This NHLBI grant is for establishing a Data Coordinating Center (DCC) to support a phased, multi-site clinical trial focused on preventing cardiovascular disease in young adults at high lifetime risk. Utilizing a milestone-driven cooperative agreement, the DCC will provide essential overall project coordination, administration, data management, and biostatistical support. This initiative runs in parallel with a companion NOFO for a Clinical Coordinating Center (CCC), and applicants must demonstrate strong collaboration plans, particularly concerning community engagement, diversity, and reducing health inequities. The grant encourages innovative trial designs, including adaptive and Bayesian methodologies. Both DCC and CCC applications must be submitted concurrently. A Plan for Enhancing Diverse Perspectives (PEDP) is required.
Opportunity ID: 355311
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-25-007 |
| Funding Opportunity Title: | Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes – Data Coordinating Center (Collaborative U24 Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.837 — Cardiovascular Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jul 10, 2024 |
| Last Updated Date: | Jul 10, 2024 |
| Original Closing Date for Applications: | Oct 28, 2024 |
| Current Closing Date for Applications: | Oct 28, 2024 |
| Archive Date: | Dec 03, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Small businesses For profit organizations other than small businesses State governments Public and State controlled institutions of higher education Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Private 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 not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This NOFO will support applications to develop and implement a Data Coordinating Center (DCC) for a multi-site clinical trial among young adults without clinical atherosclerotic cardiovascular disease (ASCVD). It will utilize a milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO that encourages applications for a collaborating Clinical Coordinating Center (RFA-HL-25-010). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. The application should also describe its approaches to collaborate with the CCC (RFA-HL-25-010) on implementation of the clinical trial community engagement and diversity plans, as well as reducing health inequities. Clinical trials using innovative designs such as platform trials, adaptive, and Bayesian designs are welcomed. Applications for both a DCC and a Clinical Coordinating Center (CCC) must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP). |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-25-007.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 355311 Full Announcement-RFA-HL-25-007 -> RFA-HL-25-007-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 after January 25, 2023 | PKG00287298 | Sep 11, 2024 | Oct 28, 2024 | View |
Package 1
Mandatory forms
355311 RR_SF424_5_0-5.0.pdf
355311 PHS398_CoverPageSupplement_5_0-5.0.pdf
355311 RR_OtherProjectInfo_1_4-1.4.pdf
355311 PerformanceSite_4_0-4.0.pdf
355311 RR_KeyPersonExpanded_4_0-4.0.pdf
355311 RR_Budget10_3_0-3.0.pdf
355311 PHS398_ResearchPlan_5_0-5.0.pdf
355311 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
355311 RR_SubawardBudget10_30_3_0-3.0.pdf
355311 PHS_AssignmentRequestForm_3_0-3.0.pdf
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