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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

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.

This is an example for the required tobacco product categorization, property description, and design parameter information in an FDA marketing application 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 FDA final rule and guidance documents for tobacco products Premarket Authorization (PMTA) and Substantial Equivalence (SE) Pathways. The applicant submitting for SE and PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

Tobacco Products (TO) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. It is similar to Device Identifiers (DI) in function. 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, model (product) name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID) (similar to Sponsor Device Identifier (SPDEVID) a consistent variable, that is available for use in other domains where data pertaining to the product may be found.This example 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. 

Show the records for the product identifiers for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT IDENTIFIERS.
Dataset wrap
Nameto
Rowcaps
Rows 1-4:
Rows 5-10:Show the records for the product descriptors for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT DESCRIPTOR.
Dataset2
RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOSCATTOVALTOVALU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIER
Cigarette
Cigarettes
2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERFiltered
, Combusted

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
9TOB07TOCIG01a9
VENTLTN
VENTLTOTTotal VentilationNEW PRODUCTPRODUCT DESCRIPTOR10.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTORMENTHOL

The manufacturing parameter specifications of the cigarette tobacco product as used intended for use are represented in the Product Design Parameters ( PD ) domain  The following example below shows the target, minimum, and maximum values associated with each of 19 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
PDCOLSRT471013141922252631323343462752305556586163646769
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1

TOB07

PDCIG01a


1

LENGTHLength

84

83.5

84.5

mm

TARGET

2TOB07PDCIG01a
2CIRCUMFCircumference24.824.625mmTARGET
3TOB07PDCIG01a
3TBFLMASSTobacco Filler Mass783753814mgTARGET
4TOB07PDCIG01a
4MOISTUREMoisture141312.0913.9114%TARGET
5TOB07PDCIG01a

Burley tobacco

5TOCUTSIZTobacco Cut Size

22

20

24

cuts/in2in

TARGET
6TOB07PDCIG01a

Reconstituted tobacco

6TOCUTSIZTobacco Cut Size

27

25

29

mm

TARGET

7TOB07PDCIG01a


7FLTRVENTVENTLFLTFilter Ventilation

30

23

37

%

TARGET

8TOB07PDCIG01a
8TPNPLGTHTipping Paper Length313032mmTARGET
9TOB07PDCIG01a
9CIGBPPORCBPPOR

Cigarette Base Paper Porosity

NA

50

NA

45

NA55CORESTA Unit (Cu)TARGET
10TOB07PDCIG01a


10CIGBPPORCBPPERMCigarette Base Paper Permeability

50

45

55

CORESTA Unit (Cu)

TARGET
11TOB07PDCIG01a
11BNDPORCPBPORCigarette Paper Band PorosityNA10NA0.2NA13CORESTA Unit (Cu) or cm2/sTARGET
12TOB07PDCIG01a
12BNDPERMCPBPERMCigarette Paper Band Permeability100.213CORESTA Unit (Cu) or cm2/sTARGET
13TOB07PDCIG01a
13BNDDIF

CPBDIFF

Cigarette Paper Band DiffusivityNACORESTA Unit (Cu) or cm2/sNATARGET14TOB07PDCIG01a36BNDDIFCigarette Paper Band DiffusivityNA0.050.0010.100CORESTA Unit (Cu) or cm2/sNAMINIMUM
1514TOB07PDCIG01a39BNDDIFCigarette Paper Band DiffusivityNACORESTA Unit (Cu) or cm2/sNAMAXIMUM


14CPBWID16TOB07PDCIG01a40CPBNDWIDCigarette Paper Band Width

7

mm

7

TARGET17TOB07PDCIG01a41CPBNDWIDCigarette Paper Band Width6.

7

mm

6.7

MINIMUM18TOB07PDCIG01a

42CPBNDWIDCigarette Paper Band Width7.3

mm

157.3MAXIMUM19TOB07PDCIG01a


15CPBNDSPCCPBSPCCigarette Paper Band Space20mm

20

TARGET20TOB07PDCIG01a44CPBNDSPCCigarette Paper Band Space

19.8

mm19.8MINIMUM21TOB07PD

CIG01a45CPBNDSPCCigarette Paper Band Space20.2

mm

20.2MAXIMUM
1622TOB07PDCIG01a


16FLTREFFFilter Efficiency

N/A30

%

N/A

TARGET23TOB07PDCIG01a47FLTREFFFilter EfficiencyN/A%N/AMINIMUM

25

35

%

1724TOB07PDCIG01a48FLTREFFFilter EfficiencyN/A%N/AMAXIMUM


1725TOB07PDCIG01a49DPFDenier Per Filament44TARGET26TOB07PDCIG01a50DPFDenier Per Filament3.63.6MINIMUMTOB07PDCIG01a51DPFDenier Per Filament4.44.4


18MAXIMUM28TOB07PDCIG01a


18TDENIERTotal Denier

30000

g/9000 m

30000

TARGET29TOB07PDCIG01a53TDENIERTotal Denier29100g/9000 m

29100

MINIMUM

TOB07PDCIG01a54TDENIERTotal Denier30900

g/

9000 m
30900MAXIMUM

9000m

1931TOB07PDCIG01a
19FLTRDENFilter Density0.1234g/cm30.1234TARGET32TOB07PDCIG01aFLTRDENFilter Density0.105g/cm30.105MINIMUM33TOB07PDCIG01a57FLTRDENFilter Density0.1419g/cm30.1419MAXIMUM
2034TOB07PDCIG01a
20FLTRLGTHFilter Length25mm25TARGET35TOB07PDCIG01a59FLTRLGTHFilter Length24.5mm24.5MINIMUM36TOB07PDCIG01a60FLTRLGTHFilter Length25.5mm25.5MAXIMUM
2137TOB07PDCIG01a
21FLTPRDRPFilter Pressure Drop60mm H2O60TARGET38TOB07PDCIG01a62FLTPRDRPFilter Pressure Drop51mm H2O51MINIMUM39TOB07PDCIG01aFLTPRDRPFilter Pressure Drop69mm H2O69MAXIMUM
4022TOB07PDCIG01a
22TORODDENTobacco Rod Density0.2678g/cm30.2678TARGET41TOB07PDCIG01a65TORODDENTobacco Rod Density0.2437g/cm30.2437MINIMUM42TOB07PDCIG01a66TORODDENTobacco Rod Density0.2919g/cm30.2919MAXIMUM
4323TOB07PDCIG01a
23Cigarette Paper LengthCIGPLGTH53mm53TARGET44TOB07PDCIG01a68Cigarette Paper LengthCIGPLGTH5352mm52MINIMUM45TOB07PDCIG01aCigarette Paper LengthCIGPLGTH54mm54MAXIMUM

The Tobacco Product Testing (PT) 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
Dataset2
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU
PTMATRIX
PTMETHOD
PTLLOQ
PTREPNUM
PTTPTPTTPTNUM
1TOB07PTCIG01a

1

LENGTHLengthDESIGN PARAMETER TESTING

83.9

mm

83.9

83.9

mm
1
Week 01
2TOB07PTCIG01a
2CIRCUMFCircumferenceDESIGN PARAMETER TESTING24.9mm24.924.9mm
1Week 0

1
3TOB07PTCIG01a
3TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING779mg779779mg
1Week 0

1
4TOB07PTCIG01a
4MOISTUREMoistureDESIGN PARAMETER TESTING13.1%13.113.1%
1
Week 01
5TOB07PTCIG01a

Burley tobacco

5
TOCUTSIZ1
TOCUTSIZTobacco Cut Size
1
DESIGN PARAMETER TESTING22cuts
per inch
/in2222cuts
per inch1Week 0
/in
1
6TOB07PTCIG01a

Reconstituted tobacco

6
TOCUTSIZ2
TOCUTSIZTobacco Cut Size
2
DESIGN PARAMETER TESTING27mm2727mm
1
Week 0
1
7TOB07PTCIG01a
7
FLTRVENT
VENTLFLTFilter VentilationDESIGN PARAMETER TESTING35%3535%
1Week 0

1
8TOB07PTCIG01a
8TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING30mm3030mm
1
Week 01
9TOB07PTCIG01a
9
CIGBPPOR
CBPPORCigarette Base Paper Porosity
N/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)1Week 01
DESIGN PARAMETER TESTING48Cu4848Cu
1
10TOB07PTCIG01a
10
CIGBPPERM
CBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING50
cm2/sWeek 0
Cu5050
cm2/s1
Cu
1
11TOB07PTCIG01a
11
BNDDIF
CPBPORCigarette Paper Band Porosity
N/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)1Week 01
DESIGN PARAMETER TESTING9.8Cu9.89.8Cu
1
12TOB07PTCIG01a
12
BNDDIF
CPBPERMCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING10
cm^2/s
Cu1010
cm2/s
Cu
1
Week 01
13TOB07PTCIG01a
13
BNDDIF
CPBDIFFCigarette Paper Band Diffusivity
N/AN/AN/A1Week 0
DESIGN PARAMETER TESTING0.06cm2/s0.060.06cm2/s
1
14TOB07PTCIG01a
14
CPBNDWID
CPBWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING7.1mm7.17.1mm
1
Week 0
1
15TOB07PTCIG01a
15
CPBNDSPC
CPBSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING19.9mm19.919.9mm
1
Week 0
1
16TOB07PTCIG01a
16FLTREFFFilter Efficiency
DESIGN PARAMETER TESTING28
N/A
%
N/A
2828
N/A
%
1
Week 01
17TOB07PTCIG01a
17DPFDenier Per FilamentDESIGN PARAMETER TESTING4.1
4.14.1
/filament


1
Week 0
1
18TOB07PTCIG01a
18
DENIER
TDENIERTotal DenierDESIGN PARAMETER TESTING29900g/9000m2990029900g/9000m
1Week 0

1
19TOB07PTCIG01a
19FLTRDENFilter DensityDESIGN PARAMETER TESTING0.1112g/cm30.11120.1112g/cm3
1
Week 01
20TOB07PTCIG01a
20FLTRLGTHFilter LengthDESIGN PARAMETER TESTING25mm2525mm
1Week 0

1
21TOB07PTCIG01a
21FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING62mm H2O6262mm H2O
1
Week 01
22TOB07PTCIG01a
22TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING0.2701g/cm30.27010.2701g/cm3
1
Week 01
23TOB07PTCIG01a
23CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING53mm5353mm
1Week 0

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