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  1. CVM Updates

Enhanced CVM eSubmitter Tool Released

July 24, 2017

CVM is pleased to announce a CVM-only version of FDA’s eSubmitter tool. This new software package will be independent from the FDA eSubmitter program. The new CVM eSubmitter tool will be available for downloading on August 21, 2017.

eSubmitter is an electronic, question-based submission tool for creating and submitting information. eSubmitter uses data-capturing templates to allow users to assemble a complete and structured submission to CVM. The templates, available for all submission types varying from simple to complex, were developed by CVM subject-matter experts.

The new version will provide 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 ADUFA/AGDUFA user fee goals.
  • Further integration of submission technology with other CVM-internal IT systems.

To take advantage of the enhancements of the new CVM eSubmitter software, users will be required to install this new version. Once installed, users can submit to the following CVM program areas:

  • Office of New Animal Drug Evaluation (ONADE), all submission types
  • Office of Surveillance and Compliance, Division of Animal Feeds (DAF)
  • Office of Minor Use and Minor Species (OMUMS)
  • Office of Surveillance and Compliance, Drug Experience Report (DER) Submissions

There will be a three month transition phase during which users will be permitted to select either the FDA eSubmitter program or the CVM-specific version to submit information.

For more information on the new CVM eSubmitter program, visit our CVM eSubmitter Program webpage.

Please contact cvmesubmitter@fda.hhs.gov with any questions.