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

Most recent NIDDK funding announcement: 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, funding opportunities, news and events, and a comprehensive list of resources for grantees.

The table below details difference between compares Phase I, Phase II, and Fast-Track funding mechanisms.

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 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 $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)
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).

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. SBIR Phase II, Phase IIB, and Fast-Track applications with NIH-defined clinical trials can be submitted in response to a targeted Clinical Trials Allowed Funding Opportunity Announcement. 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.

Funding

Phase I

According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% as a hard cap ($225,000 for Phase I). However, NIH has received a waiver from SBA, as authorized by statute, to exceed the hard cap specific topics.

Phase II

According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $1,000,000 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% as a hard cap ($1,500,000 for Phase II). However, NIH has received a waiver from SBA, as authorized by statute, to exceed the hard cap specific topics. Phase II awards are for longer periods and require a commercialization plan.

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 funding opportunity announcement available from the NIH Small Business Funding Opportunities website. Alternatively find Small Business Eligibility Criteria at the NIH SBIR/STTR website.

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.

Applying

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:

More information regarding the reauthorization and upcoming changes is available at the NIH SBIR website.

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

New Applications

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!

Review

All applications are peer reviewed by knowledgeable scientists in the relevant field of research.

Staff Contact

Contact the appropriate Small Business NIDDK Program Staff.

NIH Resources