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**ESS Hotline:**

240-402-7062CVMESS@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)
	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 eventsTop of the page

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)Top of the page

How do I Register with the FDA ESG?

Registration is found at FDA ESGTop 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?

eSubmitter templates can be found on the CVM eSubmitter pageTop 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:
		Use the CVM Registration Web Form.
	If you can’t use the FDA ESG, then
	Submit your adverse events using the Safety Reporting PortalTop of the page

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

Send these submissions to the Office of the Commissioner (OC)
	Structured Product Labeling ResourcesTop of the page

What About Medicated Feed Mill Registration?

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

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
	spl@fda.hhs.gov
	Adverse Events
	CVMAESupport@fda.hhs.gov
		240-402-7062
	CVM eSubmitter
	CVMeSubmitter@fda.hhs.gov
	All other questions
	CVMESS@fda.hhs.gov
		240-402-7062Top of the page

Other Resources

FDA CVM Electronic Submission Systems
	CVM Recommended File SpecificationsGuidances

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

CVM GFI #108 Registering with CVM's Electronic Submission SystemFDA Forms

Electronic Submission Participant Management (FDA Form 3538)Additional Information

Electronic Submissions Gateway
	Structured Product Labeling Resources
	Medicated Feeds
	Veterinary Adverse Event Reporting for Manufacturers
	FDA eSubmitterTop of the page

                                                                                  Content current as of:
      01/30/2024Electronic Submissions
 
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