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52142 Federal Register / Vol. 72, No.

176 / Wednesday, September 12, 2007 / Notices

DEPARTMENT OF HEALTH AND in patients not at high risk for adverse FDA welcomes the attendance of the
HUMAN SERVICES events from surgical revascularization. public at its advisory committee
FDA intends to make background meetings and will make every effort to
Food and Drug Administration material available to the public no later accommodate persons with physical
than 2 business days before the meeting. disabilities or special needs. If you
Circulatory System Devices Panel of If FDA is unable to post the background require special accommodations due to
the Medical Devices Advisory material on its Web site prior to the a disability, please contact AnnMarie
Committee; Notice of Meeting meeting, the background material will Williams, Conference Management
AGENCY: Food and Drug Administration, be made publicly available at the Staff, at 240–276–8932, at least 7 days
HHS. location of the advisory committee in advance of the meeting.
meeting, and the background material FDA is committed to the orderly
ACTION: Notice.
will be posted on FDA’s Web site after conduct of its advisory committee
This notice announces a forthcoming the meeting. Background material is meetings. Please visit our Web site at
meeting of a public advisory committee available at http://www.fda.gov/ohrms/ http://www.fda.gov/oc/advisory/
of the Food and Drug Administration dockets/ac/acmenu.htm, click on the default.htm for procedures on public
(FDA). At least one portion of the year 2007 and scroll down to the conduct during advisory committee
meeting will be closed to the public. appropriate advisory committee link. meetings.
Name of Committee: Circulatory Procedure: On October 10, 2007, from Notice of this meeting is given under
System Devices Panel of the Medical 8 a.m. to 6 p.m., and on October 11, the Federal Advisory Committee Act (5
Devices Advisory Committee. 2007, from 10:15 a.m. to 6 p.m., the U.S.C. app. 2).
General Function of the Committee: meeting is open to the public. Interested Dated: September 5, 2007.
To provide advice and persons may present data, information, Randall W. Lutter,
recommendations to the agency on or views, orally or in writing, on issues Deputy Commissioner for Policy.
FDA’s regulatory issues. pending before the committee. Written [FR Doc. E7–17983 Filed 9–11–07; 8:45 am]
Date and Time: The meeting will be submissions may be made to the contact
BILLING CODE 4160–01–S
held on October 10 and 11, 2007, from person on or before September 26, 2007.
8 a.m. to 6 p.m. Oral presentations from the public will
Location: Hilton Washington DC be scheduled for approximately 30 DEPARTMENT OF HEALTH AND
North/Gaithersburg, Salons A, B, and C, minutes at the beginning of committee HUMAN SERVICES
620 Perry Pkwy, Gaithersburg, MD. deliberations on each day and for
Contact Person: James Swink, Center approximately 30 minutes near the end Food and Drug Administration
for Devices and Radiological Health of the deliberations on each day. Those
[Docket No. 2004N–0226]
(HFZ–450), Food and Drug desiring to make formal oral
Administration, 9200 Corporate Blvd., presentations should notify the contact Food and Drug Administration
Rockville, MD 20850, 240–276–4179, or person and submit a brief statement of Modernization Act of 1997:
FDA Advisory Committee Information the general nature of the evidence or Modifications to the List of Recognized
Line, 1–800–741–8138 (301–443–0572 arguments they wish to present, the Standards, Recognition List Number:
in the Washington, DC area), code names and addresses of proposed 018
3014512625. Please call the Information participants, and an indication of the
Line for up-to-date information on this approximate time requested to make AGENCY: Food and Drug Administration,
meeting. A notice in the Federal their presentation on or before HHS.
Register about last minute modifications September 18, 2007. Time allotted for ACTION: Notice.
that impact a previously announced each presentation may be limited. If the
advisory committee meeting cannot number of registrants requesting to SUMMARY: The Food and Drug
always be published quickly enough to speak is greater than can be reasonably Administration (FDA) is announcing a
provide timely notice. Therefore, you accommodated during the scheduled publication containing modifications
should always check the agency’s Web open public hearing session, FDA may the agency is making to the list of
site and call the appropriate advisory conduct a lottery to determine the standards FDA recognizes for use in
committee hot line/phone line to learn speakers for the scheduled open public premarket reviews (FDA recognized
about possible modifications before hearing session. The contact person will consensus standards). This publication,
coming to the meeting. notify interested persons regarding their entitled ‘‘Modifications to the List of
Agenda: On October 10, 2007, the request to speak by September 19, 2007. Recognized Standards, Recognition List
committee will discuss; make Closed Presentation of Data: On Number: 018’’ (Recognition List
recommendations; and vote on a October 11, 2007, from 8 a.m. to 10:15 Number: 018), will assist manufacturers
premarket approval application, a.m., the meeting will be closed to who elect to declare conformity with
sponsored by Medtronic, Inc., for the permit discussion and review of clinical consensus standards to meet certain
Endeavor Zotarolimus-Eluting Coronary trial design issues for carotid artery requirements for medical devices.
Stent System, which is indicated for stents intended to reopen stenotic DATES: Submit written or electronic
improving coronary luminal diameter in carotid arteries in the neck. Information comments concerning this document at
patients with ischemic heart disease due regarding trial designs and actual any time. See section VII of this
to de novo lesions of length ≤ 27 experience in conducting ongoing trials document for the effective date of the
millimeters (mm) in native coronary is considered trade secret and/or recognition of standards announced in
arteries with reference vessel diameters confidential information (5 U.S.C. this document.
jlentini on PROD1PC65 with NOTICES

of ≥ 2.5 mm to ≤ 3.5 mm. 552b(c)(4)). ADDRESSES: Submit written requests for


On October 11, 2007, the committee Persons attending FDA’s advisory single copies of ‘‘Modifications to the
will discuss and make committee meetings are advised that the List of Recognized Standards,
recommendations regarding clinical agency is not responsible for providing Recognition List Number: 018’’ to the
trial designs for carotid artery stenting access to electrical outlets. Division of Small Manufacturers,

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