FDA ELECTRONIC SUBMISSIONS GATEWAY (ESG)

Letters of Non-Repudiation Agreement

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 in paper form (preferably on company letterhead) and signed with a traditional handwritten signature. The letter must be sent to:

Office of Regional Operations (HFC-100)
5600 Fishers Lane
Rockville, MD 20857.

A copy must be sent to:

Michael Fauntleroy
Office of the Director (HFM-25)
Center for Biologics Evaluation and Research
Food and Drug Administration
11400 Rockville Pike, Room 4119
Rockville, MD 20857.

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]

Office of Regional Operations (HFC-100)
5600 Fishers Lane
Rockville, MD 20857

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]

Office of Regional Operations (HFC-100)
5600 Fishers Lane
Rockville, MD 20857

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]