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CVM eSubmitter Resource Center


On this page:

What is the FDA Electronic Submissions Gateway (ESG)?
How do I register for the FDA ESG?
What is the CVM Electronic Submission System (ESS)?
How do I register for the CVM ESS?
What are the standards for submitting electronic documents through the CVM ESS?
What messages will I receive after submitting an electronic document through the CVM ESS?
What are the CVM eSubmitter Programs?
How do I start using the CVM eSubmitter Programs?
What are the benefits of the CVM eSubmitter Tool?
How do I use the CVM eSubmitter Tool?
Additional Training Resources Related to ADUFA and AGDUFA Reauthorization
CVM eSubmitter Webinar Series Resources
Need Help?


What is the FDA Electronic Submissions Gateway (ESG)?

The FDA Electronic Submissions Gateway (ESG) is the central transmission point for sending information electronically to the agency. Within that context, the FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. It doesn’t open or review submissions; it merely routes them to the proper destination, such as to FDA’s Center for Veterinary Medicine (CVM). 

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How do I register for the FDA ESG?

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What is the CVM Electronic Submission System (ESS)?

When the FDA ESG receives a submission intended for CVM, the gateway routes it to the CVM Electronic Submission System (ESS). This system then authenticates the submission and also performs a preliminary validation of the submission (for example, it validates the document type, makes sure that the submission number is correct, and validates that the submitter is indeed the owner of the document). 

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How do I register for the CVM ESS?

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What are the standards for submitting electronic documents through the CVM ESS?

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What messages will I receive after submitting an electronic document through the CVM ESS?

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What are the CVM eSubmitter Programs?

The CVM eSubmitter programs allow users to electronically and securely submit information to the center. With the help of templates, these programs walk users through the process of building and submitting a complete and structured submission to CVM for review.  The programs contain a number of question-based tools that capture information in a structured format and provide helpful dialog boxes to reduce redundant responses. 

Users can easily download the programs for free directly from FDA’s website, and the programs require minimal configuration by users. 

There are currently three CVM eSubmitter programs for various types of submissions: 

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How do I start using the CVM eSubmitter Programs?

To use any of the above programs, you must complete these three steps:

  1. Register for the FDA Electronic Submission Gateway.
  2. Register for the CVM Electronic Submission System.
  3. Download and install the CVM eSubmitter tool

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What are the benefits of the CVM eSubmitter Tool?

The CVM eSubmitter tool has the following benefits:

  • It helps CVM more quickly respond to feedback from stakeholders on the templates, fix bugs, and make improvements.
  • It is focused strictly on the specific needs of CVM’s stakeholders when submitting electronic submissions to the center.
  • It helps CVM meet the goals set by the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act.
  • It helps CVM improve the process for reviewing regulatory information. 
  • It helps CVM integrate the eSubmitter technology with the center’s internal IT systems.

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How do I use the CVM eSubmitter Tool?

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Additional Training Resources Related to ADUFA and AGDUFA Reauthorization

The 2018 reauthorization of the Animal Drug User Fee Act (ADUFA) for brand name animal drugs and the Animal Generic Drug User Fee Act (AGDUFA) for generic animal drugs mandated important changes to the submission process for drug applications. To help drug companies understand these changes, CVM developed several training resources which you can find on the New Animal Drug Application Training Resources page

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CVM eSubmitter Webinar Series Resources

Webinar 1 - FDA ESG and CVM ESS Registration Process

Webinar 2 - How to Use the CVM eSubmitter Tool

(Note: CVM made the following recordings on 8/22/2018, and since then, the center may have updated some of the eSubmitter templates. View the eSubmitter History page for a summary of changes.)

Division of Animal Bioengineering and Cellular Therapies (ABCT)

Template Recording Duration Transcripts
I-A-OT 10 min. Transcript
V-A-OT (Type VII) 15 min. Transcript
Tech Section Intro 4 min. Transcript
I-P-DP 11 min. Transcript
I-P-PC 25 min. Transcript

Chemistry, Manufacturing and Controls 1

Template Recording Duration Transcripts
INAD-P-MC 1 hr. 4 min. 55 sec. Transcript
JINAD-P-MC 1 hr. 38 sec. Transcript

Chemistry, Manufacturing and Controls 2

Template Recording Duration Transcripts
VMF-A-OT (Type II) 41 min. 17 sec. Transcript
VMF-A-OT (Type V) 42 min. 33 sec. Transcript
Post Approval Submissions (supplements, MCSR) 54 min 18 sec. Transcript

Target Animal Review Divisions 1

Template Recording Duration Transcripts
INAD-A-OT 8 min. 36 sec. Transcript
INAD-Es 4 min. 59 sec. Transcript
INAD-O-OT 14 min. 15 sec. Transcript
ADAA Combination Submissions 28 min. 5 sec. Transcript
NADA-A-OT Free Choice Feeds 18 min. 26 sec. Transcript

Target Animal Review Divisions 2

Template Recording Duration Transcripts
INAD-Ms 14 min. 34 sec. Transcript
NADA-A-OT 22 min. 41 sec. Transcript
Meeting Requests 46 min. 47 sec. Transcript

Environmental/Target Animal Review Divisions 3

Template Recording Duration Transcripts
INAD-X-CE 15 min. 52 sec. Transcript
INAD-P-NV 34 min. 53 sec. Transcript
INAD-P-EF 41 min. 49 sec. Transcript

Generic Review Division

Template Recording Duration Transcripts
JINAD-A-OT 18 min. Transcript
JINAD-Z-OM 19 min. Transcript
ANADA-A-OT Admin 19 min. Transcript
ANADA-A-OT Traditional 33 min. Transcript

Webinar 3: Follow-up Question and Answer Session on the CVM eSubmitter Tool

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Need Help?

Email us at cvmesubmitter@fda.hhs.gov.

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