Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://sba.gov/size.

Small business concerns (SBCs)
SBCs that are majority-owned by multiple venture capital operating companies (VCOCs), hedge funds or private equity firms are NOW eligible to apply to the NIH SBIR program at this time for any NIH SBIR funding opportunity announcement (FOA) issued after January 28, 2013.

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 CDC, FDA, and ACF SBIR program and to the NIH STTR program.

FOR SBIR FOAs issued prior to January 28, 2013:

Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, on the date of award for both Phase I and Phase II funding agreements:

1. 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;

2. 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 can be no more than 49 percent participation by foreign business entities in the joint venture;

3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and

4. Has, including its affiliates, not more than 500 employees.

FOR SBIR FOAs issued after January 28, 2013:

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

1. 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;

2. 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;

3. (i) 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), or any combination of these; OR
(ii) NIH only. Be a concern which 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; OR
(iii) 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.

4. Has, including its affiliates, not more than 500 employees.
NIH only. 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 in the SBIR FOA for additional instructions regarding required application certification.

Applicants are strongly encouraged to contact NIH/CDC/FDA staff with their questions before submitting an application.

Unless the Funding Opportunity Announcement (FOA) states otherwise, only Phase I awardees are eligible to apply for and obtain Phase II funding. Awardees identified via a “successor-in-interest” or “novated” or similarly-revised funding agreement, or those that have reorganized with the same key staff, regardless of whether they have been assigned a different tax identification number, are eligible to apply for Phase II funding. Agencies may require the original awardee to relinquish its rights and interests in an SBIR/STTR project in favor of another applicant as a condition for that applicant’s eligibility to participate in the SBIR/STTR program for that project.

You may submit a Phase II application either before or after expiration of the Phase I budget period, unless you elect to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I grantee organization should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period.

The competition for SBIR/STTR Phase I and Phase II awards satisfies any competition requirement of the Armed Services Procurement Act, the Federal Property and Administrative Services Act, and the Competition in Contracting Act. Therefore, an agency that wishes to fund an SBIR/STTR Phase III project is not required to conduct another competition in order to satisfy those statutory provisions. As a result, in conducting actions relative to a Phase III SBIR/STTR award, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is an SBIR/STTR Phase III award that is derived from, extends, or logically concludes efforts performed under prior SBIR/STTR funding agreements and is authorized under 10 U.S.C. 2304(b)(2) or 41 U.S.C. 253(b)(2).

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