[Federal Register: February 28, 2005 (Volume 70, Number 38)]
[Page 9657-9658]
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). The meeting will 
be open 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 April 11, 2005, from 8 
a.m. to 5:30 p.m., on April 12, 2005, from 8 a.m. to 6 p.m., and on 
April 13, 2005, from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 
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 3014512519. Please call the Information Line or access the 
Internet address of http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html for up-to-

date information on this meeting.
    Agenda: On April 11, 2005, the committee will hear oral 
presentations from the public. On April 12 and 13, 2005, the committee 
will discuss, make recommendations, and vote on two premarket approval 
applications for Silicone Gel-Filled Breast Prostheses. Background 
information, including the agenda and questions for the committee, will 
be available to the public on April 8, 2005, on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html

    Procedure: 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 March 28, 
2005. Oral presentations from the public will be scheduled on April 11, 
2005, between approximately 8 a.m. and 5:30 p.m., and on April 12 and 
13, 2005, between approximately 2:45 p.m. and 3:45 p.m. Time allotted 
for each presentation is limited. Those desiring to make formal oral 
presentations should notify the contact person before March 28, 2005, 
and submit a brief statement of the general nature of the comments they 
wish to present, and the names and addresses of proposed participants.
    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 240-276-0450, ext. 113, at least 7 days 
in advance of the meeting.

[[Page 9658]]

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 17, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-3741 Filed 2-25-05; 8:45 am]