[Federal Register Volume 74, Number 132 (Monday, July 13, 2009)]
[Notices]
[Page 33452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16409]
[[Page 33452]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
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 August 18 and 19, 2009,
from 8 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B and
C, 620 Perry Pkwy., 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, 240-276-3676, 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 August 18, 2009, the committee will discuss, make
recommendations and vote on a premarket approval application (PMA) for
the CoMplete Acetabular Hip System, sponsored by DePuy Orthopaedics.
This device system is intended for use as a primary joint replacement
prosthesis in total hip arthroplasty, and is indicated for skeletally
mature patients suffering severe pain and disability due to structural
damage in the hip joint from non-inflammatory degenerative joint
disease and its composite diagnoses of osteoarthritis or post-traumatic
arthritis. On August 19, 2009, the committee will discuss, make
recommendations and vote on a PMA for Durolane, sponsored by Q-Med AB.
This device is indicated for the treatment of pain caused by
osteoarthritis of the knee in patients who have failed to respond
adequately to conservative non-pharmacological therapy and simple
analgesics, e.g., acetaminophen.
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, click on the year 2009 and 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
August 4, 2009. Oral presentations from the public will be scheduled at
approximately 1 p.m., immediately following lunch on both days. 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 27, 2009. 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 28, 2009.
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 Ann Marie 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/AdvisoryCommittee/AboutAdvisoryCommittee/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: July 1, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-16409 Filed 7-10-09; 8:45 am]
BILLING CODE 4160-01-S