[Federal Register Volume 65, Number 77 (Thursday, April 20, 2000)]
[Notices]
[Page 21201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


General and Plastic Surgery 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: General and Plastic Surgery 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 May 8, 2000, 8 a.m. to 5 
p.m.
    Location: Marriott Washingtonian Center, Salons F and G, 9751 
Washingtonian Blvd., Gaithersburg, MD.
    Contact Person: David Krause, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12519. Please call the Information Line or access the 
Internet at http://www.fda.gov/cdrh/panelmtg.html for up-to-date 
information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on two premarket approval applications for: (1) An in situ 
polymerizable surgical mesh intended to be used to seal air leaks 
following thoracic cavity surgery; and (2) an interactive wound and 
burn dressing intended to be used for the treatment of diabetic foot 
ulcers.
    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 May 1, 2000. 
Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. and 8:45 a.m., 11:15 a.m. and 11:45 a.m., 1:15 
p.m. and 1:45 p.m., and 4 p.m. and 4:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 1, 2000, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the General and Plastic Surgery 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 General and Plastic Surgery Devices Panel of the Medical 
Devices Advisory Committee were available at this time, the 
Commissioner of Food and Drugs 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: April 14, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-9908 Filed 4-19-00; 8:45 am]
BILLING CODE 4160-01-F