Appendix K.    AS2 Routing IDs

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.

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

    Figure 1: Partner Profile

  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

    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.

  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

  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

    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

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.