NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed) | PAR 28 072

Opportunity Information: Apply for PAR 28 072

The NEI Translational Research Program for Therapeutics (PAR-28-072) is a National Institutes of Health grant opportunity run by the National Eye Institute that is aimed at moving promising vision science discoveries out of the lab and toward real-world therapeutic products. The program is focused on speeding up and de-risking the path from strong preclinical findings to a therapy that clinicians could eventually use to treat diseases or disorders of the visual system. It is broad in the types of products it will support, including biologics, drugs, medical devices, and combination products, as long as the work is geared toward product development and eventual clinical use rather than basic discovery research.

A defining feature of this opportunity is its two-stage (bi-phasic) structure using the R61/R33 mechanism, with heavy emphasis on defined progress benchmarks. Every funded project begins in the R61 phase, which can last up to two years. This first phase is meant for projects that already have meaningful preliminary data and a plausible therapeutic concept, but are not yet far enough along to be considered close to clinical translation. In practical terms, the R61 phase is where applicants are expected to solidify and validate the therapeutic approach and generate the additional evidence needed to justify more intensive, late-stage preclinical development.

If R61 milestones are met, the project can transition into the R33 phase, which can last up to four years, with the combined R61 plus R33 project period capped at five years total. The R33 phase is intended for projects that are in the final stages of preclinical development and are positioned for near-term clinical advancement. A major expectation of the R33 is that the work will focus on a single therapeutic candidate and push that candidate through the kinds of studies required to support a regulatory submission. Specifically, the R33 phase is expected to cover IND- or IDE-enabling activities (depending on whether the product is regulated as a drug/biologic or as a device), preparation and filing of an IND/IDE package with the FDA, and planning for future clinical trials. By the end of the award, R33 recipients must have submitted or obtained an IND/IDE application with the FDA, or (in some cases where that fits the product pathway) transitioned the product to clinical practice within the award period. Although the NOFO is labeled "Clinical Trial Not Allowed," it is designed to fund the preclinical and regulatory preparation steps that typically precede a first-in-human study, not the clinical trial itself.

Milestones are central to how applications are written, evaluated, and managed in this program. Applicants must propose clear milestones for both the R61 and R33 phases, and these milestones are expected to be SMART: specific, measurable, achievable, relevant, and time-bound. Milestones should map to real product development checkpoints, which can include manufacturing and production goals, quality and characterization targets, preclinical performance thresholds, and regulatory deliverables. The program also encourages applicants to include contingency plans that anticipate likely obstacles (for example, manufacturing scale-up issues, assay variability, unexpected toxicology findings, or device design iteration needs) and lay out credible alternative approaches to keep the project on track if delays or failures occur. Because the award is milestone-driven, the implied operating model is similar to a product development plan: hitting defined gates on schedule is not just helpful, it is part of the mechanism by which progression from R61 to R33 is justified.

On eligibility, the opportunity is open to a wide range of U.S.-based applicant organizations across government, academia, nonprofit, and industry. Eligible applicants include state, county, and local governments; public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses and other than small businesses); and certain tribal entities and housing authorities, among others listed in the notice. However, non-U.S. (foreign) organizations are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply as applicant organizations.

The NOFO also includes strict limits on international funding arrangements. While "foreign components" as defined by NIH policy may be allowed, NIH will not issue awards under this NOFO that include foreign subawards or foreign subcontracts. Applications that propose foreign subawards/subcontracts will be considered noncompliant and will not be reviewed for funding. This policy does not eliminate all forms of international interaction: unfunded collaborations can still occur, foreign consultants may be paid, and applicants can procure unique equipment or supplies from foreign vendors. The key restriction is that monetary collaborations structured as foreign subawards or subcontracts are not permitted under this announcement, and funded international collaborations must use a NOFO that is explicitly designed for that purpose.

Administratively, this is a discretionary grant opportunity in the health funding category (CFDA 93.867). The posted closing date extends to November 16, 2029, indicating a long-running program window with multiple potential submission cycles, though applicants still need to follow the specific receipt dates and instructions in the full NOFO. The award ceiling and expected number of awards are not specified in the provided listing, which is common for NIH opportunities where budgets are largely project-dependent and aligned with the scope and justification in the application.

In summary, this NEI program is meant for teams that already have a well-supported therapeutic concept for a visual system indication and are ready to operate like a product development effort. The R61 phase supports the remaining translational groundwork, and the R33 phase is designed to carry a single candidate through IND/IDE-enabling work and regulatory submission preparation, with success defined by concrete, time-bound milestones and a clear path toward near-term clinical development even though clinical trials themselves are not funded under this specific announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Translational Research Program for Therapeutics (R61/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 2026-09-25.
• Applicants must submit their applications by 2029-11-16.
• 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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