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:
You can obtains the FDA ESG Web Interface address and a temporary Login ID and password by emailing firstname.lastname@example.org and indicating your intent to register for the FDA ESG.
The remainder of this section describes the FDA ESG Test Account Application process using screenshots from the FDA ESG Web Interface.
Using the address provided by the FDA, access the FDA ESG Web Interface.
The Login page is displayed. Note the test environment warning on the Login page. If the Login page does not have this warning, do not continue. Exit the browser and contact the FDA ESG Administrator at email@example.com to request access to the test environment.
The WebTrader registration wizard is displayed. This wizard will guide the you through the remainder of the application process.
The Pick a Community page is displayed
The community represents where submissions will be sent for logging, verification, and ultimately routing to the appropriate FDA Center. The only community will be "FDA VM."
Reference Appendix E., Glossary of Terms, for more information about the community.
The Enter company information page is displayed.
This page records your company's name for identification purposes.
NOTE: If you already have an account, whether it is AS2 or WebTrader, you must enter a unique string (different from the one used when registering for their first account) in the Company name field. This is to ensure that this account is treated as a separate identity in the database.
The Locate the certificate file page is displayed.
This page is used to specify the location of the certificate file. Each submission must be accompanied by a certificate. The digital certificate must be an X.509 version 3 certificate.
Reference Appendix C., Digital Certificates for more information about digital certificates.
NOTE: There are situations when a valid certificate is not accepted by the registration module and an error message is returned. If this occurs, zip the certificate file and email it to the FDA ESG administrator at firstname.lastname@example.org. Once received, FDA will assess the certificate and send a response.
The View certificate details page is displayed.
This page is used to review the certificate information and to assign a name to the certificate. Carefully review the "Issuer" and "Subject" fields to be sure that all data fields are completed (i.e., for each data element such as "CN", there is a value that follows the equals sign).
The Enter user account information page is displayed.
This page is used to specify the user ID, password, and contact information selected by the Transaction Partner. After registration is complete, this user ID and password will be used by the Transaction Partner to log on to the FDA ESG Web Interface.
The Registration summary page is displayed.
This final page provides an account summary.
After successful Test Account setup, the FDA sends 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.
The test submission cannot be sent until this notification has been received.
Java Runtime Edition (JRE) must be installed to send a submission. Reference Appendix D., Java Runtime Edition Installation for the installation procedures.
Once you have fulfilled these criteria, proceed to Section 4.3 for instructions on sending a test submission.
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. To do this, follow the steps below.
Confirm that the correct version of the JRE is installed before you begin. Reference Appendix D., Java Runtime Edition Installation for the version information and installation procedures.
Using the address provided by the FDA, access the FDA ESG Web Interface application.
The Login page is displayed.
Note the test environment warning on the Login page. If the Login page does not have this warning, do not send a test submission. Exit the browser and contact the FDA ESG Administrator at email@example.com to request access to the test environment.
Click the Login button.
After a successful login, the My FDA submissions page is displayed. This page lists all messages received from the FDA ESG.
The WebTrader drop-down menu is displayed.
Select the Send document menu item.
The Send document page is displayed.
Select a test submission type from the Submission type drop-down box. About submission types:
Note that connectivity tests should only be sent to TESTING, not actual centers.
The completed Send document page should be populated similar to the page below.
The Enter password dialog box is displayed on top of the Send document page.
The Upload Progress dialog box is displayed on the Send document page:
When the upload is complete (indicated by the display of Done), click the Close button in the Upload Progress dialog box.
At this point, the test submission is sent. The FDA ESG logs the submission and verifies submission destination and type. When the submission is successfully received at the FDA, a receipt email will be listed on the My FDA Submissions page.
The WebTrader drop-down menu is displayed.
The My FDA submissions page is displayed.
The receipt for the test submission should be displayed here. This first receipt confirms that the submission was received by the FDA ESG. Click on the Details link to access the receipt contents.
If there are any errors in the submission, the receipt will not appear on the My FDA submissions page but will be sent to the Documents in Inbox page. The receipt will contain information about why the submission failed.
The FDA ESG will then route the test submission to the Center Holding Area. When the Center system successfully receives the submission, a second acknowledgement will be sent confirming that the Center has received the submission. The Center will then validate the test submission.
Contact the FDA ESG testing representative at firstname.lastname@example.org if the receipt for the test submission or the Center Acknowledgements is not received.
The next step is to apply for an FDA ESG Production System Account. This process is described in the following section.
The steps for applying for an FDA ESG Production System Account are the same as those described in Section 4.1, Apply for a Test Account.
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; it should look like the Login page shown below:
If the Login page does have the warning, do not send a submission. Exit the browser, contact the FDA ESG Administrator at email@example.com and obtain the correct address for the FDA ESG Login page.
After successfully completing the Production System Account setup, the FDA sends an email to the email address provided for the primary contact, indicating approval as a Transaction Partner and authorization to send submissions to the FDA ESG. Typically, the approval notification is sent on the next business day.
Submissions cannot be sent to the FDA ESG until this notification has been received.
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; it should look like the Login page shown in Section 4.5, Apply for a Production System Account.
If the Login page does have the warning, do not send a submission. Exit the browser, contact the FDA ESG Administrator at firstname.lastname@example.org, and obtain the correct address for the FDA ESG Login page.
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.
Sending large submissions may result in the FDA ESG web interface 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 Axway to provide an update to the web interface that fixes this error.
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 (> 7.5 GB), 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.
When a submission is sent using the FDA ESG Web Interface, it goes through the following steps:
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 sample Inbox looks similar to this, once submissions have been sent:
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:
To access an MDN after sending a submission,
To access an acknowledgement after sending a submission,