FDA 4057b Premarket Tobacco Product Application Grouping Submissio

Premarket Tobacco Product Applications and Recordkeeping Requirements

4057b Detailed 3.31.22.xlsx

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

OMB: 0910-0879

Document [xlsx]
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Overview

Detailed Changes
Data Elements By product


Sheet 1: Detailed Changes

Form 4057b Changes April 2022
Data Element Text Type Drop Down Choices Drop Down Choices for Product Category Change Previous Choices
Applicant Name General Text



Product Category/Subcatagory Drop Down Cigarette Filtered




Non-Filtered




Other



Cigar Cigar Compnent




Cigar Tobacco Filler




Filtered-Sheet Wrapped




Unfiltered - Leaf Wrapped




Unfiltered - Sheet Wrapped




Other



ENDS (VAPE) Closed E-Cigarette




Closed E-Liquid




ENDS Component




Open E-Cigarette




Open E-Liquid




Other



Heated Tobacco Product Closed HTP




Open HTP




HTP Consumable




HTP Component




Other



Pipe Pipe




Pipe Component




Pipe Tobacco Filler




Other



Roll Your Own Filter




Filtered Cigarette Tube




Non-Filtered Cigarette Tube




Paper Tip




Roll Your Own Tobacco Filler




Rolling Paper




Other



Smokeless Dissolvable




Loose Chewing Tobacco




Loose Dry Snuf




Loose Moist Snuf




Loose Snus




Portioned Chewing Tobacco




Portioned Moist Snuf




Portioned Snus




Other



Waterpipe Waterpipe




Waterpipe Component




Waterpipe Heat Source




Waterpipe Tobacco Filler




Other



Other Other




Unknown Delete
Product Category/Subcatagory, if other General Text



Application Type Drop Down PMTA
Unhide


















Product Name




TP Number General Text

Add
Package Type
Bag/Pouch




Blister Pack




Booklet




Bottle




Box




Cardboard Sleeve
Add


Carton




Cartridge




Cellophane




Clamshell




Film Sleeve




Foil




Hard Box




Hard Pack




Matchbook




Metal Can with Lid
Change Metal Can and Lid


Metal Can with Plastic Lid
Change Metal Can and Plastic Lid


None




Plastic Can with Lid
Change Plastic Can and Lid


Plastic Can with Metal Lid
Change Plastic Can and Metal Lid


Pod
Add


Puck




Soft Pack




Tube
Add


Wrapper
Add


Other


Package Type, if Other Free Text



Product Quantity Numeric Value Free Text (general, not numeric)



Units (Product Quantity) Dropdown Base
Add


Battery
Add


Bits
Add


Bottle
Add


Bound
Remove


Bowl
Add


Boxes




Brick
Remove


Capsules
Add


Catridges




Cigar
Add


Cigarette
Add


Coil
Add


Count




Device
Add


E-Cigarette




Filters




Grams
Add


Hose
Add


HTP
Add


Leaves




Loose Leaf Pieces




Mouthpiece
Add


Ounces
Add


Paper




Pellets
Remove


Pieces




Pipe




Plug




Pouches




Sheet




Spacer
Add


Stem
Add


Stick




Strip




Tablet




Tips




Tubes




Twist




Waterpipe
Add


Other


Units, if Other (Product Quantity) Free Text



Product Quantity Mass Numeric Value Free Text (general, not numeric)



Units (Product Quantity Mass) Dropdown Milligrams




Grams




Kilograms




Ounces




Pounds




Tons


Units, if Other (Product Quantity Mass) Free Text



Characterizing Flavor Dropdown Blueberry




Cherry
Remove


Chocolate
Remove


Cinnamon
Remove


Citrus
Remove


Coke
Remove


Cola
Remove


Menthol
Remove


Mint




Natural
Remove


None
Remove


Peach
Remove


Peppermint
Remove


Raspberry
Remove


Tobacco




Vanilla
Remove


Wintergreen
Remove


Other
Remove


Flavored
Add


Unflavored
Add
Characterizing Flavor, If flavored Free Text

Change Header Characterizing Flavor, If other
Tobacco Cut/Particle Size Description Dropdown Extra-long




Fine




Long




Straight


Tobacco Cut Style Dropdown Standard Cut




Pressed Cut




Mixture


Tobacco Cut/Particle Size Numeric Value Number



Units (Tobacco Cut/Particle Size) Dropdown Millimeters




Centimeters




Inches




Cuts Per Inch (CPI)


Portion Count Numeric Value Numeric

Change Data Type Free text
Units (Portion Count) Dropdown Bits




Bound




Boxes




Brick




Catridges




Count




E-Cigarette




Filters




Leaves




Loose Leaf Pieces




Orb
Add


Paper




Pellets




Pieces




Pipe




Plug




Pouches




Sheet




Stick




Strip




Tablet




Tips




Tubes




Twist




Other


Units, if Other (Portion Count) Free text



Portion Mass Numeric Value Free Text (general, not numeric)



Units (Portion Mass) Dropdown Milligrams




Grams




Kilograms




Ounces




Pounds




Tons


Length Description Dropdown King




Long




XL




Queen
Add


Other


Length Description, if Other Free text



Length Numeric Value Number



Units (Length) Dropdown Millimeters




Centimeters




Meters




Inches


Width Numeric Value Number



Units (Width) Dropdown Millimeters




Centimeters




Meters




Inches


Diameter Description Dropdown Regular




Slim




Super Slim




Wide
Add


Other
Remove
Diameter Description, if Other Free text

Remove
Diameter Format Dropdown Circumference




Diameter




Radius




Ring Gauge
Add
Diameter Numeric Value Number



Units (Diameter) Dropdown Millimeters




Centimeters




Meters




Inches


Portion Thickness Numeric Value Number



Units (Portion Thickness) Dropdown Millimeters




Centimeters




Meters




Inches


Filter Ventilation Percentage

Change Header Ventilation
E-liquid Volume Free Text (general, not numeric)



E-liquid Volume Units Dropdown Milliliters




Liters




Fluid Ounces




Kiloliters








Nicotine Source Dropdown Tobacco
Add


Non-Tobacco
Add


Both
Add


None
Add






Nicotine Concentration Number



Nicotine Concentration Units Dropdown %
Remove


mg/ml




%W/W




mg/unit
Change mg


Other
Remove
If mg/unit specify Unit (Nicotine Concentration)


Change Header Units, if Other (Nicotine Concentration)
PG Numeric Value Percentage

Add
PG/VG Ratio


Remove
VG Numeric Value Percentage



PG/VG Not Applicable Dropdown 1
Remove


0
Remove
Wattage Numeric Value Free Text



Units (Wattage) Dropdown Watt




Milliwatt




Volts
Add


Other
Remove
Units, if Other (Wattage) Free text

Remove
Battery Capacity Numeric Value Free text



Units (Battery Capacity) Dropdown Watt




MilliAmps




mAh




Other
Remove
Units, if Other (Battery Capacity) Free text

Remove
Tip Type Dropdown Wood




Plastic




Paper
Add


None




Other


Tip Type, if Other Free Text



Wrapper Material Dropdown Tobacco Leaf
Change Burley Tobacco Leaf


Sheet Tobacco
Change Connecticut Shade Grown Tobacco Leaf


Paper
Add


Other


Wrapper Material, if Other Free Text



Number of Hoses Whole Number

Change
Source of Energy Dropdown Charcoal




Battery




Electrical




Other


Source of Energy, if Other Free Text



Height Numeric Value Number



Units (Height) Dropdown Millimeters




Centimeters




Meters




Inches


Additional Properties (if Applicable) Free text









Diameter Not Applicable Drop Down 1
Remove


0
Remove
Width Not Applicable Drop Down 1
Remove


0
Remove

Sheet 2: Data Elements By product

Data Element Data Type Changes



Applicant Name

Product Category

Product Sub-Category

Product Category, if other

Product Sub-Category, if other

Product Name Free Text
TP Number Free Text Add
Package Type Dropdown
Package Type, if Other Free Text
Product Quantity Numeric Value Free Text (general, not numeric)
Units (Product Quantity) Dropdown
Units, if Other (Product Quantity) Free Text
Product Quantity Mass Numeric Value Free Text (general, not numeric)
Units (Product Quantity Mass) Dropdown
Units, if Other (Product Quantity Mass) Free Text
Characterizing Flavor Dropdown
Characterizing Flavor, If other Free Text
Tobacco Cut/Particle Size Description Dropdown
Tobacco Cut Style Dropdown
Tobacco Cut/Particle Size Numeric Value Number
Units (Tobacco Cut/Particle Size) Dropdown
Portion Count Numeric Value Free Text (general, not numeric)
Units (Portion Count) Dropdown
Units, if Other (Portion Count) Free text
Portion Mass Numeric Value Free Text (general, not numeric) Remove
Units (Portion Mass) Dropdown Remove
Length Description Dropdown
Length Description, if Other Free text
Length Numeric Value Number
Units (Length) Dropdown
Width Numeric Value Number
Units (Width) Dropdown
Diameter Description Dropdown
Diameter Description, if Other Free text Remove
Diameter Format Dropdown
Diameter Numeric Value Number
Units (Diameter) Dropdown
Portion Thickness Numeric Value Number
Units (Portion Thickness) Dropdown
Ventilation Free text
E-liquid Volume Free Text (general, not numeric)
E-liquid Volume Units Dropdown
Nicotine Concentration Number
Nicotine Concentration Units Dropdown
Nicotine Source Dropdown Add
Units, if Other (Nicotine Concentration) Free Text
PG Number Value Percentage Add
VG Numeric Value Percentage
PG/VG Ratio Free text Remove
PG/VG Not Applicable Dropdown Remove
Wattage Numeric Value Free Text
Units (Wattage) Dropdown
Units, if Other (Wattage) Free text Remove
Battery Capacity Numeric Value Free text
Units (Battery Capacity) Dropdown
Units, if Other (Battery Capacity) Free text Remove
Tip Type Dropdown
Tip Type, if Other Free Text
Wrapper Material Dropdown
Wrapper Material, if Other Free Text
Number of Hoses Free Text (general, not numeric)
Source of Energy Dropdown
Source of Energy, if Other Free Text
Height Numeric Value Number
Units (Height) Dropdown
Additional Properties (if Applicable) Free text



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