FDA Issues Updated Versions of PNSI

Highlights of the New Features in PNSI Versions 1.5.01, 1.5.02, and 1.5.03

According to the FDA, PNSI Versions 1.5.01 through 1.5.03 include the following new features:

1.5.01 (December 4, 2004)-

Reinforcement of new requirements in Version 1.5.00. The FDA states that PNSI was modified in Version 1.5.00 to require certain data elements. The presence of these data elements are verified at the time the module containing that data is saved. Prior Notices (PNs) created in draft prior to PNSI Version 1.5.00 or created by copying PNs submitted prior to the PNSI Version 1.5.00 release may not comply with the new data requirements.

According to the FDA, the system was modified in Version 1.5.01 to revalidate the Web Entry and PN data to ensure compliance with the Full Enforcement requirements on PN Submission. Specifically, the presence of the valid Manufacturer Registration Number or Exemption Reason, the presence of a Bill of Lading/Airway Bill Master Number, and the submission of the full Grower/Consolidator address is verified on PN Submit for the applicable entry types and Modes of Transportation.

ACS Entry Identifier validation. The Entry Identifier validation for the U.S. Customs and Border Protection (CBP) issued Entry Identifiers was modified to ensure that PNSI accepts all currently valid CBP Filer Codes/Entry Numbers.

1.5.02 (December 28, 2004) -

Certain PNSI defects. The FDA states that PNSI Version 1.5.02 addressed several defects including issues with Registration Number validation; however, there were no enhancements to PNSI functionality in this release.

1.5.03 (March 25, 2005) -

Airway Bill - Master/Bill of Lading Validation. The modifications in PNSI Version 1.5.03 improved the accuracy of the Bill of Lading (BOL) and the Airway Bill - Master (AWB) information provided by the users. The changes included validating the AWB Airline Prefix, BOL Issuer Code of Bill of Lading (ICBL) and ensuring that the remaining characters provided for AWB/BOL are valid. A valid number cannot be comprised entirely of zeros (e.g., 00000000000).

The FDA explains that the AWB is an 11-digit number. The first three characters of the AWB is the Airline Prefix. PNSI will validate that the Airline Prefix is a valid value provided by the International Air Transport Association (IATA).

The BOL is a five to sixteen-character field consisting of letters and/or numbers. The first four characters of the BOL is the ICBL. PNSI will validate that the ICBL is a valid Standard Carrier Alpha Code (SCAC) issued by the National Motor Freight Traffic Association (NMFTA).

Highlights of New Features in PSNI Version 1.6.00

According to the FDA, PNSI Version 1.6.00 includes the following new features (partial list):

"Transportation and Exportation - Express Courier" entry type. The FDA states that the Transportation and Exportation (T&E) -- Express Courier entry type has been added to accommodate T&E shipments sent via Express Courier. Similar to the Consumption -- Express Courier entry type, the user may enter a Tracking Number or an Airway Bill for Air Modes of Transportation entries and a Tracking Number or a Bill of Lading for Land Modes of Transportation entries. With this new entry type, Ultimate Consignee facility information is optional and PNSI allows for foreign Ultimate Consignees.

Quantity and Packaging Wizard and Calculations. The Quantity and Packaging Wizard and Calculations functionality has been modified to only allow data entry to no greater precision than 3 places to the right of the decimal point. For accurate calculation, the Total Calculated amount must be greater than .001 and less than 999,999,999.999.

Browser Support. According to the FDA, Mozilla Firefox is now a supported browser for accessing PNSI.

Holding Facility. PNSI Version 1.6.00 makes the following changes with regard to holding facility information:

If Holding Facility information must be provided for all PNs for a Web Entry submitted via PNSI, you can now apply the information entered for one PN to all PNs within the Web Entry. Indicate that the Holding Facility applies to all PN Articles for the Web Entry by checking the "Should this Holding Facility be applied to all Articles for this Web Entry?" checkbox on the PN: Holding Facility (Enter) page when entering Holding Facility information for one of the PN Articles. The information will be applied to all PN Articles within the Web Entry that have not been cancelled and do not have a Holding Facility.

The Holding Facility process was modified to include a verification step with a message to inform the user that holding facility information cannot be modified after submission.

The Submit Holding Facility link on the PN: Submitted page will now only be displayed if the associated Web Entry has been completed.

Web Entry Summary Confirmation Page. This release effort implemented two corrections to the data field labels on the Web Entry Summary Confirmation Page for Mail Entry Types. The Envelope Number is now correctly identified in the Web Entry section of the page and the PN Confirmation number is listed next for each PN Article.

PNSI Login. To access PNSI, users must log in through the FDA Industry Systems page at https://www.access.fda.gov/oaa/. Bookmarks or Favorites that link directly to the PNSI Welcome page will return an error message directing the user to the FDA Industry Systems page.

PNSI Help Text. PNSI has enhanced the PNSI Help to include Helpful Tips for Submitting PN (available at http://www.cfsan.fda.gov/pn/pntips.html). This section of the Help documentation contains valuable timesaving advice for PNSI users. (See ITT's Online Archives or 06/10/05 news, 05061015, for BP summary of these tips.)

Usability Enhancements. PNSI Version 1.6.00 includes the following usability enhancements:

Canada, Mexico and the United States are now the first 3 countries listed in the drop-down list of countries for the Privately-Owned Vehicle License Country field on the Carrier page. All other countries are listed in the drop-down in alphabetical order following the United States. The Privately-Owned Vehicle License Country field is listed on the Carrier page for the following Modes of Transportation: Land, Automobile; Land, Other; Land, Truck; and Land, Truck Container.

The Find Product Code Wizard functionality has been improved to remove extra spaces from the user's input that may have been entered before or after the search string. Prior to this change, the search would return an error if the user entered blank spaces before or after the text.

The images included in the Quantity and Packaging Wizard have been modified to be more intuitive, to better aid users when calculating the Total Quantity of goods being shipped into the U.S. using the Wizard.

Throughout the application, PNSI provides helpful links to sites within the FDA network. Prior to this release, PNSI provided a link to the Industry Guidance for Harmonized Tariff Schedule (HTS) Codes Flagged with PN Indicators. With this release, this link has been redirected to go directly to the list of Harmonized Tariff Schedule (HTS) Codes Flagged with PN Indicators.

The Carrier page has been modified to make it easier to enter and view multiple Rail Car Numbers and Container Numbers for Web Entries where the selected Mode of Transportation is either Rail or Rail Container. The size of the fields has been increased to hold up to 1000 characters. Rail Car Numbers and Container Numbers may range from 1 to 20 characters and must be separated by commas when entered into the field.

Error Messages have been clarified and corrected for: Invalid anticipated arrival date range as search criteria on the Find Web Entries page; Invalid use of special characters throughout PNSI; Required Full Address on the Manufacturer page; and Invalid system time-out messages.

(See ITT's Online Archives or 11/04/04 news, 04110415, for BP summary of PNSI Version 1.5, which was scheduled for release on November 6, 2004.)

FDA Notice on New Features in PNSI Versions 1.1 though 1.6 (updated 07/16/05) available athttp://www.cfsan.fda.gov/pn/pnsirev.html