FDA Updates PNSI Version 1.4 with Certain Temporary
Instructions
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The Food and Drug Administration (FDA) has issued updated (August 12, 2004) information on Version 1.4 of its Prior Notice System Interface (PNSI) in order to provide temporary instructions on how to supply prior notice (PN) if a submitter/transmitter has problems obtaining the food facility registration number for the manufacturer or in providing bill of lading/airway bill numbers due to format problems.
According to the FDA, these temporary instructions do not constitute a change in required PN information and valid information should be supplied whenever possible.
Temporary Instructions for Certain Unavailable Information, Format Problems
FDA states that the updated (August 12, 2004) information for PNSI Version 1.4 contains the following new, temporary instructions:
Bill of Lading/Airway Bill Number. FDA states that with respect to the PNSI Version 1.4 Enter Carrier page, if due to format problems, transmitters are unable to provide a bill of lading or an airway bill number, these fields should be left blank.
Manufacturer/Producer Food Facility Registration Number. FDA has previously stated that the Food Facility Registration Number for the Manufacturer/Producer is now required for all PNs for Consumption entry types (i.e. all entry types except for Transportation & Exportation (T&E), Foreign Trade Zone (FTZ), and Mail (Non-Commercial Sender)) unless an exemption is declared.
FDA's temporary instructions state that the valid format for the Registration Number is 11 numeric characters, the first one of which is "1". FDA states that format validation will apply to the registration number. Until further notice, if a Transmitter cannot obtain the manufacturer's food facility registration number and there is no legitimate registration exemption reason available, Transmitters should input '10000000000.'
In addition, if a 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.
(See ITT's Online Archives or 08/16/04 news, 04081615, for BP summary of CBP's temporary ABI instructions for supplying PN if manufacturer's food facility number cannot be obtained or if format problems occur with BL or AWB Number, which also mentions these related temporary instructions for PNSI.
See ITT's Online Archives or 08/09/04 news, 04080915, for BP summary of PNSI Versions 1.4 (original) and 1.3.)
FDA Notice on PNSI Versions 1.1 - updated 1.4 (dated 08/12/04) available at www.cfsan.fda.gov/pn/pnsirev.html