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

#108
Guidance for Industry
How to Register with the CVM
Electronic Submission System
To Submit Information in Electronic Format
Using the FDA Electronic Submissions Gateway
This version of the guidance replaces the version made available in June 2015. This document
has been revised to update submission and registration information.
Submit comments on this guidance at any time. Submit electronic comments to
http://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 Shane Burch, Center for Veterinary
Medicine (HFV-16), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855,
240-402-0722, e-mail: [email protected].
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, 7519 Standish
Place, Rockville, MD 20855, and may be viewed on the Internet at either
http://www.fda.gov/AnimalVeterinary/default.htm or http://www.regulations.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
December 2015

Contains Non-binding Recommendations

Table of Contents
I.

INTRODUCTION ................................................................................................................... 4

II. COMMUNICATION BETWEEN CVM AND STAKEHOLDERS ....................................... 5
III.
REGISTRATION TO SEND ELECTRONIC SUBMISSIONS LISTED IN
ELECTRONIC SUBMISSIONS DOCKET ................................................................................... 5
A. Stakeholder Registration ...................................................................................................... 5
B. Using the CVM Electronic Submission System (ESS) Manage Form ................................ 5
C. Adding, Deleting, or Changing Stakeholders ...................................................................... 6
IV.

PROCESSING PROCEDURES FOR ELECTRONIC SUBMISSIONS ............................ 6

A. FDA Electronic Submissions Gateway Information and Communication .......................... 6
B. Registration Procedures for FDA ESG Operations ............................................................. 7
C. Email Communication with CVM ....................................................................................... 7
D. Subject Line of Email Message ........................................................................................... 7
E. CVM ESS Registration Form (Manage form) ..................................................................... 8
F.

Email Address Policy........................................................................................................... 8

G. Digital Signatures................................................................................................................. 8
H. Configuring Adobe Acrobat for CVM ESS Digital Signatures ........................................... 9
I.

Adding a Digital Certificate to Adobe Acrobat ................................................................... 9

J.

Applying a Digital Signature to the CVM ESS Manage form............................................. 9

K. Sending Manage Forms to FDA CVM using the FDA ESG ............................................ 10
L. Electronic Response Messages from FDA......................................................................... 12
M.

Verifying FDA CVM’s Digital Signature ...................................................................... 13

V. SECURITY MEASURES FOR ELECTRONIC SUBMISSIONS........................................ 13
A. Disclosure/Non-Disclosure ................................................................................................ 14
B. Protecting the Confidentiality of the Information in Electronic Submissions ................... 14
C. Authentication Verification ............................................................................................... 14
D. Digital Signature ................................................................................................................ 14
E. Verification of the Sender's Identity .................................................................................. 14
F.

Verification of Date of Submission ................................................................................... 15

G. Submission Integrity .......................................................................................................... 15

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VI.

CHECKLIST FOR REGISTERING WITH CVM ESS ..................................................... 15

A. REGISTRATION PROCESS: ........................................................................................... 16
B. ADDING, DELETING or CHANGING STAKEHOLDER INFORMATION ................ 16
C. ADDING OR DELETING A COORDINATOR OR CHANGING AN EMAIL
ADDRESS................................................................................................................................. 17
APPENDIX 1 - Example of Registration Letter ........................................................................... 18
APPENDIX 2 - CVM ESS Registration Workflow ..................................................................... 19
APPENDIX 3 – FDA ESG Registration Workflow ..................................................................... 20

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GUIDANCE FOR INDUSTRY
How to Register with the CVM Electronic Submission System
to Submit Information in Electronic Format Using the FDA
Electronic Submissions Gateway
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 for to register with the Center
for Veterinary Medicine (CVM or the Center) Electronic Submission System (ESS) to submit
information in electronic format using the FDA Electronic Submissions Gateway (ESG).
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 11. The CVM ESS registration form and
guidance is published in the Electronic Submissions Docket No. FDA-1992-S-0039
(http://www.regulations.gov).
The Electronic Records; Electronic Signatures regulation (21 CFR 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.

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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.
III.
REGISTRATION TO SEND ELECTRONIC SUBMISSIONS LISTED IN
ELECTRONIC SUBMISSIONS DOCKET
A.

Stakeholder Registration

Stakeholders wishing to register with the CVM ESS should send a single, original,
signed paper registration letter to CVM. In an enclosure with this letter, the stakeholder
should identify:
•
•
•

The name, mailing address, phone number, and Email address of the
Coordinator(s);
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 acknowledgements to the stakeholder: (1) a paper letter
acknowledging receipt of the registration and stating that the stakeholder appears to be
able to make electronic submissions that are compatible with CVM's current technology,
and (2) after CVM successfully processes the stakeholder registration, an email is sent to
each registered stakeholder and a copy is sent to their company Coordinator.
B.

Using the CVM Electronic Submission System (ESS) Manage Form

After receiving the paper and electronic acknowledgements, the Coordinator and each
stakeholder registering 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.

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Adding, Deleting, or Changing Stakeholders

C.

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 change requested. The Coordinator may change his/her own
stakeholder information by using the Manage form. Please note that stakeholders
may only change his/her own stakeholder information.
IV.

PROCESSING PROCEDURES FOR ELECTRONIC SUBMISSIONS

Information transmitted 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
two Government business days from CVM confirming the submission was successfully
processed, after the two standard responses from FDA ESG.
FDA Electronic Submissions Gateway Information and Communication

A.

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 the central transmission point for sending information electronically to
the FDA. Within that context, 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.

Registration Procedures for FDA ESG Operations

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:
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
C.

Email Communication with CVM

While the CVM ESS system does not use Email as the vehicle to accept
submissions, there are cases where stakeholders can send an Email message to
CVM. Email messages related to stakeholder registration or the CVM ESS
should be sent to the following address:
[email protected]
D.

Subject Line of Email Message

The Email must be formatted in the following manner:
1. The Email message must have a single word as the subject. The following
table shows the allowable subject line words.
Subject
Line
CHANGE

Type of Electronic Information
Electronic notification of changes in conditions of registration

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2. Each submitted Email must have a single PDF file attached that details the
instructions to CVM for a change to an existing stakeholder registration.
E.

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) and the Office of Surveillance and Compliance (OSC) Division of
Animal Feeds’ (DAF) submission processing. The version of the electronic 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
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ElectronicSub
missions/default.htm.
FDA Form Number
3538

F.

Form Name
Electronic
Submission System
Participant
Management Form

Guidance Document
How to Register with
the CVM Electronic
Submission System
to Submit
Information in
Electronic Format
Using the FDA
Electronic
Submissions
Gateway

Email Address Policy

Please refer to the ESG e-mail address requirements found here:
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm176341.htm
G.

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.

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H.

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.
1.
Configuration of Identify Information – In Adobe Acrobat under the ‘Edit’
command selection, navigate to the ‘Preferences’ screen and then navigate to the
‘Identify’ screen and then fill out the required information on that screen. 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.
2.
Configuration of Digital Signatures -- In Adobe Acrobat under the ‘Edit’
command selection, navigate to the ‘Preferences’ screen and then navigate to the
‘Security’ screen. Select ‘New’ 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.
I.

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. The following steps will assist
you in adding a digital certificate.
In Adobe Acrobat select the ‘Advanced’ command menu option and then select ‘Security
Settings’. You should see the screen ‘Manage My Digital IDs’. Press the ‘Add ID’ icon
to either add a digital certificate or to generate an Adobe self-sign certificate. Select the
option that you want and proceed to either add an external certificate or to generate a selfsign digital certificate. After completing the Digital ID creation process you must select
the certificate you just created and then select the ‘Set Default’ icon and then select the
‘For Signing’ default option. This will insure that this certificate will be the certificate
used to apply your digital signature to the Manage form.
J.

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:

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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 - Configuring
Adobe Acrobat for CVM ESS 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’.
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.
K.

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 –
http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/Electron
icSubmissions/UCM448692.pdf

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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.
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 you’re last selected certificate.
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.

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15. The WebTrader software will now package up your submission(s) for
transmission. It will ask you for a certificate password which you must enter at
this time. After entering in the password click the ‘Ok’ button.
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.
L.

Electronic Response Messages from FDA

The FDA ESG will return a number of messages to you for each transmission you send
to FDA. In addition to the Gateway messages you will receive a message from the CVM
ESS. Please refer to the following URL to view actual screenshots of returned messages:
FDA Gateway Submissions and Receipts
(http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/ElectronicSu
bmissions/UCM448692.pdf). The messages will vary depending on what method you used

to transmit the submission(s). In all cases you will receive three messages:
1. The first message will be a FDA Gateway Receipt Message Digest Notification
(MDN). This 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 message that you will receive is 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.
3. The third message you will receive will come in one of two varieties. The
message format will depend on if 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 transmission then you will receive a
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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.
M.

Verifying FDA CVM’s Digital Signature

The CVM ESS applies a digital signature to each notification message it transmits. This
signature can be validated and trusted if you accomplish the following steps. Please refer
to the following URL to view actual screenshots of FDA CVM’s digital signature and the
steps to validate the signature: FDA Gateway Submissions and Receipts
(http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/ElectronicSu
bmissions/UCM448692.pdf).

Using Adobe Acrobat open the CVM ESS notifications receipt PDF.
1. You will receive a ‘Document Status’ information window announcing
the status of the PDF file.
2. You can check to properties of CVM’s digital signature by clicking
‘Signature Properties’.
3. You can check the legal notice and the certificate used to generate
the signature by clicking ‘Legal Notice’.
4. Selecting the ‘Signatures’ tab on the left side of the PDF document
exposes all the information about the document and it status and digital
signature information.
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 message-carrying 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.

Protecting the 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. Subsequent to the receipt of CVM's acknowledgment
letter for the registration, each stakeholder should submit to CVM ESS a digital
signature using the Manage 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.K. 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.

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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 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 that 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
(http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm)
Note: Please use the CVM Manage form as your ESG Test Submission.
Submit a registration letter to CVM
Download the CVM ESS Manage form (FORM FDA 3538) from the CVM Electronic
Submissions page
(http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/Electr
onicSubmissions/default.htm)
Submit a digital signature to CVM using FORM FDA 3538

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A.
REGISTRATION PROCESS:
(See Section III for details.)
1. Send a single, original, signed registration letter to CVM. See Appendix I for
an example of the registration letter. The letter should include:
a. the name, mailing address, phone number, and Email address of the
Coordinator;
b. the names, mailing addresses, phone numbers, and Email addresses for each
stakeholder who will submit electronic submission;
c. the subject of the letter should be Registration Letter for Electronic
Submission to CVM to clearly identify the purpose of the letter. A paper
copy of the letter should be mailed to the address given in Appendix I.
2. CVM will send an Email to the Coordinator named in the registration letter.
A paper response will also be sent once the registration process is complete.
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.
3. 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.

ADDING, DELETING or CHANGING STAKEHOLDER INFORMATION

1. 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”. Only Coordinators can add or delete stakeholders for their company.
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.

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2. 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.
C.
ADDING OR DELETING A COORDINATOR OR CHANGING AN
EMAIL ADDRESS
1. 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.

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Contains Non-binding Recommendations
APPENDIX 1 - Example of Registration Letter
______________________________________________________________________________
Office of Management
Business Informatics Team (HFV-16)
Center for Veterinary Medicine
7500 Standish Place
Rockville, Maryland 20855
Attention: Mr. Shane Burch
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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Contains Non-binding Recommendations
APPENDIX 2 - CVM ESS Registration Workflow

19

ContMins Non-binding Recommendations
APPENDIX 3 – FDA ESG Registration Workflow

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