1 / 55

December 12, 2003

Outreach Document. Prior Notice System Interface: Web Submissions Tutorial. December 12, 2003. US Food and Drug Administration. Overview. The Prior Notice Concept: Terms and Definitions Tutorial Modules. The Prior Notice Concept: Terms and Definitions. Prior Notice

gaenor
Download Presentation

December 12, 2003

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Outreach Document Prior Notice System Interface:Web Submissions Tutorial December 12, 2003 US Food and Drug Administration

  2. Overview The Prior Notice Concept: Terms and Definitions Tutorial Modules Prior Notice System Interface: Web Submissions Tutorial

  3. The Prior Notice Concept: Terms and Definitions • Prior Notice • Notification to the US Food and Drug Administration (FDA) of an import shipment of an article of food prior to arrival in the United States. • Includes information about the product identity and facilities in its chain of custody. Examples of facilities include manufacturer, grower, shipper, owner, and ultimate consignee. Information required varies by entry type. • Anyone with knowledge of the required information may submit a Prior Notice through the FDA Prior Notice System Interface. • Filers who currently submit Entries for admissibility processing through the Automated Broker Interface (ABI) to the Bureau of Customs and Border Protection (CBP) Automated Commercial System (ACS) can submit Prior Notices through that system. • Article of Food • An article is any item subject to Prior Notice. Articles are food products under FDA jurisdiction. • Web Entry • Information that applies to one or more Articles subject to Prior Notice requirements in one shipment. • This information includes information such as the anticipated arrival port, date, and time; the submitter; importer; and the carrier. Information required varies by entry type. • Tutorial Modules may cover additional terms you need to understand in their context. Prior Notice System Interface: Web Submissions Tutorial

  4. Tutorial Modules • Module 0 – Accessing the Prior Notice System Interface • Module 1 – Creating a New Web Entry • Module 2 – Finding Existing Web Entries • Module 3 – Creating and Submitting a Prior Notice • Module 4 – Finding Existing Prior Notices • Module 5 – Canceling a Prior Notice • Module 6 – Copying a Prior Notice Prior Notice System Interface: Web Submissions Tutorial

  5. Tutorial Modules • Module 0 – Accessing the Prior Notice System Interface • Module 1 – Creating a New Web Entry • Module 2 – Finding Existing Web Entries • Module 3 – Creating and Submitting a Prior Notice • Module 4 – Finding Existing Prior Notices • Module 5 – Canceling a Prior Notice • Module 6 – Copying a Prior Notice Prior Notice System Interface: Web Submissions Tutorial

  6. Module 0 – Accessing the Prior Notice System Interface • If you do not have a user account, request a user account from the FDA Unified Registration and Listing Systems (FURLS). (See the FURLS documentation for information on obtaining a user account.) • Navigate to the FDA Industry Access page (www.access.fda.gov). • On the FDA Industry Access page, click on the Login button. Prior Notice System Interface: Web Submissions Tutorial

  7. Module 0 – Accessing the Prior Notice System Interface • On the Login page, enter your FURLS Account ID and Password. • Confirm that you understand the consequences of 18 U.S.C. 1001 by clicking on the I understand radio-button. • Click on the Login button. Prior Notice System Interface: Web Submissions Tutorial

  8. Module 0 – Accessing the Prior Notice System Interface • The FURLS Welcome page displays, listing the menu of systems to which you have access. • Click on the Prior Notice button. Prior Notice System Interface: Web Submissions Tutorial

  9. Module 0 – Accessing the Prior Notice System Interface • The Welcome to the Prior Notice System Interface page displays, listing the options to which you have access on the left side. • Getting Started opens a Help module that explains how to submit a Prior Notice. • Creating a New Web Entry guides you to the first step in creating a Prior Notice. • Creating a New Prior Notice allows you to create a Prior Notice in an existing Web Entry. • Finding an Existing Web Entry allows you to find a Web Entry that you or your company has already created. • Finding an Existing Prior Notice allows you to find a Prior Notice that you or your company has already created. • Click on the Creating a New Web Entry button to display the Create Web Entry page. Prior Notice System Interface: Web Submissions Tutorial

  10. Tutorial Modules Module 0 – Accessing the Prior Notice System Interface Module 1 – Creating a New Web Entry Module 2 – Finding Existing Web Entries Module 3 – Creating and Submitting a Prior Notice Module 4 – Finding Existing Prior Notices Module 5 – Canceling a Prior Notice Module 6 – Copying a Prior Notice Prior Notice System Interface: Web Submissions Tutorial

  11. Module 1 - Creating a New Web Entry 1A. Creating a New Web Entry 1B. Entering Submitter Information 1C. Entering Importer Information 1D. Entering Carrier Information 1E. Editing and Saving a Web Entry Prior Notice System Interface: Web Submissions Tutorial

  12. Module 1A – Creating a New Web Entry: Selecting the Entry Type • Select Consumption from the Entry Type drop-down list. Consumption is one of many entry types subject to Prior Notice. All modules of this tutorial refer to the Consumption entry type. Other entry types, such as Foreign Trade Zone or Mail, require slightly different information. • Click on the Next >> button. (Clicking Cancel would return you to the Find Web Entries page.) Prior Notice System Interface: Web Submissions Tutorial

  13. Module 1A – Creating a New Web Entry: Entry Information • Input Entry information: • Entry Identifier. If you have one for the shipment, enter the Customs Entry Number in the Entry Identifier textbox. If you do not have an Entry Number, click on the Not Known checkbox to have the system generate an Entry Number. • Mode of Transportation. Select the mode of transportation (e.g., Land, Truck). • How Many…? Enter the number of Prior Notices your company intends to submit for this Web Entry, i.e., the number of articles of food subject to the Prior Notice requirement in the shipment. This number is an estimate that you can increase or decrease prior to submission. Prior Notice System Interface: Web Submissions Tutorial

  14. Module 1A – Creating a New Web Entry: Port of Arrival • Enter the Port of Arrival information: • Port of Arrival. Enter the Port Code, if you know it. Otherwise, select the State where the Port of Arrival is located, and click on the Find Port Code button to find the the Port Code. • Anticipated Point of Crossing. Enter the name of the specific border crossing point, such as the bridge name, if the Port of Arrival has multiple border crossing points. • Anticipated Arrival Date. Enter the date you expect the shipment to arrive at the Port of Arrival in MM/DD/YYYY format or click on the Calendar icon to find a date. • Anticipated Arrival Time. Enter the anticipated time of arrival in the time zone of the Port of Arrival in HH:MM format, and select AM or PM from the drop-down list. Prior Notice System Interface: Web Submissions Tutorial

  15. Module 1B – Entering Submitter Information The Submitter of a Web Entry is the individual in the Submitting Firm ultimately responsible for providing the information needed to create the Web Entry and associated Prior Notices. As the individual logged into this system, you are the “Transmitter” of the data, and may or may not be the Submitter. • If you are the Submitter of this Web Entry, select Yes in the drop-down list and continue with Module 1C – Entering Importer Information. • If you are not the Submitter, select the Country containing the Submitter’s business location and click on the Enter Submitter button. Prior Notice System Interface: Web Submissions Tutorial

  16. Module 1B – Entering Submitter Information(continued) • In the Enter Submitter page, if you have the Submitter’s Food Facility Registration Number (issued when the facility was registered with FDA’s Food Facility Registration System), enter it, the Submitting Individual’s Name, Business Name, City, and Country. If you do not have a Food Facility Registration Number for the Submitter, enter all required information, denoted by asterisks. • Click on the Save button. The View Web Entry page displays with the Entry and Submitter information in static text. Prior Notice System Interface: Web Submissions Tutorial

  17. Module 1C – Entering Importer Information • If the Importer and Submitter are the same, select Yes in the drop-down list and continue with Module 1D - Entering Carrier Information. • If the Importer and Submitter are not the same,select the Country where Importer’s business is located. • Click on the Enter Importer button. The Enter Importer page displays. Prior Notice System Interface: Web Submissions Tutorial

  18. Module 1C – Entering Importer Information (continued) • In the Enter Importer page, if you have the Importer’s Food Facility Registration Number, enter it, and the Importer’s Business Name and City. If you do not have the Importer’s Food Facility Registration Number, enter all required information, denoted by asterisks. • Click on the Save button. The View Web Entry page displays with the Entry and Importer information in static text. Prior Notice System Interface: Web Submissions Tutorial

  19. Module 1D – Entering Carrier Information 1. In the Create Web Entry page, click on the Enter Carrier button. Prior Notice System Interface: Web Submissions Tutorial

  20. Module 1D – Entering Carrier Information (continued) • To describe the carrier, enter the Standard Carrier Alpha Code (SCAC). If you do not know the code, click on the Find Code button to display the Find Carrier Code page. Note: If there is no Carrier Code, then enter the Carrier Name, and Country of the Carrier, and the license number of the truck. Required items vary by mode of transportation. Prior Notice System Interface: Web Submissions Tutorial

  21. Module 1D – Entering Carrier Information: Selecting a Carrier Code • On the Find Carrier Code page, enter at least three characters of the carrier’s business name in the Carrier Name textbox and Click on the Search>> button. A list of Carriers displays in the Carrier section. Prior Notice System Interface: Web Submissions Tutorial

  22. Module 1D – Entering Carrier Information: Selecting a Carrier Code • Click on the hyperlink for the appropriate carrier in the Carrier column. The Enter Carrier page displays with the Carrier Code and Carrier Name populated. Prior Notice System Interface: Web Submissions Tutorial

  23. Module 1D – Entering Carrier Information (continued) • To describe the shipment, enter the Trip Number and the Master Bill of Lading Number. • Click on the Save button. Prior Notice System Interface: Web Submissions Tutorial

  24. Module 1E – Editing and Saving a Web Entry • The View Web Entry page displays with the Entry, Submitter, Importer and Carrier information in static text. • To modify Web Entry information, edit information in the Entry Information and Port or Arrival sections or click on the Edit hyperlink in the Submitter, Importer, or Carrier section headers. You may continue to modify Web Entry information until you or your company has submitted the first Prior Notice for this Web Entry. • Review all of the Entry information to make sure that it is accurate. If satisfied with the information, click on the Save button. Prior Notice System Interface: Web Submissions Tutorial

  25. Tutorial Modules Module 0 – Accessing the Prior Notice System Interface Module 1 – Creating a New Web Entry Module 2 – Finding Existing Web Entries Module 3 – Creating and Submitting a Prior Notice Module 4 – Finding Existing Prior Notices Module 5 – Canceling a Prior Notice Module 6 – Copying a Prior Notice Prior Notice System Interface: Web Submissions Tutorial

  26. Module 2 – Finding Existing Web Entries • Click on the Web Entries tab at the top of the page. • The Find Web Entries page displays. From this page you can find an existing Web Entry, open an existing Web Entry to view, edit, or create a new Web Entry. This page lists all Web Entries for your company in ascending order by Entry Identifier. • To find a Web Entry, scroll through the list and select an entry by clicking on the hyperlink on the Entry Identifier. • In a future release, this functionality will include the ability to search based on the following criteria: • Anticipated Arrival Date range • Web Entry criteria (e.g., Entry Identifier) • Groups of Web Entries (e.g., those with Prior Notices Requiring Work). Prior Notice System Interface: Web Submissions Tutorial

  27. Tutorial Modules Module 0 – Accessing the Prior Notice System Interface Module 1 – Creating a New Web Entry Module 2 – Finding Existing Web Entries Module 3 – Creating and Submitting a Prior Notice Module 4 – Finding Existing Prior Notices Module 5 – Canceling a Prior Notice Module 6 – Copying a Prior Notice Prior Notice System Interface: Web Submissions Tutorial

  28. Module 3 - Creating and Submitting a Prior Notice 3A. Creating a Prior Notice 3B. Creating a Production Identifier 3C. Adding Related Facilities 3D. Submitting the Prior Notice Prior Notice System Interface: Web Submissions Tutorial

  29. 3A. Creating a Prior Notice • To create a new Prior Notice, click on the Create Prior Notice option on the View Web Entry page. Prior Notice System Interface: Web Submissions Tutorial

  30. 3A. Creating a Prior Notice: Article Information • The Create Prior Notice: Article page displays with the Entry Identifier of your Web Entry. • Enter the Article Information. a) Select the FDA Country of Production, the country in which the product was manufactured, grown, or harvested. This is same as the country where the manufacturer, grower, or harvester of the product is located. b) Select theCountry from which the Article was Shipped. Note that this country does not have to be the same as the business location of the Shipper. c) Enter the Harmonized Tariff Schedule (HTS) Code, a numeric code assigned to various commodities listed in the Harmonized Tariff Schedule of the United States. For Prior Notice, the first 6-digits of the HTS Code are required. Prior Notice System Interface: Web Submissions Tutorial

  31. 3A. Creating a Prior Notice: Product Information • Enter the Product Information, starting with the FDA Product Code. If you do not know the Product Code,click on the Search>> button to display the Find Product Code page. See Section 3B for further detail on selecting a Product Code. Prior Notice System Interface: Web Submissions Tutorial

  32. 3A. Creating a Prior Notice: Production Identifiers • Enter the Production Identifiers (production lot codes or production batch identifiers), if required. Examples of products requiring Production Identifiers include low acid canned foods, acidified foods, and infant formula. Click on the Add hyperlink and the Add Production Identifier page (not shown) allows you to enter this information.Use the Delete hyperlink to delete any incorrect Production Identifiers. When you are finished adding Production identifiers, the Production Identifier section of the page changes to display them. Prior Notice System Interface: Web Submissions Tutorial

  33. 3A. Creating a Prior Notice: Quantity and Packaging • Enter the Quantity and Packaging. • Enter the base unit: the weight or volume of the smallest unit, or the weight or volume of the bulk shipment. • Indicate whether the product is bulk-shipped. • If the product is not bulk-shipped, break down the quantity into up to five packaging levels, from largest to smallest container. For example, 100 Cases, 40 Cans per Case with a base unit of 1Lb per Can. • Click on the Calculate button to calculate the Total Quantity. If the calculated total quantity is not correct, correct the base unit or numbers of containers to arrive at the correct Total Quantity. • Click on the Save button. The system validates the information entered and determines whether the product entered is in its natural state. Prior Notice System Interface: Web Submissions Tutorial

  34. 3B. Selecting a Product Code • On the Find Product Code page, search for a particular Product Code by either: • Entering keywords in the Product Name textbox and/or portions of the Product Code, or • Building the Product Code by selecting its component parts: Industry, Class, and Group. This example illustrates how to build the Product Code for canned clam chowder by selecting on the component parts of the Product Code. Select the Product Industry (e.g., FISHERY/SEAFOOD PROD - 16) and then click on the Next>> button. Prior Notice System Interface: Web Submissions Tutorial

  35. 3B. Selecting a Product Code (continued) • The Find Product Code: Select Class page displays, listing all products within the selected Product Industry. Select a Product Class (e.g., MIXED FISHERY/SEAFOOD PRODUCTS - W) and then click on the Next>> button.Note: On the Find Product Code: Select Class page, you may also scroll through the list and click on the hyperlink of the desired product. Prior Notice System Interface: Web Submissions Tutorial

  36. 3B. Selecting a Product Code (continued) • The Find Product Code: Select Product Group page displays all Product Groups within the Product Class. Select a Product Group by clicking on a hyperlink in the Products column (e.g., CHOWDER/SOUP/STEW/BISQUE, MIXED FISHERY/SEAFOOD PRODUCTS). Prior Notice System Interface: Web Submissions Tutorial

  37. 3B. Selecting a Product Code (continued) • The Find Product: Complete Product Definition page displays, prompting you to indicate the appropriate Packaging Method (e.g., METAL - E) and Process Applied (e.g., COMMERCIALLY STERILE - E). This completes the Product Code Definition. • Click on the Select button to select the Product Code for your article. The Create Prior Notice: Article page displays, including the complete Product Code (e.g., 16WEE14) and definition (e.g., CLAM CHOWDER/SOUP/STEW/BISQUE, MIXED FISHERY/SEAFOOD PRODUCTS, METAL, COMMERCIALLY STERILE). Prior Notice System Interface: Web Submissions Tutorial

  38. 3C. Adding Related Facilities: Manufacturer • In this example, the system has determined that the product you have entered is no longer in its natural state, so the Enter Manufacturer page displays, the Country of Production you selected in the Create Prior Notice: Article page displaying as the Country. • You must have the Food Facility Registration Number of the Manufacturer of the product in order to submit the Prior Notice. This number was issued when the manufacturer registered with the FDA using FDA’s Food Facility Registration System. Enter the Food Facility Registration Number, Business Name, and City. • Click on the Save button. Prior Notice System Interface: Web Submissions Tutorial

  39. 3C. Adding Related Facilities: Shipper • Prior Notice displays the View Prior Notice: Related Facilities page. Here you may edit the Manufacturer information and enter the information for the other Related Facilities: Shipper, Owner, and Ultimate Consignee.Note: Not all entry types require every facility. • Enter the Shipper • Select the Country where the shipper is located. • Click on the Enter Shipper button. Prior Notice System Interface: Web Submissions Tutorial

  40. 3C. Adding Related Facilities: Shipper • In the Enter Shipper page, enter the Shipper’s Food Facility Registration Number, Business Name, and City, or enter all required data denoted by asterisks. If the Shipper is the same Facility as another that you have already entered for this Prior Notice, select the Facility.Note: If you indicate that the Shipper is the same as another facility (e.g., the Producer/Manufacturer) the system will ignore any other data you enter for the Shipper. • Click on the Save button. Prior Notice System Interface: Web Submissions Tutorial

  41. 3C. Adding Related Facilities: Owner • Enter the Owner of the article of food at the time of Prior Notice submission. • Click on the Enter Owner button. The Enter Owner page displays. Prior Notice System Interface: Web Submissions Tutorial

  42. 3C. Adding Related Facilities: Owner • If the Owner is not located in the United States, indicate this by clicking on the checkbox. • If the Owner is located in the United States, enter the Owner’s Food Facility Registration Number, Business Name, and City, or all required address information. • If the Owner is the same Facility as another that you have already entered for this Prior Notice, select the Facility.Note: If you do this, the system will ignore any other data you enter for the Owner. • Click on the Save button. The View Prior Notice: Related Facilities page displays with the Owner information in static text. Prior Notice System Interface: Web Submissions Tutorial

  43. 3C. Adding Related Facilities: Ultimate Consignee • Enter the Ultimate Consignee by clicking the Enter Ultimate Consignee button. The Enter Ultimate Consignee page is displayed. The Ultimate Consignee must be located in the United States. Click on the Enter Ultimate Consignee button. The process is the same as for Owner, except that the address information is mandatory.Note: Prior Notices for Mail and T&E Entry Types do not require the Ultimate Consignee. Prior Notice System Interface: Web Submissions Tutorial

  44. 3D. Submitting the Prior Notice • The View Prior Notice: Related Facilities page displays with all facility information in static text. Review this information and make corrections using any Edit hyperlink. • After you have verified that your Prior Notice is complete and accurate, click on the Submit hyperlink. The system verifies that your data is complete and issues a Confirmation Number. Prior Notice System Interface: Web Submissions Tutorial

  45. 3D. Submitting the Prior Notice (continued) • The Prior Notice Confirmation page displays with your Confirmation Number and all submitted data. • Using your Web Browser, you may print the Prior Notice Confirmation page or save it to your computer’s hard drive. Prior Notice System Interface: Web Submissions Tutorial

  46. Tutorial Modules Module 0 – Accessing the Prior Notice System Interface Module 1 – Creating a New Web Entry Module 2 – Finding Existing Web Entries Module 3 – Creating and Submitting a Prior Notice Module 4 – Finding Existing Prior Notices Module 5 – Canceling a Prior Notice Module 6 – Copying a Prior Notice Prior Notice System Interface: Web Submissions Tutorial

  47. Module 4 – Finding Existing Prior Notices • Click on the Prior Notices tab at the top of the page. The Find Prior Notices page displays. • From Find Prior Notices page you can find an existing Prior Notice, open an existing Prior Notice to view or complete it for submission, or create a new Prior Notice. The page lists the Prior Notice Articles for your company in ascending order by Entry Identifier and Article Number. • To find an article, 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. • In a future release, you will be able to search based upon the following criteria: • Entry Identifier • Prior Notice criteria (e.g., Confirmation Number, Manufacturer, Product Code) • Status (e.g., Canceled, Draft, Submitted). Prior Notice System Interface: Web Submissions Tutorial

  48. Tutorial Modules Module 0 – Accessing the Prior Notice System Interface Module 1 – Creating a New Web Entry Module 2 – Finding Existing Web Entries Module 3 – Creating and Submitting a Prior Notice Module 4 – Finding Existing Prior Notices Module 5 – Canceling a Prior Notice Module 6 – Copying a Prior Notice Prior Notice System Interface: Web Submissions Tutorial

  49. Module 5 – Canceling a Prior Notice You may cancel Prior Notices that are inaccurate or that are for articles that you will not import. Canceling a prior notice changes the status of a the Prior Notice from “Draft” or “Submitted” to “Canceled”. You may cancel Prior Notices in the Find Prior Notices page, the View Web Entry page, or the Prior Notice Confirmation page. To cancel from the Find Prior Notices page: 1. Enable the checkbox to the left of the Entry Identifier of each Prior Notice you want to cancel. You may click on more than one checkbox to select multiple prior notices to cancel. 2. Click on the Cancel PN hyperlink. The page updates to display “Canceled” as the Status and the current date/time in the Status Date. Prior Notice System Interface: Web Submissions Tutorial

  50. Module 5 – Canceling a Prior Notice (continued) To cancel from the View Web Entry page: 1. Find the Web Entry, on the Find Web Entry page. 2. Click on the hyperlink on the Entry Identifier of the Web Entry that contains the Prior Notices you want to cancel. Prior Notice System Interface: Web Submissions Tutorial

More Related