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

Frequently Asked Questions (FAQs)

What is this funding opportunity (RFA HL 26 007) about?

This opportunity supports the next phase of the Bench to Bassinet Pediatric Cardiac Genomics Consortium (PCGC) as it transitions into the B2B CHANGE Cohort (Congenital Heart disease Advancing New understanding in GEnomics). The intent is to extend the value of the existing PCGC participant cohort by enabling longer-term follow-up, richer clinical and phenotype data collection, and infrastructure that supports collaborative, multi-center research connecting genetic variation to real-world congenital heart disease (CHD) outcomes.

What does "B2B CHANGE Cohort" stand for?

B2B CHANGE stands for Congenital Heart disease Advancing New understanding in GEnomics. It is the program name for the PCGC's next-stage cohort effort focused on long-term follow-up and expanded phenotyping to better link genomics to CHD outcomes.

What are the main goals of the B2B CHANGE Cohort?

The mission is organized around three linked goals:

• Long-term clinical follow-up of people already enrolled in the original PCGC cohort to understand how CHD unfolds over time.
• Deeper phenotyping, meaning more detailed and standardized characterization of participants' clinical features (diagnoses, procedures, comorbidities, and other measurable traits) to strengthen genotype-phenotype associations.
• Enabling and accelerating ancillary studies by supporting additional multi-site collaborative projects and helping set the stage for future funding applications that leverage the cohort and its data resources.

Is this opportunity supporting a new cohort, or building on an existing one?

It is explicitly designed to build on the existing PCGC participant cohort. The core idea is to extend and increase the value of the cohort by following participants over a longer period and collecting more comprehensive and standardized data.

What NIH award mechanism is being used?

The mechanism is a single-source cooperative agreement (U01). The notice also specifies "clinical trial not allowed."

What does "cooperative agreement" imply for NIH involvement?

Because it is a cooperative agreement, NIH generally has substantial programmatic involvement compared with a standard grant. This is consistent with the opportunity's emphasis on coordinated, multi-center infrastructure and shared national resource functions.

Are clinical trials allowed under this U01?

No. The opportunity states "clinical trial not allowed."

What specific component or function is being funded?

The award specifically supports the Data Coordinating Center function, described in the notice as an Administrative Coordinating Center (ACC). The ACC is expected to serve as the operational hub that helps a distributed cohort operate as one coherent program.

What is the role of the Administrative Coordinating Center (ACC)?

Based on the notice, the ACC is responsible for operational and coordination functions that make the multi-site cohort work effectively, including improving data and resource management, ensuring consistent data collection/handling across sites, promoting effective data sharing, coordinating critical data collection efforts, and supporting participant outreach and follow-up coordination.

What types of data activities are emphasized for the ACC?

The ACC is expected to lead and improve data and resource management, help ensure data are collected and handled consistently across clinical research sites, and promote effective data sharing so the broader CHD research community can use the resource appropriately. The opportunity also emphasizes coordinating critical data collection efforts to support long-term follow-up and deeper phenotyping.

Does the ACC have responsibilities related to participants and follow-up?

Yes. The notice highlights coordination of participant outreach and follow-up at participating sites. This includes harmonizing workflows, maintaining communication channels, tracking follow-up, supporting retention activities, and helping sites meet common standards for data quality and completeness.

Is this effort intended to be a shared national research resource?

Yes. The opportunity emphasizes collaboration with site principal investigators and engagement with the larger CHD research community, reinforcing that the cohort and its resources are intended to be used as a shared national research resource rather than a siloed project.

What is meant by "deeper phenotyping" in this announcement?

In the context provided, deeper phenotyping means more detailed and standardized characterization of participants' clinical features and measurable traits. Examples mentioned include diagnoses, procedures, comorbidities, and other clinical/phenotypic data elements that can sharpen genotype-phenotype associations.

How does this opportunity connect genomics to clinical outcomes?

The overall design is to combine long-term follow-up with richer and more standardized clinical and phenotype data, and to provide infrastructure for multi-center collaboration. Together, these features aim to connect genetic variation to real-world CHD clinical trajectories and outcomes over time.

What is the maximum award amount (ceiling) listed?

The listed award ceiling is $4,010,000.

What is the opportunity's activity category and CFDA number?

The opportunity is described as a discretionary NIH opportunity under the Health activity category and lists CFDA 93.837.

When was this opportunity created and when does it close?

The creation date is 2025-01-10, and the closing date is 2025-03-18.

How many awards are expected?

The provided text does not specify the number of expected awards. However, it does state that the opportunity is single-source.

What does "single-source" mean for eligibility?

In this announcement, "single-source" is tied to a highly restricted eligibility statement: only Cincinnati Children's Hospital Medical Center is eligible to apply, even though a general category of eligible applicants is listed elsewhere.

Who is eligible to apply?

Eligibility is explicitly restricted to Cincinnati Children's Hospital Medical Center. Although the general eligible applicant category is listed as public and state-controlled institutions of higher education, the announcement states this particular opportunity is single-source and only that organization is eligible to apply.

Are non-U.S. (foreign) organizations eligible to apply?

No. The announcement states that non-U.S. entities (foreign organizations) are not eligible to apply. It also states that non-U.S. components of U.S. organizations are not eligible.

Are any types of international involvement allowed?

The notice indicates that foreign components (as defined in the NIH Grants Policy Statement) are allowed. This suggests certain international involvement may be permissible if structured as a foreign component within an eligible U.S.-led application and consistent with NIH policy, even though foreign organizations themselves are not eligible to apply.

What kinds of studies does the cohort aim to enable beyond the core follow-up work?

The opportunity emphasizes enabling and accelerating ancillary studies. These are additional, multi-site collaborative projects pursued by investigators that leverage the cohort and its data resources, including efforts that help set the stage for future funding applications built on the cohort infrastructure and data.

What is the practical value of long-term follow-up for this cohort?

The opportunity frames long-term follow-up as a way to move beyond cross-sectional snapshots and begin understanding how congenital heart disease unfolds across childhood and beyond, using ongoing clinical data to study trajectories and outcomes over time.