U.S. flag An official website of the United States government
  1. Home
  2. Animal & Veterinary
  3. Development & Approval Process
  4. Electronic Submissions
  1. Development & Approval Process

Electronic Submissions

Lizard on a laptop computer

ESS Hotline:

240-402-7062
CVMESS@fda.hhs.gov


What electronic submissions does CVM accept?

How do I register to send electronic submissions to CVM?

How do I register with the FDA ESG?

Can I Register With CVM ESS and FDA ESG at the Same Time?

Where do I find the eSubmitter templates for CVM?

What about electronic submissions for adverse events?

Where do I send animal drug registration and establishment listing SPLs?

What about medicated feed mill registration?

Who do I contact for more information or help?

Other Resources

Guidances

FDA Forms

Additional Information


What Electronic Submissions does CVM Accept?

CVM accepts the following electronic submission:

  • Registration forms for CVM Electronic Submission System (CVM ESS)
  • New animal drug applications or investigational animal drug files for the Office of New Animal Drug Evaluation (ONADE)
    • eSubmitter templates
  • Indexing submissions for the Office of Minor Use and Minor Species Animal Drugs Development (OMUMS)
    • eSubmitter templates
  • Food additive petitions (FAP), investigational food additive (IFA) files, or generally recognized as safe (GRAS) notices for the Office of Surveillance and Compliance (OSC)
    • eSubmitter templates
  • Drug Experience Reports (DER) and Antimicrobial Animal Drugs Distribution Reports for the Office of Surveillance and Compliance, Division of Surveillance
    • eSubmitter templates
  • Mandatory drug adverse event reports (i.e., adverse events, product problems, or combination adverse event and product problem reports)
    • WebTrader or AS2 connections

Do not send the following electronic submissions to CVM:

  • SPL files for drug product listing or establishment registration submissions
    • Send these files to the Office of the Commissioner (OC)
  • Medicated feed mill registration
    • Send these registrations to OC
  • Pet food adverse events, voluntary adverse drug events

Top of the page


How Do I Register to Send Electronic Submissions to CVM?

Top of the page


How do I Register with the FDA ESG?

Top of the page


Can I Register With CVM ESS and FDA ESG at the Same Time?

  • Yes. You can register for both processes at the same time.
    • FDA ESG registration can take longer and involves more technical requirements.

Top of the page


Where Do I Find the eSubmitter Templates for CVM?

Top of the page


What About Electronic Submissions for Adverse Events?

  • If you intend to submit files using the FDA ESG and:
    • If you already have a CVM ESS account:
      • Use your existing WebTrader or AS2 connection to submit your files, or
    • If you don’t have a CVM ESS account:
  • If you can’t use the FDA ESG, then

Top of the page


Where Do I Send Animal Drug Registration and Establishment Listing SPLs?

Top of the page


What About Medicated Feed Mill Registration?

  • These submissions go to the Office of the Commissioner (OC)

Top of the page


Who do I contact for more information or help?

Top of the page


Other Resources

Guidances

Listing of the electronic submission guidance documents for use in CVM ESS.

FDA Forms

Additional Information

Top of the page



Back to Top