The SBIR program was initiated as a means for government agencies to use small businesses to stimulate technological innovation and help agencies meet their research and development (R&D) needs. An additional provision of the SBIR program is the expected commercialization of the research. Many NIAID supported small business projects require clinical evaluation and FDA approval. To be successful, these types of projects often require longer periods for Phase I and Phase II and higher award amounts than those routinely awarded under the SBIR program. Despite the cost and the length of time required to move such products from the laboratory to the patient, these are precisely the products with potential to contribute significantly to the economy of the nation and to the improvement of public health. The intent of the NIAID-AT-SBIR is to support such R&D.
This funding opportunity announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for advanced technology projects that require a longer award period and greater award amount than those routinely allowed under the SBIR program. For this FOA, "advanced technology" is defined as a “clearly identified” product or service that requires approval of the Food and Drug Administration (FDA) and is within the mission of NIAID.
An example of a “clearly identified product” is a research project focused on a lead compound for an AIDS drug. A research project focused on developing an assay to identify lead compounds does not have a clearly identified product and would not be appropriate for this FOA.
Only applications meeting the above “advanced technology” definition should be submitted in response to this FOA.
For this FOA, well-justified budgets up to $300 thousand total costs per year and time periods up to 2 years for Phase I may be requested. Well-justified budgets up to $1 million total costs per year and time periods up to 3 years may be requested for Phase II. The number of awards made under this solicitation will depend on the overall scientific merit of the applications and the availability of funds.
Applications in response to this FOA must not contain clinical trials.