NOTE: The Pre-production System (v5.5.2) now supports the use of AS2 Routing IDs for all gateway systems. The ESG production system currently does not support the use of AS2 Routing IDs for non-Axway gateway software. No production implementation date for v5.5.2 has been set.
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.
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.
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.
Figure 5: Message Attributes, Added


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.
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 |
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 |
Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes |
Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes |
|
CDER |
AERS AERS_Attachments EANDA EBLA ECTD ENDA EIND |
FDA_AERS FDA_AERS_ATTACHMENTS CDER_EANDA CDER_EBLA CDER_ECTD CDER_ENDA CDER_EIND |
Yes Yes Yes Yes Yes Yes Yes |
Yes Yes Yes Yes Yes Yes Yes |
|
CDRH |
Adverse_Events Electronic_Submissions |
CDRH_AERS CDRH_ESUBS |
Yes Yes |
Yes Yes |
|
CFSAN** |
Food_Master_File Color_Master_File Food_Contact_Notification New_Protein_Consultation Threshold_of_Regulation GRAS_Notice BNFs PNC Petitions |
CFSAN_FOOD_MASTER_FILE CFSAN_COLOR_MASTER_FILE CFSAN_FOOD_CONTACT_NOTIFICATION CFSAN_NEW_PROTEIN_CONSULTATION CFSAN_THRESHOLD_OF_REGULATION CFSAN_GRAS_NOTICE CFSAN_BNFS CFSAN_PNC CFSAN_PETITIONS |
Yes Yes Yes Yes Yes Yes Yes Yes Yes |
No No No No No No No No No |
|
CTP |
Electronic_Submission |
CTP_ESUB |
Yes |
Yes |
|
CVM |
Electronic_Submissions Adverse_Events_Reports |
CVM_ESUBS CVM_AERS |
Yes Yes |
Yes No |
|
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 |
* This center is a pilot program that is only being deployed in Pre-Production. Only authorized users should submit to the OCPP.
** These submission types are only supported in the Test environment and are intended solely for testing.