NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed) | PAR 25 335

Frequently Asked Questions (FAQ)

What is the NEI Translational Research Program for Therapeutics (PAR-25-335)?

PAR-25-335 is a National Institutes of Health (NIH) funding opportunity from the National Eye Institute (NEI) that supports translational vision research aimed at moving promising lab discoveries toward real-world therapies. The focus is on preclinical development work that helps position a therapeutic candidate for a future FDA regulatory submission.

What is the main goal of this grant program?

The main goal is to generate a rigorous, decision-quality preclinical data package that can justify and support a future U.S. Food and Drug Administration submission, specifically an Investigational New Drug (IND) application (for drugs/biologics) or an Investigational Device Exemption (IDE) (for medical devices). The longer-term intent is to enable later clinical trials, even though clinical trials are not allowed under this opportunity.

What stage of research is this opportunity intended to support?

This program is designed for translational, preclinical development that bridges the gap between discovery science and early clinical testing. It is oriented toward practical enabling studies and milestone-based development rather than open-ended basic research.

Are clinical trials allowed under PAR-25-335?

No. This is explicitly a "Clinical Trial Not Allowed" funding opportunity. The supported work should not include clinical trial activities. Instead, projects should produce the preclinical and translational foundation needed to enable future clinical testing through other mechanisms.

What kinds of therapies or interventions can be supported?

The program supports a broad range of intervention types for diseases or disorders of the visual system, including biological therapies, pharmacological agents, medical devices, and combination products.

What types of studies are considered a good fit for this program?

Competitive projects typically revolve around a clearly defined therapeutic concept and a practical development plan that reduces risk before entering the clinic. Examples of the kinds of preclinical evidence and enabling work described include proof-of-concept efficacy in relevant models, dose and delivery optimization, preliminary safety/toxicology planning, and device performance verification/validation concepts (when applicable).

What does "translational" mean in the context of this NOFO?

In this NOFO, "translational" refers to research activities that actively move a therapeutic candidate toward clinical readiness by producing the kinds of data and planning needed for regulatory interactions and eventual FDA submissions (IND or IDE), rather than pursuing discovery questions without a defined path to development.

What is the funding mechanism used by this opportunity?

The opportunity uses a bi-phasic, milestone-driven R61/R33 mechanism.

What is the R61 phase intended to support?

The R61 phase is an early, exploratory but translation-oriented stage intended for projects that already have strong preliminary data but are not yet advanced enough for late-stage preclinical development. During R61, teams are generally expected to complete key experiments that de-risk the program and demonstrate feasibility for translational advancement.

What is the R33 phase intended to support?

The R33 phase is intended for projects in the final stages of preclinical development that can credibly position themselves for near-term clinical development, with the goal of being ready to support an IND or IDE submission.

Is transition from R61 to R33 automatic?

No. Transition from R61 to R33 is not automatic. It depends on achieving predefined, measurable milestones established up front and used to assess progress and readiness to advance.

Why are milestones so important in this program?

Milestones are a defining feature of this program because the overall orientation is toward practical, milestone-based development. Applicants are expected to show how each milestone moves the therapeutic candidate closer to regulatory readiness and reduces key uncertainties or risks.

What if a project is already advanced and does not need the earlier R61 phase?

The NIH notes a companion single-phase R33 funding opportunity (PAR-23-205) for advanced projects that are ready to enter directly into the later, late-stage preclinical development phase.

What kinds of teams is this program designed for?

This program is built for multidisciplinary teams that combine scientific and clinical expertise. It reflects the reality that successful translation commonly requires coordinated input across areas such as basic biology, pharmacology, bioengineering, manufacturing/CMC planning, regulatory strategy, and clinically relevant outcome considerations.

Does the program require applicants to address regulatory strategy?

Yes, the program is oriented toward producing data packages to support future FDA submissions (IND or IDE), and it emphasizes mapping a clear pathway toward regulatory readiness. The description highlights regulatory strategy and FDA submission goals as central motivations for the supported work.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organizations, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized tribal governments and other tribal organizations; 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) as well as small businesses; and other eligible entities.

Are small businesses eligible?

Yes. Small businesses are explicitly included among eligible applicant organizations in the provided opportunity description.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also eligible.

Are tribal entities eligible to apply?

Yes. Federally recognized tribal governments and other tribal organizations are included among eligible applicants, and the listing highlights Tribally Controlled Colleges and Universities and other serving institutions.

Are foreign organizations eligible to apply?

No. Foreign organizations are not eligible to apply under this opportunity.

Are non-domestic components of U.S. organizations eligible?

No. Non-domestic components of U.S. organizations are also not eligible, reinforcing that the supported work must be conducted within eligible domestic organizational structures.

Which agency sponsors this opportunity?

The sponsoring agency is the National Institutes of Health (NIH), and the program is associated with the National Eye Institute (NEI).

What is the CFDA number and category provided for this opportunity?

The listing identifies the category as health and provides CFDA 93.867.

What type of funding instrument is this?

The listing identifies the funding instrument as a grant under the discretionary category.

What is the original closing date listed for this opportunity?

The original closing date provided is 2025-03-16.

When was this opportunity created?

The listing states the opportunity was created on 2025-01-07.

Does the provided listing include the award ceiling or the expected number of awards?

No. The provided text does not include an award ceiling or the expected number of awards. Applicants would need to consult the full NOFO for budget limits, project period expectations, and any institute-specific constraints.

What is an IND and why is it mentioned here?

An IND (Investigational New Drug application) is an FDA submission associated with beginning clinical testing of drugs or biologics. This program emphasizes generating the preclinical package that would support a future IND submission, without conducting clinical trials under this award.

What is an IDE and why is it mentioned here?

An IDE (Investigational Device Exemption) is an FDA submission pathway used for medical devices to support clinical investigation. This program supports preclinical development intended to enable a future IDE submission, without conducting clinical trials under this award.

What kinds of outcomes should a strong application be able to demonstrate?

Based on the description, a strong application would present a well-justified therapeutic candidate for an eye or visual system indication, a practical plan for translational preclinical development, and concrete go/no-go milestones showing how the work will materially advance the candidate toward an IND or IDE submission and eventual clinical evaluation.