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

R41/R42: Small Business Technology Transfer Grant (STTR) is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Supports innovative research in medical devices and technologies related to NIDDK's mission.

Most recent NIDDK funding announcements: R41/R42 and other Small Business awards 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_NIH external link_ 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_NIH external link_(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_NIH external link_). The NIH SBIR/STTR website also contains Frequently Asked Questions_NIH external link_ that help delineate differences between these mechanisms.

| 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 | Abbreviations used: Small Business Concern (SBC), Direct Costs (DC), Facilities & Administrative/Indirect Costs (F&A).

### Human Subjects Research Potential applicants who are considering research involving human subjects are strongly encouraged to contact NIDDK Small Business Program Staff_NIH external link_ before submission. Please also visit the NIDDK Human Subjects Research page. 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_NIH external link_(PDF, 376 KB). Find detailed budgetary and programmatic guidance in the current “Program Descriptions and Research Topics” document_NIH external link_(PDF, 1.

90 MB). 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_NIH external link_(PDF, 376 KB). Find detailed budgetary and programmatic guidance in the current “Program Descriptions and Research Topics” document_NIH external link_(PDF, 1.

90 MB). Phase II awards are for longer periods and require a commercialization plan. 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_NIH external link_(PDF, 1. 90 MB).

### Commercialization Readiness Pilot (CRP) Program ### 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_NIH external link_ 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. 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_NIH external link_ for goals, guidance, resources, news, and references. NIH has simplified the policy for late application submission (see NOT-OD-15-039_NIH external link_). Submit early to ensure receipt by NIH, as staff **cannot** amend the NIH rules!

All applications are peer reviewed by knowledgeable scientists in the relevant field of research. Contact the appropriate NIDDK Small Business Program Staff_NIH external link_.