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

Quick Facts

Grant Title
R43/R44 Small Business Innovation Research Grant (SBIR)

Application Deadlines

  • September 5
  • January 5
  • April 5

The Small Business Innovation Research Awards (SBIR) (R43/R44) program exists to stimulate technological innovation, strengthen the role of small businesses in meeting Federal 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, funding opportunities, news and events, program statistics, and a comprehensive list of resources for grantees.

All applications are peer reviewed by knowledgeable scientists in the relevant field of research. The table below details difference between compares Phase I, Phase II, and Fast-Track funding mechanisms.

Clinical Trials

Potential applicants who are considering research involving human subjects are strongly encouraged to contact NIDDK program staff before submission. The NIDDK will not support clinical trials submitted through the Omnibus SBIR and STTR solicitations (see https://grants.nih.gov/grants/guide/notice-files/NOT-DK-16-030.html). SBIR Phase II, Phase IIB, and Fast-Track applications with NIH-defined clinical trials (see http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials) can be submitted in response to PAR-17-034. Clinical studies and research in which biospecimens are obtained from patients prospectively (e.g., for biomarker development) may meet the NIH definition of a clinical trial.

NIH Guidance Phase I (1 R43) Phase II (2 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
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 $150,000 total costs (DC + F&A + fee)* Normally up to $1,000,000 total costs (DC + F&A + fee)* Normally up to $1,150,000 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)
Concurrent Awards and No No Yes
Just-in-Time Yes Yes Yes
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: Direct Costs (DC), Facilities & Administrative/Indirect Costs (F&A).

Additional Details

Eligible 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 of the criteria as described in the current SBIR or STTR parent funding opportunity announcement available from the NIH Small Business Funding Opportunities website. Alternatively find Small Business Eligibility Criteria at the NIH SBIR/STTR website. 

Eligible 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. 

Budget and Application Details

*The Phase I budget hard cap is $225,000 (total costs); applications with budgets over this amount will normally not be considered.  Phase II awards are for longer periods, permit greater costs, and require a commercialization plan. The Phase II budget hard cap is $1,500,000 (total costs); applications with budgets over this amount will normally not be considered. 

The NIH has been implementing key changes to the SBIR/STTR programs in response to the SBIR/STTR Reauthorization Act of 2011. Key changes affect: award-size hard caps, registration requirements prior to submission, commercialization standards, and company certification on fraud, waste and abuse. More information regarding the reauthorization and upcoming changes is available at the NIH SBIR website.

Deadlines for Application and Policies

Many SBIR & STTR funding opportunities use standard due dates, but check the funding opportunity announcement 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. The policy will not be applied retroactively; for prior policies see NOT-OD-11-035 and NOT-OD-10-123. Submit early to ensure receipt by NIH, as staff CANNOT amend the NIH rules!

There have also 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.

Find R43/R44 and other Small Business funding opportunities at our Current Funding Opportunities page.

For more information about SBIR & STTR programs at NIDDK, visit our Small Business Programs website.

NIH Resources