[Federal Register: April 19, 2006 (Volume 71, Number 75)]
[Notices]
[Page 20111]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap06-97]
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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, 2006, from 8:30
a.m. to 3:30 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., 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: The committee will discuss and make a recommendation on the
reclassification of the noninvasive bone growth stimulator indicated
for the treatment of established nonunion fractures acquired secondary
to trauma and as an adjunct to the treatment of lumbar spinal fusion
surgery for one or two levels.
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: 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 19, 2006.
Oral presentations from the public will be scheduled between
approximately 8:45 a.m. and 9:45 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before May 19, 2006, 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 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: April 12, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-5783 Filed 4-18-06; 8:45 am]
BILLING CODE 4160-01-S