NEI Audacious Goals Initiative: Translation-Enabling Models to Evaluate Survival and Integration of Regenerated Neurons in the Visual System (U24 Clinical Trial Not Allowed) | RFA EY 20 001

Opportunity Information: Apply for RFA EY 20 001

The National Eye Institute (NEI), part of the National Institutes of Health (NIH), is offering a discretionary research funding opportunity under its Audacious Goals Initiative (AGI) focused on neural regeneration in the visual system. The aim of this announcement is to support translation-enabling work that uses in vivo models to evaluate two closely related challenges in vision restoration: whether regenerated neurons can survive over time and whether they can properly integrate into existing visual circuits. In practical terms, the opportunity is centered on building and refining experimental models and approaches that help move regenerative strategies closer to eventual clinical use, rather than testing interventions in human patients.

This opportunity is published as a cooperative agreement (U24), which typically means the funded projects are expected to involve substantial scientific and/or programmatic involvement from NIH staff compared to a standard research grant. The “Clinical Trial Not Allowed” designation is important because it limits the scope to preclinical and other non-clinical trial activities. Applicants should therefore expect that proposed studies must stay on the translation-enabling side of the pipeline, emphasizing robust in vivo modeling, measurement, and validation frameworks for neuronal survival and functional integration, instead of human efficacy testing or other clinical trial designs.

The specific program title highlights the kind of work NEI is trying to accelerate: “Translation-Enabling Models to Evaluate Survival and Integration of Regenerated Neurons in the Visual System.” That framing indicates the emphasis is not only on regeneration itself, but on credible, well-characterized in vivo systems that can answer whether regenerated neurons persist, connect appropriately, and contribute meaningfully within the visual pathway. These models may include methods to track regenerated cell fate, assess synaptic connectivity and circuit incorporation, and evaluate structural or functional outcomes in the visual system, all in ways that can inform later-stage development. Because the goal is translation enabling, strong applications would typically be expected to produce broadly useful resources, standardized approaches, or validated paradigms that reduce uncertainty for the field and help align preclinical evidence with eventual translational needs.

From an administrative standpoint, the announcement is identified as Funding Opportunity Number RFA-EY-20-001, with the funding activity category listed as Health and the CFDA number 93.867, which corresponds to eye and vision-related NIH assistance. The original closing date shown in the source information is January 15, 2021, and the opportunity was created on September 4, 2020. The listed award ceiling is $1,000,000, which signals that NEI anticipated relatively substantial budgets per award (though the actual awarded amount can vary based on the approved scope and NIH policy). The source data lists “ExpectedAwards” but does not provide a number, so the exact count of awards is not specified in the excerpt.

Eligibility is broad and includes many common public and private research-performing organizations. Eligible applicants include state, county, and local 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; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding higher education institutions where applicable); for-profit organizations other than small businesses; and small businesses. In addition, the opportunity explicitly calls out several categories of “other eligible applicants,” including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); faith-based or community-based organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments other than federally recognized; tribally controlled colleges and universities (TCCUs); regional organizations; U.S. territories or possessions; eligible federal government agencies; and even non-U.S. entities (foreign organizations). That expanded list suggests NEI is open to a wide range of institutions that can contribute specialized in vivo modeling capabilities and related expertise, including international collaborators when appropriate under NIH rules.

Overall, the opportunity is designed to push the AGI’s regenerative vision goals forward by investing in rigorous in vivo model systems and evaluation methods that can demonstrate, with increasing confidence, whether regenerated neurons in the visual system can both survive and functionally integrate. The structure (U24 cooperative agreement) and the “clinical trial not allowed” boundary together signal a programmatic focus on field-enabling, translationally relevant infrastructure and evidence generation that can support downstream therapeutic development, rather than clinical testing in humans at this stage.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Audacious Goals Initiative: Translation-Enabling Models to Evaluate Survival and Integration of Regenerated Neurons in the Visual System (U24 Clinical Trial Not Allowed)" 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 2020-09-04.
• Applicants must submit their applications by 2021-01-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
• 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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