This grant, offered by the National Heart, Lung, and Blood Institute (NHLBI), is designed to support investigator-initiated Phase I clinical trials for diagnostic and therapeutic interventions targeting heart, lung, blood, and sleep (HLBS) disorders in both adults and children. The funding opportunity covers crucial clinical trial start-up and implementation activities, as well as final stage preclinical work essential for the proposed trial’s execution. Utilizing a bi-phasic, milestone-driven R61/R33 mechanism, the initial R61 phase can be used to finalize pre-trial activities such as stability and shipping studies, and site training. This grant is for advancing early-stage clinical research to address critical HLBS conditions.
Opportunity ID: 357543
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-026 |
| Funding Opportunity Title: | NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (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 05, 2024 |
| Last Updated Date: | Dec 05, 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: | Small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments State governments Public housing authorities/Indian housing authorities |
| 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: | The objective of this funding opportunity is to support investigator-initiated, Phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-026.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 357543 Full Announcement-PAR-25-026 -> PAR-25-026-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 | PKG00289459 | Jan 03, 2025 | Jan 07, 2027 | View |
Package 1
Mandatory forms
357543 RR_SF424_5_0-5.0.pdf
357543 PHS398_CoverPageSupplement_5_0-5.0.pdf
357543 RR_OtherProjectInfo_1_4-1.4.pdf
357543 PerformanceSite_4_0-4.0.pdf
357543 RR_KeyPersonExpanded_4_0-4.0.pdf
357543 RR_Budget10_3_0-3.0.pdf
357543 PHS398_ResearchPlan_5_0-5.0.pdf
357543 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357543 RR_SubawardBudget10_30_3_0-3.0.pdf
357543 PHS_AssignmentRequestForm_4_0-4.0.pdf
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