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).
To create a new prior notice for this Web Entry, choose the Create Prior Notice button at the top or bottom of the Web Entry (View) page (Figure 16).
The Prior Notice: Article (Create) page displays with the Entry Identifier of your Web Entry.
Enter the Article Information (Figure 17). Select the Country from which the Article is Shipped. Note that this country does not have to be the same as the business location of the Shipper.
Enter the Product Information (Figure 17).
Enter the FDA Product Code. (If you do not know the Product Code, choose the Search button to display the Find Product Code page and use the Product Code Wizard. See the additional section for further detail on Using the Product Code Wizard.)
Enter the Common or Usual Name/Market Name of the product.
Enter the Production Identifiers (production lot codes or production batch identifiers), if the product is required to bear such numbers by the FD&C Act or by FDA regulations (Figure 19). Examples of products requiring Production Identifiers include low acid canned foods, acidified foods, and low acid canned infant formula.
Choose the Add button in the Production Identifiers section header to go to the Prior Notice: Production Identifiers (Add) page (not shown) and enter the information.
When you are finished adding Production Identifiers, select the Save button and the Production Identifier section of the Prior Notice: Article (Create) page changes to display them (Figure 19).
Check the box in front of an identifier and choose the Delete button in the Production Identifiers section header to delete any incorrect Production Identifiers.
Enter the Quantity and Packaging (Figure 19).
Enter the base unit: the weight or volume of the smallest unit, or the weight or volume of the bulk shipment. You must create a separate Prior Notice for each article of food with a different base unit.
Indicate whether the product is bulk-shipped using the checkbox.
If the product is not bulk-shipped, 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.) For example, 100 Cases, 40 Cans per Case with a base unit of 16oz per Can.
Choose the Calculate button to calculate the Total Quantity. If the calculated total quantity is not correct, correct the base unit or numbers of containers to arrive at the correct Total Quantity.
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 Quantity and Packaging information in a step-by-step process.
Enter the Refusal Information (Figure 20), If required:
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 by any country/countries, select no.
Choose the Save button. (Figure 20) The system validates the information entered, determines from the product code whether the product entered is manufactured or grown and goes directly to the Prior Notice: Related Facilities (View) page. Begin Adding Related Facility information.
When Copying a Prior Notice, choosing the Save button displays the Prior Notice: Article (View) page (Figure 21). Choose the Related Facilities tab to begin Adding Related Facilities to your prior notice. Use this tab to get to the Prior Notice: Related Facilities (View) page at any time.
(For Figures 22 - 25 see Using the Product Code Wizard)
In this example, the product you have entered is no longer in its natural state. The system determines this from the Product Code selected earlier and provides the interface for entering information about the Manufacturer of the Article. (See Step 1a of this section if the product you have entered is in its natural state) 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 (Figure 26). The Prior Notice: Manufacturer (Enter) page will display, the Country of Production you selected displaying as the Country (Figure 27).
Alternately, if the product you have entered is in its natural state, the Prior Notice: Related Facilities (View) page will display a section for information on the Grower/Consolidator of the product. Select the FDA Country of Production from the dropdown box in the Grower/Consolidator section of the Prior Notice: Related Facilities (View) page and choose the Enter Grower/Consolidator button (Figure 26a). The Prior Notice: Grower/Consolidator (Enter) page will display, the Country of Production you selected displaying as the Country (Figure 27a).
For all Entry Types, you must have the Food Facility Registration Number of the Manufacturer of the product in order to submit the Prior Notice. This number was issued when the manufacturer registered with the FDA using FDA's Food Facility Registration System. Enter the Food Facility Registration Number, Business Name, and City. If the registration number provided does not match the manufacturer name, city and country, transmitters will receive a message prompting them to provide the street address for the manufacturer.
If the Manufacturer is not required to register according to the Registration Rule or you are unable to obtain the registration number, select the checkbox indicating this, select the reason the registration number is not being provided from the dropdown box, and provide Name and full address of the facility.
Choose the Save button.
If you do not have the Grower/Consolidator information, mark the checkbox to indicate that the Grower/Consolidator is Unknown and choose the Save button.
If you do have information on the Grower/Consolidator, first use the Facility Type dropdown box to indicate whether the Facility is a Grower or a Consolidator.
If you have the Facility's Food Facility Registration Number, enter it. Also enter the Name and complete growing location address information of the Grower/Consolidator.
Choose the Save button.
Prior Notice returns to the Prior Notice: Related Facilities (View) page (Figure 28). Here you may edit the Manufacturer or Grower/Consolidator information by choosing the Edit button for that section. You may also enter the information for the other Related Facilities: Shipper, Owner, Ultimate Consignee, and Holding Facility here.
Note: Not all entry types require every facility.
To Enter the Shipper
Select the Country where the shipper is located (Figure 28).
Choose the Enter Shipper button.
In the Prior Notice: Shipper (Enter) page (Figure 29), enter the Shipper's Business Name and Full Address. You may also provide the Shipper's Food Facility Registration number, if known. If the Shipper is the same Facility as another that you have already entered for this Prior Notice, select the Facility and choose the Save button.
Note: If you indicate that the Shipper is the same as another facility (e.g. the Manufacturer or Grower/Consolidator) the system will ignore any other data you enter for the Shipper.
Choose the Save button. The View Prior Notice: Related Facilities (View) will display with the Shipper information in static text
Enter the Owner of the article of food at the time of Prior Notice submission.
Select the Country where the Owner's business is located from the dropdown box (Figure 28).
Choose the Enter Owner button. The Prior Notice: Owner (Enter) page displays (Figure 30).
If the Owner is the same Facility as another that you have already entered for this Prior Notice, select the Facility and choose the Save button.
Note: If you do this, the system will ignore any other data you enter for the Owner.
Enter the Owner's full address. You may also provide the Owner's Food Facility Registration Number, if known.
Choose the Save button. The Prior Notice: Related Facilities (View) will display with the Owner information in static text.
Enter the Ultimate Consignee by choosing the Enter Ultimate Consignee button (Figure 28). The Prior Notice: Ultimate Consignee (Enter) page is displayed. The Ultimate Consignee must be located in the United States. The process is the same as for Owner.
If CBP has already directed your food article to a Holding Facility, enter the Holding Facility of the article of food at the time of Prior Notice submission. If you did not transmit the Prior Notice through PNSI you may still Submit Holding Information after any Prior Notice Submission.
If you need to enter information about a holding facility Choose the Enter Holding Facility button. The Prior Notice: Holding Facility (Enter) page will display (Figure 31).
Enter the Specific Holding Location (within the Holding Facility), Contact Name, Phone, and Date Available at Location.
Select an appropriate Holding Location Type (Port/Import Lot, Secure Facility at Port, or Secure Facility outside of Port) from the Holding Location Type drop-down list.
If you want this Holding Facility to be the default when you indicate that Articles for the Web Entry are held, select Yes from the drop-down list in response to the question "Should this Holding Facility be the default for Articles you later indicate are held for this Web Entry?"
Enter the Holding Facility's Food Facility Registration Number, Business Name, and City, or all required address information denoted by asterisks.
Choose the Save button. The Prior Notice: Related Facilities (View) will display with the Holding Facility information in static text.
The Prior Notice: Related Facilities (View) page displays with all facility information in static text (Figure 32). Review this information and make corrections using any Edit button.
After you have verified that your Prior Notice is complete and accurate, choose the Save Prior Notice button.
The Save Prior Notice? page (Figure 33) will display all the Web Entry and Prior Notice information for review and verification.
Please review and verify that the information contained within your Prior Notice is correct to the best of your knowledge. If so, click “yes” at the bottom of the page. If you need to make edits, click “no” and you will be directed to the “Prior Notice: Article (View)” page to edit your Prior Notice.
The Complete Web Entry? page (Figure 34) will display and ask if you wish to complete this Web Entry 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. Your Prior Notices will NOT be submitted to the FDA until the Web Entry is completed.
The system will issue a Confirmation Number. The Web Entry (View) page displays with your Confirmation Number and submitted data (Figure 35).
You may choose the Print Summary button to view your Prior Notice as a PDF. You may print the PDF file or save it to your computer's hard drive.