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.Apply for RFA ES 20 005
- 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.
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Frequently Asked Questions (FAQs)
What is the title and identifier of this grant opportunity?
The opportunity is titled "Organotypic Culture Models developed from Experimental Animals for Chemical Toxicity Screening (R43/R44 Clinical Trial Not Allowed)" and is identified as RFA-ES-20-005.
What type of funding program is this?
This is an NIH Small Business Innovative Research (SBIR) funding announcement. It uses the SBIR phased award structure and is intended to support small businesses developing innovative technologies.
What is the main goal of the funding announcement?
The central goal is to support the development of more physiologically relevant in vitro screening systems for chemical toxicity testing. The program is especially interested in advanced 3D engineered tissues and organotypic culture models that better reflect how real animal tissues behave.
What kinds of models are specifically encouraged?
The announcement emphasizes advanced 3D engineered tissues and organotypic culture models developed using cells taken from animal species that are commonly used in traditional toxicology studies.
Why does the FOA focus on animal-derived cells for in vitro models?
The FOA is targeting the gap between in vitro screening and in vivo animal toxicology. By using animal-derived cells from commonly studied toxicology species, the program aims to improve alignment between results generated in the lab (in vitro) and results observed in animal studies (in vivo).
How should the proposed in vitro systems perform from a toxicology standpoint?
A key emphasis is that the in vitro systems should reproduce toxicological responses observed in animal organs or tissues in vivo. In other words, NIH is looking for platforms whose assay results line up well with outcomes from animal studies so meaningful comparisons can be made.
What problem is NIH trying to address with this funding announcement?
The announcement highlights that many existing in vitro assays are not predictive enough to replace or reduce animal testing. NIH is seeking improved model systems that better capture complex biological interactions (multiple cell types and tissue structures) that often drive toxicity outcomes.
What is meant by "organotypic culture model" in the context of this opportunity?
Based on the description provided, organotypic culture models refer to in vitro systems designed to reflect key features of real tissues, including relevant tissue structure and interactions between different cell types, rather than simplified flat (2D) cell cultures.
Does this funding support organ-on-chip platforms?
The information provided emphasizes models built from animal-derived cells rather than "purely human organ-on-chip platforms." The stated intent is to strengthen comparability to animal in vivo toxicology outcomes.
How does this program relate to reducing animal use in toxicology?
The intent is that stronger in vitro-to-in vivo alignment can improve screening and refine study design, which could reduce unnecessary animal use over time. The focus is on developing in vitro platforms that better predict animal study results.
What award phases and application options are available?
The funding mechanism follows SBIR phases and allows for Phase I (R43), Phase II (R44), Direct Phase II (R44), and Fast Track (R44) applications that combine Phase I and Phase II into a single submission.
What is the purpose of Phase I (R43) for this opportunity?
Phase I (R43) is described as supporting early feasibility work and establishing proof of concept for the proposed technology or model system.
What is the purpose of Phase II (R44) for this opportunity?
Phase II (R44) is described as supporting expanded development, further validation, and refinement of the technology beyond early feasibility.
What is a Direct Phase II (R44) application in this FOA?
A Direct Phase II (R44) option is available for projects that are ready to skip initial feasibility because they already have strong preliminary data.
What is a Fast Track (R44) application in this FOA?
A Fast Track (R44) application combines Phase I and Phase II plans into a single, streamlined submission.
Are clinical trials allowed under this funding announcement?
No. The opportunity is labeled "Clinical Trial Not Allowed," which means the funded work cannot include clinical trials. This aligns with the focus on non-clinical toxicity screening technology development.
Who is eligible to apply?
Eligible applicants are limited to U.S. small business concerns, consistent with SBIR rules.
Are foreign institutions eligible to apply as the applicant organization?
No. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible as applicant components.
Can a U.S. applicant include any foreign components or collaborations?
The FOA notes that foreign components may be allowed in some cases as defined by the NIH Grants Policy Statement. This typically means a U.S. applicant might include a justified foreign collaboration or project element if it is necessary and consistent with NIH policy requirements.
What federal program area and administrative category does this opportunity fall under?
It is an NIH discretionary grant within the environment and health activity area.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.113.
When was the FOA created and what was the original closing date?
The FOA was created on 2019-10-10 and had an original closing date of 2020-01-03.
Is an award ceiling or expected number of awards provided in the summary?
No. The information provided does not list an award ceiling or the expected number of awards.
What is the overall commercial or practical intent of the program?
The opportunity is intended to stimulate development of commercially relevant screening platforms that small businesses can advance toward broader adoption for chemical toxicity testing workflows.
What distinguishes the models sought here from traditional cell culture approaches?
The FOA contrasts the desired models with "flat, simplified cell cultures" and emphasizes systems that incorporate more realistic tissue biology, including complex interactions among cell types and tissue structures that can influence toxicity outcomes.
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