Pumps for Kids, Infants, and Neonates (PumpKIN)

This Sources Sought Notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The purpose of this Source Sought Notice is to identify qualified small business concerns [including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB)] that are interested in and capable of performing the work described herein. The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this Sources Sought Notice, the NHLBI may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this Sources Sought Notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The NHLBI is seeking capability statements from all eligible and qualified small business concerns [particularly Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB)] under the North American Industry Classification System (NAICS) code 541712 with a size standard of 500 employees. Based on the responses received from this Sources Sought Notice, the proposed acquisition may be solicited as a Total Small Business Set-Aside. The Pumps for Kids, Infants, and Neonates (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. Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the Sources Sought Notice described above. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All capability Statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Stephen Crooks (Contract Specialist) and Pamela Lew (Contracting Officer), at crookss@nhlbi.nih.gov and pl116x@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by October 10, 2008, 3:00PM, EST. All responses must be received by the specified due date and time in order to be considered.