This NHLBI grant supports essential pilot studies crucial for planning subsequent Phase II-IV clinical trials focused on preventing and treating heart, lung, blood, and sleep disorders. The National Heart, Lung, and Blood Institute expects applications to detail the proposed future clinical trial, demonstrating that the R34 research is scientifically necessary and will yield sufficient information to inform its design without further preliminary studies. This mechanism provides new scientific or operational insights to finalize the development of the larger trial, which will test the efficacy, safety, clinical management, or implementation of interventions. Regardless of the R34’s outcome, the future clinical trial will require a new, separate application.
Opportunity ID: 357800
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-032 |
| Funding Opportunity Title: | NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional) |
| 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 18, 2024 |
| Last Updated Date: | Dec 18, 2024 |
| Original Closing Date for Applications: | Jan 07, 2027 |
| Current Closing Date for Applications: | Jan 07, 2027 |
| Archive Date: | Feb 12, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) For profit organizations other than small businesses Small businesses County governments City or township governments Special district governments Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are 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 Opportunity Announcement (NOFO) intends to supports studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI’s mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, this NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials (as described at https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization), the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-032.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 357800 Full Announcement-PAR-25-032 -> PAR-25-032-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 | PKG00289726 | Jan 16, 2025 | Jan 07, 2027 | View |
Package 1
Mandatory forms
357800 RR_SF424_5_0-5.0.pdf
357800 PHS398_CoverPageSupplement_5_0-5.0.pdf
357800 RR_OtherProjectInfo_1_4-1.4.pdf
357800 PerformanceSite_4_0-4.0.pdf
357800 RR_KeyPersonExpanded_4_0-4.0.pdf
357800 PHS398_ResearchPlan_5_0-5.0.pdf
357800 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357800 RR_Budget_3_0-3.0.pdf
357800 RR_SubawardBudget30_3_0-3.0.pdf
357800 PHS398_ModularBudget_1_2-1.2.pdf
357800 PHS_AssignmentRequestForm_4_0-4.0.pdf
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