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, 18849 [2010-8311]
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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.
sroberts on DSKD5P82C1PROD with NOTICES
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,
VerDate Nov<24>2008
17:33 Apr 12, 2010
Jkt 220001
10903 New Hampshire Ave., Bldg. 66,
rm. 1110, Silver Spring, MD 20993,
301–796–6309,
donna.lochner@fda.hhs.gov.
Registration: To register for the public
workshop and optional session, please
visit the following Web site: https://
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 firstcome, 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 https://www.fda.gov/
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
18849
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0183]
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[Federal Register Volume 75, Number 70 (Tuesday, April 13, 2010)]
[Notices]
[Page 18849]
From the Federal Register Online via the Government Printing 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,
donna.lochner@fda.hhs.gov.
Registration: To register for the public workshop and optional
session, please visit the following Web site: https://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
https://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