Guidance on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway

#108
Registering with CVM’s
Electronic Submission System
Guidance for Industry
This version of the guidance replaces the version made available in December 2015.
This document has been revised to update submission and registration information.
Submit comments on this guidance at any time. Submit electronic comments to
https://www.regulations.gov/. Submit written comments to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD
20852. All written comments should be identified with the Docket No. FDA-1992-S-0039.
For further information regarding this document, contact AskCVM@fda.hhs.gov.
Additional copies of this guidance document may be requested from the Policy and Regulations
Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish
Place, Rockville, MD 20855, and may be viewed on the Internet at either
https://www.fda.gov/AnimalVeterinary/default.htm or https://www.regulations.gov/.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
May 2018

Contains Nonbinding Recommendations

Table of Contents
I.
II.
III.

INTRODUCTION ................................................................................................................3
COMMUNICATION BETWEEN CVM AND STAKEHOLDERS.....................................3
REGISTERING WITH THE CVM ELECTRONIC SUBMISSION SYSTEM ..................4
A.
Stakeholder Registration............................................................................................... 4
B.
CVM ESS Registration Form (Manage form) .............................................................. 4
C.
Submitting a Digital Signature ..................................................................................... 5
D.
Adding, Deleting, or Changing Stakeholders ............................................................... 5
E.
Adding or Deleting a Coordinator or Changing an Email Address .............................. 6
IV. PROCESSING PROCEDURES FOR ELECTRONIC SUBMISSIONS .............................6
A.
FDA Electronic Submissions Gateway Information and Communication ................... 6
B.
Registering with the FDA ESG .................................................................................... 7
C.
FDA ESG Email Address Policy .................................................................................. 7
Digital Signatures ......................................................................................................... 7
D.
E.
Configuring Adobe Acrobat for CVM ESS Digital Signatures ................................... 7
F.
Adding a Digital Certificate to Adobe Acrobat ............................................................ 8
Applying a Digital Signature to the CVM ESS Manage form ..................................... 8
G.
H.
Sending Manage Forms to FDA CVM using the FDA ESG........................................ 9
Electronic Response Messages from FDA ................................................................. 10
I.
J.
Verifying FDA CVM’s Digital Signature .................................................................. 11
V.
SECURITY MEASURES FOR ELECTRONIC SUBMISSIONS .....................................11
A.
Disclosure/Non-Disclosure ......................................................................................... 12
Confidentiality of the Information in Electronic Submissions ................................... 12
B.
C.
Authentication Verification ........................................................................................ 12
D.
Digital Signature ......................................................................................................... 12
E.
Verification of the Sender's Identity ........................................................................... 12
F.
Verification of Date of Submission ............................................................................ 12
Submission Integrity ................................................................................................... 13
G.
VI. CHECKLIST FOR REGISTERING WITH CVM ESS......................................................13
VII. HELP...................................................................................................................................14
APPENDIX 1 - Example of Registration Letter ............................................................................15
APPENDIX 2 - CVM ESS Registration Workflow ...................................................................16
APPENDIX 3 - FDA ESG Registration Workflow .......................................................................17

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Registering with CVM’s Electronic Submission System
Guidance for Industry
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.
I.

INTRODUCTION

This guidance provides general standards which should be used to register with the Center for
Veterinary Medicine (CVM or the Center) Electronic Submission System (ESS).
The Center’s ability to receive and process information submitted electronically is limited by its
current information technology capabilities and the requirements of the Electronic Records;
Electronic Signatures regulation, 21 CFR part 11. The CVM ESS registration form and guidance
is published in the Electronic Submissions Docket No. FDA-1992-S-0039
(https://www.regulations.gov/).
The Electronic Records; Electronic Signatures regulation (21 CFR part 11) requires that the
Agency identify in the Electronic Submission Docket the types of documents or parts of
documents acceptable for official electronic submission.
This guidance implements provisions of the Government Paperwork Elimination Act, Pub. L.
No. 105-277, 112 Stat. 2681 (1998), which requires that executive agencies, by October 21,
2003, provide: (1) for the option of the electronic maintenance, submission, or disclosure of
information, if practicable, as a substitute for paper; and (2) for the use and acceptance of
electronic signatures when practicable.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II.

COMMUNICATION BETWEEN CVM AND STAKEHOLDERS

Successful electronic submission of information for review and evaluation using the FDA ESG
requires a successful partnership between CVM and regulated industry. Information needs to be
exchanged and errors need to be resolved. The Center has set up a hotline to resolve any
problems and questions (240-402-7062). The stakeholder should identify at least one person to
be the Coordinator who will be responsible for communication with the Center.

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III. REGISTERING WITH THE CVM ELECTRONIC SUBMISSION SYSTEM
A. Stakeholder Registration
Stakeholders wishing to register with the CVM ESS should send an original, signed paper
registration letter to CVM. The registration letter should identify:
•
•
•

The name, mailing address, phone number, and email address of the Coordinator(s)
[CVM recommends more than one coordinator];
The name, mailing address, phone number, and email address for each stakeholder
who will be submitting information electronically; and
The subject of the letter should be Registration Letter for Electronic Submission
to CVM to clearly identify the purpose of the letter.

The Center will send two acknowledgements to the stakeholder: (1) a paper
acknowledgement of the registration letter stating that the stakeholder appears able to send
compliant electronic submissions compatible with CVM's current technology, and (2) an
email acknowledgement to each registered stakeholder with an email copy to their company
Coordinator requesting stakeholders submit their digital signature. If the coordinator has
not received both of the acknowledgements within 30 days, contact CVM by calling the
CVM Electronic Submissions Hotline at 240-402-7062.
The Coordinator and all stakeholders must submit their digital signatures once they are
registered. To submit a digital signature, complete Section II – Digital Signature
Validation on the Manage form and submit it through the FDA ESG.
B. CVM ESS Registration Form (Manage form)
CVM has created an Agency- and OMB-approved electronic registration form (Manage
form) for stakeholder use. The Manage form is the only registration form that the CVM
ESS accepts for the Office of New Animal Drug Evaluation’s (ONADE), the Office of
Surveillance and Compliance’s (OSC) Division of Animal Feeds (DAF) and Division of
Surveillance (DS), and the Office of Minor Use and Minor Species Animal Drug
Development’s (OMUMS) submissions processing. The version of the Manage form must
be Adobe Acrobat version 10.x or greater. Any version less than 10.x will be rejected and
not processed. The Manage form can be found on the CVM Electronic Submissions Page
at
https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ElectronicSubmissi
ons/default.htm.

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FDA Form Number
3538

Form Name
Electronic
Submission System
Participant
Management Form

Guidance Document
Registering with CVM’s
Electronic Submission
System

C. Submitting a Digital Signature
After receiving the paper and electronic acknowledgements, each registered stakeholder
must provide a digital signature (created by using Adobe® Acrobat®’s self-signing
process) by submitting form FDA 3538 (Electronic Submission System Participant
Management Form, also known as the Manage form). Each stakeholder must:
•
•
•

fill out Section II of the Manage form (form FDA 3538).
digitally sign the Manage form using Adobe Acrobat.
submit the signed Manage form through the FDA ESG.

D. Adding, Deleting, or Changing Stakeholders
The Coordinator may add or delete stakeholders to the CVM ESS by using Manage form.
The Coordinator should fill out all required fields in Section I of the Manage form for the
changes requested. Only Coordinators are able to add or delete other stakeholders in their
companies.
To add or delete stakeholder, Coordinators must complete Section I –
Registration/Information on the Manage form by checking the radio buttons “Add” or
“Delete.” Select the “Validate” button to confirm the require fields are completed. Select
the “Save” button to save the form. Select the “Signature” button to add the Coordinator’s
digital signature. Submit the form through the FDA ESG. Please be aware that the added
Stakeholders must submit their own Manage forms signed with their digital signatures to
activate their ESS accounts, as well as make sure they have registered for their own FDA
ESG accounts.
Stakeholders also may change his/her own stakeholder information by using the Manage
form. Please note that stakeholders may only change his/her own stakeholder information.
To change a stakeholder’s information (except for changing an email address), stakeholders
must complete Section I – Registration/Information on the Manage form by checking the
radio button “Change.” Complete the fields to be changed. Select the “Validate” button to
confirm the require fields are completed. Select the “Save” button to save the form. Select
the “Signature” button to add the Coordinator’s digital signature. Submit the form through
the FDA ESG.

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E. Adding or Deleting a Coordinator or Changing an Email Address
To add or delete a Coordinator or to change an email address, send a single, original,
signed change letter to CVM. The letter should list the changes to be made. The subject
line of the letter should be Change for ESS Stakeholders to clearly identify the purpose
of the letter.
IV.

PROCESSING PROCEDURES FOR ELECTRONIC SUBMISSIONS

Information submitted to CVM through the FDA ESG should adhere to minimum standards to
ensure confidentiality, integrity, security, and authenticity. CVM can process only submissions
that comply with the Electronic Records; Electronic Signatures regulation. In addition,
registration procedures described in this guidance take into consideration the current information
technology capabilities of CVM. Adherence to these standards is verified by the CVM ESS
processing, and generally only submissions in full compliance can be successfully processed as
electronic submissions. If stakeholders wish to use a different approach, they should discuss it
first with CVM.
Each transmission of an electronic submission will be acknowledged with a receipt issued within
2 Government business days from CVM confirming the submission was successfully processed,
after the two standard responses from FDA ESG. If stakeholders do not receive an
acknowledgement from CVM within 2 business days, please contact CVM.
A. FDA Electronic Submissions Gateway Information and Communication
The Agency has established the FDA Electronic Submissions Gateway (FDA ESG) for
accepting electronic regulatory submissions. The FDA ESG enables the submission of
regulatory information for review. The overall purpose of the FDA ESG is to provide a
centralized, Agency-wide communications point for securely receiving electronic
regulatory submissions. The FDA ESG enables the FDA to process regulatory information
through automated mechanisms while it enables:
•
•
•

A single point of entry for the receipt and processing of all electronic submissions in
a highly secure environment;
Automation of the current electronic processes such as the electronic
acknowledgments of submissions; and
Support of the electronic standards of FDA regulated submissions.

The electronic submission process is defined as the receipt, acknowledgment, routing, and
notification to a receiving Center of the receipt of an electronic submission by the FDA
ESG. In this definition:
•
•

“Receipt” means transfer of a submission from a sender’s system to a temporary
storage area in the FDA ESG.
“Acknowledgment” to the sender means that the submission was sent from the
sender’s system and received by the FDA ESG.
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•
•

“Routing” refers to delivering a submission to a Center-level storage area and
initiating a load process to place a submission into a Center receiving system.
“Notification” of a submission’s arrival is made to those individuals responsible for
the Center’s receiving system.

Each of these terms denotes a step in the process of electronic submission delivery, and
together, these steps comprise the whole scope of electronic submission delivery.
The FDA ESG is a conduit, or “highway,” along which submissions travel to reach their
final destination. It does not open or review submissions; it merely routes them to the
proper destination.
The FDA ESG uses a software application certified to comply with secure messaging
standards.
B. Registering with the FDA ESG
The registration processes and procedures to use the FDA ESG are separate and distinct
from the CVM ESS registration processes. Stakeholders must register with the FDA ESG
using the FDA ESG registration process. Access to the FDA ESG documentation can be
found at: https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
C. FDA ESG Email Address Policy
Please refer to the FDA ESG e-mail address requirements found here:
https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm176341.htm
D. Digital Signatures
The Manage form has a location for stakeholders’ digital signatures that becomes activated
when the ‘Signature’ command button is pressed on the form. When the Adobe digital
signature process is invoked by applying your digital signature, you are certifying that you
attest to the contents of the form.
A critical piece of the digital signature is your registered email address, which is contained
in the ‘Contact Information’ field. This email address must match the email address that
was registered with the CVM ESS. If the email addresses do not match, your
submission will be rejected and it will not be processed.
E. Configuring Adobe Acrobat for CVM ESS Digital Signatures
This section documents the configuration procedures that each CVM ESS stakeholder must
accomplish before sending submissions to FDA CVM for those stakeholders required to
register with the CVM ESS.

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1. Configuration of Identify Information – In Adobe Acrobat you must fill out the
required information regarding your identity. You must pay strict attention to the
email address that you enter. Please make sure that the entered email address
matches the email address that the CVM ESS has registered for you. For more
information regarding identity configuration please visit Adobe’s website here:
https://helpx.adobe.com/support.html
2. Configuration of Digital Signatures -- In Adobe Acrobat you will need to add a new
Digital Signature configuration. You must supply a title to the signature
configuration. Make sure that in the ‘Configure Text’ area that all options are
checked. For more information regarding digital signatures please visit Adobe’s
website here: https://helpx.adobe.com/support.html
F. Adding a Digital Certificate to Adobe Acrobat
In order to apply a digital signature to any CVM ESS Form, you must have added a valid
digital certificate to the Adobe Digital ID library. Information regarding digital certificates
can be found on Adobe’s website here: https://helpx.adobe.com/support.html.
G. Applying a Digital Signature to the CVM ESS Manage form
The CVM ESS registration procedure requires that you digitally sign your Manage
form. The following text documents how you apply a digital signature to the CVM ESS
Manage form.
When you press the ‘Signature’ command button a signature box will be presented and
to sign the form you need to click inside the magenta signature box. After clicking
inside the signature box the ‘Apply Signature to Document’ dialogue box is presented.
The information within the dialogue box needs to be verified before applying the digital
signature to the form. The following needs to be verified in the signature details box:
1. The ID being shown is the correct Digital ID.
2. The certificate password has been entered in the ‘Confirm Password’ field.
3. A reason for signing has been selected in the ‘Reason for Signing’ field.
4. The ‘Option’ section is visible
5. The Digital Signature the user created within ‘Section G - Digital Signatures’ is
visible in the ‘Signature Appearance’ field within the ‘Option” section.
6. The correct email address that you registered with CVM is displayed in ‘Your
Contact Information.’

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If all of the above information is correct and all of the steps have been completed you
should now press the ‘Sign’ button. Note, once you sign the document and save it you will
no longer be able to modify the Manage form nor will you be able to export data from the
form.
H. Sending Manage Forms to FDA CVM using the FDA ESG
After you have completed filling out and applied your digital signature to the Manage form,
you must submit your form to CVM to activate your CVM ESS account to complete your
registration. Once you receive notification from CVM that your account has been
activated, you can begin sending in electronic submissions to CVM using the FDA ESG.
CVM ESS allows Coordinators to group multiple Manage form submissions into a single
FDA ESG transmission. Coordinators also have the option of sending an individual
Manage form per transmission or sending a group of Manage forms with a single
transmission. Note: Because of FDA ESG technical reasons, CVM recommends
stakeholders always send in Manage forms using the ‘Send directory’ method of
transmission. Use this method even if you are sending a single Manage form submission.
The following are the steps that you are required to accomplish to use the WebTrader©
component of the FDA ESG. Please refer to the following URL to view actual screenshots
to aid in sending your Manage form to FDA: FDA Gateway Submission and Receipts –
https://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/Electron
%20icSubmissions/UCM448692.pdf.
1.

Open your web browser and enter in the following URL: https://esg.fda.gov/

2.

Enter in your assigned FDA ESG User ID.

3.

Enter in your assigned FDA ESG Password.
Note: The FDA ESG User ID and Password are both case sensitive.

4.

Click the terms agreement button.

5.

Click the ‘Login’ button

6.

After logging in you will be presented with your ‘Inbox.’ You can check for past
submissions and move/copy or delete messages from the ‘Inbox.’

7.

To send a transmission to FDA navigate the cursor to the WebTrader menu tab and
select ‘Send Document.’

8.

After you are presented with the ‘Send Document’ screen proceed with the next
steps.

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9.

On the ‘Center:’ pull down select ‘CVM.’

10. On the Submission ‘Type:’ pull down list and select ‘Electronic Submissions’ to
submit your Manage form(s).
11. On the ‘Path:’ textbox user may click on the ‘Browse’ button then navigate to the
submission file or a directory where the submission exists, or type in the full path to
file or directory of the submission in that text box.
Note: for Manage Form submission, we recommend that you use the directory
submission method even if you are sending a single submission.
12. If this is the first time you have made a transmission to FDA ESG, you must browse
for your digital certificate that is stored on your system. This certificate must be
verifiable by the FDA ESG. Select the certificate that you want to apply to this
transmission. If you have already sent a successful transmission to FDA ESG, you
do not need to select a certificate again as the WebTrader software will remember
your last selected certificate. You must enter your certificate password at this time.
13. Review all of the ‘Send Document’ screen information for correctness.
14. If all items have been verified and are correct then press the ‘Send’ button.
15. The WebTrader software will now package up your submission(s) for transmission.
Note: Do not close the browser window or attempt any other operation until the
WebTrader software has completed. If you do interrupt the sending process your
submission will not be received.
16. When the ‘Upload Progress’ screen indicates that the transmission is completed you
may close the ‘Upload Progress’ window. You have completed the transmission
process and you now can close the WebTrader browser and/or go on to other tasks.
17. The next section documents the messages that you will receive from the FDA ESG
and the CVM ESS.
I. Electronic Response Messages from FDA
The FDA ESG will return at least two acknowledgements to you for each transmission you
send to FDA. In addition to the Gateway acknowledgements you will receive a
notification from the CVM ESS. Please refer to the following URL to view actual
screenshots of returned acknowledgements: FDA Gateway Submissions and Receipts
(https://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/Electro
nicSubmissions/UCM448692.pdf). The messages will vary depending on what method
you used to transmit the submission(s). In all cases you will receive three
acknowledgements:

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1.

The first acknowledgement will be a FDA Gateway Receipt Message Digest
Notification (MDN). This acknowledgement message can be ignored as it has
information that is unreadable using the WebTrader software. It is used for the
Gateway-to-Gateway transmission method and not the WebTrader transmission
method.

2.

The second acknowledgement that you will receive occurs when the FDA ESG
transfers the incoming transmission to the CVM ESS. This is the official receipt that
the FDA has received your transmission. This receipt does not signify that your
submission has been validated, accepted or reviewed by CVM.

3.

The third acknowledgement you will receive will come in one of two formats. The
acknowledgement format will depend on whether you sent in a single submission
transmission or you sent in a multiple submission transmission.
a. If you sent in a single Manage form transmission, you will receive a single
Adobe PDF file that details the processing of your submission. This receipt will
indicate that your Manage form was either accepted or rejected with a processing
error.
b. If you sent in multiple Manage forms transmissions, you will receive a Zip file
that contains a number of PDF files. The number of files within the Zip file will
directly relate to the number of Manage forms that you sent in your transmission.
These individual receipts will indicate that your submission(s) were either
accepted or rejected with a processing error.
Note: The Zip file that contains the stakeholder notifications will contain both
accepted submissions and rejected submission notifications.

J. Verifying FDA CVM’s Digital Signature
The CVM ESS applies a digital signature to each notification acknowledgement it
transmits. This digital signature can be validated and trusted. Please refer to the following
URL to view actual screenshots of FDA CVM’s digital signature: FDA Gateway
Submissions and Receipts
(https://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/Electro
nicSubmissions/UCM448692.pdf)
V.

SECURITY MEASURES FOR ELECTRONIC SUBMISSIONS

Corporations have used the Internet as an expeditious vehicle for the exchange of information for
several years. However, many corporations and government agencies have avoided using the
Internet for the exchange of sensitive and/or confidential information because of concerns about
security. In developing an electronic submission project using the Internet as the messagecarrying vehicle, four areas of security should be addressed adequately by all participants prior to
its adoption.

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A. Disclosure/Non-Disclosure
Information submitted to CVM is subject to the Freedom of Information Act and FDA's
regulations on public information at 21 CFR parts 20 and 514. Some information, such as
trade secrets, certain commercial and financial information is confidential in nature and is
not to be disclosed. Therefore, using the Internet to submit confidential information can be
done only with adequate encryption.
B. Confidentiality of the Information in Electronic Submissions
The CVM ESS will only accept digitally signed PDF files to protect the confidentiality of
submitted information. The person submitting the electronic information should digitally
sign the document.
C. Authentication Verification
Currently, CVM receives paper submissions from stakeholders by US Postal Service,
Federal Express, United Parcel Service, etc. With these submissions, there is a cover letter
on letterhead signed by an authorized stakeholder official. This information allows CVM
to authenticate that the submission is from the stated stakeholder. Any electronic
submission should also provide a means by which CVM can authenticate the origin of the
electronic document, such as the digital signature.
D. Digital Signature
The registration letter should contain the name and email address for each authorized
stakeholder. After the receipt of CVM's acknowledgment letter for the registration, each
stakeholder should submit to CVM ESS a digital signature using the Manage form (form
FDA 3538) as described in Section IV.I of this guidance. The digital signature will serve
as the electronic signature under 21 CFR 11.200(a)(1) and will authenticate the identity of
the sender. CVM will maintain a database of digital signatures and will automatically
reject any electronic submission received that does not match the digital signature on file.
E. Verification of the Sender's Identity
An additional precaution will be taken to ensure that the submission received at CVM did
indeed come from the stakeholder designated. CVM will acknowledge receipt of the
electronic submission as described in Section IV.I. If a sender receives an
acknowledgment but has not sent an electronic submission to CVM, he/she should
immediately report this to CVM by telephone to 240-402-7062.
F. Verification of Date of Submission
Currently, time-sensitive information is submitted by certified mail so that the stakeholder
has a record verifying the date and name of an individual who received the information at

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CVM. This also provides a legal basis by which stakeholders can assert their compliance
with laws and regulations.
Currently, CVM uses the date of FDA ESG receipt (following successful CVM ESS
validation) to determine whether information was submitted within the time required by
statute or regulation.
G. Submission Integrity
The integrity of the content of a submission to CVM is the responsibility of the
stakeholder. If sections of a paper submission are missing or illegible, CVM requires the
stakeholder to provide copies of the missing or illegible information. A remote possibility
exists that intentional or unintentional changes could be made to an electronic submission
that could not be made to a paper submission. For example, unintentional "scrambling" of
the submission may occur during transmission so that CVM receives a corrupted, unusable
file.
CVM will rely on the digital signature of the PDF file to ensure the integrity of the
electronic transmission. If the transmission is received by CVM intact and can be
processed and opened by Adobe Acrobat, and CVM can verify via the digital signature that
no changes occurred to the submission once it was submitted to the FDA ESG, then CVM
will accept the transmission. If CVM receives a corrupted file and can identify who the
sender is, CVM will notify the sender that its file was corrupted and the sender will be
required to resubmit the file.
VI.

CHECKLIST FOR REGISTERING WITH CVM ESS

To register for the CVM ESS, stakeholders should:
 Register with the FDA ESG
(https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm)
Note: Please use the CVM Manage form as your ESG Test Submission.
(See Section IV for details.)
 Submit a registration letter to CVM (See Section III for details.)
 Download the CVM ESS Manage form (form FDA 3538) from the CVM Electronic
Submissions page
(https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ElectronicSubmis
sions/default.htm) (See Section III for details.)
 Submit a digital signature to CVM using form FDA 3538 (See Section III for details.)

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VII. HELP
While the CVM ESS system does not use email as the vehicle to accept submissions, email
messages related to stakeholder registration or the CVM ESS can be sent to the following
address:
CVMDCU@FDA.HHS.GOV

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APPENDIX 1 - Example of Registration Letter
CVM/Office of Management
Attention: Kenneth Shane Burch
MPN 2, Room N134
12225 Wilkins Avenue
Rockville, MD 20852
Subject: Registration Letter for Electronic Submission to CVM
Dear CVM ESS Administrator:
This letter notifies the Center for Veterinary Medicine (CVM) of our intent to electronically
submit documents listed in the Electronic Submissions Docket No. FDA-1992-S-0039 using the
FDA Electronic Submissions Gateway (ESG). An enclosure to this registration letter contains
the name of the person who will serve as our Coordinator and the names of the persons who will
be submitting electronic information, along with their mailing addresses, phone numbers, and
email addresses for initializing the Electronic Submission System.
We have certified to the Food and Drug Administration, Office of Regional Operations (HFC100), that the electronic signatures used to submit information on our behalf are intended to be
the legally binding equivalent of traditional handwritten signatures.
We look forward to receipt of CVM's letter acknowledging our intent to submit information
using the FDA ESG and stating that we appear to be able to make electronic submission that are
compatible with CVM's current technology.
Sincerely yours,

/s/
Enclosure

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APPENDIX 2 - CVM ESS Registration Workflow
How to Register or Make a Change request for the CVM ESS
(Electronic Submission System)

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APPENDIX 3 - FDA ESG Registration Workflow
How to Register for the FDA ESG
(Electronic Submission Gateway)

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