New NIH Policy Announced at Joint FDA-NIH Workshop on Reducing Animal Testing

By: Galen Cobb
Thursday, July 24, 2025
On July 7, the National Institutes of Health (NIH) held a joint workshop with the U.S. Food and Drug Administration (FDA) on Reducing Animal Testing. The workshop featured presentations on the agencies’ commitment to prioritizing New Approach Methods (NAMs) and reducing reliance on the use of animal models in their respective research portfolios. FDA and NIH leaders highlighted two recently announced initiatives: the FDA Roadmap to Reducing Animal Testing in Preclinical Studies and the proposed NIH Office of Research Innovation, Validation, and Application (ORIVA) initiative. 

FDA Commissioner Marty Markary, MD, MPH, discussed the historic nature of this transition within both agencies. Makary also noted that moving away from animal models will not be an overnight transition and will need to be done in a “stepwise, iterative fashion,” starting with the areas for which there is greatest evidence of success. 

NIH Deputy Director of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Nicole Kleinstreuer, PhD, discussed objectives for the recently announced NIH initiative to prioritize human-centered research.  

1. Establishment of an Office of Research Innovation, Validation, and Application (ORIVA): This new NIH office will formalize and coordinate the development, validation, and adoption of NAMs in partnership with FDA and other federal agencies.
2. Training and Infrastructure Development: NIH will train grant reviewers and regulatory staff, develop curricula, and expand infrastructure to support the accessibility and implementation of NAMs.
3. Funding Policy Reform and Public Accountability: NIH will change funding language to prioritize NAMs and stop accepting proposals focused exclusively on animal models, while also committing to publicly report research spending to track progress in reducing animal model use.

During her presentation, Kleinstreuer announced the implementation of one of these objectives: “NIH will no longer seek proposals exclusively for animal models.” This announcement was followed by a news release on the NIH Extramural Nexus, NIH Funding Announcements to Align with NIH Initiative to Prioritize Human-based Research, that detailed the new policy. NIH will no longer issue funding calls specifying use of animal model systems. Instead, NIH will issue Notices of Funding Opportunity (NOFOs) that allow for consideration of all available methodologies with the intent to “ensure investigators consider the models most appropriate for understanding human states of health and disease and are not constrained by the NOFO.” NOFOs excluding animal use entirely may be issued. 

A full recording of the workshop can be accessed here.

On July 14, FASEB submitted comments to the workshop’s open request, reiterating the points made in our June letter to NIH Director Jayanta “Jay” Bhattacharya that called for greater transparency and stakeholder engagement for new policies affecting the methodologies used by the biomedical and biological research community. A full transcript of FASEB’s comments can be accessed here.