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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

    AERS FDA_AERS Yes Yes
    AERS_Attachments FDA_AERS_ATTACHMENTS Yes Yes
    EBLA CBER_EBLA Yes Yes
    ECTD CBER_ECTD Yes Yes
    EIDE CBER_EIDE Yes Yes
    EIND CBER_EIND Yes Yes
    eDMF CBER_EDMF Yes Yes
    Promotional_Material CBER_PROMOTIONAL_MATERIAL Yes Yes
    Lot_Distribution_Data CBER_LOT_DISTRIBUTION_DATA Yes Yes
    H1N1_Lot_Release CBER_H1N1_LOT_RELEASE Yes Yes
    510K CBER_510K Yes Yes
    CDISC CBER_CDISC Yes Yes
    PRE_IND CBER_PRE_IND Yes Yes
    SPL_LDD CBER_SPLLDD Yes Yes
    VAERS CBER_VAERS Yes Yes
    Pilot_Lot_Release CBER_PILOT_LOT_RELEASE Yes Yes

    CDER

    AERS FDA_AERS Yes Yes
    AERS_Attachments FDA_AERS_ATTACHMENTS Yes Yes
    EANDA CDER_EANDA Yes Yes
    EBLA CDER_EBLA Yes Yes
    ECTD CDER_ECTD Yes Yes
    ENDA CDER_ENDA Yes Yes
    EIND CDER_EIND Yes Yes
    ACA6004_Drug_Samples CBER_AVA6004 Yes Yes
    GDUFA_Facility_Registration CDER_GDUFA_FACILITY_REGISTRATION Yes Yes

    CDRH

    Adverse_Events CDRH_AERS Yes Yes
    Electronic_Submissions CDRH_ESUBS Yes Yes
    GUDID CDRH_GUDID Yes Yes

    CFSAN

    Form 3480 CFSAN_FORM3480 Yes Yes
    Form 3480A CFSAN_FORM3480A Yes Yes
    Form 3666 CFSAN_FORM3666 Yes Yes
    Threshold_of_Regulation CFSAN_THRESHOLD_OF_REGULATION Yes Yes
    Form 3667 CFSAN_FORM3667 Yes Yes
    Form 3665 CFSAN_FORM3665 Yes Yes
    Form 3503 CFSAN_FORM3503 Yes Yes
    Food_Pilot_Listing CFSAN_FPL Yes Yes
    NDI CFSAN_NDI Yes Yes
    EON_Payload_Files CFSAN_EON_PAYLOAD_FILES Yes Yes
    EON-Notification-Files CFSAN_EON_NOTIFICATON_FILES Yes Yes

    CTP

    Electronic_Submission CTP_ESUB Yes Yes
    Adverse_Events CTP_AE No No

    CVM

    Electronic_Submissions CVM_ESUBS Yes Yes
    Adverse_Events_Reports CVM_AERS Yes Yes
    eSubmitter CVM_ESUBMITTER Yes Yes
    OC SPL OC_REGLIST_SPL Yes Yes

    OOPD

    HUD_Designation_Requests OOPD_HUD_DESIGNATIONS Yes No
    Orphan_drug_Designation_Requests OOPD_ORPHAN_DRUG_DESIGNATIONS Yes No

    GWTEST

    ConnectTest GWTEST_CONNECTION Yes No
    SizeTest GWTEST_7GB Yes No
    HC ECTD HC_ECTD Yes Yes

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

 

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