For Industry
ESG Appendix K: AS2 Routing IDs
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NOTE: The Pre-production & Production System (v5.5.2) now supports the use of AS2 Routing IDs for all gateway systems.
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.
- In your FDA partner profile, click on the "Routing IDs" link.
Figure 1: Partner Profile

- 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.
- 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.
- 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

Click on the Message attributes tab. This will access the following screen:
Figure 4: Message Attributes, Adding

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.
- 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

- Click on the Save changes button to commit the changes to the integration pickup.
- 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 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.
- 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.
- 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
Center Destination | Submission Types | Routing ID | Test | Production |
CBER | AERS AERS_Attachments EBLA ECTD EIDE EIND eDMF Promotional_Material Lot_Distribution_Data H1N1_Lot_Release 510K CDISC PRE_IND SPLLDD VAERS | FDA_AERS FDA_AERS_ATTACHMENTS CBER_EBLA CBER_ECTD CBER_EIDE CBER_EIND CBER_EDMF CBER_PROMOTIONAL_MATERIAL CBER_LOT_DISTRIBUTION_DATA CBER_H1N1_LOT_RELEASE CBER_510K CBER_CDISC CBER_PRE_IND CBER_SPLLDD CBER_VAERS | Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes | Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes No Yes |
CDER | AERS AERS_Attachments EANDA EBLA ECTD ENDA EIND ACA6004 GDUFA_Facility_Registration | FDA_AERS FDA_AERS_ATTACHMENTS CDER_EANDA CDER_EBLA CDER_ECTD CDER_ENDA CDER_EIND CBER_AVA6004 CDER_GDUFA_FACILITY_REGISTRATION | Yes Yes Yes Yes Yes Yes Yes Yes Yes | Yes Yes Yes Yes Yes Yes Yes Yes Yes |
CDRH | Adverse_Events Electronic_Submissions UDID HL7 SPL XML | CDRH_AERS CDRH_ESUBS CDRH_UDID | Yes Yes Yes | Yes Yes Yes |
CFSAN | Food_Master_File (Form 3503) Food_Master_File_for_FCS (Form 3480) Color_Master_File (Form 3503) Food Additive Petition (Form 3503) Food_Contact_Notification (Form 3480) Food_Contact_Notification_Amendment (Form 3480A) New_Protein_Consultation (Form 3666) Threshold_of_Regulation Generally_Recognized_As_Safe_Notice (Form 3667) Biotechnology_Final_Consultation (Form 3665) Pre-Notification_Consultation (Form 3480) Color_Additive_Petition (Form 3503) Food_Pilot_Listing NDI EON_Payload_Files EON-Notification-Files | CFSAN_FORM3503 CFSAN_FORM3480 CFSAN_FORM3503 CFSAN_FORM3503 CFSAN_FORM3480 CFSAN_FORM3480A CFSAN_FORM3666 CFSAN_THRESHOLD_OF_REGULATION CFSAN_FORM3667 CFSAN_FORM3665 CFSAN_FORM3480 CFSAN_FORM3503 CFSAN_FPL CFSAN_NDI CFSAN_EON_PAYLOAD_FILES CFSAN_EON_NOTIFICATON_FILES | Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes | Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes |
CTP | Electronic_Submission Adverse_Events | CTP_ESUB CTP_AE | Yes Yes | Yes No |
CVM | Electronic_Submissions Adverse_Events_Reports eSubmitter | CVM_ESUBS CVM_AERS CVM_ESUBMITTER | Yes Yes Yes | Yes No Yes |
OCPP | SPL | OC_REGLIST_SPL | Yes | Yes |
OOPD | HUD_Designation_Requests Orphan_drug_Designation_Requests | OOPD_HUD_DESIGNATIONS OOPD_ORPHAN_DRUG_DESIGNATIONS | Yes Yes | No No |
GWTEST | ConnectTest SizeTest | GWTEST_CONNECTION GWTEST_7GB | Yes Yes | No No |
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