Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF FEBRUARY 14,2000 PSA#2536

National Medical Technology TestBed(NMTB), 11165 Mountain View Avenue, Suite 121, Loma Linda, CA 92354

A -- PROPOSALS SOLICITED FOR RESEARCH THAT WILL RESULT IN NEAR-TERM COMMERCIALIZABLE TECHNOLOGY TO IMPROVE MILITARY AND CIVILIAN HEALTHCARE SOL NMTB 2000-1 DUE 031000 POC Lydia Pearson, Contracts Administrator, 909-558-6184 E-MAIL: click here to contact the contracts administrator, lpearson@ahs.llumc.edu. INTRODUCTION This is the FY 2000 National Medical Technology Testbed (NMTB) Broad Agency Announcement issued under Cooperative Agreement DAMD 17-97-2-7016 with the U.S. Army Medical Research Acquisition Activity. This announcement is intended to solicit proposals for research that will result in near term commercializable technology products that will improve the delivery of military and civilian healthcare to the nation's population. This announcement is an expression of interest only and does not commit NMTB to make any award or pay for any response preparation costs. There will be no formal request for proposal or any solicitation document issued regarding this BAA. As described below, certain candidates that submit a two-page letter of interest will be invited to submit a comprehensive detailed application for final evaluation. Questions concerning this announcement may be addressed to Ms. Lydia Pearson at 909-558-6184, Fax 909-558-6200 or E-mail lpearson @ ahs.llumc.edu BACKGROUND NMTB was established as part of Loma Linda University Medical Center (LLUMC), Loma Linda CA, in March 1992 as a prototype defense conversion program and incorporated as a non-profit public benefit organization the following year. Initially, funding was first made available to NMTB by Congress "for laboratory and other efforts associated with research, development, and other programs of major importance to the Department of Defense." Its objective has been to develop a comprehensive suite of deliverable technologies that would improve military and civilian health care delivery. Congressional funding has been provided to NMTB as part of the annual Defense Appropriations Bill with funding flowing through the U.S. Army to NMTB by way of a cooperative agreement. Although it is a recipient of Federal research funding, NMTB does not itself perform scientific research. Instead, it identifies, evaluates, and selects researchers throughout the country who accomplish the research projects through a subcooperative agreement with theresearcher's institution. NMTB's emphasis through the years has been on the research and development of medical technology for subsequent commercialization and medical use. Its long term goal has been to obtain a level of self-sufficiency by receiving a fair share of revenue generated by sales of the technology developed and then reinvesting that capital in more research. Previous research areas of interest have been in medical instrumentation, management of trauma and shock, hypertension, diabetes, neurological disorders, the prevention of premature delivery, and modalities that may improve the rate of tissue and bone healing. Over the years, 66 projects have been funded with over $20 million. The average award last year was approximately $225,000. CURRENT AREAS OF RESEARCH EMPHASIS This year NMTB is especially interested in receiving proposals for research and technology development projects in the following areas: n Telemetry -- remote diagnosis and treatment; acquisition, fusion, and analysis of physiological data with low cost, light-weight, wearable, wireless, non-invasive low power sensors and associated information processes n Genetic engineering -- especially accelerated wound and bone healing and cholera and dysentery prevention n Biomaterials -- especially for knee and hip replacements and radioactive stents to prevent heart attack and stroke n Metabolic control -- especially treatment of shock, obesity, and diabetes n Pattern recognition/cancer detection n Oxygen separation from air/treatment of lung disease n Development of noninvasive handheld, portable, or deployable digital image acquisition devices that may be used to image bone, internal organs, and soft tissues n Development of wireless medical information systems that facilitate medical situational awareness (data acquisition and fusion) and display (data distribution and situational interfaces) systems (and necessary support infrastructure) to acquire (medical) information, process and direct multimedia (medical and logistical) data, and maintain the integrity of processed information Proposals for research into technology development and application for health care areas not mentioned above are not excluded from consideration. Also, a wide range of research methods are acceptable, ranging from mathematical models, laboratory bench work, the study of animal models, human individuals, to population studies. However, only those proposals that advance a testable and hence disprovable hypothesis or devise, develop, adapt or use advanced technology for the purpose of improving health care will be selected. A small fraction of NMTB funds may be used to support early, highly innovative research and development when pilot data is not yet available to support a major award. This smaller pilot project award will be made through a special selection process conducted by NMTB's Scientific Director. Use of Loma Linda Medical Center to clinically test and evaluate the practicality of technologies may be possible. Proposals concerned with health care organizations or health care policy do not meet the intent of this program and are not considered. AWARD SELECTION PROCESS In response to this announcement, potential applicants are invited to submit a two-page introductory letter identifying: the purpose and importance of the proposed work; the hypothesis to be challenged; why the proposed work is innovative; the technology expected to result from the research with a projected timetable; an estimate of the overall budget, including costs for personnel, equipment, and supplies; the qualifications of the principal investigator; and the total length of time estimated to be needed to complete the project. These two-page introductory letters are then reviewed by a panel of technical and business experts. The reviewers evaluate and rank the projects based on the information contained in the letters and determine which applicants will be asked to become final candidates by submitting detailed and comprehensive applications. These applications are preparedand submitted by applicants in accordance with instructions provided by NMTB. Once received, the final applications then undergo thorough scientific and business evaluations by experts in the field of the research being proposed. This evaluation will take place at the annual NMTB National Scientific Panel meeting and will focus on the central idea of the research, its potential for near-term technology development, and its importance to telemedicine, biomedicine, or improved healthcare. Technical merit, cost effectiveness, and adequacy of the proposed budget are important considerations. The proposer's qualifications and articles published are also considered during the scientific review. The business evaluation will consider such factors as potential for successful commercialization; expected profit margin; expected market size; expected market share; useful life of technology; production time to marketability; cost of marketing; technology development hurdles; regulatory hurdles; intellectual property protection; and the importance of the technology. During the meeting, the panel will evaluate the full applications, prioritize them based on their scientific merit and economic potential, and forward its funding recommendations to NMTB's Board of Directors. Existing or continuing projects with demonstrated success will also be evaluated given program priorities and funding availability. NMTB's Board of Directors will give final approval to projects selected. AWARD ADMINISTRATION CONSIDERATIONS: n NMTB encourages commercial activities, educational institutions, nonprofit organizations, small businesses, small disadvantaged businesses, historically black colleges and universities, and minority institutions to submit proposals in response to this BAA. n The period of performance for projects funded under this BAA is one year. No-cost extensions may be requested. Second and subsequent year funding may also be applied for. n NMTB reserves the right to select for award any, all, part, or none of the responses received. The amount of funding offered by NMTB may not be the same as the amount requested. n To be eligible for an award, applicants must meet appropriate minimum standards contained in the Federal Acquisition Regulation, Department of Defense Grant and Agreement Regulations, OMB Circulars, and other Government directives. n Administrative requirements are contained in a subcooperative agreement (not a procurement contract) between the awardee institution and NMTB n Payment to the awardee is through the submission of monthly invoices and supporting documentation on a cost reimbursement basis. n The award will not provide for the payment of a fee or profit. Approved indirect costs and G & A will be paid upon submission of evidence of approved rates by the awardee institution to NMTB. n Costs of purchasing personal computers and other general purpose equipment are not reimbursable. n Travel costs are reimbursable if the travel is directly related to the conduct and completion of the project. n Periodic scientific and financial progress reports are required. n NMTB will require a "fair" level of future compensation for the funding it provides. This compensation will be in the form of royalties and/or equity that will be used to fund other applicants in subsequent years. The specific agreed-upon revenue sharing rates and/or equity provisions will be part of the subcooperative agreement. TIMETABLE FOR APPLICATION SUBMISSION AND AWARD SELECTION n March 10, 2000 -- two page proposals due n March 21, 2000 -- review panel meets n March 31, 2000 -- applicants notified of results n June 30, 2000 -- full proposals due n August 8-11, 2000 -- National Scientific Panel meeting n September 18, 2000 -- award notification letters mailed!! Posted 02/10/00 (W-SN424165). (0041)

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