Electronic+Submission+Gateway+(ESG)


 * [November 18, 2013} Change to ESG Mailbox **
 * Beginning Monday, December 2, 2013 the FDA Electronic Submissions Gateway (ESG) Help Desk email address will change to ESGHelpDesk@fda.hhs.gov**.

Until 12/2/13, please continue to email the FDA ESG Help Desk at esgreg@gnsi.com. After 12/2/13 all responses from the ESG Help Desk will come from ESGHelpDesk@fda.hhs.gov. Please make sure that you can accept emails from ESGHelpDesk@fda.hhs.gov.

To use the Electronic Submissions Gateway (ESG), you must:
 * Submit a **[|Letter of Non-Repudiation Agreement]** to the FDA
 * Obtain a [|Digital Certificate]
 * Determine Submission Method
 * Understand [|Submission Guidelines]
 * Have an ESG Production Account. The FDA has provided a more detailed checklist [|here]

For policy questions and to request a WebTrader account, contact esgprep@fda.hhs.gov.

For assistance with the registration or testing process, contact esgreg@gnsi.com. After December 2, 2013, contact ESGHelpDesk@fda.hhs.gov.

Click [|here] for frequently asked questions and answers about the ESG.

**[21-Dec-2009]**

Instructions for Computer Configuration for Viewing SPL Error Messages
Internet Explorer 7.0 1. Click the "Tools" menu and select "Internet Options". 2. Click the "Security" tab. 3. Click the "Custom level" button. 4. Scroll down to the "Miscellaneous" section. 5. Enable the "Access data sources across domains". 6. Click "OK" to accept the update. 7. Click "OK" to close the security dialog.

1. From your Windows control panel start the Java Control Panel. 2. In the Java Control panel dialog that appears, select the “Delete Files…” button in the Temporary Internet Files section.
 * Clearing the Java Applet Cache**

3. Select all three checkboxes in the “Delete Temporary Files” dialog that appears and select OK.

** Start ** the process **as soon as** possible!

Training and further details on the ESG are available at the FDA's [|ESG page]. This page has [|training videos], [|user guides], [|Letter of Non-Repudiation Agreement] examples,and a whole lot more.

Here's a of what your screen should look like when sending ER/DL submissions through FDA Webtrader.

Tips on keeping your computer ESG-ready

Validating your SPL
The [|FDA Data Standards Council's website’s home page] now includes a page titled ([|Validators].) On this new web page is a link to a validation tool, Pragmatic Validator Lite™, that can be utilized to validate SPL Release Four documents prepared for submission to FDA. The company that coded the Validator is [|Pragmatic, LLC].

SPL submissions for Requests for Labeler Codes, Establishment Registrations, and Drug Listings are to be made through the FDA's [|Electronic Submission Gateway].

These submissions are subject to [|Validation Rules] established by the FDA.

...From the [|Instructions for using Electronic Drug Establishment Registration and Drug Listing v1.0]

5 Sending in SPL files

 * The **root id** from the document identifiers is used for the name of the SPL file with the extension "xml".
 * The **version number** is increased for every subsequent submission that is successfully processed by the FDA system (i.e., does not fail validation). The Agency communicates with the designated contact person using email if there are problems.
 * The name of the "center" and the "type of submission" are used to properly route the files. For electronic drug registration and listing, the center is "**OC**" and the type of submission is "**SPL**".