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This is an example for the required design parameter information in a PMTA submission for one type of tobacco product Cigarette. There are many more and various types of tobacco products, and their parameters can be found in the in the PMTA Final Rule. The applicant submitting for PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results for all these parameters.

Device Identifiers (DI) is a study reference dataset that provides a mechanism for uniquely identifying a device. The primary purpose of this dataset is to provide a list of the devices used in a study and to provide identifying information for each device, such as device type, manufacturer, model name, etc., as applicable. All identifying information is grouped by the Sponsor Device Identifier (SPDEVID), a consistent variable, that is available for use in other domains where data pertaining to the device may be found.

...

Namedi

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illustrates the representation of a cigarette product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors. 

Dataset wrap
Nameto
Dataset2
RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOSCATTOVALTOVALU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIERCigarettes
2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERFiltered
3TOB07TOCIG01a3MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Cigs USA
4TOB07TOCIG01a4TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIERTreetop Menthol King Size
5TOB07TOCIG01a5PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORHARD PACK
6TOB07TOCIG01a6PRDQUANProduct QuantityNEW PRODUCTPRODUCT DESCRIPTOR20CIGARETTE
7TOB07TOCIG01a7LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR86.0mm
8TOB07TOCIG01a8CIRCUMFCircumferenceNEW PRODUCTPRODUCT DESCRIPTOR26.0mm
9TOB07TOCIG01a9VENTLTOTTotal VentilationNEW PRODUCTPRODUCT DESCRIPTOR10.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTORMENTHOL

The manufacturing parameter specifications of the cigarette tobacco product as intended for use are represented in the PD domain  The following example shows the target, minimum, and maximum values associated with each of 23 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

Note the use of the variable IGDCMPID (Ingredient or Component Identifier) in rows 5-6. This tobacco product had 2 tobacco ingredients with 2 different tobacco cut sizes. IGDCMPID identifies to which tobacco ingredient the cut size applies. IGDCMPID originates in the IT (Tobacco Ingredients) and IN (Non-Tobacco Ingredients) domains. See Section 3.1.3.1, Ingredients and Additives, for more information.

Dataset wrap
Namepd
Dataset2
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1

TOB07

PDCIG01a


1

LENGTHLength

84

83.5

84.5

mm

2TOB07PDCIG01a
2CIRCUMFCircumference24.824.625mm
3TOB07PDCIG01a
3TBFLMASSTobacco Filler Mass783753814mg
4TOB07PDCIG01a
4MOISTUREMoisture131214%
5TOB07PDCIG01a

Burley tobacco

5TOCUTSIZTobacco Cut Size

22

20

24

cuts/in

6TOB07PDCIG01a

Reconstituted tobacco

6TOCUTSIZTobacco Cut Size

27

25

29

mm

7TOB07PDCIG01a


7VENTLFLTFilter Ventilation

30

23

37

%

8TOB07PDCIG01a
8TPNPLGTHTipping Paper Length313032mm
9TOB07PDCIG01a
9CBPPOR

Cigarette Base Paper Porosity

50

45

55Cu
10TOB07PDCIG01a


10CBPPERMCigarette Base Paper Permeability

50

45

55

Cu

11TOB07PDCIG01a
11CPBPORCigarette Paper Band Porosity100.213Cu
12TOB07PDCIG01a
12CPBPERMCigarette Paper Band Permeability100.213Cu
13TOB07PDCIG01a
13

CPBDIFF

Cigarette Paper Band Diffusivity0.050.0010.100cm2/s
14TOB07PDCIG01a


14CPBWIDCigarette Paper Band Width

7

6.7

7.3

mm

15TOB07PDCIG01a


15CPBSPCCigarette Paper Band Space20

19.8

20.2

mm

16TOB07PDCIG01a


16FLTREFFFilter Efficiency

30

25

35

%

17TOB07PDCIG01a


17DPFDenier Per Filament43.64.4


18TOB07PDCIG01a


18TDENIERTotal Denier

30000

29100

30900

g/9000m

19TOB07PDCIG01a
19FLTRDENFilter Density0.12340.1050.1419g/cm3
20TOB07PDCIG01a
20FLTRLGTHFilter Length2524.525.5mm
21TOB07PDCIG01a
21FLTPRDRPFilter Pressure Drop605169mm H2O
22TOB07PDCIG01a
22TORODDENTobacco Rod Density0.26780.24370.2919g/cm3
23TOB07PDCIG01a
23CIGPLGTHCigarette Paper Length535254mm

Finally, the PT domain is used to represent the actual results of testing the manufactured cigarette product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. As described in the PD example, IGDCMPID is also used here to differentiate 2 records of the same test performed on each of 2 different types of tobacco that are ingredients of the tobacco product. 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.

Dataset wrap
Namept

...

The Device-In-Use (DU) domain represents properties of the device as used. The DU domain now contains information that was previously found in the Device Properties (DO) domain).  The domain now captures characteristics and properties of a device that do not change and can include characteristics and properties that can vary from subject to subject (not applicable here but added for reviewers comprehension). This is a findings domain and defines important characteristics of a device that the sponsor wishes to include in the submission but do not form part of the unique sponsor-defined identification of the device. Each property is identified using controlled terminology and is stored in DUTESTCD/DUTEST.

Shows the heat source is xxx.  HARD PACK
Dataset wrap
Namedu
Rowcaps
Rows 1-4:Show the package type is a hard pack that each contain 20 cigarettes that are 86.0 mm long and 26.0 mm in circumference.
Row 5:Shows the ventilation flow expressed as a percentage. Ventilation is the aspiration of atmospheric air in an unlit cigarette. (ISO 9512:2019) - 1
Row 6:Shows the characterizing flavor is menthol for this package of cigarettes.
Row 7:
Dataset2
RowSTUDYIDDOMAIN
SPDEVIDDUSEQDUTESTCDDUTESTDUCATDUSCATDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU1TOB08
SPTOBIDIGDCMPIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTMETHODPTREPNUM
1TOB07PT
DU
CIG01a

1

PACKTYPPackage TypeCIGARETTEFILTERED, COMBUSTEDHARD PACK
LENGTHLengthDESIGN PARAMETER TESTING

83.9

mm

83.9

83.9

mm
1
2TOB07
DU
PTCIG01a
2
PRDQUAN
CIRCUMF
Product QuantityCIGARETTE FILTERED, COMBUSTED20CIGARETTE2020
CircumferenceDESIGN PARAMETER TESTING24.9mm24.924.9mm
1
CIGARETTE
3TOB07
DU
PTCIG01a
3
LENGTHLengthCIGARETTEFILTERED, COMBUSTED86.0mm86.086.0mm4TOB07DUCIG01a4DIAMETERDiameterCIGARETTEFILTERED, COMBUSTED26.0mm26.026.0mm5TOB07DUCIG01a5VENTLTNVentilationCIGARETTEFILTERED, COMBUSTED10.0%10.010.0%6TOB07DUCIG01a6CHARFLAVCharacterizing FlavorCIGARETTEFILTERED, COMBUSTEDMENTHOL7TOB07DUCIG01a7HTSOURCEHeat SourceCIGARETTEFILTERED, COMBUSTED xxx

This images shows the filtration zone where the ventilation occurs.

Image Removed

Question - is this helpful?  Will need permission.  This is from the second reference.

References:

TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING779mg779779mg
1
4TOB07PTCIG01a
4MOISTUREMoistureDESIGN PARAMETER TESTING13.1%13.113.1%
1
5TOB07PTCIG01a

Burley tobacco

5TOCUTSIZTobacco Cut SizeDESIGN PARAMETER TESTING22cuts/in2222cuts/in
1
6TOB07PTCIG01a

Reconstituted tobacco

6TOCUTSIZTobacco Cut SizeDESIGN PARAMETER TESTING27mm2727mm
1
7TOB07PTCIG01a
7VENTLFLTFilter VentilationDESIGN PARAMETER TESTING35%3535%
1
8TOB07PTCIG01a
8TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING30mm3030mm
1
9TOB07PTCIG01a
9CBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTING48Cu4848Cu
1
10TOB07PTCIG01a
10CBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING50Cu5050Cu
1
11TOB07PTCIG01a
11CPBPORCigarette Paper Band PorosityDESIGN PARAMETER TESTING9.8Cu9.89.8Cu
1
12TOB07PTCIG01a
12CPBPERMCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING10Cu1010Cu
1
13TOB07PTCIG01a
13CPBDIFFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTING0.06cm2/s0.060.06cm2/s
1
14TOB07PTCIG01a
14CPBWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING7.1mm7.17.1mm
1
15TOB07PTCIG01a
15CPBSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING19.9mm19.919.9mm
1
16TOB07PTCIG01a
16FLTREFFFilter EfficiencyDESIGN PARAMETER TESTING28%2828%
1
17TOB07PTCIG01a
17DPFDenier Per FilamentDESIGN PARAMETER TESTING4.1
4.14.1

1
18TOB07PTCIG01a
18TDENIERTotal DenierDESIGN PARAMETER TESTING29900g/9000m2990029900g/9000m
1
19TOB07PTCIG01a
19FLTRDENFilter DensityDESIGN PARAMETER TESTING0.1112g/cm30.11120.1112g/cm3
1
20TOB07PTCIG01a
20FLTRLGTHFilter LengthDESIGN PARAMETER TESTING25mm2525mm
1
21TOB07PTCIG01a
21FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING62mm H2O6262mm H2O
1
22TOB07PTCIG01a
22TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING0.2701g/cm30.27010.2701g/cm3
1
23TOB07PTCIG01a
23CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING53mm5353mm
1

References:

  1. International Organization for Standardization. ISO 9512:2019(en) - Cigarettes — Determination of ventilation — Definitions and measurement principles. ISO; June 2019. Accessed October 15, 2023. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
  2. Song M-A, Benowitz NL, Berman M, et al. Cigarette filter ventilation and its relationship to increasing rates of lung adenocarcinoma. J Natl Cancer Inst. 2017;109(12):djx075. https://wwwdoi.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/org/10.1093/jnci/djx075