[Federal Register: August 22, 2006 (Volume 71, Number 162)]
[Notices]
[Page 48930-48931]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au06-58]
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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.
[[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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