ESG User Guide - Table of Contents

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.
   1. 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	510K	CBER_510K	Yes	Yes
      	AERS	FDA_AERS	Yes	Yes
      	AERS_Attachments	FDA_AERS_ATTACHMENTS	Yes	Yes
      	BEST	CBER_BEST	Yes	Yes
      	CDISC	CBER_CDISC	Yes	Yes
      	EBLA	CBER_EBLA	Yes	Yes
      	EIDE	CBER_EIDE	Yes	Yes
      	EIND	CBER_EIND	Yes	Yes
      	eDMF	CBER_EDMF	Yes	Yes
      	EUA	CBER_EUA	Yes	Yes
      	H1N1_Lot_Release	CBER_H1N1_LOT_RELEASE	Yes	Yes
      	Lot_Release_Protocol	CBER_ LOT_RELEASE_PROTOCOL	Yes	Yes
      	NDA	CBER_NDA	Yes	Yes
      	PMA	CBER_PMA	Yes	Yes
      	PRE_IND	CBER_PRE_IND	Yes	Yes
      	Promotional_Material	CBER_PROMOTIONAL_MATERIAL	Yes	Yes
      	QSUBS	CBER_QSUBS	Yes	Yes
      	SEND_PILOT	CBER_SEND_PILOT	Yes	No
      	SPL_LDD	CBER_SPLLDD	Yes	Yes
      	VAERS	CBER_VAERS	Yes	Yes
      CDER	ACA6004_Drug_Samples	CDER_ACA6004	Yes	Yes
      	AERS	FDA_AERS	Yes	Yes
      	AERS_Attachments	FDA_AERS_ATTACHMENTS	Yes	Yes
      	AERS IND	AERS_IND	Yes	No
      	AERS Attachment IND	AERS_ATTACHMENTS_IND	Yes	No
      	AERS_PREMKT	FDA_AERS_ PREMKT	Yes	No
      	AERS_Attachments_PREMKT	FDA_AERS_ATTACHMENTS_ PREMKT	Yes	No
      	ECTD	CDER_ECTD	Yes	Yes
      	EIND	CDER_EIND	Yes	Yes
      	FFU-PILOT	CDER_FFU-PILOT	Yes	No
      	GDUFA_Facility_Registration	CDER_GDUFA_FACILITY_REGISTRATION	Yes	Yes
      	PFC	CDER_PFC	Yes	Yes
      	Voluntary_Direct_AEs	WebTrader Submission ONLY	N/A	N/A
      CDRH	Adverse_Events	CDRH_AERS	Yes	Yes
      	Electronic_Submissions	CDRH_ESUBS	Yes	Yes
      	GUDID	CDRH_GUDID	Yes	Yes
      CFSAN	Form 3480	CFSAN_FORM3480	Yes	Yes
      	Form 3480A	CFSAN_FORM3480A	Yes	Yes
      	Form 3666	CFSAN_FORM3666	Yes	Yes
      	Threshold_of_Regulation	CFSAN_THRESHOLD_OF_REGULATION	Yes	Yes
      	Form 3667	CFSAN_FORM3667	Yes	Yes
      	Form 3665	CFSAN_FORM3665	Yes	Yes
      	Form 3503	CFSAN_FORM3503	Yes	Yes
      CTP	Electronic_Submission	CTP_ESUB	Yes	Yes
      	Adverse_Events	CTP_AE	No	No
      CVM	Electronic_Submissions	CVM_ESUBS	Yes	Yes
      	Adverse_Events_Reports	CVM_AERS	Yes	Yes
      	eSubmitter	CVM_ESUBMITTER	Yes	Yes
      CVM-VDD	eSubmitter (WebTrader: Electronic_Submissions)	CVMVDD_eSubmitter	Yes	Yes
      OC	SPL	OC_REGLIST_SPL	Yes	Yes
      OOPD	HUD_Designation_Requests	OOPD_HUD_DESIGNATIONS	Yes	No
      	Orphan_drug_Designation_Requests	OOPD_ORPHAN_DRUG_DESIGNATIONS	Yes	No
      ORA	Inspection	ORA_Inspection	Yes	No
      GWTEST	ConnectTest	GWTEST_CONNECTION	Yes	No
      	SizeTest	GWTEST_7GB	Yes	No
      HC	Transaction	HC_Transaction	Yes	Yes

9. In order to communicate the filename to the FDA, the FDA requires the FileName Preserve on all AS2 submissions.

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