The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is offering this grant for investigator-initiated, high-risk, multi-center clinical trials. This grant is specifically for studies involving more than one clinical center, designed to be hypothesis-driven, and possess the potential to significantly impact clinical practice or public health. Proposed research must align with NIDDK’s mission, focusing on relevant diseases. Applicants must ensure all planning activities are completed prior to submission, as this cooperative agreement does not support a planning phase. Interested parties who require a planning period should seek alternative funding opportunities first. Consultation with NIDDK Scientific/Research staff is strongly encouraged before submitting an application.
Opportunity ID: 357989
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PA-25-147 |
| Funding Opportunity Title: | NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 03, 2025 |
| Last Updated Date: | Jan 03, 2025 |
| Original Closing Date for Applications: | Nov 05, 2026 |
| Current Closing Date for Applications: | Nov 05, 2026 |
| Archive Date: | Dec 11, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Small businesses Native American tribal governments (Federally recognized) County governments Independent school districts Public and State controlled 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 Private institutions of higher education 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; 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. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This NOFO invites applications for investigator-initiated, high-risk multi-center clinical trials involving more than one clinical center. Proposed trials should be hypothesis-driven, have the potential to change clinical practice and/or public health, and focus on a disease relevant to the mission of NIDDK. Planning activities must be completed prior to submission and are not permitted under this NOFO. Applicants who require a planning phase may first apply for an implementation planning cooperative agreement (U34; see TEMP9971).Consultation with NIDDK Scientific/Research staff is strongly encouraged prior to the submission of either a U34 or U01 application. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PA-25-147.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 357989 Full Announcement-PA-25-147 -> PA-25-147-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 | PKG00289877 | Jan 03, 2025 | Nov 05, 2026 | View |
Package 1
Mandatory forms
357989 RR_SF424_5_0-5.0.pdf
357989 PHS398_CoverPageSupplement_5_0-5.0.pdf
357989 RR_OtherProjectInfo_1_4-1.4.pdf
357989 PerformanceSite_4_0-4.0.pdf
357989 RR_KeyPersonExpanded_4_0-4.0.pdf
357989 PHS398_ResearchPlan_5_0-5.0.pdf
357989 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357989 RR_Budget_3_0-3.0.pdf
357989 RR_SubawardBudget30_3_0-3.0.pdf
357989 PHS398_ModularBudget_1_2-1.2.pdf
357989 PHS_AssignmentRequestForm_4_0-4.0.pdf
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