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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.

Steve H's suggestion of combining our  previous product identifiers and product descriptors into a single dataset. This is a more traditional findings dataset structure. Advantages: it doesn't break any rules. SPTOBID is the Sponsor-defined Tobacco Product Identifier, and serves as the "subject" of all records since these are not (human) subject-level data.

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

RowSTUDYIDDOMAINSPTOBIDTOSEQTOTESTCDTOTESTTOCATTOORRESTOORRESUTOSTRESCTOSTRESNTOSTRESU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERCigarette
Cigarette

2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERFiltered, Combusted
Filtered, Combusted

3TOB07TOCIG01a3MANUFManufacturerPRODUCT IDENTIFIERJoes Cigs USA
Joes Cigs USA

4TOB07TOCIG01a4TRADENAMTrade NamePRODUCT IDENTIFIERTreetop Menthol King Size
Treetop Menthol King Size

5TOB07TOCIG01a5PACKTYPPackage TypePRODUCT DESCRIPTORHARD PACK
HARD PACK

6TOB07TOCIG01a6PRDQUANProduct QuantityPRODUCT DESCRIPTOR20CIGARETTE2020CIGARETTE
7TOB07TOCIG01a7LENGTHLengthPRODUCT DESCRIPTOR86.0mm86.086.0mm
8TOB07TOCIG01a8CIRCUMFCircumferencePRODUCT DESCRIPTOR26.0mm26.026.0mm
9TOB07TOCIG01a9VENTLTNVentilationPRODUCT DESCRIPTOR10.0%10.010.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorPRODUCT DESCRIPTORMENTHOL
MENTHOL

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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

pd.xpt

pd.xpt

RowSTUDYIDDOMAINSPTOBIDPDSEQPDTESTCDPDTESTPDCATPDORRESPDORRESUPDSTRESCPDSTRESNPDSTRESUPDCOLSRT
1

TOB07

PDCIG01a

1

LENGTHLengthDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
2TOB07PDCIG01a2LENGTHLengthDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
3TOB07PDCIG01a3LENGTHLengthDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
4TOB07PDCIG01a4CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
5TOB07PDCIG01a5CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
6TOB07PDCIG01a6CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
7TOB07PDCIG01a7TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION
mg

mgTARGET
8TOB07PDCIG01a8TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION
mg

mgMINIMUM
9TOB07PDCIG01a9TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATION
mg

mgMAXIMUM
10TOB07PDCIG01a10MOISTUREMoistureDESIGN PARAMETER SPECIFICATION
%

%TARGET
11TOB07PDCIG01a11MOISTUREMoistureDESIGN PARAMETER SPECIFICATION
%

%MINIMUM
12TOB07PDCIG01a12MOISTUREMoistureDESIGN PARAMETER SPECIFICATION
%

%MAXIMUM
13TOB07PDCIG01a13TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION
cuts per inch2

cuts per inch2TARGET
14TOB07PDCIG01a14TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
15TOB07PDCIG01a15TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION
cuts per inch2

cuts per inch2MINIMUM
16TOB07PDCIG01a16TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
17TOB07PDCIG01a17TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION
cuts per inch2

cuts per inch2MAXIMUM
18TOB07PDCIG01a18TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
19TOB07PDCIG01a19FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION
%

%TARGET
20TOB07PDCIG01a20FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION
%

%MINIMUM
21TOB07PDCIG01a21FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION
%

%MAXIMUM
22TOB07PDCIG01a22TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
23TOB07PDCIG01a23TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
24TOB07PDCIG01a24TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
25TOB07PDCIG01a25CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu)

CORESTA Unit (Cu)TARGET
26TOB07PDCIG01a26CIGBPPORCigarette Base Paper PermeabilityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu)

CORESTA Unit (Cu)TARGET
27TOB07PDCIG01a27CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu)

CORESTA Unit (Cu)MINIMUM
28TOB07PDCIG01a28CIGBPPORCigarette Base Paper PermeabilityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu)

CORESTA Unit (Cu)MINIMUM
29TOB07PDCIG01a29CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu)

CORESTA Unit (Cu)MAXIMUM
30TOB07PDCIG01a30CIGBPPORCigarette Base Paper PermeabilityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu)

CORESTA Unit (Cu)MAXIMUM
31TOB07PDCIG01a31BNDPORCigarette Paper Band PorosityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sTARGET
32TOB07PDCIG01a32BNDPERMCigarette Paper Band PermeabilityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sTARGET
33TOB07PDCIG01a33BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sTARGET
34TOB07PDCIG01a34BNDPORCigarette Paper Band PorosityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sMINIMUM
35TOB07PDCIG01a35BNDPERMCigarette Paper Band PermeabilityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sMINIMUM
36TOB07PDCIG01a36BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sMINIMUM
37TOB07PDCIG01a37BNDPORCigarette Paper Band PorosityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sMAXIMUM
38TOB07PDCIG01a38BNDPERMCigarette Paper Band PermeabilityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sMAXIMUM
39TOB07PDCIG01a39BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or cm2/s

CORESTA Unit (Cu) or cm2/sMAXIMUM
40TOB07PDCIG01a40CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
41TOB07PDCIG01a41CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
42TOB07PDCIG01a42CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
43TOB07PDCIG01a43CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
44TOB07PDCIG01a44CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
45TOB07PDCIG01a45CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
46TOB07PDCIG01a46FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION
%

%TARGET
47TOB07PDCIG01a47FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION
%

%MINIMUM
48TOB07PDCIG01a48FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION
%

%MAXIMUM
49TOB07PDCIG01a49DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION



/filamentTARGET
50TOB07PDCIG01a50DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION



/filamentMINIMUM
51TOB07PDCIG01a51DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION



/filamentMAXIMUM
52TOB07PDCIG01a52TDENIERTotal DenierDESIGN PARAMETER SPECIFICATION
g/9000 m

g/9000 mTARGET
53TOB07PDCIG01a53TDENIERTotal DenierDESIGN PARAMETER SPECIFICATION
g/9000 m

g/9000 mMINIMUM
54TOB07PDCIG01a54TDENIERTotal DenierDESIGN PARAMETER SPECIFICATION
g/9000 m

g/9000 mMAXIMUM
55TOB07PDCIG01a55FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3TARGET
56TOB07PDCIG01a56FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3MINIMUM
57TOB07PDCIG01a57FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3MAXIMUM
58TOB07PDCIG01a58FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
59TOB07PDCIG01a59FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
60TOB07PDCIG01a60FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
61TOB07PDCIG01a61FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATION
mm H2O

mm H2OTARGET
62TOB07PDCIG01a62FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATION
mm H2O

mm H2OMINIMUM
63TOB07PDCIG01a63FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATION
mm H2O

mm H2OMAXIMUM
64TOB07PDCIG01a64TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3TARGET
65TOB07PDCIG01a65TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3MINIMUM
66TOB07PDCIG01a66TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATION
g/cm3

g/cm3MAXIMUM
67TOB07PDCIG01a67Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATION
mm

mmTARGET
68TOB07PDCIG01a68Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATION
mm

mmMINIMUM
69TOB07PDCIG01a69Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATION
mm

mmMAXIMUM
$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

RowSTUDYIDDOMAINSPTOBIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PTCIG01a

1

LENGTHLengthDESIGN PARAMETER TESTING
mm

mm



1Week 01
2TOB07PTCIG01a2CIRCUMFCircumferenceDESIGN PARAMETER TESTING
mm

mm






3TOB07PTCIG01a3TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING
mg

mg






4TOB07PTCIG01a4MOISTUREMoistureDESIGN PARAMETER TESTING
%

%






5TOB07PTCIG01a5TOCUTSIZ1Tobacco Cut Size 1DESIGN PARAMETER TESTING
cuts per inch

cuts per inch






6TOB07PTCIG01a5TOCUTSIZ2Tobacco Cut Size 2DESIGN PARAMETER TESTING
mm

mm






7TOB07PTCIG01a6FLTRVENTFilter VentilationDESIGN PARAMETER TESTING
%

%






8TOB07PTCIG01a7TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING
mm

mm






9TOB07PTCIG01a8CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTING
CORESTA Unit (Cu)

CORESTA Unit (Cu)






10TOB07PTCIG01a8CIGBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING
cm2/s

cm2/s






11TOB07PTCIG01a9BNDDIFCigarette Paper Band PorosityDESIGN PARAMETER TESTING
CORESTA Unit (Cu)

CORESTA Unit (Cu)






12TOB07PTCIG01a9BNDDIFCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING
cm^2/s

cm2/s






13TOB07PTCIG01a9BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTING











14TOB07PTCIG01a10CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING
mm

mm






15TOB07PTCIG01a11CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING
mm

mm






16TOB07PTCIG01a12FLTREFFFilter EfficiencyDESIGN PARAMETER TESTING
%

%






17TOB07PTCIG01a13DPFDenier Per FilamentDESIGN PARAMETER TESTING



/filament






18TOB07PTCIG01a14DENIERTotal DenierDESIGN PARAMETER TESTING
g/9000m

g/9000m






19TOB07PTCIG01a15FLTRDENFilter DensityDESIGN PARAMETER TESTING
g/cm3

g/cm3






20TOB07PTCIG01a16FLTRLGTHFilter LengthDESIGN PARAMETER TESTING
mm

mm






21TOB07PTCIG01a17FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING
mm H2O

mm H2O






22TOB07PTCIG01a18TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING
g/cm3

g/cm3






23TOB07PTCIG01a19CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING
mm

mm






$warningHtml

pt.xpt

pt.xpt

Row
STUDYIDDOMAINSPTOBIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTSPCCNDPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1

1

TOB07PTCIG01a

1

LENGTHLengthDESIGN PARAMETER TESTING
mm

mm



1Week 01
22TOB07PTCIG01a2CIRCUMFCircumferenceDESIGN PARAMETER TESTING
mm

mm



1Week 01
33TOB07PTCIG01a3TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING
mg

mg



1Week 01
44TOB07PTCIG01a4MOISTUREMoistureDESIGN PARAMETER TESTING
%

%



1Week 01
55TOB07PTCIG01a5TOCUTSIZ1Tobacco Cut Size 1DESIGN PARAMETER TESTING
cuts per inch

cuts per inch



1Week 01
66TOB07PTCIG01a6TOCUTSIZ2Tobacco Cut Size 2DESIGN PARAMETER TESTING
mm

mm



1Week 01
77TOB07PTCIG01a7FLTRVENTFilter VentilationDESIGN PARAMETER TESTING
%

%



1Week 01
88TOB07PTCIG01a8TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING
mm

mm



1Week 01
99TOB07PTCIG01a9CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTING
CORESTA Unit (Cu)

CORESTA Unit (Cu)



1Week 01
1010TOB07PTCIG01a10CIGBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING
cm2/s

cm2/s



1Week 01
1111TOB07PTCIG01a11BNDDIFCigarette Paper Band PorosityDESIGN PARAMETER TESTING
CORESTA Unit (Cu)

CORESTA Unit (Cu)



1Week 01
1212TOB07PTCIG01a12BNDDIFCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING
cm^2/s

cm2/s



1Week 01
1313TOB07PTCIG01a13BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTING








1Week 01
1414TOB07PTCIG01a14CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING
mm

mm



1Week 01
1515TOB07PTCIG01a15CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING
mm

mm



1Week 01
1616TOB07PTCIG01a16FLTREFFFilter EfficiencyDESIGN PARAMETER TESTING
%

%



1Week 01
1717TOB07PTCIG01a17DPFDenier Per FilamentDESIGN PARAMETER TESTING



/filament



1Week 01
1818TOB07PTCIG01a18DENIERTotal DenierDESIGN PARAMETER TESTING
g/9000m

g/9000m



1Week 01
1919TOB07PTCIG01a19FLTRDENFilter DensityDESIGN PARAMETER TESTING
g/cm3

g/cm3



1Week 01
2020TOB07PTCIG01a20FLTRLGTHFilter LengthDESIGN PARAMETER TESTING
mm

mm



1Week 01
2121TOB07PTCIG01a21FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING
mm H2O

mm H2O



1Week 01
2222TOB07PTCIG01a22TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING
g/cm3

g/cm3



1Week 01
2323TOB07PTCIG01a23CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING
mm

mm



1Week 01

Dataset Debug Message

There seems to be a variable name missing in the heading row.



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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