NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)

Source-based overview

The purpose of NEI's Translational Research program (TRP) is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. The TRP will support the product development of biological, pharmaceutical, medical device, and/or combination therapies for any disease or disorder of the visual system.The TRP will utilize a bi-phasic, milestone-driven mechanism of award. The R61 phase can be up to two years and will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The R33 phase can be up to four years and will support research that is in the final states of preclinical development with potential for near-term clinical development. The total duration of both R61 and R33 cannot exceed five years. The R33 is to focus on advancing a single therapeutic candidate through Investigational New Drug or Investigational Device Exemption (IND/IDE) enabling studies, filing an IND/IDE package with the FDA, and designing future clinical trials. R33 recipients must submit or obtain an IND/IDE application to FDA, or must transition the product to clinical practice, within the period of performance. The specific activities appropriate for the R33 phase will depend on the product under study and available preliminary data on the product. Delineation of milestones by the applicant for the R61 and R33 phases is a key characteristic of this program. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. This program will support applications that propose a series of milestones including manufacturing and product development goals. Applications that address contingency plans to proactively confront potential delays in meeting the milestones are strongly encouraged. Milestones are required for both phases. Milestones must be specific, measurable, achievable, relevant, and time-bound (SMART). All projects will begin with a R61 phase regardless of therapeutic starting point. The official record contains the controlling eligibility, budget, attachment and submission requirements for opportunity PAR-28-072.

Eligibility

Eligible applicant types listed by the agency: Native American tribal governments (Federally recognized); Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Public housing authorities/Indian housing authorities; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); Private institutions of higher education; For profit organizations other than small businesses; Independent school districts; Special district governments; Small businesses; City or township governments; State governments; County governments; Public and State controlled institutions of higher education; Native American tribal organizations (other than Federally recognized tribal governments). Applicants must also satisfy every programme-specific condition in the official notice.

Funding and benefits

Award ceiling: See official notice

Themes and supported activities

The purpose of NEI's Translational Research program (TRP) is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. The TRP will support the product development of biological, pharmaceutical, medical device, and/or combination therapies for any disease or disorder of the visual system.The TRP will utilize a bi-phasic, milestone-driven mechanism of award. The R61 phase can be up to two years and will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The R33 phase can be up to four years and will support research that is in the final states of preclinical development with potential for near-term clinical development. The total duration of both R61 and R33 cannot exceed five years. The R33 is to focus on advancing a single therapeutic candidate through Investigational New Drug or Investigational Device Exemption (IND/IDE) enabling studies, filing an IND/IDE package with the FDA, and designing future clinical trials. R33 recipients must submit or obtain an IND/IDE application to FDA, or must transition the product to clinical practice, within the period of performance. The specific activities appropriate for the R33 phase will depend on the product under study and available preliminary data on the product. Delineation of milestones by the applicant for the R61 and R33 phases is a key characteristic of this program. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. This program will support applications that propose a series of milestones including manufacturing and product development goals. Applications that address contingency plans to proactively confront potential delays in meeting the milestones are strongly encouraged. Milestones are required for both phases. Milestones must be specific, measurable, achievable, relevant, and time-bound (SMART). All projects will begin with a R61 phase regardless of therapeutic starting point.

Opportunity number: PAR-28-072

Deadline and timeline

Applications close 2029-11-16: Applications close 2029-11-16: Nov 16, 2029.

Applicants should confirm the exact deadline time, time zone, required documents, portal steps and any institutional approvals on the official call page before submitting.

How to apply

Open the official Grants.gov record, review the full notice and attachments, and use the application package or agency route stated there.

Before applying, check eligibility rules, budgets, attachments, page limits, partner requirements, cost-share conditions and whether the opportunity uses an expression of interest, full proposal, registration or nomination stage.