Investigator Initiated Research in Computational Genomics and Data Science (R43/R44 Clinical Trial Not Allowed) | PAR 19 061

Opportunity Information: Apply for PAR 19 061

The NIH funding opportunity PAR 19 061, titled "Investigator Initiated Research in Computational Genomics and Data Science (R43/R44 Clinical Trial Not Allowed)," is a discretionary grant program designed specifically for small businesses pursuing commercialization-focused research and development. It uses the SBIR/STTR-style phased mechanisms (R43/R44) to support projects that move beyond purely academic research and instead aim to produce practical, market-ready computational products for the genomics community. While the announcement is framed around genomics, its real emphasis is on building broadly useful computational capabilities that can accelerate genomic science and translate across many areas of human health and disease rather than targeting a single disorder or niche use case.

The scope is intentionally broad and covers computational genomics, data science, statistics, and bioinformatics, with relevance to basic genomics research, clinical genomics research, or both. The kinds of projects NIH is trying to stimulate here include innovative analytical methods, new computational approaches, and commercializable software tools and platforms that address persistent technical bottlenecks in genomics. This can include early-stage development of tools and software (where a concept is being turned into a usable prototype) as well as later-stage refinement, "hardening," and maturation of existing tools that already show strong value but need engineering work to become robust, scalable, reliable, secure, maintainable, and user-friendly enough for wide adoption.

A central theme is that funded work should be enabling for genomics and broadly applicable. In practice, that means the proposed product should generalize across diseases, cohorts, and biological systems, and it should address needs that many genomics users face rather than being narrowly tailored to a single dataset, institution, or highly specific clinical workflow. The FOA is therefore a good fit for commercial products such as analysis pipelines, statistical frameworks, variant interpretation or prioritization tools, scalable infrastructure for genomic data processing, reproducible workflow systems, methods for integrating multi-omics data, approaches to quality control and benchmarking, and other computational technologies that make genomic analysis more accurate, efficient, interpretable, or reproducible. The emphasis on broad applicability also implies an expectation that the tool or method will be useful to the larger biomedical genomics community, not just to the applicant company or a single collaborator.

The activity category is health (CFDA 93.172), and the sponsoring agency is the National Institutes of Health. The announcement explicitly states that clinical trials are not allowed under this FOA, meaning applications should not propose studies that meet NIH's definition of a clinical trial (for example, prospective assignment of human participants to interventions to evaluate health-related outcomes). Projects can still be clinically relevant and can use clinical genomic data in appropriate ways, but they must remain within the bounds of computational research and product development rather than interventional clinical testing.

Eligibility is limited to small businesses. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. At the same time, the FOA notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed in some circumstances. In practical terms, this usually means the applicant organization must be U.S.-based and eligible as a small business, while certain well-justified parts of the work could potentially be performed abroad if NIH policy allows and if it is clearly necessary for the project. The listing provides an original closing date of 2021-09-05 and shows the opportunity was created on 2018-11-08. The public summary does not specify an award ceiling or expected number of awards in the provided fields, so applicants typically would need to consult the full FOA text and NIH standard SBIR/STTR guidelines for budget structure, phase expectations, and other program details.

Overall, this opportunity is aimed at helping small businesses turn advanced computational genomics ideas into real-world products by supporting both novel method development and the engineering work needed to make tools dependable and broadly usable. The strongest fits are projects that solve common, high-impact computational problems in genomics and can be adopted widely across different diseases, research settings, and clinical genomics contexts, without involving clinical trial activities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigator Initiated Research in Computational Genomics and Data Science (R43/R44 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): 93.172.
• This funding opportunity was created on 2018-11-08.
• Applicants must submit their applications by 2021-09-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 19 061

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: