[Federal Register Volume 75, Number 70 (Tuesday, April 13, 2010)]
[Notices]
[Page 18849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8311]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Food and Drug Administration/National Heart Lung and Blood 
Institute/National Science Foundation Workshop on Computer Methods for 
Cardiovascular Devices: The Integration of Nonclinical and Clinical 
Models; Public Workshop

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 
Cardiovascular Devices: The Integration of Nonclinical and Clinical 
Models.'' The workshop will include a smaller, optional session 
entitled ``Microstructure Modeling Session.'' FDA is cosponsoring the 
workshop with the National Heart Lung and Blood Institute of the 
National Institutes of Health and the National Science Foundation. 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 cardiovascular medical devices.
    Dates and Times: The optional session will be held on June 9, 2010, 
from 1 p.m. to 5:30 p.m. and the public workshop will be held on June 
10 and 11, 2010, from 8 a.m. to 5 p.m.
    Location: The public workshop and optional session 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, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1110, Silver Spring, MD 20993, 301-796-6309, 
[email protected].
    Registration: To register for the public workshop and optional 
session, please visit the following Web site: http://scpd.stanford.edu/publicViewHome.do?method=load. There is a registration fee to attend 
the public workshop to cover the expenses and attendees must register 
in advance. The fee for the meeting is $350. Students will be offered a 
discounted fee of $175. The exhibitors' fee is $600 and includes 
registration of one person. Fees will be waived for invited speakers 
and the organizing committee. The registration process will be handled 
by the Stanford Center for Professional Development. Although the 
facility is spacious, registration will be on a first-come, first-
served basis.
    If you need special accommodations because of a disability, please 
contact Donna R. Lochner 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 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, 
with our overall theme being the integration of computer and 
nonclinical models. Topics include, but are not limited to the 
following:
     Multiscale, multiphysics, and multiphase modeling;
     Modeling of cardiovascular diseases and therapies;
     Patient-specific modeling, including virtual surgical 
planning and predictive biomedicine;
     Open source projects, including public policy initiatives, 
database development and data presentation, and standards and 
protocols; and
     Regulatory issues with implementation of computer 
modeling.

III. 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/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm

    Dated: April 7, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
[FR Doc. 2010-8311 Filed 4-12-10; 8:45 am]
BILLING CODE 4160-01-S