Electronic Submissions
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 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
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)
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