[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]
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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.
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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recommendations on a draft guidance document for clinical performance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 The draft guidance document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]
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