NOT-98-117: SMALL BUSINESS INNOVATION RESEARCH PROGRAM

Department of Health
and Human Services (HHS)

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SMALL BUSINESS INNOVATION RESEARCH PROGRAM Release Date: August 25, 1998 P.T. National Institutes of Health Centers for Disease Control and Prevention Agency for Health Care Policy and Research Contract Proposal Receipt Date: November 5, 1998 Innovative technologies and methodologies fuel progress in biomedical and behavioral research and represent an increasingly important area of the economy. The Small Business Innovation Research (SBIR) program provides support for research and development (R&D) of new or improved technologies and methodologies which have the potential to succeed as commercial products. The purpose of this notice is to (1) announce the issuance of the SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH CONTRACT PROPOSALS (PHS 99-1) with a due date for receipt of SBIR CONTRACT proposals of November 5, 1998, and (2) inform the public about the opportunities that the SBIR program offers to small business concerns as well as to scientists at research institutions, including colleges and universities. The SBIR legislation requires the Public Health Service (PHS), Department of Health and Human Services, and certain other federal agencies to reserve 2.5 percent of their extramural research or R&D budgets for an SBIR program. The PHS SBIR set-aside requirement for FY 1999 is estimated to be $290-$300 million. The offeror organization must be a small business concern, and the PRIMARY EMPLOYMENT of the principal investigator MUST be with the small business concern at the time of award and during the conduct of the proposed project. In accord with the intent of the SBIR program to increase private sector commercialization of innovations derived from federal R&D, scientists at research institutions can play an important role in an SBIR project by serving as consultants and/or subcontractors to the small business concern. Generally, one-third of the Phase I budget may be spent on consultant and/or subcontractual costs, and, generally, one-half of the Phase II budget may be spent on such costs. In this manner, a small business concern with limited expertise and/or research facilities may benefit from teaming with a scientist(s) at a research institution, for the scientist(s) at a research institution, this team effort provides support for R&D not otherwise obtained. The SBIR program consists of the following three phases: PHASE I: The objective of this phase is to determine the scientific and technical merit and feasibility and potential for commercialization of the proposed research or R&D efforts and the quality of performance of the small business concern, before consideration of further federal support in Phase II. PHASE II: The objective of this phase is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II proposal. Only Phase I contractors are eligible to apply for Phase II funding, and Phase II proposals may be submitted upon the request of the Contracting Officer ONLY. (However, see Fast-Track Initiative below.) PHASE III: The objective of this phase, where appropriate, is for the small business concern to pursue, with non-SBIR funds, the commercialization of the results of the research or R&D funded in Phases I and II. The amount and period of support for SBIR awards are as follows: PHASE I: Generally, awards do not exceed $100,000 for direct costs, indirect costs, and negotiated fixed fee for a period generally not to exceed six months. PHASE II: Generally, awards do not exceed $750,000 for direct costs, indirect costs, and negotiated fixed fee for a period generally not to exceed two years, that is, generally, a two-year Phase II project does not cost more than $750,000 for that project. Only one Phase II award may be made for any SBIR project. FAST-TRACK INITIATIVE (Applicable only to proposals submitted to National Institutes of Health [NIH]) Fast-Track is a parallel review option available to those small business concerns (offeror organizations) whose proposals satisfy additional criteria which enhance the probability of the project"s commercial success. Proposals that do not meet these criteria may be redirected for review through the standard review procedures described in the PHS SBIR Contract Solicitation under Section XI, Method of Selection and Evaluation Criteria. Fast-Track offers two major advantages: 1. Concurrent peer review of both Phase I and Phase II projects. Fast-Track SBIR proposals for both Phase I and Phase II must be submitted together for concurrent initial peer review and evaluation. To identify the proposals as Fast-Track, check the box marked Yes next to the words "Fast- Track Proposal" shown on the Phase I Proposal Cover Sheet (Appendix A). The Phase I proposal must specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. Failure to provide clear, measurable goals may be sufficient reason for the peer review committee to exclude the Phase II proposal from Fast-Track review, retaining it for Phase I consideration only. The peer review committee will evaluate the goals and may suggest other milestones that should be achieved prior to the Phase II award. The Phase I and Phase II proposals will be scored individually and the scores for both phases totaled. Following the initial peer review, Fast-Track proposals may receive secondary review by the program staff of the respective NIH awarding component. 2. Minimal or no funding gap between Phase I and Phase II. Fast-Track Phase II proposals may be funded following submission of the Phase I progress report and other documents necessary for continuation. Phase II proposals will be selected for award based on the project"s scientific and technical merit of the proposed Phase II research, the awarding component"s assessment of the Phase I progress report and determination that the Phase I objectives were met and feasibility demonstrated, the potential of the proposed research for technological innovation, and the availability of funds. (See Section XI of the PHS SBIR Contract Solicitation for discussion of the Technical Evaluation Criteria.) SBIR contract proposals submitted to the NIH are eligible for the Fast-Track review process upon meeting the following criteria: 1. The Phase II proposal must be accompanied by a commitment(s) for funds and/or resources for commercialization of the product(s) or service(s) resulting from the SBIR contract. Although a specific level of commitment is not specified, funds or resources matching or greater than the Phase II award are encouraged. Any commitment(s) from an investor or partner organization must be described in a letter of agreement or contract signed by an official of the investor or partner organization with the authority to legally bind the organization. Details of the commitment(s) must be included in a COMMITMENT APPENDIX to the Phase II proposal. 2. The COMMITMENT APPENDIX must specify the amount of funds and/or the nature of resources that will be dedicated to activities directly related to the SBIR project and must describe those activities. Non-federal commitments may support additional R&D on the project or activities that are beyond the scope of federal SBIR funding, such as market research. The activities supported by the commitment(s) should begin in Phase II and provide for a smooth transition into Phase III commercialization. 3. Because of the risk involved, the commitment(s) may be contingent upon the small business concern receiving the Phase II award, achieving technical objectives, and the technology continuing to be scientifically and economically viable in the marketplace. Details of commitment contingencies must be described in the COMMITMENT APPENDIX. Withdrawal of the commitment(s) may be considered sufficient reason by the participating awarding component to remove the Phase II proposal from consideration under Fast-Track or withhold further Phase II support. 4. The small business concern must submit a concise Product Development Plan (limited to five pages) as a PRODUCT DEVELOPMENT PLAN APPENDIX to the Phase II proposal addressing each of the following areas: a. Company information, including size, specialization area(s), products with significant sales, and history of previous federal and non-federal funding, regulatory experience, and subsequent commercialization. b. Value of SBIR project, including lay description of key technology objectives, current competition, and advantages to competing products or services. c. Commercialization plans, milestones, target dates, market analyses of market size, and estimated market share after first year sales and after five years. d. Patent status or other protection of project intellectual property. Following are the research topics contained in the SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH CONTRACT PROPOSALS (PHS 99-1) for the contract proposal receipt date of November 5, 1998: NATIONAL INSTITUTES OF HEALTH NATIONAL CANCER INSTITUTE (NCI) o Isolation of High Quality mRNA from Human Epithelial Tissues o Development of New Methodologies for Preservation of Human Tissue Specimens o Web Based Visualization and Analysis of DNA Micro-Array Data o Conversion of Existing cDNA Libraries into Vectors for Functional Studies NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) o Assays for Identification of High Risk Individuals for the Development of Insulin Dependent Diabetes (IDDM) o Transplantation of Human Islets or Beta Cells o Improved Methods for Production of Clinical Gene Therapy Vectors for Diseases of Interest to NIDDK o Acute Renal Failure o New Noninvasive Body Iron Test o Mechanical Approaches to Achieving Euglycemia o Chronic Renal Failure o Measurement of Pancreatic Beta-Cell Mass or Inflammation in the Diabetic Patient o Generation of cDNA Libraries from Hematopoietic Lineages NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) o Drug Supply Services Support o Chemical Libraries for Drug Development o Analytical Techniques Program o Develop Prevention Research Dissemination o Measurement Modules for Prevention Interventions NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS) o Development of a Transgenic Teleost Animal Model fro Assessing Mutagenesis o Commercialization of Laboratory Methods for Assessing the Genetic Responses to Chemicals o Rapid Mutational Analysis of Rodent DNA Samples o Development of Assay Systems for Determining the Formation of Mutagens by Prostaglandin H Synthase-2 o Development of Applications of Human Breath Analysis for Metabolic Phenotyping of Individuals o Development and Evaluation of Transgenic Mouse/Rat Models for Problems in Environmental Toxicology and Carcinogenesis o Development of Arrayed Mouse Unigene Libraries for Use in cDNA Micro-arrays o Development of High Capacity/High Throughput Genotyping Methods for Human Polymorphisms o Development of Low Cost Gene Expression Array Technology o Development of Improved Alternative Test Methods for Ocular and Dermal Toxicity o Development of Humane Innovative Technologies for the Refinement of Toxicity Testing NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) o Fluorescent Indicator Dyes for Extracellular Ions o Transgenic Mice Expressing Cre-Recombinase in Specific Renal Tubule Segments NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) o Development of Non-Pharmacological Therapy of Epilepsy o Anti-Epileptic Drug Delivery Systems and Formulations o Portable Devices for Sleep Disorder Screening/Monitoring o Non-Pharmacological Therapy of Sleep Disorders o Models for Screening Antiepileptic and Antiepileptogenic Therapy o Alertness Measures o Improved EEG/ICU/OR Interface o Improving Magnetic Resonance Imaging to Evaluate the Central Nervous System of Critically-ill Neonates o Inducible Knockout Technology o Genome Scanning o Direct Gene Transfer o NIRS Device Development for Cerebral Monitoring in the Infant and Child o Development of a MRI Head Coil for Pediatric Use o Neuroimaging in HIV Infection CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) NATIONAL CENTER FOR HIV, STD AND TB PREVENTION (NCHSTP) o Development and Visual Case Analysis Software for Use by Disease Intervention Specialists During Syphilis Interviews o Production of Health Message Videos Targeting STD/HIV Risk Reduction for High Risk Adolescents NATIONAL IMMUNIZATION PROGRAM (NIP) o Assay to Detect Minimal Infectious Dose of HBsAg or Blood Surrogate o Simple Aerosol Nebulizer for Measles Vaccine Administration o Safe Injection Practice NATIONAL CENTER FOR INFECTIOUS DISEASES (NCID) o Production of Specialized Diagnostic Products and Reagents o Develop a Portable Glovebox for Safe Management of Trapped Wild Mammals o Develop Humanized Monoclonal Antibodies for Medically Important Arboviruses EPIDEMIOLOGY PROGRAM OFFICE (EPO) o Design and Develop an Interactive, Multi-media Program on Teaching the Principles of Epidemiology, Surveillance and/or Prevention Effectiveness PUBLIC HEALTH PRACTICE PROGRAM OFFICE (PHPPO) o Geographic Information Systems and Community Health Planning AGENCY FOR HEALTH CARE POLICY AND RESEARCH (AHCPR) o Tools to Assist Children/Parents Manage Their Chronic Health Needs o Internet-Based Decision Support for Health Related Quality of Life Instruments INQUIRIES Eligibility requirements, definitions, submission procedures, review considerations, contract proposal forms and instructions, and other pertinent information, including the Fast-Track Initiative, are contained in the SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH CONTRACT PROPOSALS (PHS 99-1) for the proposal receipt date of November 5, 1998. This PHS SBIR Contract Solicitation is available electronically through the NIH’s Small Business Funding Opportunities home page at http://grants.nih.gov/grants/funding/sbir.htm on the World Wide Web. A limited number of hard copies of the PHS SBIR Contract Solicitation is produced. Subject to availability, they may be obtained from: PHS SBIR/STTR Solicitation Office 13687 Baltimore Avenue Laurel, MD 20707-5096 Phone: (301) 206-9385 Fax: (301) 206-9722 E-mail: a2y@cu.nih.gov Those interested in the PHS SBIR GRANT program may access electronically, at the same website above, the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT APPLICATIONS (PHS 98-2) for the calendar year 1998 grant application receipt dates of April 15, August 15, and December 15 (same dates each year). The Fast-Track review option is an initiative for SBIR grant applications also. Hard copies of the PHS SBIR GRANT Solicitation may be obtained also from the Solicitation Office identified above.

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