Organotypic Culture Models developed from Experimental Animals for Chemical Toxicity Screening (R43/R44 Clinical Trial Not Allowed) | RFA ES 20 005

Opportunity Information: Apply for RFA ES 20 005

This grant opportunity, titled "Organotypic Culture Models developed from Experimental Animals for Chemical Toxicity Screening (R43/R44 Clinical Trial Not Allowed)" (RFA-ES-20-005), is an NIH Small Business Innovative Research (SBIR) funding announcement aimed at helping small businesses build more realistic lab-based models for chemical safety testing. The central goal is to support development of physiologically relevant in vitro screening systems, especially advanced 3D engineered tissues and organotypic culture models, made using cells taken from animal species that are commonly used in traditional toxicology studies. Instead of relying only on flat, simplified cell cultures, the program is looking for models that better capture how real animal tissues behave, including the complex biological interactions between different cell types and tissue structures that often drive toxicity outcomes.

A key emphasis of the announcement is that the in vitro systems should reproduce toxicological responses that are observed in animal organs or tissues in vivo. In practical terms, NIH is pushing for platforms that can generate assay results that line up well with animal study outcomes, so researchers and regulators can make meaningful comparisons between what happens in a dish and what happens in an animal. That comparability is important because many existing in vitro assays are not predictive enough to replace or reduce animal testing. By funding models built from animal-derived cells (rather than, for example, purely human organ-on-chip platforms), the FOA is specifically targeting the gap between in vitro screening and in vivo animal toxicology, with the idea that stronger in vitro-to-in vivo alignment could improve screening, refine study design, and reduce unnecessary animal use over time.

The funding mechanism is structured around SBIR phases, meaning it supports early feasibility work as well as more advanced development and validation. Applicants can propose Phase I (R43) projects to establish proof of concept, Phase II (R44) projects to expand and further validate and refine the technology, Direct Phase II (R44) for projects that are ready to skip initial feasibility because they already have strong preliminary data, and Fast Track (R44) applications that combine Phase I and Phase II plans into a single streamlined submission. The "Clinical Trial Not Allowed" label clarifies that the funded work cannot include clinical trials, which fits the scope since the work centers on non-clinical toxicity screening technology development.

Eligible applicants are limited to U.S. small business concerns, consistent with SBIR rules. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the FOA notes that foreign components may be allowed in some cases as defined by the NIH Grants Policy Statement, which typically means a U.S. applicant might include a justified foreign collaboration or element if it is necessary for the project and meets NIH policy requirements, even though the primary applicant organization must be domestic.

Administratively, the opportunity is a discretionary grant under the NIH, within the environment and health activity area, with CFDA number 93.113. The FOA was created on 2019-10-10 and had an original closing date of 2020-01-03. While the summary information provided does not list an award ceiling or the expected number of awards, the intent is clearly to stimulate development of commercially relevant screening platforms that small businesses can advance toward broader adoption. Overall, the announcement is about building better animal-cell-based 3D and organotypic test systems that reflect real tissue biology, yield data that can be compared to animal study results, and ultimately support more efficient and potentially less animal-intensive chemical toxicity testing workflows.

• The National Institutes of Health in the environment, health sector is offering a public funding opportunity titled "Organotypic Culture Models developed from Experimental Animals for Chemical Toxicity Screening (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): 93.113.
• This funding opportunity was created on 2019-10-10.
• Applicants must submit their applications by 2020-01-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for RFA ES 20 005

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