FDA Industry Systems
Prior Notice Systems Interface (PNSI)

Prior Notice for Food Articles sent by International Mail
Step-by-Step Web System Instructions
PNSI Version 1.5.02

New Features in the Prior Notice System Interface (PNSI)

Table of Contents

•             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. (see Figure 1)
   (For help with creating an account see the Create New Account Quick Start Guide).
3. Choose the "Prior Notice" button. (see Figure 2)

Step 1: Entry Information

1. Choose "Create New Web Entry" from the Welcome to the Prior Notice System Interface page. (see Figure 3)
2. Select "Mail (Commercial)" or "Mail (Non-Commerical Sender)" from the Entry Type dropdown list and choose the Next button. (see Figure 4) The Web Entry (Create) page is displayed.(see Figure 5m)
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. (see Figure 7)
   • 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. (see Figure 8)
        • If the Submitter is associated with a facility that is required to register and you have the registration number assigned to the submitter's facility (issued when the facility was registered with FDA's Food Facility Registration System), enter it, the Submitting Individual's Name, Business Name, City, and Country.
        • If you do not have a Registration Number for the Submitter, enter all required information, which is denoted by asterisks, and the phone, fax, or e-mail contact information for the Submitter if they exist.
     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. (see Figure 9m)
   • 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. (see Figure 10m)
        • 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. (see Figure 15m) 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. (see Figure 16)

1. Select the "Country from which the Article is Shipped" from the dropdown list.(see Figure 17m)
2. Select the FDA Product Code "Search" button to build an FDA Product Code for your article of food. (see Figure 18)
   1. Enter a word, or part of a word, that describes the product in the "Product name" field. (see Figure 22)
      • 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. (see Figure 23)
      • 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." (see Figure 25)
      • For more information on how to find a product code, you can access the Product Code Builder Tutorial on the PNSI Help Page.
3. 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. (see Figure 20)
   • 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. (see Figure 26)
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 Entry Type is Mail (Non-Commercial Sender):
     • If you do not know the Registration Number, enter the full address of the manufacturer.
     • If the article of food is being sent by an individual as a personal gift, you may provide the name and address of the firm that appears on the label of the article of food.
   • If the Entry Type is Mail (Commercial): (see Figure 27)
     • New in version 1.4 If the Manufacturer is not required to register according to the Registration Rule or the Manufacturer identity is not known, select the checkbox indicating this, select the reason the manufacturer is not required to register or is not known from the dropdown box, and provide all Name and address information available.
       New in version 1.5: New Manufacturer Registration Not Provided reasons have been added to PNSI to identify an article being imported as a sample for quality assurance, research and analysis purposes and gift packs imported for non-business purposes.
     • If the article of food is being sent by an individual as a personal gift, select the checkbox indicating Manufacturer is not required to register, select "Individual Gift" as the reason the manufacturer is not required to register from the dropdown box, and provide the name and address of the firm that appears on the label of the article of food.
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." (see Figure 28m)
2. Enter the facility information for the shipper. (see Figure 29)
   • 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." (see Figure 32m)
2. Select the "Submit Prior Notice" button to submit your entry to the FDA.
3. The "Submit Prior Notice?" page will display all the Web Entry and Prior Notice information for review and verification. After you submit your first Prior Notice, you may no longer edit information in that Prior Notice or the associated Web Entry. (see Figure 33)
4. At the bottom of the page you may choose "Yes" to submit 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. The "Prior Notice Confirmation: Submitted" screen will appear with your confirmation number. Record this number for your records it will need to be entered on the customs form that accompanies your package. (see Figure 34)
6. 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.
7. If you need to cancel a Prior Notice entry select the box next to "Article" on the "Web Entry (View)" page and select "Cancel PN."

Step 9: Complete Web Entry

1. When you have submitted all Prior Notices you intend to submit for a Web Entry, complete the Web Entry by choosing the "Complete Web Entry" button located at the top right of the Prior Notice Confirmation: Submitted 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.

For more information see:

• New Features in the Prior Notice System Interface (PNSI)
• Sending Food Gifts through International Mail
• Prior Notice Fact Sheet
• Guidance for Industry: Prior Notice Questions and Answers (Edition 2)
• Index of FIS Help Files
• FDA Industry Systems Help Desk

See also Create New Account Quick Start Guide