Single Source: Bench to Bassinet Congenital Heart disease Advancing New understanding in GEnomics Cohort (B2B CHANGE Cohort) Data Coordinating Center (U01 Clinical Trial Not Allowed) | RFA HL 26 007

Opportunity Information: Apply for RFA HL 26 007

This funding opportunity (RFA HL 26 007) is an NIH single-source cooperative agreement (U01; clinical trial not allowed) focused on supporting the next phase of the Bench to Bassinet Pediatric Cardiac Genomics Consortium (PCGC) as it transitions into the B2B CHANGE Cohort, short for Congenital Heart disease Advancing New understanding in GEnomics. The core idea is to take the existing PCGC participant cohort and extend its value by following those individuals over a longer period of time, collecting richer clinical and phenotype data, and creating the infrastructure needed for collaborative, multi-center research that connects genetic variation to real-world congenital heart disease outcomes.

The B2B CHANGE Cohorts mission is built around three linked goals. First, it aims to conduct long-term clinical follow-up of people already enrolled in the original PCGC cohort, which allows researchers to move beyond cross-sectional snapshots and start understanding how congenital heart disease unfolds across childhood and beyond. Second, it emphasizes deeper phenotyping, meaning more detailed and standardized characterization of participants clinical features, diagnoses, procedures, comorbidities, and other measurable traits that can sharpen genotype-phenotype associations. Third, it is designed to enable and accelerate ancillary studies by supporting investigators who want to pursue additional, multi-site collaborative projects, including helping set the stage for applications for future funding that leverage the cohort and its data resources.

The award specifically supports the Data Coordinating Center function described here as an Administrative Coordinating Center (ACC). In practical terms, the ACC is expected to be the operational hub that makes a distributed cohort function like a single, coherent program. That includes leading and improving data and resource management, ensuring that data are collected and handled consistently across clinical research sites, and promoting effective data sharing so that the broader congenital heart disease research community can use the resource appropriately. It also includes coordinating critical data collection efforts and participant outreach at the participating sites, which typically involves harmonizing workflows, maintaining communication channels, tracking follow-up, supporting retention activities, and helping sites meet common standards for data quality and completeness. The opportunity also highlights that the ACC must work collaboratively with site principal investigators and engage with the larger CHD research community, reinforcing that this is intended as a shared national research resource rather than a siloed project.

From an administrative and funding standpoint, this is a discretionary NIH opportunity under the Health activity category (CFDA 93.837) and uses the cooperative agreement mechanism, which generally means NIH will have substantial programmatic involvement compared with a standard grant. The listed award ceiling is $4,010,000. The posting indicates a closing date of 2025-03-18 and a creation date of 2025-01-10. The notice does not specify the number of expected awards in the provided text, but it clearly indicates that it is single-source.

Eligibility is highly restricted. Although the general eligible applicant category is listed as public and state-controlled institutions of higher education, this particular announcement is explicitly single-source and states that only Cincinnati Children’s Hospital Medical Center is eligible to apply. The announcement also states that non-U.S. entities (foreign organizations) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. At the same time, it allows foreign components as defined in the NIH Grants Policy Statement, meaning certain types of international involvement may be permissible if structured as a foreign component within an eligible U.S.-led application, consistent with NIH policy.

Overall, this opportunity is about maintaining and upgrading the infrastructure that makes a major congenital heart disease genomics cohort usable over the long term: keeping participants connected, making follow-up data reliable and comparable across sites, ensuring resources are shared responsibly, and positioning the cohort to support the next wave of collaborative studies that link genetic findings to clinical trajectories and outcomes.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Single Source: Bench to Bassinet Congenital Heart disease Advancing New understanding in GEnomics Cohort (B2B CHANGE Cohort) Data Coordinating Center (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837.
• This funding opportunity was created on 2025-01-10.
• Applicants must submit their applications by 2025-03-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $4,010,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education.

Apply for RFA HL 26 007

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: