The FDA Center for Veterinary Medicine (CVM) eSubmitter programs allow users to electronically and securely submit information to the center. With the help of templates, these programs walk users through the process of submitting a complete and structured submission to CVM for review. The programs contain a number of question-based tools that capture information in a structured format and provide helpful dialog boxes to reduce redundant responses.
Users can easily download the programs for free directly from FDA’s website, and the programs require minimal configuration by users.
Current CVM eSubmitter Programs
There are currently three CVM eSubmitter programs for various types of submissions:
- CVM eSubmitter Program for Animal Drugs—Office of New Animal Drug Evaluation (ONADE) for drug companies to submit information related to the approval of animal drugs.
- CVM eSubmitter Program for Drug Experience Reports (DERs) for Approved Animal Drugs—Office of Surveillance and Compliance (OSC) for drug companies to submit Form FDA 2301 (“Transmittal of Periodic Reports and Promotional Material for New Animal Drugs”) and Form FDA 3744 (“Antimicrobial Animal Drug Distribution Report”).
- CVM eSubmitter Program for Animal Food Ingredients—Office of Surveillance and Compliance’s Division of Animal Food Ingredients (OSC DAFI) for companies to submit food additive petitions, generally recognized as safe Notices, and Investigational Food Additive files.
Before using any of the above programs, users must complete these three steps:
- Register for the FDA Electronic Submission Gateway.
- Register for the CVM Electronic Submission System.
- Download and install the CVM eSubmitter tool.
The CVM eSubmitter tool has the following benefits:
- It helps CVM more quickly respond to feedback from stakeholders on the templates, fix bugs, and make improvements.
- It is focused strictly on the specific needs of CVM’s stakeholders when submitting electronic submissions to the center.
- It helps CVM meet the goals set by the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act.
- It helps CVM improve the process for reviewing regulatory information.
- It helps CVM integrate the eSubmitter technology with the center’s internal IT systems.
CVM eSubmitter Webinar Series
This webinar series discusses how to register for both the FDA Electronic Submission Gateway and the CVM Electronic Submission System and how to use the CVM eSubmitter tool. For the links to the webinar materials, see the CVM eSubmitter Resource Center page under “CVM eSubmitter Webinar Series Resources.”
- Getting Started with eSubmitter
- CVM eSubmitter Resource Center
- Download the CVM eSubmitter Tool
- CVM eSubmitter Application History