[Federal Register: June 26, 2003 (Volume 68, Number 123)]
[Page 38067]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


    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 
    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 
    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]