The National Institute of Allergy and Infectious Diseases (NIAID) is offering a Cooperative Agreement (U01) for the implementation of investigator-initiated, high-risk clinical trials. This grant also supports mechanistic studies directly associated with these high-risk trials. The NIAID emphasizes that mechanistic work within clinical trials is crucial, as it enhances the understanding of human diseases and aids in developing future therapeutic modalities. This funding opportunity aims to advance high-priority research aligned with NIAID’s mission. Investigators are reminded that only one clinical trial can be proposed per application for this Implementation Cooperative Agreement.
Opportunity ID: 352066
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-100 |
| Funding Opportunity Title: | NIAID Clinical Trial Implementation Cooperative Agreement (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: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 29, 2024 |
| Last Updated Date: | May 15, 2025 |
| Original Closing Date for Applications: | Jan 13, 2027 |
| Current Closing Date for Applications: | May 23, 2025 |
| Archive Date: | Jun 22, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Independent school districts Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Small businesses Native American tribal governments (Federally recognized) |
| 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: |
This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role).Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-100.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 |
|---|---|---|
| Update close date per NOT-OD-25-113. | May 15, 2025 | |
| Jan 29, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-100 |
| Funding Opportunity Title: | NIAID Clinical Trial Implementation Cooperative Agreement (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: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 29, 2024 |
| Last Updated Date: | May 15, 2025 |
| Original Closing Date for Applications: | Jan 13, 2027 |
| Current Closing Date for Applications: | May 23, 2025 |
| Archive Date: | Jun 22, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Independent school districts Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Small businesses Native American tribal governments (Federally recognized) |
| 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: |
This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role).Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-100.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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-100 |
| Funding Opportunity Title: | NIAID Clinical Trial Implementation Cooperative Agreement (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: | 93.855 — Allergy and Infectious Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 29, 2024 |
| Last Updated Date: | Jan 29, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jan 13, 2027 |
| Archive Date: | Feb 18, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments For profit organizations other than small businesses Small businesses Special district governments Independent school districts Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education 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 State governments Native American tribal governments (Federally recognized) City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| 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: | This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role). Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-100.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 |
Related Documents
Folder 352066 Full Announcement-PAR-24-100 -> PAR-24-100-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-H | Use for due dates on or before January 24, 2025 | PKG00284621 | Apr 12, 2024 | Jan 24, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289248 | Nov 27, 2024 | May 23, 2025 | View |
Package 1
Mandatory forms
352066 RR_SF424_5_0-5.0.pdf
352066 PHS398_CoverPageSupplement_5_0-5.0.pdf
352066 RR_OtherProjectInfo_1_4-1.4.pdf
352066 PerformanceSite_4_0-4.0.pdf
352066 RR_KeyPersonExpanded_4_0-4.0.pdf
352066 PHS398_ResearchPlan_5_0-5.0.pdf
352066 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
352066 RR_Budget_3_0-3.0.pdf
352066 RR_SubawardBudget30_3_0-3.0.pdf
352066 PHS398_ModularBudget_1_2-1.2.pdf
352066 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
352066 RR_SF424_5_0-5.0.pdf
352066 PHS398_CoverPageSupplement_5_0-5.0.pdf
352066 RR_OtherProjectInfo_1_4-1.4.pdf
352066 PerformanceSite_4_0-4.0.pdf
352066 RR_KeyPersonExpanded_4_0-4.0.pdf
352066 PHS398_ResearchPlan_5_0-5.0.pdf
352066 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
352066 RR_Budget_3_0-3.0.pdf
352066 RR_SubawardBudget30_3_0-3.0.pdf
352066 PHS398_ModularBudget_1_2-1.2.pdf
352066 PHS_AssignmentRequestForm_4_0-4.0.pdf
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