Electronic Submissions
Notice (February 28, 2025):
In alignment with FDA ESG NextGen Go-Live (Late March 2025), CVM will no longer require stakeholders to register separately with CVM. This means that registration will only be required with FDA ESG in order to electronically submit to CVM. In addition, CVM will no longer require test submissions for ESG Production accounts.
ESG NextGen Timeline and more information about the modernized gateway can be found here: https://www.fda.gov/industry/esg-next-generation. CVM will be updating all of its guidance in alignment with ESG NextGen Go-Live.
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?
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 for the Office of New Animal Product Evaluation (ONAPE) and Office of Generic Animal Drugs (OGAD)
- 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
How Do I Register to Send Electronic Submissions to CVM?
- For electronic submissions to ONAPE and OGAD, 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)
How do I Register with the FDA ESG?
- Registration is found at FDA ESG
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.
Where Do I Find the eSubmitter Templates for CVM?
- eSubmitter templates can be found on the CVM eSubmitter 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:
- Use the CVM Registration Web Form.
- If you already have a CVM ESS account:
- If you can’t use the FDA ESG, then
- Submit your adverse events using the Safety Reporting Portal
Where Do I Send Animal Drug Registration and Establishment Listing SPLs?
- Send these submissions to the Office of the Commissioner (OC)
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
Who do I contact for more information or help?
- FDA ESG
- ESGHelpDesk@fda.hhs.gov (technical questions)
- CVM ESS
- CVMESS@fda.hhs.gov
- 240-402-7062
- SPL
- Adverse Events
- CVMAESupport@fda.hhs.gov
- 240-402-7062
- CVM eSubmitter
- All other questions
- CVMESS@fda.hhs.gov
- 240-402-7062
Other Resources
Guidances
Listing of the electronic submission guidance documents for use in CVM ESS.
FDA Forms
Additional Information
- Electronic Submissions Gateway
- Structured Product Labeling Resources
- Medicated Feeds
- Veterinary Adverse Event Reporting for Manufacturers
- FDA eSubmitter