[Federal Register: February 8, 2007 (Volume 72, Number 26)]
[Notices]
[Page 5976]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe07-42]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Circulatory System 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Circulatory System 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 March 1, 2007, from 8
a.m. to 5:30 p.m., and March 2, 2007, from 8 a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: James Swink, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240-276-4179, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512625. Please call the Information Line for up-to-date
information on this meeting.
Agenda: On March 1, 2007, the committee will discuss and make
recommendations regarding the premarket approval application, sponsored
by Medtronic Inc., for the Chronicle Implantable Hemodynamic Monitoring
System. This implantable device is intended to reduce hospitalization
events or equivalent events for worsening heart failure in patients
with moderate to advanced heart failure. On March 2, 2007, the
committee will discuss and make recommendations regarding clinical
trial designs for Patent Foreman Ovale closure devices intended to
prevent recurrent stroke.
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: On March 1, 2007, from 8 a.m. to 5:30 p.m., and March 2,
2007, from 8 a.m. to 10 a.m. and 12 p.m. to 6 p.m., the meeting is 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
February 23, 2007. Oral presentations from the public will be scheduled
for approximately 30 minutes at the beginning of committee
deliberations on each day and for approximately 30 minutes near the end
of the committee deliberations on each day. 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 February 15, 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 February 16, 2007.
Closed Presentation of Data: On March 2, 2007, from 10 a.m. to 12
p.m., the meeting will be closed to permit the discussion and review of
trade secret and/or confidential information (5 U.S.C. 552b(c)(4))
presented by sponsors.
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, 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).
Dated: February 1, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-2122 Filed 2-7-07; 8:45 am]
BILLING CODE 4160-01-S