Animal & Veterinary

Electronic Submissions

 

Lizard on a laptop computer

ESS Hotline:

240-402-7062
CVMDCU@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?

Resources


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

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How Do I Register to Send Electronic Submissions to CVM?

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How do I Register with the FDA ESG?

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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.

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Where Do I Find the eSubmitter Templates for CVM?

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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

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

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What About Medicated Feed Mill Registration?

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

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Who do I contact for more information or help?

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Resources

Guidances

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

FDA Forms

Additional Information

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Page Last Updated: 08/07/2018
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