This grant is for funding investigator-initiated, high-risk multi-center observational studies. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for projects involving more than one clinical center. Proposed studies must be hypothesis-driven and address diseases relevant to NIDDK’s mission. It is crucial that all planning activities are completed prior to submission, as they are not permitted under this specific funding opportunity (U01). Researchers who require a planning phase should first consider applying for an implementation planning cooperative agreement (U34). Prospective applicants are strongly encouraged to consult with NIDDK Scientific/Research staff before submitting either a U34 or U01 application to ensure alignment and guidance.
Opportunity ID: 357995
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-089 |
| Funding Opportunity Title: | NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Not Allowed) |
| 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: | Special district governments Private institutions of higher education County governments State governments Public and State controlled institutions of higher education Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Public housing authorities/Indian housing authorities 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 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; 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: | This NOFO invites applications for investigator-initiated, high-risk multi-center observational studies involving more than one clinical center. Proposed studies should be hypothesis-driven 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/PAR-25-089.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 357995 Full Announcement-PAR-25-089 -> PAR-25-089-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 | PKG00289882 | Jan 03, 2025 | Nov 05, 2026 | View |
Package 1
Mandatory forms
357995 RR_SF424_5_0-5.0.pdf
357995 PHS398_CoverPageSupplement_5_0-5.0.pdf
357995 RR_OtherProjectInfo_1_4-1.4.pdf
357995 PerformanceSite_4_0-4.0.pdf
357995 RR_KeyPersonExpanded_4_0-4.0.pdf
357995 PHS398_ResearchPlan_5_0-5.0.pdf
357995 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357995 RR_Budget_3_0-3.0.pdf
357995 RR_SubawardBudget30_3_0-3.0.pdf
357995 PHS398_ModularBudget_1_2-1.2.pdf
357995 PHS_AssignmentRequestForm_4_0-4.0.pdf
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