Here you will learn which criteria are evaluated for your business to be eligible for the small business programs and other considerations NIH takes into account.
Only United States small business concerns are eligible to submit applications to SBIR and STTR solicitations. Collaborating research institutions (e.g., universities) are subcontractors to the small businesses and may not apply as applicants. See the Small Business Administration's (SBA) Eligibility Guide for more detailed information.
A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the below criteria, as well as the Phase I to Phase II Transition Benchmark Rate:
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) SBIR and STTR. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of 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), an Indian tribe, Alaska Native Corporation (ANC) or Native Hawaiian Organization (NHO) (or a wholly-owned business entity of such tribe, ANC or NHO), or any combination of these; OR
(ii) SBIR-only. Be a concern that 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 unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR
(iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.
Has, including its affiliates, not more than 500 employees.
If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.
If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.
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 concerns must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.
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Additional SBIR/STTR Eligibility Considerations
This Transition Rate requirement applies to SBIR and STTR Phase I applicants that have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past 5 fiscal years, excluding the most recently completed fiscal year. For these companies, the benchmark establishes a minimum number of Phase II awards the company must have received for a given number of Phase I awards received during the 5-year time period in order to be eligible to receive a new Phase I award. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period.
Companies that apply for a Phase I award and do not meet or exceed the benchmark rate will not be eligible for a Phase I award for a period of one year from the date of the application submission. The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently completed year. The benchmark minimum Transition Rate is 0.25.
SBA calculates individual company Phase I to Phase II Transition Rates daily using SBIR and STTR award information across all federal agencies. For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.gov. Information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.
Applicants that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past 5 years should, prior to application preparation, verify that their company’s Transition Rate on the Company Registry at SBIR.gov meets or exceeds the minimum benchmark rate of 0.25.
Before April 16, 2014, NIH permitted one resubmission (A1) of an unfunded application (see NOT-OD-09-016). The extension on the NIH grant number could follow the pattern (A0, A1). A first-time submission is informally referred to as an A0, and the first resubmission is known as an A1. Any virtual A2s would be flagged by the NIH Center for Scientific Review.
For all application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate new application due date (see NOT-OD-14-074).
Resubmissions (A1) must be submitted within 37 months of the new (A0) application (see NOT-OD-10-140). For more details on the Resubmission Policy, visit the Resubmissions webpage and the Guide Notice, NOT-OD-14-074.
The research or R&D project must be performed in its entirety in the United States. Foreign institutions are not eligible to apply for SBIR/STTR awards, and foreign components of U.S. organizations are not eligible to apply.
The United States is defined as the 50 States, the territories and possessions of the United States, the Commonwealth of Puerto Rico, the Federated States of Micronesia, the Republic of Palau, the Republic of the Marshall Islands, and the District of Columbia.
In those rare instances where the study design requires the use of a foreign site (e.g., to conduct testing of specific patient populations), the investigator must provide compelling scientific justification in the application for the need/use of a foreign site. Similarly, in those rare instances where it may be necessary to purchase materials from other countries, investigators must thoroughly justify the request. NIH will consider these instances on a case-by-case basis, and they should be discussed with cognizant NIH staff before submitting an application. Approval will not be considered unless the application is being considered for an award. IC program officials have the authority to approve these waiver requests. Whether the request is approved or disapproved, it will be explicitly addressed in the Notice of Award if an award is made. Whenever possible, work outside the United States, which is necessary to the completion of the project, should be supported by funding other than SBIR/STTR.
For more information, please see the Grants Policy Statement, Section 22.214.171.124 Place of Performance.
The principal investigator (PI) is the individual who is responsible for the scientific and technical direction of the project. As long as the PI has the skills, knowledge, and resources necessary to carry out the proposed research, legally resides in the United States, and is available to perform the research proposed for the duration of the project, they can work with the small business to develop an application.
For more information about multiple PIs, please see our Company/Investigator Eligibility FAQs.