 5 p.m., FDA staff will present to the committee confidential 
information regarding present and future device issues. The committee 
will also hear and review trade secret and/or confidential commercial 
information on a product development protocol. This portion of the 
meeting will be closed to permit discussion of this information (5 
U.S.C. 552b(c)(4).
    FDA regrets that it was unable to publish this notice 15 days prior 
to the February 12, 1998, Gastroenterology and Urology Devices Panel of 
the Medical Devices meeting. Because the agency believes there is some 
urgency to bring these issues to public discussion and qualified 
members of the Gastroenterology and Urology Devices Panel of the 
Medical Devices 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: January 26, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-2409 Filed 1-30-98; 8:45 am]
BILLING CODE 4160-01-F