[Federal Register: March 26, 2003 (Volume 68, Number 58)]
[Notices]
[Page 14667]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr03-92]
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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 April 10, 2003, from 9
a.m. to 5 p.m.
Location: Hilton DC North/Gaithersburg, Salons A, B, and C, 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.
Agenda: The committee will discuss, make recommendations, and vote
on a premarket approval application for an endovascular graft and
delivery system intended for the treatment of patients with abdominal
aortic, aortoiliac, or iliac aneurysm. 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
Internet at http://www.fda.gov/cdrh/panelmtg.html. Material will be
posted on April 9, 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 April 3, 2003.
Oral presentations from the public will be scheduled for approximately
30 minutes at the beginning of committee deliberations and for
approximately 30 minutes near the end of the deliberations. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before April
3, 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 Shirley Meeks,
Conference Management Staff, at 301-594-1283, ext. 105, at least 7 days
in advance of the meeting.
FDA regrets that it was unable to publish this notice 15 days prior
to the April 10, 2003, 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: March 20, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-7278 Filed 3-25-03; 8:45 am]
BILLING CODE 4160-01-S