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

Background
The NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed) is a funding opportunity provided by the National Eye Institute (NEI), which is part of the National Institutes of Health (NIH). The program aims to accelerate the translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. The ultimate goal is to make new technological, biological, and pharmacological resources available to clinicians and their patients.

Grant Details
The program requires multidisciplinary teams of scientists and clinicians to focus on generating preclinical data that will lead to the development of biological, pharmacological, medical device, and/or combination product interventions. The R33 phase focuses on advancing a single therapeutic candidate through IND/IDE-enabling studies, filing an IND package with the FDA, and designing future clinical trials. The NOFO will utilize a milestone-driven R33 mechanism, with a maximum period of three years for the R33 phase. Applicants are encouraged to use project management principles to facilitate achievement of performance milestones.

The program supports activities such as cGMP manufacturing of material for IND-enabling and/or Phase I clinical testing, IND/IDE-enabling safety pharmacology and toxicology studies, and evidence of a pre-IND/IDE meeting with the FDA.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, federal agencies, U.S. territories or possessions, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), faith-based or community-based organizations, and regional organizations. Foreign institutions are not eligible to apply directly but foreign components of U.S. organizations are allowed. All applicants must complete and maintain required registrations including System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), Unique Entity Identifier (UEI), and eRA Commons.

Period of Performance
The period of performance for the R33 phase can be up to three years. The open date for submission is July 24, 2023, with an expiration date of March 17, 2025.

Grant Value
Application budgets for the R33 should not exceed $1,000,000 in direct costs per year. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.