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  5. Letters of Non-Repudiation Agreement
  1. Getting Started with ESG NextGen

Letters of Non-Repudiation Agreement

A Non-Repudiation Letter (NRL) for digital signatures is required to register as a transaction partner with FDA ESG NextGen.

New users requesting an ESG NextGen account must generate or upload an electronic NRL during account registration in the Unified Submission Portal (USP).

AS2 (Gateway-to-Gateway) users may also generate or upload an electronic NRL through the USP.

 

Individual vs. Company-Wide Letters

There are two types of Non-Repudiation Letters. You may use either type when registering for ESG NextGen.

  • Individual NRL – Signed and uploaded by the registered individual. This letter covers the named person(s) in the NRL and must be signed by the named individual(s).
  • Company-Wide NRL – Signed by someone authorized to act on behalf of an entire company. This letter covers all employees of that company.

 

Physical Letters Are No Longer Required

You no longer need to mail a physical copy of your NRL to the FDA. Sending a physical copy is now optional.

If you choose to send a physical copy, mail it to:
Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

⚠️ Note: If using USPS, do not use Priority Mail Express.

 

Letter Review Requirements for New Users

When an ESG NextGen Admin reviews your new account request, they will also review your NRL. Your registration will be rejected if the letter does not meet all of the following criteria:

  • Company letterhead or logo – The letter must be on company letterhead, or you must use an official company logo when generating the letter in the USP.
  • Individual NRL – matching information – The name of the person registered in ESG NextGen, the name in the letter, and the signature of the named person must all match.
  • Company-Wide NRL – authorized signature – The letter must be signed by someone authorized to sign on behalf of the company.
  • Company-Wide NRL – clear scope – The letter must be clearly designated as a company-wide letter and must state that it covers the entire company and all its employees. (see example below)

Power Users: Make sure that any users you approve going forward have a valid NRL on file.

 

NRLs for CROs, Agencies, and Consultants

An NRL is required for any signature on or within a submission.

If you are an Agency, CRO, or Consultant submitting on behalf of another company, you must have a company-wide NRL uploaded in the Authorization Letter section of your profile for each company on whose behalf you are submitting.

The authorizing company may also register directly in ESG NextGen and upload their own NRL. Once their account is created, they can view the submission details for any submissions their Agent, CRO, or Consultant has uploaded on their behalf.

 

Sample Letters

Two sample NRLs are provided below. Fill in all information shown in square brackets [ ] with your own details.

In both samples, company information must appear in the body of the letter. For the Individual NRL, the signature of each person named in the letter must also be included.

 

INDIVIDUAL NON-REPUDIATION LETTER EXAMPLE

[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]

 

COMPANY-WIDE NON-REPUDIATION LETTER EXAMPLE

[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]

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