This grant, from the National Heart, Lung, and Blood Institute (NHLBI), supports investigator-initiated single-site clinical trials. These trials encompass efficacy, comparative effectiveness, pragmatic, and implementation research for therapeutic, behavioral, or prevention strategies. All projects must align with NHLBI’s mission and NIH clinical trial definitions. This bi-phasic, milestone-driven award requires a robust scientific rationale and a detailed operational plan. Applicants should address project management, subject recruitment/retention, performance milestones, trial conduct, and results dissemination. The multiple PD/PI model is encouraged, especially with expertise in biostatistics and clinical trial design.
Opportunity ID: 357659
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-028 |
| Funding Opportunity Title: | Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 11, 2024 |
| Last Updated Date: | May 21, 2025 |
| Original Closing Date for Applications: | Sep 11, 2025 |
| Current Closing Date for Applications: | Jan 11, 2026 |
| Archive Date: | Feb 10, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities For profit organizations other than small businesses County governments Public and State controlled institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Notice of Funding Opportunity (NOFO) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-028.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-HL-25-011. | May 21, 2025 | |
| Dec 11, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-028 |
| Funding Opportunity Title: | Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 11, 2024 |
| Last Updated Date: | May 21, 2025 |
| Original Closing Date for Applications: | Sep 11, 2025 |
| Current Closing Date for Applications: | Jan 11, 2026 |
| Archive Date: | Feb 10, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities For profit organizations other than small businesses County governments Public and State controlled institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Notice of Funding Opportunity (NOFO) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-028.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-25-028 |
| Funding Opportunity Title: | Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.233 — National Center on Sleep Disorders Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 11, 2024 |
| Last Updated Date: | Dec 11, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 11, 2025 |
| Archive Date: | Oct 17, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Private institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments City or township governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts State 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Notice of Funding Opportunity (NOFO) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-028.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 357659 Full Announcement-PAR-25-028 -> PAR-25-028-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 | PKG00289584 | Jan 11, 2025 | Jan 11, 2026 | View |
Package 1
Mandatory forms
357659 RR_SF424_5_0-5.0.pdf
357659 PHS398_CoverPageSupplement_5_0-5.0.pdf
357659 RR_OtherProjectInfo_1_4-1.4.pdf
357659 PerformanceSite_4_0-4.0.pdf
357659 RR_KeyPersonExpanded_4_0-4.0.pdf
357659 RR_Budget10_3_0-3.0.pdf
357659 PHS398_ResearchPlan_5_0-5.0.pdf
357659 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357659 RR_SubawardBudget10_30_3_0-3.0.pdf
357659 PHS_AssignmentRequestForm_4_0-4.0.pdf
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