[Federal Register: March 21, 2007 (Volume 72, Number 54)]
[Notices]
[Page 13288-13289]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21mr07-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Devices Dispute Resolution 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: Medical Devices Dispute Resolution Panel of the
Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on scientific disputes between the Center
for Devices and Radiological Health and sponsors, applicants, and
manufacturers.
Date and Time: The meeting will be held on April 19, 2007, from
8:30 a.m. to 5:30 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Nancy Collazo-Braier, Center for Devices and
Radiological Health (HFZ-1), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3959, e-mail:
nancy.braier@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014510232. Please call the Information Line for up-to-date information
on this meeting.
Agenda: The committee will discuss, make recommendations, and vote
regarding a scientific dispute between the agency and Cardima Inc.
related to the not-approvable determination for the premarket approval
application (PMA) for the REVELATION Tx Microcatheter with NavAblator
Ablation System, indicated for the treatment of drug refractory
paroxysmal atrial fibrillation.
FDA intends to make background material available to the public no
later than 1 business day 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 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
April 5, 2007. Oral presentations from the public will be scheduled
between approximately 9 a.m. and 9:30 a.m. and between approximately
1:30 p.m. and 2 p.m. 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
March 28, 2007. 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 March 29, 2007.
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, at 301-827-7291, 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).
[[Page 13289]]
Dated: March 14, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-5152 Filed 3-20-07; 8:45 am]
BILLING CODE 4160-01-S