NIBIB Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required) | PA 18 631

Opportunity Information: Apply for PA 18 631

The NIBIB Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required) funding opportunity (PA-18-631) is an NIH Small Business Innovation Research (SBIR) grant mechanism designed specifically to help eligible small business concerns move biomedical imaging and bioengineering technologies into early human testing. The core idea is to give small companies a clear pathway to run investigator-initiated exploratory clinical trials that generate practical, early clinical evidence needed to guide continued technology development, de-risk the product, and inform next-stage investment or follow-on research. Projects must align with the mission and programmatic interests of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), which generally centers on innovative devices, imaging tools, diagnostics, and enabling bioengineering technologies that can improve health care and biomedical research.

A key requirement of this FOA is that the application must propose at least one clinical trial. This is not a “clinical trial optional” announcement; the clinical trial is built into the purpose of the award. At the same time, NIBIB’s scope here is intentionally limited to early-stage human studies. Supported trials are those typically considered Phase I or similarly early in development, including first-in-human studies, safety-focused studies, feasibility studies, and other small clinical trials that help refine the technology, evaluate whether it can be used as intended in real clinical settings, and gather initial human data that informs design decisions. The emphasis is on learning and iteration: establishing that the technology can be deployed, measuring usability and performance characteristics, confirming safety signals, and identifying operational or engineering changes needed before larger studies.

What this FOA does not support is just as important. NIBIB explicitly excludes later-stage trials such as Phase II, Phase III, Phase IV, and pivotal clinical trials. In addition, trials where the primary endpoint is efficacy or effectiveness are not considered responsive to this announcement, nor are post-market studies where the primary focus is addressing post-approval or post-market concerns. In practical terms, applicants should frame their proposed clinical trial around early validation and de-risking of the technology rather than making a definitive claim that the intervention works better than standard of care. The work should be positioned as exploratory and developmental, aimed at generating the kind of early clinical evidence that supports subsequent, more definitive clinical testing or regulatory planning.

Eligibility is limited to small businesses, consistent with SBIR requirements, and the opportunity is categorized as a discretionary grant within NIH’s health funding portfolio (CFDA 93.286). Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply under this FOA. However, “foreign components” may be allowable in some cases as defined by the NIH Grants Policy Statement, which typically means limited, justified portions of the project can be performed outside the U.S. if they are clearly necessary and appropriately documented, but the applicant organization itself must be an eligible U.S. small business.

Administratively, the sponsoring agency is the National Institutes of Health, with NIBIB as the participating institute. The opportunity was created on 2018-02-05 and listed an original closing date of 2021-01-05 in the provided record. The listing does not specify an award ceiling or expected number of awards in the excerpt, so applicants would need to consult the full FOA and NIH SBIR budget guidance for current budget limits, allowable costs, and submission details. Overall, this announcement is best suited for small businesses that already have a promising imaging or bioengineering technology with sufficient preclinical development to justify early human testing, and that can propose a well-controlled, early-stage clinical study designed to answer focused questions about safety, feasibility, and real-world use.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIBIB Exploratory Clinical Trials for Small Business (R44 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286.
• This funding opportunity was created on 2018-02-05.
• Applicants must submit their applications by 2021-01-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PA 18 631

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