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Pumps for Kids, Infants, and Neonates (PumpKIN)

Solicitation Number: NHLBI-HV-09-14(2)
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD
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NHLBI-HV-09-14(2)
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Modification/Amendment
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Added: Oct 03, 2008 12:00 pm Modified: Oct 31, 2008 4:39 pmTrack Changes
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 performing activities necessary to receive Investigational Device Exemptions (IDEs) from the 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.
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Amendment 1

Type:
Mod/Amendment
Posted Date:
October 31, 2008
Description: Amendment 001 to PumpKIN Request for Proposal.
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Office of Acquisitions
6701 Rockledge Dr RKL2/6100 MSC 7902
Bethesda, Maryland 20892-7902
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National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7902, Room 6220
Bethesda, Maryland 20892-7902
United States
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Stephen Crooks,
Contract Specialist
Phone: (301) 435-0340
Fax: (301) 480-3338
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Joanne F Deshler,
Contracting Officer
Phone: (301) 435-0340
Fax: (301) 480-3338