Appendix K.    AS2 Routing IDs

NOTE:  The use of unique AS2 Routing IDs to identify the type of submission and destination currently works only for Transaction Partners using Cyclone/Axway gateway software. Version 5.5.2 of Axway Interchange will add support for the use of Routing IDs for other gateway systems.  No implementation date for v5.5.2 has been set.  

 

The use of unique routing IDs to indicate submission type and Center is provided as an alternative to using the AS2 Header Attributes (Appendix G) process for sending submissions to the FDA ESG.  This Appendix describes how to automate the selection of the routing ID in Cyclone/Axway products through the incoming back-end integration pickup.  A list of routing IDs for each of the submission types received by the FDA ESG is shown at the end of the appendix. 

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

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

    Figure 1: Partner Profile

  2. Use the "Add" button to add the extra routing IDs to the FDA partner. The "ZZFDA" (production) or "ZZFDATST" (test) must be the first routing ID listed. Even if you never intend to directly use that routing ID, it must be listed first. Otherwise, the submission will not be processed correctly by the FDA.

    Figure 2: Change Routing IDs Page

Only file system integration pickups have the ability to automatically select a routing ID. If not currently using file system pickup to interface to the back-end server, a file system integration pickup must be created.  Refer to the Cyclone/Axway Administration Guide for complete step-by-step instructions of this process.

  1. After creating a file system integration pickup, create both a directory structure on disk that matches the routing IDs and configure the integration pickup to automatically select a routing ID based on directory names.

  2.  

  3. 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.  Adjust all references to this directory to refer to the directory in the integration pickup created.

  4. Figure 3: File System Settings, Directory Name

     

  5. Click on the Message attributes tab (as highlighted in the above screenshot).  This will access a screen similar to the following:

  6. Figure 4: Message Attributes, Adding

     

  7. The list of Available attributes (1) on a system might be smaller or larger, but as long as the To routing ID attribute is available the steps outlined here are offered.

  8.  

  9. Click on To routing ID (2) in the list of attributes. Then click on the  button.  After the screen refreshes, it should look like the next screenshot.

  10. Figure 5: Message Attributes, Added

  11. Click on the  button to commit the changes to the integration pickup.

  12.  

  13. Next, create the appropriate directories in the file system to match the FDA Routing IDs to which submissions are to be sent.

  14. Figure 6: Available Routing

     

  15. Figure 6: Available Routing shows a sample directory C:\bin\cyclone\common\data\out 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.

  16.  

  17. Create sub-directories beneath the base integration pickup directory as shown, then drop the documents that you wish to send into the appropriate directory.  For example, to send an AERS report, place the document in the ”FDA_AERS" directory.

  18. 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.  The tar and gzip process must be done 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

CBER

AERS

AERS Attachments

EBLA

ECTD

EIDE

EIND

eDMF

Promotional Material

Lot Distribution Data

FDA_AERS

FDA_AERS_ATTACHMENTS

CBER_EBLA

CBER_ECTD

CBER_EIDE

CBER_EIND

CBER_EDMF

CBER_PROMOTIONAL_MATERIAL

CBER_LOT_DISTRIBUTION_DATA

CDER

AERS

AERS Attachments

EANDA

EBLA

ECTD

ENDA

EIND

FDA_AERS

FDA_AERS_ATTACHMENTS

CDER_EANDA

CDER_EBLA

CDER_ECTD

CDER_ENDA

CDER_EIND

CDRH

Adverse Events

Electronic Submissions

CDRH_AERS

CDRH_ESUBS

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

CVM

Electronic_Submissions

CVM_ESUBS

OOPD

HUD_Designation_Requests

Orphan_drug_Designation_Requests

OOPD_HUD_DESIGNATIONS

OOPD_ORPHAN_DRUG_DESIGNATIONS

GWTEST *

ConnectTest

SizeTest

GWTEST_CONNECTION

GWTEST_7GB

* These submission types are only supported in the Test environment and are intended solely for testing.