Computational Modeling for Cardiovascular Devices; Public Workshop, 19097-19098 [E9-9474]
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Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices
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Jeffrey Shuren,
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[FR Doc. E9–9521 Filed 4–24–09; 8:45 am]
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[FR Doc. E9–9503 Filed 4–24–09; 8:45 am]
DEPARTMENT OF HEALTH AND
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Centers for Disease Control and
Prevention
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(Pub. L. 92–463), CDC announces the
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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.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Computational Modeling for
Cardiovascular Devices.’’ FDA is cosponsoring 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, email: 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.
E:\FR\FM\27APN1.SGM
27APN1
19098
Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices
• 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 https://
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 https://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]
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ACTION: Notice of Noncompetitive
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SUMMARY: The Health Resources and
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SUPPLEMENTARY INFORMATION:
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Former Grantee of Record: Caritas
Health Care, Inc.
Original Period of Grant Support: July
1, 2006, to June 30, 2011.
Replacement Awardee: Joseph P.
Addabbo Family Health Center.
Amount of Replacement Award:
$388,253.
Period of Replacement Award: The
period of support for the replacement
award is March 1, 2009, to March 31,
2010.
Authority: Section 2651 of the Public
Health Service Act, 42 U.S.C. 300ff–51.
CFDA Number: 93.918.
Justification for the Exception to
Competition: The former grantee, Caritas
Health Care, Inc., notified HRSA that it
would not continue providing services
after February 28, 2009, as it is ceasing
operations. It is critical that there be
continuity in the medical care and
treatment of approximately 430 lowincome patients with HIV/AIDS in the
original service area, Jamaica/Southeast
Queens, Borough of Queens, New York
City, in New York. The Joseph P.
Addabbo Family Health Center is
located in the same geographical area
previously served by Caritas Health
Care, Inc., is a current Part C grantee
with an established record of providing
critical HIV/AIDS care and treatment,
and has purchased the St. Dominic’s
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This temporary replacement award will
ensure that there is no disruption of
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population while the service area is recompeted.
This service area will be included in
the upcoming competition for the Part C
HIV Early Intervention Services
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project periods starting April 1, 2010.
FOR FURTHER INFORMATION CONTACT:
Maria C. Rios, via e-mail
mrios@hrsa.gov, or via telephone, 301–
443–0493.
Dated: April 17, 2009.
Mary K. Wakefield,
Administrator.
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
https://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