NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- PAR-28-072
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
-
- 93.867 Vision Research
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- City/Township Governments
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- For Profit Organizations
- County Governments
- State Governments
- 501(c)(3) Nonprofits
- Special District Governments
- Tribal Organizations (Not Federally Recognized)
- Other
- Independent School Districts
- Tribal Governments (Federally Recognized)
- Public or Indian Housing Auth.
- Small Businesses
- Higher Education Inst. (Public)
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health National Eye Institute is soliciting applications for the Translational Research Program for Therapeutics, a bi-phasic R61/R33 grant mechanism supporting product development of biological, pharmaceutical, medical device, and combination therapies for visual system diseases and disorders, with applications due by November 16, 2029. Clinical trial applications are not allowed.
Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations, state and local governments, tribal governments (federally recognized and not federally recognized), small businesses, faith-based and community-based organizations, school districts, and housing authorities. No cost share is required. Foreign organizations and non-domestic components of U.S. organizations are ineligible; foreign subawards and subcontracts are prohibited, though unfunded international collaborations and foreign consultants are permitted.
The R61 phase supports up to two years of research with significant preliminary data not yet advanced to clinical translation, with annual budgets rarely exceeding $500,000 in direct costs. The R33 phase supports up to four years of final preclinical development work, with annual budgets not exceeding $1,000,000 in direct costs. Total duration of both phases combined cannot exceed five years. R33 recipients must submit or obtain an Investigational New Drug or Investigational Device Exemption application to the FDA, or transition the product to clinical practice, during the award period.
Applications must include milestone planning with SMART criteria (specific, measurable, achievable, relevant, time-bound) for both phases, a target product profile, Gantt chart, intellectual property strategy, regulatory strategy, and data management and sharing plan. Contingency plans addressing potential milestone delays are strongly encouraged.
Applications undergo scientific peer review by chartered Scientific Review Groups followed by National Advisory Eye Council review. Funding decisions are based on scientific merit, fund availability, and program relevance. Pre-submission contact with NEI staff at least 12 weeks before submission is strongly encouraged. The program is assigned to CFDA 93.867 (Vision Research).
Synopsis
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.
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Files
| File | Type | Posted |
|---|---|---|
| PKG00294241.pdf | ||
| PAR-28-072-Full-Announcement.html | HTML file |
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