[Federal Register: July 27, 2005 (Volume 70, Number 143)]
[Page 43439]
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 August 25 and 26, 2005, 
from 8 a.m. to 6 p.m on both days.
    Location: Hilton Washington DC North/Gaithersburg, 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 3014512519. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On August 25, 2005, the committee will hear a presentation 
on the FDA Critical Path Initiative and a presentation by the Office of 
Surveillance and Biometrics in the Center for Devices and Radiological 
Health outlining their responsibility for the review of postmarket 
study design. On August 25 and 26, 2005, the committee will discuss and 
make recommendations on the classification of five preamendments 
medical devices: Bone wax, medical maggots, medicinal leeches, tissue 
expander, and wound dressing with a drug. Background information for 
this meeting, including the agenda and questions for the committee, 
will be made available at least 1 business day before the meeting 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 August 11, 
2005. On August 25, 2005, oral presentations from the public will be 
scheduled between approximately 10:15 a.m. and 10:45 a.m., 1:45 p.m. 
and 2:15 p.m., and 4:30 p.m. and 5 p.m. On August 26, 2005, oral 
presentations from the public will be scheduled between approximately 
9:30 a.m. and 10 a.m., 1 p.m. and 1:30 p.m., and 3:45 p.m. and 4:15 
p.m. Time allotted for each presentation may be limited. Those desiring 
to make formal oral presentations should notify the contact person 
before 5 p.m. on August 11, 2005, 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.
    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 at 
240-276-0450, 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: July 20, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-14749 Filed 7-26-05; 8:45 am]