Version 14.0.00 - August 24, 2019
Version 2.2.00 - August 13, 2011
Version 2.0.01 - May 19, 2009
Version 2.0.00 - May 6, 2009
Version 1.10.00 - January 14, 2009
Version 1.9.00 - December 8, 2007
Version 1.8.00 - September 8, 2007
Version 1.7.01 - August 15, 2006
Version 1.7.00 - August 10, 2006
Version 1.6.02 - December 3, 2005
Version 1.6.01 - October 29, 2005
Version 1.6.00 - July 9, 2005
Version 1.5.03 - March 25, 2005
Version 1.5.02 - December 28, 2004
Version 1.5.01 - December 4, 2004
Version 1.5 - November 6, 2004
Version 1.4 - August 7, 2004
Version 1.3 - July 10, 2004
Version 1.2.01 - June 5, 2004
Version 1.2 - May 8, 2004
Version 1.1 - February 29, 2004
Version v14.0.0 of the Prior Notice System Interface (PNSI) is a change related to the completion of web entries. The application has been updated to require that the Web Entry is completed before a user's Prior Notices are submitted. The system no longer automatically completes web entries when the Prior Notice submission timeframe elapses. After creating a Prior Notice, users will be given the option to save their Prior Notice or cancel their Prior Notice rather than to submit their Prior Notice. All Prior Notices must be created and saved before submitting the Web Entry. Once the Web Entry is submitted, it will be closed and the user will not have the ability to add additional Prior Notices to their Web Entry.
In addition, users will no longer have the ability to cancel individual Prior Notices once a Web Entry is completed. Users will have to cancel the entire Web Entry to cancel a Prior Notice. Any Prior Notices that the user did not wish to cancel can be copied and re-filed on a new Web Entry.
Version v2.2.00 of the Prior Notice System Interface (PNSI) is a change related to a new data requirement on the Prior Notice Article page. When applicable, users must supply information if the article has been refused entry by any Country/Area. User can select multiple countries by holding Ctrl key and then selecting different countries. The application has the functionality to store this information. The application has also been updated to display the information on all the screens where the Article information can be viewed.
Version v2.0.01 of the Prior Notice System Interface (PNSI) is a patch release to address an issue related to the Prior Notice Final Rule (PN FR) release implementation that affected hardware and infrastructure. There is no impact to the users with the implementation of this change.
Version v2.0.00 of the Prior Notice System Interface (PNSI) release addresses implementation of system changes mandated by the Prior Notice Final Rule (PN FR). Additionally, modifications to the Help and Instructional Text were made.
The PNSI v2.0.00 Release includes the following functionality:
- Allowing to file a Prior Notice (PN) 15 days prior to the Anticipated Arrival Date.
- Submitter Fax is now optional.
- Submitter Phone and Email Address is required.
- Manufacturer name and registration number, city and country or the full address including the facility's street name and number; suite/unit number, as appropriate; city; Province or State as appropriate; mail code as appropriate; mail code as appropriate; and country, and the reason the registration number is not provided are now required for all entry types.
- The reasons for not providing the Manufacturer Registration number will be made available for selection for Mail Entry Types (Commercial and Gift), since the Manufacturer Registration number is now required for mail entries.
- Shipper name and full address including the facility's street name and number; suite/unit number, as appropriate; city; Province or State as appropriate; mail code as appropriate; and country, are required if different than the manufacturer. If the Shipper is also a registered facility, the registration number may also be submitted.
- Changes to the list of reasons a food facility registration is not provided for the manufacturer.
- The full address of the Importer, Ultimate Consignee, and Owner (if different than the Importer or Ultimate Consignee) is now required. The full address including the facility's street name and number; suite/unit number, as appropriate; city; Province or State as appropriate; mail code as appropriate; and country, is now required irrespective of the registration number being provided except for the Transportation and Exportation entries and mail entries. For mail entries, the name and address of the U.S. Recipient is required.
- Carrier Country is now removed from the PNSI User Interface (UI) because it is no longer required under the PN FR.
- Privately-Owned Vehicle Country is now removed from the PNSI UI because it is no longer required under the PN FR. The Privately-Owned Vehicle License Country Subdivision/State or Province is a free form text field now.
- HTS Code is now removed from the PNSI UI because it is no longer required under the PN FR.
- Anticipated Border Crossing is now removed from the PNSI UI because it is no longer required under the PN FR.
- PNSI Instructional Text and Help Text Modifications to reflect the changes made for the PN FR.
Version v1.10.00 of the Prior Notice System Interface release addresses implementation of one major enhancements as well as documentation updates, defect corrections and system maintenance database backend modifications. Additionally, modifications to the Instructional Text were made.
The PNSI v1.10 Release includes the following functionality:
- Re-design of how the PNSI application calls the Firms Master List Service (FMLS) for firm validation.
- Making the "Login" button available for Safari web browser users.
- Modification of the PNSI main page and release notes links to include Safari web browser support.
- Help and Instructional Text Changes include:
- Changing the help link text from Producer to Grower/Consolidator.
- Changing the instructional text for the Web Entry Identifier's format for In Transit (IT) and Transportation and Exportation (T&E) entry types. The valid format is one of the following: a paper inbond number which is 9 digits NNNNNNNNN where N is a number; a paperless inbond number which is 11 digits - the first 3 are VXX, an identifier assigned to a broker (much like a filer code) followed by 8 digits NNNNNNNN) where V is a letter, X may be a letter or number and N is a number.
- Provide solutions to identified software defects.
Version 1.9.00 of the Prior Notice System Interface release implements minor enhancement as well as defect corrections and system maintenance database backend modifications. Additionally, modifications to the Instructional Text were made.
The PNSI v1.9 Release includes the following functionality:
- Adding a Reset button to the Find Existing Web Entry, Find Prior Notice and Find Prior Notices to Copy screens
- Re-sort the list of Manufacturer Exemption Reasons by code
- Provide solutions to identified software defects
Version 1.8.00 of the Prior Notice System Interface release addresses usability enhancements, implementation of minor enhancements as well as defect corrections and system maintenance database backend modifications. Additionally, modifications to the Instructional Text were made.
The PNSI v1.8.00 Release includes the following functionality:
- Personalized list of frequently used facilities (Firms with valid FFR only) to serve as an address book to allow PN Submitters to create and submit PNs faster and easier.
- Ability to copy a PN between Web Entries of like Entry Type to allow PN Submitters to easily reuse data that has already been entered.
- Several application enhancements to provide ease of use.
- Provide solutions to identified software defects.
Version 1.7.01 of the Prior Notice System Interface (PNSI) is a patch release that addresses an issue that has prevented some users from submitting Prior Notice to the FDA. The modification for the Quantity and Packaging number format in the v1.7.00 release was found to have an unintended result for users who set the primary language in their web browser to something other than English (United States). Users received an error when displaying formatted values on the PN Article View, Submit PN Confirmation Message, Quantity & Packaging Wizard Step 4, and Prior Notice PDF. This release addresses this issue and does not introduce any additional enhancements.
Version 1.7.00 of the Prior Notice System Interface (PNSI) addresses several defects and some minor enhancements. There are no major enhancements to PNSI functionality in this release.
Version 1.6.02 of the Prior Notice System Interface (PNSI) is an upgrade to the database. The application version number was incrementally updated to 1.6.02 to indicate this strictly backend change. There are no enhancements to PNSI functionality in this release.
Version 1.6.01 of the Prior Notice System Interface (PNSI) includes minor changes to improve the stability of the system. Forms that create or modify data in PNSI have checks to prevent users from submitting the form more than once. If the back button is used or a form is submitted more than once, users will receive an error message stating that the form has expired. When using PNSI, please do not use the Back button in your Browser to navigate to a previous page or submit a form more than once by clicking the Save or Next button more than once.
Version 1.6.00 of the Prior Notice System Interface (PNSI) includes the following new features:
"Water, Other" Mode of Transportation
The "Water, Other" Mode of Transportation has been created to allow imports via personal watercraft navigating across US boundary waters which do not issue valid Bill of Lading numbers. The information required for this Mode of Transportation is similar to the "Water, Vessel (Non-Container)" except that the Bill of Lading number is optional. This mode can be selected from the Mode of Transportation on the Web Entry and Web Entry: Carrier pages. It is available for the Consumption, Foreign Trade Zone (FTZ), Immediate Transportation (IT), Informal, Temporary Import Under Bond (TIB), Transportation and Exportation (T&E), and Warehouse entry types.
"Transportation and Exportation (T&E) -- Express Courier" Entry Type
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 was 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.
Mozilla Firefox is now a supported browser for accessing PNSI.
- If Holding Facility information must be provided for all Prior Notices for a Web Entry submitted via PNSI, you can now apply the information entered for one Prior Notice to all Prior Notices within the Web Entry. Indicate that the Holding Facility applies to all Prior Notice Articles for the Web Entry by checking the "Should this Holding Facility be applied to all Articles for this Web Entry?" checkbox on the Prior Notice: Holding Facility (Enter) page when entering Holding Facility information for one of the Prior Notice Articles. The information will be applied to all Prior Notice 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 Prior Notice: 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 Prior Notice Confirmation number is listed next for each Prior Notice Article.
To access PNSI, users must log in through the FDA Industry Systems page. 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 Prior Notice. This section of the Help documentation contains valuable timesaving advice for PNSI users.
- 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
- 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 US 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 Prior Notice Indicators. With this release, this link has been redirected to go directly to the list of Harmonized Tariff Schedule (HTS) Codes Flagged with Prior Notice 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 Message 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
- Invalid system time-out messages.
Version 1.5.03 of the Prior Notice System Interface (PNSI) includes the following new features:
Airway Bill - Master/Bill of Lading Validation
The modifications in PNSI v1.5.03 improve the accuracy of the Bill of Lading (BOL) and Airway Bill - Master (AWB) information provided by the users. The changes include 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 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).
Version 1.5.02 of the Prior Notice System Interface (PNSI) addresses several defects including issues with Registration Number validation. There are no enhancements to PNSI functionality in this release.
Release Date: December 4, 2004
Version 1.5.01 of the Prior Notice System Interface (PNSI) includes the following new features:
Reinforce New Requirements in v1.5.00
PNSI was modified in v1.5.00 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 created in draft prior to PNSI v1.5.00 or created by copying Prior Notices submitted prior to the PNSI v1.5.00 release may not comply with the new data requirements.
The system is modified in V1.5.01 to revalidate the Web Entry and Prior Notice 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 the PNSI accepts all currently valid CBP Filer Codes/Entry Numbers.
Version 1.5 of the Prior Notice System Interface (PNSI) includes the following new features:
"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", has been created. 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 for this new entry type; "Express Courier - Air" and "Express Courier - Land". The information required for the "Consumption, Express Courier" entry type is the same as for the Consumption entry type with the exception that the Anticipated Port of Arrival, Anticipated Arrival Date and Time and the Harmonized Tariff Schedule (HTS) code are optional. The shipment Tracking Number issued by the Express Courier can be provided in lieu of an Airway Bill Number or a Bill of Lading number. This Tracking Number should be entered in the field otherwise used for the Airway Bill Number or the Bill of Lading.
PNSI provides the ability to submit Holding Facility information in the case where FDA has refused a food article. If FDA or U.S. Customs and Border Protection (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.
PNSI now allows any party to submit the Holding Facility information, regardless of whether or not they transmitted the original Prior Notice. PN Transmitters can search for PNs submitted via their account to submit Holding Facility information. If the PN was submitted via ACS or was submitted via PNSI by a PN Transmitter using a different account, the identifying information for the article can be used to allow another Transmitter to submit the Holding Facility information.
Once Holding Facility information has been submitted, the Transmitter can view the status of the Holding Facility information submission to determine if it was matched to a Prior Notice that was originally submitted.
Quantity and Packaging Wizard
PN Transmitters now 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 Prior Notice Article page.
Firm Registration Validation
PNSI 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 can not be validated, you 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 now requires 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.
Three new Manufacturer Registration Not Provided qualifiers have been added to PNSI, to accommodate situations in which the PN Transmitter does not provide the Food Facility Registration Number of the Manufacturer.
Additionally, new Manufacturer Registration Not Provided qualifiers have been added to PNSI to identify an article being imported as a sample for quality assurance, research and analysis purposes and gift packs imported for non-business purposes.
With the introduction of these additional qualifiers, Transmitters should no longer input 10000000000, as that will no longer be accepted by the system.
Submitter Address Validation
If the Food Facility Registration Number of the Submitter is not valid or not entered, PNSI validates the full address information of the Submitter. If PNSI is able to validate the address, you may be asked to select between the information you originally entered and the matching address, which may contain additional or alternate information. For example, PNSI may match a 5-digit U.S. Zip Code to the extended 9-digit U.S. Zip Code. If PNSI is unable to validate the address information, you will be asked to review the data and verify that it is correct.
Harmonized Tariff Schedule Guidance
The instructional text on the Prior Notice Article now has a link to the FDA guidance on Harmonized Tariff Schedule (HTS) Codes.
- The Find Web Entries and Find Prior Notices pages were modified to include links to navigate between the two pages.
- The Find Web Entries and Find Prior Notices pages will display the total number of records that are retrieved.
- The Prior Notice Summary and the Web Entry Summary Confirmation PDF documents will display a date and time stamp of when the document was generated.
- Error handling was enhanced to explain all data errors on a particular page, direct the users where to go to correct the errors and warn users from using the "Back" browser button.
- Several discrepancies related to copying Prior Notices and using the default facilities option have been resolved.
Multiple Container and Rail Car Numbers
The Container Number field on the Carrier page was expanded to allow the input of multiple container numbers for the containerized modes of transportations. The Rail Car Number field on the Carrier page was 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).
In accordance with the Prior Notice Interim Final Rule and to avoid possible confusion the reference to Producer was removed and the Producer page was renamed to the Grower/Consolidator. If the Grower/Consolidator is known, the full address of the Grower/Consolidator facility is required.
Version 1.4 of the Prior Notice System Interface (PNSI) includes the following new features:
August 12, 2004 Update:
The following update provides temporary instructions on how to supply prior notice 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. This does not constitute a change in required prior notice information and valid information should be supplied whenever possible.
Bill of Lading/Airway Bill Number
The Enter Carrier page was modified to change the required format for the Bill of Lading Number. The valid format for the Bill of Lading Number is a minimum 5 characters and a maximum 16 characters that are either letters or numbers. Format validation will not be applied to the Bill of Lading for Land Modes of Transportation (MOTs), because multiple formats are accepted by the US Bureau of Customs and Border Protection (CBP). If, due to format problems, Transmitters are unable to provide a bill of lading, this field should be left blank.
The valid format for Airway Bill Number - Master remains unchanged as AAANNNNNNNN, where A is a letter or a number and N is a number. Format validation will not be applied to the Airway Bill Number - House. The maximum acceptable length of this field is 12 alphanumeric characters.If, due to format problems, Transmitters are unable to provide an airway bill, this field should be left blank.
Foreign Trade Zone Entry Identifier Format
The Web Entry Identifier field (FTZ Number) for the Foreign Trade Zone (FTZ) entry type was modified to require a minimum of 5 and to allow up to 29 characters that are either letters or numbers. The PN Transmitter should provide the CBP Location of Goods code as the first four characters of the FTZ number.
Carrier - Privately Owned Vehicle
The Enter Carrier page for the Land - Automobile, Land - Other, Land - Truck, Land - Truck Container, and Land - Passenger Hand-Carried modes of transportation was modified to allow PN transmitters to enter alternate data if the Standard Carrier Alpha Code (SCAC) is not available. If the SCAC is not provided, the transmitter should enter the Carrier Name and Country or the Privately Owned Vehicle License Number, Country Subdivision (if applicable) and Country of the License Issuer. The Country Subdivision of the License Issuer is required for the United States.
Carrier - Rail
The Enter Carrier page for the 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.
Manufacturer/Producer Food Facility Registration Number
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. The valid format for the Registration Number is 11 numeric characters, the first one of which is "1". 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. If the 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.
Manufacturer Food Facility Registration Exemption Reason
If the manufacturer is exempt from registration, the system now requires PN Transmitters to provide the reason for that exemption. A list of reasons approved by the Food and Drug Administration (FDA) is available for selection.
More information on Food Facility Registration, including exemptions from the Registration requirements, is available at Food Facility Registration.
Manufacturer Firm Address Information
Full firm address is required if (a) a registration number has been provided and the facility information cannot be validated because the information entered does not match the facility information provided when the facility was registered, (b) a Food Facility Exemption reason is declared for the Manufacturer because registration is not required.
Harmonized Tariff Schedule Code
The system allows PN Transmitters to provide a 6, 8 or 10-digit Harmonized Tariff Schedule (HTS) code for the PN article. A minimum 6-digit code must be entered for all entry types except Mail.
The Country Subdivision is not required as part of the firm address information for countries other than the United States. The Country Subdivision (State) is required as part of the full firm address for the United States addresses.
Web Entry/Prior Notice Cancellations
The Web Entry and Prior Notice cancellation functionality was modified to prevent cancellation of Web Entries and Prior Notices with the PN Confirmation Numbers that were used as evidence of having filed prior notice (i.e. Affirmation of Compliance) in a commercial entry submitted to the U.S. Customs and Border Protection's (CBP's) Automated Commercial System (ACS). The entry that has referenced the PN Confirmation Number must be canceled in ACS first before the Prior Notice can be canceled. PN Transmitters can then resubmit the PN with holding facility information, if required, and then file the entry via ACS.
The name of the "Mail" entry type was changed to "Mail (Commercial)" to further differentiate it from the "Mail (Non-Commercial Sender)" entry type. The business rules for this entry type remain unchanged.
Instructional Text Changes
The instructional text on the Welcome and Web Entry Summary Confirmation pages was modified to emphasize that PN Transmitters must complete the Web Entry to allow U.S. Customs and Border Protection to receive the Prior Notice review decisions in time from the U.S. Food and Drug Administration for all articles in the Web entry.
Version 1.3 of the Prior Notice System Interface (PNSI) includes the following new features:
Bill of Lading/Airway Bill Number
The Carrier page was modified to require the Bill of Lading for entries with a Rail or Sea Mode of Transportation. The Airway Bill number is required for entries with an Air Mode of Transportation. The Bill of Lading requirement is not applicable to Baggage and Mail entry types.
The Carrier page was enhanced to ensure that the Bill of Lading/Airway Bill Numbers are provided in the valid format. The valid format for Bill of Lading Number is AAAANNNNNNNNNNNN, where A is a letter or a number and N is a number. The valid format for Airway Bill Number is AAANNNNNNNN, where A is a letter or a number and N is a number.
Web Entry Identifier 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 Transportation & Exportation (T&E) entries. The valid Entry Identifier format for the IT and T&E entries is one of the following: VXXNNNNNNNC, NNNNNNNNC, or NNNNNNNNNNC, where V and X are letters or numbers and N and C are numbers.
Firm Registration Validation
PNSI validates facilities using the Food Facility Registration Number along with the Business Name, City, and Country. You will now be required to enter additional information (the facility Street Address and, if applicable, the Country Subdivision and/or Mail/Zip code) only if (a) the facility information cannot be validated because the information entered does not match the facility information provided when the facility was registered, or (b) no Food Facility Registration number was entered.
Prior Notice Submit Confirmation Page
The Prior Notice Submit Confirmation page was enhanced to display the Web Entry and Prior Notice information for review and verification before you confirm that you are ready to submit the Prior Notice to the FDA. You have the opportunity on the Prior Notice Submit Verification page to go back and edit the Prior Notice information, if needed, or to submit the Prior Notice.
Complete Web Entry Confirmation Page
The Complete Web Entry Confirmation page was enhanced to display the Prior Notices within the Web entry that are still in Draft status. The system alerts you that any Prior Notices in Draft status will be canceled if you choose to complete the Web Entry before submitting the Draft Prior Notices. You have the opportunity to return to the Web Entry (View) page and continue working on the Draft Prior Notices or to complete the Web Entry.
Instructional Text Changes
The instructional text on the Prior Notice: Related Facilities (View) page was enhanced to emphasize that you do not need to submit the Holding Facility information unless US Customs and Border Protection (CBP) directs your food article to a Holding Facility before you submit the Prior Notice.
Welcome to the Prior Notice System Interface
The display of instructional text on the Welcome to the Prior Notice System Interface (Home) page was changed to make the text more understandable.
Web Entry Summary Confirmation
The instructional text related to the Web Entry Summary Confirmation was modified to clarify the usage of the Web Entry Summary Confirmation. The Web Entry Summary Confirmation print out is available to facilitate passing through the Port of Arrival and for personal records.
Version 1.2.01 of the Prior Notice System Interface (PNSI) includes the following new features:
Enhanced Check-Digit Support
Prior Notice Transmitters who have Entry Identifiers assigned by the Bureau of Customs and Border Protection (CBP Entry Number) that follow the Check-Digit Plus format may now use those Entry Identifiers to submit Prior Notice via PNSI.
FDA Industry Systems - Account Management Integration
PNSI has been modified to integrate with the latest version of the FDA Industry Systems Account Management module.
Version 1.2 of the Prior Notice System Interface (PNSI) includes the following new features:
Completing Web Entries
For all non-Mail Entry Types, United States Customs and Border Protection (CBP) now requires that the Carrier present a copy of the Web Entry Summary Confirmation at the Port of Arrival. This one document replaces the previous requirement that the Carrier present a copy of each Prior Notice Confirmation at the Port of Arrival, and allows CBP to more efficiently process shipments as they cross the US border.
Completing Web Entries is required after submitting all Prior Notices for the Web Entry. Completing the Web Entry alerts FDA to expect no further Prior Notices for the Web Entry and cancels any remaining Prior Notices in Draft status. When a Web Entry is "Completed", the system accepts no additional Prior Notices, but allows you to cancel the Web Entry or associated Prior Notices.
When you have submitted all Prior Notices you intend to submit for your Web Entry, complete the Web Entry by clicking on the Complete Web Entry button.
Except if you are sending the Web Entry via International Mail, you will then need to print the Web Entry Summary Confirmation.
Web Entry Summary Confirmation
After submitting all Prior Notices and completing the Web Entry, access the Web Entry Summary Confirmation by clicking on the Print Summary button on the Web Entry (View) page. This opens a new page in Adobe Acrobat Reader from which you may now print, save, or e-mail your Web Entry Summary Confirmation as a Portable Document Format (PDF) file. Adobe Acrobat Reader is available as a free download from Adobe (www.adobe.com).
For Mail Entry Types, printing the Web Entry Summary Confirmation is optional, but you may want to print or save it for your records. The Web Entry Summary Confirmation contains the Shipment Confirmation Number you should place on your Customs declaration form before sending the food articles to the United States.
Autocomplete Web Entry
When you have submitted all Prior Notices, complete the Web Entry. If you do not Complete your Web Entry before the end of the timely submission period based upon the mode of transportation (2 hours before arrival for Land, 4 hours before arrival for Air or Rail, or 8 hours before arrival for Water), the system completes it automatically. If the system automatically completes your Web Entry and you need to submit additional Prior Notices for it, copy the Web Entry and continue creating and submitting Prior Notices.
Changes to Look and Feel
Numbered Steps Added
The pages and buttons now reflect the 5 basic steps involved in the Prior Notice process. The numbered steps are as follows:
- Create Web Entry
- Create Prior Notice.
- Submit Prior Notice
- Complete Web Entry
- Print Summary
The pages that relate to these basic steps now also have new titles to convey the related process step and function. For example:
- - Precedes the titles for all pages used to create and edit the Web Entry and related facilities. For example, 1 Web Entry (Create) and 1 Web Entry: Submitter (Edit).
- - Precedes the titles for all pages used to create and edit the Prior Notice and related facilities. For example, 2 Prior Notice: Related Facilities (View) and 2 Prior Notice: Manufacturer (Edit).
Web Entries and Prior Notices Tabs Removed
PNSI no longer has the Web Entries and Prior Notice tabs. To access the Find Web Entries or Find Prior Notices pages from any place in the application, click on the Home hyperlink above your name at the top of the page, then click on either the Find Existing Web Entry or the Find Existing Prior Notice button.
Mode of Transportation Drop-Down List Moved
Mode of Transportation is now an attribute of the Carrier and is now in the Carrier section of the Web Entry page as the first step for entering Carrier information.
If US Customs and Border Protection (CBP) directs your food article to a Holding Facility before you submit a Prior Notice for it, the US Food and Drug Administration (FDA) requires that you submit the Holding Facility information as part of your Prior Notice. If CBP directs your food article to a Holding Facility because the Prior Notice information is inadequate or untimely, you must cancel the original Prior Notice and submit a new Prior Notice with the Holding Facility information. The Prior Notice System Interface allows you to submit this information on the Prior Notice: Related Facilities page.
Non-Unique Entry Identifiers
The Prior Notice System Interface no longer requires the In-Bond or FTZ Number to be unique if used as an Entry Identifier for FTZ, IT, and T&E Entry Types.
For all other Entry Types, if using Entry Numbers issued by United States Customs and Border Protection as Entry Identifiers, only one "Open" Web Entry (i.e., not Completed or Canceled) may use the Entry Identifier at a time.
Other Features for Managing Web Entries
Canceling Web Entries
The Cancel Web Entry feature allows you to cancel Web Entries and associated Prior Notices if the Web Entry will not arrive or if you need to substantially change Web Entry information after you have submitted your first Prior Notice. Should you need to do so, you may then use the Copy Web Entry feature to resubmit the information.
Copying Web Entries
The Copy Web Entry feature allows you to copy Web Entries and, if you like, associated Prior Notices. This creates a new, Open Web Entry, and associated Draft Prior Notices. You may copy any Web Entry that belongs to your "Company", whether it is in Open, Completed or Canceled status.
You may also use this feature to continue submitting late Prior Notices, if the system "Autocompletes" your Web Entry.
The following pages paginate if the number of Prior Notices or Web Entries exceeds 20:
- Web Entry (View)
- Find Web Entries
- Find Prior Notices
Use the Next and Previous buttons to navigate between pages or select a page the drop-down list and click the Go button.
Improved Search for Web Entries and Prior Notices
On the Find Web Entries and the Find Prior Notices pages, the criteria textboxes now allow a search using multiple strings. For example, if you enter "XYZ ABC", the system will search for all items that contain "XYZ" and "ABC" in any order. The search is not case sensitive, meaning that "X" will find both "X" and "x".
Verification Steps for "Destructive" Actions
The system now prompts you to verify that you wish to go ahead with the following actions:
- Submit Prior Notice
- Complete Web Entry
- Cancel Prior Notice
- Cancel Web Entry
On each page of the Prior Notice System Interface, the Help hyperlink links to the applicable Help topic rather than the Prior Notice System Interface Help page. For example, the Help hyperlink on the Find Prior Notices page opens the Finding Prior Notices topic.
Version 1.1 of the Prior Notice System Interface (PNSI) includes the following new features:
Prior Notice Data Purge
Effective on or about March 7, the system will begin to automatically remove Web Entry and Prior Notice data for Web Entries with an Anticipated Arrival Date or Shipment Date that is more than 30 days in the past. The system will also remove data for Web Entries and Prior Notices that have not been edited for more than 30 days.
You may now print or save your Prior Notice Confirmation as a Portable Document Format (PDF) file using Adobe Acrobat Reader. The Adobe Acrobat Reader is available for free download from Adobe Systems Inc (www.adobe.com).
FDA Country of Production is now on the View Prior Notice: Related Facilities page as the first step in entering the Manufacturer/Producer of the food article.
The system now expresses all times in the 24-hour format. The Anticipated Time of Arrival is now selectable in two drop-down lists on the Prior Notice: Article pages. The submission and status times remain in the Eastern Time Zone and the Anticipated Time of Arrival should be in the time zone of the Port of Arrival.
Prior Notice Related Facilities
- Manufacturer: If the Manufacturer is not required to register according to the Registration Rule, the system does not require the Food Facility Registration Number for the Manufacturer of the food product in Web Entries with "Consumption" Entry Types.
- Owner: If the Owner does not have a United States address and is required for the Entry Type, the address is now required.
The system now automatically generates the Entry Identifier for Mail, Mail (Non-Commercial/Gift), and Baggage Web Entries.
Mail is now split into two Entry Types: Mail and Mail (Non-Commercial Sender).
- Both Mail Entry Types now require a United States Recipient instead of an Importer. The United States Recipient may only be the same as the Submitter if the Submitter has an address in the United States.
- The system now automatically generates the Entry Identifier for both Mail Entry Types.
Other Changes for the Mail Entry Type:
Harmonized Tariff Schedule (HTS) Code is now an optional data element for the Article.
How does the Mail (Non-Commercial Sender) Entry Type differ from the Mail Entry Type?
- Harmonized Tariff Schedule (HTS) Code is not a data element for the Article in the Mail (Non-Commercial Sender) Entry Type.
- For the Manufacturer, the system only requires the name and address of the firm that appears on the product label, including at least the Name, City, and Country (the FDA Country of Production).
- For the Producer, if address information is available, the system only requires the Name, City, and Country (the FDA Country of Production).
Finding Prior Notices and Web Entries
You may now use new search capabilities in the Find Prior Notices and Find Web Entries pages.