Electronic Submissions

 

 

ESS Hotline: 240-276-8584 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?

 

What Electronic Submissions does CVM Accept?

CVM accepts the following electronic submission:

• Registration forms for CVM Electronic Submission System (CVM ESS)
  • Manage form (FDA 3538)
• New animal drug applications or investigational animal drug files to the Office of New Animal Drug Evaluation (ONADE)
  • eSubmitter tool
• 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?

• For electronic submissions to ONADE, please follow the steps outlined in Guidance for Industry #108
• For electronic adverse events, please follow the steps outlined here (Veterinary Adverse Event Reporting for Manufacturers)

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How do I Register with the FDA ESG?

• Registration is found at 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?

• eSubmitter templates can be found on the CVM eSubmitter page

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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:
    • Use the CVM Registration Web Form.
• If you can’t use the FDA ESG, then
  • Submit your adverse events using the Safety Reporting Portal

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

• Send these submissions to the Office of the Commissioner (OC)
  • Structured Product Labeling Resources

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What About Medicated Feed Mill Registration?

• These submissions go to the Office of the Commissioner (OC)
  • For more information see the resources at Medicated Feeds

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Who do I contact for more information or help?

• FDA ESG
  • esgreg@gnsi.com (technical questions)
  • esgprep@fda.hhs.gov (registration/preparation/policy)
• CVM ESS
  • cvmdcu@fda.hhs.gov
  • 240-276-8584
• SPL
  • spl@fda.hhs.gov
• Adverse Events
  • CVMAESupport@fda.hhs.gov
  • 240-276-8584
• CVM eSubmitter
  • CVMeSubmitter@fda.hhs.gov
• All other questions
  • cvmdcu@fda.hhs.gov
  • 240-276-8584

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