The National Heart, Lung, and Blood Institute (NHLBI) is offering this grant to support investigator-initiated, phase I clinical trials. This grant is for advancing diagnostics and therapeutics for heart, lung, blood, and sleep (HLBS) disorders in adults and children. Trials, which can be single or multisite, must be ready to initiate within the project’s first quarter. Applicants must secure all required regulatory approvals (FDA, DSMB, IRB), drug supplies, and third-party agreements by the award date. This opportunity aims to accelerate early-phase clinical research in HLBS.
Opportunity ID: 353319
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-172 |
| 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 2 |
| Posted Date: | Apr 01, 2024 |
| Last Updated Date: | Dec 05, 2024 |
| Original Closing Date for Applications: | Jan 07, 2027 |
| Current Closing Date for Applications: | Jan 05, 2025 |
| Archive Date: | Feb 04, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,515,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Small businesses 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 Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) 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; 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-24-172.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 |
|---|---|---|
| updated close date | Dec 05, 2024 | |
| Apr 01, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-172 |
| 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 2 |
| Posted Date: | Apr 01, 2024 |
| Last Updated Date: | Dec 05, 2024 |
| Original Closing Date for Applications: | Jan 07, 2027 |
| Current Closing Date for Applications: | Jan 05, 2025 |
| Archive Date: | Feb 04, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,515,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Public housing authorities/Indian housing authorities Small businesses 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 Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) 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; 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-24-172.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-24-172 |
| 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: | Apr 01, 2024 |
| Last Updated Date: | Apr 01, 2024 |
| Original Closing Date for Applications: | – |
| 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: | County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities For profit organizations other than small businesses Special district governments Independent school districts Native American tribal governments (Federally recognized) State governments City or township governments Small businesses Public and State controlled institutions of higher education 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 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-24-172.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 353319 Full Announcement-PAR-24-172 -> PAR-24-172-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 | PKG00285680 | May 04, 2024 | Jan 24, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289023 | Nov 25, 2024 | Jan 05, 2025 | View |
Package 1
Mandatory forms
353319 RR_SF424_5_0-5.0.pdf
353319 PHS398_CoverPageSupplement_5_0-5.0.pdf
353319 RR_OtherProjectInfo_1_4-1.4.pdf
353319 PerformanceSite_4_0-4.0.pdf
353319 RR_KeyPersonExpanded_4_0-4.0.pdf
353319 RR_Budget_3_0-3.0.pdf
353319 PHS398_ResearchPlan_5_0-5.0.pdf
353319 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
353319 RR_SubawardBudget30_3_0-3.0.pdf
353319 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
353319 RR_SF424_5_0-5.0.pdf
353319 PHS398_CoverPageSupplement_5_0-5.0.pdf
353319 RR_OtherProjectInfo_1_4-1.4.pdf
353319 PerformanceSite_4_0-4.0.pdf
353319 RR_KeyPersonExpanded_4_0-4.0.pdf
353319 RR_Budget_3_0-3.0.pdf
353319 PHS398_ResearchPlan_5_0-5.0.pdf
353319 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
353319 RR_SubawardBudget30_3_0-3.0.pdf
353319 PHS_AssignmentRequestForm_4_0-4.0.pdf
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