R41/R42: Small Business Technology Transfer Grant (STTR)
Most recent NIDDK funding announcement: R41/R42 and other Small Business awards
The R41/42 at NIDDK
The Small Business Technology Transfer (STTR) (R41/R42) program supports innovative research conducted by small businesses that has the potential for commercialization.
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, and a comprehensive list of resources for grantees.
The table below details difference between Phase I, Phase II, and Fast-Track mechanisms.
| 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) | 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 |
| 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 |
| FIXED FEE | 7% maximum for grantee organization only | 7% maximum for grantee organization only | See Phase I and Phase II |
| 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).
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. SBIR Phase II, Phase IIB, and Fast-Track applications with NIH-defined clinical trials can be submitted in response to a targeted Clinical Trials Allowed Funding Opportunity Announcement. It is critical that applicants correctly identify whether their application contains a clinical trial before applying as application forms and funding opportunities will be different than for those without a clinical trial.
Funding
Phase I
According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% as a hard cap ($225,000 for Phase I). However, NIH has received a waiver from SBA, as authorized by statute, to exceed the hard cap specific topics.
Phase II
According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $1,000,000 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% as a hard cap ($1,500,000 for Phase II). However, NIH has received a waiver from SBA, as authorized by statute, to exceed the hard cap specific topics. Phase II awards are for longer periods and require a commercialization plan.
Eligibility
Institutions/Organizations
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 to be conducted by the SBC, and at least 30 percent of the work to be conducted by the single "partnering" research institution.
Additionally, only United States 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 the criteria as described on the NIH SBIR/STTR Small Business Eligibility Criteria page.
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. The PD/PI may be employed with the SBC or the participating nonprofit research institution if 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.
Applying
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
- company certification on fraud, waste and abuse
More information regarding the reauthorization and upcoming changes is available at NIH SBIR website.
There have 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.
Human Subjects Research
Potential applicants who are considering research involving human subjects are strongly encouraged to contact NIDDK program staff before submission.
Deadlines
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
NIH has simplified the policy for late application submission (see NOT-OD-15-039). The policy will not be applied retroactively; for policies prior to 2015, see NOT-OD-11-035 and NOT-OD-10-123. Submit early to ensure receipt by NIH, as staff cannot amend the NIH rules!
Review
All applications are peer reviewed by knowledgeable scientists in the relevant field of research.