Prior Notices

Prior Notice Process Overview

1. After you have created the Web Entry for the shipment, do one of the following to begin to create a Prior Notice:

• Click on the Create New Prior Notice button on the Welcome to the Prior Notice System Interface page.

• Select the Create Prior Notice option on the Web Entry (View) page.

2. Enter Prior Notice Article information.

3. Enter Prior Notice Related Facility information.

4. Review and edit the Prior Notice and Web Entry.  You may make corrections to the Web Entry BEFORE submitting your Web Entry.  To edit the Web Entry, see the Creating and Editing Web Entries topic.

5. Save the Prior Notice: Saving your Prior Notice changes it from "draft" to "saved" status, it does NOT submit the Prior Notice information to FDA. The Web Entry must be completed before the Prior Notice is submitted to FDA.

6. Repeat steps 1-5 to create and submit other Prior Notices until you have submitted Prior Notices for every article in your shipment.

7. Complete your Web Entry: When you have saved all of the Prior Notices for your Web Entry, you should then Complete the Web Entry and Print the Web Entry Summary Confirmation.  See the Completing a Web Entry and Accessing the Web Entry Summary Confirmation topics. In order to to make your Prior Notices available to the United States Food and Drug Administration (FDA) and United States Customs and Border Protection (CBP), you must complete your Web Entry. For your own records, you may also use the Print/Save button to view and print a Portable Document Format (PDF) version of your Prior Notice Confirmation.

8. After creating Prior Notices, you can:

• Find existing Prior Notices

• Copy Prior Notices within the Web Entry, to create others with similar information.

• Copying Prior Notices to Another Web Entry, to another of like entry type.

• Cancel Prior Notices for food articles that you no longer intend to be a part of the Web Entry.

  1. Note: This can only be done before your Web Entry is completed. Once your Web Entry is completed, if you would like to cancel a Prior Notice, you must cancel the Web Entry and re-file any Prior Notices that you did not wish to cancel.

Entering Prior Notice Article Information

The Prior Notice: Article (Create) page displays including the Entry Identifier of your Web Entry, and a system-generated Article Number (counting up from 0001).

1. Enter the Article Information.

1. Select the Country from which the Article is Shipped into the United States.  Note that this country does not have to be the same as the business location of the Shipper.

2. Enter the Prior Notice Product Information.

1. Enter the FDA Product Code.  If you do not know the Product Code, click on the Search button to build the Product Code by finding the appropriate product, packaging, and processing.
   For more information about FDA Product Codes and how to search for them, see the FDA Product Codes topic.
   
   If the Product Code does not list the specific product, use the FDA Product that most closely identifies the product. For example in Citrus Fruit, Topping or Syrup (N.E.C.),  N.E.C., means Not Elsewhere Classified.  Use the Common Name to specify further.

2. Enter the common, usual, or market name of the product in the Common Name or Usual Name/Market textbox (e.g., Oatmeal Chocolate Chip Cookies).

3. Enter the Production Identifiers (identifiers such as production lot codes or production batch identifiers).  FDA statute or regulation requires Production Identifiers for low-acid canned foods, acidified foods, and low-acid canned infant formula.  The production identifiers are mandatory if the product is required to bear such numbers by the FD&C Act or by FDA regulations. These identifiers are optional for other types of food.

1. Click on the Add button. The Prior Notice: Production Identifiers (Add) page displays. Enter only one Production Identifier per textbox on this page.  After adding Production Identifiers, click on the Save button and the Production Identifiers section of the page changes to display them.

2. Use the Delete button to delete any incorrect Production Identifiers.

4. Enter the Quantity and Packaging. If you would like step-by-step instructions for entering the Quantity and Packaging information click on the Wizard button. The information entered using the Wizard will display in the Quantity and Packaging section on the Prior Notice: Article page. To enter the Quantity and Packaging directly on the page follow the instructions below:

1. Enter the Base Unit: the weight or volume of the smallest unit, or the weight or volume of the bulk shipment.  

2. If the food is bulk-shipped, check the Bulk-shipment checkbox.

3. If the food is not bulk-shipped, provide the estimated quantity of food that will be shipped, described from the largest container to smallest package size (up to five packaging levels may be provided).  For example, 100 Cartons, 40 Cans per Carton with a base unit of 1Lb per Can.

4. Click on the Calculate button to calculate the Total Quantity. If the calculated total quantity is not correct, correct the base unit or packaging container numbers to arrive at the correct total quantity.  The system can calculate the Total Quantity up to the millions place (100,000,000) and the thousands decimal place (.001).  For amounts between .0005 and .0009, the system rounds the value to .001.

5. Enter the Refusal Information.

1. Select Yes or No from the drop-down list if the article of food has been refused entry by any Country/Area. Note that this only applies if the actual food in this current shipment (not previous shipments of the same food product) has been refused entry by any Country/Area, including the United States.

2. Select the Country(s)/Area(s) that has Refused the Article.

6. Click on the Save button.  The system validates the information entered and determines whether the food is in its natural state. (See the topic, Manufacturer or Grower/Consolidator? for further information.)  The system displays the Prior Notice: Related Facilities (View) page, if you have created a new Prior Notice, or the Prior Notice: Article (Edit) page, if you have previously saved the article and have modified it.

7. Continue with the next topic, Entering Prior Notice Related Facility Information.

>> Return to the Prior Notice Process Overview

Entering Prior Notice Quantity and Packaging Information using Wizard

1. Select the packaging type: Packaged or Bulk-shipment.  Click on the Next button.

2. For the Packaged type follow the instructions below:

1. Enter the base unit for this article. This is the quantity contained in the smallest package you are shipping. For example, a 12 ounce can or a 750 milliliter bottle. Click on the Next button.

2. Enter level of packaging. For packaged product, provide the estimated quantity that will be shipped, described from the largest container to smallest package size (up to five packaging levels may be provided). For example, 500 Cases, with 40 Cans per Case (The weight of the individual can is the base unit).

3. Click on the Next button to enter the next level of packaging or click on the Finish button to return to the Quantity and Packaging section.

3. For the Bulk-shipment type follow the instructions below:

1. Enter the total quantity of this bulk shipment (e.g. 143 Metric Tons).

2. Click on the Finish button to finish and return to the Quantity and Packaging section.

>> Return to the Prior Notice Process Overview

Entering Prior Notice Related Facility Information

The Prior Notice may include up to five related facilities: the Manufacturer or the Grower/Consolidator, Shipper, Owner, Ultimate Consignee, and the Holding Facility.  The hyperlink on each facility type leads to related topics that provide further information.

Manufacturer or Grower/Consolidator

• Manufacturer: The Manufacturer is required, if the food is not in its natural state, meaning the article of food has been made from one or more ingredients or it has been synthesized, prepared, treated, modified, or manipulated.

• Grower or Consolidator of a product that is left in its natural state.  If the product is in its natural state, if known, you should provide information about the Grower or the Consolidator.

Shipper

• Information about the Shipper of the Article is required for Prior Notices related to all Entry Types.  

• For the "Baggage" Entry Type, the individual carrying or otherwise accompanying food is both the Importer and the Shipper.  Because the Importer is the same as the Shipper, data entered for the Importer is sufficient for providing Shipper information.

Owner

• Information about the Owner of the Article is required for Prior Notices related to all Entry Types, except for Mail (Commercial), Mail (Non-Commercial Sender) and Transportation and Exportation (T&E).  

Ultimate Consignee

• Information about the Ultimate Consignee is required for Prior Notices related to all Entry Types, except for Mail (Commercial), Mail (Non-Commercial Sender) and Transportation and Exportation (T&E).  

• For other Entry Types, the Prior Notice requires an address in the United States for the Ultimate Consignee.

Holding Facility

• Information about the Holding Facility is required if the United States Customs and Border Protection (CBP) has directed the article to a Holding Facility (Port/Import Lot, Secure Facility at Port, or Secure Facility outside of Port) before or after you submit your Prior Notice.

>> Return to the Prior Notice Process Overview

>> Return to the Time Saving Tips for Submitting Prior Notice

Manufacturer or Grower/Consolidator?

When you click on the Save button in the Prior Notice: Article (Create) page, based on the FDA Product Code you entered, the system determines whether the food article is in its natural state.  

• If the system determines that the food article is no longer in its natural state, the Prior Notice: Related Facilities (View) page displays a Manufacturer section.  The article of food is no longer in its natural state, if it has been made from one or more ingredients, or it has been synthesized, prepared, treated, modified, or manipulated.

• If the system determines that the food article is in its natural state, the Prior Notice: Related Facilities (View) page displays a Grower/Consolidator section. The Product Code that you entered indicates that the food article is in its natural state. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or collection or treated against pests, waxed, or polished are still in their natural state for purposes of Prior Notice. Whole fish headed, eviscerated, or frozen attendant to harvest, are still in their natural state.

If the food is no longer in its natural state, the Prior Notice rule requires that, if the Manufacturer was required to register, you supply the Manufacturer's valid Food Facility Registration Number in order to submit the Prior Notice for all Entry Types. The Food Facility Registration Number was issued when the Manufacturer registered with the FDA using FDAs Food Facility Registration System. 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. If the Food Facility Registration Number is not available, you may select an FDA approved exemption reason from the list of available reasons and provide the business name, street address, city and country for the Manufacturer.

Continue with one of the following:

• Manufacturer (All Entry Types)

• Grower or Consolidator of a food product in its natural state

>> Return to the Prior Notice Process Overview

Manufacturer (All Entry Types)

If the system indicates that the article of food is not in its natural state, Manufacturer information is required. For All Entry Types, the Prior Notice rules states that you must have a valid Manufacturer's Food Facility Registration Number in order to submit the Prior Notice, unless specified (See Step 3 in this topic and Codified 1.281(a)(6)). This number was issued when the Manufacturer registered with the FDA using FDAs Food Facility Registration System.
 

1. Select the FDA Country of Production in the Manufacturer section of the Prior Notice: Related Facilities (View) page and then click on the Enter Manufacturer button.  The Prior Notice: Manufacturer (Enter) page displays with the Country in static text.  
   
   Note: If you have edited or copied the Prior Notice, after saving the article, in the Prior Notice: Article (View) page, select the Related Facilities tab above and to the right of the page title and then click on the Edit button in the Manufacturer section, to access the Prior Notice: Manufacturer (Edit) page.

2. Verify that the Country (the FDA Country of Production) displayed is the same as the Manufacturer facility location. If the Country is not correct, do the following:

1. Click on the Change Country button.  The Change Country page displays.

2. Select the country where the Manufacturer's facility is located and click on the Next>> button.  The Prior Notice: Manufacturer (Enter) page displays with the new country in static text and the Country Subdivision drop-down list contains applicable subdivisions for that country.

3. Do one of the following to provide Manufacturer information:

• If the Manufacturer is required to register as specified in the FDA Food Facility Registration Rule, enter the Manufacturer's Food Facility Registration Number, Business Name, and City.

• If the Manufacturer is not required to register as specified in the FDA Food Facility Registration Rule, check the 'Manufacturer is not required to register or Manufacturer Identity not known' checkbox and select a 'Reason for Registration Number Exemption or Identity of Manufacturer Not Provided' from the list of reasons approved by the FDA. Enter the complete facility information for the Manufacturer (Business Name; Street Address; Country Subdivision, if applicable for the country; and ZIP/Mail Code, if applicable for the country).

4. If you want this facility to be the default Manufacturer or Grower/Consolidator for future Prior Notices for the Web Entry, select Yes from the drop-down list in response to the question "Should this Facility be the default Manufacturer for new Prior Notices for this Web Entry?" question at the bottom of the page.

5. Click on the Save button.  The Prior Notice: Related Facilities (View) page displays the Manufacturer information in static text.

6. Move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.  

>> Return to the Prior Notice Process Overview

Grower/Consolidator

Grower or Consolidator applies to a food product in its natural state.  

If the food in your Prior Notice is not in its natural state, see the Manufacturer (All Entry Types) topic.  

1. Select the FDA Country of Production in the Grower/Consolidator section of the Prior Notice: Related Facilities (View) page and then click on the Enter Grower/Consolidator button.  The Prior Notice: Grower/Consolidator (Enter) page displays with the Country displaying in static text.
   
   Note: If you edited or copied the Prior Notice, after saving the article, in the Prior Notice: Article (View) page, select the Related Facilities tab above and to the right of the page title and then click on the Edit button in the Grower/Consolidator section, to access the Prior Notice: Grower/Consolidator (Edit) page.

2. Verify that the Country (the FDA Country of Production) displayed is the same as the Grower/Consolidator facility location. If the Country is not correct, do the following:

1. Click on the Change Country button.  The Change Country page displays.

2. Select the country where the Grower's/Consolidator's facility is located and click on the Next>> button.  The Enter Grower/Consolidator page displays with the new country in static text and the Country Subdivision drop-down list contains applicable subdivisions for that country.

3. If you want this facility to be the default Grower/Consolidator or Manufacturer for future Prior Notices for the Web Entry, select Yes from the drop-down list in response to the question "Should this Facility be the default Grower/Consolidator for new Prior Notices for this Web Entry?" question at the bottom of the page.

4. If you do not have Grower/Consolidator information for the food article, check the Grower/Consolidator Unknown checkbox and then click on the Save button and move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.

5. Indicate whether the Facility is a Grower or a Consolidator by selecting a value from the Grower/Consolidator Type drop-down list.

6. Enter the Grower's/Consolidator's Food Facility Registration Number if you have it. Enter the full address of the Grower/Consolidator including the Business Name, Street Address and City. Also enter the Country Subdivision and ZIP/Mail Code, if applicable for the country.

7. Click on the Save button.  The Prior Notice: Related Facilities (View) page displays the Grower/Consolidator information in static text.

8. Move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.  

>> Return to the Prior Notice Process Overview

Shipper

The Transmitter must enter Shipper information for all Entry Types, except for Baggage. (For the "Baggage" Entry Type, the individual carrying or otherwise accompanying food is both the Importer and the Shipper.  Because the Importer is the same as the Shipper, data entered for the Importer is sufficient for providing Shipper information.)

1. Access the Prior Notice: Shipper (Enter) page from the Prior Notice: Related Facilities (View) page.

1. Select the country where the Shipper is located from the Country drop-down list.

2. Click on the Enter Shipper button.  The Prior Notice: Shipper (Enter) page displays.

2. If the Shipper is the same facility as another facility you have already entered for this Prior Notice or Web Entry:

1. Select the applicable facility from the "Shipper same Facility as" drop-down list.  The "Shipper same Facility as" drop-down list only contains facilities that you have previously entered for the Web Entry or the Prior Notice.

2. Click on the Save button and move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.  
   
   Note:  The system will ignore any Shipper information after you select a value from the "Shipper same Facility as" drop-down list.

3. Enter the Shipper's full business 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.)

• If you have the Shipper's Food Facility Registration Number, enter it along with the Shipper's Business Name and Full Address.

4. If you want this facility to be the default Shipper in future Prior Notices for the Web Entry:

• If your Entry Type is Mail (Non-Commercial Sender), select Yes from the drop-down list in response to the question "Is the Shipper the same for other items in this Web Entry?" question at the bottom of the page.

• For all other Entry Types, select Yes from the drop-down list in response to the question "Should this Facility be the default Shipper for new Prior Notices for this Web Entry?" question at the bottom of the page.

5. Click on the Save button.  The Prior Notice: Related Facilities (View) page displays the Shipper information in static text.

6. Move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.  

>> Return to the Prior Notice Process Overview

>> Return to the Time Saving Tips for Submitting Prior Notice

Owner

Owner information is required for all Entry Types except for Mail (Commercial), Mail (Non-Commercial Sender), Transportation and Exportation (T&E) and Transportation and Exportation (T&E) - Express Courier.  

1. Access the Prior Notice: Owner (Enter) page from the Prior Notice: Related Facilities (View) page.

1. Select the country where the Owner is located from the Country drop-down list.

2. Click on the Enter Owner button.  The Prior Notice: Owner (Enter) page displays.

2. If the Owner is the same facility as the Manufacturer or Grower/Consolidator, Ultimate Consignee, Submitter or Importer:

1. Select the applicable facility from the "Owner same Facility as" drop-down list.  The "Owner same Facility as" drop-down list only contains facilities that you have previously entered for the Web Entry or the Prior Notice.

2. Click on the Save button and move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.  
   
   Note:  The system will ignore any Owner information after you select a value from the "Owner same Facility as" drop-down list.

3. Enter the Owner's full business 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.

• If you have the Owner's Food Facility Registration Number, enter it along with the Owner's Business Name and Full Address.

4. If you want this facility to be the default Owner in future Prior Notices for the Web Entry, select Yes from the drop-down list in response to the question "Should this Facility be the default Owner for new Prior Notices for this Web Entry?" question at the bottom of the page.

5. Click on the Save button.  The Prior Notice: Related Facilities (View) page displays the Owner information in static text.

6. Move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.

>> Return to the Prior Notice Process Overview

>> Return to the Time Saving Tips for Submitting Prior Notice

Ultimate Consignee

The Ultimate Consignee must be located in the United States.  Ultimate Consignee information is required for all Entry Types except for Mail (Commercial), Mail (Non-Commercial Sender), Transportation and Exportation (T&E) and Transportation and Exportation (T&E) - Express Courier.  

1. Access the Prior Notice: Ultimate Consignee (Enter) page from the Prior Notice: Related Facilities (View) page by clicking on the Enter Ultimate Consignee button.

2. Enter the Ultimate Consignee's business 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.

• If you have the Ultimate Consignee's Food Facility Registration Number, enter it along with the Ultimate Consignee's Business Name and Full Address.

3. If the Ultimate Consignee is the same facility as the Owner, Submitter or Importer:

1. Select the applicable facility from the "Ultimate Consignee same Facility as" drop-down list.  The "Ultimate Consignee same Facility as"  drop-down list only displays United States facilities that you have previously entered for the Web Entry or the Prior Notice.

2. Click on the Save button and move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.  
   
   Note:  The system will ignore any Ultimate Consignee information after you select a value from the "Ultimate Consignee same Facility as" drop-down list.

4. If you want this facility to be the default Ultimate Consignee in future Prior Notices for the Web Entry, select Yes from the drop-down list in response to the question "Should this Facility be the default Ultimate Consignee for new Prior Notices for this Web Entry?" question at the bottom of the page.

5. Click on the Save button. The Prior Notice: Related Facilities (View) page displays the Ultimate Consignee information in static text.

6. Move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.

>> Return to the Prior Notice Process Overview

>> Return to the Time Saving Tips for Submitting Prior Notice

Holding Facility

If United States Customs and Border Protection (CBP) has directed this article to a Holding Facility you will need to provide the Holding Facility information.  Holding Facility information applies to all Entry Types except for Mail (Commercial) and Mail (Non-Commercial Sender).  

1. Access the Prior Notice: Holding Facility (Enter) page from the Prior Notice: Related Facilities (View) page by clicking on the Enter Holding Facility button.

2. Enter the following specific holding information:

• Specific Holding Location (within the Holding Facility)

• Contact Name

• Phone

• Date Available at Location

3. Select an appropriate Holding Location Type (Port/Import Lot, Secure Facility at Port, or Secure Facility outside of Port) from the Holding Location Type drop-down list.

4. If you want this Holding Facility to be the default when you indicate that Articles for the Web Entry are held, select Yes from the drop-down list in response to the question "Should this Holding Facility be the default for Articles you later indicate are held for this Web Entry?" question.

5. Enter the Holding Facility physical address:

• If you have the Holding Facility's Food Facility Registration Number, enter it along with the Holding Facility's Name and City.

• If you do not have the Holding Facility's Food Facility Registration Number, enter the Holding Facility's Name, Street Address and City, State, and ZIP Code.

6. Click on the Save button. The Prior Notice: Related Facilities (View) page displays the Holding Facility information in static text.

7. Move on to the next applicable facility in the Prior Notice: Related Facilities (View) page.

>> Return to the Prior Notice Process Overview

Post Submit Holding Facility PN Transmitter within the same account

If United States Customs and Border Protection (CBP) has directed this article to a Holding Facility after you or another person within the same PN Transmitter account have already submitted the Prior Notice by completing the Web Entry you will need to provide the Holding Facility information post submission of the Prior Notice.  Holding Facility information applies to all Entry Types except for Mail (Commercial) and Mail (Non-Commercial Sender).  The Web Entry must be complete in order to enter Holding Facility information.

1. Access the Prior Notice: Submitted page from the Web Entry: (View) page by double-clicking on the selected Prior Notice.

2. If the Prior Notice does not already have a Holding Facility, the Submit Holding Facility button will be active.  Click the Submit Holding Facility button.  All mandatory fields are marked with an "*".  Enter the following information

• Specific Holding Location (within the Holding Facility) - optional

• Contact First Name

• Contact Last Name

• Phone

• Date Available at Location

3. Select an appropriate Holding Location Type (Port/Import Lot, Secure Facility at Port, or Secure Facility outside of Port) from the Holding Location Type drop-down list.

4. If all of the Prior Notices within this entry are being held at this location, check the box for the question, "Should this Holding Facility be applied to all articles in the Web Entry?"

5. Enter the Holding Facility physical address:

• If you have the Holding Facility's Food Facility Registration Number, enter it along with the Holding Facility's Name and City.

• If you do not have the Holding Facility's Food Facility Registration Number, enter the Holding Facility's Name, Street Address and City, State, and ZIP Code.

4. Click on the Save button.

5. Once Holding Facility information has been saved for a Prior Notice, the information can not be modified.  If the Holding Facility information is correct, click Yes to the "Submit Holding Facility?" page question.  The Prior Notice: Confirmation page displays the Holding Facility information in static text. The status of the Holding Facility is set to Pending. You should come back to check the status update of the Holding Facility on the Prior Notice: Confirmation page shortly.  If the Holding Facility information is incorrect, click No in response to the "Submit Holding Facility?" question, modify the information and resubmit or exit the Submit Holding Facility page by clicking Cancel.

>> Return to the Prior Notice Process Overview

Post Submit Holding Facility Automated Commercial System (ACS) entry or PN Transmitter from another account

If United States Customs and Border Protection (CBP) has directed this article to a Holding Facility after you have transmitted the Prior Notice via ACS or a person from another PN Transmitting company have transmitted the Prior Notice via PNSI you will need to provide the Holding Facility information post submission of the Prior Notice.  Holding Facility information applies to all Entry Types except for Mail (Commercial) and Mail (Non-Commercial Sender).

1. Access the View Holding Facility page from the Prior Notice System Interface Home page by clicking on the View/Submit Holding Facility button. Holding Facility records that were submitted using the PN Transmitter account are displayed.  

2. Click on the Submit Holding Facility button. Enter the Prior Notice Confirmation Number on the Holding Facility Enter Prior Notice Information page and click the Next button to proceed.

3. All mandatory field names are marked with a "*".  Enter the following specific holding information on the Prior Notice: Holding Facility (Enter) page:

• Specific Holding Location (within the Holding Facility)

• Contact First Name

• Contact Last Name

• Phone

• Date Available at Location

4. Select an appropriate Holding Location Type (Port/Import Lot, Secure Facility at Port, or Secure Facility outside of Port) from the Holding Location Type drop-down list.

5. Enter the Holding Facility physical address:

• If you have the Holding Facility's Food Facility Registration Number, enter it along with the Holding Facility's Name and City.

• If you do not have the Holding Facility's Food Facility Registration Number, enter the Holding Facility's Name, Street Address and City, State, and ZIP Code.

6. Click on the Save button. The Holding Facility (View) page displays the Holding Facility information in static text. The status of the Holding Facility is set to Pending. You should come back to check the status update of the Holding Facility on the Holding Facility (View) page shortly.

Holding Facility Statuses:

• Accepted - the Prior Notice identifiers have been successfully matched with an existing Prior Notice and the Holding Facility information has been successfully submitted to the FDA.

• Duplicate - the Prior Notice identifiers have been matched to an existing Prior Notice, but Holding Facility information has already been submitted for the Prior Notice.

• Pending - the Holding Facility information has been submitted to the FDA, but the Prior Notice identifiers have not yet been matched to a submitted Prior Notice.

• Rejected - the Holding Facility information has been submitted to the FDA, but the Prior Notice identifiers have not been matched to a Prior Notice.

>> Return to the Prior Notice Process Overview

Favorite Facility

This feature is a personalized list of frequently used facilities (Firms with Food Facility Registration number only) to serve as an address book to allow PN Submitters to create and submit PNs faster and easier.

Adding a Favorite Facility

To create a Favorite Facility, the PN Transmitter has to navigate to any Prior Notice Facility Enter/Edit page (except Carrier Page).  Each of the facility pages will have a new checkbox Add to my Favorite List.

1. Click on the 'Add to my Favorite list' checkbox

2. Click on Save button.  If the PN Transmitter has selected another facility from the same as drop down, the system will display the error message asking the user to clear out either the same as selection or Add to my Favorite List checkbox selection. Additionally, in case of Producer facility, if the user has selected the Producer Unknown and the Add to my Favorite List checkboxes, the system will display the error message asking the user to clear out either one. The intent is to have the user enter all the firm data in order to save the facility as a favorite. For those facilities that are US based i.e. US Recipient and Consignee, if the user selects a non-US facility from the list of favorite facilities, the system will display the error message asking the user to select only a US facility.  Additionally, to improve the data quality, the system will enforce entering a valid registration number by way of displaying an error message if the user has selected Add to my Favorite List checkbox but has not entered registration number of the facility. Thus, only those firms validated by FMLS will be saved in the Favorite Facility list.

3. After a facility is saved as a favorite, it will be available to any user belonging to the same company as the user who created it. The user can select the favorite facility by navigating to the Prior Notice Facility Enter/Edit page (except Carrier Page) and click on the Find From Favorites button. The system will display the My Favorite Facilities page,

4. Click on the hyperlink for the name of the facility to navigate back to the Prior Notice Facility Enter/Edit page.

>> Return to the Prior Notice Process Overview

Editing a Favorite Facility

1. To edit a Favorite Facility, the PN Transmitter must navigate to the Welcome page and click on the  Manage Facilities button.

2. In the My Favorite Facilities page, click on the name of the facility that you wish to edit.

3. The Edit Favorite Facility page is displayed.  Edit the information and click on the Save button.

4. The My Favorite Facilities page is displayed.

>> Return to the Prior Notice Process Overview

Deleting a Favorite Facility

1. To delete a Favorite Facility,navigate to the Welcome page and click on the  Manage Facilities button.

2. On the My Favorite Facilities page, click on the checkbox of the facility that you wish to delete.

3. The Delete Favorite Facility page is displayed.  Click on the Yes button to delete the facility.

4. The My Favorite Facilities page is displayed.

>> Return to the Prior Notice Process Overview

Reviewing and Editing a Prior Notice

1. Review the Prior Notice and Web Entry information to make sure that it is complete and accurate.

• To review the Web Entry, click on the Web Entry tab above and to the right of the page title and then click on the Prior Notice (View) page. You may edit the Web Entry only if you have not yet completed the Web Entry. Click on the Edit button in the section header of the section you want to edit. The process for editing the Web Entry is similar to creating the Web Entry, as described in the Web Entry Process Overview topic.  Until you complete the Web Entry, you may edit all Web Entry data, except for the Entry Type and system-generated Entry Identifier.

• To edit a Prior Notice from the Prior Notice: Article (View) page, click on the Edit option at the top of the page.  The Prior Notice: Article (Edit) page displays.  Review and edit the data as required and click on the Save button.  The Prior Notice: Article (View) page displays the information you edited in static text.  You may edit all Article data, except for the Article Number, until you complete the Web Entry or cancel the Prior Notice.

• The Prior Notice: Related Facilities (View) page displays all facility information in static text.  Review this information and make corrections using the Edit button corresponding to the applicable facility.

2. Modify information as required and click the Save button.

>> Return to the Prior Notice Process Overview

Saving a Prior Notice

1. After you have verified that your Prior Notice is complete and accurate, click on the Save Prior Notice button.   The Save Prior Notice? Page appears with all of the Prior Notice data that you entered displayed.

2. If the information is accurate, click on the Yes button in response to the prompt. The Complete Web Entry? page appears.
   (If you click on the No button, the appropriate Prior Notice (View) page displays and the status of the Prior Notice does not change. Edits can be made from this page. )
   

Completing the Web Entry and Printing the Prior Notice Confirmation(s):

1. Once you have saved a Prior Notice, the Complete Web Entry? Page appears. If you have saved all of the Prior Notices that you intend to submit for this Web Entry, click on the Yes button. If you have additional Prior Notices to complete, or if you would like to edit your Web Entry or Prior Notices, click the NO button. Your Prior Notices will not be submitted to FDA until you complete your Web Entry.

Note: The Prior Notice Confirmation Number must accompany food carried by or otherwise accompanying an individual (21 CFR 1.279(f)). FDA and CBP suggest that the Carrier present a copy of the Web Entry Summary Confirmation at the Port of Arrival. See the Accessing the Web Entry Summary Confirmation topic.

2. To Print or Save a copy of  the Prior Notice in Adobe Portable Document Format (PDF) to your computers hard drive, do the following:

1. Select the Print/Save button on the top of the Prior Notice Confirmation page. [Note: If you do not have Adobe Acrobat Reader, download the free software from Adobe Systems Incorporated (http://www.adobe.com/products/acrobat/readermain.html).]  Adobe Acrobat Reader opens as a separate window.

2. Select the Save icon, , or the Print icon, , in the upper left-hand corner of the window and follow the Browser prompts to save or print the Prior Notice Confirmation.

>> Return to the Prior Notice Process Overview

Managing Existing Prior Notices

Finding Prior Notices

1. From the Welcome to the Prior Notice System Interface page (Home), click on the Find Existing Prior Notice button. The Find Prior Notices page displays.

2. From the Find Prior Notices page you can find an existing Prior Notice, open an existing Prior Notice to view or edit it for submission, create a new Web Entry, or navigate to the Find Web Entries page. The page lists the Prior Notice Articles for your company in ascending order by Entry Identifier and Article Number. The Total Records Found indicates how many non-purged Prior Notices exist within the PN Transmitters account.

3. Enter or select additional search criteria and then click on the Search>> button, if applicable.  You may filter your search results using any or all of the following criteria:

   • Status. This criterion defaults to All, meaning all Prior Notices.  Select a value from the drop-down list to indicate whether you want to see Prior Notices with Canceled, Draft, Saved or Submitted status.

• Entry Identifier.  Enter all or part of the Entry Identifier to find Prior Notices associated with specific Web Entries.

• <Selectable>. Select a criterion from the drop-down list to search on all or part of a Confirmation Number, Manufacturer or Grower/Consolidator Name, or Product (Common Name or Usual/Market Name).

• Submission Date range. Enter dates using the MM/DD/YYYY format in the Submission Date from: and/or to: textboxes to view a list of Prior Notices submitted within the specified date range.

4. To find a Prior Notice, scroll through the list.  Select the Web Entry by clicking on the hyperlink on the Entry Identifier or select the Article by clicking on the hyperlink on the Article Number.  If your search criteria apply to more than 15 Prior Notices, the page breaks the list into groups of 15 that you can access by using the Next and Previous buttons above the list header.

5. Click on the Reset button to reset the search criteria to the default values.

>> Return to the Prior Notice Process Overview

>> Return to the Time Saving Tips for Submitting Prior Notice

Copying Prior Notices

Use the Copy feature to copy a Prior Notice within a Web Entry.  Copying allows you to avoid repetitive data entry for similar Prior Notices.  You may also cancel a Prior Notice and then copy it, to modify or correct errors in a Prior Notice you have already submitted.

1. Navigate to the Prior Notice you wish to copy.  For example, if you wish to access a Prior Notice from the Web Entry (View) page, click on the corresponding Article Number hyperlink in the Article column.

2. If the Prior Notice is in Submitted or Canceled status, the Prior Notice Confirmation: Submitted page displays.  If the Prior Notice is in Draft status, the Prior Notice: Article (View) page displays.

3. Click on the Copy option.  It displays in the same place on the Confirmation and Prior Notice (View) pages.  The Prior Notice: Article (View) page displays the new Prior Notice with the same information as in the Prior Notice you copied, except that it has the next available Article Number for the Prior Notice within the Web entry.  For example, copying a Prior Notice for Article 0001 creates a Prior Notice for Article 0002, if 0002 has not been previously created within the Web Entry.

4. Continue with the normal flow of creating and submitting a Prior Notice by editing the information that should be different.

>> Return to the Prior Notice Process Overview

Copying  Prior Notices to Another Web Entry

The Copy Prior Notice to Another Web Entry functionality allows the Prior Notice (PN) Transmitter to copy a PN from one Web Entry to another entry of the same entry type.  This feature allows the Transmitter to easily re-use data that has already been entered.

1. Navigate to the  Web Entry (View) page.  Click on the Copy Prior Notice From Another Web Entry button

2. The Find Prior Notices page displays. The search results will be limited to PNs of the same entry type as the target Web Entry.  The search results can be further refined by entering the search criteria.  The available Prior Notices will be of like entry type and will be shown on the top of the screen.

3. To copy the Prior Notice, click on the Article link of the PN desired to be copied.  

4. After selecting the PN to copy the PN Transmitter will be brought back the Prior Notice to Copy: Article (View) page, where the PN which was just copied will be shown and asked to be verified.

5. Once the PN transmitter has clicked on the 'Yes' link, the PN transmitter will be brought the Prior Notice: Article (Edit) page where the PN can be saved.

>> Return to the Prior Notice Process Overview

Canceling Prior Notices

You may cancel Prior Notices that are inaccurate or for articles that you will not import. To do this, you must cancel the entire Web Entry, which will cancel all attached Prior Notices. If your Web Entry has Prior Notices that need to be cancelled as well as Prior Notices that do not need to be cancelled, you must re-file the Prior Notices that do not need to be cancelled on a new Web Entry. You can do this easily and quickly by copying the Prior Notices that you wish to re-file (see Copy Prior Notices) For Instructions on how to cancel a Web Entry plus attached Prior Notices, see Canceling Web Entries

>> Return to the Prior Notice Process Overview