FDA Issues Updated Version of PNSI
The Food and Drug Administration (FDA) has issued a notice announcing PNSI Version 1.5, which is scheduled for release on November 6, 2004.
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Phase 5 of PN Program Scheduled to Go into Effect on November 8, 2004
FDA sources state that Phase 5 of its enforcement strategy for PN for imported food is now scheduled to go into effect on November 8, 2004 (from November 1, 2004), but this date could be pushed back if necessary. (See today's ITT, 04110420 and 04110410, for BP summaries of OASIS/PNSI scheduled downtime and the FDA's new Compliance Policy Guide.)
Highlights of the New Features in PNSI Version 1.5
According to the FDA, PNSI Version 1.5 includes the following new features (partial list):
"Consumption, Express Courier" Entry Type. To accommodate those transmitters shipping via an Express Courier, where the transmitter does not have access to the required anticipated arrival information and/or planned shipment information, a new Entry Type, "Consumption, Express Courier", will be created in Version 1.5. This entry type is to be used only by shippers sending articles of food to the United States via express couriers. It is not to be used by express couriers transmitting prior notice on behalf of their customers. There are two Modes of Transportation available: "Express Courier - Air" and "Express Courier - Land."
Holding Facility. Version 1.5 provides the ability to submit Holding Facility information in the case where FDA has refused a food article. If FDA or CBP direct an article to a Holding Facility, a party with the knowledge of the Holding Facility location, date available at the location, and a contact at the location associated with the Prior Notice must submit the information to the FDA. PNSI must be used to submit the Holding Facility information for PNs initially submitted either through the Automated Commercial System (ACS) or through PNSI.
Quantity and Packaging Wizard. In Version 1.5, PN Transmitters have an option of using the Prior Notice Article Quantity and Packaging Wizard that will take them step-by-step through filling out the Quantity and Packaging information. PN Transmitters still have the option of entering the information directly on the PN Article page.
Firm Registration Validation. PNSI Version 1.5 will validate the information entered for a food facility against the information entered when the facility was registered with the FDA using the Food Facility Registration Number, Business Name, City, and Country. If the facility information cannot be validated, the submitter will be required to enter additional information (street address of the facility and, if applicable, country subdivision and/or mail/zip code).
Manufacturer Registration Enforcement. For articles entering the U.S. for consumption, PNSI Version 1.5 will require a valid Food Facility Registration Number, business name, city and country, or, if a Food Facility Registration Number is not available, an FDA approved exemption reason, business name, street address, city and country.
Submitter Address Validation. If the Food Facility Registration Number of the Submitter is not valid or not entered, PNSI Version 1.5 will validate the full address information of the Submitter. If PNSI is able to validate the address, the submitter may be asked to select between the information they originally entered and the matching address, which may contain additional or alternate information. If PNSI is unable to validate the address information, the submitter will be asked to review the data and verify that it is correct.
Multiple Container and Rail Car Numbers. The Container Number field on the Carrier page will be expanded to allow the input of multiple container numbers for the containerized modes of transportation. The Rail Car Number field on the Carrier page will be expanded to allow the input of multiple rail car numbers for the rail mode of transportation. To enter multiple container or rail car numbers, enter each number in a comma-separated list (e.g. 1023, 1045, 1056).
Grower/Consolidator. In accordance with the PN interim final rule and to avoid possible confusion, the reference to Producer will be removed and the Producer page will be renamed to the Grower/Consolidator. If the Grower/Consolidator is known, the full address of the Grower/Consolidator facility is required.
(See ITT's Online Archives or 08/09/04 news, 04080915, for BP summary of Versions 1.4 and 1.3.)
FDA Notice describing PNSI Versions 1.1 through 1.5 available atwww.cfsan.fda/gov/pn/pnsirev.html