[Federal Register: August 24, 2005 (Volume 70, Number 163)]
[Notices]
[Page 49660]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au05-77]
[[Page 49660]]
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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). At least one
portion of the meeting will be closed 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 September 8, 2005, from
8 a.m. to 6 p.m., and on September 9, 2005, from 8 a.m. to 1 p.m.
Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620
Perry Pkwy., 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 September 8, 2005, the committee will hear 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. The committee will also hear an
update on the status of recent devices brought before the committee.
Subsequently, the committee will discuss, make recommendations, and
vote on a premarket approval application for a hip joint metal/metal
semi-constrained resurfacing hybrid prosthesis (cemented femoral
component and uncemented acetabular component). The device is intended
to relieve hip pain and improve hip function in patients who have
adequate bone stock and are at risk of requiring more than one hip
joint replacement over their lifetimes.
On September 9, 2005, the committee will discuss the design of
clinical studies for spinal devices indicated for treatment of mild to
moderate low back pain.
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/panel/index.html.
Material for the September 8 session will be posted
September 7, 2005; material for the September 9 session will be posted
September 8, 2005.
Procedure: On September 8, 2005, from 8:30 a.m. to 6 p.m., the
meeting will be 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 August 29, 2005. On September 8, 2005, oral presentations
from the public will be scheduled for approximately 30 minutes at the
beginning of the committee deliberations and for approximately 30
minutes near the end of the deliberations. On September 9, 2005, oral
presentations from the public will be scheduled from approximately 8:30
a.m. to 9:30 a.m. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person before August 29, 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.
Closed Committee Deliberations: On September 8, 2005, from 8 a.m.
to 8:30 a.m., the meeting will be closed to permit discussion and
review of 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
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 Shirley Meeks at
240-276-0450, ext. 105, 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: August 18, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-16787 Filed 8-23-05; 8:45 am]
BILLING CODE 4160-01-S