Form FDA 4057b Unique Identifying Information for New Tobacco Products

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Overview

Introduction
Product

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Sheet 1: Introduction

Unique Identifying Information for New Tobacco Products			DRAFT FDA FORM 4057b
Instructions: 1. First, enter Applicant Name then Product Category and Subcategory as required by 21 CFR § 1114.7(c)(3). 2. Click "Enter Unique Product Properties" button then enter applicable product information as specified in Table 1 to 21 CFR § 1114.7(c)(3)(iii) under the Product Tab. 3. Verify completion then SAVE AS .XLS or .XLSX and name appropriately. Must be XLS or XLSX to attach to eSubmitter file for submission.		Please note:					OMB Control No. 0910-0879 Expiration Date: xx/xx/xxxx 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. Continue through the errors and save the file as "Tobacco_Product_list.xls" or "Tobacco_Product_list.xlsx". If there are multiple product files, save the files as "Tobacco_Product_list_n.xls" or "Tobacco_Product_list_n.xlsx"(where n=1,2,3,etc.) Use "Additional Property" to differentiate the products if all the other unique product properties are exactly the same. If you categorize your product as "other" in rows 5 and 6, please enter the "other" category information in rows 7 and 8. The "Product" tab will then be populated with all the unique product properties listed in Tables 1 -21. Use the "Reset" button to delete all data previously entered in the "Introduction" tab and reset the columns in the "Product" tab.
Applicant Name
Product Category
Product Subcategory
Product Category, If other
Product Subcategory, if Other
Version: 2.0
Release Date: 03/02/2020
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 4 hours 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: PRAStaff@fda.hhs.gov 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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Sheet 2: Product

Product Name

Package Type

Package Type, if Other

Product Quantity Numeric Value

Units (Product Quantity)

Units (Product Quantity Mass)

Units, if Other (Product Quantity Mass)

Characterizing Flavor

Characterizing Flavor, If other

Tobacco Cut Style

Portion Count Numeric Value

Units (Portion Count)

Units, if Other (Portion Count)

Portion Mass Numeric Value

Units (Portion Mass)

Length Description

Length Description, if Other

Length Numeric Value

Units (Length)

Width Numeric Value

Units (Width)

Diameter Description

Diameter Description, if Other

Diameter Format

Diameter Numeric Value

Units (Diameter)

Portion Thickness Numeric Value

Units (Portion Thickness)

Ventilation

E-liquid Volume

E-liquid Volume Units

Nicotine Concentration

Nicotine Concentration Units

Units, if Other (Nicotine Concentration)

PG/VG Ratio

PG/VG Not Applicable

Wattage Numeric Value

Units (Wattage)

Units, if Other (Wattage)

Battery Capacity Numeric Value

Units (Battery Capacity)

Units, if Other (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)