Animal & Veterinary
Resources for You
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.
Presentations on CVM's Electronic Submission System
Guidances
Listing of the electronic submission guidance documents for use in ESS II.
- CVM GFI #108 Submit Information using the FDA Electronic Submission Gateway (PDF - 189KB)
How to Submit Information to CVM using the FDA ESG - CVM GFI #59 How to Submit a Notice of Claimed Investigational Exemption in Electronic Format to CVM (PDF - 45KB)
Notice of Claimed Investigational Exemptions - CVM GFI #86 How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to CVM (PDF - 42KB)
Notices of Final Dispositions of Animals Not Intended for Immediate Slaughter - CVM GFI #87 How to Submit a Notice of Intent to Slaughter for Human Food Purpose in Electronic Format to CVM (PDF - 42KB)
Notices of Intent to Slaughter for Human Food Purposes - CVM GFI #88 How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVM (PDF - 43KB)
Requests for a Meeting or Teleconference with ONADE - CVM GFI #107 How to Submit a Protocol without Data in Electronic Format to CVM (PDF - 100KB)
Protocols without Data for Non-Clinical Laboratory and Effectiveness Studies
FDA Forms
- Electronic Submission System Participant Password or Addition (PDF - 75KB)
Manage Form - Notice of Claimed Investigational Exemption (PDF - 228KB)
NCIE form - Notice of Final Disposition of Animals Not Intended for Immediate Slaughter (PDF - 117KB)
Final Disposition form - Notice of Intent to Slaughter for Human Food Purposes (PDF - 132KB)
Slaughter form - Request for a Meeting or Teleconference (PDF - 221KB)
Meeting Request form - Protocol for Non-Clinical and Effectiveness Studies (PDF - 102KB)
Protocol Without Data form