FDA Issues Two Updated Versions of PNSI Which Contain Additional Features
The Food and Drug Administration (FDA) has issued a notice describing new features to its Prior Notice System Interface (PNSI). The FDA's announcement concerns PNSI Version 1.3, which was released on July 10, 2004, and PNSI Version 1.4, which is scheduled for an August 7, 2004 release.
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(FDA sources have previously explained that new versions of PNSI are issued periodically so as to incorporate new features and fix problems that have been identified.
FDA sources have also stated that when a user logs onto PNSI, they will automatically access the most up-to-date version of PNSI. These sources have also noted that there should be no system compatibility issues with new versions of PNSI.)
Highlights of PNSI Version 1.4 New Features
According to the FDA, PNSI Version 1.4 includes the following new features (partial list):
Manufacturer/Producer Food Facility Registration Number now required. The Food Facility Registration Number for the Manufacturer/Producer is now required for all Prior Notices (PNs) for Consumption entry types (i.e., all entry types except for Transportation and Exportation (T&E), Foreign Trade Zone (FTZ), and Mail (Non-Commercial Sender)) unless an exemption is declared.
Manufacturer Food Facility Registration Exemption Reason required. The FDA states that if the manufacturer is exempt from registration, the system now requires PN Transmitters to provide the reason for that exemption from a list of available exemption reason selections.
Minimum of 6-digit HTS code must be provided (except for Mail). PNSI Version 1.4 allows PN transmitters to provide a 6, 8, or 10-digit Harmonized Tariff Schedule (HTS) code for the PN article. It should be noted that a minimum 6-digit code must be entered for all entry types except Mail.
'Enter Carrier' page modified to change required format of Bill of Lading. The FDA states that in PNSI Version 1.4, the 'Enter Carrier' page was modified to change the required format for the Bill of Lading Number. FDA notes that format validation will not be applied to the Bill of Lading for Land Modes of Transportation because multiple formats are accepted by U.S. Customs and Border Protection.
In addition, the valid format for the Airway Bill Number - Master remains unchanged while format validation will not be applied to the Airway Bill Number - House. See FDA notice for PNSI Version 1.4 valid formats of the above-described bills.
'Enter Carrier' page for Rail enhanced. The 'Enter Carrier' page for Rail modes of transportation was enhanced to allow PN Transmitters to enter the Carrier Name and Country if the Standard Carrier Alpha Code (SCAC) is not available/known.
Highlights of PNSI Version 1.3 New Features
The FDA states that PNSI Version 1.3 includes the following new features (partial list):
'Carrier' page modified to require Bill of Lading/Airway Bill. PNSI's 'Carrier' page was modified to require the Bill of Lading for entries with a Rail or Sea Mode of Transportation, while the Airway Bill number is required for entries with an Air Mode of Transportation. The Bill of Lading requirement is not applicable to Baggage or Mail entry types.
'Create Web Entry' page enhanced to ensure valid format. The 'Create Web Entry' page was enhanced to ensure that the Web Entry Identifier Numbers are provided in the valid format for In Transit (IT) and T&E entries. See FDA notice for Version 1.3's valid format.
Additional information may be required to validate facility information. The FDA states that PNSI validates facilities using the Food Facility Registration Number along with the Business Name, City, and Country. In Version 1.3, PNSI requires entry of certain additional information only if the facility information cannot be validated because the information entered does not match the facility information provided when the facility registered or in cases where no Food Facility Registration number was entered.
'PN Submit Confirmation' page enhanced. The 'PN Submit Confirmation' page was enhanced to display the Web Entry and PN information for review and verification before the user confirms that s/he is ready to submit PN to FDA. FDA adds that under this enhancement, users have the opportunity to edit PN information or submit PN.
(See ITT's Online Archives or 06/15/04 and 05/06/04 news, 04061515 and 04050620, for BP summaries of the three previous PNSI Versions.)
FDA Notice describing PNSI Versions 1.1 through 1.4 available atwww.cfsan.fda.gov/pn/pnsirev.html