[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Page 49660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16787]



[[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://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