NOT-98-014: SMALL BUSINESS INNOVATION RESEARCH PROGRAM

Department of Health
and Human Services (HHS)

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SMALL BUSINESS INNOVATION RESEARCH PROGRAM Release Date: February 12, 1998 P.T. National Institutes of Health Centers for Disease Control and Prevention Food and Drug Administration Annual Grant Application Receipt Dates: April 15, August 15, and December 15 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 technologies and methodologies which have the potential to succeed as commercial products. The purpose of this notice is to inform the public about the special opportunities that the SBIR program offers to small business concerns as well as to scientists at research institutions, including colleges and universities. The applicant organization must be a small business concern, and the primary employment of the principal investigator must be with the small business 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. Normally, up to one-third of the Phase I budget may be spent on consultant and/or contractual costs, and up to 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 at a research institution, for the scientist at a research institution, this team effort provides support for R&D not otherwise obtained. Current legislation (Public Law 102-564, signed October 28, 1992) requires the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), Public Health Service (PHS), Department of Health and Human Services, and certain other federal agencies, to set-aside 2.5 percent of their extramural budgets for an SBIR program each year through fiscal year 2000. In fiscal year 1998, a total of $268.5 million has been reserved for the SBIR program by these PHS agencies: NIH - $264.7 million, CDC - $3.3 million, and FDA - $0.5 million. 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 project and the quality of performance of the small business concern, before consideration of further federal support in Phase II. (SEE "FAST- TRACK" INITIATIVE BELOW.) 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 application. (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. Both Phase I and Phase II grant applications -- initial and revised -- will be accepted on the application receipt dates identified above. However, the NIH will accept no more than two revised (amended) applications within a time period of two years from the receipt date of the initial, unamended application. The amount and period of support for SBIR awards are as follows: PHASE I: Normally, the award period for Phase I is for six months and the statutory guideline is $100,000 for direct costs, indirect costs, and fixed fee. However, these award levels are guidelines and NOT ceilings. Therefore, APPLICANTS MAY PROPOSE LONGER PERIODS OF TIME AND GREATER AMOUNTS OF FUNDS NECESSARY FOR COMPLETION OF THE RESEARCH PROJECT. IN ADDITION, UNDER SPECIAL CIRCUMSTANCES, REQUESTS FOR SUPPLEMENTAL FUNDS TO EXISTING PHASE I GRANTS OR REQUESTS FOR AN EXTENSION OF THE PERIOD OF SUPPORT WITH FUNDS, WILL BE CONSIDERED. (The above applies to NIH ONLY, as CDC and FDA do NOT make awards greater than the stated guidelines.) PHASE II: Normally, Phase II is for two years and the statutory guideline is $750,000 for direct costs, indirect costs, and fixed fee. However, these award levels are guidelines and NOT ceilings. Therefore, APPLICANTS MAY PROPOSE LONGER PERIODS OF TIME AND GREATER AMOUNTS OF FUNDS NECESSARY FOR COMPLETION OF THE RESEARCH PROJECT. IN ADDITION, UNDER SPECIAL CIRCUMSTANCES, REQUESTS FOR SUPPLEMENTAL FUNDS TO EXISTING PHASE II GRANTS OR REQUESTS FOR AN EXTENSION OF THE PERIOD OF SUPPORT WITH FUNDS, WILL BE CONSIDERED. (The above applies to NIH ONLY, as CDC and FDA do NOT make awards greater than the stated guidelines.) INQUIRIES Eligibility requirements, definitions, application procedures, review considerations, application forms and instructions, and other pertinent information are contained in the "OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT APPLICATIONS." This solicitation, including application forms, is available electronically from 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 solicitation for calendar year 1998 will be produced. Subject to availability, they may be obtained from: SBIR/STTR Solicitation Office 13687 Baltimore Avenue Laurel, MD 20707-5096 Telephone: (301) 206-9385 FAX: (301) 206-9722 Email: a2y@cu.nih.gov "FAST-TRACK" INITIATIVE (NIH ONLY) Fast-Track is a parallel review option available to those small business concerns (applicant organizations) whose applications satisfy additional criteria which enhance the probability of the project’s commercial success. Applications that do not meet these criteria may be redirected for review through the standard review procedures described in the Omnibus Solicitation under section VII, 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 applications for both Phase I and Phase II must be submitted together for concurrent initial peer review and evaluation. In order to identify the applications as such, the words "Fast-Track" must be shown in item 2 on the face page of the Phase I application. The Phase I application 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 application from Fast-Track review. The peer review committee will evaluate the goals and may suggest other milestones that should be achieved prior to Phase II funding. The Phase I and Phase II applications will receive a single rating. Following the initial peer review, Fast-Track applications will receive secondary review by the respective advisory council or board of the respective NIH awarding component that is the potential funding component. 2. Minimal or no funding gap between Phase I and Phase II. Fast-Track Phase II applications may be funded following submission of the Phase I progress report and other documents necessary for continuation. Phase II applications will be selected for funding based on the project’s scientific and technical merit, the awarding component’s assessment of the Phase I progress report and determination that the Phase I goals were achieved, an update and verification of the Commitment and Product Development Plans as described below, the project’s potential for meeting the mission of the awarding component and for commercial success, and the availability of funds. SBIR applications are eligible for the Fast-Track review process upon meeting the following criteria: 1. The Phase II application 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 grant. 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 application. 2. The Commitment Appendix must specify the amount of funds and/or 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 research and development 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 application 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 application 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. BEFORE SUBMITTING APPLICATIONS UNDER THE FAST-TRACK INITIATIVE, APPLICANT SMALL BUSINESS CONCERNS AND INVESTIGATORS ARE STRONGLY ENCOURAGED TO CONSULT WITH THE NIH PROGRAM STAFF NAMED BELOW FOR SPECIFIC DETAILS RELEVANT TO THAT AWARDING COMPONENT. Dr. Miriam F. Kelty National Institute on Aging 7201 Wisconsin Avenue, Suite 2C218 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 FAX: (301) 402-2945 Email: mk46u@nih.gov Dr. Michael Eckardt National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402 Bethesda, MD 20892-7003 Telephone: (301) 443-4224 FAX: (301) 594-0673 Email: me25t@nih.gov Dr. Gregory Milman National Institute of Allergy and Infectious Diseases Solar Building, Room 2C06 Bethesda, MD 20892-7620 Telephone: (301) 496-8378 FAX: (301) 402-3211 Email: gm16s@nih.gov Dr. Steven J. Hausman National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 31, Room 4C32 Bethesda, MD 20892-2350 Telephone: (301) 402-1691 FAX: (301) 480-6069 Email: sh41g@nih.gov Ms. Jo Anne Goodnight National Cancer Institute 6130 Executive Boulevard, Room 500 Bethesda, MD 20892-7380 Telephone: (301) 496-5307 FAX: (301) 496-8656 Email: jg128w@nih.gov Dr. Louis A. Quatrano National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: lq2n@nih.gov Ms. Jeanne Borger National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-55 Rockville, MD 20857 Telephone: (301) 443-1056 FAX: (301) 443-6277 Email: jb170g@nih.gov Dr. Lynn E. Huerta National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: lh99s@nih.gov Dr. Joyce Reese National Institute of Dental Research Building 45, Room 4AN-32K Bethesda, MD 20892-6402 Telephone: (301) 594-2088 FAX: (301) 480-8318 Email: jr55r@nih.gov Mr. John R. Garthune National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 6AS49E Bethesda, MD 20892-6600 Telephone: (301) 594-8842 FAX: (301) 480-3504 Email: jg60d@nih.gov Dr. Michael Galvin National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-03, North Campus Research Triangle Park, NC 27709 Telephone: (919) 541-7825 FAX: (919) 541-3843 Email: mg63c@nih.gov Dr. Ralph Helmsen National Eye Institute 6120 Executive Boulevard, Suite 350 Bethesda, MD 20892-7164 Telephone: (301) 496-5301 FAX: (301) 402-0528 Email: rh27v@nih.gov Dr. Michael R. Martin National Institute of General Medical Sciences Building 45, Room 2AN-32K Bethesda, MD 20892-6200 Telephone: (301) 594-3910 FAX: (301) 480-1852 Email: mm72k@nih.gov Dr. John T. Watson National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 9178 Bethesda, MD 20892-7940 Telephone: (301) 435-0513 FAX: (301) 480-1336 Email: jw53f@nih.gov Dr. Bettie J. Graham National Human Genome Research Institute Building 38A, Room 613 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: bg30t@nih.gov Dr. Michael F. Huerta National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-5625 FAX: (301) 443-1731 Email: mh38f@nih.gov Dr. Joseph S. Drage National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 Bethesda, MD 20892-9190 Telephone: (301) 496-4188 FAX: (301) 402-4370 Email: jd66x@nih.gov Dr. Mary W. Leveck National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5968 FAX: (301) 480-8260 Email: ml118t@nih.gov Dr. Louise E. Ramm National Center for Research Resources Building 12A, Room 4009 Bethesda, MD 20892-5662 Telephone: (301) 496-6023 FAX: (301) 402-0006 Email: lr34m@nih.gov Mr. Peter Clepper National Library of Medicine Building 38A, Room 5S518 Bethesda, MD 20894 Telephone: (301) 496-4621 FAX: (301) 402-0421 Email: pc49n@nih.gov

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