NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required) | PAR 24 066

Opportunity Information: Apply for PAR 24 066

The National Eye Institute (NEI), part of the National Institutes of Health (NIH), is offering a Small Business Innovation Research (SBIR) cooperative agreement opportunity designed to help small businesses run early-stage clinical trials that involve greater than minimal risk. This funding opportunity is titled "NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44 - Clinical Trial Required)" and it is published as PAR-24-066. The intent is to support investigator-initiated clinical studies, most often Phase I or Phase II, where the proposed work goes beyond low-risk human subjects research and therefore needs stronger oversight, tighter coordination, and more formal safety monitoring than minimal-risk studies.

A key feature of this opportunity is the use of the U44 mechanism, which is a cooperative agreement rather than a standard grant. In practical terms, a cooperative agreement typically means NEI expects to be more actively involved during the project compared with a traditional grant mechanism. The reason this matters here is the risk profile: trials with greater than minimal risk require robust performance oversight and safety monitoring structures. Applicants should expect the award to come with additional expectations around trial conduct, monitoring, and reporting, consistent with the realities of higher-risk early clinical testing.

The clinical trial must be focused on vision and eye health. Specifically, the proposed study must evaluate an intervention intended for screening, diagnosis, prevention, or treatment of vision disorders. The emphasis on "interventions" signals that NEI is looking for trials that test something actionable in a clinical setting, such as a therapeutic approach, device, diagnostic tool, preventive strategy, or similar clinical solution directly relevant to vision-related conditions. Because the NOFO is explicitly "Clinical Trial Required," applications are expected to include a clinical trial component rather than proposing only preclinical work or observational human subjects research that does not meet the NIH definition of a clinical trial.

Eligibility is limited to small business concerns, consistent with SBIR rules. Non-U.S. entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the notice indicates that "foreign components" may be allowed as defined by the NIH Grants Policy Statement, which typically refers to discrete project elements carried out outside the United States that are justified and receive prior approval. This is a narrower concept than allowing a non-U.S. organization to apply or lead the award, and applicants considering any non-U.S. activity would need to align carefully with NIH policy and the terms of the award.

NEI strongly encourages potential applicants to consult with NEI program staff before submitting an application that involves human subjects. That advice is especially important for this opportunity because the correct NIH funding mechanism depends heavily on how the study is classified (for example, whether it is truly a clinical trial and what risk level it presents). Early discussion can help applicants confirm fit with the NOFO, avoid misalignment with NIH clinical trial requirements, and clarify expectations around safety monitoring and oversight for higher-risk trials.

Administrative details from the source information include that the opportunity is categorized as discretionary funding and uses a cooperative agreement as the funding instrument, with an activity category in health and CFDA number 93.867. The original closing date listed is January 7, 2027, and the opportunity record shows a creation date of December 1, 2023. The public summary does not list an award ceiling or expected number of awards in the provided excerpt, so applicants would typically look to the full announcement or NIH guidance for budget structure, project period expectations, and any institute-specific limits or norms.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.867.
• This funding opportunity was created on 2023-12-01.
• Applicants must submit their applications by 2027-01-07.
• Eligible applicants include: Small businesses.

Apply for PAR 24 066

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