The steps for the electronic submission process for FDA ESG Web Interface users are provided in the following sections.
4.1 Apply for a Test Account
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 obtains the FDA ESG Web Interface address and a temporary Login ID and password by emailing esgprep@fda.hhs.gov 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 esgprep@fda.hhs.gov to request access to the test environment.
Enter the User ID and Password provided by the FDA and click the Login button.
The WebTrader registration wizard is displayed. This wizard will guide the you through the remainder of the application process.
Click the Next button.
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."
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.
Click the Next button.
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.
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 atesgprep@fda.hhs.gov. Once received, FDA will assess the certificate and send a response.
Provide the desired digital certificate file in the Certificate file field by entering the name of the certificate or browsing for one on your hard drive by clicking on the Browse... button.
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).
Click Next.
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.
Check box to certify the accuracy of your information..
Click the Finish button to return to the Login page, or close the browser window.
4.2 Test Account Setup and Approval
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.
Once you have fulfilled these criteria, proceed to Section 4.3 for instructions on sending a test submission.
4.3 Send 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 esgprep@fda.hhs.gov to request access to the test environment.
After a successful login, the My FDA submissions page is displayed. This page lists all messages received from the FDA ESG.
Click the WebTrader icon.
The WebTrader drop-down menu is displayed.
Select the Send document menu item.
The Send document page is displayed.
Select an FDA Center from the Center drop-down box. The Centers that can be selected at present are CBER, CDER, CDRH, CFSAN, CVM, GWTEST, and OOPD. Upon choosing a Center, the Submission type drop-down box will be populated with the correct submission types for that Center.
Single File Submissions: Click the Browse button associated with the Path textbox to select the test submission.
Multi-File Submissions: Click the Browse button associated with the Root Directory textbox to select the directory that contains all the files in the test submission. Make sure that the name of any file or sub-directory does not start with "." (dot). Note:the Path field is still required for multi-file submissions. Make sure you have entered a path as well as a root directory.
Select a test submission type from the Submission type drop-down box. About submission types:
Connectivity tests ensure that your connection to the ESG is up and running. They should be sent to the "Testing" Center.
Load tests ensure that you are able to send large submissions through the ESG; you should perform a load test if you are planning on sending submissions larger than 100MB. Load tests should be sent to the "Testing Center." See Section 4.4, Sending Large Submissions.
Guidance-compliant submission tests are reviewed by your Center so they can clear you for a production account. Guidance-compliant submissions should be sent to your Center.
Select a signing certificate by clicking the associated Browse button and selecting the signing certificate. All submissions require a certificate to digitally sign and encrypt the submission.
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.
Click the Send button on the Send document page.
The Enter password dialog box is displayed on top of the Send document page.
Enter the certificate password and click OK in this dialog box.
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.
To access the receipt, click on the WebTrader icon to access the Inbox.
The WebTrader drop-down menu is displayed.
Select the My Submissions menu item.
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 esgprep@fda.hhs.gov 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.
4.4 Apply for a Production System Account
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 esgprep@fda.hhs.gov and obtain the correct address for the FDA ESG Login page.
4.5 Production System Account Setup and Approval
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.
4.6 Send Submissions to the Production System
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 esgprep@fda.hhs.gov, and obtain the correct address for the FDA ESG Login page.
4.7 Sending Large (> 7.5 GB) Submissions
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, send a 7.5 GB 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 "Testing" Center with “7.5 GB Submission ” as the submission type.
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.
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.
4.8 Tracking Submissions
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.
4.8.1 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 delivered from the FDA ESG to a central holding area for all the Centers.
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.
4.8.2 Message Delivery Notifications (MDNs) and Acknowledgements
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.
A sample Inbox looks similar to this, once submissions have been sent:
4.8.3 Message IDs and Core IDs
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:
4.8.4 Accessing MDNs and Acknowledgements
To access an MDN after sending a submission,
Log on to the ESG using the user name and password for the account from which you sent the submissions.
From the WebTrader menu, select the "Check inbox" option. The receipts that are displayed specify the name of the submission file as part of their name.
Click the Details link next to the name of the required receipt to see its details.
To access an acknowledgement after sending a submission,
Log on to the ESG using the user name and password for the account from which you sent the submissions.
From the WebTrader menu, select the "Check inbox" option. The messages with ".ack" or ".txt" extensions are the acknowledgements from Centers for submissions. The message name before the extension denotes the Core ID generated by the Center for the submission.
Click on the name of the required acknowledgement to see its details.
