Limited Competition: Genome Sequencing Center for the Gabriella Miller Kids First Pediatric Research Program (U24 Clinical Trial Not Allowed) | RFA RM 21 013

Opportunity Information: Apply for RFA RM 21 013

The NIH funding opportunity titled "Limited Competition: Genome Sequencing Center for the Gabriella Miller Kids First Pediatric Research Program (U24 Clinical Trial Not Allowed)" (RFA-RM-21-013) supports renewal of one or more Genome Sequencing Centers that serve the Kids First Pediatric Research Program. The core aim is to rapidly produce high-quality, research-grade genomic and functional genomics datasets at scale from human specimens tied to two major pediatric disease areas: childhood cancers and structural birth defects. The sequencing centers funded through this announcement are expected to generate consistent, robust data outputs that can be broadly shared and reused by the research community, accelerating discovery across many studies rather than serving a single project.

This FOA emphasizes comprehensive data generation across multiple assay types. It calls for production of whole-genome sequencing and variant data, RNA sequencing, and long-read sequencing, alongside genome-wide methylation profiling and chromatin accessibility data. In practical terms, that means awardees are expected to deliver not only DNA-level variant calls and sequence reads, but also layers of regulatory and expression information that help explain how variants may affect gene activity and cellular behavior. By including epigenomic assays such as methylation and chromatin accessibility, the program is positioned to support deeper mechanistic work, such as identifying regulatory disruptions, tumor-specific epigenetic patterns, or developmental pathways implicated in congenital anomalies.

A central structural feature of the program is the separation between data generation and data harmonization/public distribution. While the Genome Sequencing Center(s) produce the primary data, all outputs generated under this FOA will be re-processed and harmonized by the Gabriella Miller Kids First Pediatric Data Resource Center (Kids First DRC). The DRC is responsible for standardizing datasets so they can be compared across projects, ensuring consistent processing pipelines, quality control, metadata alignment, and integration across different contributing studies. The DRC also maintains a public-facing, cloud-based platform that allows researchers to search, access, aggregate, analyze, and share annotated datasets spanning genomic sequences, genomic variants, epigenomic and transcriptomic profiles, and associated phenotypic data. The overall design is meant to reduce fragmentation in pediatric genomics, making it easier for scientists to combine cohorts, replicate findings, and pursue cross-cutting questions that span cancer and birth defects.

The award mechanism is a cooperative agreement (U24), meaning NIH expects substantial programmatic involvement compared with a standard research grant. Cooperative agreements typically involve close coordination with NIH staff, shared expectations around deliverables and timelines, and active participation in program-wide governance, standards, and reporting. The FOA explicitly states "Clinical Trial Not Allowed," signaling that proposed activities should focus on data generation and resource-building rather than testing clinical interventions or conducting clinical trial research as defined by NIH.

Eligibility is limited. The FOA is described as a limited competition and lists eligible applicants as public and state-controlled institutions of higher education. It also clearly restricts foreign involvement: non-U.S. entities (foreign institutions) cannot apply; non-domestic components of U.S. organizations are not eligible; and foreign components, as defined in the NIH Grants Policy Statement, are not allowed. These restrictions mean the sequencing work and supported activities must be carried out within allowable U.S.-based organizational structures.

In terms of basic administrative details, the opportunity is categorized as discretionary funding, with a health focus under CFDA 93.310. The announcement was created on August 17, 2021, and the original closing date was October 29, 2021. The listed award ceiling is $7,200,000. While the notice references expected awards, the provided source text does not include a specific number, but the intent is to support renewal of Genome Sequencing Center capacity for the Kids First program.

Overall, this FOA is aimed at sustaining national-scale sequencing and functional genomics capacity dedicated to pediatric cancer and structural birth defects, with an emphasis on speed, quality, consistency, and broad data sharing. The sequencing centers are not meant to operate as isolated service cores; they are part of an integrated pipeline where the Kids First DRC standardizes and disseminates the resulting data through a cloud-based platform, enabling the wider pediatric research community to perform large-scale analyses and collaborative studies using harmonized multi-omic and phenotype-linked datasets.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Genome Sequencing Center for the Gabriella Miller Kids First Pediatric Research Program (U24 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): 93.310.
• This funding opportunity was created on 2021-08-17.
• Applicants must submit their applications by 2021-10-29. (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 $7,200,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education.

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