The National Eye Institute (NEI) is offering this U01 cooperative agreement grant to support investigator-initiated early-stage clinical trials. This grant is specifically designed for studies that are greater than minimal risk, typically falling under Phase I or II trials. Its purpose is to fund research evaluating interventions aimed at screening, diagnosing, preventing, or treating various vision disorders. Given the inherent risk level, the trials funded by this grant require robust performance oversight and stringent safety monitoring to ensure participant well-being and research integrity. The NEI provides these awards to advance critical early-stage evaluations in vision health.
Opportunity ID: 339409
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-149 |
| Funding Opportunity Title: | NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| 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: | Apr 12, 2022 |
| Last Updated Date: | Apr 12, 2022 |
| Original Closing Date for Applications: | May 07, 2025 |
| Current Closing Date for Applications: | May 07, 2025 |
| Archive Date: | Jun 12, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses State 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments County governments Independent school districts Native American tribal governments (Federally recognized) For profit organizations other than small businesses 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The NEI uses U01 cooperative agreement awards to support investigator-initiated early-stage clinical trials that are greater than minimal risk and typically are Phase I or II trials. The risk level of the U01 trial requires appropriate performance oversight and safety monitoring. For purposes of this FOA, the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-149.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 339409 Full Announcement-PAR-22-149 -> PAR-22-149-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00273274 | Apr 24, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or before January 24, 2025 | PKG00277961 | Nov 04, 2022 | Jan 24, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289208 | Nov 27, 2024 | May 07, 2025 | View |
Package 1
Mandatory forms
339409 RR_SF424_5_0-5.0.pdf
339409 PHS398_CoverPageSupplement_5_0-5.0.pdf
339409 RR_OtherProjectInfo_1_4-1.4.pdf
339409 PerformanceSite_4_0-4.0.pdf
339409 RR_KeyPersonExpanded_4_0-4.0.pdf
339409 PHS398_ResearchPlan_4_0-4.0.pdf
339409 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
339409 RR_Budget_3_0-3.0.pdf
339409 RR_SubawardBudget30_3_0-3.0.pdf
339409 PHS398_ModularBudget_1_2-1.2.pdf
339409 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
339409 RR_SF424_5_0-5.0.pdf
339409 PHS398_CoverPageSupplement_5_0-5.0.pdf
339409 RR_OtherProjectInfo_1_4-1.4.pdf
339409 PerformanceSite_4_0-4.0.pdf
339409 RR_KeyPersonExpanded_4_0-4.0.pdf
339409 PHS398_ResearchPlan_5_0-5.0.pdf
339409 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
339409 RR_Budget_3_0-3.0.pdf
339409 RR_SubawardBudget30_3_0-3.0.pdf
339409 PHS398_ModularBudget_1_2-1.2.pdf
339409 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
339409 RR_SF424_5_0-5.0.pdf
339409 PHS398_CoverPageSupplement_5_0-5.0.pdf
339409 RR_OtherProjectInfo_1_4-1.4.pdf
339409 PerformanceSite_4_0-4.0.pdf
339409 RR_KeyPersonExpanded_4_0-4.0.pdf
339409 PHS398_ResearchPlan_5_0-5.0.pdf
339409 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
339409 RR_Budget_3_0-3.0.pdf
339409 RR_SubawardBudget30_3_0-3.0.pdf
339409 PHS398_ModularBudget_1_2-1.2.pdf
339409 PHS_AssignmentRequestForm_4_0-4.0.pdf
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