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).

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Instructions

• Getting Started
• Step 1: Entry Information
• Step 2: Submitter Information
• Step 3: United States Recipient Information
• Step 4: Create Prior Notice for Food Article
• Step 5: Enter Quantity and Packaging
• Step 6: Enter Manufacturer
• Step 7: Enter Shipper
• Step 8: Review and Submit the Prior Notice
• Step 9: Complete Web Entry

Getting Started

1. Go to FDA's Prior Notice System Interface (PNSI) website.
2. Choose the Login/Create Account button to get to the Login page. Login with your account ID and Password.
   (For help with creating an account see the Create New Account Quick Start Guide).
3. Choose the "Prior Notice" button.

Step 1: Entry Information

1. Choose "Create New Web Entry" from the Welcome to the Prior Notice System Interface page.
2. Select "Mail (Commercial)" or "Mail (Non-Commerical Sender)" from the Entry Type dropdown list and choose the Next button. The Web Entry (Create) page is displayed.
3. Enter the date on which you will be mailing the articles in the box for Shipment Date in US date format: MM/DD/YYYY or choose the calendar icon to find a date.
4. In the box "How many Prior Notices do you or your company intend to submit for this Web Entry?" enter the number of Prior Notices your company intends to submit for this Web Entry, i.e. the number of articles of food in the shipment subject to the prior notice requirement. This number is an estimate that you can increase or decrease prior to submission.

Step 2: Submitter Information

1. Select "Yes" or "No" from the "Are you the Submitter for this Web Entry?" dropdown list.
   • Select "Yes" if you are the individual mailing the shipment.
   • Select "No" if you are submitting the Prior Notice for someone else, then complete the following:
     1. Select the "Country" containing the Submitter's location from the dropdown list.
     2. Choose the "Enter Submitter" button.
     3. Complete the "Enter Submitter" page with your information.
        • Do not select the box "Submitter same Individual as Transmitter" unless the submitter and the transmitter are associated with the same facility.
        • If you have the Submitter's Food Facility Registration Number (issued when the facility was registered with FDA's Food Facility Registration System), enter it, the Business Name, City, and Country and the Submitting individual's name, phone and email address.
        • If you do not have a Food Facility Registration Number enter all required information, denoted by asterisks, and the name, phone, and e-mail contact information for the Submitter.
   4. Select "Save."

Step 3: United States Recipient Information

Mail Entry Types now require a United States Recipient instead of an Importer.

1. Select "Yes" or "No" from the "Is the United States Recipient the same as the Submitter?" dropdown list.
   • Select "Yes" if the person in the U.S. that will be receiving the food (the U.S. Recipient) is the person submitting the prior notice
   • Select "No" if the person in the U.S. that will be receiving the food (the U.S. Recipient) is not the person submitting the prior notice, then complete the following:
     1. Choose the "Enter U.S. Recipient" button.
     2. Complete the "Web Entry: United States Recipient (Enter)" page with your information.
        • Do not select the box "The United States Recipient is the same as the Submitter of this Prior Notice" unless the submitter and the U.S. Recipient are associated with the same facility
        • If the U.S. Recipient is associated with a facility that is required to register and you have the registration number assigned to the U.S. Recipient's facility (issued when the facility was registered with FDA's Food Facility Registration System), enter the registration number, along with the Name of the Recipient (Individual or Business Name) and the City.
        • If you do not have a Registration Number for the U.S. Recipient, enter all required information, which is denoted by asterisks.
     3. Select "Save."
2. Review the information about your web entry. To modify Web Entry information, select the "Edit" button in any section header.
3. Select "Save."

Step 4: Create Prior Notice for Food Article

Create a prior notice for the specific article(s) of food you are mailing. Select "Create Prior Notice" to enter the information about the product.

1. Select the "Country from which the Article is Shipped" from the dropdown list.
2. Answer the following questions. If the Article has been refused entry by any country/countries, select yes. If yes was selected, select the country/countries from which the Article was refused entry. If the Article has not been refused entry by any country/countries, select no. (see Refusal Information)
3. Select the FDA Product Code "Search" button to build an FDA Product Code for your article of food.
   1. Enter a word, or part of a word, that describes the product in the "Product name" field.
      • Use the generic name rather than a brand name in your search and always use the singular form of the word (orange, not oranges).
   2. Select "Search."
   3. Find and select the product you are mailing, by selecting the product name in the list.
      • If you do not find the product on the list, or no items are found, you may repeat the search by choosing "Previous" and performing another search.
   4. Highlight the appropriate "Packaging Method" and "Process Applied" and choose "Select."
      • For more information on how to find a product code, you can access the Product Code Builder Tutorial on the PNSI Help Page.
4. Enter the "Common or Usual Name/Market Name:" name of the Article you are mailing.

Step 5: Enter Quantity and Packaging

Provide the estimated quantity of food that will be shipped, described from the largest container to the smallest package size (up to five packaging levels may be provided.) New in version 1.5: You may also use a Packaging Wizard to help you enter this information by choosing the Wizard button. The Wizard assists users in entering the packaging and quantity information in a step-by-step process.

1. For the "base unit" entry - Type in number of units and then select the unit measure from the dropdown list. This is the smallest size unit of the package.
   • Example: If you are mailing 4 boxes and each box contains 2 dozen cookies, your base unit is 2 dozen. You would then type 2 in the "Number" field and select "dozen" from the dropdown list.
2. Now proceed to the "largest container to smallest container" field. Here enter the value for how many larger containers in the "Number of containers" field and select the type of container in the "Container Type" dropdown list.
   • Example: If you are mailing 4 boxes of 2 dozen cookies, You would then enter 4 in the "Number of containers" field and box in the "Container type" field.
3. Select "Calculate."
4. Select "Save."

Step 6: Enter Manufacturer

1. Select the "FDA Country of Production" from the dropdown box in the Manufacturer section of the Prior Notice: Related Facilities (View) page and choose the "Enter Manufacturer" button.
2. Enter the Food Facility Registration Number, business name, and the city of the company which manufactured the product in their correct fields.
   • If the Manufacturer is required to register, enter the Manufacturer's Food Facility Registration Number along with the Facility Name and the City to identify the Facility. The Registration Number is issued to the Manufacturer when the facility is registered with the Food and Drug Administration via the Food Facility Registration Module (FFRM). You should contact the Manufacturer to get the appropriate Registration Number.
   • If the Manufacturer is not required to register or the manufacturer’s registration number is not known, enable the checkbox below, select the reason that the registration number is not being provided and provide the full address of the facility (Street Name and Number; Suite/Unit Number, as appropriate; City; State or Province as appropriate; Zip/Mail Code, as appropriate; and Country.)
3. If you are sending more than one item from the same manufacturer, you may wish to answer "Yes" to: "Should this Facility be the default Manufacturer for new Prior Notices for this Web Entry." This will tell PNSI to use this manufacturer for the other articles of food.
4. Select "Save."

Step 7: Enter Shipper

1. Select the country of the Shipper from the "Country" dropdown list and select "Enter Shipper."
2. Enter the facility information for the shipper.
   • If the information for the shipper is the same as information entered in another section you can select from the "Shipper same facility as" dropdown list.
   • If you have not entered the information for the Shipper in a previous section enter the Shipper's Food Facility Registration Number, Business Name and City, or enter all required data denoted by asterisks.
3. Select "Save."

Step 8: Review and Submit Prior Notice

1. Review your prior notice to make sure the information is accurate. You may choose the tabs for the "Web Entry" and "Article" to see the other information. If editing is required, select "Edit."
2. Select the "Save Prior Notice" button to save your Prior Notice.
3. The "Save Prior Notice?" page will display all the Web Entry and Prior Notice information for review and verification. Your Prior Notice will NOT be submitted to FDA when you save it, you must complete your web entry in order you’re your Prior Notice to be submitted.
4. At the bottom of the page you may choose "Yes" to save or "No" to continue editing the Prior Notice.
   • If the number of Prior Notices that have been submitted for this Web Entry is within 2 or 90% of the number entered previously on the Web Entry (Create) screen (Figure 15m), the "Complete Web Entry?" page will display and ask if you wish to complete this Web Entry.(see Figure 35)
5. If you have additional articles of food you are sending with this shipment, you will need to create additional prior notices by repeating Steps 4 through 8.
6. If you need to cancel a Prior Notice, select the box next to "Article" on the "Web Entry (View)" page and select "Cancel PN." A Prior Notice can only be cancelled before the Web Entry is submitted. After the Web Entry is submitted, a Prior Notice can only be cancelled by cancelling the entire Web Entry.

Step 9: Complete Web Entry

1. When you have saved all Prior Notices you intend to create for a Web Entry, complete the Web Entry by choosing the "Complete Web Entry" button located at the top right of the Web Entry (View) page (see Figure 34).
2. The system will display the "Complete Web Entry?" page (see Figure 35). Select the "Yes" button to complete the Web Entry, or "No" to return.