Organotypic Culture Models developed from Experimental Animals for Chemical Toxicity Screening (R43) | RFA ES 17 008

Opportunity Information: Apply for RFA ES 17 008

The grant opportunity titled "Organotypic Culture Models developed from Experimental Animals for Chemical Toxicity Screening (R43)" (Funding Opportunity Number RFA-ES-17-008) is a National Institutes of Health (NIH) Small Business Innovative Research (SBIR) solicitation aimed at helping small businesses build better lab-based models for chemical toxicity testing. It sits in the environment and health space (CFDA 93.113) and focuses on creating in vitro screening systems that more closely reflect what happens inside living organisms, especially the kinds of animals commonly used in regulatory and research toxicology studies.

The core goal is to fund Phase I (R43) SBIR projects, as well as Fast Track applications that combine Phase I and Phase II under the R44 mechanism, to develop novel, physiologically relevant experimental platforms. In practical terms, NIH is looking for engineered three-dimensional (3D) tissue models, organotypic cultures, and related advanced cell-based systems that use cells derived from animal species routinely used in toxicity testing. Rather than relying on simplistic cell monolayers, these proposed models should recreate key tissue-level features such as multicellular interactions, architecture, and microenvironmental cues that drive real biological responses to chemicals. The emphasis is not just on building a model that looks realistic, but on building a model that behaves in ways that meaningfully mirror animal tissue or organ toxicology.

A major requirement embedded in the announcement is that the resulting assays and readouts should produce data that can be compared directly to in vivo animal toxicology outcomes. The intention is to improve crosswalks between in vitro and in vivo findings: if a chemical causes a particular toxicity pattern in an animal organ, the in vitro organotypic or 3D model should be capable of reproducing relevant biological interactions and responses that align with that pattern. This comparative suitability matters because it supports validation, interpretability, and eventual uptake of these tools in chemical safety decisions. Along the way, these systems are expected to improve scientific understanding of toxicity mechanisms by enabling more precise investigation of pathways and processes that are difficult to isolate or measure in whole-animal studies.

Although the models are specifically developed from experimental animal-derived cells (rather than human cells), the long-term public health and research impact is framed around reducing overall reliance on animal testing. The announcement reflects a broader push in toxicology toward alternative approaches that can screen chemicals more efficiently, generate mechanistic insight, and reduce animal use where possible. By creating in vitro systems that better predict animal responses, researchers can potentially narrow down which chemicals truly require in vivo follow-up, refine study designs, or replace certain animal tests entirely, thereby reducing animal numbers and focusing animal studies only where they are most informative.

Eligibility is limited to small business concerns, consistent with SBIR rules, and the FOA is not open to non-U.S. (foreign) institutions as applicants. It also states that non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" may be allowed as defined under the NIH Grants Policy Statement, meaning a U.S. small business applicant may be able to include certain foreign activities or collaborations if they meet NIH policy requirements and are justified, but the applicant organization itself must be eligible and domestic.

Administratively, this is a discretionary grant opportunity administered by NIH, created on September 5, 2017, with an original closing date of January 12, 2018. The FOA is positioned as an early-stage innovation catalyst: Phase I funding is typically meant to establish feasibility, demonstrate proof of concept, and de-risk the technical approach, while Fast Track is designed for projects that can credibly outline a direct path from feasibility to more advanced development and commercialization-oriented milestones. Overall, the opportunity is centered on accelerating robust, animal-relevant in vitro toxicity screening platforms that produce interpretable, comparable data and support modern strategies for chemical exposure and hazard assessment while working toward reduced dependence on animal testing.

• 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)" 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 2017-09-05.
• Applicants must submit their applications by 2018-01-12. (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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