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Notice

Workshop on Preclinical Testing for Endovascular Grafts

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of meeting.

This notice announces the forthcoming workshop on preclinical testing for endovascular grafts, sponsored by the Food and Drug Administration (FDA). The meeting will be open to the public.

Date and Time: The meeting will be held on July 31, 2001, 9 a.m. to 6 p.m., and August 1, 2001, 9 a.m. to 5 p.m.

Location: Gaithersburg Holiday Inn, Walker-Whetstone Room, Two Montgomery Village Ave., Gaithersburg, MD.

Contact: The workshop organizers are Megan Moynahan, 301-443-8517, ext. 171, mbm@cdrh.fda.gov, and Dorothy Abel, 301-443-8262, ext. 165, dba@cdrh.fda.gov, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850.

Agenda: The workshop will concern endovascular grafts used in the treatment of abdominal aortic aneurysms. The goal of the workshop is to find ways to improve how these grafts are tested. Participants of the workshop will first be asked to describe the environment to which these grafts are exposed. Then they will identify the failure modes of the grafts and examine how the devices have been tested to date. Finally, the participants will be asked to suggest ways to modify the testing of these devices by taking into consideration the graft environment.

Workshop participation is by invitation only and is therefore limited. However, the public may observe as audience members. Background information for the workshop will be available to the public on the Internet at http://www.fda.gov/​cdrh/​meetings/​073101workshop.html.

Procedure: Members of the public who are interested in attending as audience members should contact the workshop organizers by July 13, 2001.

If you need special accommodations due to a disability, please contact either one of the contact persons listed above at least 7 days in advance.

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Dated: June 25, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

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[FR Doc. 01-16471 Filed 6-29-01; 8:45 am]

BILLING CODE 4160-01-S