U -- CRITICAL PATH PROGRAM

The Food and Drug Administration intends to award a contract to Pennsylvania State University of State College, PA. This is NOT a request for competitive quotes. The contract will be made on a sole source basis in accordance with FAR Part 13 - Simplified Acquisition Procedures and 13.501(A) - Sole source acquisitions for the following services. This contract will provide support to FDA/CDRH in researching complex medical devices. At a minimum, the contractor will provide a student researcher, laboratory resources and supplies. DESCRIPTION OF WORK: To research how existing computational fluid dynamic methods may be used in the design and evaluation of safety in new medical devices, the following tasks will be performed: 1) engineering design of flow models representing blood contacting medical devices, 2) consultation on the fabrication of transparent flow models, 3) evaluation of the flow models using flow visualization and other engineering modalities, 4) development of computational representations of the flow models, 5) evaluation of the flow models using computational fluid dynamic simulations, 6) comparison of engineering test results obtained by both flow visualization and computational fluid dynamic simulations, and 7) prediction of the blood damage potential of the flow models based upon mathematical models of blood damage applied to the computational simulations. All academic collaborators must demonstrate expertise in the following five critical elements of this task: (1) experience with the design and analysis of blood contacting medical devices, (2) engineering design and precise fabrication of flow models, (3) use of computational fluid dynamic techniques to predict flow fields within models, (4) quantitative determination of velocity flow fields (including transient and turbulent measurements) within the models using flow visualization techniques, and (5) experience in analyzing the hemocompatibility and safety of blood contacting medical devices. PERIOD OF PERFORMANCE: Approximate dates are August 30, 2007 - August 29, 2008. SECURITY AND PRIVACY: Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information. Contractor will be required to undergo a security clearance, acceptable to FDA. Performance of work may require the contractor personnel to have access to and use of data and information which may be considered proprietary to a government agency or Government contractor, or which may otherwise be of such nature that its dissemination or use, other than in performance of a subsequent work statement, would be adverse to the interest of FDA or others. FDA, thereof, owns all proprietary information and all copies. The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA, except to authorized FDA personnel or upon written approval of Project Officer. Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contract; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation. FDA owns all proprietary information and all copies shall be returned to FDA upon completion of the work for which it was obtained or developed. Due to the sensitive nature of the information involved, all contractor personnel will be required to sign a non-disclosure agreement before data and information otherwise exempt from public disclosure (e.g., Privacy Act or Data Collected Under an Assurance of Confidentiality) may be disclosed to them. CONTRACTOR CONFORMANCE WITH APPLICABLE LAWS, REGULATIONS, POLICIES, AND STANDARDS: The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov. HHS documents are found at: http://www.cdc.gov/irmo. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your DUN and Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to contact@example.gov no later than July 30, 2007, 2:00pm EST. ANTICIPATED AWARD DATE: The anticipated award date is August 28, 2007; however, all dates in this announcement are subject to change. PROVISIONS and CLAUSES: The following FAR clauses apply to this combined synopsis/solicitation. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items,52.217-8 Option to Extend Services (Nov 1999), 52.217-9 Option to Extend the Term of the Contract (Mar 2000). All information received by 2:00pm EST on August 6, 2007 will be considered by the Government. Responses to this notice must be sent via email to contact@example.gov. No phone calls will be accepted.