NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 Clinical Trial Required) | PAR 22 149

Opportunity Information: Apply for PAR 22 149

The National Eye Institute (NEI), part of the National Institutes of Health (NIH), is offering a discretionary funding opportunity under Funding Opportunity Announcement (FOA) number PAR-22-149 titled "NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 Clinical Trial Required)." This program uses the U01 cooperative agreement mechanism to fund investigator-initiated clinical trials that are early stage in nature, most often aligning with Phase I or Phase II development. A key feature of this FOA is that it is specifically meant for studies considered greater than minimal risk, meaning the trial design and the intervention being tested require a higher level of safety planning, monitoring, and real-time oversight than low-risk human subjects research.

The scientific scope is tightly focused on vision and eye health. To fit the intent of the announcement, the proposed clinical trial must evaluate an intervention aimed at screening, diagnosing, preventing, or treating vision disorders. In practical terms, this could include testing a new diagnostic approach, validating a screening method, evaluating a preventive strategy for an eye disease, or conducting an early efficacy and safety assessment of a therapeutic intervention. The FOA is not framed as an observational study announcement; it is explicitly a "Clinical Trial Required" opportunity, so applicants are expected to propose an actual interventional clinical trial rather than a purely mechanistic, natural history, or epidemiologic project.

Because this is a cooperative agreement (rather than a standard research project grant), the relationship between the awardee and NEI is structured to be more interactive. Cooperative agreements are commonly used when an institute anticipates the need for substantial scientific or programmatic involvement during the conduct of the study. Here, that expectation is driven by the elevated risk profile of the trials being supported. Applicants should be prepared for more robust performance oversight and safety monitoring expectations, which generally translates to detailed monitoring plans, clearly defined stopping rules or safety triggers when appropriate, and governance structures that can respond quickly to safety signals or operational issues during trial execution.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations capable of conducting clinical trials. Eligible applicants listed for this opportunity include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, Indian/Native American tribal governments other than federally recognized entities, and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility is consistent with the goal of supporting capable trial teams and infrastructure wherever they are located, provided the proposed work aligns with NEI priorities and the trial can be responsibly conducted.

Administratively, the opportunity is categorized under Health, and the associated CFDA number is 93.867. The FOA was created on 2022-04-12, and the original closing date listed is 2025-05-07. The award ceiling and expected number of awards are not specified in the provided source data, which typically means applicants need to refer to the full FOA text for budget guidance, project period limits, and any institute-specific expectations around scale, milestones, or enrollment targets.

Overall, this grant opportunity is best understood as a pathway for researchers and clinical trial teams to move promising vision-related interventions into early human testing when the work involves meaningful risk and therefore needs stronger-than-usual oversight. It is geared toward studies that can justify a Phase I or Phase II interventional trial, demonstrate a serious approach to participant safety and data integrity, and align clearly with the mission of improving the screening, diagnosis, prevention, or treatment of vision disorders.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 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 2022-04-12.
• Applicants must submit their applications by 2025-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 22 149

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