[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Notices]
[Pages 19097-19098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


Computational Modeling for Cardiovascular Devices; Public 
Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Computational Modeling for Cardiovascular 
Devices.'' FDA is co-sponsoring the conference with the National Heart, 
Blood and Lung Institute of the National Institutes of Health and the 
National Science Foundation. The purpose of the public workshop is to 
facilitate discussion among FDA and other interested parties on the use 
of computational modeling in the design, development, and evaluation of 
cardiovascular medical devices.
    Date and Time: The public workshop will be held on June 1 and 2, 
2009, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Hilton Washington 
DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, 
MD 20852.
    Contact Person: Donna R. Lochner, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4043, e-mail: 
donna.lochner@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

    The purpose of the public workshop is to facilitate discussion 
among FDA and other interested parties on the use of computational 
modeling in cardiovascular device design, development, and evaluation.

II. What Are the Topics We Intend to Address at the Public Workshop?

    We hope to discuss a large number of issues at the public workshop, 
including, but not limited to:
     Multi-scale modeling.
     Imaging for cardiovascular device modeling.
     Physiologic input data for cardiovascular device modeling.
     Device-specific issues related to modeling, including a 
focus on heart valves, drug-eluting and bare metal stents, endovascular 
stents, cardiac rhythm management, and mechanical and circulatory 
support devices.

[[Page 19098]]

     Regulatory issues with implementation of computer 
modeling.

III. Is There a Fee and How Do I Register for the Public Workshop?

    There is a fee to attend the public workshop to defray the costs of 
meals provided and other expenses. The fee for the public workshop is 
$250. The registration process will be handled by BL Seamon. BL Seamon 
has extensive experience in planning, executing, and organizing 
educational meetings. Register online at http://www.blseamon.com. 
Although the facility is spacious, registration will be on a first-
come, first-served basis.
    If you need special accommodations due to a disability, please 
contact Donna R. Lochner at least 7 days before the public workshop.

IV. Where Can I Find Out More About This Public Workshop?

    Background information on the public workshop, registration 
information, the agenda, information about lodging, and other relevant 
information will be posted, as it becomes available, on the Internet at 
http://www.fda.gov/cdrh/dsma/workshop.html.

    Dated: April 16, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-9474 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S