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 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 scientific program areas and a comprehensive list of resources for grantees. Additionally, find detailed budgetary and programmatic guidance in the current "Program Descriptions and Research Topics" document (PDF, 1.54 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 (PDF, 386 KB) . The topic should be indicated in the budget justification.

The NIDDK also accepts Phase IIB STTR applications from NIDDK Phase II grantees and accepts Commercialization Readiness Pilot (CRP) program applications from NIDDK Phase II and IIB grantees. 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 $275,766 total costs (DC + F&A + fee) Normally $1,838,436 total costs (DC + F&A + fee) Normally $2,114,202 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: 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 Funding Opportunity Announcement (SBIR-only, not STTR). NIDDK may participate in some targeted funding opportunity announcements 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 $275,766 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, 386 KB) . Find detailed budgetary and programmatic guidance in the current "Program Descriptions and Research Topics" document (PDF, 1.83 MB) .

Phase II

Total funding support (direct costs, indirect costs, fee) normally may not exceed $1,838,436 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, 386 KB) . Find detailed budgetary and programmatic guidance in the current "Program Descriptions and Research Topics" document (PDF, 1.83 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, 1.83 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 funding opportunity announcements 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

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

Application instructions can be found within funding opportunity announcements. 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 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). 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.

NIH Resources