This draft guidance describes the electronic submission of certain data and information in standardized formats, and supersedes the previously issued draft guidance for industry Providing Submissions in Electronic Format — Summary Level Clinical Site Data for CDER’s Inspection Planning. This guidance applies to electronic submissions of data and information from all major (i.e., pivotal) studies used to support safety and efficacy claims in new drug applications (NDAs), biologics license applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER), and supplemental applications containing new clinical study reports. It also applies when these data and information are submitted in certain investigational new drug applications (INDs) in advance of a planned NDA, BLA, or supplemental submission.