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

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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, orrepresentatives, located anywhere in the world, are the legally binding equivalent of traditionalhand-written signatures.Sincerely yours,[Hand-written signature][Name of Company Representative][Company Representative Title]Appendix I.EDIFACT Message StructureRequired message structure (EDIFACT)S/MIME SMTP E-mail HeaderExample:UNB+UNOB:1+016968919:01+FDA:ZZ+060310:0127+37' HeaderSGML documentDocument'UNZ+1+37'SGMLTrailer
EDIFACT UNB Header InformationDescription Code CommentsIdentification of thestart of the UNBheaderVersion of the standardof the UNB headerInterchange senderidentification code andsender code qualifierUNBUNOB:1xxxxxxx:01 (for AS2submissions this shouldmatch the routing ID)The code for the start of the UNB headershould be UNB in upper case lettersThe current version code should be UNOBin upper case lettersxxxxxxx should be the number assigned toyour company by Dun and BradstreetInformation Services. (For industry sendingto the FDA, the sender code qualifier is 01.)Interchange recipient FDA:zz xxxx should be the code for the receivingcenter (CDER, CBER, CDRH, CVM,Date and time ofpreparationInterchange controlreferenceyymmdd:hhmmUp to 14 alphanumericcharactersCFSAN)For now, a two-digit designation should beused for the yearYou should assign a unique referencenumber for each interchange. Otherwise thesystem will not recognize the transmissionas newUNZ Trailer InformationDescription Code CommentsIdentification of thestart of the trailerInterchange controlcountInterchange controlreferenceUNZUp to 6 numericalcharactersUp to 14alphanumericcharactersThe code for the start of the trailer is UNZ inupper case lettersCounts either the number of messages or thenumber of functional groups within theinterchange. Usually, this is 1This should be the same as the interchange controlreference in the UNB headerEDI headers and trailers are made up of a series of data elements separated by plus (+) signs. Acolon should separate segments of the individual data elements. An apostrophe should be used toterminate the header, body of the message, and the trailer.
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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
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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 and 68: Table G-1: Allowable Center Attribu
Page 69: SAMPLE LETTER #1[Company Letterhead
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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