R -- FDA/NSF/NIH WORKSHOP ON COMPUTER METHODS IN CARDIOVASCULAR DEVICE DESIGN & EVALUATION

The Food and Drug Administration intends to award a contract to Leland Stanford Junior University of Stanford, CA. 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. DESCRIPTION OF WORK: Identify a physician and assistant who have extensive experience in the field of cardiovascular computer simulation methods - computational models. The contractor must be familiar with or have participated in many of the changes and techniques associated with computational models associated with cardiovascular devices. The physician should be able to help in the planning and implementation of workshops on Computational Methods for Cardiovascular Devices, but be able to lead the preparation of publications describing best practices in computational methods. The contractor must possess expertise in the field, and connections to experts in the computational area who will be the speakers at the workshop. Select and provide a physician for this contract to the FDA's Office of Device Evaluation (ODE) in a part-time capacity as an expert in the field of cardiovascular computational modeling. The Office of Device Evaluations is interested in computational methods as they relate to cardiovascular device development. DELIVERABLES: In addition to assisting in the preparation and organization of the Cardiovascular Computational Methods Workshop and follow-up meeting in 2008, the secondary products include: 1. An official scientific Position Paper will be written on best-practices and unmet needs in industry and academia related to modeling the cardiovascular system and predicting safety and efficacy of cardiovascular devices. This paper will be submitted to Annals of Biomedical Engineering in order to reach a broad audience. 2. An additional White Paper will be written for use by FDA, NIH and NSF. This White Paper will present the consensus obtained by the workshop participants related to a strategy to promote the development, application and validation of computational methods for cardiovascular device design and evaluation. This paper will identify the roles of device companies, engineering software companies, academic institutions and government agencies. In addition, it will propose specific research topics with an emphasis on discovery sciences and translational research, and the means to enhance the competitiveness of U.S. medical device industry. Regulatory issues will also be considered. The contractor must be able to serve as an expert clinical reviewer of computation modeling methods, provide scientific and technical leadership and guidance in the area of cardiovascular computational modeling set specific objectives, determine the appropriate approaches to solve the problem, schedule assignments and direct the work associated with the successful completion and implementation of the Computation al Methods for Cardiovascular Devices Workshop and follow-up meeting. Throughout the contract period, the Office of Device Evaluation (ODE) will be expecting the contractor to participate in or provide following items: 1. Written formal consultative memoranda with the time constraints dictated by regulations/guidelines 2. Be available for telephone communication and verbal consultations with the staff of DCD on an ad-hoc basis 3. Commit to regularly scheduled weekly telephone interaction with DCD staff 4. Participate telephonically at meetings and conferences as necessary 5. Assist management in preparing various guidance document reviews relevant to the position paper PERIOD OF PERFORMANCE: Approximate dates are September 1, 2007 - September 30, 2008. 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 August 13, 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 13, 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.