Form FDA 3741b FDA 3741b Tobacco Product List Spreadsheet

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Overview

Introduction to FDA Form 3741b
Data

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Sheet 1: Introduction to FDA Form 3741b

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form FDA 3741b Tobacco Product List Spreadsheet - DRAFT
Form Approved: OMB No. 0910-0650 Expiration Date: xx/xx/20xx
Paperwork Reduction Act Statement: The Paperwork Reduction Act of 1995 provides that an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0650. The time required to complete this information collection is estimated to average 20 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.
Form FDA 3741b (XX/25)
Overview of Tobacco Product List Electronic Submission through FDA’s Tobacco Registration & Product Listing Module Next Generation (TRLM-NG): 1. FDA created the 3741b Tobacco Product List spreadsheet (or “the spreadsheet”) to help owners, operators, and authorized representatives of tobacco product manufacturing establishments with compiling the information necessary to submit a list of their tobacco products to FDA (see section 905 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). 2. The spreadsheet has predefined macro programming aligned with data requirements for its successful upload to FDA’s Tobacco Registration & Product Listing Module Next Generation (TRLM-NG). Overwriting the macro headers may result in errors during the spreadsheet upload process. When copying and pasting multiple tobacco products, it is recommended to preselect the values that align to each column header. 3. After opening the spreadsheet, enable macros when prompted. 4. Select the Data tab and enter a new row per each tobacco product manufactured at each establishment(s) being registered with FDA. All required fields must be provided. If a product attribute or property is not applicable to your product, you must enter "0" (if a numeric value field) or "None" (if a free text field or selectable drop down field). Tobacco products that differ (i.e., flavor, size, packaging, nicotine levels) must be listed individually on separate rows. Do not include tobacco products that have already been added or uploaded to your TRLM-NG product list, as they will be flagged as duplicates. Each spreadsheet can list up to 1,000,000 (one million) products. If your product list exceeds 1,000,000 (one million) products, you must complete and upload multiple spreadsheets. 5. Do not rearrange, delete, or add columns to the spreadsheet, as TRLM-NG will not accept your revised spreadsheet. 6. When you have completed the entry of your product information, select the "Validate Data" button in the TRLM NG ribbon.
7. Export the spreadsheet to CSV using the "Export to CSV" button within the spreadsheet.
8. Sign in to your TRLM-NG account (https://trlm-ng-industry.fda.gov/login) and follow the on-screen instructions for uploading your product list. Overview for Mailing the 3741b to FDA’s Document Control Center (DCC): If you are unable to submit your product list electronically through FDA’s Tobacco Registration & Product Listing Module Next Generation (TRLM-NG), the 3741b Tobacco Product List Spreadsheet (or “the spreadsheet”) can be filled out manually, printed, and mailed or saved to a USB flash drive or DVD to be mailed to FDA’s Document Control Center (DCC) for FDA to process and upload to TRLM-NG on your behalf. The 3741b Tobacco Poduct List Spreadsheet can be mailed to: Food and Drug Administration Center for Tobacco Products Document Control Center Building 71, Room G335 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

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Sheet 2: Data

Product Name

Brand Name

Subbrand Name

Product Category

Product Category (if Other)

Product Subcategory

Product Subcategory (if Other)

Intent of Use

Universal Product Code (UPC)

Alternative (Industry) Product Identification #

Alternative (Industry) Product Identification # Type

Alternative (Industry) Product Identification # Type (if Other)

Package Type

Package Type (if Other)

Product Quantity (Numeric Value)

Product Quantity (Units)

Product Quantity (Units, if Other)

Product Quantity Mass (Numeric Value)

Product Quantity Mass (Units)

Characterizing Flavor

Flavor Name (if Flavored)

Flavor Description (if Flavored)

Nicotine Concentration (Numeric Value)

Nicotine Concentration (Units)

Nicotine Concentration (if mg/unit, specify Unit)

Nicotine Source

Tobacco Cut Style

Portion Count (Numeric Value)

Portion Count (Units)

Portion Count (Units, if Other)

Portion Mass (Numeric Value)

Portion Mass (Units)

Length Description

Length Description (if Other)

Length (Numeric Value)

Length (Units)

Width (Numeric Value)

Width (Units)

Diameter (Description)

Diameter (Format)

Diameter (Numeric Value)

Diameter (Units)

Portion Thickness (Numeric Value)

Portion Thickness (Units)

Filter Ventilation (Percentage)

E-Liquid Volume (Numeric Value)

E-Liquid Volume (Units)

PG (Numeric Value)

VG (Numeric Value)

Wattage (Numeric Value)

Wattage (Units)

Battery Capacity (Numeric Value)

Battery Capacity (Units)

Number of Hoses

Height (Numeric Value)

Height (Units)

Source of Energy

Source of Energy (if Other)

Wrapper Material

Wrapper Material (if Other)

Tip Type

Tip Type (if Other)

Additional Properties (if Applicable)