Population Genomic Screening in Primary Care Sequencing Center (U01 - Clinical Trial Optional) | RFA HG 24 023

Opportunity Information: Apply for RFA HG 24 023

The Population Genomic Screening in Primary Care Sequencing Center grant opportunity (RFA-HG-24-023) is a National Institutes of Health (NIH) funding announcement seeking a dedicated Sequencing Center to serve a newly forming population screening network. The award mechanism is a U01 cooperative agreement, meaning the project is expected to be carried out with substantial programmatic involvement from NIH staff rather than functioning as a fully independent investigator-initiated grant. The activity area is health (CFDA 93.172), and the opportunity is labeled "Clinical Trial Optional," which signals that applicants may propose work that includes a clinical trial component if appropriate, but a trial is not strictly required by the announcement itself.

At its core, the NOFO is focused on building the sequencing and genomic analysis backbone for large-scale population genomic screening delivered through primary care settings. The selected Sequencing Center is expected to provide sequencing services for approximately 20,000 study participants, and to deliver the full downstream technical and clinical-lab-adjacent workflow needed to transform raw sequence data into actionable outputs. This includes variant calling (identifying genetic variants from sequencing data), annotation (adding relevant biological and clinical context to those variants), confirmation (verifying variants using appropriate orthogonal methods when needed), interpretation (assessing potential clinical significance), and reporting (returning results in a structured, usable form for the broader network). In practice, this means applicants need to demonstrate both high-throughput operational capacity and rigorous quality systems across the end-to-end process, from sample handling through final report generation.

This funding opportunity is part of a coordinated set of parallel solicitations intended to stand up an integrated network rather than a single standalone project. Specifically, it runs alongside companion NOFOs for the Clinical Groups (RFA-HG-24-021), which are expected to enroll participants and implement primary-care-facing workflows, and for the Coordinating Center (RFA-HG-24-022), which would typically oversee harmonization, logistics, data coordination, and network-level governance. The Sequencing Center funded under this NOFO would therefore be expected to operate in close collaboration with those awardees, aligning methods, timelines, data standards, and reporting practices so that sequencing outputs can be consistently used across multiple clinical sites and study populations.

Eligibility is broad and includes many common domestic applicant categories such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant types that NIH specifically encourages in many programs, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, there are clear restrictions on foreign involvement: non-U.S. (foreign) organizations are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed under this NOFO. In short, the work and the applicant organization must be fully domestic as defined by NIH.

Key administrative details from the posted listing include an original closing date of December 2, 2024, with the NOFO created on August 14, 2024. The listing describes the award as a cooperative agreement but does not provide an award ceiling or the expected number of awards in the excerpt provided, which typically means applicants should consult the full NOFO text for budget expectations, project period, and any limits or guidance on allowable costs and scale.

Overall, this opportunity is aimed at establishing a centralized, high-quality sequencing and interpretation operation that can reliably process and return genomic screening results at population scale within a primary care research framework. Success in this role depends on demonstrated capacity for throughput and turnaround time, robust analytical validity and quality management, strong variant curation and interpretation practices, and the ability to coordinate tightly with clinical and coordinating partners so results are consistent, clinically meaningful, and delivered in a way that supports the network's screening and research objectives.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Population Genomic Screening in Primary Care Sequencing Center (U01 - Clinical Trial Optional)" 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.

Apply for RFA HG 24 023

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