[Federal Register Volume 75, Number 123 (Monday, June 28, 2010)]
[Notices]
[Page 36660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15350]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
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 July 27, 2010, from 8
a.m. to 6 p.m.
Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Tracy Phillips, Food and Drug Administration,
Center for Devices and Radiological Health, 10903 New Hampshire Ave.,
Bldg. 66, rm. 1611, Silver Spring, MD 20993-0002, 301-796-6150 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. A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On July 27, 2010, the committee will discuss, make
recommendations and vote on a premarket approval application for the
AMPLIFY rhBMP-2 Matrix, sponsored by Medtronic, Inc. The AMPLIFY rhBMP-
2 Matrix is used for posterolateral fusion treatment of single level
lumbar (L2-S1) degenerative disc disease.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
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 on or before July
21, 2010. Oral presentations from the public will be scheduled between
approximately 1 and 2 p.m., immediately following lunch. 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 July 13, 2010. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by July 14, 2010.
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 AnnMarie Williams,
Conference Management Staff, 301-796-5966, at least 7 days in advance
of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 18, 2010.
Thinh Nguyen,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-15350 Filed 6-23-10; 4:15 pm]
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