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

---

Overview

Introduction
Product

---

Sheet 1: Introduction

Unique Identifying Information for New Tobacco Products			DRAFT FORM
Instructions: 1. You MUST enter the Applicant Name, Product Category and Product Subcategory as required by 21 CFR § 1114.7(c)(3) on this page. 2. Enter values for the applicable product properties specified in Table 1 to 21 CFR § 1114.7(c)(3)(iii) in Product Tab. 3. Verify Completion before saving as XLS or XLSX. You must save as XLS or XLSX for eSubmitter.		Additional Comments					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.) 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
Version: 12.0 Microsoft Excel
Release Date: 11/17/2019
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

Package Type

Package Type, if Other

Package Quantity Numeric Value

Units (Package Quantity)

Characterizing Flavor

Characterizing Flavor, If other

Length Description

Length Description, if Other

Length Numeric Value

Units (Length)

Diameter Description

Diameter Description, if Other

Diameter Format

Diameter Numeric Value

Units (Diameter)

Ventilation

Additional Property