The 3Rs Collaborative, a US-based non-profit dedicated to advancing better science – for both people and animals – believes that progress in scientific research, the 3Rs, and NAMs must be measured by improved outcomes for patients and public health. We commend FDA-NIH efforts to advance the responsible use of New Approach Methodologies, defined as any approach that provides scientific information and supports replacement, reduction, or refinement of animal use (3Rs).

We recommend:

1. Increasing federal partnership with and funding for the 3Rs Collaborative. The 3Rs Collaborative should remain a key resource for the FDA and NIH, as we are the only non-partisan, non-profit in the United States that is balanced across all 3Rs and trusted by animal and non-animal researchers. We already collaborate with the FDA and NIH through the FNIH’s NAMs Validation and Qualification network, a PPP with FDA-CDER, and through federal representatives on our board and initiatives focused on AI and microphysiological systems.
   • To expand our reach, we recommend increased funding and establishing us as a U.S.-based, independent 3Rs center– modeled after the UK’s NC3Rs. Such a center would provide the infrastructure for sustained progress and unbiased training.
   • We also recommend mandating comprehensive 3Rs training as part of responsible conduct of research. We recently released our 3Rs Certificate Course which could fulfill such a requirement.

2. Prioritizing strategic partnerships across all scientific research. Meaningful culture change requires inclusive engagement across the scientific ecosystem – from laboratory animal veterinarians to in vitro scientists. This includes communications, workshops, and funding that are realistic, balanced, and evidence-based. Overpromising the current capacity of NAMs while dismissing the continued value of animal models risks alienating the very research organizations we need to reach while simultaneously undermining public trust in science.
3. Focusing on the most predictive models that incorporate all 3Rs to advance public health and patient outcomes. We urge federal agencies prioritize research with the highest scientific merit and potential impact, regardless of the model type, ensuring full implementation of all 3Rs. As replacement will not happen overnight, reduction and refinement should be pursued in parallel to promote ethical, translational research through good experimental design and improved animal welfare

Conclusion: A Call for 3Rs Partnership
The 3Rs Collaborative appreciates the opportunity to contribute to public dialogue. There is a clear need for funding on 3Rs research, education, reproducibility, translation, and dissemination. The convergence of regulatory willingness, technological advancement, and organizational support presents an immense opportunity. We remain committed to ongoing partnerships with FDA, NIH, ICCVAM, SACATM, federal agencies, and the broader scientific community to advance patient and public health outcomes through the responsible, evidence-driven implementation of the 3Rs. Please consider the 3Rs Collaborative as a resource and partner in these efforts.