Getting Started

Welcome to the Prior Notice System Interface!

This section explains the basic information you need to know to start entering Prior Notice information for submission to the United States Food and Drug Administration (FDA).

Topics:

Basic Concepts

Prior Notice Submission Process

Getting Help

 

 

 

Basic Concepts

Web Entry

The Web Entry information is the basic data that relates to a shipment of food articles requiring Prior Notice.  Creating the Web entry is the first step in the Prior Notice submission process.  The Web Entry can relate to one or more food articles, each of which must have a separate confirmed Prior Notice.

Prior Notice
Article of Food

 

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Prior Notice Submission Process

 

  1. Collect Prior Notice Information. Accumulate all the information required for your Prior Notice Submission.

  2. Create the Web Entry. The Web Entry contains information about the collective shipment. You must create a Web Entry before creating the Prior Notices associated with the Web Entry.  For more information, see the Web Entries topic.

  3. Create a Prior Notice. The Prior Notice contains information directly related to the food products imported in the shipment. A Web Entry may contain one or more Prior Notices. As you create your Prior Notice, you may set facilities that apply to other articles in the shipment as default, to avoid duplicate data entry. For example, if all food products in this shipment have the same manufacturer, you should set the manufacturer as default. You may save the Prior Notices in "Draft" status and update them later. For more information, see the Prior Notices topic.

  4. Review and Edit the Web Entry and the First Prior Notice. Review your information and make all necessary changes. After you submit Prior Notice information to the FDA, you cannot make changes to the Prior Notice or to the Web Entry. For more information, see the Reviewing and Editing a Prior Notice topic.

  5. Submit the Prior Notice to FDA. After the FDA receives the Prior Notice, the system displays a Confirmation Page including a Confirmation Number. For more information, see the Submitting a Prior Notice topic.

  6. Print Prior Notice Confirmation. The Confirmation Page is your proof that you have filed a Prior Notice with the FDA. The Prior Notice Confirmation Number must accompany food carried by or otherwise accompanying an individual (1.279(f)). You may wish to print and keep a copy of each Prior Notice for your files, but presenting a copy of the Prior Notice Confirmation is not required.

  7. Create an Additional Prior Notice. Continue to create additional Prior Notices until you have completed one for each food article in the shipment. If individual Prior Notices within the Web Entry contain similar information, select the Prior Notice that is most similar to the one you need to create, use the copy function, and then make changes as required. For more information, see the Prior Notices topic.

  8. Review and Edit the Additional Prior Notice. After you have submitted your first Prior Notice, you may only edit information in Prior Notices you have not submitted.  Make any necessary corrections and return to step E. For more information, see the Reviewing and Editing a Prior Notice topic.

  9. Complete the Web Entry and Print the Summary Confirmation.  When you have submitted all Prior Notices you intend to submit for your Web Entry, complete the Web Entry. Completing the Web Entry indicates to FDA that you are done adding Prior Notices to the Web Entry and cancels all Prior Notices in Draft status. (See the Completing a Web Entry topic.) FDA recommends printing the Web Entry Summary Confirmation for your records and to facilitate presentation of the confirmation number(s) to CBP or FDA upon arrival at the port. Note that a copy of the confirmation (with the PN Confirmation Number) must accompany any article of food carried or otherwise accompanying an individual (unless excluded under IFR 1.277(b)(1)), and be provided to CBP or FDA upon arrival.  (See the Accessing the Web Entry Summary Confirmation topic.)

    If you do not Complete your Web Entry before the end of the timely submission period, based upon the mode of transportation (2 hours before arrival for Land,  4 hours before arrival for Air or Rail, or 8 hours before arrival for Water) the system will complete it automatically.  If the system automatically completes your Web Entry and you need to submit additional Prior Notices for it, copy the Web Entry and continue creating and submitting Prior Notices.  When you have finished all Prior Notices, make sure that you Complete the Web Entry.

  10. Present the Summary Confirmation Information at the Port of Arrival. To facilitate presentation of the confirmation number(s) to CBP and FDA upon arrival and the passing through the Port of Arrival, the FDA and CBP suggest the Carrier provide a Copy of the Web Entry Summary Confirmation to United States Bureau of Customs and Border Protection (CBP).  If you are sending your Web Entry via International Mail, you must note the Shipment Confirmation Number on your Customs Declaration Form affixed to the package.

 

For more information, see the Web Entries and Prior Notices topics.

 

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Getting Help

If you need to find more information about the Prior Notice Rule, FDA Product Codes, or if you need to contact FDA for Help, click on the Contact Us hyperlink in the upper right-hand corner of any page in the Prior Notice System Interface, to get information from the FDA Help Desk.

 

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