Funding-DHHS-Pumps
for children grants; January 14, 2009
Pumps for
Kids, infants, and neonates (PumpKIN)
Agency
Department of
Health and Human Services
Description
The National
Institutes of Health (NIH), National Heart Lung, and Blood Institutes (NHLBI),
Office of Acquisitions (OA), will be seeking proposals from all interested
developers/manufacturers for refining, assembling, validating and obtaining FDA
approval for the Pumps for Kids, Infants, and Neonates (PumpKIN)
program. PumpKIN pre-clinical contractors will
perform activities necessary to receive Investigational Device Exemptions
(IDEs) from the Food and Drug Administration (FDA) for investigational
circulatory assist devices for infants and/or small children. The required
activities include pre-clinical tests and analyses, development and
documentation of manufacturing processes and procedures, and collaboration to
develop an IDE clinical study. The IDEs are needed so that the appropriate
clinical study can be conducted to provide the evidence needed to support
approval of Humanitarian Device Exemption (HDE) applications so that the
devices may be marketed as Humanitarian Use Devices (HUDs).
The contractors will conduct all pre-clinical testing and analysis and develop
all manufacturing documentation necessary for the IDE in the first three years
of the contract. During the third year, they will develop the clinical study in
partnership with a to-be-awarded Data Coordinating Center and other
pre-clinical contractors, submit the IDE, and complete the necessary activities
to receive FDA approval of the IDE. Following the IDE approval, the contractors
will provide regulatory, technical, and clinical support for the investigational
device during the clinical study.
Devices eligible for consideration in the PumpKIN
program are limited to investigational devices that are appropriately designed
and can provide suitable circulatory support for neonates, infants, and small
children (<25 kg) with congenital and acquired cardiovascular disease who
experience cardiopulmonary failure and circulatory collapse. Eligible devices
should be designed and developed to address the unique clinical performance
issues which are relevant to this patient population. Any eligible device
should be substantially developed and should have undergone and successfully
demonstrated reasonable performance in a relevant animal study.
This acquisition has not been designated a type of set aside, this information
will be available upon solicitation posting. It is anticipated that multiple
awards will be made for a period of 4 years. THIS PRESOLICITATION NOTICE IS NOT
THE REQUEST FOR PROPOSALS (RFP); the Request For
Proposals will be available on or about October 18, 2008. The estimated due
date for proposals is January 14, 2009.
Announcement
Number: NHLBI-HV-09-14(2)
Closing
Date: Jan 14, 2009
Link to Full
Announcement
Contact
Information
Stephen
Crooks,
Contract
Specialist
Phone: (301)
435-0340
Fax: (301)
480-3338
Joanne F
Deshler,
Contracting
Officer
Phone: (301)
435-0340
Fax: (301)
480-3338