Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01)

Electronic data standards are needed for the animal efficacy studies and natural history studies for Animal Rule applications (see 21 CFR 314.600-650 for drugs and 21 CFR 601.90-95 for biological products). CDER is seeking organization(s) to refine and complete its preliminary work in this area and to publish a complete set of voluntary consensus standards for these studies, incorporating the relevant current electronic data standards from Standard for Exchange of Nonclinical Data (SEND) and Study Data Tabulation Model (SDTM) and creating any new standards needed to characterize data from these studies.