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FDA Issues Updated Step-by-Step Web System Instructions Through PNSI Version 1.4

The Food and Drug Administration (FDA) has issued an updated version of its guidance document entitled, Prior Notice for Food Articles Step-by-Step Web System Instructions for PNSI Version 1.4.

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This guidance document includes definitions for certain terms associated with Prior Notice (PN). It also includes instructions for the following actions associated with submitting PN: accessing the Prior Notice System Interface (PNSI), creating a new web entry, creating and submitting a PN, and completing a Web entry.

FDA sources have previously stated that PNSI Version 1.4 did not make many changes to the features discussed in this and certain other FDA guidance documents. The following are highlights of the information added as a result of PNSI Version 1.4, which was released on August 7, 2004:

an explanation of the valid format for the Bill of Lading Number; and

use of alternate data if the Standard Carrier Alpha Code (SCAC) is unavailable for Rail and privately owned vehicles.

Changes & Updates (Versions 1.1-1.4) to Guidance Document Are Printed in Red

If the FDA's updated guidance document is viewed or printed in color, text that has been added or changed as a result of PNSI versions 1.1 through 1.4 will be shown in red. Most of these updates appear in text boxes along the right-hand column of the document.

(See ITT's Online Archives or 08/11/04 news, 04081115, for BP summary of FDA's Guidance documents on PNSI, etc. See ITT's Online Archives or 08/09/04 news, 04080915, for BP summary of PNSI Versions 1.4 and 1.3.

See ITT's Online Archives or 11/10/03 news, 03111010, for final part of BP's multipart summary of FDA's interim final rule on PN of imported food.)

FDA Updated Guidance Document (dated August 2004) available at www.cfsan.fda.gov/pn/pnstep.html