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U.S. Department of Health and Human Services

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ESG Appendix K: AS2 Routing IDs

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As an alternative to using the AS2 Header Attributes (Appendix G) process for sending submissions to the FDA ESG, you can use unique routing IDs for your submissions to indicate the type of submission and the intended Center.  This Appendix describes how to automate the selection of the routing ID in Cyclone/Axway products through the incoming back-end integration pickup.  If you are not using a Cyclone/Axway product, refer to your gateway software's documentation for help configuring routing IDs.

The routing IDs for each submission type are listed at the end of the appendix. 

Before routing IDs can be selected, they must be added to your partner profile.

  1. In your FDA partner profile, click on the "Routing IDs" link.

    Figure 1: Partner Profile

     Screen Shot - FDA partner profile - Select "Routing IDs"

  2. Use the "Add" button at the bottom of the page to add extra routing IDs to the FDA partner.

    Note: "ZZFDA" (production) or "ZZFDATST" (test) must be the first routing ID listed. Otherwise, the submission will not be processed correctly by the FDA.

    Figure 2: Change Routing IDs Pages

    Only file system integration pickups have the ability to automatically select a routing ID. If you are not currently using file system integration pickups to interface with the back-end server, you must create a file system integration pickup must be created.  Refer to your gateway software's documentation for more information on this procedure.

  3. After you create a file system integration pickup, create a directory structure on the disk that matches the routing ID's path and configure the integration pickup to automatically select a routing ID based on directory names.
  4. In this example, the path to the integration pickup is C:\bin\cyclone\common\data\out, as shown in Figure 3: File System Settings, Directory Name.  This path should match the directory structure you created in step 3.

    Figure 3: File System Settings, Directory Name

     Screen Shot - Select "Message attributes"

    Click on the Message attributes tab. This will access the following screen:

    Figure 4: Message Attributes, Adding

     Screen Shot - Select "To routing ID" then selct "Add >>"

    Your list of Available attributes may differ from those shown. The only attribute here that must be on your list is To routing ID which is highlighted here.

  5. Click on To routing ID in the list of attributes. Then click on the Add button. After the screen refreshes, To routing ID should be listed under Selected attributes:

    Figure 5: Message Attributes, Added

     Screen Shot - Selected "To routing ID"

  6. Click on the Save changes button to commit the changes to the integration pickup.
  7. Next, create the appropriate directories in the file system to match the FDA Routing IDs to which submissions are to be sent.

    Figure 6: Available Routing

     Screen Shot - Select the "outbound" File

    Figure 6: Available Routing shows a sample directory and subdirectories that correspond to some of the available routing IDs.  A complete list of routing IDs for the FDA ESG are in Figure 7: Submission Types Supported by the FDA ESG.

  8. Create subdirectories beneath the base integration pickup directory as shown, then drop the documents that you wish to submit into the appropriate directory.  For example, to send an AERS report, place the document in the "FDA_AERS" directory.
  9. For multi-document submissions, the original directory structure must be converted to a single file by using "tar" and then "gzip", and the resulting file must have an extension of .tar.gz for the FDA ESG to correctly recognize it as a multi-document submission.  You must  perform the tar and gzip procedure before dropping the file into the appropriate directory, since the Cyclone/Axway software does not know how to tar and gzip on its own.

    Note: FDA_AERS and FDA_AERS_ATTACHMENTS submissions cannot be sent as multi-document submissions under any circumstances.

    Figure 7: Submission Types Supported by the FDA ESG

    Figure 7: Submission Types Supported by the FDA ESG

    Center Destination

    Submission Types

    Routing ID

    Test

    Production

    CBER

    AERSFDA_AERSYesYes
    AERS_AttachmentsFDA_AERS_ATTACHMENTSYesYes
    EBLACBER_EBLAYesYes
    EIDECBER_EIDEYesYes
    EINDCBER_EINDYesYes
    eDMFCBER_EDMFYesYes
    Promotional_MaterialCBER_PROMOTIONAL_MATERIALYesYes
    Lot_Distribution_DataCBER_LOT_DISTRIBUTION_DATAYesYes
    H1N1_Lot_ReleaseCBER_H1N1_LOT_RELEASEYesYes
    510KCBER_510KYesYes
    CDISCCBER_CDISCYesYes
    PRE_INDCBER_PRE_INDYesYes
    SPL_LDDCBER_SPLLDDYesYes
    VAERSCBER_VAERSYesYes
    Pilot_Lot_ReleaseCBER_PILOT_LOT_RELEASEYesYes

    CDER

    AERSFDA_AERSYesYes
    AERS_AttachmentsFDA_AERS_ATTACHMENTSYesYes
    EANDACDER_EANDAYesYes
    EBLACDER_EBLAYesYes
    ECTDCDER_ECTDYesYes
    ENDACDER_ENDAYesYes
    EINDCDER_EINDYesYes
    ACA6004_Drug_SamplesCBER_AVA6004YesYes
    GDUFA_Facility_RegistrationCDER_GDUFA_FACILITY_REGISTRATIONYesYes

    CDRH

    Adverse_EventsCDRH_AERSYesYes
    Electronic_SubmissionsCDRH_ESUBSYesYes
    GUDIDCDRH_GUDIDYesYes

    CFSAN

    Form 3480CFSAN_FORM3480YesYes
    Form 3480ACFSAN_FORM3480AYesYes
    Form 3666CFSAN_FORM3666YesYes
    Threshold_of_RegulationCFSAN_THRESHOLD_OF_REGULATIONYesYes
    Form 3667CFSAN_FORM3667YesYes
    Form 3665CFSAN_FORM3665YesYes
    Form 3503CFSAN_FORM3503YesYes
    Food_Pilot_ListingCFSAN_FPLYesYes
    NDICFSAN_NDIYesYes
    EON_Payload_FilesCFSAN_EON_PAYLOAD_FILESYesYes

    CTP

    Electronic_SubmissionCTP_ESUBYesYes
    Adverse_EventsCTP_AENoNo

    CVM

    Electronic_SubmissionsCVM_ESUBSYesYes
    Adverse_Events_ReportsCVM_AERSYesYes
    eSubmitterCVM_ESUBMITTERYesYes
    OCSPLOC_REGLIST_SPLYesYes

    OOPD

    HUD_Designation_RequestsOOPD_HUD_DESIGNATIONSYesNo
    Orphan_drug_Designation_RequestsOOPD_ORPHAN_DRUG_DESIGNATIONSYesNo

    GWTEST

    ConnectTestGWTEST_CONNECTIONYesNo
    SizeTestGWTEST_7GBYesNo
    HCECTDHC_ECTDYesYes

     

  10. In order to communicate the filename to the FDA, the FDA requires the FileName Preserve on all AS2 submissions.

 

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