The Foundation for National Institutes of Health (FNIH) is inviting the scientific community to submit project concepts to help them study New Approach Methodologies (NAMs). The goal is to build scientific confidence in human-based research models, with a focus on regulatory acceptance.
This initiative is part of the Complement-ARIE NAMs Validation & Qualification Network (VQN), a program managed by the FNIH in partnership with NIH and other federal and private stakeholders.
Applications must be submitted by Aug. 31, 2025 at 8 p.m. ET to be considered during the first cycle of review. After that, rolling reviews will be completed every one-two months, depending on the volume of submissions, through Dec. 31, 2025.
Open to Government, industry, academia, and NGOs.
Visit the FNIH-Seeking Concepts for NAMs Pilot Projects site to learn more.
Concept Requirements
Submitted concepts should clearly define the intended application and Context of Use (COU).
Examples for COU may include but are not limited to: safety evaluations for specific organ toxicities (e.g., hepatotoxicity, cardiotoxicity, etc.) for pharmaceuticals, consumer products, pesticides, and other regulated substances; prioritization of lead candidates in therapeutic pipelines; and delineation of specific disease processes.
Applicants are strongly encouraged to clearly define how their proposed concept may reduce, replace, or refine the use of live animals. Proposals without a defined 3Rs impact will be considered incomplete.
Concepts submitted through this RFI are not formal applications for funding. Instead, they will inform the strategic design of cooperative, precompetitive studies to advance human/species-relevant alternatives in biomedical research.
This is an opportunity to co-develop regulatory-ready NAMswith cross-sector stakeholders, including government, industry, academia, and NGOs.
Submission form title: Request for Information (RFI) on Concepts for New Approach Methodologies (NAMs) Precompetitive Projects for the Complement Animal Research In Experimentation (Complement-ARIE) NAMs Validation and Qualification Network (VQN) Public Private Partnership (PPP).