FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
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GRAS NoticeNew_Protein_ConsultationPetitionsPNCCVMOOPDGWTESTOCThreshold_of_Regulation<strong>Electronic</strong>_<strong>Submissions</strong>Orphan-drug_Designation_RequestsHUD_Designation_RequestsConnectTestSizeTestSPLAppendix H. Sample Letters of Non-Repudiation AgreementA letter of Non-Repudiation Agreement for digital signatures must be submitted to the <strong>FDA</strong>prior to registering as a transaction partner for the <strong>FDA</strong> <strong>ESG</strong>. The letter must be submitted inpaper form (preferably on company letterhead) and signed with a traditional handwrittensignature. The letter must be sent to:Office of Regional Operations (HFC-100)5600 Fishers LaneRockville, MD 20857.A copy must be sent to:Michael FauntleroyOffice of the Director (HFM-26)Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Room 4119Rockville, MD 20852.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.