R41/R42: Small Business Technology Transfer Grant (STTR)

The Small Business Technology Transfer (STTR) (R41/R42) program supports innovative research conducted by small businesses that has the potential for commercialization. In order to receive an STTR grant, the small business concern (SBC) must have a formal collaborative relationship with a research partner at a university or other nonprofit research institutions. At least 40 percent of the STTR research project is to be conducted by the SBC, and at least 30 percent of the work is to be conducted by the single "partnering" research institution. The objective of Phase I (R41) is to establish the technical merit and feasibility of the proposed Research/Research & Development efforts and to determine the quality of performance of the small business awardee prior to providing further Federal support in Phase II (R42). 

Please visit our NIDDK SBIR-STTR Programs website for detailed information on programmatic divisions, funding opportunities, news and events, program statistics, and a comprehensive list of resources for grantees.

All applications are peer reviewed by knowledgeable scientists in the relevant field of research. The table below details difference between compares Phase I, Phase II, and Fast-Track funding mechanisms.

Clinical Trials

Potential applicants who are considering research involving human subjects are strongly encouraged to contact NIDDK program staff before submission. The NIDDK will not support clinical trials submitted through the Omnibus SBIR and STTR solicitations (see https://grants.nih.gov/grants/guide/notice-files/NOT-DK-16-030.html). SBIR (not STTR) Phase II, Phase IIB, and Fast-Track applications with NIH-defined clinical trials (see http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials) can be submitted in response to PAR-17-034. Clinical studies and research in which biospecimens are obtained from patients prospectively (e.g., for biomarker development) may meet the NIH definition of a clinical trial.

NIH Guidance	PHASE I (1 R41)	PHASE II (2 R42)	FAST-TRACK (1 R42)
PURPOSE OF GRANT	To support high-risk feasibility projects with a research institution partnership	To support continued research & development with a research institution partnership	See Phase I and Phase II; allows concurrent review for both applications; shortens review to award process for Phase II
INSTITUTION ELIGIBILITY	Small, for-profit organizations (40% minimum effort) plus research institution partner (30% minimum effort)	Small, for-profit organizations (40% minimum effort) plus research institution partner (30% minimum effort)	Dependent on phase (See Phase I and Phase II)
EFFORT REQUIRED	10% minimum effort for PD/PI	10% minimum effort for PD/PI	10% minimum effort for PD/PI
PERIOD OF SUPPORT	6 Months to 1 Year	2 to 3 Years	6 mo. to 1 yr. Phase I; 2-3 yr. Phase II; Combination not to exceed 4 years.
AMOUNT OF SUPPORT	Normally up to $150,000 total costs (DC + F&A + fee)*	Normally $1,000,000 total costs (DC + F&A + fee)*	Normally $1,150,000 total costs (Phase I + Phase II; DC + F&A + fee)*
THIRD PARTY COSTS	30-60% of total costs	30-60% of total costs	See Phase I and Phase II – same for Fast-Track
FACILITIES AND ADMINISTRATIVE COSTS	40% maximum if no current negotiated rate; NIH will not negotiate for Phase I	40% maximum or current negotiated rate; Grantee may negotiate with NIH	See Phase I and Phase II – same for Fast-Track
FIXED FEE	7% maximum for grantee organization only	7% maximum for grantee organization only	See Phase I/Phase II – same for Fast-track
APPLICATION USED	SF424 (R&R)	SF424 (R&R)	SF424 (R&R)
CONCURRENT APPLICATION & AWARDS	No	No	No
JUST-IN-TIME	Additional Costs	Additional Costs	Additional Costs
RESEARCH EXPERIENCE REQUIRED AND/OR ELIGIBLE DEGREE	No	No	No
SALARY RANGE	NIH Salary Cap	NIH Salary Cap	NIH Salary Cap
TRANSFER	Yes, to other eligible for-profit small business	Yes, to other eligible for-profit small business	Yes, to other eligible for-profit small business

 Abbreviations used: Direct Costs (DC), Facilities & Administrative/Indirect Costs (F&A).

How to Apply

Eligible Institutions/Organizations:

Only United States small business concerns (SBCs) are eligible to submit STTR applications.  An SBC is one that, on the date of award for both Phase I and Phase II funding agreements, meets all of the criteria as described in the current SBIR or STTR parent funding opportunity announcement available from the NIH Small Business Funding Opportunities website. Alternatively find Small Business Eligibility Criteria at the NIH SBIR/STTR website.

Eligible Project Directors/Principal Investigators:

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their SBC to develop an application for support.  Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for SBIR support.  On an SBIR application, the PD/PI must have his/her primary employment (51% or greater) with the SBC at the time of award and for the duration of the project.  Under the STTR Program, primary employment is not stipulated; on an STTR application, the PD/PI may be employed with the SBC or the participating nonprofit research institution as long as he/she has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual.

*The Phase I budget hard cap is $225,000; applications with budgets over this amount will normally not be considered.  Phase II awards are for longer periods, permit greater costs, and require a commercialization plan. The Phase II budget hard cap is $1,500,000; applications with budgets over this amount will normally not be considered. 

The NIH has been implementing key changes to the SBIR/STTR programs in response to the SBIR/STTR Reauthorization Act of 2011. Key changes affect: award-size hard caps, registration requirements prior to submission, commercialization standards, and company certification on fraud, waste and abuse.  More information regarding the reauthorization and upcoming changes is available at NIH SBIR website.

Deadlines for Application and Policies

Many SBIR & STTR funding opportunities use standard due dates, but check the funding opportunity announcement to confirm. Beginning 2015, new due dates are in effect:

• September 5
• January 5
• April 5

Effective for applications submitted for due dates on or after January 25, 2015, NIH has simplified the NIH policy for late application submission. See NOT-OD-15-039. The policy will not be applied retroactively; for prior policies see NOT-OD-11-035 and NOT-OD-10-123. Submit early to ensure receipt by NIH, as staff CANNOT amend the NIH rules!

There have also been updates to application instructions and review language intended to enhance reproducibility through rigor and transparency. Please visit the Rigor and Reproducibility page for goals, guidance, resources, news, and references.

Find R41/R42 and other Small Business funding opportunities at our Current Funding Opportunities page.

For more information about SBIR & STTR programs at NIDDK, visit our Small Business Programs website.