Simplified FDA Prior Notice Instructions

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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.
  3. Click the link for the “Prior Notice System Interface.”
  4. You will create a “Prior Notice” for each spirit you are shipping, within one “Web Entry.”

Step 1: Entry Information

  1. Choose “Create New Web Entry” from the Welcome to the Prior Notice System Interface page.
  2. Select “Mail (Commercial)” 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 spirits (not bottles) your company intends to ship.

Step 2: Submitter Information

  1. Select “Yes” from the “Are you the Submitter for this Web Entry?” dropdown list.
    • Select “Yes” if you are the individual mailing the shipment.
    • Choose the “Enter Submitter” button.
      1. Complete the “Enter Submitter” page with your information.
        • Select the box “Submitter same Individual as Transmitter”.
        • If you do not have a Food Facility Registration Number enter all required information, denoted by asterisks.
        • If you do have the Submitter’s Food Facility Registration Number, enter it and the Submitting individual’s name, phone and email address.
    1. Select “Save.”

Step 3: United States Recipient Information

  1. Select “No” from the “Is the United States Recipient the same as the Submitter?” dropdown list.
    • Click the “Enter U.S. Recipient” button.
      1. Complete the “Web Entry: United States Recipient (Enter)” page with the following information.
        • Food Facility Registration Number: 17278633636
        • Name: Preiss Imports
        • Street Address 432 Maple St
        • Unit 4
        • City: Ramona
        • State: California
        • ZIP: 92065
      2. 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 Spirit

Create a prior notice for the specific spirits 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. Select “Search” to find the correct the FDA Product Code for your spirit.
    1. Select “Alcoholic Beverage – 32 from section labeled “Select Product Industry” and click Next.
    2. Click the link for the product type the most closely matches the spirit class (gin, rum etc.).
    3. Select spirit container type from “Packaging Method” list (e.g. Glass, Metal, etc.)
    4. Select “Packaged Food (Not Commercially Sterile)” form “Process Applied” list.
  3. Enter the “Common or Usual Name/Market Name:” name of the spirit you are mailing.

Step 5: Enter Quantity and Packaging

  1. For the “base unit” entry – Type in number of units and then select the unit measure from the dropdown list.
    • Example: 700   Milliliters
  2. Enter number of how many cans/bottles in the “Number of containers” field and select the type of container in the “Container Type” dropdown list.
    • Example: 2      Bottle, Non-Protected, Cyl
  3. Select “Calculate.”
  4. Select “No” for the question “Has this article of food been refused entry by any Country/Area?”
  5. 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 and choose the “Enter Manufacturer” button.
  2. Enter the business name, and the city of the company which manufactured the spirit .
    • If you do not have a Food Facility Registration Number for the Manufacturer, select “K. Unable to determine the registration number of the manufacturer” from the list “Reason the Registration Number is Not Being Provided.
  3. If you are sending more than one item from the same manufacturer, 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 any other spirits.
  4. Select “Save.”

Step 7: Enter Shipper

  1. Select the country of the Shipper from the “Country” dropdown list and select “Enter Shipper.”
  2. Select “Submitter” or “Transmitter” from the dropdown list “Shipper same Facility as:”
  3. Select “Save.”

Step 8: Review and Submit Prior Notice

  1. Select the “Save Prior Notice” button to save your Prior Notice.
  2. If all the information you entered is correct, choose “Yes” to save or choose “No” to go back and edit this Prior Notice.
  3. If you have additional spirits you are sending with this shipment, you will need to create additional prior notices by repeating Steps 4 through 8.

Step 9: Complete Web Entry

  1. When you have saved all Prior Notices for all your spirits, click “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.

Step 10: Web Entry Completed & Print Summary

After selectin “Yes” to complete the Web Entry, a new summary page or the completed prior notices will load.

  1. Choose the Print Summary button to create a PDF of the Web Entry Summary Confirmation page. of your completed prior notices.
  2. Save the Web Entry Summary of your FDA Prior Notices and upload it to your carrier of choice before shipping your spirits.
  3. Print the Web Entry Summary of your FDA Prior Notices and include it in your external shipping pouch.