R43/R44: Small Business Innovation Research Grant (SBIR)
Most recent NIDDK funding announcements: R43/R44 and other Small Business awards
The R43/R44 at NIDDK
The Small Business Innovation Research Awards (SBIR) (R43/R44) program exists to stimulate technological innovation, strengthen the role of small businesses in meeting Federal Research/Research & Development (R/R&D) needs, increase private-sector commercialization of innovations developed through SBIR R&D, and increase small business participation in R/R&D.
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 grantees. 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 (PDF, 376 KB) . The topic should be indicated in the budget justification.
The NIDDK also accepts Phase IIB SBIR 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, 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.
| NIH Guidance | Phase I (1 R43) | Phase II (2 R44) Direct Phase II (1 R44) |
Fast-Track (1 R44) |
|---|---|---|---|
| Purpose of Grant | 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 |
| Institution Eligibility | 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 Criteria | 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 |
| 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 four years |
| Amount of Support | 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) |
| Third Party Costs | Up to 33% of total costs | Up to 50% 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% or current negotiated rate; Grantee may negotiate with NIH | See Phase I/Phase II - same for Fast-track |
| Fixed Fee | 7% maximum for grantee organization only | 7% maximum for grantee organization only | 7% maximum for grantee organization only |
| Application Used | SF424 (R&R) | SF424 (R&R) | SF424 (R&R) |
| 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 $2,095,448 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.
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 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
Only United States small business concerns (SBCs) are eligible to submit SBIR applications. An SBC is one that, on the date of award for both Phase I and Phase II funding agreements, meets all the criteria as described in the current SBIR or STTR Parent notices of funding opportunities. Alternatively find Small Business Eligibility Criteria at the NIH SEED website.
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. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH 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.
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 September 2015, new standard due dates will be in effect:
- September 5
- January 5
- April 5
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!
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.