The National Heart, Lung, and Blood Institute (NHLBI) is offering this grant to support investigator-initiated, phase I clinical trials. This grant is for developing new diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. Trials can be single or multisite. Applicants must be ready to initiate the clinical trial within the first quarter of the project period. All essential regulatory approvals (FDA, DSMB, IRB), drug supplies, and third-party agreements must be secured by the time of award. For those needing more time for pre-clinical or trial readiness, a companion R61/R33 phased grant is available. This NHLBI grant aims to advance early-phase clinical research for HLBS conditions.
Opportunity ID: 357542
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-025 |
| Funding Opportunity Title: | NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT 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: | $1,515,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | 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 State governments City or township governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education County 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 Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Small businesses |
| 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: | 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. The proposed trial can be single or multisite. Applicants applying for funding under this NOFO should be ready to initiate the clinical trial within the first quarter of the project period. Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award. If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion NOFO which utilizes an R61/R33 phased approach. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-025.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 357542 Full Announcement-PAR-25-025 -> PAR-25-025-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 | PKG00289458 | Jan 03, 2025 | Jan 07, 2027 | View |
Package 1
Mandatory forms
357542 RR_SF424_5_0-5.0.pdf
357542 PHS398_CoverPageSupplement_5_0-5.0.pdf
357542 RR_OtherProjectInfo_1_4-1.4.pdf
357542 PerformanceSite_4_0-4.0.pdf
357542 RR_KeyPersonExpanded_4_0-4.0.pdf
357542 RR_Budget_3_0-3.0.pdf
357542 PHS398_ResearchPlan_5_0-5.0.pdf
357542 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357542 RR_SubawardBudget30_3_0-3.0.pdf
357542 PHS_AssignmentRequestForm_4_0-4.0.pdf
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