Animal & Veterinary

FDA Releases Specialized CVM-only Version of eSubmitter Tool

August 21, 2017

The Center for Veterinary Medicine (CVM) is pleased to announce a CVM-only version of FDA’s eSubmitter tool. This new software package is independent from the FDA eSubmitter program. The new CVM eSubmitter tool is available for download as of August 21, 2017.

CVM eSubmitter 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 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.

To take advantage of the enhancements of the software, users are required to install this new version of CVM eSubmitter software. 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 (OSC)
    • Division of Animal Feeds (DAF), all submission types
    • Division of Surveillance, Drug Experience Report (DER) submissions
  • Office of Minor Use and Minor Species (OMUMS), all indexing submission types

If you are currently using the FDA eSubmitter tool, CVM will continue to accept submissions created using this tool until March 1, 2018. After March 1, 2018, you must use the CVM eSubmitter tool to prepare electronic submissions to CVM, as the FDA eSubmitter tool will no longer support the packaging of CVM submissions.

Starting December 1, 2017, users will no longer be able to create new CVM submissions within the FDA eSubmitter tool. However, as stated above, the CVM eSubmitter tool will be available for preparing new submissions as of August 21, 2017. There will be a six-month transition phase during which users will be transitioned away from using the FDA eSubmitter program toward the CVM-specific version to submit information. It is recommended that any new users during this transition period select the CVM-specific version.

For more information, and to download the new CVM eSubmitter program, visit our website at: https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm226814.htm

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

Contact FDA

240-402-7002
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7519 Standish Place, HFV-1

Rockville, MD 20855

Page Last Updated: 08/21/2017
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