ESG Appendix J: AS2 Routing IDs
ESG User Guide - Table of Contents
As an alternative to using the AS2 Header Attributes (Appendix F) 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
Legend: (A) denotes AS2 only. (W) denotes WebTrader only. (P) denotes Production environment only. (T) denotes Test environment only. (NGP) denotes Not for General Public. (*) CDRH's only eligible submission categories via the FDA ESG CDRH "Electronic_Submissions" submission type are "Recall Reports of Corrections and Removals" and "Radiological Health Reports and Correspondence". Further, CDRH Premarket submissions should be sent via the CDRH Customer Collaboration Portal. Note: If a WebTrader Display Name or an AS2 Submission Type does not have either the (P) or (T) annotation, then it is allowed in both Production and Test. Note: If an item does not have the (W) or (A) annotation, then it is allowed in both WebTrader and AS2. Center WebTrader Display Name AS2 Submission Type AS2 Routing ID CBER 510K 510K CBER_510K AERS AERS FDA_AERS AERS Attachments AERS_ATTACHMENTS FDA_AERS_ATTACHMENTS AERS_PREMKT_CBER AERS_PREMKT_CBER FDA_AERS_PREMKT_CBER AERS_ATTACHMENTS_PREMKT_CBER AERS_ATTACHMENTS_PREMKT_CBER FDA_AERS_ATTACHMENTS_PREMKT_CBER BEST BEST CBER_BEST CDISC CDISC CBER_CDISC EBLA EBLA CBER_EBLA eDMF eDMF CBER_EDMF EIDE EIDE CBER_EIDE EIND EIND CBER_EIND EUA EUA CBER_EUA H1N1_Lot_Release (A) CBER_H1N1_LOT_RELEASE Lot_Release_Protocol Lot_Release_Protocol CBER_LOT_RELEASE_PROTOCOL NDA NDA CBER_NDA PMA PMA CBER_PMA Pre_IND PRE_IND CBER_PRE_IND Promotional_Materials Promotional_Materials CBER_PROMOTIONAL_MATERIAL QSUBS QSUBS CBER_QSUBS SEND_PILOT (T) SEND_PILOT (T) CBER_SEND_PILOT SPL_LDD SPL_LDD CBER_SPLLD VAERS VAERS CBER_VAERS CDER ACA6004_Drug_Samples ACA6004_Drug_Samples CDER_ACA6004 AERS AERS FDA_AERS AERS Attachments AERS_ATTACHMENTS FDA_AERS_ATTACHMENTS AERS IND (T) AERS_IND (T) AERS_IND AERS Attachment IND (T) AERS_ATTACHMENTS_IND (T) AERS_ATTACHMENTS_IND AERS_PREMKT (T) AERS_PREMKT (T) FDA_AERS_PREMKT AERS_Attachments_PREMKT (T) AERS_Attachments_PREMKT (T) FDA_AERS_ATTACHMENTS_PREMKT AERS_PREMKT_CDER AERS_PREMKT_CDER FDA_AERS_PREMKT_CDER AERS_ATTACHMENTS_PREMKT_CDER AERS_ATTACHMENTS_PREMKT_CDER FDA_AERS_ATTACHMENTS_PREMKT_CDER ECTD ECTD CDER_ECTD ECTD WAIVED ECTD_WAIVED CDER_ECTD_WAIVED EDMF TYPEIII EDMF_TYPEIII CDER_EDMF_TYPEIII EIND EIND CDER_EIND FFU-PILOT (T) FFU-PILOT (T) CDER_FFU-PILOT GDUFA_Facility_Registration GDUFA_Facility_Registration CDER_GDUFA_FACILITY_REGISTRATION PFC PFC CDER_PFC POR Large Molecule Documents POR_Large_Molecule_Docs CDER_POR_Large_Molecule_Docs Voluntary_Direct_AEs (W) CDRH Adverse Events Adverse_Events CDRH_AERS Electronic_Submissions (*) Electronic_Submissions (*) CDRH_ESUBS GUDID GUDID CDRH_GUDID HFP (formerly CFSAN) DSR_Adverse_Events (A) CFSAN_DSR_ADVERSE_EVENTS EON-Payload-Files (P) EON-Payload-Files (P) CFSAN_EON_PAYLOAD_FILES Food_Pilot_Listing (P) Food_Pilot_Listing (P) CFSAN_FOOD_PILOT_LISTING Form3479 Form3479 CFSAN_Form3479 Form3480 Form3480 CFSAN_FORM3480 Form3480A Form3480A CFSAN_FORM3480A Form3503 Form3503 CFSAN_FORM3503 Form3665 Form3665 CFSAN_FORM3665 Form3666 Form3666 CFSAN_FORM3666 Form3667 Form3667 CFSAN_FORM3667 NDI (P) NDI (P) CFSAN_NDI Threshold_of_Regulation Threshold_of_Regulation CFSAN_TRESHOLD_OF_REGULATION CTP Adverse_Events (A) CTP_AE Electronic_Submission Electronic_Submission CTP_ESUB CVM Adverse_Events_Reports Adverse_Events_Reports CVM_AERS eSubmitter eSubmitter CVM_ESUBMITTER Manage Form Electronic_Submissions CVM_ESUBS CVM-VDD eSubmitter (T) eSubmitter (T) CVMVDD_eSubmitter GWTEST ConnectTest (T) ConnectTest (T) GWTEST_CONNECTION SizeTest (T) SizeTest (T) GWTEST_7GB HC Transaction Transaction HC_Transaction MWP MWP_Report (A, NGP) MWP_REPORT OC SPL SPL OC_REGLIST_SPL OCAC OCAC AERS_PSTMKT_OCAC OOPD HUD_Designation_Requests (T) HUD_Designation_Requests (T) OOPD_HUD_DESIGNATIONS Orphan_drug_Designation_Requests (T) Orphan_drug_Designation_Requests (T) OOPD_ORPHAN_DRUG_DESIGNATIONS OPQ 704a4_Pharma_Inspection_Records (W) ORA Document_Requests (W) POR Small Molecule Documents POR_Small_Molecule_Docs ORA_POR_Small_Molecule_Docs
- 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.
- In order to communicate the filename to the FDA, the FDA requires the FileName Preserve on all AS2 submissions.