[Federal Register: January 14, 1998 (Volume 63, Number 9)]
[Notices]               
[Page 2249]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja98-80]

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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). At least one 
portion of the meeting may be closed 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 regulatory issues.
    Date and Time: The meeting will be held on January 29, 1998, 8:45 
a.m. to 6 p.m., and January 30, 1998, 8:45 a.m. to 1:30 p.m.
    Location: Gaithersburg Marriott Washingtonian Center, 9751 
Washingtonian Blvd., Salons F and G, Gaithersburg, MD.
    Contact Person: Gail G. Gantt, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-3090, 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 address of http://www.fda.gov.cdrh for up-to-date information 
on this meeting.
    Agenda: On January 29, 1998, the committee will discuss, make 
recommendations, and vote on one premarket approval application (PMA) 
for a wound dressing for use on diabetic foot ulcers and a second PMA 
for a wound dressing for use on venous stasis ulcers. On January 30, 
1998, the committee will discuss, make recommendations, and vote on a 
PMA for a skin adhesive for wound edge approximation.
    Procedure: On January 29, 1998 from 8:45 a.m. to 10 a.m and from 11 
a.m. to 6 p.m., and on January 30, 1998, from 8:45 a.m. to 1:30 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 
January 22, 1998. Oral presentations from the public will be scheduled 
between approximately 8:45 a.m. and 9:45 a.m. on January 29 and 30, 
1998. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before January 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.
    Closed Presentation of Data: On January 29, 1998, from 10 a.m to 11 
a.m. the meeting may be closed to permit discussion and review of trade 
secret and/or confidential information presented by the PMA sponsor(s) 
(5 U.S.C. 552b(c )(4)).
    FDA regrets that it was unable to publish this notice 15 days prior 
to the January 29 and 30, 1998, General and Plastic Surgery Devices 
Panel of the Medical Devices Advisory Committee meeting. Because the 
agency believes there is some urgency to bring this issue 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 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 8, 1998.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 98-887 Filed 1-9-98; 1:52 pm]
BILLING CODE 4160-01-F