Testing Centers for Evaluation of Somatic Cell Genome Editing Approaches for Translational Applications (U42 Clinical Trial Not Allowed)

This Notice of Funding Opportunity (NOFO) seeks to fund up to three Testing Centers that will provide pre‑clinical evaluation services for somatic cell genome‑editing technologies. Centers will develop in‑vivo and in‑vitro models, create standard operating procedures, and offer fee‑for‑service testing to NIH‑funded investigators and the broader biomedical community. The effort emphasizes new approach methodologies (NAMs) and aims to generate data on efficacy, safety, off‑target effects, and feasibility for therapeutic applications. Funding is provided via a Cooperative Agreement with a ceiling of $900,000 and a floor of $580,000 per award. • Up to three centers to be funded, each receiving $580‑$900 K. • Scope includes assay development, SOP creation, and fee‑for‑service testing of genome‑editing tools. • Centers must support NIH investigators and external users, offering both in‑vivo and in‑vitro (including NAM) models. • Emphasis on translational relevance, safety profiling, and reproducibility of genome‑editing approaches. • Cooperative Agreement (CA) mechanism; award expected July 2028 with project start August 2028.