[Federal Register: July 3, 2002 (Volume 67, Number 128)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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.,
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
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
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,
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