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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

 Food and Drug Administration, HHS.

# ACTION:

 Notice of public workshop.

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.       ( print 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