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.Apply for PAR 22 149
- 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.
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Frequently Asked Questions (FAQs)
What is the name and FOA number of this grant opportunity?
This funding opportunity is titled "NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 Clinical Trial Required)" and the Funding Opportunity Announcement (FOA) number is PAR-22-149.
Which NIH institute is offering this opportunity?
The opportunity is offered by the National Eye Institute (NEI), which is part of the National Institutes of Health (NIH).
What funding mechanism is used (and what does it mean)?
This FOA uses the U01 cooperative agreement mechanism. A cooperative agreement is more interactive than a standard research project grant, with NEI expecting substantial scientific or programmatic involvement during the conduct of the study. This is especially relevant here because the supported trials are greater than minimal risk and require stronger oversight.
What type of clinical trials is this FOA intended to support?
This FOA is intended to support investigator-initiated, early-stage interventional clinical trials, most often aligning with Phase I or Phase II development.
Does this FOA require an interventional clinical trial?
Yes. This is a "Clinical Trial Required" opportunity, meaning applicants are expected to propose an actual interventional clinical trial rather than a purely observational, mechanistic, natural history, or epidemiologic study.
What does "greater than minimal risk" mean in the context of this program?
In this FOA, "greater than minimal risk" indicates that 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.
Why does NEI expect more oversight for these awards?
Because the trials supported under this FOA are greater than minimal risk, NEI anticipates the need for robust performance oversight and safety monitoring during trial conduct. The cooperative agreement structure supports that more interactive involvement.
What kinds of safety and monitoring expectations should applicants plan for?
Applicants should be prepared for 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.
What is the scientific focus area of the FOA?
The scientific scope is 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.
What types of interventions or study aims might fit this FOA?
Examples described in the opportunity 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 (as long as it is an interventional clinical trial and aligns with NEI priorities).
Are observational studies a good fit for this announcement?
This FOA is not framed as an observational study opportunity. It is explicitly "Clinical Trial Required," so projects that are purely observational (including natural history or epidemiologic studies) would not match the stated intent based on the provided information.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. and non-U.S. organizations capable of conducting clinical trials. Eligible categories listed include various government entities, institutions of higher education (public and private), tribal governments and organizations, nonprofits (with or without 501(c)(3) status, other than institutions of higher education), for-profit organizations (other than small businesses), and small businesses.
Are state, county, or local governments eligible applicants?
Yes. State governments, county governments, and city or township governments are listed as eligible applicants. Special district governments are also included.
Are universities and colleges eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are nonprofits eligible, including those without 501(c)(3) status?
Yes. Nonprofits with 501(c)(3) status (other than institutions of higher education) and nonprofits without 501(c)(3) status (other than institutions of higher education) are listed as eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed as eligible.
Are tribal entities and serving institutions included in the eligibility list?
Yes. The FOA explicitly includes federally recognized Native American tribal governments, tribal organizations other than federally recognized tribal governments, Tribally Controlled Colleges and Universities (TCCUs), and other categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, and additional tribal government categories noted in the eligibility list.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly called out as eligible.
Can non-U.S. (foreign) organizations apply?
Yes. The eligibility list includes non-domestic (non-U.S.) entities (foreign organizations).
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly included as eligible applicants.
What is the program area/category for this funding opportunity?
The opportunity is categorized under Health.
What is the CFDA number associated with this opportunity?
The associated CFDA number is 93.867.
When was this FOA created?
The FOA was created on 2022-04-12.
What is the closing date listed in the provided information?
The original closing date listed is 2025-05-07.
Is the award ceiling provided in the information above?
No. The award ceiling is not specified in the provided source data.
Is the expected number of awards provided?
No. The expected number of awards is not specified in the provided source data.
Where should applicants look for budget guidance and project period limits?
Because the award ceiling and expected number of awards are not specified in the provided information, applicants would typically need to refer to the full FOA text for budget guidance, project period limits, and any institute-specific expectations (for example, around scale, milestones, or enrollment targets).
What is the overall goal of this FOA?
The overall goal is to support early human testing of promising vision-related interventions when the work involves meaningful risk and therefore requires stronger-than-usual oversight. It is intended for trials that can justify Phase I or Phase II interventional testing and that demonstrate serious attention to participant safety and data integrity.
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Apply for PAR 22 149
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