[Federal Register Volume 71, Number 162 (Tuesday, August 22, 2006)]
[Notices]
[Pages 48930-48931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13823]


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

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). 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.

[[Page 48931]]

    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 19, 2006, from 
8 a.m. to 5:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons C, D and 
E, 620 Perry Parkway, Gaithersburg, MD.
    Contact Person: Ronald P. Jean, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-2036, ext. 181, 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: The committee will discuss, make recommendations and vote 
on a premarket approval application for a cervical disc prosthesis 
intended to treat skeletally mature patients with degenerative disc 
disease at one level from C3-C7. 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 (click on Upcoming CDRH Advisory Panel/
Committee Meetings).
    Procedure: On September 19, 2006, from 8:30 a.m. to 5:30 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 on or before September 5, 2006. Oral presentations from the 
public will be scheduled for 30 minutes at the beginning of the 
committee deliberations and for 30 minutes near the end of the 
deliberations. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person 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 on or before September 5, 2006.
    Closed Committee Deliberations: On September 19, 2006, from 8 a.m. 
to 8:30 a.m., the meeting will be closed to permit FDA to present to 
the committee 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, 
Conference Management Staff, at 301-827-7292, 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 14, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-13823 Filed 8-21-06; 8:45 am]
BILLING CODE 4160-01-S