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ESG Chapter 4 FDA ESG Web Interface Electronic Submissions

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4 FDA ESG Web Interface Electronic Submissions
     4.1 Apply for a Test Account
     4.2 Test Account Setup and Approval
     4.3 Send a Test Submission
     4.4 Production System Account Setup
     4.5 Send Submissions to the Production System
     4.6 Optional: Sending Large Submissions
     4.7 Tracking Submissions
          4.7.1 The Submission Process
          4.7.2 Message Delivery Notifications (MDNs) and Acknowledgements
          4.7.3 Message IDs and Core IDs
          4.7.4 Accessing MDNs and Acknowledgements

 

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.

 

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 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.

The remainder of this section describes the FDA ESG Test Account Application process using screenshots from the FDA ESG Web Interface:

  1. Launch your Internet browser and access the URL provided by FDA. The Login screen will be displayed:

     4.1 Apply for a Test Account sm image 1

  2. Enter the User ID and Password provided by the FDA and click on the “I agree to the terms set forth in the System Notification below” radio button. Click Login. The following page will be displayed:

     4.1 Apply for a Test Account sm image 2

  3. Click the ‘Next’ button. The following page will be displayed:

     4.1 Apply for a Test Account sm image 3

  4. Make sure the community is set to “FDATST”. Click the ‘Next’ button. The following page will be displayed:

    4.1 Apply for a Test Account sm image 4 

  5. Enter Company name. If company has more than one WebTrader account, please enter company name followed by a ‘-‘ and your initials. Click the ‘Next’ button. The following page will be displayed:

     4.1 Apply for a Test Account sm image 5

  6. Click the “Choose File” button and select your public key. (For more information on digital certificates, click here). After you have selected your public key, click the ‘Next’ button. The following page will be displayed:

    4.1 Apply for a Test Account sm image 6

  7. In most cases, the system will generate a certificate name. If the system does not generate a certificate name, insert the name to be used to identify the digital certificate. Click the ‘Next’ button. The following page will be displayed:

    4.1 Apply for a Test Account sm image 7 

  8. Create your own personalized WebTrader User ID, insert the user’s name (first and last name), create your own personalized WebTrader Password and insert your email address. Click the ‘Next’ button. The following page will be displayed:

     

    4.1 Apply for a Test Account sm image 8

  9. Click the checkbox to certify your information and click the ‘Finish registration’ button. You will receive an email from ESGHelpDesk@fda.hhs.gov in the next 48 hours with test registration details.
 

4.2 Test Account Setup and Approval

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.

If you plan to make submissions utilizing WebTrader directly, as opposed to WTHS, Java Runtime Edition (JRE) must be installed to send a submission. Please 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.

 

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.

  1. After obtaining a WebTrader test account, launch Internet Explorer* and go to https://esgtest.fda.gov/. The Login screen will be displayed:

     4.3 Send a Test Submission image 1

  2. Enter your User ID and Password and click on the “I agree to the terms set forth in the System Notification below” radio button. (If you cannot remember your personal User ID and Password email ESGHelpDesk@fda.hhs.gov). Click the Log In button. The My FDA submissions page will be displayed:

    4.3 Send a Test Submission image 2

  3. Hover, but do NOT click on the WebTrader menu at the top of the screen. Click on Send document:

     4.3 Send a Test Submission image 3

  4. After clicking on Send document, the following page will be displayed:

     4.3 Send a Test Submission image 4

  5. In order to select the file and certificate to be submitted, perform the following steps:
    1. In the Center drop-down menu, select the Center that is to receive the submission
    2. In the Submission type drop-down menu, select the type of submission that is to be sent
    3. Select the file / folder that is to be submitted
      1. To the right of the Path field, click the Browse button
      2. Select the file that is to be submitted
    4. Select the digital certificate for signing
      1. To the right of the New file field, click the Browse button
      2. Select the digital certificate
  6. When the page has been completely populated, it should look similar to this:

    4.3 Send a Test Submission image 6

  7. Click the Send button. The following page will be displayed

    4.3 Send a Test Submission image 7

  8. Enter the digital certificate password and click the OK button. The following page will be displayed:

    4.3 Send a Test Submission image 8

  9. The Upload Progress dialog box will be displayed. The dialog box will say "Done" when a file has been successfully uploaded. Click the Close button to proceed to the My FDA submissions page.
 

4.4 Production System Account Setup

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.

 

4.5 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.

 

4.6 Optional: Sending Large 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, 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.

 

4.7 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.

 

4.7.1 The Submission Process

When a submission is sent using the FDA ESG Web Interface, it goes through the following steps:

  1. 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. 
  2. The submission is delivered from the FDA ESG to a central holding area for all the Centers.
  3. 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.
 

4.7.2 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.

  1. 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.
  2. 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.

A sample Inbox looks similar to this, once submissions have been sent:

 Screen Shot - My FDA submissions page

 

 

4.7.3 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.

 Screen Shot - A sample MDN with The Message ID and date stamp

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_3_2nd image 

 

4.7.4 Accessing MDNs and Acknowledgements

To access an MDN after sending a submission,

  1. Log on to the ESG using the user name and password for the account from which you sent the submissions.
  2. 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.
  3. Click the Details link next to the name of the required receipt to see its details.

To access an acknowledgement after sending a submission,

  1. Log on to the ESG using the user name and password for the account from which you sent the submissions.
  2. 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.
  3. Click on the name of the required acknowledgement to see its details.

 

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