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

The summary for the NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

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

Federal Grant Title:	NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)
Federal Agency Name:	National Institutes of Health (HHS-NIH11)
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	PAR-28-072
Type of Funding:	Grant
CFDA Numbers:	93.867
CFDA Descriptions:	Information not provided
Current Application Deadline:	November 16th, 2029
Original Application Deadline:	November 16th, 2029
Posted Date:	September 25th, 2026
Creation Date:	September 25th, 2026
Archive Date:	January 15th, 2030
Total Program Funding:
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching:	No
Last Updated:	September 25th, 2026

Applicants Eligible for this Grant: 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 (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on 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.
Grant Announcement Contact: NEI Extramural Programs
[email protected]
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