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.Apply for PAR 23 205
- 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.
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FAQs: NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed) - PAR-23-205
What is this funding opportunity?
This opportunity is the National Eye Institute (NEI) Translational Research Program for Therapeutics using the R33 mechanism (clinical trials not allowed), under funding opportunity PAR-23-205. It is an NIH grant program focused on advancing promising discoveries toward real-world therapies for diseases and disorders of the visual system.
What is the main purpose of this R33 program?
The program is designed to generate the preclinical evidence needed to move an innovative therapeutic concept toward clinical use. The emphasis is on translation: completing the practical, enabling work that positions a therapeutic candidate for a future clinical trial by preparing for an FDA regulatory submission (such as an IND for drugs/biologics or an IDE for devices).
Are clinical trials allowed under this R33 award?
No. Clinical trials are not supported under this R33 award. The program is intended to set up future clinical testing by completing IND/IDE-enabling and other preclinical development activities that make clinical trials possible under later funding.
What kinds of therapeutic candidates does NEI expect applicants to advance?
Applicants are expected to advance a single defined therapeutic candidate. The candidate may be a biologic, a drug or other pharmacologic therapy, a medical device, or a combination product.
What stage of development is this program intended for?
This R33 mechanism is intended for teams that are beyond very early applied research and are ready to advance a well-defined therapeutic candidate through a structured preclinical development path toward IND/IDE readiness.
What types of activities are typically supported under this NOFO?
Supported work 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 for regulatory discussions, preparing manufacturing/quality elements or device design controls as appropriate, and compiling documentation needed for an FDA submission.
What is the expected regulatory endpoint for supported projects?
Projects are expected to map to 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. A key deliverable is readiness for regulatory filing, and in many cases the actual filing of an IND package.
What does "milestone-driven" mean for this program?
The program requires a goal-driven plan organized around clear, measurable milestones that directly align with a development pathway to IND/IDE readiness. Milestones should include concrete go/no-go decision points and define what data will be generated, how success will be judged, and how tasks depend on one another.
What should milestones include in an R33 application?
Milestones should show a coherent sequence from the project’s current status to IND/IDE readiness, including key de-risking steps, measurable success criteria, planned outputs/data packages, dependencies across tasks, and explicit go/no-go decision points that guide whether the program should proceed.
What is NEI looking for in the overall project approach?
NEI is looking for projects that function more like development programs than open-ended research studies. The emphasis is on efficiency, accountability, reproducibility, and progress toward a clearly articulated regulatory path that supports future clinical testing.
What types of teams are best suited for this award?
The program expects multidisciplinary teams that can cover scientific, clinical, and product development expertise needed to generate rigorous preclinical data packages and to execute an IND/IDE-enabling development plan.
What diseases or conditions are in scope?
The opportunity targets diseases and disorders of the visual system, consistent with NEI’s mission and the stated focus on eye-related conditions.
Who is eligible to 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.
Are minority-serving or community-based institutions eligible?
Yes. The announcement 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 and regional organizations.
Are federal agencies eligible to apply?
Yes. Eligible applicants include eligible federal agencies, as indicated in the opportunity summary.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed among eligible applicant categories.
Can non-U.S. (foreign) organizations apply?
No. Non-U.S. (foreign) organizations are not eligible to apply under this opportunity.
Can a non-U.S. component of a U.S. organization apply?
No. Non-U.S. components of U.S. organizations are not eligible to apply.
Are foreign components allowed in any form?
Foreign components may be allowed when they meet the NIH definition and are justified under NIH policy, even though foreign organizations and non-U.S. components of U.S. organizations are not eligible to apply.
What is the award ceiling listed for this opportunity?
The award ceiling shown in the provided information is $1,000,000.
Which NIH institute administers this opportunity?
This opportunity is administered by the National Institutes of Health (NIH) and is associated with the National Eye Institute (NEI) program focus.
What is the CFDA number and category?
The opportunity is listed in the health category with CFDA 93.867.
What is the closing date listed in the source information?
The original closing date listed is 2025-03-16.
What does it mean that this is a discretionary grant opportunity?
It is described as a discretionary grant opportunity, meaning the funding agency has discretion in making awards based on program priorities and the merits of applications, consistent with the information provided.
Who is this opportunity best suited for?
It is best suited for applicants with 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.
What if a project is still at an earlier applied research stage?
Applicants whose work is still at an earlier applied stage are directed to consider the companion R61/R33 pathway referenced in the announcement.
What is the expected connection between the project plan and FDA interactions?
Projects are expected to generate the kinds of preclinical evidence, assays/endpoints, and documentation that support regulatory discussions and submissions, with milestones aligned to the specific requirements of an IND or IDE pathway.
Does the program support combination products?
Yes. The candidate may be a combination product, as explicitly included among eligible therapeutic candidate types.
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