Small for-profit businesses located in the United States with no more than 500 employees, as well as people working at these small businesses, are eligible to apply for the NIAID Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) program. See below for more in-depth eligibility criteria.
Note: The SBIR/STTR Reauthorization Act of 2011 may affect future eligibility requirements. Potential applicants should review the NIH Grants and Funding page to confirm the latest changes.
Excerpted from the SBIR and STTR Parent Program Announcements.
Only U.S. small business concerns (SBCs) are eligible to submit applications for these opportunities. An SBC must meet all of the following criteria:
NIH only. If the business is more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these, it 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 business, each stock trustee and plan member is considered an owner.
If a trust owns all or part of the business, each trustee and trust beneficiary is considered an owner.
SBCs 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 SF 424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
SBCs that are more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the Food and Drug Administration and Administration for Children and Families SBIR and NIH STTR programs.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed before the application is submitted. Registration can take six weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
All program directors/principal investigators must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with that of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least six weeks before the deadline.
Eligible Individuals (Program Director/Principal Investigator)
Anyone with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his or her organization to develop an application for support. People from underrepresented racial and ethnic groups as well as those with disabilities are always encouraged to apply for NIH support.
Under the SBIR program Phases I and II, the Program director (PD) or Principal investigator (PI) must be primarily employed with the small business concern at the time of award and during the proposed project. For projects with multiple PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
For the STTR program, the PD(s)/PI(s) may be employed with the SBC or the single, “partnering” non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. Each PD/PI must commit a minimum of 10 percent effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration.
The SF 424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For organizations proposing multiple PDs/PIs, see the multiple principal investigators section of the guide.
These funding opportunity announcements don't require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunities, including the SBIR and STTR Parent announcements.
NIH will not accept any application that is essentially the same as one already reviewed within the past 37 months (as described in the NIH Grants Policy Statement), except for submission:
A Phase I awardee may submit a Phase II application either before or after the Phase I budget period expires, unless the awardee elects 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 awardee should submit a Phase II application within the first six due dates after the Phase I budget period expires.
Normally in Phase I of an SBIR award, the small business concern must carry out a minimum of 67 percent of the research or analytical effort. The total amount of all consultant and contractual arrangements to third parties generally may not exceed 33 percent of the total amount requested.
Normally in Phase II of an SBIR award, the small business concern must carry out a minimum of 50 percent of the research or analytical effort. The total amount of consultant and contractual arrangements to third parties may not exceed 50 percent of the total Phase II amount requested.
In Phase I and Phase II of an STTR award, the small business concern must carry out at least 40 percent of the research or analytical effort while the single, “partnering” research institution must perform at least 30 percent. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and facilities and administrative (F&A) costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS 398 Research Plan component of the SF 424 (R&R) application forms.
A small business concern may subcontract a portion of its SBIR or STTR award to a federal laboratory within the limits above. A federal laboratory, as defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a federal agency and funded by the federal government, whether operated by the government or by a contractor.
The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS 398 Research Plan component of SF 424 (R&R) application forms.
Additional details are contained in the SF 424 (R&R) SBIR/STTR Application Guide.
Last Updated June 06, 2016
Last Reviewed February 04, 2015