5 AS2 Gateway-to-Gateway Electronic Submissions

The steps below represent the current understanding of the AS2 Gateway-to-Gateway submission process. Further refinement and clarification of these steps will be provided in future revisions of the user guide.

5.1 Apply for a Test Account

1. An online application form is provided for Transaction Partners to register for AS2 test accounts. The registration URL and a temporary Login ID and password can be obtained from the FDA ESG Administrator by sending an email to [email protected] indicating intent to register for the FDA ESG.
2. The following information is required to complete the AS2 application form:
   • Contact information - The name and contact information of a person whom the FDA may contact for questions or additional information. Enter the following information:
   • Company name
   • Primary Contact name
   • Primary Contact phone
   • Primary Contact email
   • Alternate contact name
   • Alternate phone
   • Alternate email
     • NOTE: Partners who have either an FDA ESG Webtrader or AS2 account already, must enter a unique string (different from the one used when registering for the FDA ESG Webtrader or AS2 account) in the Company name field. This is to ensure that this account is treated as a separate identity in the database.
   • The URL from where test submissions will be sent and where acknowledgements and notifications will be received from the FDA.
   • The digital certificate used to digitally sign and encrypt the test submission.
   • The organization’s ID number. This could be, but does not have to be the Data Universal Numbering System (DUNS) number.
   • Firewall security information:
   • Secure Socket Layer (SSL) Information – user name and password (if one is needed for SSL)
   • Proxy Information – if a proxy server is used.

5.2 Test Account Setup and Approval

After submitting the application information as described above, the FDA ESG Administrator will communicate with the Primary Contact to validate the information provided, to setup the test account, and to test the AS2 Gateway-to-Gateway connection. At that time, the FDA ESG Administrator will also obtain security and proxy information from the Transaction Partner.

The FDA ESG Administrator will provide the following information so that the Transaction Partner can set up an account for the FDA ESG within their own Gateway. This FDA ESG account will enable the receipt of messages from the FDA ESG.

• The FDA ESG Administrator’s contact information
• The URL to which the Transaction Partner will send test submissions
• The FDA digital certificate for test submissions
• The FDA ID number

At this point the Gateway-to-Gateway connection will be tested to ensure that secure messages from the Transaction Partner to the FDA ESG and from the FDA ESG to the Transaction Partner’s AS2 Gateway are successfully received.

NOTE:  The FDA ESG uses SSL over port 4080 for all AS2 inbound and outbound transactions. 

5.3 Send a Test Submission

1. Contact the appropriate Center testing representative or appropriate programmatic representative for safety reporting to schedule a specific test date and time. Reference Section 3.3, Understand Submission Guidelines, in the FDA Electronic Submissions Gateway User Guide for information on how to prepare an electronic submission and Center contact information.
2. For multi-file submission, the entire submission must reside in a single directory. This directory must then be converted to a single .tar.gz file. Reference Appendix B.,Creating tar Files and Compressing Files for Submission, for instructions on creating this compressed file. Take special note of the naming conventions for files and directories to ensure delivery of a complete submission. 
3. There are two ways to set up routing controls dictating where a document is sent:
   • Add the custom header attributes to the header of the message to indicate the type of submission (e.g., an IND) and destination (e.g., CBER). Reference Appendix G., AS2 Header Attributes, for information on header attributes content and format. OR
   • Use a unique routing ID to identify the types of submissions and destination.  The selection of the routing ID can be automated in the Cyclone/Axway products through the back-end integration pick-up as described in Appendix K., AS2 Routing IDs.
4. At the scheduled date and time, send the test submission to the FDA. The FDA ESG will send a Mail Delivery Notification (MDN) indicating that the test submission was received successfully.The FDA ESG will then route the test submission to the Center Holding Area.  The Center will validate the test submission.  For all submissions, an Acknowledgement will be sent documenting the official date and time of receipt by FDA, and in some cases the Center/programmatic area business rules describing the establishment of that date and time.The Centers/programmatic area has the option to send an Acknowledgement (via AS2) indicating whether the submission was valid or invalid.
5. Contact the FDA ESG System Administrator at [email protected] if either the MDN or the Center Acknowledgement is not received.

Once a test submission has been successfully received and validated, the Transaction Partner is approved to apply for and setup a Production System Account. This account will be used to send submissions to the FDA.

5.4 Apply for a Production System Account

The steps for applying for a Production System AS2 Gateway Account are the same as those described in Section 2.1, Apply for a Test Account in the FDA Electronic Submissions Gateway User Guide.

Be sure to indicate on the application form that this application is for a Production System Account.

5.5 Production System Account Setup and Approval

The steps for setup and approval of a Production System AS2 Gateway Account are the same as those described in Section 2.1, Apply for a Test Account in the FDA Electronic Submissions Gateway User Guide. Upon completion of this step, the Transaction Partner is now ready to send submissions to the FDA ESG.

5.6 Send Submissions to the Production System

For each submission sent to the FDA ESG, at least two messages will be sent, and up to three messages will be sent back to the Transaction Partner. 

1. The Transaction Partner will receive the MDN from the FDA ESG indicating that the submission was received successfully. 
2. For all submissions, an Acknowledgement will be sent documenting the official date and time of receipt by FDA, and in some cases the Center/programmatic area business rules describing the establishment of that date and time.
3. Indication of submission validity or invalidity (at Center/programmatic area option).

5.7 Sending Large (> 7.5 GB) Submissions

NOTE:  This section primarily applies to Transaction Partners sending regulatory submissions to CBER and CDER and does not apply to Transaction Partners sending Safety Reports. 

The FDA ESG is able to receive and process regulatory submissions up to 100 GB in size.  The major consideration in determining how quickly large submissions are transmitted to the FDA ESG is the bandwidth available to the Transaction Partner between their company and the FDA ESG.  Transaction Partners who will be sending regulatory submissions larger than 1 GB in size, FDA has the following recommendations.

• During the testing phase, send a 7.5 GB test submission.  This test will allow Transaction Partners to evaluate bandwidth availability, transmission time, and to adjust their network configuration as necessary.  During pilot testing of the FDA ESG, industry testers found that bandwidth availability and network configuration had a major impact on the time to transmit submissions larger than 5 GB.  This submission should be sent to "GW TEST" Centers with "SIZE TEST" as the submission type.
• Send a 7.5 GB test submission that is representative of an actual submission (PDF files and SAS transport files).  The web interface archives and compresses the submission into a single file prior to transmission.  Submissions that consist of text files will compress to a greater extent than PDF files, will transmit faster, and thus give an inaccurate assessment of the time it takes for submissions to be sent and processed by the FDA ESG.  FDA strongly encourages Transaction Partners to send test submissions comprised of PDF files and SAS transport files. 
• Send submissions greater than 7.5 GB in size overnight.  Pilot testing with selected Industry Transaction Partners has shown that, depending on available bandwidth, it takes approximately 24 hrs for submissions 15 GB to 25 GB in total size to be transmitted and processed by the FDA ESG.  These companies had T3 network connections or better.  FDA recommends that large submissions be sent overnight, starting at 4:30 PM EST, in order for the submission to be received by the target Center before the end of the next business day.

Sending large submissions may result in the FDA ESG erroneously reporting that the transmission was not successful, even though the FDA ESG has successfully received the transmission.  This is a known bug and FDA has asked Cyclone Commerce to provide an update to that fixes this error.

When the FDA ESG has received a complete submission, a backup copy is made before a reply from the FDA ESG is sent confirming the submission is complete.  For large submissions (> 7.5 GB), this can take many minutes.  Since there is no network activity for such a long time, the session timeouts and a response is not received.  The FDA ESG has received the submission successfully, but an error is generated indicating that the submission needs to be resumed.  Receipt of the first acknowledgement (MDN) confirms that the submission was successfully received by the FDA ESG and that it is okay to cancel the resume request.  Since this is a large submission, it will take several hours before the first acknowledgement is received. 

If you receive this error and it has clearly occurred at the end of the transmission, do not resend the submission right away.  Wait for several hours (or longer depending on the size of the submissions) and see if the MDN is sent before attempting to resend the submission. 

5.8 Common AS2 Errors

Here are some of the most common causes of failed AS2 submissions:

• Your firewall rules are not set to allow connections with the FDA over port 4080. The FDA requires that all communications with the ESG occur with HTTPS over port 4080.
• You provide a private URL during registration. (A private URL is one located inside of your company's firewall.)
• The submissions's message header does not contain custom attributes.

We recommend two strategies to avoid these errors:

• Work with your IT infrastructure team throughout the registration process. Make sure they are aware of specific security settings that need to be enabled for successful AS2 registration and transmission.
• Create a local environment that simulates the FDA to test your submissions before you actually connect to the FDA. Trading partners who test locally have a much higher rate of success than those who don't.

Contact [email protected] if you have any problems with your registration or submissions.