R43/R44: Small Business Innovation Research Grant (SBIR) - NIDDK

R43/R44: Small Business Innovation Research Grant (SBIR) - NIDDK is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The NIDDK participates in the SBIR program to support innovative research conducted by small businesses with commercialization potential, particularly in areas like digestive diseases, nutritional disorders, and obesity.

R43/R44: Small Business Innovation Research Grant (SBIR) - NIDDK R43/R44: Small Business Innovation Research Grant (SBIR) Most recent NIDDK funding announcements: R43/R44 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.

The objective of Phase I (R43) is to establish the technical merit and feasibility of the proposed R/R&D efforts and to determine the quality of performance of the small business awardee organization prior to providing further federal support in Phase II (R44). Please visit our NIDDK SBIR-STTR Programs website for detailed information on programmatic divisions 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 SBIR 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, Direct 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, including the Direct Phase II authority.

To support high-risk feasibility projects To support continued research & development See Phase I and Phase II; allows concurrent review of both; shortens review to award process for Phase II Small, for-profit organizations (67% minimum effort by SBC) Small, for-profit organizations (50% minimum effort by SBC) Small, for-profit organizations (minimum effort dependent on phase; See Phase I and Phase II) PI employed (51% or greater) with small business concern PI employed (51% or greater) with small business concern PI employed (51% or greater) with small business concern 6 Mo.

to 1 Yr. Phase I; 2-3 Yr.

Phase II; Combination not to exceed four years Normally up to $314,363 total costs (DC + F&A + fee) Normally up to $2,095,748 total costs (DC + F&A + fee) Normally up to $2,410,111 total costs (Phase I + Phase II; DC + F&A + fee) Facilities and Administrative Costs 40% maximum if no current negotiated rate; NIH will not negotiate for Phase I 40% or current negotiated rate; Grant recipient may negotiate with NIH See Phase I/Phase II - same for Fast-track 7% maximum for grantee organization only 7% maximum for grantee organization only 7% maximum for grantee organization only Research Experience Required and/or Eligible Degree 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).

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 . 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) . Total funding support (direct costs, indirect costs, fee) normally may not exceed $2,095,448 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. 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 Institutions/Organizations 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. 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.

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 ). 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 . Small Business Programs at the NIH SBIR/STTR Form Registration Page Last Reviewed November 2024