CVM eSubmitter Program
The CVM Only Version of eSubmitter is now available for download!
The CVM eSubmitter tool is an electronic, question-based submission tool for creating information to be transmitted electronically to FDA through its secure Electronic Submission Gateway (ESG). eSubmitter uses data-capturing templates to allow users to assemble a complete and appropriately structured submission to CVM. The templates, available for all submission types varying from simple to complex, were developed by CVM subject-matter experts. The tool was originally developed on March 11, 2011, for submissions to the Office of New Animal Drug Evaluation (ONADE). Since the initial release of the ONADE Program, CVM's eSubmitter has been expanded to include the OMUMs Indexing Program, OSC Drug Experience Report Program, and the OSC Division of Animal Feeds Program. The eSubmitter program is a free program that is designed to minimize redundant data entry while collecting data in a structured format. In August 2017 CVM released their own version of the eSubmitter tool. The new version provides stakeholders and CVM with the following benefits:
- Greater agility and responsiveness to CVM stakeholder feedback on templates and tool bug fixes and enhancements.
- Singular focus on CVM stakeholder-specific submission needs.
- Enhanced ability for CVM to meet user fee goals.
- Further integration of submission technology with other CVM-internal IT systems.
Download CVM eSubmitter Here!
Critical eSubmitter Update to Support ADUFA IV and AGDUFA III
Changes made to the eSubmitter templates to support the goals outlined in the ADUFA and AGDUFA legislation will require the most recent version of the templates. CVM will be releasing an update to the CVM eSubmitter program on Sunday September 30th. This is a critical update that must be installed to utilize the new processes and timelines agreed upon in both user fee acts. Following this update, users will still have the usual 6-month window to make any submission that was started prior to the update using the previous template versions. However, it is important to note that if you are using an outdated template version, you will not be able to enable all functionality related to the new updates. Users can update the template version of submissions currently being worked on by selecting “Save As” from the file menu. (Note: in some cases, previously entered data may be lost due to significant changes in the template).
eSubmitter Webinar Series
Beginning on May 23, 2018, the Center for Veterinary Medicine (CVM) will host a three-part webinar series to provide information on the new animal drug application approval process. CVM’s Office of New Animal Drug Evaluation (ONADE) is hosting this webinar series to address the FDA Electronic Submission Gateway (ESG) and CVM Electronic Submission System (ESS) registration processes as well as to provide information on how to use the eSubmitter tool.
Since the release of eSubmitter in March 2011, the number of electronic submissions has increased. The purpose of these webinars is to support the use of eSubmitter in the new animal drug application approval process as we move to 100% electronic submission on October 1, 2018, with the anticipated reauthorization of the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). Each webinar listed below will be live-cast and recordings will be available on FDA.gov shortly after the presentation date.
Webinar 1: FDA ESG and CVM ESS Registration Process
Wednesday May 23, 2018: Time: 9 - 11 AM EDST
Specific topics to be discussed:
- Overview of electronic submission process
- How to complete registration with FDA ESG
- How to complete registration with CVM ESS
- Types of connections (AS2 v. Webtrader)
- Webtrader basics
Webinar 2: How to Use the eSubmitter Tool
Wednesday August 22, 2018: Time: 9 AM – 12 PM and 1 PM – 4 PM EDST
Specific topics to be discussed:
- Downloading and installing CVM eSubmitter
- Launching eSubmitter and basic navigation
- Creating a new submission
- Finalizing and packaging a submission
- Submitting to CVM and viewing CVM Reponses
Afternoon Breakout Sessions will focus on building specific submission types.
Webinar 3: Follow-up Question and Answer Session
Wednesday September 19, 2018: Time: 9 – 11 AM EDST
Webinar Agendas, recordings, and meeting materials are available on the CVM eSubmitter Resource Center page.