FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

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GRAS NoticeNew_Protein_ConsultationPetitionsPNCCVMOOPDGWTESTOCThreshold_of_RegulationElectronic_SubmissionsOrphan-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 FDAprior to registering as a transaction partner for the FDA ESG. 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.
SAMPLE LETTER #1[Company Letterhead][Today’s Date]Office of Regional Operations (HFC-100)5600 Fishers LaneRockville, MD 20857Re: Electronic SignaturesDear 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 ouremployees, [List of employee names] are the legally binding equivalent of traditional handwrittensignatures.Sincerely yours,[Hand-written signature][Name of Company Representative][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 LaneRockville, MD 20857Re: Electronic Signature Certificate Statement
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FDA Electronic Submissions Gateway
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Appendix C. Digital Certificates...
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Figure 1: Overview of the Registrat
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2.6 Send Submissions to the Product
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eCTD - Electronic Common Technical
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FDAPreparation of multi-filesubmiss
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3.7 Help and InformationThere are r
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4. Click the Next button.The Pick a
Page 18: 8. Click the Next button.The Locate
Page 21 and 22: 14. Enter a new login User ID and P
Page 23 and 24: Confirm that the correct version of
Page 25 and 26: 7. Select the Send document menu it
Page 27 and 28: - Load tests ensure that you are ab
Page 29 and 30: 20. To access the receipt, click on
Page 31 and 32: 4.4 Apply for a Production System A
Page 33 and 34: submissions (> 7.5 GB), this can ta
Page 35 and 36: When a Center receives a submission
Page 37 and 38: The following information is requir
Page 39 and 40: Be sure to indicate on the applicat
Page 41 and 42: - Create a local environment that s
Page 43 and 44: ___________________________________
Page 45 and 46: Upon receiving the file, signature
Page 47 and 48: or by obtaining a certificate from
Page 49 and 50: 3. Click on the Export button to cr
Page 51 and 52: 9. Give a file name and select the
Page 53 and 54: 4. Create a password for your priva
Page 55 and 56: 2. Select "Windows" from the platfo
Page 57 and 58: 2. Click on the link under Required
Page 59 and 60: 4. With the box unchecked, a warnin
Page 61 and 62: . From the Add or Remove Programs d
Page 63 and 64: Appendix E. Glossary of TermsTable
Page 65 and 66: Appendix F. AcronymsA list of acron
Page 67: Table G-1: Allowable Center Attribu
Page 71 and 72: EDIFACT UNB Header InformationDescr
Page 73 and 74: Consult with an FDA Center represen
Page 75 and 76: Figure 3: File System Settings, Dir
Page 77 and 78: 6. Click on the Save changes button
Page 79 and 80: Figure 7: Submission Types Supporte
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FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

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