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Warning

THIS EXAMPLE IS UNDER RECONSTRUCTION FOLLOWING DISCUSSIONS ON THE TEAM CALL 17 JAN. Updates include: 1) Simplifying PD.xpt to one record per parameter and (2), simplifying TO.xpt to a parameter-based dataset

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

Image Removed

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.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.

Rows 1-3:
Dataset wrap
Nameto
Rowcaps
Rows 1-4:Show the records for a tobacco product given SPTOBID of VAPE-Z27.
TOSTRESU
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-Cigarettes that is 107.2 mm long and 9.0 mm in diameter.
Rows 9-12:Show the attributes or characteristics of the content of the e-liquid within the E-cigarette.
Rows 13-15:Show the attributes or characteristics of the heating element for the E-cigarette .
Dataset2
RowSTUDYIDDOMAINSPTOBIDTOSEQ
TOTESTCD
TOPARMCD
TOTEST
TOPARMTOCAT
TOORRES
TOSCAT
TOORRESUTOSTRESCTOSTRESN
TOVALTOVALU
1TOB09TOVAPE-Z27

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIERElectronic Nicotine Delivery Systems (ENDS
(VAPES
)
ENDS
(
VAPES
Vapes)
2TOB09TOVAPE-Z272TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERClosed E-Cigarette
Closed E-Cigarette

3TOB09TOVAPE-Z273MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Vapes USA
Joes Vapes USA

4TOB09TOVAPE-Z274TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIER
Everyday Rich Tobacco
Everyday Rich Tobacco
5TOB09TOVAPE-Z275PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORBOX
BOX

6TOB09TOVAPE-Z276PRDQUANProduct QuantityNEW PRODUCTPRODUCT DESCRIPTOR1E-CIGARETTE
11
E-CIGARETTE
7TOB09TOVAPE-Z277LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR107.2mm
107.2107.2mm
8TOB09TOVAPE-Z278DIAMETERDiameterNEW PRODUCTPRODUCT DESCRIPTOR9mm
9
9mm9
TOB09TOVAPE-Z279NICTNCNCNicotine ConcentrationNEW PRODUCTPRODUCT DESCRIPTOR
2mg/L2
2mg/L
10TOB09TOVAPE-Z2710
PGVGRTPG/VG Ratio*
PRPYLGLYPropylene GlycolNEW PRODUCTPRODUCT DESCRIPTOR
50/
50
50/5050/50
%
11TOB09TOVAPE-Z2711VEGGLY
CHTRFLAV
Vegetable GlycerinNEW PRODUCT
Characterizing Flavor
PRODUCT DESCRIPTOR
TOBACCO
50
TOBACCO
%
TOBACCO
12TOB09TOVAPE-Z2712
VOLUMEEVolume, E-liquid
CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTOR
1mL11mL
Tobacco
13TOB09TOVAPE-Z2713
WATTWattage
ELQDVOL

E-Liquid Volume

NEW PRODUCTPRODUCT DESCRIPTOR
5.2Watt5.25.2
1mL
Watt
14TOB09TOVAPE-Z2714
BATTCAP
BATCAPCBattery CapacityNEW PRODUCTPRODUCT DESCRIPTOR600mAh
600
600mAh
15TOB09TOVAPE-Z2715
DISPCRTG
DSCRTINDDisposable Cartridge IndicatorNEW PRODUCTPRODUCT DESCRIPTORY
YY

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.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. 

Dataset wrap
Namepd
Rowcaps
Rows 1-94:Show the design parameter specification with target, minimum, and maximum value reflected in the PDCOLSRT variable.
Rows 80-82:Show the design parameter specification with the test condition of 20 degrees Celsius using the PDTSTCND variable.
Dataset2
PDCOLSRT Resistance TARGET count (for full tank/cartridge) volumeTARGET heating elements element length4 element diameter5TARGET element resistanceTARGET element rangeTARGET element configuration voltage operating rangeTARGET current operating rangeTARGET capacityTARGET nominal voltageTARGETTARGETTARGET end discharge voltageTARGET maximum charging current maximum discharging currentTARGET upper limits charging voltageTARGETPower Delivery Unit (PDU) voltage operating range current operating range temperature cut (if applicable) rateTARGET current cut (if applicable) aerosol temperatureVENTLTNTARGET viscosity  volumeTARGET number concentration median diameterPM
RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1TOB09PDVAPE-Z27

1

DRWRSTDraw Resistance90.080.0120.0mm H2O
2TOB09PDVAPE-Z2742PUFCNTPuff Count300290310
7311NUMBER COUNTTARGET3TOB09PDVAPE-Z2773CRTVOLCartridge Volume315mL
4TOB09PDVAPE-Z27104HTELNUMNumber of Heating Elements11

1

NUMBER COUNTTARGET
5TOB09PDVAPE-Z27135HTELGTHHeating Element Length32.73.3mmTARGET
6TOB09PDVAPE-Z27166HTEDIAMHeating Element Diameter32.93.2mm
7TOB09PDVAPE-Z27197HTELRSTHeating Element Resistance0.750.251.5ohm
8TOB09PDVAPE-Z27228HTELRNGHeating Element Range175100250C
9TOB09PDVAPE-Z27259HTELCFGHeating Element ConfigurationSPIRALSPIRALSPIRALTARGET
10TOB09PDVAPE-Z272610BTVLTORG

Battery

Voltage Operating Range

4.536V
11TOB09PDVAPE-Z272911BTCRTORG

Battery

Current Operating Range

10006501600mAh
12TOB09PDVAPE-Z273212BATCAPCBattery Capacity11008003000mAh
13TOB09PDVAPE-Z273513BATNOMV

Battery

Nominal Voltage

4.24.04.5V
14TOB09PDVAPE-Z273814BTCRTRTBattery Current Rating250020002800mA
15TOB09PDVAPE-Z274115BTCHTPLBattery Charging Temperature Limits200100315C
16TOB09PDVAPE-Z274416BTDCTMPLBattery Discharge Temperature Limits20-2060CTARGET
17TOB09PDVAPE-Z274717BTENDCVBattery End of Discharge Voltage3.02.03.5V
18TOB09PDVAPE-Z275018BTMXCHCBattery Maximum Charging Current242030mATARGET
19TOB09PDVAPE-Z275319BTMXDCC

Battery

Maximum Discharging Current

270024003000mA
20TOB09PDVAPE-Z275620BTULCHVBattery Upper Limits Charging Voltage4.24.14.3V
21TOB09PDVAPE-Z275921PDUVORPDU Voltage Operating Range3.73.24.2VTARGET
22TOB09PDVAPE-Z276222PDUCORPDU Current Operating Range12008501800mATARGET
23TOB09PDVAPE-Z2765PDUWTORPDU wattage operating range757080WTARGET2324TOB09PDVAPE-Z2768PDUTCTOFPDU Temperature Cut-off705565CTARGET
2524TOB09PDVAPE-Z277124AIRFLRTAirflow Rate720700740L/min
2526TOB09PDVAPE-Z277425PDUCRCOFPDU Current Cut-off352050mATARGET
2726TOB09PDVAPE-Z277726INHAERTInhaled Aerosol Temperature373540CTARGET
2827TOB09PDVAPE-Z278027VENTLTOTTotal Ventilation504060%
2829TOB09PDVAPE-Z278328ELQDVISCE-Liquid Viscosity500751130mPa/s
29TARGET30TOB09PDVAPE-Z278629ELQDVOLE-liquid Volume6010120mL
3031TOB09PDVAPE-Z278930PNUMCNCParticle Number Concentration5001081010/cm3
31#/cm3TARGET32TOB09PDVAPE-Z279231CTMDDIAMCount Median Diameter200150250nmTARGET
3332TOB09PDVAPE-Z279532PMPM2.5Particulate Matter 2.5ug/m3TARGET

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

251235ug/m3

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. 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 (??? PD dataset).

Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test.
Dataset wrap
Namept
Rowcaps
Rows 1-32:Show the tobacco design parameter specification test and the result in ORRES (needs populated).
Row 28:
Dataset2
RowSTUDYIDDOMAINSPTOBIDPTSEQPTREFIDPTTESTCDPTTESTPTTSTCNDPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU

PTREPNUM

PTTPTPTTPTNUM
1TOB09PTVAPE-Z27

1


DRWRSTDraw
Resistance 
Resistance
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
91mm H2O9191mm H2O1
Week 01
2TOB09PTVAPE-Z272
PUFCNTPuff
count (for full tank/cartridge)
Count
DESIGN PARAMETER
SPECIFICATION TEST RESULTNUMBER COUNTNUMBER COUNT1Week 0
TESTING
309
309309
1
3TOB09PTVAPE-Z273
CRTVOLCartridge
volume
Volume
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
3.09mL
mL1
3.093.09mL
Week 0
1
4TOB09PTVAPE-Z274
HTELNUMNumber of
heating elements
Heating Elements
DESIGN PARAMETER
SPECIFICATION TEST RESULTNUMBER COUNT
TESTING
1
1
NUMBER COUNT
1
Week 0

1
5TOB09PTVAPE-Z275
HTELGTHHeating
element length
Element Length
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
2.97mm
mm1
2.972.97mm
Week 0
1
6TOB09PTVAPE-Z276
HTELRST

HTEDIAMHeating
element resistance
Element Diameter
DESIGN PARAMETER
SPECIFICATION TEST RESULTohmohm1
TESTING
3.05mm3.053.05mm
Week 0

1

7TOB09PTVAPE-Z277
HTELRNG

HTELRSTHeating
element range
Element Resistance
DESIGN PARAMETER
SPECIFICATION TEST RESULTCC1
TESTING
0.77ohm0.770.77ohm
Week 0
1
8TOB09PTVAPE-Z278
HTELCFG

HTELRNGHeating
element configuration
Element Range
DESIGN PARAMETER
SPECIFICATION TEST RESULT1
TESTING
174C174174C
Week 0
1
9TOB09PTVAPE-Z279
BTVLTORGBattery voltage operating range

HTELCFGHeating Element Configuration
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
V

SPIRAL
V1

SPIRALSPIRAL
Week 0

1
10TOB09PTVAPE-Z2710
BTCRTORG

BTVLTORG

Battery

current operating range

Voltage Operating Range


DESIGN PARAMETER
SPECIFICATION TEST RESULTmAhmAh1
TESTING
4.6V4.64.6V
Week 0
1
11TOB09PTVAPE-Z2711
BATCAPC

BTCRTORG

Battery

capacity

Current Operating Range


DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
997mAh
mAh
997
1
997
Week 0
mAh1
12TOB09PTVAPE-Z2712
BATNOMV

BATCAPCBattery
nominal voltage
Capacity
DESIGN PARAMETER
SPECIFICATION TEST RESULTVV1
TESTING
1112mAh11121112mAh
Week 0
1
13TOB09PTVAPE-Z2713
BTCRTRT

BATNOMV

Battery

Current Rating

Nominal Voltage


DESIGN PARAMETER
SPECIFICATION TEST RESULTmA1
TESTING
4.18V4.184.18V
Week 0
1
14TOB09PTVAPE-Z2714
BTCHTPL

BTCRTRTBattery
Charging Temperature Limits
Current Rating
DESIGN PARAMETER
SPECIFICATION TEST RESULTC1
TESTING
2488mA24882488mA
Week 0
1
15TOB09PTVAPE-Z2715
BTDCTMPL

BTCHTPLBattery
Discharge
Charging Temperature Limits
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
198C
1
198198C
Week 0
1
16TOB09PTVAPE-Z2716
BTENDCV

BTDCTMPLBattery
end of discharge voltage
Discharge Temperature Limits
DESIGN PARAMETER
SPECIFICATION TEST RESULTV1
TESTING
19C1919C
Week 0
1
17TOB09PTVAPE-Z2717
BTMXCHC

BTENDCVBattery
maximum charging current
End of Discharge Voltage
DESIGN PARAMETER
SPECIFICATION TEST RESULTmA1
TESTING
3.03V3.033.03V
Week 0
1
18TOB09PTVAPE-Z2718
BTMXDCC

BTMXCHCBattery
maximum discharging current
Maximum Charging Current
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
23.5mA
1
23.523.5mA
Week 0
1
19TOB09PTVAPE-Z2719
BTULCHV

BTMXDCC

Battery

upper limits charging voltage

Maximum Discharging Current


DESIGN PARAMETER
SPECIFICATION TEST RESULTV1
TESTING
2696mA26962696mA
Week 0
1
20TOB09PTVAPE-Z2720
PDUVORPower Delivery Unit (PDU) voltage operating rangeDESIGN PARAMETER SPECIFICATION TEST RESULTV1

BTULCHVBattery Upper Limits Charging Voltage
DESIGN PARAMETER TESTING
4.21V4.214.21V
Week 0
1
21TOB09PTVAPE-Z2721
PDUCOR

PDUVORPDU
current operating range
Voltage Operating Range
DESIGN PARAMETER
SPECIFICATION TEST RESULTmA1
TESTING
3.65V3.653.65V
Week 0
1
22TOB09PTVAPE-Z2722
PDUWTOR

PDUCORPDU
wattage operating range
Current Operating Range
DESIGN PARAMETER
SPECIFICATION TEST RESULTW1
TESTING
1202mA12021202mA
Week 0
1
23TOB09PTVAPE-Z2723
PDUTCTOFPDU
temperature cut
Temperature Cut-off
(if applicable)

DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
69.9C
1
69.969.9C
Week 0
1
24TOB09PTVAPE-Z2724
AIRFLRTAirflow
rate
Rate
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
727L/min727
1
727L/min
Week 0
1
25TOB09PTVAPE-Z2725
PDUCRCOFPDU
current cut
Current Cut-off
(if applicable)

DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
34.8mA
1
34.834.8mA
Week 0
1
26TOB09PTVAPE-Z2726
INHAERTInhaled
aerosol temperature
Aerosol Temperature
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
36.9C
1
36.936.9C
Week 0
1
27TOB09PTVAPE-Z2727
VENTLTN

VENTLTOTTotal Ventilation
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
51%51
1
51
Week 0
%1
28TOB09PTVAPE-Z2728
ELQDVISCE-Liquid
viscosity
ViscosityTest performed at 20 degrees CelsiusDESIGN PARAMETER
SPECIFICATION TEST RESULT1
TESTING
496mPa/s496496mPa/s
Week 0
1
29TOB09PTVAPE-Z2729
ELQDVOLE-liquid
volume
Volume
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
60.1mL60.160.1
Week 0
mL1
30TOB09PTVAPE-Z2730
PNUMCNCParticle
number concentration
Number Concentration
DESIGN PARAMETER
SPECIFICATION TEST RESULT#/cm31
TESTING
511/cm3511511/cm3
Week 0
1
31TOB09PTVAPE-Z2731
CTMDDIAMCount
median diameter
Median Diameter
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
202nm202
1
202
Week 0
nm1
32TOB09PTVAPE-Z2732
PM

PM2.5Particulate Matter
PM
2.5
DESIGN PARAMETER
SPECIFICATION TEST RESULT
TESTING
24.4ug/
m3
m324.424.4ug/m3
1Week 0
1