Screens, descriptions, and examples are subject to change as enhancements are made to the system. They are not intended to take the place of the written regulations found in the Final Rule (Nov. 7, 2008).
Please note: As of August 24th, 2019, new changes are in effect for the Prior Notice System Interface:
Version v14.0.0 of the Prior Notice System Interface (PNSI) includes changes related to the completion of Web Entries. The application has been updated to require that the Web Entry is completed before a user's Prior Notices are submitted. The system no longer automatically completes Web Entries when the Prior Notice submission timeframe elapses. After creating a Prior Notice, users will be given the option to save their Prior Notice or cancel their Prior Notice rather than to submit their Prior Notice. All Prior Notices must be created and saved before submitting the Web Entry. Once the Web Entry is submitted, it will be closed and the user will not have the ability to add additional Prior Notices to their Web Entry.
In addition, users will no longer have the ability to cancel individual Prior Notices once a Web Entry is completed. Users will have to cancel the entire Web Entry to cancel a Prior Notice. Any Prior Notices that the user did not wish to cancel can be copied and re-filed on a new Web Entry.
Completing Web Entries is required in order for associated saved Prior Notices to be transmitted to FDA. Completing the Web Entry submits your Prior Notices to the FDA and cancels any remaining Prior Notices in Draft status. When a Web Entry is "Completed", the system accepts no additional Prior Notices, but allows you to cancel the Web Entry.
When you have saved all Prior Notices you intend to submit for a Web Entry, you will be navigated to the Complete Web Entry page.
- You may also complete a web entry at any time by using the Find Web Entries page to accessing the Web Entry (View) page (Figure 15b), and choosing the Complete Web Entry button located at the top right. This button will not appear until at least one Prior Notice has been saved.
The system will display the Complete Web Entry? page to remind users that once a Web Entry has been completed the Web Entry and associated prior notices may no longer be modified and ask for confirmation that the Web Entry should be completed (Figure 35). Select the Yes button to complete the Web Entry, or No to return. Selecting No will allow you to create additional Prior Notices, and edit your web entry and associated Prior Notices.
Once your Web Entry is completed, you will not be able to add any additional Prior Notices and all Prior Notices that have been saved will be submitted to FDA.
The Web Entry (View): Completed page displays (Figure 36). Choose the Print Summary button to create the Web Entry Summary Confirmation page as a PDF. You may print the PDF file or save it to your computer's hard drive. Make sure the Carrier receives a copy to present to United States Customs and Border Protection or the Food and Drug Administration at the Port of Arrival. The Prior Notice Confirmation Number must accompany food carried by or otherwise accompanying an individual.
Remember: Your Prior Notices will NOT be submitted to FDA until your Web Entry is completed and submitted.