CDER’s SEND (Standard for Exchange of Nonclinical Data) allows for data transfer to the FDA and other national regulatory agencies in a harmonized format allowing for more efficient and standardized regulatory review readable by Janus Nonclinical software. SEND mirrors the Study Data Tabulation Model (SDTM) used for clinical trial results. At present, tox studies fitting in the electronic Common Technical Document format (eCTD) modules 4.2.1.3 (Safety Pharmacology), 4.2.3.1 (Single Dose Toxicity), 4.2.3.2 (Repeat-Dose Toxicity), and 4.2.3.4 (Carcinogenicity) with study start dates on or after March 15, 2019 for NDA/BLA submissions and on or after March 15, 2020 for commercial IND submissions require data submission following the SENDIG 3.1 (SEND Implementation Guide version 3.1). New data standards will be needed for any studies started 24 months after the publication of a Federal Register Notice (FRN) announcing FDA support of the standard and placement on the FDA Data Standards Catalog. The FDA Office of Computational Science (OCS) currently offers a KickStart Program to assist applicants and reviewers in the SEND standard and data transfers to Janus Nonclinical.