FDA 4057b Unique Identifying Information for New Tobacco Products

Premarket Tobacco Product Applications and Recordkeeping Requirements

Form FDA 4057b Product Grouping_v3.0_Sept_23.xlsm

PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers

OMB: 0910-0879

Document [xlsx]

Download: xlsx | pdf

Overview

Instructions
Introduction

Sheet 1: Instructions

Product Name

TP Number

Package Type

Package Type, if Other

Product Quantity Numeric Value

Units (Product Quantity)

Units, if Other (Product Quantity)

Product Quantity Mass Numeric Value

Units (Product Quantity Mass)

Characterizing Flavor

Characterizing Flavor, If Flavored

Tobacco Cut Style

Portion Count Numeric Value

Units (Portion Count)

Units, if Other (Portion Count)

Length Description

Length Description, if Other

Length Numeric Value

Units (Length)

Width Numeric Value

Units (Width)

Diameter Description

Diameter Format

Diameter Numeric Value

Units (Diameter)

Portion Thickness Numeric Value

Units (Portion Thickness)

Filter Ventilation

E-liquid Volume

E-liquid Volume Units

Nicotine Concentration

Nicotine Concentration Units

If mg/unit specify Unit (Nicotine Concentration)

Nicotine Source

PG Numeric Value

VG Numeric Value

Wattage Numeric Value

Units (Wattage)

Battery Capacity Numeric Value

Units (Battery Capacity)

Tip Type

Tip Type, if Other

Wrapper Material

Wrapper Material, if Other

Number of Hoses

Source of Energy

Source of Energy, if Other

Height Numeric Value

Units (Height)

Additional Properties (if Applicable)

Enter Product Name, including brand and sub-brand (or other commercial name(s) used in commercial distribution).

This is the Tobacco Product Number issued from TRLM-NG when registration and listing is completed.

Select from drop-down list the packaging of the product (e.g., Soft Pack, Cartridge).

Only use if "Other" was selected for Package Type.

Provide the product quantity as a number, maximum of 7 digits.

Select product units from drop-down list for amount or number of products contained in the package (e.g., Bottles, Leaves).

Only use if “Other” was selected for Product Quantity Units.

Provide product quantity mass as a number, maximun of 7 digits.

Select product units from drop-down list for amount or number of products contained in the package (e.g., Milligrams, Grams).

Select product flavor from the drop-down list (Menthol, Tobacco, Flavored, Unflavored).

Only use if “Flavored” was selected for Characterizing Flavor.

Select the tobacco cut style (e.g., Standard Cut, Pressed Cut) from drop-down list.

Provide portion count as a number, maximum of 7 digits.

Select from the drop-down list the unit of portions in the product (e.g., count, E-Cigarette, Tablet).

Only use if “Other” was selected for Portion Count Units.

Select from the drop-down list length description of the product (e.g., King, Long).

Only use if “Other” was selected for Length Description.

Provide length of the product as a number, maximum of 7 digits.

Select unit of length from drop-down list of the product (e.g., Millimeters, Centimeters).

Provide width of the product as a number, maximum of 7 digits.

Select from the drop-down list unit of the width of the product (e.g., Millimeters, Centimeters).

Select from the drop-down list description of the diameter of the product (e.g. Regular, Wide).

Select from the drop-down list format of the diameter (e.g., Circumference).

Provide diameter of the product as a number, maximum of 7 digits.

Select from the drop-down list unit of the diameter of the product (e.g., Millimeters, Centimeters).

Provide the portion thickness of the product as a number, maximum of 7 digits.

Select from the drop-down list unit of the portion thickness of the product (e.g., Millimeters, Centimeters).

Enter the filter ventilation (e.g., 0%, 25%).

Enter the E-liquid volume as a number, maximum of 7 digits.

Select from the drop-down list e-liquid volume units (e.g., Milliliters, Fluid Ounces).

Provide the nicotine concentration of the product as a number, maximum of 7 digits.

Select from the drop-down list nicotine concentration units (e.g., %W/W, mg/unit).

Only use if “mg/unit” was selected for Nicotine Concentration Units.

Select from the drop-down list nicotine source (e.g., Tobacco, Non-Tobacco, Both or None).

Enter as a number the percentage of propylene glycol in the PG/VG ratio, maximum of 7 digits.

Enter as a number the percentage of vegetable glycerin in the PG/VG ratio, maximum of 7 digits.

Provide the wattage as a number, maximum of 7 digits.

Select from drop-down list units of wattage (e.g., Milliwatts, Volts).

Provide battery capacity as a number, maximum of 7 digits.

Select from drop-down list units of battery capacity (e.g., Watt, mAh).

Select from drop-down list tip type material (e.g., Wood, Paper).

Only use if “Other” was selected for Tip Type. Enter the tip material type.

Select from drop-down list Wrapper Material (e.g., Tobacco Leaf, Paper).

Only use if “other” was selected for Wrapper Material.

Provide the product quantity as a number, maximum of 2 digits.

Select from the drop-down list the product source of energy (e.g., Charcoal, Battery).

Only use if “Other” was selected for Source of Energy. Enter product source of energy.

Provide the height of the product as a number, maximum of 7 digits.

Select from the drop-down list units for the height of the product (e.g., Millimeters, Centimeters).

Enter any additional relevant product property information.

Limit to 500 characters including spaces.

If you do not have values for a field, you must leave the cell blank. Please refer to the Premarket Tobacco Product Applications and Record keeping Requirements rule for the required properties based on product category and subcategory.

If possible, avoid using "Other".

Enter a description of the package type for the product.

Provide a single value, cannot be a range.

If possible, avoid using “Other”.

Enter a description of the units for the product quantity.

Only enter positive numbers.

If you are populating a column with units, you must provide the corresponding numeric value.

If "Flavored" selected, enter the concise flavor description in the next column.

Enter the Flavor that is identified on the package and labelling.

Provide a single value, cannot be a range.

If possible, avoid using “Other”.

Enter description of the units for the Portion count.

If possible, avoid using “Other”.

Enter a description of the length of the product.

Provide a single value, cannot be a range.

If you are populating a column with units, you must provide the corresponding numeric value.

Provide a single value, cannot be a range.

If you are populating a column with units, you must provide the corresponding numeric value.

Provide a single value, cannot be a range.

If you are populating a column with units, you must provide the corresponding numeric value.

Provide a single value, cannot be a range.

If you are populating a column with units, you must provide the corresponding numeric value.

Only enter a number up to 100.

Provide a single value, cannot be a range.

If you are populating a column with units, you must provide the corresponding numeric value.

Provide a single value, cannot be a range.

If you are populating a column with units, you must provide the corresponding numeric value.

Enter only unit for the nicotine concentration units.

Provide a single value, cannot be a range.

If you are populating a column with units, you must provide the corresponding numeric value.

Provide a single value, cannot be a range.

If you are populating a column with units, you must provide the corresponding numeric value.

If possible, avoid using “Other”.

If you did not select "other" then you must leave this cell blank. Please refer to the Premarket Tobacco Product Applications and Record keeping Requirements rule for the required properties based on product category and subcategory.

If possible, avoid using “other”.

Enter wrapper material type.

Provide a single value, cannot be a range.

If possible, avoid using “Other”.

Provide a single value, cannot be a range.

If you are populating a column with units, you must provide the corresponding numeric value.

Maximum of 5,000.

No special characters except percent sign (%), slash (/), period (.), ampersand (&), quotation marks (“ “), apostrophe (‘), colon (:), copyright symbol (©).

Only enter positive numbers.

If you are populating a column with units, you must provide the corresponding numeric value.

Entry should be concise and specific.

Entry cannot contain any letters.

Limit to 500 characters including spaces.

Only enter positive numbers.

If you are populating a column with units, you must provide the corresponding numeric value.

Only enter positive numbers.

If you are populating the Diameter Format column, you must provide the corresponding diameter numeric value and unit.

Only enter positive numbers.

Provide a single value, cannot be a range.

Only enter positive numbers.

If you are populating a column with units, you must provide the corresponding numeric value.

Only enter positive numbers.

Entry cannot contain any letters.

If you are populating a column with units, you must provide the corresponding numeric value.

Entry cannot contain any special characters
(refer to the Electronic Submission File Formats and Specifications which can be found on the FDA website).

No special characters except percent sigh (%), slash (/), period (.), ampersand (&), quotation marks (“ “), apostrophe (‘), colon (:), copyright symbol (©).

Entry cannot contain any letters.

Only enter positive numbers.

Entry cannot contain any letters.

Entry cannot contain any letters

Entry cannot contain any special characters (refer to the Electronic Submission File Formats and Specifications which can be found on the FDA website).

If you are populating the numeric value, you must provide the corresponding unit.

Entry cannot contain any special characters
(refer to the Electronic Submission File Formats and Specifications which can be found on the FDA website).

For non-circular, rod-like, or rectangular products, diameter can be provided by calculating the maximum distance between two points of the product’s borders; For rectangular products, Diameter= v(width)2 + (height)2.

Entry cannot contain any special characters
(refer to the Electronic Submission File Formats and Specifications which can be found on the FDA website).

Entry cannot contain any letters.

Entry cannot contain any special characters
(refer to the Electronic Submission File Formats and Specifications which can be found on the FDA website).

If you are populating the numeric value, you must provide the corresponding unit.

Entry cannot contain any special characters
(refer to the Electronic Submission File Formats and Specifications which can be found on the FDA website).

If you are populating the numeric value, you must provide the corresponding unit.

Entry cannot contain any special characters
(refer to the Electronic Submission File Formats and Specifications which can be found on the FDA website).

If you are populating the numeric value, you must provide the corresponding unit.

If you do not have values for a field, you must leave the cell blank. Please refer to the Premarket Tobacco Product Applications and Recordkeeping Requirements rule for the required properties based on product category and subcategory.

If you are populating the numeric value, you must provide the corresponding unit.

Sheet 2: Introduction

Unique Identifying Information for New Tobacco Products			FDA Form 4057b
Instructions: 1. Applicant name must be entered as required by 21 CFR § 1114.7(c)(3). 2. Product Category must be entered as required by 21 CFR § 1114.7(c)(3). To ensure ingestion use the drop-down menu. 3. Product Subcategory must be entered as required by 21 CFR § 1114.7(c)(3). To ensure ingestion use the drop-down menu. 4. To populate your unique identification of your products, once you have completed entry of applicant name, product category, product subcategory, and application type, click on the “Enter Unique Product Properties” button to enter each tobacco product. This will allow for a new tab called “Product” to generate. 5. Complete product tab for all tobacco products you are submitting. Refer to the “Instructions Tab” for information to correctly populate each product property for ingestion. Enter applicable product information as specified in Table 1 to 21 CFR § 1114.7(c)(3)(iii) under the Product Tab. 6. If you click on the "reset" button you will lose your product tab and all product data entered. 7. Once you have completed data entry for both your introduction and product tabs, SAVE AS .XLS or .XLSX and name appropriately. For file naming convention, reference the Electronic Submission File Formats and Specifications which can be found on the FDA website. 8. Your spreadsheet must be XLS or XLSX to attach to eSubmitter file for submission, otherwise it will not be processed. 9. Create a separate spreadsheet for each product Category/Subcategory. Do not exceed 5000 rows of products as the spreadsheet will not validate. If total number of products for each product Category/Subcategory exceeds 5000 products, then create a new spreadsheet for the additional products. 10. Only use this spreadsheet for PMTA submissions.		Please note:		OMB Control No. 0910-0879 Expiration Date: 12/31/2025 See PRA Statement on bottom of page
Product Information		Saving as an .xls or .xlsx will cause all drop down menus to disappear, so be certain you are completely finished. Your data will be saved, but you will not have drop down functions if you must re-open. For file naming convention, reference the Electronic Submission File Formats and Specifications which can be found on the FDA website.
*Applicant Name*
*Product Category*
*Product Subcategory*
*Application Type*	PMTA










Version: 3.0
Release Date: September 2023


This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW. The burden time for this collection of information is estimated to average 35 minutes per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to the following email address: For PRA questions: [email protected] OMB Statement: “An agency may not conduct or sponsor and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

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