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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
Collection of Establishment Information Related to Chemistry, Manufacturing, and Controls Submissions
Original Type V Veterinary Master File Webinar
CVM eSubmitter Webinar Series Resources
Need Help?

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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?

• FDA ESG User Guide – This guide explains how you prepare and send electronic documents through the FDA Electronic Submission Gateway (ESG).
• Setting up a WebTrader Account Checklist – This checklist goes over how to set up a WebTrader account for sending electronic documents through the FDA ESG. 
• Important Information About Digital/Electronic Signatures – This page has information about digital signatures on electronic documents. 
• Form FDA 3538 (Electronic Submission System Participant Management) – You must complete this fillable PDF form before you can send electronic documents to FDA through the ESG.
• FDA ESG Home Page – This is the main page for information about the FDA ESG.
• FDA ESG Frequently Asked Questions - General – Answers to your frequently asked questions about using the ESG to send electronic documents to FDA.

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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?

• CVM Guidance for Industry (GFI) #108 Registering with CVM’s Electronic Submission System – This guidance explains the general standards for registering with the CVM Electronic Submission System, the processing procedures for electronic submissions, and the security measures for electronic submissions. 
• CVM ESS and FDA ESG Registration Diagram Flows – This page shows flowcharts illustrating the registration processes for both the FDA Electronic Submissions Gateway (see below) and the CVM Electronic Submission System. 

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

• CVM Recommended File Specifications for eSubmitter – This page lists the recommended PDF specifications for electronic documents submitted through the CVM ESS.
• Electronic Stability Data Standard – Information about FDA’s standards for receiving stability and other quality (chemistry, manufacturing and controls) data in electronic submissions.

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

• CVM Electronic Submission System (ESS) – Acceptance and Rejection Messages – The CVM ESS responds to your submission with either an acceptance or rejection message. This document explains the various acceptance and rejection messages that you may receive. 

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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: 

• CVM eSubmitter Program for Animal Drugs—Office of New Animal Drug Evaluation (ONADE) for drug companies to submit information related to the approval of animal drugs.
• CVM eSubmitter Program for Drug Experience Reports (DERs) for Approved Animal Drugs—Office of Surveillance and Compliance (OSC) for drug companies to submit Form FDA 2301 (“Transmittal of Periodic Reports and Promotional Material for New Animal Drugs”) and Form FDA 3744 (“Antimicrobial Animal Drug Distribution Report”).
• CVM eSubmitter Program for Animal Feeds—Office of Surveillance and Compliance’s Division of Animal Feeds (OSC DAF) for companies to submit Food Additive Petitions, Generally Recognized as Safe notices, and Investigational Food Additive files. 

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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?

• Getting Started with eSubmitter – This guide explains the 5 steps to get started with the CVM eSubmitter tool.
• CVM eSubmitter Quick Guide – This guide goes over the basics of using the CVM eSubmitter tool to send electronic documents to CVM.
• CVM eSubmitter Frequently Asked Questions – Answers to your frequently asked questions about how to use the CVM eSubmitter tool to send electronic documents to CVM.
• Creating an Adobe Digital Signature Quick Guide – The CVM eSubmitter tool allows you to digitally sign your submissions after you create an Adobe self-sign digital ID to identify yourself. This guide shows you how to create a digital ID in Adobe Reader and Adobe Acrobat. 
• CVM eSubmitter Preferences Quick Guide – This guide explains how you can adjust your preferences (settings) in the CVM eSubmitter tool so you can configure your submission to best suit your needs. 
• CVM eSubmitter New Product Description and Product Book Quick Guide – This guide explains the improvements that CVM made to the eSubmitter tool to increase the consistency in how a drug product is described across submissions for the same drug product. 
• CVM eSubmitter New File Attachment Quick Guide – This guide explains the current features for including external files in your submission.
• CVM eSubmitter Packaging Quick Guide – This guide explains how to package your submission into a zip format to send to CVM.
• CVM eSubmitter File Import Quick Guide – This guide details the data import capability which alleviates the task of manually performing data entry of large amounts of data that already exists elsewhere by allowing it to be imported automatically into the submission where the data import functionality is enabled.
• CVM eSubmitter Data Book Quick Guide – This guide shows how to us the Data Book to store information from within a section of a submission and how to reuse it at a later time in sections where the data book functionality is enabled. 
• CVM eSubmitter ADMS Book Quick Guide – This guide outlines the functions associated with viewing and managing establishment information and supply chains in the Animal Drugs and Manufacturing System, or ADMS, data books.
• CVM eSubmitter Master File Quick Guide – This guide explains how to use the Master File book to store and reused master file information to support ADMS supply chain information.

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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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Collection of Establishment Information Related to Chemistry, Manufacturing, and Controls Submissions

CVM is pleased to announce eSubmitter updates designed to improve the collection of establishment information related to Chemistry, Manufacturing, and Controls submissions. Two new databooks (ADMS Establishment and ADMS Supply Chain) are now available to allow improved input and recall of information across multiple templates. Updated templates will be released over the next several months as follows:

CVM is also making a series of webinars available to walk users through the new functionality and templates:

• ADMS Establishment databook
• ADMS Supply Chain databook
• (J)INAD P MC template

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Original Type V Veterinary Master File Webinar

These videos will walk through each section of the Original Type V VMF template (V-A-OT) and describe the functionality and the questions associated with each screen. Disclaimer: The data included in these eSubmitter template videos are for demonstration purposes only and do not reflect guidance from the FDA on the scientific content required to answer individual questions in the V-A-OT Type V template. If you have specific questions regarding any of the questions within the template, please contact CVM at [email protected].

Section 1.0 General Information: https://youtu.be/YUBlAvgqNBk

Section 2.0 Product Information: https://youtu.be/3Ijj2v51ivE

Section 3.0 Buildings and Facilities: https://youtu.be/8mSs_DJFmik

Section 4.0 Sterilization In Place: https://youtu.be/ZORB_uo1YDQ

Section 5.0 Sterilization of Components Equipment by Moist Steam: https://youtu.be/5ePyYPKyfVM

Section 6.0 Sterilization of Components Equipment by Irradiation: https://youtu.be/wPm1uCYblGk

Section 7.0 Terminal Sterilization by Moist Steam: https://youtu.be/gcrQBtcsPlA

Section 8.0 Terminal Sterilization by Irradiation: https://youtu.be/ydHCSMSCERs

Section 9.0 Depyrogenation: https://youtu.be/FsJ8nTk_Kxs

Section 10.0 Environmental Monitoring: https://youtu.be/h1fMi5wJb0g

Section 11.0 Media Fills: https://youtu.be/2AKHOJaSe_0

Section 12.0 Single Use Disposables: https://youtu.be/HSJUFRfBUmk

Section 13.0 Other Information: https://youtu.be/FMjWnUzxRC8

Section 14.0 Evidence of Formal Written Procedures: https://youtu.be/HDhkJk4estc

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CVM eSubmitter Webinar Series Resources

Webinar 1 - FDA ESG and CVM ESS Registration Process

• Webinar 1 Agenda
• Webinar 1 Recording
• Overview of Electronic Submission Process Slides
• FDA ESG Registration Slides
• CVM ESS Registration Slides

Webinar 2 - How to Use the CVM eSubmitter Tool

• Webinar 2 Agenda
• Webinar 2 Recording
• How to Use the CVM eSubmitter Tool Slides
• CVM eSubmitter Installation Slides
• Webinar 2 Afternoon Breakout Session Recordings have been removed due to significant changes in the eSubmitter templates.  For questions concerning how to populate specific submission templates, please contact [email protected].

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

•  Webinar 3 Recording
•  Webinar 3 Slides 

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Need Help?

Email us at [email protected].

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