Discovery of the Genetic Basis of Childhood Cancers and of Structural Birth Defects: Gabriella Miller Kids First Pediatric Research Program (X01 Clinical Trial Not Allowed) | PAR 22 054

Opportunity Information: Apply for PAR 22 054

This NIH funding opportunity, offered under the Gabriella Miller Kids First Pediatric Research Program (Kids First), supports the generation of high-quality genomic (and related) data from existing pediatric cohorts so researchers can better understand the genetic drivers of childhood cancers and the genetic causes of structural birth defects. Rather than funding a traditional hypothesis-driven clinical study, the core purpose is to enable investigators who already have well-characterized pediatric samples and associated clinical or phenotypic information to submit those materials for sequencing at a Kids First-supported sequencing center. The resulting datasets are then integrated into the Kids First Data Resource, where they can be broadly used by the pediatric research community to accelerate discovery.

The scientific emphasis is on two major areas. First, the program encourages proposals that sequence existing pediatric cancer cohorts to clarify the genetic contribution to childhood cancers, including somatic alterations in tumors and germline variation that may affect risk, tumor biology, or outcomes. Second, it encourages proposals that expand the variety of conditions represented in the Kids First Data Resource for structural birth defects, with the goal of uncovering genetic etiologies across a wider range of congenital anomalies. In practical terms, applicants are expected to bring cohorts that are already assembled, with samples and accompanying data positioned for immediate sequencing and data sharing, so that the program can efficiently build a resource that supports many downstream studies.

While whole genome sequencing is central to the announcement, the opportunity is intentionally flexible about the specific assay types, as long as the proposed approach is justified by the scientific needs of the cohort and the questions the resulting data could help address. The program will consider whole genome sequencing, whole exome sequencing, transcriptome sequencing, and, when appropriate, epigenomic assays performed on tumor tissue or affected tissue. This flexibility recognizes that different diseases, tissue types, and cohort designs can benefit from different data modalities, and that combining modalities (for example, genome plus transcriptome, or genome plus epigenomic profiling) can improve interpretation of variants and disease mechanisms.

A key feature is the expectation that the genomic outputs will be paired with relevant clinical and phenotypic information and then deposited into the Kids First Data Resource. That means the value of an application is not only the sequencing itself, but also the quality, completeness, and utility of the accompanying metadata, since those contextual details are what make the genomic data reusable and interpretable for other investigators. In effect, the award supports the conversion of a cohort into a community resource: samples are processed through standardized sequencing pipelines at designated centers, and the combined genomic and clinical/phenotypic data become available for broad research use under the program’s data sharing framework.

Administratively, this is a discretionary NIH grant opportunity (Funding Opportunity Number PAR 22 054) within the health research category (CFDA 93.310). It is labeled "X01 Clinical Trial Not Allowed," indicating it is not intended to support prospective interventional clinical trials. The mechanism is structured around enabling access to sequencing and data generation rather than running a clinical intervention, and it is designed to complement the broader Kids First mission of building a shared pediatric data resource.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and additional "other" entities. The announcement also explicitly calls out additional eligible categories such as 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, eligible federal agencies, regional organizations, non-domestic (non-U.S.) entities, and U.S. territories or possessions. This breadth is meant to encourage participation from diverse institutions and to increase representation of different populations and disease cohorts within the Kids First Data Resource.

Key dates provided in the source include a creation date of 2021-11-01 and an original closing date of 2022-02-23. The listing does not specify an award ceiling or the expected number of awards in the provided fields, suggesting those details may be variable, handled through program-specific budgeting, or described elsewhere in the full solicitation package. Overall, the opportunity is best understood as an NIH-supported pathway for investigators with pediatric cancer or structural birth defect cohorts to obtain high-value sequencing and contribute those data, together with strong phenotypic and clinical annotation, to a centralized, widely usable Kids First resource intended to speed progress in pediatric disease genetics.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Discovery of the Genetic Basis of Childhood Cancers and of Structural Birth Defects: Gabriella Miller Kids First Pediatric Research Program (X01 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 2021-11-01.
• Applicants must submit their applications by 2022-02-23. (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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