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Small Business Innovation Research (SBIR) Program (R43/44)

NIGMS has set aside funds for a Small Business Innovation Research Program. Grant applications are accepted in the scientific areas for which the Institute provides support. Under this program, awards are intended to:

  • Stimulate technological innovation.
  • Use small business to meet federal research and development needs.
  • Increase private sector commercialization of innovations derived from federal research and development.
  • Foster and encourage participation by socially and economically disadvantaged small business and women-owned business concerns in technological innovation.

Potential SBIR applicants often assume that, like some other federal agencies, NIGMS will be an end user of the tools, devices, products or services being created under the grant or will play an active role in their ongoing development toward eventual commercialization. As a result, potential applicants may ask questions like:

  • How can I ensure that my project offers what NIGMS needs?
  • Can NIGMS provide technical and/or regulatory assistance to help my project obtain FDA approval?
  • What clinical trial/technology development expertise does NIGMS have that I may access?

These assumptions are not correct. Like the vast majority of NIGMS-funded research, its SBIR program is investigator-initiated. Applicants propose what to do, how to do it and the best path toward commercialization. Although NIGMS may occasionally issue or participate in SBIR funding opportunity announcements targeted to stimulate activity in a specific area, these are still independent projects because the Institute does not prescribe what the activity should be or how it should be pursued.

The goal of NIGMS is to support innovative SBIR projects that could benefit the broader research and development communities and/or directly impact human health.

The SBIR program consists of three phases:

Phase I (R43) establishes the scientific and technical merit and feasibility as well as the potential for commercialization of the proposed research.

The Phase II grant (R44) continues research or research and development (R&D) efforts initiated in Phase I. At this time, only Phase I awardees are eligible to apply for Phase II funding. NIGMS also allows a limited number of Phase IIB competing renewal grant applications meant to continue the process of developing products that ultimately require clinical evaluation, approval by a federal regulatory agency and continuing refinements to durable medical equipment designs such as cost reduction, testing for safety and durability, and meeting or establishing standards.

Phase III, where appropriate, is for the small business to pursue with non-SBIR funds the commercialization of the results of the research or R&D funded in Phase I and Phase II.

According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50 percent ($225,000 for Phase I and $1,500,000 for Phase II, a hard cap). NIGMS will not accept applications with budget requests exceeding this hard cap with the exception of projects fitting within the list of SBA-approved topics for awards over the statutory budget limitations; the entire list for NIH (including NIGMS) may be found in Appendix A of the PHS 2015-2 SBIR/STTR Program Descriptions and Topics [PDF, 1.6MB]. If considering a project with a budget exceeding the hard cap, applicants are strongly encouraged to contact NIGMS program officials prior to submission, and preferably earlier during application preparation. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.

Grant solicitation announcements and additional information are available on the NIH Small Business Funding Opportunities Web site. For information about NIGMS SBIR programs, e-mail Dr. Scott Somers or call 301-594-3827.

List of NIGMS funding announcements (program announcements, requests for applications and notices) for the SBIR and STTR Programs.

This page last reviewed on May 11, 2016