#108 
 
Registering with CVMs 
Electronic Submission System 
 
Guidance for Industry 
 
This version of the guidance replaces the version made available in June 2022.  
This document has been revised to update information regarding the authorization letter for a 
U.S. Agent or Consultant. 
 
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 https://www.fda.gov/animal-
veterinary, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
 April 2023
  Contains Nonbinding Recommendations 
 
Table of Contents 
I.  INTRODUCTION .................................................................................................................... 1 
II.  COMMUNICATION BETWEEN CVM AND STAKEHOLDERS ....................................... 1 
III.  REGISTERING WITH THE CVM ELECTRONIC SUBMISSION SYSTEM ...................... 2 
A.  Stakeholder Registration ................................................................................................ 2 
B.  CVM ESS Registration Form (Manage Form) .............................................................. 2 
C.  Submitting a Digital Signature....................................................................................... 3 
D.  Adding, Deleting, or Changing Stakeholders ................................................................ 3 
E.  Adding or Deleting a Coordinator or Changing an Email Address. .............................. 3 
F.  Registering as a U.S. Agent or Consultant .................................................................... 4 
IV.  PROCESSING PROCEDURES FOR ELECTRONIC SUBMISSIONS ................................. 4 
A.  FDA Electronic Submissions Gateway Information and Communication .................... 4 
B.  Registering with the FDA ESG...................................................................................... 5 
C.  FDA ESG Email Address Policy ................................................................................... 5 
D.  Digital Signatures........................................................................................................... 5 
E.  Configuring Adobe Acrobat for CVM ESS Digital Signatures ..................................... 6 
F.  Adding a Digital Certificate to Adobe Acrobat ............................................................. 6 
G.  Applying a Digital Signature to the CVM ESS Manage Form ...................................... 6 
H.  Sending Manage Forms to CVM using the FDA ESG .................................................. 7 
I.  Electronic Response Messages from FDA .................................................................... 8 
J.  Verifying FDA CVMs Digital Signature...................................................................... 9 
V.  SECURITY MEASURES FOR ELECTRONIC SUBMISSIONS .......................................... 9 
A.  Disclosure/Non-Disclosure ............................................................................................ 9 
B.  Confidentiality of the Information in Electronic Submissions ...................................... 9 
C.  Authentication Verification ........................................................................................... 9 
D.  Digital Signature .......................................................................................................... 10 
E.  Verification of the Sender's Identity ............................................................................ 10 
F.  Verification of Date of Submission ............................................................................. 10 
G.  Submission Integrity .................................................................................................... 10 
VI.  CHECKLIST FOR REGISTERING WITH THE CVM ESS ................................................ 11 
VII. HELP....................................................................................................................................... 11 
APPENDIX 1  Example of CVM ESS Registration Letter ......................................................... 12 
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APPENDIX 2  CVM ESS Registration Workflow ...................................................................... 13 
APPENDIX 3  FDA ESG Registration Workflow ....................................................................... 14 
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Registering with CVMs 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 Medicines (CVM or the Center) Electronic Submission System (CVM ESS). 
 
CVMs ability to receive and process information submitted electronically is limited by its current 
information technology capabilities and the requirements of FDAs 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/). 
 
FDAs regulation at 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 of 1998 (Pub. 
L. No. 105-277, 112 Stat. 2681), 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. 
 
The contents of this document do not have the force and effect of law and are not meant to bind the 
public in any way, unless specifically incorporated into a contract.  This document is intended only 
to provide clarity to the public regarding existing requirements under the law. FDA guidance 
documents, including this guidance, should be viewed only as recommendations, unless specific 
regulatory or statutory requirements are cited.  The use of the word should in Agency guidance 
means that something is suggested or recommended, but not required. 
 
II.  COMMUNICATION BETWEEN CVM AND STAKEHOLDERS 
Successful electronic submission of information to the CVM ESS for review and evaluation must 
occur through the FDA Electronic Submissions Gateway (FDA ESG).  The FDA ESG is separate 
and distinct from the CVM ESS.  The purpose of the FDA ESG is to provide a centralized, Agency-
wide communications point for securely receiving electronic regulatory submissions.  The FDA 
ESG is a conduit or portal through which electronic submissions to the CVM ESS must first pass.  
Stakeholders seeking to make electronic submissions to the CVM ESS must register separately both 
with the FDA ESG and the CVM ESS.  Section IV. Processing Procedures for Electronic 
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Submissions of this guidance provides a detailed description of the FDA ESG, its relationship with 
the CVM ESS, and instructions regarding how to register with both systems. 
 
The successful electronic submission of information to the CVM ESS 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, two people, if possible, to be the 
Coordinator(s) who will be responsible for communication with the Center. This will ensure a 
backup coordinator is established in case a coordinator leaves the company or is unavailable. 
 
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 template can be found in APPENDIX 1  
Example of CVM ESS Registration Letter.  The registration letter should identify: 
  The name, mailing address, phone number, and email address of the Coordinator(s) 
[CVM recommends more than one coordinator, as explained above]; 
  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 CVM ESS 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 or emailing CVMESS@fda.hhs.gov. 
 
Once registered, the Coordinator(s) and all stakeholders will need to submit their digital 
signatures for use with the CVM ESS.  To submit a digital signature, complete Section II  
Digital Signature Validation on the Electronic Submission System Participant Management 
Form FDA 3538 (Manage Form) and submit it through the FDA ESG. 
 
B.  CVM ESS Registration Form (Manage Form) 
CVM created the Agency- and OMB-approved Manage Form for stakeholder registration.  
The Manage Form is the only registration form that the CVM ESS accepts for Office of New 
Animal Drug Evaluation (ONADE), the Office of Surveillance and Compliance (OSC) 
Division of Animal Feeds (DAF) and Division of Surveillance (DS), and the Office of Minor 
Use and Minor Species Animal Drug Development (OMUMS) submissions processing.  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 
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Submissions Page at: https://www.fda.gov/animal-veterinary/development-approval-
process/electronic-submissions. 
 
FDA Form Number  Form Name  Guidance Document 
3538  Electronic  Registering with CVMs 
Submission System  Electronic Submission 
Participant  System 
Management Form 
 
C.  Submitting a Digital Signature 
After receiving the paper and electronic acknowledgements, each registered stakeholder must 
 
provide a digital signature (created by using Adobe Acrobats self-signing process) by 
submitting the Manage Form.  Each stakeholder must: 
  Fill out Section II  Digital Signature Validation of the Manage Form; 
  Digitally sign the Manage Form using Adobe Acrobat; and 
  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 the Manage Form.  
The Coordinator should fill out all required fields in Section I  Registration / Information 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 Coordinators digital signature.  Submit the 
Manage Form through the FDA ESG.  Please be aware that all added stakeholders need to 
submit their own Manage Forms signed with their digital signatures to activate their CVM 
ESS accounts, as well as make sure they have registered for their own FDA ESG accounts. 
 
Stakeholders also may change their own stakeholder information by using the Manage Form.  
Please note that stakeholders may only change their own stakeholder information. 
 
To change a stakeholders 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 Coordinators digital signature.  Submit the Manage Form 
through the FDA ESG. 
 
E.  Adding or Deleting a Coordinator or Changing an Email Address. 
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To add or delete a Coordinator or to change an email address, send an original, signed paper 
change registration letter to CVM.  The letter should list the changes to be made.  The subject 
line of the letter should be Change for CVM ESS Stakeholders to clearly identify the 
purpose of the letter 
 
F.  Registering as a U.S. Agent or Consultant 
The identification of a U.S. agent authorized to act on behalf of a foreign stakeholder is either 
required by regulation1 or if not required, a longstanding practice to guard against 
unauthorized communication with FDA on behalf of the stakeholder.   This takes the form of 
an authorization letter.  This letter should be submitted to the applicable file(s).  Direct any 
questions that you may have to the receiving office prior to your submission. 
 
Before a U.S. agent or consultant makes his/her first submission on behalf of a new firm, 
he/she will need to confirm how the firm name will appear in the CVM ESS, as it will need to 
be entered exactly the same in CVMs eSubmitter programs in order to be successfully 
received.  This firm name will be included on the paper response letter sent to the original 
sender as part of the registration process.  The U.S. agent or consultant can also confirm this 
by emailing CVMESS@fda.hhs.gov, if necessary. 
 
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 only process submissions that 
comply with 21 CFR part 11.  In addition, the 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 
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 
As previously discussed, the Agency has established the 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 
 
1 21 CFR 514.1(a); 21 CFR 207.69(b) 
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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.  
For purposes of this guidance, the electronic submission process includes the following 
definitions: 
  Receipt means transfer of a submission from a senders system to a temporary 
storage area in the FDA ESG; 
  Acknowledgment to the sender means that the submission was sent from the 
senders system and received by the FDA ESG; 
  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; and  
  Notification of a submissions arrival is made to those individuals responsible for 
the Centers 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/industry/electronic-submissions-gateway. 
 
C.  FDA ESG Email Address Policy 
Please refer to the FDA ESG e-mail address requirements found at:  
https://www.fda.gov/industry/policiesguidance/important-email-policy. 
 
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 
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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 
For those stakeholders required to register with the CVM ESS, the following configuration 
procedures must be completed by each CVM ESS stakeholder before sending submissions to 
CVM. 
1.  Configuration of Identify Information  In Adobe Acrobat, you must fill out the 
required information regarding your identity.  You should 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 Adobes website at: 
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 Adobes website at: 
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 already added a 
valid digital certificate to the Adobe Digital ID library.  Information regarding digital 
certificates can be found on Adobes website at: 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 documents how you apply a digital signature to this 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; 
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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; and 
6.  The correct email address that you have registered with CVM is displayed in Your 
Contact Information. 
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 Manage Form, nor will you be able to export data from the Form. 
 
H. Sending Manage Forms to CVM using the FDA ESG 
After you have completed filling out and applying your digital signature to the Manage Form, 
you must submit your Form to CVM in order 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.  Because of FDAs ESG technical characteristics, CVM recommends 
stakeholders always send in Manage Forms using the Send directory method of 
transmission.  We recommend that you use this method even if you are sending a single 
Manage Form submission. 
 
 
The following are the steps that you need to complete to be able to use the WebTrader
component of the FDA ESG.  Please refer to our CVM Electronic Submission System 
document to view actual screenshots to aid in sending your Manage Form to FDA. 
1.  Open your web browser and enter the following URL:  https://esg.fda.gov/. 
2.  Enter 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. 
9.  On the Center: pull down select CVM. 
10.  On the Submission Type: pull down list and select Manage Form to submit your 
Manage Form(s). 
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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 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 running.  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 three acknowledgements to you for each transmission you send to 
FDA.  In addition to the two FDA ESG acknowledgements, you will receive a notification 
from the CVM ESS.  Please refer to our CVM Electronic Submission System document to 
view actual screenshots of returned acknowledgements.  The messages will vary depending on 
what method you used to transmit the submission(s).  In all cases, you will receive three 
acknowledgements. 
 
1.  The first acknowledgement will be an 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 
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 
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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 and rejected submission notifications. 
J.  Verifying FDA CVMs 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 our CVM Electronic 
Submission System document to view actual screenshots of CVMs digital signature. 
 
V.  SECURITY MEASURES FOR ELECTRONIC SUBMISSIONS 
Corporations have used the Internet as an expeditious vehicle for the exchange of information for 
many 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 message-carrying 
vehicle, four areas of security should be addressed adequately by all participants prior to its 
adoption. 
 
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 and 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 stakeholder submitting the electronic information should digitally 
sign the document. 
 
C.  Authentication Verification 
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Currently, CVM receives paper submissions from stakeholders via the U.S. 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 CVM ESS 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  as described in section IV.H. Sending Manage Forms to FDA CVM Using the 
FDA ESG 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. Electronic Response Messages from FDA 
of this guidance.  If a stakeholder receives an acknowledgment but has not sent an electronic 
submission to CVM, he/she should immediately report this to CVM via telephone at 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 CVM.  
This also provides a legal basis by which stakeholders can assert their compliance with laws 
and regulations. 
 
Currently, CVM uses the date of the 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. 
 
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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 stakeholder is, CVM 
will notify the stakeholder that its file was corrupted and the stakeholder will be required to 
resubmit the file. 
 
VI.  CHECKLIST FOR REGISTERING WITH THE CVM ESS 
To register for the CVM ESS, stakeholders should: 
 
  Register with the FDA ESG (https://www.fda.gov/industry/electronic-submissions-
gateway).  Please use the CVM Manage Form (Form FDA 3538) as your ESG Test 
Submission.  (See section IV. Processing Procedures for Electronic Submissions of this 
guidance for details.) 
 
  Submit a CVM ESS registration letter to CVM.  (See section III. Registering with the CVM 
Electronic Submission System of this guidance for details.) 
 
  Download the CVM ESS Manage Form (Form FDA 3538) from the CVM Electronic 
Submissions page (https://www.fda.gov/animal-veterinary/development-approval-
process/electronic-submissions).  (See section III. Registering with the CVM Electronic 
Submission System of this guidance for details.) 
 
  Submit a digital signature to CVM using the Manage Form (Form FDA 3538).  (See 
section III. Registering with the CVM Electronic Submission System of this guidance for 
details.) 
 
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:  
CVMESS@fda.hhs.gov. 
   
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APPENDIX 1  Example of CVM ESS Registration Letter 
 
CVM/Office of Management 
Attention: CVM ESS Administrator 
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(s) of the person(s) who will serve as our Coordinator(s) 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 (HFC-100), 
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 
   
12  Contains Nonbinding Recommendations 
APPENDIX 2  CVM ESS Registration Workflow 
 
How to Register or Make a Change Request for the CVM ESS 
(Electronic Submission System) 
 
   
13  Contains Nonbinding Recommendations 
APPENDIX 3  FDA ESG Registration Workflow 
 
How to Register for the FDA ESG 
(Electronic Submission Gateway) 
 
 
14