Electronic Submissions

The Center for Veterinary Medicine (CVM) has developed and implemented methods to accept electronic files as legal, original submissions for review. This electronic submission process was made possible by the publication of FDA's Final Rule on Electronic Records and Electronic Signatures (21 CFR 11) in March 1997, which set the standards for Electronic Records for FDA and its regulated industries.

The current list of submissions acceptable in electronic format is available on the Agency Electronic Submissions Dockets. Guidances and forms for all acceptable submission types are available in Fill-in PDF Forms which communicate with the Center's tracking database and process the submissions into the Center for review automatically. The PDF forms have been upgraded for Adobe® 8.0 and are compatible with Adobe® Acrobat® 6.0 and later.

Compliance information on Electronic Records; Electronic Signatures is available from the Office of Regulatory Affairs Compliance Reference Title 21 CFR Part 11 - Electronic Records/Signatures page. This site includes links to information for Agency compliance initiatives and current activity.

Electronic Registration and Listing of Animal Drugs and Structured Product Labeling (SPL) Information

Currently, the CVM Electronic Submission System (ESS II) supports pre-market electronic submissions. If you are required to electronically register an animal drug establishment or list an animal drug product under Section 510 of the Federal Food, Drug and Cosmetic Act (21 USC 360) and 21 CFR part 207, those registration and listing submissions must be routed through the FDA Electronic Submissions Gateway (ESG) to the Office of the Commissioner (OC) and not to CVM. In addition, you are not required to register with CVM's ESS II to send in your registration and listing submissions. To assist you in preparing these submissions, please visit the Structured Product Labeling Resources website.

CVM Electronic Submissions Process using the Electronic Submissions System (ESS II)

Anyone sending in electronic submissions to the Center must first register with the FDA Electronic Submissions Gateway and follow all requirements for setting up an account with the Gateway (FDA ESG). Once you have established your FDA ESG account, you must register with CVM and follow the requirements in the Guidance for Industry #108 How to Submit Information in Electronic Format to CVM using the FDA Electronic Submission Gateway.

Digital Signatures using Adobe® Acrobat®

We have provided some screen shots to aid you in configuring your Adobe Acrobat for digital signatures and how to apply your signature to the PDF Forms. Applying Digital Signatures

Using the FDA ESG WebTrader

We have provided some screen shots on how to use the FDA ESG WebTrader to send electronic submissions to CVM, what the FDA ESG receipts look like, what CVM’s sponsor notifications look like, and what the FDA CVM Digital Signature looks like. FDA Gateway Submissions and Receipts.