NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed) | PAR 25 363

Opportunity Information: Apply for PAR 25 363

The NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed), PAR-25-363, is a National Institutes of Health (NIH) funding opportunity from the National Eye Institute (NEI) designed to push promising lab discoveries toward real-world treatments for diseases and disorders of the visual system. The core intent is translation: taking an innovative therapeutic concept that has already emerged from prior research and moving it through the key preclinical and regulatory steps needed before human testing can begin. NEI is looking for projects that are practical, tightly focused, and driven by a clear development plan that results in a credible path to an FDA submission and eventual clinical evaluation, even though the award itself does not support clinical trials.

This R33 mechanism is centered on advancing a single therapeutic candidate, meaning applicants are expected to pick one lead approach and develop it rather than propose a broad platform exploration or multiple unrelated candidates. The program supports development of a wide range of intervention types, including biologics, drugs or other pharmacologic agents, medical devices, and combination products. A strong application will typically bring together a multidisciplinary team, often spanning basic scientists, clinicians, translational researchers, and development specialists, to generate the preclinical evidence package that clinicians and regulators will require. The emphasis is on producing decision-quality data, such as data that support dose selection, safety assessment, proof-of-concept in relevant models, product performance testing for devices, and other IND/IDE-enabling studies appropriate to the modality.

A defining feature of the opportunity is its milestone-driven structure. Applicants are expected to lay out the steps of the development program as concrete, measurable milestones that map to the practical needs of therapeutic development. These milestones should demonstrate how the project will progress from its current state toward IND or IDE readiness, including the studies needed to support an FDA submission. The NOFO explicitly calls out key deliverables: completing IND/IDE-enabling work, preparing and filing an IND package with the FDA (or the device equivalent steps leading to an IDE pathway where appropriate), and developing the plan for subsequent clinical testing, including the design of future clinical trials. In other words, the endpoint is not a publication or an exploratory dataset, but a development package that positions the candidate to enter first-in-human or other clinical studies after the award period, using resources outside this R33 if necessary.

This opportunity is specifically labeled "Clinical Trial Not Allowed," which means applicants should not propose studies that meet NIH’s definition of a clinical trial under this award. The funded work should remain on the preclinical and translational development side, focused on readiness for clinical testing rather than conducting that testing. Applicants who are earlier in the applied research pipeline, and who need support to mature initial concepts before entering the IND/IDE-enabling phase, are directed to consider the companion R61/R33 program (referenced as PA-23-XXX in the text) instead of this standalone R33.

In terms of eligibility, the NOFO is broadly open to many types of U.S.-based organizations. Eligible applicants include various levels of government (state, county, city/township, special districts), independent school districts, public and private institutions of higher education, federally recognized Native American tribal governments, and tribal organizations that are not federally recognized. Nonprofit organizations are eligible whether or not they hold 501(c)(3) status, and for-profit organizations (including entities other than small businesses as well as small businesses) may apply. The NOFO also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible, reinforcing that the funded work must be carried out within allowable domestic organizational structures.

From the published opportunity data, the application due date is listed as March 16, 2025, and the award ceiling is noted as $1,000,000. The program is categorized under Health (CFDA 93.867) and uses the grant funding instrument type. Overall, the opportunity is best suited for teams that already have a credible therapeutic lead for an eye or visual system indication and are ready to execute a disciplined, milestone-based plan to reach IND/IDE submission readiness and a well-defined clinical trial design for the next stage.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Translational Research Program for Therapeutics (R33 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 2025-01-07.
• Applicants must submit their applications by 2025-03-16. (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.

Apply for PAR 25 363

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