This NIDDK grant supports small, short-term pilot and feasibility clinical trials conducted in humans. It is designed to lay the essential foundation for larger, more comprehensive clinical trials related to the prevention and/or treatment of diseases and conditions within the NIDDK’s mission. The program helps acquire preliminary data regarding the intervention’s effects, alongside crucial feasibility data concerning participant recruitment, retention, and overall study conduct. Successful applications will have clearly defined aims and objectives, demonstrating a high likelihood that their findings will lead to definitive, hypothesis-driven trials. These projects aim to significantly improve the understanding, diagnosis, prevention, or treatment of diseases, ultimately impacting clinical practice and public health. Preliminary data on intervention efficacy are not required.
Opportunity ID: 345748
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAS-23-086 |
| 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 2 |
| Posted Date: | Feb 02, 2023 |
| Last Updated Date: | Jan 08, 2025 |
| Original Closing Date for Applications: | May 07, 2026 |
| Current Closing Date for Applications: | Jan 07, 2025 |
| Archive Date: | Feb 06, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $200,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Special district governments City or township governments State governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Public and State controlled 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 |
| 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 Institutions) 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 Funding Opportunity Announcement 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 FOA 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-23-086.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 reissued NOFO PAS-25-102. | Jan 08, 2025 | |
| Feb 02, 2023 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAS-23-086 |
| 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 2 |
| Posted Date: | Feb 02, 2023 |
| Last Updated Date: | Jan 08, 2025 |
| Original Closing Date for Applications: | May 07, 2026 |
| Current Closing Date for Applications: | Jan 07, 2025 |
| Archive Date: | Feb 06, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $200,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Special district governments City or township governments State governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Public and State controlled 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 |
| 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 Institutions) 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 Funding Opportunity Announcement 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 FOA 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-23-086.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: | PAS-23-086 |
| 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: | Feb 02, 2023 |
| Last Updated Date: | Feb 02, 2023 |
| Original Closing Date for Applications: | – |
| 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: | Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Special district governments Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) County governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Independent school districts Private institutions of higher education State governments City or township governments |
| 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 Institutions) 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 Funding Opportunity Announcement 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 FOA 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-23-086.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 345748 Full Announcement-PAS-23-086 -> PAS-23-086-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 | PKG00279625 | May 15, 2023 | Jan 09, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288635 | Nov 07, 2024 | Jan 09, 2025 | View |
Package 1
Mandatory forms
345748 RR_SF424_5_0-5.0.pdf
345748 PHS398_CoverPageSupplement_5_0-5.0.pdf
345748 RR_OtherProjectInfo_1_4-1.4.pdf
345748 PerformanceSite_4_0-4.0.pdf
345748 RR_KeyPersonExpanded_4_0-4.0.pdf
345748 PHS398_ResearchPlan_5_0-5.0.pdf
345748 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
345748 RR_Budget_3_0-3.0.pdf
345748 RR_SubawardBudget30_3_0-3.0.pdf
345748 PHS398_ModularBudget_1_2-1.2.pdf
345748 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
345748 RR_SF424_5_0-5.0.pdf
345748 PHS398_CoverPageSupplement_5_0-5.0.pdf
345748 RR_OtherProjectInfo_1_4-1.4.pdf
345748 PerformanceSite_4_0-4.0.pdf
345748 RR_KeyPersonExpanded_4_0-4.0.pdf
345748 PHS398_ResearchPlan_5_0-5.0.pdf
345748 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
345748 RR_Budget_3_0-3.0.pdf
345748 RR_SubawardBudget30_3_0-3.0.pdf
345748 PHS398_ModularBudget_1_2-1.2.pdf
345748 PHS_AssignmentRequestForm_4_0-4.0.pdf
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