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This example has been updated according to the approached discussed on the team call on 1/17. Additionally, we have simplified the Tobacco Product Identifiers and Descriptors (TO) domain by using parameters (TOPARM) instead of tests (TOTEST)

https://www.sciencedirect.com/science/article/pii/S004060311930752X

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This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for one type of tobacco product an Electronic Nicotine Delivery System (ENDS) (Vapes). There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco product Premarket Authorization (PMTA) and Substantial Equivalence pathways. The applicant submitting for SE and PMTAs may include test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

Tobacco Product Identifier (TO) (similar to Device Identifiers (DI)) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the product may be found.

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Name	to

Rowcaps

Rows 1-4:	Show the records for a tobacco product given SPTOBID of VAPE-Z27.
Rows 1-3:	Show the tobacco product is a Electronic Nicotine Delivery Systems (ENDS) Vape closed e-cigarette.
Rows 5-8:	Show the package type is a Box that contains 1 E-Cigarette that is 107.2 mm long and 9.0 mm in diameter.
Rows 9-1213:	Show the attributes or characteristics of the content of the e-liquid within the E-cigarette.
Rows 1314-1516:	Show the attributes or characteristics of the heating element for the E-cigarette .

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOCAT	TOVAL	TOVALU
1	TOB09	TO	VAPE-Z27	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	ENDS (VAPES)
2	TOB09	TO	VAPE-Z27	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Closed E-Cigarette
3	TOB09	TO	VAPE-Z27	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	Joes Vapes USA
4	TOB09	TO	VAPE-Z27	4	TRADENAM	Trade Name	PRODUCT IDENTIFIER	Everyday Rich Tobacco
5	TOB09	TO	VAPE-Z27	5	PACKTYP	Package Type	PRODUCT DESCRIPTOR	BOX
6	TOB09	TO	VAPE-Z27	6	PRDQUAN	Product Quantity	PRODUCT DESCRIPTOR	1	E-CIGARETTE
7	TOB09	TO	VAPE-Z27	7	LENGTH	Length	PRODUCT DESCRIPTOR	107.2	mm
8	TOB09	TO	VAPE-Z27	8	DIAMETER	Diameter	PRODUCT DESCRIPTOR	9	mm
9	TOB09	TO	VAPE-Z27	9	NICTNCNC	Nicotine Concentration	PRODUCT DESCRIPTOR	2	mg/L
10	TOB09	TO	VAPE-Z27	10	PGVGRT	PG	Propylene GlycolPG/VG Ratio*	PRODUCT DESCRIPTOR	50/50	%
11	TOB09	TO	VAPE-Z27	11	VG	Vegetable Glycerin	PRODUCT DESCRIPTOR	50	%
12	TOB09	TO	VAPE-Z27	12	CHTRFLAV	Characterizing Flavor	PRODUCT DESCRIPTOR	TOBACCO
1213	TOB09	TO	VAPE-Z27	1213	VOLUMEE	Volume, E-liquid	PRODUCT DESCRIPTOR	1	mL
1314	TOB09	TO	VAPE-Z27	1314	WATT	Wattage	PRODUCT DESCRIPTOR	5.2	Watt
1415	TOB09	TO	VAPE-Z27	1415	BATTCAP	Battery Capacity	PRODUCT DESCRIPTOR	600	mAh
1516	TOB09	TO	VAPE-Z27	1516	DISPCRTG	Disposable Cartridge	PRODUCT DESCRIPTOR	Y

The Product Design Parameters (PD) domain is used to represent design specification parameters of the tobacco product. Each property is identified using controlled terminology and is stored represented in PDPARMCD/PDPARM.

Show the design parameter specification with target, minimum, and maximum value reflected in the PDCOLSRT variable.

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Name	pd

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Rows 1-94:

Rows 80-82:

Show the design parameter specification with the test condition of 20 degrees Celsius using the PDTSTCND variable.

Dataset2

count (for full tank/cartridge) element diameter

Row	STUDYID	DOMAIN	SPTOBID	PDSEQ	PDPARMCD	PDPARM	PDVALTRG	PDVALMIN	PDVALMAX	PDVALU
1	TOB09	PD	VAPE-Z27	1	DRWRST	Draw Resistance	90.0	80.0	120.0	mm H2O
2	TOB09	PD	VAPE-Z27	2	PUFCNT	Puff	Count	300	290	310	7	3	11	NUMBER COUNT
3	TOB09	PD	VAPE-Z27	3	CRTVOL	Cartridge volumeVolume	3	1	5	mL
4	TOB09	PD	VAPE-Z27	4	HTELNUM	Number of heating elementsHeating Elements	1	1	1NUMBER COUNT
5	TOB09	PD	VAPE-Z27	5	HTELGTH	Heating element lengthElement Length	3	2	4	mm
6	TOB09	PD	VAPE-Z27	6	HTEDIAM	Heating	Element Diameter	3	2	5	mm
7	TOB09	PD	VAPE-Z27	7	HTELRST	Heating element resistanceElement Resistance	0.75	0.25	1.5	ohm
8	TOB09	PD	VAPE-Z27	8	HTELRNG	Heating element rangeElement Range	175	100	250	C
9	TOB09	PD	VAPE-Z27	9	HTELCFG	Heating element configurationElement Configuration	SPIRAL	SPIRAL	SPIRAL
10	TOB09	PD	VAPE-Z27	10	BTVLTORG	Battery voltage operating range Voltage Operating Range	4.5	3	6	V
11	TOB09	PD	VAPE-Z27	11	BTCRTORG	Battery current operating range Current Operating Range	1000	650	1600	mAh
12	TOB09	PD	VAPE-Z27	12	BATCAPC	Battery capacityCapacity	1100	800	3000	mAh
13	TOB09	PD	VAPE-Z27	13	BATNOMV	Battery nominal voltage Nominal Voltage	4.2	4.0	4.5	V
14	TOB09	PD	VAPE-Z27	14	BTCRTRT	Battery Current Rating	2500	2000	2800	mA
15	TOB09	PD	VAPE-Z27	15	BTCHTPL	Battery Charging Temperature Limits	200	100	315	C
16	TOB09	PD	VAPE-Z27	16	BTDCTMPL	Battery Discharge Temperature Limits	20	-20	60	C
17	TOB09	PD	VAPE-Z27	17	BTENDCV	Battery end End of discharge voltageDischarge Voltage	3.0	2.0	3.5	V
18	TOB09	PD	VAPE-Z27	18	BTMXCHC	Battery maximum charging currentMaximum Charging Current	24	20	30	mA
19	TOB09	PD	VAPE-Z27	19	BTMXDCC	Battery maximum discharging current Maximum Discharging Current	2700	2400	3000	mA
20	TOB09	PD	VAPE-Z27	20	BTULCHV	Battery upper limits charging voltageUpper Limits Charging Voltage	4.2	4.1	4.3	V
21	TOB09	PD	VAPE-Z27	21	PDUVORPower	Delivery Unit (PDU) voltage operating rangePDU Voltage Operating Range	3.7	3.2	4.2	V
22	TOB09	PD	VAPE-Z27	22	PDUCOR	PDU current operating range Current Operating Range	1200	850	1800	mA
23	TOB09	PD	VAPE-Z27	23	PDUWTOR	PDU wattage operating rangeWattage Operating Range	75	70	80	W
24	TOB09	PD	VAPE-Z27	24	PDUTCTOF	PDU temperature cut-off (if applicable)Temperature Cut-off	70	55	65	C
25	TOB09	PD	VAPE-Z27	25	AIRFLRT	Airflow rateRate	720	700	740	L/min
26	TOB09	PD	VAPE-Z27	26	PDUCRCOF	PDU current cutCurrent Cut-off (if applicable)	35	20	50	mA
27	TOB09	PD	VAPE-Z27	27	INHAERT	Inhaled aerosol temperatureAerosol Temperature	37	35	40	C
28	TOB09	PD	VAPE-Z27	28	VENTLTN	Ventilation	50	40	60	%
29	TOB09	PD	VAPE-Z27	29	ELQDVISC	E-Liquid viscosityViscosity	500	75	1130	mPa/s
30	TOB09	PD	VAPE-Z27	30	ELQDVOL	E-liquid volumeVolume	60	10	120	mL
31	TOB09	PD	VAPE-Z27	31	PNUMCNC	Particle number concentrationNumber Concentration	500	108	1010	#/cm³cm3
32	TOB09	PD	VAPE-Z27	32	CTMDDIAM	Count median diameterMedian Diameter	200	150	250	nm
33	TOB09	PD	VAPE-Z27	33	PM	PM 2.5	25	12	35	ug/m³m3

*PG/VG Ratio = Propylene Glycol to Vegetable Glycerin Ratio

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