This NIDDK grant, designated as Small R01s, aims to support pilot and feasibility clinical trials in humans. It is designed to generate foundational data for larger, more definitive clinical trials focused on preventing and treating diseases within NIDDK’s mission. The program specifically funds small, short-term proof-of-concept human trials to gather preliminary data on intervention effects, and assess feasibility in terms of recruitment, retention, and overall study conduct. Applicants should propose trials with clear objectives, demonstrating a high likelihood that findings will inform future hypothesis-driven research. This will ultimately enhance understanding, diagnosis, prevention, or treatment of studied diseases, with potential impact on clinical practice and public health. Preliminary efficacy data for interventions are not a prerequisite for application.
Opportunity ID: 358089
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAS-25-102 |
| Funding Opportunity Title: | Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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 08, 2025 |
| Last Updated Date: | Jan 08, 2025 |
| Original Closing Date for Applications: | May 07, 2026 |
| Current Closing Date for Applications: | May 07, 2026 |
| Archive Date: | Jun 12, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $200,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Private institutions of higher education Small businesses Independent school districts Public housing authorities/Indian housing authorities For profit organizations other than small businesses County governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than 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. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Notice of Funding Announcement (NOFO) encourages the submission ofpilot and feasibilityclinical trialsconducted in humans that will lay the foundation for larger clinical trials related to the prevention and/or treatment of diseases and conditions within the mission of NIDDK. The program will support small, short-term proof-of-concept clinical trials in humans to acquire preliminary data regarding the effects of the intervention, as well as feasibility data related to recruitment and retention, and study conduct. Applications for clinical trials submitted under this NOFO should have clearly described aims and objectives and have a high likelihood that the trial findings will lead to more definitive, hypothesis-driven trials to improve understanding, diagnosis, prevention or treatment of the diseases studied and have the potential to impact clinical practice and/or public health.Preliminary data regarding intervention efficacy are not required. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAS-25-102.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 358089 Full Announcement-PAS-25-102 -> PAS-25-102-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 | PKG00289957 | Jan 08, 2025 | May 07, 2026 | View |
Package 1
Mandatory forms
358089 RR_SF424_5_0-5.0.pdf
358089 PHS398_CoverPageSupplement_5_0-5.0.pdf
358089 RR_OtherProjectInfo_1_4-1.4.pdf
358089 PerformanceSite_4_0-4.0.pdf
358089 RR_KeyPersonExpanded_4_0-4.0.pdf
358089 PHS398_ResearchPlan_5_0-5.0.pdf
358089 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
358089 RR_Budget_3_0-3.0.pdf
358089 RR_SubawardBudget30_3_0-3.0.pdf
358089 PHS398_ModularBudget_1_2-1.2.pdf
358089 PHS_AssignmentRequestForm_4_0-4.0.pdf
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