Population Genomic Screening in Primary Care Cooperative Agreement (U01 - Clinical Trial Required) | RFA HG 24 021

Opportunity Information: Apply for RFA HG 24 021

The Population Genomic Screening in Primary Care Cooperative Agreement (U01 - Clinical Trial Required), RFA-HG-24-021, is an NIH funding opportunity aimed at launching a multi-site pilot program that tests how population-level genomic screening can be implemented in real-world primary care. The focus is on generating practical evidence about what works, for whom, and under what conditions when screening is offered broadly (not just to high-risk patients) for common, medically actionable genomic conditions. Because it is a U01 cooperative agreement, awardees should expect substantial NIH program involvement during planning and execution, and because it is designated as a clinical trial required mechanism, applicants need to be prepared to meet NIH expectations for clinical trial design, oversight, registration, and reporting.

At the core of the program is the requirement for participating sites to select, implement, and evaluate screening for a defined set of genomic conditions, specifically 4 to 8 conditions that are considered common enough and actionable enough to justify population screening. The emphasis on primary care signals that the program is not just about sequencing and returning results, but about integrating genomic screening into routine care pathways where most people receive healthcare. The intent is to test implementation in diverse populations and varied primary care environments, which often differ widely in resources, workflows, patient demographics, access to specialists, and local health system constraints. In practice, this means applicants are expected to propose approaches that can function in the day-to-day realities of clinics, including how patients are identified and invited, how consent is handled, how samples are collected, how results are returned and explained, and how downstream care is initiated and tracked.

A major pillar of the NOFO is meaningful community engagement throughout the project lifecycle. The expectation is not limited to outreach at the recruitment stage; instead, it includes involving communities in program design, implementation decisions, evaluation, and interpretation of findings. This is particularly important in genomic screening, where trust, understanding, cultural considerations, and historical experiences with research and healthcare systems can strongly influence participation, perceived benefits and harms, and follow-through with recommended care. Applicants should therefore anticipate the need for structured engagement strategies such as community advisory boards, partnerships with trusted local organizations, co-design of communication materials, feedback loops during rollout, and transparent handling of issues like privacy, data use, and potential implications for families.

Another central deliverable is building and testing effective strategies to connect individuals who are found to carry actionable genomic risk variants to appropriate follow-up care. Identifying risk is only clinically meaningful if patients can access confirmatory testing when needed, genetic counseling or education, specialist evaluation, preventive interventions, and ongoing management. The NOFO is explicitly pushing applicants to address the practical handoffs that often break down in genomic programs, such as referral pathways, insurance and cost barriers, provider readiness to act on results, patient navigation support, and ensuring that care recommendations are implemented over time. The results of this pilot are meant to strengthen the evidence base for how population genomic screening can be responsibly scaled in healthcare systems, especially in ways that do not widen existing disparities.

This funding opportunity operates alongside two companion solicitations that support the overall network: one for a Coordinating Center (RFA-HG-24-022) and one for a Sequencing Center (RFA-HG-24-023). That parallel structure signals a larger, coordinated initiative in which clinical sites funded under this NOFO will likely interface with centralized infrastructure for coordination, harmonization, and sequencing operations. Applicants should read the companion NOFOs closely because the division of responsibilities across the clinical sites, the Coordinating Center, and the Sequencing Center will shape how site proposals should be scoped, including what work is performed locally versus centrally and how data, operations, and reporting will be standardized across the program.

Eligibility is broad across U.S.-based entities, including state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The NOFO also calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it clearly excludes non-domestic (non-U.S.) entities from applying, disallows non-domestic components of U.S. organizations, and prohibits foreign components as defined by NIH policy. In short, the program is designed to be implemented entirely within the U.S. context and infrastructure.

Key administrative details include that the sponsoring agency is the National Institutes of Health, the funding instrument is a cooperative agreement (U01), the activity category is Health, and the CFDA number listed is 93.172. The original application due date is December 2, 2024, and the NOFO was created on August 14, 2024. While the excerpt provided does not specify an award ceiling or the expected number of awards, the structure and emphasis on multi-site implementation suggests NIH intends to fund multiple clinical site projects that collectively represent diverse settings and populations and that can contribute comparable data to an overall evidence-generation effort.

Overall, this NOFO is best understood as an implementation-focused population genomics pilot in primary care, designed to move beyond proof-of-concept sequencing projects and into the practical questions that determine whether genomic screening can be delivered equitably, responsibly, and effectively at scale. It prioritizes real-world workflow integration, community partnership, and reliable linkage to follow-up care, all within a coordinated network that includes central sequencing and program coordination support through companion awards.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Population Genomic Screening in Primary Care Cooperative Agreement (U01 - Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172.
• This funding opportunity was created on 2024-08-14.
• Applicants must submit their applications by 2024-12-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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