Chapter 4 FDA ESG Web Interface Electronic Submissions
The steps for the electronic submission process for FDA ESG Web Interface users are provided in the following sections.
Applying for an FDA ESG WebTrader Test account is a multi-step process. You should have the following information before beginning the process:
- Company and contact information
- Digital Certificate file location
You can request a WebTrader Test Account by send an email to ESGHelpDesk@fda.hhs.gov and requesting a WebTrader test account. The subject of the email should be “New WebTrader Test Account Registration”. For more information, please review Setting up a WebTrader Account Checklist.
After successful Test Account setup, the ESG Help Desk will send an email to the email address provided for the contact, indicating approval as a Transaction Partner and authorization to send a test submission. Typically, the approval notification is sent on the next business day, but may take up to 48 hours. The test submission cannot be sent until this notification has been received.
After Test Account Setup and Transaction Partner approval, a test submission must be sent to ensure that the submission "conduit" is working properly from end to end. For more information on test account setup, please review Setting up a WebTrader Account Checklist.
Once you completed the test account setup and approval process, and the guidance compliant submission meets FDA requirements, your account will be migrated to production.
The steps to send a Submission to the FDA ESG are the same as those in Section 4.3, Send a Test Submission. However, there is a difference in the Login page. The Login page should not have the test environment warning that it has when sending a test submission.
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. FDA has the following recommendations concerning the transmission of large regulatory submissions.
- During the testing phase, WebTrader users have the option to send a large (greater than 2 GB) load test submission. This test will allow Transaction Partners to evaluate bandwidth availability and to adjust their network configuration as necessary. This test submission should be sent to the “GWTEST” Center and Submission Type of “SizeTest”.
- Send a 7.5 GB test submission that is representative of an actual submission. 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.
- Send submissions greater than 7.5 GB in size overnight. Pilot testing with selected Industry Transaction Partners has shown that 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.
When the FDA ESG has received a complete submission, a backup copy is made before the Java applet receives a reply from the server confirming the submission is complete. For large submissions, this can take many minutes. Since there is no network activity for such a long time, the session timeouts and the Java applet never receives the response. The FDA ESG has received the submission successfully, but the Java applet returns an error and indicates 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.
Once a submission has been sent using the FDA ESG Web Interface, the Transaction Partner can track the submission to ensure that it was received by the FDA ESG and the Center.
4.7.1 The Submission Process
When a submission is sent using the FDA ESG Web Interface, it goes through the following steps:
- The submission is transmitted using the FDA ESG Web Interface to the Gateway. When the FDA ESG receives this submission, it sends a receipt known as a Message Delivery Notification (MDN) to the Inbox of the account from which the submission was received.
- The submission is then delivered from the holding area to the appropriate Center. When a Center receives a submission, it sends an acknowledgement to the Inbox of the account from which the submission was sent.
When a submission is sent using the FDA ESG web interface, the following two messages are delivered to the Inbox of the account from which the submission was sent.
- A receipt from the FDA ESG, also known as an MDN. This message denotes that the submission has been delivered to the FDA ESG. The name of the receipt message includes the file name of the submission that was sent. If a directory of files was submitted, the file name of the submission will be the name of the directory followed by the extension ".tar.gz". The MDN message contains the message ID of the submission and a date stamp for when the submission was received by the FDA ESG. These items may be used to track a submission.
- An acknowledgement from the Center to which the submission was sent. This file is named with a unique alphanumeric string known as the Core ID. The Core ID is also used by the FDA ESG to track a submission. The date and time stamp contained in this acknowledgment conveys when (Center name or Programmatic entity) received your submission from the Electronic Submission Gateway.
Among other information, the MDN contains a Message ID and a time stamp denoting the time the submission was received. The Message ID is a unique alphanumeric string that identifies each submission. This Message ID can also be used to track a submission and to correlate a submission to its Center acknowledgement.
A sample MDN looks similar to the file shown below. The Message ID and date stamp in this MDN are highlighted.
When a Center receives a submission, it associates the submission’s Message ID with a Core ID. This Core ID can be used along with the Message ID generated as part of the MDN to track a submission on the FDA ESG. A sample acknowledgement message with the Core ID highlighted is shown below: