This grant is for supporting investigator-initiated Phase I clinical trials focusing on diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. Beyond trial implementation, the funding also covers essential start-up and final stage preclinical activities required for trial readiness. All activities proposed in the R61 phase must directly prepare for the clinical trial. This opportunity uses a bi-phasic, milestone-driven award mechanism. The initial R61 phase allows for critical pre-trial preparations, including stability studies, shipping logistics, and site training, facilitating successful trial commencement across single or multisite settings.
Opportunity ID: 353331
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-173 |
| 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 2 |
| Posted Date: | Apr 02, 2024 |
| Last Updated Date: | Dec 05, 2024 |
| Original Closing Date for Applications: | Jan 07, 2027 |
| Current Closing Date for Applications: | Jan 08, 2025 |
| Archive Date: | Feb 07, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments County governments Private institutions of higher education Public and State controlled institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Nonprofits that do not have 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) For profit organizations other than small businesses State governments Independent school districts |
| 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. 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-24-173.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 02, 2024 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-173 |
| 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 2 |
| Posted Date: | Apr 02, 2024 |
| Last Updated Date: | Dec 05, 2024 |
| Original Closing Date for Applications: | Jan 07, 2027 |
| Current Closing Date for Applications: | Jan 08, 2025 |
| Archive Date: | Feb 07, 2025 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments County governments Private institutions of higher education Public and State controlled institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Nonprofits that do not have 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) For profit organizations other than small businesses State governments Independent school districts |
| 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. 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-24-173.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-24-173 |
| 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: | Apr 02, 2024 |
| Last Updated Date: | Apr 02, 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: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | City or township governments Public and State controlled institutions of higher education Private institutions of higher education For profit organizations other than small businesses Special district governments State governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts |
| 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. 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-24-173.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 353331 Full Announcement-PAR-24-173 -> PAR-24-173-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 | PKG00285691 | May 04, 2024 | Jan 24, 2025 | View | |
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00289100 | Nov 26, 2024 | Jan 08, 2025 | View |
Package 1
Mandatory forms
353331 RR_SF424_5_0-5.0.pdf
353331 PHS398_CoverPageSupplement_5_0-5.0.pdf
353331 RR_OtherProjectInfo_1_4-1.4.pdf
353331 PerformanceSite_4_0-4.0.pdf
353331 RR_KeyPersonExpanded_4_0-4.0.pdf
353331 RR_Budget10_3_0-3.0.pdf
353331 PHS398_ResearchPlan_5_0-5.0.pdf
353331 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
353331 RR_SubawardBudget10_30_3_0-3.0.pdf
353331 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
353331 RR_SF424_5_0-5.0.pdf
353331 PHS398_CoverPageSupplement_5_0-5.0.pdf
353331 RR_OtherProjectInfo_1_4-1.4.pdf
353331 PerformanceSite_4_0-4.0.pdf
353331 RR_KeyPersonExpanded_4_0-4.0.pdf
353331 RR_Budget10_3_0-3.0.pdf
353331 PHS398_ResearchPlan_5_0-5.0.pdf
353331 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
353331 RR_SubawardBudget10_30_3_0-3.0.pdf
353331 PHS_AssignmentRequestForm_4_0-4.0.pdf
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