[Federal Register: May 12, 2004 (Volume 69, Number 92)]
[Notices]               
[Page 26397]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my04-55]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 June 2, 2004, from 10 
a.m. to 6 p.m. and June 3, 2004, from 8 a.m. to 5 p.m.
    Location: Gaithersburg Marriott, Salons A, B, C, and D, 9751 
Washingtonian Blvd., Gaithersburg, MD.
    Contact Person: Janet L. Scudiero, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512521. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: On June 2, 2004, the committee will discuss, make 
recommendations, and vote on a premarket approval application for an 
artificial lumbar disc intended for spinal arthroplasty in skeletally 
mature patients with degenerative disc disease at one level from L4-S1. 
On June 3, 2004, from 8 a.m. to 1 p.m., the committee will discuss, 
make recommendations, and vote on a reclassification petition for total 
and unicompartmental mobile bearing knee joint prostheses. Also on June 
3, 2004, from 1 p.m. to 5 p.m., the committee will discuss and make 
recommendations on a draft guidance document for clinical performance 
data requirements for hip joint prostheses. The draft guidance document 
is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dailys/04/apr04/040504/03n-0561-c00001-vol2.pdf.
 Background information for the topics, 

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. Material for the June 2 session 

will be posted June 1, 2004. Material for the June 3 session will be 
posted June 2, 2004.
    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 May 18, 2004. 
On June 2, 2004, oral presentations from the public will be scheduled 
for approximately 30 minutes at the beginning of committee 
deliberations and for approximately 30 minutes near the end of the 
deliberations. On June 3, 2004, oral presentations from the public will 
be scheduled between approximately 8:15 a.m. and 8:45 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 May 18, 2004, 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 
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 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: May 3, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-10752 Filed 5-11-04; 8:45 am]

BILLING CODE 4160-01-S