[Federal Register Volume 67, Number 128 (Wednesday, July 3, 2002)]
[Notices]
[Pages 44612-44613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16734]


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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 will 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's regulatory issues.
    Date and Time: The meeting will be held on July 8, 2002, from 1 
p.m. to 5 p.m., and July 9, 2002, from 8 a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
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 address of http://www.fda.gov/cdrh/panelmtg.html for up-to-
date information on this meeting.
    Agenda: On July 8, 2002, the committee will discuss and make 
recommendations on the classification of a preamendment device, the 
silicone elastomer for scar management. The committee will also discuss 
and make recommendations on the reclassification of a transitional 
class III device, the absorbable hemostatic agent and dressing device 
intended for hemostasis during surgical procedures. On July 9, 2002, 
FDA and two manufacturers of approved saline inflatable breast implant 
devices will present postmarket

[[Page 44613]]

information to the committee for their consideration. Background 
information for each day's topic, including the agenda and questions 
for the committee, will be available to the public 1-business day 
before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the July 8, 2002, session will be posted on 
July 5, 2002; material for the July 9, 2002, session will be posted on 
July 8, 2002.
    Procedure: On July 8, 2002, from 1:30 p.m. to 5 p.m., and on July 
9, 2002, from 8 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 July 5, 2002. Oral presentations 
from the public will be scheduled between approximately 1:45 p.m. and 
2:15 p.m. and 4 p.m. and 4:30 p.m. on July 8, 2002; and between 
approximately 8:30 a.m. and 10:30 a.m. on July 9, 2002. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person by July 5, 2002, 
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 July 8, 2002, from 1 p.m. to 
1:30 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)) relating to pending issues and applications.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams, 
Conference Management Staff, at 301-594-1283, ext. 113, by July 5, 
2002.
    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: June 25, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-16734 Filed 6-28-02; 3:10 pm]
BILLING CODE 4160-01-S