[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://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