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
RAMSSLRandom Access MemorySecure Socket LayerAppendix G.AS2 Header AttributesIn addition to tarring/gzipping the actual documents, AS2 submissions must include thefollowing attributes in their AS2 headers. The additional information is comprised of:- FDA submissions Type- FdaSubmissionType: Abbreviated New Drug (add submission type information)- Center Name-- FdaCenter: CDER (add Center information)The Mime Headers are to be located in the outermost MIME wrapper and will appear as follows:X-Cyclone-Metadata-FdaSubmissionType: Abbreviated New DrugX-Cyclone-Metadata-FdaCenter: CDERThe following example represents how the standard AS2 mime header should appear afterappending the Center and SubmissionType attributes and upon and presented at the FDA ESG.Message-ID: 1115406057162.328983@WIN2K3-ESX6Date: Fri, 06 May 2005 19:00:57 GMTFrom: esx6Mime-Version: 1.0Content-Type: application/pkcs7-mime; smime-type=enveloped-data;name=smime.p7mContent-Transfer-Encoding: binaryContent-Disposition: attachment; filename=smime.p7mDisposition-Notification-To: esx6Disposition-Notification-Options: signed-receipt-protocol=optional,pkcs7-signature; signed-receipt-micalg=optional, sha1AS2-Version: 1.1AS2-To: db-as2AS2-From: esx6-as2X-Cyclone-Metadata-FdaSubmissionType: EANDAX-Cyclone-Metadata-FdaCenter: CDERContent-Length: 3607This information must be included in the outermost portion of the outermost MIME wrapper.The table below indicates the allowable attribute values for each FDA Center destination:
Table G-1: Allowable Center Attribute ValuesCenterDestinationCBERAllowed Attribute ValuesAERSAERS_AttachmentsEBLAECTDEIDEEINDeDMFPromotional_MaterialCDERLot_Distribution_DataAERSAERS_AttachementsEANDAEBLAECTDENDACDRHCFSANEINDAdverse_EventsElectronic_SubmissionsBNFsColor_Master_FileFood_Contact_NotificationFood_Master_File
- Page 16 and 17: 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: Appendix F. AcronymsA list of acron
- Page 69 and 70: SAMPLE LETTER #1[Company Letterhead
- 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
Table G-1: Allowable Center Attribute ValuesCenterDestinationCBERAllowed Attribute ValuesAERSAERS_AttachmentsEBLAECTDEIDEEINDeDMFPromotional_MaterialCDERLot_Distribution_DataAERSAERS_AttachementsEANDAEBLAECTDENDACDRHCFSANEINDAdverse_Events<strong>Electronic</strong>_<strong>Submissions</strong>BNFsColor_Master_FileFood_Contact_NotificationFood_Master_File
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