THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI) is planning to negotiate and award a new task area, without providing for full and open competition, to New England Research Institutes (NERI) under Contract HHSN268201200001I. The purpose of this announcement is to provide a Presolicitation Notice as a follow-up to the sources sought synopsis (HHS-NIH-NHLBI-SBSS-HV-14-13), which was posted within FedBizOpps on October 18, 2013. The intended procurement is classified under NAICS code 541712 with a Size Standard of 500 employees. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. Proposals are not being requested and a written solicitation will not be posted to FedBizOpps. Background The NHLBI is planning to award a new task area to NERI to serve as an Administrative Center (AC) for the NHLBI Pre-Clinical PumpKIN contract program. The Pre-Clinical PumpKIN contractors are completing development and testing of their pediatric circulatory support devices which are necessary for submission of Investigational Device Exemptions (IDEs) from the FDA so that clinical trials can be performed on one or more devices. The NHBLI anticipates that the AC will be needed from January 15, 2014 through December 31, 2014 to complete the goal of submitting the IDEs to the FDA for the trials. As the AC, NERI will be responsible for subcontracting with one or more PumpKIN Pre-clinical Contractors to complete the remaining work to submit the IDE(s) during the period from January 15, 2014 - December 31, 2014, including oversight and management of the remaining work and budget for the work. The PumpKIN Administrative Center is expected to execute and manage subcontracts with one more PumpKIN Pre-Clinical Developers for each to: Complete all necessary pre-clinical activities to submit an IDE for their pediatric circulatory support device funded through the PumpKIN Pre-clinical contract program. The activities to be completed by the subcontractors should include that work necessary to (1) complete development of their investigational pediatric circulatory support device and (2) apply for and receive an approved Investigation Device Exemption (IDE) for the device so that a clinical study with the objective of obtaining an approved Humanitarian Device Exemption (HDE) from the US Food and Drug Administration (FDA) can be conducted. The work should be required by the FDA for the IDE or provide necessary information for the protocols developed for the PumpKIN clinical trials. To accomplish this, one or more PumpKIN pre-clinical contractors shall be subcontracted with to: 1. Conduct all activities which are necessary to finalize the design of the investigational device. This may involve modifications to the design based on previous testing to improve the device so that it is better suited for the proposed PumpKIN clinical trial for the device. 2. Complete or amend as needed the development and documentation of (1) all methods, facilities, and controls for the manufacturing, processing, packing, storage, and installation of the device, (2) labeling for the device, and (3) characterizations of the device system and components including pump, cannulae, controllers, etc. 3. Fabricate the required the investigational devices based on the final design for all necessary pre-clinical testing per FDA requirements for the IDE(s). 4. Conduct and document all necessary pre-clinical testing and analyses of the final design of the investigational device needed for the IDE application(s). 5. Submit the IDE application(s). 6. Respond to any deficiencies and resubmit an IDE if the initial IDE is not-approved. This synopsis is not a request for competitive proposals and the Government is not committed to award a contract pursuant to this announcement. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by Wednesday, November 27, 2013 at 3:00 pm eastern time and must reference number NHLBI-HV-14-13. Responses shall be submitted electronically to Scott Bredow, Contracting Officer, at bredowsa@nhlbi.nih.gov. Fax responses will not be accepted.
