This NHLBI grant is for supporting investigator-initiated, Phase I clinical trials focused on diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. This funding opportunity provides comprehensive support, covering both clinical trial start-up and implementation activities. Crucially, it also extends assistance to the final-stage preclinical activities essential for successfully initiating the proposed trial. Utilizing a bi-phasic, milestone-driven R61/R33 mechanism, the initial R61 phase can be dedicated to finalizing essential pre-trial preparations, such as stability studies, shipping protocols, and site-specific training. The proposed trials can be conducted at single or multiple sites.
Opportunity ID: 330978
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-21-119 |
| Funding Opportunity Title: | NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (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: | Jan 15, 2021 |
| Last Updated Date: | Jan 15, 2021 |
| Original Closing Date for Applications: | Jan 07, 2024 |
| Current Closing Date for Applications: | Jan 07, 2024 |
| Archive Date: | Feb 12, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education 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 Special district governments City or township governments Native American tribal governments (Federally recognized) 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 Independent school districts Small businesses State governments County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than 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 Institutions) 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 FOA 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: | http://grants.nih.gov/grants/guide/pa-files/PAR-21-119.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 330978 Full Announcement-PAR-21-119 -> PAR-21-119-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00265025 | May 04, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270565 | Nov 22, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278342 | Nov 14, 2022 | Jan 07, 2024 | View |
Package 1
Mandatory forms
330978 RR_SF424_2_0-2.0.pdf
330978 PHS398_CoverPageSupplement_5_0-5.0.pdf
330978 RR_OtherProjectInfo_1_4-1.4.pdf
330978 PerformanceSite_2_0-2.0.pdf
330978 RR_KeyPersonExpanded_2_0-2.0.pdf
330978 RR_Budget_1_4-1.4.pdf
330978 PHS398_ResearchPlan_4_0-4.0.pdf
330978 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
330978 RR_SubawardBudget30_1_4-1.4.pdf
330978 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
330978 RR_SF424_5_0-5.0.pdf
330978 PHS398_CoverPageSupplement_5_0-5.0.pdf
330978 RR_OtherProjectInfo_1_4-1.4.pdf
330978 PerformanceSite_4_0-4.0.pdf
330978 RR_KeyPersonExpanded_4_0-4.0.pdf
330978 RR_Budget_3_0-3.0.pdf
330978 PHS398_ResearchPlan_4_0-4.0.pdf
330978 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
330978 RR_SubawardBudget30_3_0-3.0.pdf
330978 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
330978 RR_SF424_5_0-5.0.pdf
330978 PHS398_CoverPageSupplement_5_0-5.0.pdf
330978 RR_OtherProjectInfo_1_4-1.4.pdf
330978 PerformanceSite_4_0-4.0.pdf
330978 RR_KeyPersonExpanded_4_0-4.0.pdf
330978 RR_Budget_3_0-3.0.pdf
330978 PHS398_ResearchPlan_5_0-5.0.pdf
330978 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
330978 RR_SubawardBudget30_3_0-3.0.pdf
330978 PHS_AssignmentRequestForm_3_0-3.0.pdf
Share This Post, Choose Your Platform!
About the Author: osnqt
