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.Apply for RFA ES 17 008
- 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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Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Organotypic Culture Models developed from Experimental Animals for Chemical Toxicity Screening (R43)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-ES-17-008.
Which agency is offering this funding?
This is a National Institutes of Health (NIH) funding opportunity.
What type of program is this (SBIR/STTR/etc.)?
This is a Small Business Innovative Research (SBIR) solicitation.
What grant mechanism does this opportunity support?
The opportunity supports Phase I SBIR projects under the R43 mechanism, and it also allows Fast Track applications that combine Phase I and Phase II under the R44 mechanism.
What is the overall purpose of this funding opportunity?
The goal is to help small businesses develop improved lab-based (in vitro) models for chemical toxicity screening that better reflect what happens in living organisms, particularly the experimental animals commonly used in regulatory and research toxicology.
What scientific area does this program focus on?
It sits in the environment and health space and is associated with CFDA 93.113.
What kinds of models is NIH looking to fund?
NIH is looking for novel, physiologically relevant in vitro screening systems, including engineered three-dimensional (3D) tissue models and organotypic cultures, along with related advanced cell-based systems.
What cell sources are expected for the proposed models?
The models are expected to use cells derived from animal species routinely used in toxicity testing (experimental animals used in regulatory and research toxicology studies).
Are human cell-based models the focus of this announcement?
No. The models described here are specifically developed from experimental animal-derived cells rather than human cells.
How are these models expected to improve on traditional in vitro approaches?
Rather than relying on simplistic cell monolayers, the proposed systems should recreate key tissue-level features such as multicellular interactions, tissue architecture, and microenvironmental cues that shape real biological responses to chemicals.
Is it enough for a model to look like real tissue?
No. The emphasis is not only on realistic structure, but also on realistic function: the model should behave in ways that meaningfully mirror animal tissue or organ toxicology responses to chemical exposure.
What is a major requirement regarding assay results and readouts?
A major requirement is that assays and readouts should generate data that can be compared directly to in vivo animal toxicology outcomes.
Why is comparability to in vivo animal outcomes important in this FOA?
Comparability supports crosswalks between in vitro and in vivo findings. If a chemical produces a toxicity pattern in an animal organ, the in vitro model should be capable of reproducing relevant biological interactions and responses that align with that pattern, improving validation and interpretability.
What is meant by improving "crosswalks" between in vitro and in vivo findings?
It refers to strengthening the ability to relate (map) responses seen in an in vitro organotypic or 3D system to outcomes observed in whole-animal studies, so the in vitro results can be interpreted alongside established animal toxicology evidence.
What benefits are expected beyond screening chemicals?
These systems are also expected to improve scientific understanding of toxicity mechanisms by enabling more precise investigation of pathways and processes that can be difficult to isolate or measure in whole-animal studies.
How does this program relate to reducing animal testing?
Although the models use animal-derived cells, the long-term impact is framed around reducing overall reliance on animal testing by improving in vitro tools that can screen chemicals more efficiently, generate mechanistic insight, and help narrow which chemicals truly require in vivo follow-up.
Can these models replace animal tests entirely?
The opportunity is framed around reducing animal use where possible: by better predicting animal responses, these in vitro systems may help refine study designs, reduce animal numbers, or potentially replace certain animal tests, while still supporting chemical safety decisions.
Who is eligible to apply?
Eligibility is limited to small business concerns, consistent with SBIR rules.
Are foreign (non-U.S.) institutions eligible to apply?
No. The FOA is not open to non-U.S. (foreign) institutions as applicants.
Are non-domestic components of U.S. organizations eligible to apply?
No. The FOA states that non-domestic components of U.S. organizations are not eligible to apply.
Are "foreign components" allowed in any form?
Potentially yes. The FOA notes that "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.
What is the administrative type of this award?
This is a discretionary grant opportunity administered by NIH.
When was this funding opportunity created?
The opportunity was created on September 5, 2017.
What was the original closing date?
The original closing date was January 12, 2018.
What is the role of Phase I (R43) in this program?
Phase I is positioned as early-stage support to establish feasibility, demonstrate proof of concept, and reduce technical risk for the proposed organotypic/3D toxicity screening platform.
What is the purpose of the Fast Track option mentioned here?
Fast Track is intended for projects that can credibly describe a direct path from Phase I feasibility to more advanced Phase II development, with commercialization-oriented milestones.
What end use or impact is NIH aiming for with these platforms?
The program 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 moving toward reduced dependence on animal testing.
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| Population-Based Model Organism Research for G x E Exploration in Complex Disease Outcomes (R01 Clinical Trial Not Allowed) Apply for RFA ES 17 009 Funding Number: RFA ES 17 009 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $499,999 |
| Immuno-Oncology Translational Network (IOTN): Cancer Immunotherapy Research Projects (U01) Apply for RFA CA 17 045 Funding Number: RFA CA 17 045 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $500,000 |
| Outstanding New Environmental Scientist (ONES) Award (R01 Clinical Trial Optional) Apply for RFA ES 18 001 Funding Number: RFA ES 18 001 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Environmental Health Sciences Core Centers (EHS CC) (P30 Clinical Trial Optional) Apply for RFA ES 18 003 Funding Number: RFA ES 18 003 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Transition to Independent Environmental Health Research (TIEHR) Career Transition Award (K01 Clinical Trial Required) Apply for PAR 18 261 Funding Number: PAR 18 261 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Transition to Independent Environmental Health Research (TIEHR) Career Transition Award (K01 Clinical Trial Not Allowed) Apply for PAR 18 291 Funding Number: PAR 18 291 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| The Role of the Microbiome in the Developmental Origins of Health and Disease (DOHaD) (R01 Clinical Trial Not Allowed) Apply for RFA ES 18 005 Funding Number: RFA ES 18 005 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $400,000 |
| Revolutionizing Innovative, Visionary Environmental health Research (RIVER) (R35 Clinical Trial Not Allowed) Apply for RFA ES 18 004 Funding Number: RFA ES 18 004 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $600,000 |
| SBIR E-learning for HAZMAT and Emergency Response (R43/R44 Clinical Trial Not Allowed) Apply for RFA ES 18 006 Funding Number: RFA ES 18 006 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $100,000 |
| Exposure Analysis Services for the Environmental Influences on Child Health Outcomes (ECHO) Program (Admin Supp - Clinical Trial Not Allowed) Apply for PA 18 783 Funding Number: PA 18 783 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Novel Approaches for Characterizing Exposure and Response to Engineered Nanomaterials (R43 Clinical Trials Not Allowed) Apply for RFA ES 18 008 Funding Number: RFA ES 18 008 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) (D43)(Clinical Trial Optional) Apply for PAR 18 901 Funding Number: PAR 18 901 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Telomeres as Sentinels of Environmental Exposures, Psychosocial Stress, and Disease Susceptibility: A Methods Comparison Study (U01 Clinical Trial Optional) Apply for RFA AG 19 023 Funding Number: RFA AG 19 023 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $200,000 |
| Research Network on Telomeres as Sentinels of Environmental Exposures, Psychosocial Stress, and Disease Susceptibility (U24 Clinical Trial Not Allowed) Apply for RFA AG 19 022 Funding Number: RFA AG 19 022 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $345,000 |
| Human Health Exposure Analysis Resource: Data Repository, Analysis and Science Center (U2C Clinical Trial Not Allowed) Apply for RFA ES 18 014 Funding Number: RFA ES 18 014 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $1,700,000 |
| Human Health Exposure Analysis Resource: Coordinating Center (U24 Clinical Trial Not Allowed) Apply for RFA ES 18 010 Funding Number: RFA ES 18 010 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $700,000 |
| Human Health Exposure Analysis Resource: UnTargeted Exposure Analysis Laboratories (U2C Clinical Trial Not Allowed) Apply for RFA ES 18 012 Funding Number: RFA ES 18 012 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $1,500,000 |
| Human Health Exposure Analysis Resource: Targeted Exposure Analysis Laboratories (U2C Clinical Trial Not Allowed) Apply for RFA ES 18 011 Funding Number: RFA ES 18 011 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $1,500,000 |
| Human Health Exposure Analysis Resource: Environmental Exposure Analysis Laboratories (U2C Clinical Trial Not Allowed) Apply for RFA ES 18 013 Funding Number: RFA ES 18 013 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $700,000 |
| Maintain and Enrich Resource Infrastructure for Existing Environmental Epidemiology Cohorts (R24 Clinical Trial Not Allowed) Apply for RFA ES 18 009 Funding Number: RFA ES 18 009 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $250,000 |
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