R41/R42: Small Business Technology Transfer Grant (STTR)
Most recent NIDDK funding announcements: R41/R42 and other Small Business awards
The R41/42 at NIDDK
The Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs, also known as America's SEED Fund, are a key part of NIH's mission to turn discovery into health. The statutory purpose of the SBIR program is to strengthen the role of innovative small business concerns (SBCs) in Federally-funded research or research and development (R/R&D). Specific program purposes are to: (1) stimulate technological innovation; (2) use small business to meet Federal R/R&D needs; (3) foster and encourage participation by emerging and undercapitalized SBCs in technological innovation and, (4) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth. In addition to the broad goals of the SBIR program, the statutory purpose of the STTR program is to stimulate a partnership of ideas and technologies between innovative SBCs and non-profit Research Institutions. By providing awards to SBCs for cooperative R/R&D efforts with Research Institutions, the STTR program assists the U.S. small business and research communities by supporting the commercialization of innovative technologies.
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 scientific program areas and a comprehensive list of resources for grant recipients. Additionally, find detailed budgetary and programmatic guidance in the current “Program Descriptions and Research Topics” document (PDF, 1.90 MB) . With appropriate justification from the applicant, the NIDDK may consider budgets that exceed these amounts to support research that aligns with a SBA-approved waiver eligible topic. The topic should be indicated in the budget justification.
The NIDDK also accepts Phase IIB STTR applications from NIDDK Phase II grant recipients and accepts Commercialization Readiness Pilot (CRP) program applications from NIDDK Phase II and IIB grant recipients. Please review the “Program Descriptions and Research Topics” document for additional details, including budgetary guidance.
The table below compares Phase I, Phase II, and Fast-Track application types. Note, the Direct Phase II authority does not apply to the STTR program (see NOT-OD-19-019). The NIH SBIR/STTR website also contains Frequently Asked Questions that help delineate differences between these 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 $314,363 total costs (DC + F&A + fee) | Normally $2,095,748 total costs (DC + F&A + fee) | Normally $2,410,111 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; Grant recipient 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: Small Business Concern (SBC), 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 support NIH-defined clinical trials through the SBIR Omnibus/Parent Clinical Trial Required Notice of Funding Opportunity (SBIR-only, not STTR). NIDDK may participate in some targeted notices of funding opportunities that allow clinical trials. 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.
Human Subjects Research
Potential applicants who are considering research involving human subjects are strongly encouraged to contact NIDDK Small Business Program Staff before submission. Please also visit the NIDDK Human Subjects Research page.
Funding
Phase I
Total funding support (direct costs, indirect costs, fee) normally may not exceed $314,363 for Phase I awards. Appropriate budget justification is required. With appropriate justification from the applicant, the NIDDK may consider budgets that exceed these amounts to support research that aligns with a SBA-approved waiver eligible topic (PDF, 376 KB) . Find detailed budgetary and programmatic guidance in the current “Program Descriptions and Research Topics” document (PDF, 1.90 MB) .
Phase II
Total funding support (direct costs, indirect costs, fee) normally may not exceed $2,095,748 for Phase II awards. Appropriate budget justification is required. Appropriate budget justification is required. With appropriate justification from the applicant, the NIDDK may consider budgets that exceed these amounts to support research that aligns with a SBA-approved waiver eligible topic (PDF, 376 KB) . Find detailed budgetary and programmatic guidance in the current “Program Descriptions and Research Topics” document (PDF, 1.90 MB) . Phase II awards are for longer periods and require a commercialization plan.
Phase IIB
Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR and STTR Phase II to achieve commercialization. NIDDK allows small businesses who have been awarded a NIDDK Phase II SBIR or STTR to submit a Phase IIB (second, sequential Phase II) SBIR or STTR application that will provide additional funding for Phase II SBIR or STTR projects. These renewals are typically offered for those projects that require extraordinary time and effort, including those requiring regulatory approval or developing complex instrumentation, clinical research tools, and behavioral interventions. Commercial potential (i.e. the probability that an application will result in a commercial product) will be strongly considered in review and making funding decisions. An applicant's ability to secure substantial independent third-party investor funds will help validate the commercial potential of the proposed Phase IIB project. Applicants are encouraged to secure substantial independent third-part investor funds (i.e., third-party funds that equal or exceed the requested NIH funds). Find detailed budgetary and programmatic guidance in the current “Program Descriptions and Research Topics” document (PDF, 1.90 MB) .
Commercialization Readiness Pilot (CRP) Program
The Commercialization Readiness Pilot (CRP) program aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R&D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)/Investigational Device Exemption (IDE) enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R&D throughout the award. Please see current CRP notices of funding opportunities for NIDDK-specific budget guidance. NIDDK does not support clinical trials through the CRP program. The CRP program uses the SB1 grant mechanism.
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
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for 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
Application instructions can be found within notices of funding opportunities. The NIH SEED website also contains a number of useful resources related to applying.
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.
Deadlines
Many SBIR & STTR funding opportunities use standard due dates, but check the notice of funding opportunity 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). 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.
Staff Contact
Contact the appropriate NIDDK Small Business Program Staff.