[Federal Register: October 30, 2003 (Volume 68, Number 210)]
[Notices]               
[Page 61812-61813]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30oc03-71]                         

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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). The meeting will 
be open 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 November 20, 2003, from 
9 a.m. to 5 p.m.
    Location: Hilton Washington DC North, Grand Ballroom, 620 Perry 
Pkwy., Gaithersburg, MD.
    Contact Person: Geretta Wood, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8320, ext. 143, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12625. Please call the Information Line for up-to-date 
information on this meeting.

[[Page 61813]]

    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for a drug-eluting stent indicated 
for improving luminal diameter and reducing restenosis for the 
treatment of de novo lesions. Background information for the topic, 
including the agenda and questions for the committee, will be available 
to the public 1 business day before the meeting on the Internet at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. Material will be posted on 
November 19, 2003.
    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 by November 10, 
2003. Oral presentations from the public will be scheduled for 
approximately 30 minutes at the beginning of committee deliberation and 
for approximately 30 minutes near the end of the committee 
deliberations. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before November 10, 2003, 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.
    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 301-594-1283, ext. 113, 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: October 21, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-27291 Filed 10-29-03; 8:45 am]

BILLING CODE 4160-01-S