[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Page 52142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-17983]



[[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://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://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