The following example illustrates the representation of an ENDS tobacco product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOPARMCD | TOPARM | TOCAT | TOSCAT | TOVAL | TOVALU |
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1 | TOB09 | TO | VAPE-Z27 | | TBPRDCAT | Tobacco Product Category | NEW PRODUCT | PRODUCT IDENTIFIER | Electronic Nicotine Delivery Systems (ENDS) (Vapes) |
| 2 | TOB09 | TO | VAPE-Z27 | 2 | TBPRSCAT | Tobacco Product Subcategory | NEW PRODUCT | PRODUCT IDENTIFIER | Closed E-Cigarette |
| 3 | TOB09 | TO | VAPE-Z27 | 3 | MANUF | Manufacturer | NEW PRODUCT | PRODUCT IDENTIFIER | Joes Vapes USA |
| 4 | TOB09 | TO | VAPE-Z27 | 4 | TRADENAM | Trade Name | NEW PRODUCT | PRODUCT IDENTIFIER | Everyday Rich Tobacco |
| 5 | TOB09 | TO | VAPE-Z27 | 5 | PACKTYP | Package Type | NEW PRODUCT | PRODUCT DESCRIPTOR | BOX |
| 6 | TOB09 | TO | VAPE-Z27 | 6 | PRDQUAN | Product Quantity | NEW PRODUCT | PRODUCT DESCRIPTOR | 1 | E-CIGARETTE | 7 | TOB09 | TO | VAPE-Z27 | 7 | LENGTH | Length | NEW PRODUCT | PRODUCT DESCRIPTOR | 107.2 | mm | 8 | TOB09 | TO | VAPE-Z27 | 8 | DIAMETER | Diameter | NEW PRODUCT | PRODUCT DESCRIPTOR | 9 | mm | 9 | TOB09 | TO | VAPE-Z27 | 9 | NICTNCNC | Nicotine Concentration | NEW PRODUCT | PRODUCT DESCRIPTOR | 2 | mg/L | 10 | TOB09 | TO | VAPE-Z27 | 10 | PRPYLGLY | Propylene Glycol | NEW PRODUCT | PRODUCT DESCRIPTOR | 50 | % | 11 | TOB09 | TO | VAPE-Z27 | 11 | VEGGLY | Vegetable Glycerin | NEW PRODUCT | PRODUCT DESCRIPTOR | 50 | % | 12 | TOB09 | TO | VAPE-Z27 | 12 | CHARFLAV | Characterizing Flavor | NEW PRODUCT | PRODUCT DESCRIPTOR | Tobacco |
| 13 | TOB09 | TO | VAPE-Z27 | 13 | ELQDVOL | E-Liquid Volume | NEW PRODUCT | PRODUCT DESCRIPTOR | 1 | mL | 14 | TOB09 | TO | VAPE-Z27 | 14 | BATCAPC | Battery Capacity | NEW PRODUCT | PRODUCT DESCRIPTOR | 600 | mAh | 15 | TOB09 | TO | VAPE-Z27 | 15 | DSCRTIND | Disposable Cartridge Indicator | NEW PRODUCT | PRODUCT DESCRIPTOR | Y |
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The manufacturing parameter specifications of the ENDS product as intended for used are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.
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Row | STUDYID | DOMAIN | SPTOBID | PDSEQ | PDPARMCD | PDPARM | PDVALTRG | PDVALMIN | PDVALMAX | PDVALU |
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1 | TOB09 | PD | VAPE-Z27 | | DRWRST | Draw Resistance | 90.0 | 80.0 | 120.0 | mm H2O | 2 | TOB09 | PD | VAPE-Z27 | 2 | PUFCNT | Puff Count | 300 | 290 | 310 |
| 3 | TOB09 | PD | VAPE-Z27 | 3 | CRTVOL | Cartridge Volume | 3 | 1 | 5 | mL | 4 | TOB09 | PD | VAPE-Z27 | 4 | HTELNUM | Number of Heating Elements | 1 | 1 | |
| 5 | TOB09 | PD | VAPE-Z27 | 5 | HTELGTH | Heating Element Length | 3 | 2.7 | 3.3 | mm | 6 | TOB09 | PD | VAPE-Z27 | 6 | HTEDIAM | Heating Element Diameter | 3 | 2.9 | 3.2 | mm | 7 | TOB09 | PD | VAPE-Z27 | 7 | HTELRST | Heating Element Resistance | 0.75 | 0.25 | 1.5 | ohm | 8 | TOB09 | PD | VAPE-Z27 | 8 | HTELRNG | Heating Element Range | 175 | 100 | 250 | C | 9 | TOB09 | PD | VAPE-Z27 | 9 | HTELCFG | Heating Element Configuration | SPIRAL | SPIRAL | SPIRAL |
| 10 | TOB09 | PD | VAPE-Z27 | 10 | BTVLTORG | Battery Voltage Operating Range | 4.5 | 3 | 6 | V | 11 | TOB09 | PD | VAPE-Z27 | 11 | BTCRTORG | Battery Current Operating Range | 1000 | 650 | 1600 | mAh | 12 | TOB09 | PD | VAPE-Z27 | 12 | BATCAPC | Battery Capacity | 1100 | 800 | 3000 | mAh | 13 | TOB09 | PD | VAPE-Z27 | 13 | BATNOMV | Battery 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 of Discharge Voltage | 3.0 | 2.0 | 3.5 | V | 18 | TOB09 | PD | VAPE-Z27 | 18 | BTMXCHC | Battery Maximum Charging Current | 24 | 20 | 30 | mA | 19 | TOB09 | PD | VAPE-Z27 | 19 | BTMXDCC | Battery Maximum Discharging Current | 2700 | 2400 | 3000 | mA | 20 | TOB09 | PD | VAPE-Z27 | 20 | BTULCHV | Battery Upper Limits Charging Voltage | 4.2 | 4.1 | 4.3 | V | 21 | TOB09 | PD | VAPE-Z27 | 21 | PDUVOR | PDU Voltage Operating Range | 3.7 | 3.2 | 4.2 | V | 22 | TOB09 | PD | VAPE-Z27 | 22 | PDUCOR | PDU Current Operating Range | 1200 | 850 | 1800 | mA | 23 | TOB09 | PD | VAPE-Z27 | 23 | PDUTCTOF | PDU Temperature Cut-off | 70 | 55 | 65 | C | 24 | TOB09 | PD | VAPE-Z27 | 24 | AIRFLRT | Airflow Rate | 720 | 700 | 740 | L/min | 25 | TOB09 | PD | VAPE-Z27 | 25 | PDUCRCOF | PDU Current Cut-off | 35 | 20 | 50 | mA | 26 | TOB09 | PD | VAPE-Z27 | 26 | INHAERT | Inhaled Aerosol Temperature | 37 | 35 | 40 | C | 27 | TOB09 | PD | VAPE-Z27 | 27 | VENTLTOT | Total Ventilation | 50 | 40 | 60 | % | 28 | TOB09 | PD | VAPE-Z27 | 28 | ELQDVISC | E-Liquid Viscosity | 500 | 75 | 1130 | mPa/s | 29 | TOB09 | PD | VAPE-Z27 | 29 | ELQDVOL | E-liquid Volume | 60 | 10 | 120 | mL | 30 | TOB09 | PD | VAPE-Z27 | 30 | PNUMCNC | Particle Number Concentration | 500 | 108 | 1010 | /cm3 | 31 | TOB09 | PD | VAPE-Z27 | 31 | CTMDDIAM | Count Median Diameter | 200 | 150 | 250 | nm | 32 | TOB09 | PD | VAPE-Z27 | 32 | PM2.5 | Particulate Matter 2.5 | 25 | 12 | 35 | ug/m3 |
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Finally, the PT domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.
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 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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The Tobacco Design Parameters (PD) is similar to the Device Properties (DO) domain represents properties of the tobacco product that do not vary over the life of the product. This is a findings domain and defines important characteristics of a product that the sponsor manufacturer wishes to include in the submission but do not form part of the unique sponsor-defined identification of the product. Each property is identified using controlled terminology and is stored in TPTESTCD/TPTEST.
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*PG/VG Ratio = Propylene Glycol to Vegetable Glycerin Ratio
The Tobacco Product Testing (PT) (similar to the Laboratory Test Results (LB) domain) dataset shows the tobacco product test demonstrating the actual tests and test results for the specified Design Parameter Specification as noted in the DU dataset (??? DP dataset).
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Rows 1-32: | Show the tobacco design parameter specification test and the result in ORRES (needs populated).
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Row 28: | Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test. | Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTTSTCND | PTCAT | PTSCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | |
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1 | TOB09 | PT | VAPE-Z27 | |
| DRWRST | Draw | Resistance Resistance |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTmm H2O | mm H2O | TESTING |
| 91 | mm H2O | 91 | 91 | mm H2O | 1 | 2 | TOB09 | PT | VAPE-Z27 | 2 |
| PUFCNT | Puff Count |
| DESIGN PARAMETER TESTING |
| 309 |
| 309 | 309 |
| 1 | 3 | 22PUFCNT | Puff count (for full tank/cartridge) SPECIFICATION TEST RESULTNUMBER COUNT | NUMBER COUNT | 3 | TESTING |
| 3.09 | mL | 3.09 | 3.09 | mL | 1 | 4 | 3CRTVOL |
| HTELNUM | Number of Heating Elements | Cartridge volume SPECIFICATION TEST RESULTmL | mL | 44HTELNUM | Number of heating elements | DESIGN PARAMETER SPECIFICATION TEST RESULT | NUMBER COUNT | NUMBER COUNT |
| HTELGTH | Heating Element Length |
| DESIGN PARAMETER TESTING |
| 2.97 | mm | 2.97 | 2.97 | mm | 1 | 6 | 55 | HTELGTH | Heating element length | DESIGN PARAMETER SPECIFICATION TEST RESULT | mm | mm | | 6 |
| HTEDIAM | Heating Element Diameter |
| DESIGN PARAMETER TESTING |
| 3.05 | mm | 3.05 | 3.05 | mm | | 7 | 66 element resistanceElement Resistance |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTTESTING |
| 0.77 | ohm | 0.77 | 0.77 | ohm | 1 | 77 element rangeElement Range |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTC88 element configurationElement Configuration |
| DESIGN PARAMETER | SPECIFICATION TEST RESULT9TESTING |
| SPIRAL |
| SPIRAL | SPIRAL |
| 1 | 10 | TOB09 | PT | VAPE-Z27 | 9 voltage operating rangeVoltage Operating Range |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTV | V | 1010 current operating rangeCurrent Operating Range |
| DESIGN PARAMETER | SPECIFICATION TEST RESULT1111 capacity SPECIFICATION TEST RESULTTESTING |
| 1112 | mAh | 1112 | 1112 | mAh | 1212 nominal voltageNominal Voltage |
| DESIGN PARAMETER | SPECIFICATION TEST RESULT131314 |
| BTCRTRT | Battery Current Rating |
| DESIGN PARAMETER | SPECIFICATION TEST RESULT141415 |
| BTCHTPL | Battery Charging Temperature Limits |
| DESIGN PARAMETER | SPECIFICATION TEST RESULT151516 |
| BTDCTMPL | Battery Discharge Temperature Limits |
| DESIGN PARAMETER | SPECIFICATION TEST RESULT16 | TOB09 | PT | VAPE-Z27 | 16 | BTENDCV | Battery end of discharge voltage | DESIGN PARAMETER SPECIFICATION TEST RESULT | VBTMXCHC maximum charging currentEnd of Discharge Voltage |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTmATESTING |
| 3.03 | V | 3.03 | 3.03 | V | 1 | 18 | TOB09 | PT | VAPE-Z27 | 18 |
BTMXDCC | Battery maximum discharging current | DESIGN PARAMETER SPECIFICATION TEST RESULT |
| BTMXCHC | Battery Maximum Charging Current |
| DESIGN PARAMETER TESTING |
| 23.5 | mA | 23.5 | 23.5 | mA | 1 | mABTULCHV upper limits charging voltageMaximum Discharging Current |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTVTESTING |
| 2696 | mA | 2696 | 2696 | mA | 1 | 20 | TOB09 | PT | VAPE-Z27 | 20 |
PDUVOR | Power Delivery Unit (PDU) voltage operating range | DESIGN PARAMETER SPECIFICATION TEST RESULT | |
| BTULCHV | Battery Upper Limits Charging Voltage |
| DESIGN PARAMETER TESTING |
| 4.21 | V | 4.21 | 4.21 | V | 1 | VPDUCOR current operating rangeVoltage Operating Range |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTmATESTING |
| 3.65 | V | 3.65 | 3.65 | V | 1 | 22 | TOB09 | PT | VAPE-Z27 | 22 |
PDUWTOR | PDU wattage operating range | DESIGN PARAMETER SPECIFICATION TEST RESULT |
| PDUCOR | PDU Current Operating Range |
| DESIGN PARAMETER TESTING |
| 1202 | mA | 1202 | 1202 | mA | 1 | W | 23 | TOB09 | PT | VAPE-Z27 | 23 |
| PDUTCTOF | PDU | temperature cut (if applicable) SPECIFICATION TEST RESULTTESTING |
| 69.9 | C | 69.9 | 69.9 | C | 1 | 24 | TOB09 | PT | VAPE-Z27 | 24 |
| AIRFLRT | Airflow | rate SPECIFICATION TEST RESULTTESTING |
| 727 | L/min | 727 | 727 | L/min | 1 | 25 | TOB09 | PT | VAPE-Z27 | 25 |
| PDUCRCOF | PDU | current cut (if applicable) SPECIFICATION TEST RESULTTESTING |
| 34.8 | mA | 34.8 | 34.8 | mA | 1 | 26 | TOB09 | PT | VAPE-Z27 | 26 |
| INHAERT | Inhaled | aerosol temperatureAerosol Temperature |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTCTESTING |
| 36.9 | C | 36.9 | 36.9 | C | 1 | 27 | TOB09 | PT | VAPE-Z27 | 27 | VENTLTN
| VENTLTOT | Total Ventilation |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTTESTING |
| 51 | % | 51 | 51 | % | 1 | 28 | TOB09 | PT | VAPE-Z27 | 28 |
| ELQDVISC | E-Liquid | viscosityViscosity | Test performed at 20 degrees Celsius | DESIGN PARAMETER | SPECIFICATION TEST RESULTTESTING |
| 496 | mPa/s | 496 | 496 | mPa/s | 1 | 29 | TOB09 | PT | VAPE-Z27 | 29 |
| ELQDVOL | E-liquid | volume SPECIFICATION TEST RESULTmLTESTING |
| 60.1 | mL | 60.1 | 60.1 | mL | 1 | 30 | TOB09 | PT | VAPE-Z27 | 30 |
| PNUMCNC | Particle | number concentrationNumber Concentration |
| DESIGN PARAMETER | SPECIFICATION TEST RESULT#/cm3TESTING |
| 511 | /cm3 | 511 | 511 | /cm3 | 1 | 31 | TOB09 | PT | VAPE-Z27 | 31 |
| CTMDDIAM | Count | median diameterMedian Diameter |
| DESIGN PARAMETER | SPECIFICATION TEST RESULTTESTING |
| 202 | nm | 202 | 202 | nm | 1 | 32 | TOB09 | PT | VAPE-Z27 | 32 |
PM | PM SPECIFICATION TEST RESULTTESTING |
| 24.4 | ug/m3 | 24.4 | 24.4 | ug/ | m3 |
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