Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway

This information collection request collects information from sponsors of new animal drug applications who wish to submit pre-market information to Center for Veterinary Medicine (CVM) using the FDA Electronic Submissions Gateway (ESG). These types of documents are listed in public docket FDA-1992-S-0039 as required by 21 CFR 11.2. CVM's guidance # 108 entitled "Guidance for Industry: How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway," outlines general standards to be used for the submission of any electronic information to CVM using the FDA ESG, including how to register with CVM's Electronic Submission System (ESS).

The latest form for Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway expires 2022-11-30 and can be found here.