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Letters of Non-Repudiation AgreementA 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) A copy must be sent to: Michael Fauntleroy 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) 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] [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) 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] |