FDA Premarket Tobacco Product Application User Guide

U.S. Food and Drug Administration
Center for Tobacco Products (CTP)
Product Form Validator Tool
User Guide
Document Version Number: 1
September 2023

Introduction

The FDA Center for Tobacco Products (CTP) requires that a Premarket Tobacco Product Application (PMTA) include scientific data that demonstrates a product is appropriate with regards to the protection of public health. Specifically, the application being submitted must include this data in the form of the “FDA 4057b – Premarket Tobacco Product Application Product Grouping Spreadsheet” (Version 3.0).
The Product Validator Tool can be used to validate the data in your “FDA 4057b – Premarket Tobacco Product Application Grouping Spreadsheet” (Version 3.0) and to check the file for errors or omissions prior to submission; thereby, reducing the time spent in review, correction, and resubmission. While utilizing the tool is not required, it is highly recommended, as it may reduce back-and-forth and save time.

1.1 System Requirements

1. Windows (64-bit system)
2. Java Development Kit (JDK)
3. Microsoft Excel®
4. Adobe® Acrobat Reader
5. 100 MB of disk space

1.2 Installing the Java Development Kit

1. Download the Java 8 JDK installation file – https://www.java.com/en/download/

2. Run the installation

3. Set up the Environmental Variables for Windows
   a. Open File Explorer and choose This PC to continue. Then right-click it and choose Properties from the context menu to continue.
   b. Scroll down and click on “Advanced System settings”
   c. Click on the Advanced Tab and then click on Environment Variables

4. Click To configure JAVA_HOME by clicking on the New button present below System variable section.

5. Add Variable name as JAVA_HOME and Variable value as the location of the JDK/java installation directory, C:\Program Files\Java\jdk i.e., C:\Program Files\Java\jdk1.8.0_101. Your version might have a different number.

6. Save the settings by clicking OK.

7. To check the installation, open the windows command prompt by typing in cmd into the search bar and run the following command: java -version. The command should be understood, and the version number is returned.

Installing and Accessing the Product Validator Tool

2.1 Installing the Product Form Validator Tool (Windows Operating System)

1. Navigate to FDA Tobacco Product Application Tips – Premarket Tobacco Product Applications | FDA
2. Select the .zip file for PC.
3. Extract or unzip the exe file for a PC.
4. Double-click on the file to run it and gain immediate access to the Product Validator Tool.

Note: Persons with disabilities having problems accessing the file may call 1-877-CTP-1373 for assistance.

2.2 Software Requirements for Assistive Technology

1. JAWS (Job Access with Speech) is the recommended accessibility tool.
2. For Windows Vista and Later, Enable Java Access Bridge using the steps below in section 2.2.1.

2.2.1 Instructions to Enable Java Access Bridge:

1. Navigate to the Windows Start button.
2. Click the Control Panel button.
3. Click the Ease of Access button.
4. Click the Ease of Access Center button.
5. Click the Use the computer without a display button.
6. In the section titled Other programs installed, select the checkbox next to Enable Java Access Bridge (you may have to scroll down).

Navigating the Tool

The below describes the various features of the Product Validator Tool:

• A – Choose File: Click this button to browse your PC and select the file (Form 4057b Spreadsheet) you’d like to validate.
• B – Submit File: Click this button to submit the file for validation.
• C – Validation Results: This area displays the validation results (i.e., if your file passed or failed validation).
• D – Issue Report: If your file failed validation, click this button to view the errors causing the failure.
• E – Application Logs: Refer here if you are troubleshooting issues with the tool and the Help Desk specialist requests these logs.

How to Use the Product Validator Tool

This section included step-by-step instructions for how to use the Product Validator Tool to validate a “FDA 4057b – Premarket Tobacco
Product Application Product Grouping Spreadsheet” (v3.0) prior to submitting an application.
Please note: Only one file can be validated at a time.

1. Click the Choose File button.

2. Browse your PC to locate the completed “FDA 4057b – Premarket Tobacco Product Application Product Grouping Spreadsheet” file.
   Note: This file must be in Version 3.0 of the 4057b Product Grouping Spreadsheet with a file extension of .xls or .xlsx.

3. Click the desired file.

4. Click the Open button.

5. Click the Validate File button.
   Note: The Product Validator Tool will now begin validating the file. A “processing” pop-up will display while the tool processes the uploaded file.

6. View the Validation Status, which indicates that either the file has successfully passed validation or failed validation.
   If the Validation Status displays “Validation Successful”, please complete steps 7-10 to save the Completion Certificate:
   Note: Make sure to save the certificate before validating another file, as choosing a new file will remove the previous file’s certificate:

7. Click the Completion Certificate button.
   Note: This will save the certificate to a folder on your PC that you designate.

8. Browse and locate the desired folder on your PC where you would like the certificate to be saved.

9. Click the Save button.

10. Navigate to the folder and double-click the Completion Certificate to open and check the file. Note: You can attach this Completion Certificate to your application to the FDA.
    If the Validation Status displays “Validation Failed”, please complete steps 11-15:
    Note: Premarket Tobacco Product Applications and Recordkeeping Requirements Rule identifies the product characteristics that must be provided to accurately submit a file for FDA CTP review. The Issue Report provides descriptions of the product-level data that is required yet missing from the uploaded file.

11. Select the Issue Report button.
    Note: This will save the Issue Report to a folder on your PC that you designate.

12. Browse and locate the desired folder on your PC where you would like the Issue Report to be saved.

13. Click the Save button.

14. Navigate to the folder and double-click the Issue Report to open the file.

15. Review the Issue Report details, which includes the incorrect or omitted data that caused the file to be rejected.

16. Once the spreadsheet has been corrected, you can repeat steps 1-15 until the spreadsheet passes validation.

Application Log

The Application Log can be used to troubleshoot issues with the Product Validator Tool. The log is a reference for the Help Desk to identify and solve a problem with the tool. It is to be attached to an email to CTP eSub CTPeSub@fda.hhs.gov to assist in determining the problem experienced with the tool. This is the helpdesk email for the validator tool. Inquiries as well as application log should be sent here.

1. Select the Application button. Note: This will save the Application Log to a folder on your PC that you designate.
2. Browse and locate the desired folder on your PC where you would like the Application Log to be saved.
3. Click the Save button.
4. Navigate to the folder double-click the Application Log to open it.
5. Send an email with the attached Application Log to CTP eSub CTPeSub@fda.hhs.gov

FDA CTP
Product Validator Tool
Quick User Guide

References

• HHS Accessibility & Section 508 | HHS.gov

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