- Introduction to the NHLBI Small Business Programs
- What are the SBIR and STTR programs?
- Structure: Three-Phase Program
- Funding and Resources
Introduction to the NHLBI Small Business Programs
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are one of the largest sources of early-stage capital for U.S. small business, acting as engines of innovation for developing and commercializing novel technologies and products to promote the prevention, diagnosis, and treatment of heart, lung, blood, and sleep diseases and disorders. The NHLBI provides grant and contract funding opportunities and resources to support small businesses performing research and development on technologies related to the mission of NHLBI.
The links on the left will assist you in finding funding opportunities, resources, and help related to the NHLBI SBIR/STTR program.
What are the SBIR and STTR Programs?
The SBIR and STTR programs were created by Congress to strengthen the role of small, innovative companies in federally-supported research and development. These are highly competitive awards-based programs that support scientific excellence and technological innovation across eleven federal agencies.
Federal agencies with extramural research budgets over $100 million are required to set aside a certain percentage of their budget to SBIR, and those with research budgets over $1 billion are required to set aside a certain portion for STTR. For fiscal year 2014, the set-aside for SBIR is 2.8% and STTR is 0.4%. This set-aside will be increasing each year through 2017 as a result of the SBIR/STTR Reauthorization Act of 2011.
The goals of the SBIR program are to:
- Stimulate technological innovation;
- Increase private-sector commercialization of innovations derived from federal research and development funding;
- Foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons;
- Meet federal research and development needs.
Though similar in overall objectives and structure, the STTR program aims to facilitate cooperative R&D between small business concerns and U.S. non-profit research institutions by requiring the small business applicant to formally collaborate with a research institution.
There are two primary distinctions between the SBIR and STTR programs regarding the Program Director (PD)/Principal Investigator (PI) and non-profit research partner:
- For the SBIR program, the PD/PI must be primarily employed (greater than half time) with the small business concern at the time of award and for the duration of the project period.
- For the STTR program, the PD/PI may be primarily employed either by the small business concern or the collaborating non-profit research institution.
- The SBIR program allows and encourages research partnerships. However, the small business typically performs a minimum of 67% of the work supported by the award in Phase I, and a minimum of 50% of the work supported by a Phase II award
- Under the STTR program, the small business must perform at least 40% of the work and the research institution must perform at least 30% of the work. The remaining 30% may be done by either the small business concern, the non-profit research institution partner, or an additional third party.
Structure: Three-Phase Program
Both the SBIR and STTR programs are divided into three phases. NIH has a Fast-Track application option that allows small businesses to submit one application for Phase I and Phase II, and has a pilot Direct to Phase II SBIR solicitation which permits small businesses to receive a Phase II award even if they have not previously received a Phase I award for the research/research and development of their technology.
Phase I: Feasibility and Proof of Concept
The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R&D efforts and to determine the quality of performance of the small business awardee organization prior to providing further federal support in Phase II. Phase I awards typically do not exceed $225,000 total costs for 6 months (SBIR) or 1 year (STTR).
Phase II: Research and Development
The objective of Phase II is to continue the R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II. SBIR/STTR Phase II awards typically do not exceed $1,500,000 total costs for 2 years.
Phase IIB: Additional Research and Development Support
To facilitate and accelerate the capital-intensive steps required to transition SBIR/STTR Phase II projects to the commercialization stage, NHLBI created two Phase IIB funding opportunities that promote partnerships between Phase II awardees and third-party investors and/or strategic partners. Intended for projects that require FDA approval or clearance, these awards provide up to $3 million over three years, with the expectation of third-party investment.
NHLBI SBIR Phase IIB Bridge Awards – learn more
NHLBI SBIR Phase IIB Small Market Awards – learn more
Phase III: Commercialization
The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase I/II R/R&D activities. The NIH SBIR/STTR programs do not fund Phase III.
Small Business Innovation Research (SBIR)
Only United States small business concerns (SBCs) are eligible to participate in the SBIR program. To be eligible, a small business must meet all of the criteria described in the current funding opportunity announcement at the time of Phase I and II awards, including:
- Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
- Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;
- (i) Is more than 50% directly owned and controlled by one or more individuals (who are citizens of or permanent resident aliens in the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these;
- (ii) For NIH SBIR only: Is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern;
- (iii) Be a joint venture in which each entity to the joint venture meets the requirements above. Has, including its affiliates, no more than 500 employees. For additional guidance on eligibility, see the Small Business Administration Guide to SBIR/STTR Program Eligibility.
Definitions (NIH Only):
Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
Private equity firm has the meaning given the term "private equity fund" in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
Venture capital operating company means an entity described in § 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
Small Business Technology Transfer (STTR)
The Small Business Technology Transfer (STTR) Program is similar in structure to SBIR but funds cooperative research and development projects involving a small business and a research institution (i.e., non-profit college or university, federally funded research and development center (FFRDC), or domestic nonprofit research organization). The purpose of the STTR program is to create an effective vehicle for moving ideas from our nation's research institutions to the commercial market.
To participate in the STTR Program, the small business must meet all the criteria specified in the current funding opportunity announcement at the time of Phase I and II awards, including:
- Is organized for profit, with a place of business located in the U.S. and no more than 500 employees; there is no size limit on the research institution, but it must also be located in the U.S.;
- Is more than 50% U.S.-owned and independently operated;
- In addition, the small business must be engaged in a formal cooperative research and development effort with the research institution.
The effort must be managed by the small business, with a minimum of 40% of the work done by the small business and a minimum of 30% of the work done by the research institution.
The research institution must be a U.S. nonprofit college or university, domestic nonprofit research organization, or federally-funded research and development center (FFRDC).
The principal investigator may be principally employed at either the small business or the research institution.
Funding & Resources
Use the links on the left or below to navigate to more information about the funding opportunities and resources available through the NHLBI Small Business program.
SBIR and STTR Grant Funding Opportunities
NHLBI accepts investigator-initiated applications through the Omnibus solicitations -
Targeted NHLBI funding opportunities -
SBIR Contract Funding Opportunities NHLBI participates in the annual NIH and CDC SBIR Contract solicitation - http://www.nhlbi.nih.gov/research/funding/sbir/funding-opportunities/contract-topics-FY2015/
The NIH offers a number of resources beyond funding to support small businesses, including in-kind research services, expert advisory personnel, and more. http://www.nhlbi.nih.gov/research/funding/sbir/resources
Last Updated June 2016