[Federal Register: October 17, 2002 (Volume 67, Number 201)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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 October 22, 2002, from
10 a.m. to 5:30 p.m., and October 23, 2002, from 8:30 a.m. to 4:30 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
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.
Agenda: On October 22, 2002, the committee will discuss, make
recommendations, and vote on a premarket approval application for a
drug-coated coronary artery stent intended to treat coronary artery
obstructions and to help prevent in-stent stenosis. On October 23,
2002, the committee will discuss and make recommendations on a
premarket notification (510(k)) submission for an arterial cannula
intended to prevent an adverse neurological or limb threatening event.
Background information for each day's topic, including the agenda and
questions for the committee, will be available to the public one
business day before the meeting on the Internet at http://www.fda.gov/
cdrh/panelmtg.html. Material for the October 22, 2002, session will be
posted on October 21, 2002; material for the October 23, 2002, session
will be posted on October 22, 2002.
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 October 18,
2002. On both days, oral presentations from the public will be
scheduled for approximately 30 minutes at the beginning of each topic
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 October 18, 2002, 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
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, as soon as
FDA regrets that it was unable to publish this notice 15 days prior
to the October 22, 2002, Circulatory System Devices Panel of the
Medical Devices Advisory Committee Meeting. Because the agency believes
there is some urgency to bring these issues to public discussion and
qualified members of the Circulatory System Devices Panel of the
Medical Devices Advisory Committee were available at this time, the
Commissioner of Food and Drugs concluded that it was in the public
interest to hold this meeting even if there was not sufficient time for
the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 10, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-26471 Filed 10-11-02; 4:26 pm]
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