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 In this section:

                About ESG

About ESG

                        User Guide
          ESG Account Management Portal User Guide
          Submission Statistics
          Impact of the Gateway
          Center Submission Types
          Submission Acknowledgements
          ESG Submission Process
          Planned Maintenance and Status History
          Submission Times Home
          For Industry
          Electronic Submissions Gateway
          About ESG
          Appendix G: Letters of Non-Repudiation AgreementAbout ESG Appendix G: Letters of Non-Repudiation Agreement
  
  	
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    PrintESG User Guide - Table of Contents

A Letter of Non-Repudiation Agreement for digital signatures must be submitted to the FDA prior to registering as a transaction partner for the FDA ESG. The letter must be submitted (preferably on company letterhead) and signed with a traditional handwritten signature. Users requesting a new WebTrader ESG user account must upload an electronic copy of their Letter of Non-Repudiation Agreement during account registration via the FDA ESG User Portal (https://esgportal.fda.gov/). AS2 (Gateway-to-Gateway) users must send an electronic copy of their Letter of Non-Repudiation Agreement to the ESG Help Desk at ESGHelpDesk@fda.hhs.gov. Users are no longer required to submit a physical copy to the FDA. Submitting a physical copy is now optional. Users who would like to continue to send a physical copy to the FDA can do so by sending the letter to:

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Samples: Letter of Non-Repudiation Agreement

The following two letters are provided as samples for a Letter of Non-Repudiation Agreement. The information in square brackets [ ] will be provided by the submitter.

**SAMPLE LETTER #1**

[Company Letterhead]

[Today's Date]

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Re: Electronic Signatures

Dear Sir or Madam:

Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that [Company Name], [Company Address], intends that electronic signatures executed by our employees, [List of employee names] are the legally binding equivalent of traditional hand-written signatures.

Sincerely yours,

[Hand-written signature]
[Company Representative Title]

[Employee Name #1]: _________ [Hand-written signature of employee #1]

[Employee Name #2]: _________ [Hand-written signature of employee #2]

[Employee Name #3]: _________ [Hand-written signature of employee #3]

[etc]



**SAMPLE LETTER #2**

[Company Letterhead]

[Today's Date]

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Re: Electronic Signature Certificate Statement

To Whom It May Concern:

Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that [Company Name], intends that all electronic signatures executed by our employees, agents, or representatives, located anywhere in the world, are the legally binding equivalent of traditional hand-written signatures.

Sincerely yours,

[Hand-written signature]

[Name of Company Representative]
[Company Representative Title]



*If using USPS, do NOT use Priority Mail Express.

                                                                                  Content current as of:
      03/02/2023About ESG

          
                        User Guide
          Account Management Portal User Guide
          Submission Statistics
          Impact of the Gateway
          Center Submission Types
          Submission Acknowledgements
          ESG Submission Process
          Planned Maintenance and Status History
          Submission Times
 
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