NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed) | PAR 23 205

Opportunity Information: Apply for PAR 23 205

The NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed), PAR-23-205, is a National Institutes of Health (NIH) funding opportunity designed to push promising lab discoveries toward real-world treatments for diseases and disorders of the visual system. The core emphasis is translation: taking an innovative therapeutic concept that has emerged from prior research and generating the preclinical evidence needed to move it toward use by clinicians. Projects are expected to be highly goal-driven and organized around clear, measurable milestones that map directly onto a development pathway leading to an FDA submission, such as an Investigational New Drug (IND) application for drugs/biologics or an Investigational Device Exemption (IDE) for medical devices. While clinical trials are not supported under this R33 award, the program is explicitly oriented toward setting up future clinical testing by completing the enabling work that makes a clinical trial possible.

This R33 mechanism is intended for teams that are already beyond very early applied research and are ready to advance a single defined therapeutic candidate. That candidate may be a biologic, a drug or pharmacologic therapy, a medical device, or a combination product. The expectation is that applicants will assemble multidisciplinary teams that can cover the scientific, clinical, and product development expertise needed to produce rigorous preclinical data packages. In practical terms, the work supported under this NOFO typically aligns with IND/IDE-enabling activities, such as refining the candidate, demonstrating proof-of-concept and reproducibility in relevant models, addressing safety or performance questions, developing or validating assays and endpoints needed for regulatory discussions, preparing elements of manufacturing/quality or device design controls as appropriate, and compiling the documentation required for an FDA submission. A key deliverable is readiness for regulatory filing (and in many cases the actual filing of an IND package), along with a well-developed plan for subsequent clinical trials, even though the trial itself would occur under later funding.

A defining feature of the program is its milestone-driven structure. Applicants are expected to lay out the major steps that will de-risk the therapeutic and move it toward the clinic, with concrete go/no-go decision points. The milestones should show a coherent sequence from current status to IND/IDE readiness, including what data will be generated, how success will be judged, and what dependencies exist across tasks. This milestone focus signals that NEI is looking for projects that function more like development programs than open-ended research studies, with a strong emphasis on efficiency, accountability, and progress toward a regulatory path.

In terms of who can apply, eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, and city/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; tribal organizations (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, non-U.S. (foreign) organizations and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components may be allowed when they meet the NIH definition and are justified under NIH policy.

Administratively, this is a discretionary grant opportunity in the health category (CFDA 93.867) administered by NIH, with an original closing date listed as 2025-03-16. The award ceiling shown in the source information is $1,000,000. Taken together, the opportunity is best suited for applicants who have a well-characterized therapeutic candidate for an eye-related condition, a credible preclinical and regulatory strategy, and a team prepared to execute IND/IDE-enabling studies on a defined timeline. Applicants whose work is still at an earlier applied stage are directed to consider the companion R61/R33 pathway referenced in the announcement.

• 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 2023-06-27.
• 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 23 205

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