The guidance provides additional clarity regarding when the FDA will notify parties about refusals and holds, and when their 5-calendar-day deadline to request review begins.

Press the Manufacturer button and provide information such as Food Facility Registration Number, business name and city for the product's manufacturer. Similarly, press Grower/Consolidator button and provide their Food Facility Registration Number, name and complete growing location address for their grower/consolidator operation.

Identifying the Product

The Prior Notice System Interface (PNSI) makes it simple and fast to create new Prior Notices for food articles. After identifying your product, select an entry type, enter all necessary data, save your Prior Notice and get back on the market!

To create a Prior Notice, start by clicking on the LOGIN button from either FDA Industry Systems Page or Prior Notice of Imported Foods Homepage and visiting PNSI login screen using account ID and password to log-in with. Once in, choose Prior Notice Web Entry under Unified Registration and Listing Systems list of systems for creating it.

When selecting a Prior Notice type, the system prompts you to enter several pieces of information:

Food Facility Registration Number, Business Name and Address, City and Country information must all be entered to submit entries to PNSI on behalf of companies other than manufacturers. In cases where entries are being submitted on behalf of third-party entities (non-manufacturers), contact person name and number is entered as well as Product Code description of product being entered; If this entry includes bulk commodities check the box next to "Bulk" within Production Identifiers section - add multiple identifiers by choosing "Add" button followed by selecting them from drop down menu; To delete an identifier select "Delete".

Identifying the Country

FDA regulations stipulate that prior notice must identify the country to which food was originally shipped - even if later reshipped to another location. Furthermore, CBP needs this information so they know whether to refuse entry or take other enforcement measures such as detention or seizure of shipment.

If the manufacturer's registration number is unknown, recent FDA guidance allows a PN submission/transmission without providing the number and reason code (e.g. "Factory not Registered").

Submitting a PN, the system will display a Web Entry (View) page with your confirmation number and submission data, which you can print using the Print Summary button.

Importers or brokers must submit a Preliminary Notice no more than 30 days in advance for food shipments arriving via ACS/ABI, or 15 days ahead for PNSI shipments, via either mode of transportation (ACS/ABI or PNSI) entering the United States; additionally, this requirement applies regardless of mode or port of entry (for air shipment arrivals this requirement must be submitted within two hours prior to arrival at American port of entry).

Identifying the Holding Facility

Establishing the holding facility is key when providing prior notice. The FDA mandates this information on every incoming shipment of food or beverages, to ensure consumer safety. Growers, consolidators or shippers may provide this data; however it must be accurate or else the shipment could be considered illegal and you could face fines for illegal practices.

Once the Identifying the Holding Facility page displays, enter details for your location such as its Specific Holding Location, Contact Name, Phone Number and Date Available at Location (Figure 32). From the drop-down box select an appropriate Holding Location Type such as Port/Import Lot, Secure Facility at Port or Secure Facility outside Port before entering your Food Facility Registration Number, Business Name and City or all necessary address information marked with an asterisks (*).

The FDA's fourth edition guidance has introduced changes to how prior notice submission and review occurs, including eliminating the requirement that certain submissions go through Customs and Border Protection's Automated Commercial System or US FDA Prior Notice System Interface; while at the same time preserving timeframes set forth by IFR 2003 regarding when prior notice must be filed.

Changes to previous guidelines also include notifying CBP of any refusal or hold under Section 801(m)(1) of the Food, Drug, and Cosmetic Act for inadequate prior notification or food that isn't imported into or offered within the United States. Previously, carriers were intended to notify others who may be involved with transporting this food themselves.

Identifying the Related Facilities

Under the Bioterrorism Act, FDA is mandated to review and validate prior notice for food shipments imported for distribution, storage or use within the U.S. This requirement encompasses human and animal food imported for distribution, storage or use within U.S. borders as well as gifts or market research samples in transit across country lines. CBP currently transmits most Prior Notice information through their Operational and Administrative System for Import Support (OASIS) or ABI/ACS; if either system are unavailable then FDA PNSI still accepts submissions.

Once your Web Entry and Prior Notice have been completed, select the Save Prior Notice button located top or bottom right of your screen to display a summary page called "Save Prior Notice?" for review and verification. If all information is accurate, choose yes at the bottom of this page to proceed, otherwise select no to go back into edit mode for both entries.

US FDA Prior Notice requires you to submit contact details of the manufacturer, shipper, owner and ultimate consignee whose entry type you're filing against. Anyone possessing this knowledge may submit their entry online.