FDA 4057b Unique Identifying Information for New Tobacco Products

Premarket Tobacco Product Applications and Recordkeeping Requirements

FDA 4057b.xlsm

OMB: 0910-0879

Document [xlsx]
Download: xlsx | pdf

Overview

Introduction
Product


Sheet 1: Introduction

Unique Identifying Information for New Tobacco Products
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: 10/31/2022
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.)

Using "Additional Property" to differentiate the products if all the other unique product properties are exactly same.



Applicant Name


Product Category


Product Subcategory


Product Category, If other


Product Subcategory, if Other


Application Type PMTA










































Version: 2.1




Release Date: 8/22/2022
















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:
[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.”



Sheet 2: Product

Product Name TP Number Package Type Package Type, if Other Product Quantity Numeric Value Units (Product Quantity) 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)
File Typeapplication/vnd.openxmlformats-officedocument.spreadsheetml.sheet
File Modified0000-00-00
File Created0000-00-00

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