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.Apply for PAR 19 061
- 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.
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FAQs: NIH PAR-19-061 - Investigator-Initiated Research in Computational Genomics and Data Science (R43/R44 Clinical Trial Not Allowed)
What is PAR-19-061?
PAR-19-061 is a National Institutes of Health (NIH) funding opportunity titled "Investigator Initiated Research in Computational Genomics and Data Science (R43/R44 Clinical Trial Not Allowed)." It supports commercialization-focused research and development by small businesses building computational products for the genomics community.
What type of funding mechanism does this opportunity use?
This opportunity uses SBIR/STTR-style phased small business grant mechanisms: R43 and R44. These mechanisms are designed to support development work that moves toward practical, market-ready products rather than purely academic research outputs.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the program's main goal?
The main goal is to help small businesses turn advanced computational genomics and data science ideas into broadly useful, real-world products. The emphasis is on enabling capabilities that accelerate genomic science and translate across many areas of human health and disease, rather than tools aimed at a single disorder or highly niche use case.
Is this grant intended for academic research or commercialization-focused development?
It is designed specifically for commercialization-focused R&D. While it can include innovative methods and algorithms, the expectation is that the work advances toward a usable product (for example, a tool, software platform, workflow system, or scalable analysis capability) that can be adopted widely.
What scientific and technical areas are within scope?
The scope is intentionally broad and includes computational genomics, data science, statistics, and bioinformatics. Projects may be relevant to basic genomics research, clinical genomics research, or both, as long as they stay within computational research and product development boundaries.
What kinds of projects is NIH trying to stimulate under this FOA?
NIH is trying to stimulate innovative analytical methods, new computational approaches, and commercializable software tools and platforms that address persistent technical bottlenecks in genomics. This includes both early-stage prototype development and later-stage engineering work to mature existing tools.
Are both early-stage and later-stage development efforts eligible?
Yes. The opportunity can support early-stage development where a concept becomes a usable prototype, as well as later-stage refinement and "hardening" of tools that already demonstrate value but need engineering improvements to become robust and broadly adoptable.
What does "hardening" or maturation mean in this context?
In this FOA, maturation refers to engineering work needed to make software or computational systems more robust, scalable, reliable, secure, maintainable, and user-friendly, so they can be adopted widely by the genomics community.
What does NIH mean by "broadly useful" or "enabling" for genomics?
Funded work is expected to be enabling for genomics and broadly applicable, meaning the product should generalize across diseases, cohorts, and biological systems. The intent is to support tools that meet common needs across many genomics users, rather than solutions narrowly tailored to one dataset, one institution, or a highly specific workflow.
Can a project be clinically relevant and still fit this FOA?
Yes. Projects can be clinically relevant and can use clinical genomic data in appropriate ways, as long as the work remains computational research and product development and does not cross into activities that meet NIH's definition of a clinical trial.
Are clinical trials allowed under PAR-19-061?
No. The FOA explicitly states "Clinical Trial Not Allowed." Applications should not propose studies that meet NIH's definition of a clinical trial, such as prospective assignment of human participants to interventions to evaluate health-related outcomes.
If clinical trials are not allowed, what kind of work is still acceptable?
Acceptable work includes computational method development, software/tool development, platform engineering, workflow and reproducibility systems, data processing infrastructure, and other non-interventional activities focused on improving genomic analysis. The key is staying within computational R&D and avoiding prospective interventional testing that would be considered a clinical trial.
What are some example product types that align with this opportunity?
Examples mentioned or implied by the opportunity include analysis pipelines, statistical frameworks, variant interpretation or prioritization tools, scalable infrastructure for genomic data processing, reproducible workflow systems, methods for integrating multi-omics data, and approaches to quality control and benchmarking.
Is the opportunity limited to genomics only, or can it support broader computational capabilities?
Although framed around genomics, the emphasis is on broadly useful computational capabilities that can accelerate genomic science and translate across many areas of human health and disease. The focus is on capabilities that many genomics users can apply across contexts.
Who is eligible to apply?
Eligibility is limited to small businesses.
Are foreign institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible to apply?
No. Non-U.S. components of U.S. organizations are also not eligible to apply.
Does the FOA allow any work to be performed outside the United States?
The FOA notes that "foreign components," as defined in the NIH Grants Policy Statement, may be allowed in some circumstances. In practical terms, the applicant organization must be a U.S.-based eligible small business, while certain well-justified parts of the work could potentially be performed abroad if NIH policy allows and if that foreign component is clearly necessary for the project.
What is the activity category and CFDA listing?
The activity category is health, and the CFDA listing provided is 93.172.
What are the key dates provided for this opportunity?
The public listing indicates the opportunity was created on 2018-11-08 and shows an original closing date of 2021-09-05.
Does the provided summary include an award ceiling or expected number of awards?
No. The provided fields do not specify an award ceiling or an expected number of awards. Applicants typically would need to consult the full FOA text and NIH SBIR/STTR guidelines for details on budgets, phase expectations, and other requirements.
What should a strong-fit application emphasize based on this summary?
A strong-fit application should emphasize solving common, high-impact computational problems in genomics with a product that is broadly applicable and adoptable across diseases and settings. It should focus on practical development and/or engineering maturation and avoid proposing any clinical trial activities.
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