NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders (X01 - Clinical Trial Not Allowed) | PAR 22 194

Opportunity Information: Apply for PAR 22 194

The NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders opportunity (PAR 22-194) is a National Institutes of Health (NIH) grant mechanism designed to expand and strengthen the Trans-Omics for Precision Medicine (TOPMed) program by generating new, large-scale omics and phenotype datasets focused on heart, lung, blood, and sleep (HLBS) disorders. The main purpose is to help the field move beyond identifying genetic associations (the "map") and toward understanding how those associations actually cause disease (the "mechanism"), often described as a transition from Map to Mechanism (M2). In practical terms, the FOA is looking for projects that can produce integrated genetic and multi-omics data in areas where TOPMed’s existing resources do not yet provide enough coverage, depth, population diversity, disease representation, or relevant phenotypic detail to fully answer key biological questions.

A defining feature of this FOA is that it uses the X01 activity code and explicitly provides no direct funding to the applicant. Instead of supplying dollars for research expenses, the program primarily offers access to TOPMed-supported capabilities and infrastructure to generate omics data at scale, with the expectation that applicants bring well-phenotyped samples and strong scientific rationales for why new omics profiling would fill a major gap in current datasets. This structure is meant to accelerate community access to high-quality, standardized multi-omics resources by leveraging centralized TOPMed processes, rather than having many separate labs produce smaller, less harmonized datasets. The FOA also notes that clinical trials are not allowed, meaning applications must be focused on observational research, biospecimen-based analyses, data generation, and related discovery work rather than interventional human studies.

The work supported through this program centers on producing and integrating genetic and multi-omics information to clarify molecular pathways that contribute to HLBS conditions. While the FOA summary does not list every assay type, "multi-omics" in TOPMed contexts commonly refers to combinations of genome-wide sequencing or genotyping with other layers such as transcriptomics, epigenomics, proteomics, metabolomics, and other molecular phenotypes, paired with carefully curated clinical and physiological measurements. The emphasis on "omics phenotypes" signals that the program is not only interested in DNA sequence variation, but also in molecular readouts that sit between genes and disease traits, helping researchers identify causal mechanisms, regulatory effects, biomarkers, and potential therapeutic targets.

Another core expectation is broad data sharing. Omics outputs and the associated phenotypic data are intended to be deposited into NIH-designated controlled-access repositories, specifically calling out dbGaP (the Database of Genotypes and Phenotypes) and NHLBI’s BioData Catalyst (BDC). Controlled access means the data become widely available to qualified investigators under NIH data use and governance rules, helping maximize scientific return, promote reproducibility, and enable secondary analyses across studies. This also implies that applicants must be prepared for the consent, privacy, governance, and data harmonization requirements that come with generating datasets destined for public controlled-access distribution.

In terms of who can apply, eligibility is broad and spans many organization types. The FOA allows applications from state, county, city, township, and special district governments; public housing authorities; independent school districts; and a wide range of academic institutions including public and state-controlled universities, private institutions of higher education, and other research-performing organizations. It is also open to nonprofit organizations both with and without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses. Importantly, it highlights inclusion of institutions and organizations that expand participation across communities and geographies, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as tribal governments and tribal organizations, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) entities. This breadth aligns with TOPMed’s broader goals of improving representation and ensuring that omics reference resources are relevant across diverse populations.

From an administrative standpoint, this is a discretionary NIH grant opportunity categorized under health research and linked to multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840), reflecting NHLBI’s involvement across heart, lung, blood, and related research areas. The opportunity was created on June 1, 2022, and the listed closing date is October 17, 2024. While typical grant announcements include an award ceiling and expected number of awards, those fields are not specified here, and the most important operational detail remains that the FOA does not provide funds directly, instead supporting omics data generation and deposition through TOPMed program resources.

Overall, this FOA is best understood as an access pathway into the TOPMed data-generation ecosystem for investigators who have valuable cohorts, samples, and phenotypes relevant to HLBS disorders, and who can clearly justify how new multi-omics profiling would fill a meaningful gap in existing TOPMed datasets. The end product is not just a single-study dataset for the applicant, but a community resource that can power large-scale mechanism-focused discovery when combined with other TOPMed and NIH datasets in dbGaP and BioData Catalyst.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders (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): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2022-06-01.
• Applicants must submit their applications by 2024-10-17. (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 PAR 22 194

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