Pre-Clinical PumpKIN Administrative Center

Introduction This Sources Sought Notice is for interested small businesses. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether small businesses are classified as HUBZone; service-disabled, veteran-owned; 8(a); veteran-owned; woman-owned; or small disadvantaged; and (3) the size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition for any interested businesses. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS code for this acquisition is 541712. Background The NHLBI is seeking an Administrative Center (AC) for an ongoing program - the NHLBI Pre-Clinical PumpKIN contract program. The Pre-Clinical PumpKIN contractors are completing development and testing of their pediatric circulatory support devices (the Jarvik Infant 2000 VAD and the Thoratec PediPL) which are necessary for submission of Investigational Device Exemptions (IDEs) from the FDA so that clinical trials can be performed on each of the devices. The NHBLI anticipates that the AC will be needed until August 31, 2014 to complete the goal of submitting the IDEs to the FDA for the trials. The contractor will be the Administrative Center (AC) and will be responsible for subcontracting with the PumpKIN Pre-clinical Contractors to complete the remaining work to submit the IDEs during the period from January 15, 2014 - August 31, 2014, including oversight and management of the remaining work and budget for the work. Project Requirements The PumpKIN Administrative Center is expected to execute and manage subcontracts to the PumpKIN Pre-Clinical Developers (Jarvik Heart, Inc. and University of Maryland Medical Center) to: Complete all necessary pre-clinical activities to submit IDEs for (1) the Jarvik Infant 2000 Ventricular Assist System and the (2) Thoratec PediPL device developed under the PumpKIN 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, Jarvik Heart, Inc. and the University of Maryland Medical Center (Baltimore) shall be subcontracted 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. 4. Conduct and document all necessary pre-clinical testing and analyses of the final design of the investigational device needed for the IDE application. 5. Submit the IDE application. Capability Statement Small businesses that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Scott Bredow, Contracting Officer, at bredowsa@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate (1) cost plus fixed fee task order for a period of seven and a half (7 ) months from January 15, 2014 - August 31, 2014.