The National Eye Institute (NEI) offers this grant to accelerate the translation of innovative laboratory research into therapeutic interventions for visual system diseases and disorders. This program seeks multidisciplinary teams of scientists and clinicians to generate robust preclinical data for biological, pharmacological, medical device, or combination product development. The ultimate goal is to provide new technological and pharmacological resources for clinicians and their patients. Projects must clearly outline milestones leading to an Investigational New Drug (IND) or Investigational Device Exception (IDE) application to the FDA, or direct clinical trial testing. This bi-phasic, milestone-driven award supports research from early preliminary data (R61 phase) through final preclinical development with near-term clinical potential (R33 phase).
Opportunity ID: 358045
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-335 |
| Funding Opportunity Title: | NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.867 — Vision Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 07, 2025 |
| Last Updated Date: | Jan 07, 2025 |
| Original Closing Date for Applications: | Mar 16, 2025 |
| Current Closing Date for Applications: | Mar 16, 2025 |
| Archive Date: | Apr 21, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) For profit organizations other than small businesses Small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled 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) City or township governments County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Private institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Notice of Funding Opportunity (NOFO) is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. Multidisciplinary teams of scientists and clinicians must focus on generating preclinical data that will lead to the development of biological, pharmacological, medical device and/or combination product interventions. The ultimate goal of this program is to make new technological, biological and pharmacological resources available to clinicians and their patients. The steps towards this goal should be clearly delineated in a series of milestones that support the development of a therapeutic or device that will lead to an Investigational New Drug (IND) or Investigational Device Exception (IDE) application to the U.S. Food and Drug Administration (FDA) and/or testing in a clinical trial. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The R61 phase will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The R33 phase will support research that is in the final states of preclinical development with potential for near-term clinical development. Support for a single phased award that does not need the R61 Exploratory phase is available in the companion R33, PAR-23-205. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-335.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 358045 Full Announcement-PAR-25-335 -> PAR-25-335-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289914 | Jan 16, 2025 | Mar 16, 2025 | View |
Package 1
Mandatory forms
358045 RR_SF424_5_0-5.0.pdf
358045 PHS398_CoverPageSupplement_5_0-5.0.pdf
358045 RR_OtherProjectInfo_1_4-1.4.pdf
358045 PerformanceSite_4_0-4.0.pdf
358045 RR_KeyPersonExpanded_4_0-4.0.pdf
358045 RR_Budget10_3_0-3.0.pdf
358045 PHS398_ResearchPlan_5_0-5.0.pdf
358045 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
358045 RR_SubawardBudget10_30_3_0-3.0.pdf
358045 PHS_AssignmentRequestForm_4_0-4.0.pdf
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