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

###### Food and Drug Administration

          - [Docket No. FDA-2011-N-0002]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of public workshop.

# SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop entitled “FDA/NHLBI/NSF Workshop on Computer Methods for Medical Devices.” FDA is cosponsoring the conference workshop with the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health and the National Science Foundation (NSF). The purpose of the workshop is to facilitate discussion between FDA and other interested parties on the use of computational modeling in the design, development and evaluation of medical devices.

*Dates and Times:*                         The public workshop will be held on September 7, 8, and 9, 2011, from 9 a.m. to 5 p.m. An optional FDA Microstructure Modeling session will be held from 1 to 5 p.m. on September 6, 2011. Participants are encouraged to arrive early to ensure time for parking and security screening before the meeting. Security screening will begin at 8 a.m. Persons interested in attending this public workshop must register by 5 p.m. on August 30, 2011.                    

*Location:*                         The public workshop and optional session will be held at the FDA White Oak Campus, 10903 New Hampshire Ave, Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002.                    

*Contact Persons:*                         Donna R. Lochner, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, rm. 3220, Silver Spring, MD 20993-0002, 301-796-6309,                         *e-mail: donna.lochner@fda.hhs.gov;*                         or                    

                        Tina M. Morrison, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1272, Silver Spring, MD 20993-0002, 301-796-6310,                         *e-mail: tina.morrison@fda.hhs.gov.*

*Registration:*                         To register for the public workshop and optional session, please visit the following Web site:                         *http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​default.htm*                         (or go to                         *http://www.fda.gov*                         and select the FDA Medical Devices News & Events—Workshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. For those without Internet access, please call the contact person to register. Registration is mandatory as space is limited and onsite registration will not be available. FDA may limit the number of participants from each organization. There is no registration fee for the public workshop.                    

Registrants requesting to present written materials or to make oral presentations at the public workshop, please call the contact persons by August 23, 2011.

                        If you need special accommodations because of a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4321, Silver Spring,                               ( print page 49776)                            MD 20993-0002, 301-796-5661 at least 7 days before the public workshop.                    

# SUPPLEMENTARY INFORMATION:

## I. Why are we holding this public workshop?

The purpose of the public workshop is to facilitate discussion between FDA and other interested parties on the use of computational modeling in medical 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, with our overall theme being the validation of computer models with nonclinical models. Topics include, but are not limited to the following:
    - Advancing Computational Modeling Studies—how is computational modeling being used for device design, development, and/or evaluation?
    - Best Validation Practices—what validation scheme has worked for computational model systems?
    - Lessons Learned—what validation schemes have been unsuccessful for computational model systems?
    - Data Resources—where are data for boundary conditions, loading conditions, material properties, etc. obtained for model systems?

## III. Where can I find out more about this public workshop?

                    Background information on the public workshop, registration information, the agenda, information about lodging, food services, and other relevant information will be posted, as it becomes available, on the Internet at:                     *http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​default.htm*                     (or go to                     *http://www.fda.gov*                     and select the FDA Medical Devices News & Events—Workshops & Conferences calendar and select this public workshop from the posted events list).                

                        Dated                         *August 8, 2011.*

Nancy K. Stade,

 Deputy Director for Policy, Center for Devices and Radiological Health.

[FR Doc. 2011-20446 Filed 8-10-11; 8:45 am]

BILLING CODE 4160-01-P