[Federal Register: October 26, 2006 (Volume 71, Number 207)]
[Notices]
[Page 62594-62595]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc06-42]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Dental Products 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: Dental Products 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 November 9, 2006, from 8
a.m. to 5 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Michael J. Ryan, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 175, e-mail
at: michael.ryan@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512518. 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 collagen material, which
contains a bone morphogenetic protein, for oral maxillofacial bone
grafting procedures. Background information, 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 November 9, 2006, from 8:30 a.m. to 5 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 November 2, 2006. Oral presentations from the
public will be scheduled for approximately 30 minutes at the beginning
of committee deliberations and for approximately 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
November 2, 2006.
Closed Committee Deliberations: On November 9, 2006, from 8 a.m. to
8:30 a.m., the meeting will be closed to the public to permit FDA to
present to the committee trade secret and/or confidential commercial
information regarding pending and future agency issues (5 U.S.C.
552b(c)(4)) for the next year.
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, 301-827-7291, at least 7 days in advance
of the meeting.
FDA regrets that it was unable to publish this notice 15 days prior
to the Dental Products Panel of the Medical Devices Advisory Committee
meeting. Because the agency believes there is some urgency to bring
these issues to public discussion and qualified members of the Dental
Products Panel of the Medical Devices Advisory Committee were available
at this time, the Commissioner of Food and Drugs concluded that it was
in the public interest to hold this meeting even if there was not
sufficient time for the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
[[Page 62595]]
Dated: October 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-17932 Filed 10-25-06; 8:45 am]
BILLING CODE 4160-01-S