[Federal Register: September 12, 2007 (Volume 72, Number 176)]
[Notices]
[Page 52142]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se07-99]
[[Page 52142]]
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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 October 10 and 11, 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. 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 October 10, 2007, the committee will discuss; make
recommendations; and vote on a premarket approval application,
sponsored by Medtronic, Inc., for the Endeavor Zotarolimus-Eluting
Coronary Stent System, which is indicated for improving coronary
luminal diameter in patients with ischemic heart disease due to de novo
lesions of length < = 27 millimeters (mm) in native coronary arteries
with reference vessel diameters of >= 2.5 mm to <= 3.5 mm.
On October 11, 2007, the committee will discuss and make
recommendations regarding clinical trial designs for carotid artery
stenting in patients not at high risk for adverse events from surgical
revascularization.
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://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 October 10, 2007, from 8 a.m. to 6 p.m., and on
October 11, 2007, from 10:15 a.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 September
26, 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
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 September 18, 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 September 19, 2007.
Closed Presentation of Data: On October 11, 2007, from 8 a.m. to
10:15 a.m., the meeting will be closed to permit discussion and review
of clinical trial design issues for carotid artery stents intended to
reopen stenotic carotid arteries in the neck. Information regarding
trial designs and actual experience in conducting ongoing trials is
considered trade secret and/or confidential information (5 U.S.C.
552b(c)(4)).
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 240-276-8932, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.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: September 5, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-17983 Filed 9-11-07; 8:45 am]
BILLING CODE 4160-01-S