[Federal Register: June 26, 2003 (Volume 68, Number 123)]
[Notices]
[Page 38067]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn03-98]
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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 24, 2003, from 8
a.m. to 5 p.m.
Location: Hilton Washington, DC North/Gaithersburg, Ballroom Salons
A, B, and C, 620 Perry Pkwy., 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
``CDRH Advisory Committees'' Web page at http://www.fda.gov/cdrh/panelmtg.html
for up-to-date information on this meeting.
Agenda: The committee will 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. There will also be a discussion of clinical trial
issues for devices designed for percutaneous removal of breast tumors.
Background information for each 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
.
Procedure: On July 24, 2003, from 8:30 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 10, 2003. Oral presentations from the public will be scheduled
between approximately 8:30 a.m. and 8:45 a.m., 11 a.m. and 11:15 a.m.,
and 1:15 p.m. and 1:45 p.m. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before July 10, 2003, 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 24, 2003, from 8 a.m. to
8:30 a.m., the meeting will be closed to permit FDA to present to the
committee 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, at least 7 days
in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 19, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-16112 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S