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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.

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.

Rows 1-4: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.
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.

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOVALTOVALU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERCigarette
2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERFiltered, Combusted
3TOB07TOCIG01a3MANUFManufacturerPRODUCT IDENTIFIERJoes Cigs USA
4TOB07TOCIG01a4TRADENAMTrade NamePRODUCT IDENTIFIERTreetop Menthol King Size
5TOB07TOCIG01a5PACKTYPPackage TypePRODUCT DESCRIPTORHARD PACK
6TOB07TOCIG01a6PRDQUANProduct QuantityPRODUCT DESCRIPTOR20CIGARETTE
7TOB07TOCIG01a7LENGTHLengthPRODUCT DESCRIPTOR86.0mm
8TOB07TOCIG01a8CIRCUMFCircumferencePRODUCT DESCRIPTOR26.0mm
9TOB07TOCIG01a9VENTLTNVentilationPRODUCT DESCRIPTOR10.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorPRODUCT DESCRIPTORMENTHOL
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The manufacturing parameter specifications of the tobacco product as used are represented in the Product Design Parameters (PD) domain  The example below shows the target, minimum, and maximum values associated with each of 19 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

pd.xpt

pd.xpt

RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALUPDCOLSRT
1

TOB07

PDCIG01a

1

LENGTHLength

84

83.5

84.5

mm

TARGET
2TOB07PDCIG01a4CIRCUMFCircumference24.824.625mmTARGET
3TOB07PDCIG01a7TBFLMASSTobacco Filler Mass783753814mgTARGET
4TOB07PDCIG01a10MOISTUREMoisture1412.0913.91%TARGET
5TOB07PDCIG01a13TOCUTSIZTobacco Cut Size

22

20

24

cuts/in2

TARGET
6TOB07PDCIG01a14TOCUTSIZTobacco Cut Size

27

25

29

mm

TARGET
7TOB07PDCIG01a19FLTRVENTFilter Ventilation

30

23

37

%

TARGET
8TOB07PDCIG01a22TPNPLGTHTipping Paper Length313032mmTARGET
9TOB07PDCIG01a25CIGBPPORCigarette Base Paper PorosityNANANACORESTA Unit (Cu)TARGET
10TOB07PDCIG01a26CIGBPPORCigarette Base Paper Permeability

50

45

55

CORESTA Unit (Cu)

TARGET
11TOB07PDCIG01a31BNDPORCigarette Paper Band PorosityNANANACORESTA Unit (Cu) or cm2/sTARGET
12TOB07PDCIG01a32BNDPERMCigarette Paper Band Permeability100.213CORESTA Unit (Cu) or cm2/sTARGET
13TOB07PDCIG01a33BNDDIFCigarette Paper Band Diffusivity
NACORESTA Unit (Cu) or cm2/sNATARGET
14TOB07PDCIG01a36BNDDIFCigarette Paper Band Diffusivity
NACORESTA Unit (Cu) or cm2/sNAMINIMUM
15TOB07PDCIG01a39BNDDIFCigarette Paper Band Diffusivity
NACORESTA Unit (Cu) or cm2/sNAMAXIMUM
16TOB07PDCIG01a40CPBNDWIDCigarette Paper Band Width


7

mm

7

TARGET
17TOB07PDCIG01a41CPBNDWIDCigarette Paper Band Width
6.7mm6.7MINIMUM
18TOB07PDCIG01a42CPBNDWIDCigarette Paper Band Width
7.3mm7.3MAXIMUM
19TOB07PDCIG01a43CPBNDSPCCigarette Paper Band Space


20

mm

20

TARGET
20TOB07PDCIG01a44CPBNDSPCCigarette Paper Band Space
19.8mm19.8MINIMUM
21TOB07PDCIG01a45CPBNDSPCCigarette Paper Band Space
20.2mm20.2MAXIMUM
22TOB07PDCIG01a46FLTREFFFilter Efficiency


N/A

%

N/A

TARGET
23TOB07PDCIG01a47FLTREFFFilter Efficiency
N/A%N/AMINIMUM
24TOB07PDCIG01a48FLTREFFFilter Efficiency
N/A%N/AMAXIMUM
25TOB07PDCIG01a49DPFDenier Per Filament
4
4TARGET
26TOB07PDCIG01a50DPFDenier Per Filament
3.6
3.6MINIMUM
27TOB07PDCIG01a51DPFDenier Per Filament
4.4
4.4MAXIMUM
28TOB07PDCIG01a52TDENIERTotal Denier


30000

g/9000 m

30000

TARGET
29TOB07PDCIG01a53TDENIERTotal Denier
29100g/9000 m29100MINIMUM
30TOB07PDCIG01a54TDENIERTotal Denier
30900g/9000 m30900MAXIMUM
31TOB07PDCIG01a55FLTRDENFilter Density
0.1234g/cm30.1234TARGET
32TOB07PDCIG01a56FLTRDENFilter Density
0.105g/cm30.105MINIMUM
33TOB07PDCIG01a57FLTRDENFilter Density
0.1419g/cm30.1419MAXIMUM
34TOB07PDCIG01a58FLTRLGTHFilter Length
25mm25TARGET
35TOB07PDCIG01a59FLTRLGTHFilter Length
24.5mm24.5MINIMUM
36TOB07PDCIG01a60FLTRLGTHFilter Length
25.5mm25.5MAXIMUM
37TOB07PDCIG01a61FLTPRDRPFilter Pressure Drop
60mm H2O60TARGET
38TOB07PDCIG01a62FLTPRDRPFilter Pressure Drop
51mm H2O51MINIMUM
39TOB07PDCIG01a63FLTPRDRPFilter Pressure Drop
69mm H2O69MAXIMUM
40TOB07PDCIG01a64TORODDENTobacco Rod Density
0.2678g/cm30.2678TARGET
41TOB07PDCIG01a65TORODDENTobacco Rod Density
0.2437g/cm30.2437MINIMUM
42TOB07PDCIG01a66TORODDENTobacco Rod Density
0.2919g/cm30.2919MAXIMUM
43TOB07PDCIG01a67Cigarette Paper LengthCIGPLGTH
53mm53TARGET
44TOB07PDCIG01a68Cigarette Paper LengthCIGPLGTH
52mm52MINIMUM
45TOB07PDCIG01a69Cigarette Paper LengthCIGPLGTH
54mm54MAXIMUM
$warningHtml

The Tobacco Product Testing (PT) domain is used to represent the actual results of testing for conformance to the tobacco product design parameters shown in PD above. 


pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDPTSEQPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTMATRIXPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PTCIG01a

1

LENGTHLength

83.9

mm

83.9

83.9

mm


1Week 01
2TOB07PTCIG01a2CIRCUMFCircumference24.9mm24.924.9mm


1Week 01
3TOB07PTCIG01a3TBFLMASSTobacco Filler Mass779mg779779mg


1Week 01
4TOB07PTCIG01a4MOISTUREMoisture13.1%13.113.1%


1Week 01
5TOB07PTCIG01a5TOCUTSIZ1Tobacco Cut Size 122cuts per inch2222cuts per inch


1Week 01
6TOB07PTCIG01a6TOCUTSIZ2Tobacco Cut Size 227mm2727mm


1Week 01
7TOB07PTCIG01a7FLTRVENTFilter Ventilation35%3535%


1Week 01
8TOB07PTCIG01a8TPNPLGTHTipping Paper Length30mm3030mm


1Week 01
9TOB07PTCIG01a9CIGBPPORCigarette Base Paper PorosityN/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)


1Week 01
10TOB07PTCIG01a10CIGBPPERMCigarette Base Paper Permeability50cm2/s5050cm2/s


1Week 01
11TOB07PTCIG01a11BNDDIFCigarette Paper Band PorosityN/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)


1Week 01
12TOB07PTCIG01a12BNDDIFCigarette Paper Band Permeability10cm^2/s1010cm2/s


1Week 01
13TOB07PTCIG01a13BNDDIFCigarette Paper Band DiffusivityN/A
N/AN/A



1Week 01
14TOB07PTCIG01a14CPBNDWIDCigarette Paper Band Width7.1mm7.17.1mm


1Week 01
15TOB07PTCIG01a15CPBNDSPCCigarette Paper Band Space19.9mm19.919.9mm


1Week 01
16TOB07PTCIG01a16FLTREFFFilter EfficiencyN/A%N/AN/A%


1Week 01
17TOB07PTCIG01a17DPFDenier Per Filament4.1
4.14.1/filament


1Week 01
18TOB07PTCIG01a18DENIERTotal Denier29900g/9000m2990029900g/9000m


1Week 01
19TOB07PTCIG01a19FLTRDENFilter Density0.1112g/cm30.11120.1112g/cm3


1Week 01
20TOB07PTCIG01a20FLTRLGTHFilter Length25mm2525mm


1Week 01
21TOB07PTCIG01a21FLTPRDRPFilter Pressure Drop62mm H2O6262mm H2O


1Week 01
22TOB07PTCIG01a22TORODDENTobacco Rod Density0.2701g/cm30.27010.2701g/cm3


1Week 01
23TOB07PTCIG01a23CIGPLGTHCigarette Paper Length53mm5353mm


1Week 01
$warningHtml



References:

  1. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/


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