SMALL BUSINESS INNOVATION RESEARCH AND SMALL BUSINESS TECHNOLOGY TRANSFER GRANT PROGRAMS Release Date: January 12, 2000 NOTICE: OD-00-012 National Institutes of Health Centers for Disease Control and Prevention Food and Drug Administration Annual SBIR/STTR Grant Application Receipt Dates: National Institutes of Health (SBIR and STTR) April 1, 2000, August 1, 2000, and December 1, 2000 Centers for Disease Control and Prevention (SBIR only) December 1, 2000 Food and Drug Administration (SBIR only) April 1, 2000, August 1, 2000, and December 1, 2000 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 and the Small Business Technology Transfer (STTR) program provide support for research and development (R&D) of new technologies and methodologies which have the potential to succeed as commercial products. The SBIR and STTR programs stimulate technological innovation in the private sector by strengthening the role of small business concerns in meeting Federal research and development needs, increasing the commercial application of federally supported research results, and fostering and encouraging participation by socially and economically disadvantaged persons and women-owned small businesses in technological innovation. The STTR program further expands the goals through cooperative research and development carried out between small business concerns and research institutions. The purpose of this notice is to inform the public about the special opportunities that the SBIR/STTR programs offer to small business concerns as well as to scientists at research institutions, including colleges and universities. The National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) invite eligible small business concerns to submit Phase I applications for the Calendar Year (CY) 2000 Small Business Innovation Research (SBIR) program and, applicable to NIH only, for the CY 2000 Small Business Technology Transfer (STTR) program. In the past, NIH has issued separate SBIR and STTR Grant Solicitations. Because of the similarities between the two solicitations, both in research topics that may be of interest to small businesses and in application instructions, a single Omnibus Solicitation of the NIH, CDC, and FDA for SBIR/STTR Grant Applications will be issued for coincident CY 2000 grant application receipt dates of April 1, August 1 and December 1. The significant difference between the SBIR and STTR programs is that the STTR requires researchers at universities and other non-profit research institutions to have a formal collaboration with the small business concern and play a significant intellectual role in the conduct of each STTR project. The SBIR or STTR applicant organization must be a small business concern, and, under the SBIR Program, 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. Under the STTR program, the Principal Investigator may be from the small business concern or the research institution. In addition, a Principal Investigator from the research institution is not required to be employed by the small business concern. 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. The Small Business Innovation Research (SBIR) program was established by the Small Business Research and Development Enhancement Act of 1992. 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. Under this program, agencies of the Public Health Service (PHS), Department of Health and Human Services (HHS), and certain other Federal agencies are required to reserve 2.5% of their current fiscal year extramural budgets for small companies to conduct research or research and development (R/R&D). The Small Business Technology Transfer (STTR) program, currently in five Federal agencies, was established by the Small Business Technology Transfer Act of 1992 (Public Law 102-564, Title II). Under this program, 0.15% of a Federal agency"s extramural R/R&D effort is reserved for awards to small business concerns and their non-profit research institution partners for cooperative research and development efforts. The SBIR and STTR programs consist of three phases: The objective of Phase I is to establish the technical merit and feasibility of the proposed R/R&D efforts and to determine the quality of performance of the small business grantee organization prior to providing further Federal support in Phase II. Preliminary data is not required. SBIR Phase I awards normally may not exceed $100,000 total costs (direct costs, indirect costs, and negotiated fixed fee) for a period normally not to exceed 6 months. STTR Phase I awards normally may not exceed $100,000 total costs for a period of 1 year. For SBIR projects, the total amount of all contractual costs and consultant fees normally may not exceed 33% of the total costs requested. The objective of Phase II is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I, scientific and technical merit, and commercial potential of the Phase II application. SBIR Phase II awards normally may not exceed $750,000 in total costs (direct costs, indirect costs, and negotiated fixed fee) for a period normally not to exceed 2 years. STTR Phase II awards normally may not exceed $500,000 total costs (direct costs, indirect costs, and negotiated fixed fee) for a period normally not to exceed 2 years. Only Phase I grantees are eligible to obtain Phase II funding, and only one Phase II award may be made for a single SBIR/STTR project. Phase II applications may be submitted either before or after expiration of the Phase I budget period, except for those applicants electing to concurrently submit Phase I and Phase II applications under the Fast-Track procedures. (See Phase I/Phase II Fast-Track Review Option below.) Note: The Phase I and Phase II award levels and project periods are statutory guidelines. Therefore, applicants are encouraged to propose a budget and project period that is appropriate for completion of the research project. Deviations from the guidelines must be well justified. 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.) The objective of Phase III, where appropriate, is for the small business concern to pursue with non-SBIR/STTR funds (either Federal or non-Federal) the commercialization objectives resulting from the results of the research or R&D funded in Phases I and II. In some Federal agencies, Phase III may involve follow-on, non-SBIR/STTR funded R&D, or production contracts for products or processes intended for use by the U.S. Government. 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. INQUIRIES Applicants are strongly encouraged to contact NIH program staff listed below prior to submitting an SBIR/STTR grant application for information regarding research topics. Eligibility requirements, definitions, application procedures, review considerations, application forms and instructions, and other pertinent information are contained in the OMNIBUS SOLICITATION of the NATIONAL INSTITUTES OF HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, and FOOD AND DRUG ADMINISTRATION for SMALL BUSINESS INNOVATION RESEARCH (SBIR) and SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) 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 2000 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 Phase I/Phase II Fast-Track Review Option (APPLICABLE TO NIH ONLY) The SBIR/STTR Fast-Track procedures described below are designed to expedite the decision and award of Phase II funding for scientifically meritorious applications for projects that have a high potential for commercialization. Fast-Track is a parallel review option available to those small business concerns (applicant organizations) whose applications satisfy additional criteria that 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 above. Fast-Track offers two major advantages: Concurrent submission and peer review of both Phase I and Phase II projects. Minimal or no funding gap between Phase I and Phase II. Fast-Track Phase II applications that are recommended for approval 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 Product Development Plan and any commitment(s) for funds and/or resources from an investor or partner organization, 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/STTR Fast-Track Application Eligibility Criteria and Process Identify the application as Fast-Track, by typing the words Fast- Track in Item 2 on the Face Page of the Phase I application. Prepare and submit both a Phase I and Phase II SBIR/STTR application together for concurrent initial peer review and evaluation. (Phase I and Phase II application forms and instructions are available electronically on the NIH"s Small Business Funding Opportunities home page found at http://grants.nih.gov/grants/funding/sbir.htm.) Specify in the Phase I application 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 scientific peer review group to exclude the Phase II application from Fast-Track review. The scientific peer review group 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 advisory council or board of the NIH awarding component that is the potential funding component. Submit a concise Product Development Plan (limited to ten pages). Label this section clearly and include it as an Appendix to the Phase II application addressing each of the following areas: 1. 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 (see Section III of this solicitation for definition of commercialization ). 2. Value of SBIR/STTR project, including lay description of key technology objectives, current competition, and advantages compared to competing products or services. 3. Commercialization plans, milestones, target dates, market analyses of market size, and estimated market share after first year sales and after five years. 4. Patent status or other protection of project intellectual property. Applicants are ENCOURAGED to seek commitment(s) of funds and/or resources from an investor or partner organization for commercialization of the product(s) or service(s) resulting from the SBIR/STTR grant. 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. National Institute on Aging http://www.nia.nih.gov/ Dr. Miriam F. Kelty Phone: 301-496-9322 Fax: 301-402-2945 Email: mk46u@nih.gov National Institute on Alcohol Abuse and Alcoholism http://www.niaaa.nih.gov Dr. Michael Eckardt Phone: 301-443-6107 Fax: 301-443-6077 Email: me25t@nih.gov National Institute of Allergy and Infectious Diseases http://www.niaid.nih.gov Mr. Vincent Thomas Phone: 301-435-8563 Fax: 301-402-0369 Email: vt5e@nih.gov National Institute of Arthritis and Musculoskeletal and Skin Diseases http://www.nih.gov/niams Dr. Steven J. Hausman Phone: 301-594-2463 Fax: 301-480-4543 Email: sh41g@nih.gov National Cancer Institute http://www.nci.nih.gov Dr. Jay George Phone: 301-496-1550 Fax: 301-496-7807 Email: jg249o@nih.gov National Institute of Child Health and Human Development http://www.nichd.nih.gov Dr. Louis A. Quatrano Phone: 301-402-2242 Fax: 301-402-0832 Email: lq2n@nih.gov National Institute on Drug Abuse http://www.nida.nih.gov Dr. Cathrine Sasek Phone: 301-443-1056 Fax: 301-443-6277 Email: csasek@nih.gov National Institute on Deafness and Other Communication Disorders http://www.nidcd.nih.gov/ Dr. Lynn E. Luethke Phone: 301-402-3458 Fax: 301-402-6251 Email: lh99s@nih.gov National Institute of Dental and Craniofacial Research http://www.nidr.nih.gov/ Dr. Joyce Reese Phone: 301-594-2088 Fax: 301-480-8318 Email: jr55r@nih.gov National Institute of Diabetes and Digestive and Kidney Diseases http://www.niddk.nih.gov Dr. Judith Podskalny Phone: 301-594-8876 Fax: 301-480-8300 Email: jp53s@nih.gov National Institute of Environmental Health Sciences http://www.niehs.nih.gov Dr. Jerrold Heindel Phone: 919-541-0781 Fax: 919-541-5064 Email: jh190f@nih.gov National Eye Institute http://www.nei.nih.gov Dr. Ralph Helmsen Phone: 301-496-5301 Fax: 301-402-0528 Email: rh27v@nih.gov National Institute of General Medical Sciences http://www.nigms.nih.gov/ Dr. Peter Preusch Phone: 301-594-1832 Fax: 301-480-2802 Email: pp27g@nih.gov National Heart, Lung, and Blood Institute http://www.nhlbi.nih.gov Dr. John T. Watson Phone: 301-435-0513 Fax: 301-480-1336 Email: jw53f@nih.gov National Human Genome Research Institute https://www.genome.gov Dr. Bettie J. Graham Phone: 301-496-7531 Fax: 301-480-2770 Email: bg30t@nih.gov National Institute of Mental Health http://www.nimh.nih.gov Dr. Michael F. Huerta Phone: 301-443-5625 Fax: 301-443-1731 Email: mh38f@nih.gov National Institute of Neurological Disorders and Stroke http://www.ninds.nih.gov Dr. Joseph S. Drage Phone: 301-496-4188 Fax: 301-402-4370 Email: jd66x@nih.gov National Institute of Nursing Research http://www.ninr.nih.gov Dr. Hilary Sigmon Phone: 301-594-5970 Fax: 301-480-8260 Email: hs38k@nih.gov National Center for Research Resources http://www.ncrr.nih.gov Dr. Louise E. Ramm Phone: 301-496-6023 Fax: 301-402-0006 Email: lr34m@nih.gov National Center for Complementary and Alternative Medicine http://nccam.nih.gov Dr. Richard Nahin Phone: 301-496-4792 Fax: 301-402-4741 Email: rn8p@nih.gov National Library of Medicine http://www.nlm.nih.gov Mr. Peter Clepper Phone: 301-496-4621 Fax: 301-402-0421 Email: pc49n@nih.gov Centers for Disease Control and Prevention (CDC) http://www.cdc.gov Ms. Nina Waters Phone: 770-488-2805 Fax: 770-488-2847 Email: jvw0@cdc.gov Food and Drug Administration (FDA) http://www.fda.gov Ms. Rosemary Springer Phone: 301-827-7182 Fax: 301-827-7106 Email: rspringe@oc.fda.gov

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