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changes.mady.by.user Jon Neville

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title	Tobacco domains

DI = TO for Tobacco Product Identifier

SPDEVID = SPTOBID for Sponsor Tobacco Device Identifier

DO/DU = Tobacco Design Parameters (DP)

LB = Tobacco Product Testing (TT)

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.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.

rowcaps

Dataset wrap

Name	to

TOSTRESU

Rows 1-4:

Show the records for a tobacco product identifiers that were previously represented in a separate DI dataset

Rows 5-10:

Show the product descriptors which we would have originally put in a DO-like dataset.

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ

TOTESTCD

TOPARMCD

TOTEST

TOPARM	TOCAT

TOORRES

TOSCAT

TOORRESU

TOSTRESC

TOSTRESN

TOVAL	TOVALU
1	TOB07	TO	CIG01a	1	TBPRDCAT	Tobacco Product Category	NEW PRODUCT	PRODUCT IDENTIFIER

Cigarette

Cigarettes

Cigarette


2	TOB07	TO	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory	NEW PRODUCT	PRODUCT IDENTIFIER

Filtered, Combusted

Filtered

, Combusted


3	TOB07	TO	CIG01a	3	MANUF	Manufacturer	NEW PRODUCT	PRODUCT IDENTIFIER

Joes Cigs USA

	Joes Cigs USA
4	TOB07	TO	CIG01a	4	TRADENAM	Trade Name	NEW PRODUCT	PRODUCT IDENTIFIER	Treetop Menthol King Size

Treetop Menthol King Size


5	TOB07	TO	CIG01a	5	PACKTYP	Package Type	NEW PRODUCT	PRODUCT DESCRIPTOR

HARD PACK

	HARD PACK
6	TOB07	TO	CIG01a	6	PRDQUAN	Product Quantity	NEW PRODUCT	PRODUCT DESCRIPTOR	20	CIGARETTE

2020CIGARETTE

TOB07

CIG01a

LENGTH

Length

NEW PRODUCT

PRODUCT DESCRIPTOR

86.0

mm
8	TOB07	TO	CIG01a	8	CIRCUMF	Circumference	NEW PRODUCT	PRODUCT DESCRIPTOR

26.0

mm
9	TOB07	TO	CIG01a	9

VENTLTN

VENTLTOT	Total Ventilation	NEW PRODUCT	PRODUCT DESCRIPTOR	10.0	%
10

10.0%10

TOB07

CIG01a

CHARFLAV

Characterizing Flavor

NEW PRODUCT

PRODUCT DESCRIPTOR

MENTHOL

The Tobacco Product Design Parameters (DP) represents the manufacturing parameter specifications of the cigarette tobacco product as used. The example below intended for use are represented in the PD domain The following example shows the target, minimum, and maximum values associated with each of 19 23 separate design parameters. These parameters are defined as manufacturing guidelinesspecifications, 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.

TARGET

Dataset wrap

Name	dppd

Dataset2

Row	STUDYID	DOMAIN	SPTOBID

DPSEQ

IGDCMPID

DPTESTCD

PDSEQ

DPTEST

PDPARMCD

DPCAT

PDPARM

DPORRES

PDVALTRG

DPORRESU

PDVALMIN

DPSTRESC

PDVALMAX

DPSTRESN

PDVALU

DPSTRESU

DPCOLSRT

TOB07

CIG01a

LENGTH

Length

DESIGN PARAMETER SPECIFICATION

	84	83.5	84.5	mm
2	TOB07

CIG01a

CIRCUMF

LENGTH

Circumference

LengthDESIGN PARAMETER SPECIFICATION

24.8

24.6

MINIMUM

TOB07

CIG01a

LENGTH

TBFLMASS

LengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM

Tobacco Filler Mass	783	753	814	mg
4	TOB07

CIG01a

CIRCUMF

MOISTURE

Circumference

Moisture

DESIGN PARAMETER SPECIFICATION

TARGET

%
5	TOB07

CIG01a

Burley tobacco

CIRCUMF

TOCUTSIZ

CircumferenceDESIGN PARAMETER SPECIFICATIONmmmm

Tobacco Cut Size

cuts/in

MINIMUM


6	TOB07

CIG01a

Reconstituted tobacco

CIRCUMFCircumferenceDESIGN PARAMETER SPECIFICATION

TOCUTSIZ

Tobacco Cut Size

MAXIMUM

TOB07

CIG01a

TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATIONmgmg

VENTLFLT

Filter Ventilation

TARGET


8	TOB07

CIG01a

TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATIONmgmg

TPNPLGTH

Tipping Paper Length

MINIMUM


9	TOB07

CIG01a

TBFLMASSTobacco Filler MassDESIGN PARAMETER SPECIFICATIONmgmg

CBPPOR

Cigarette Base Paper Porosity

MAXIMUM


10	TOB07

CIG01a

MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%

CBPPERM

Cigarette Base Paper Permeability

TARGET


11	TOB07

CIG01a

MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%

CPBPOR

Cigarette Paper Band Porosity

0.2

MINIMUM


12	TOB07

CIG01a

MOISTUREMoistureDESIGN PARAMETER SPECIFICATION%%

CPBPERM

Cigarette Paper Band Permeability

0.2

MAXIMUM


13	TOB07

CIG01a

TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmm or cuts per inch ²mm or cuts per inch ²

CPBDIFF

Cigarette Paper Band Diffusivity

0.05

0.001

0.100

cm2/s

TARGET


14	TOB07

CIG01a

TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmm or cuts per inch ²mm or cuts per inch ²MINIMUM

	CPBWID	Cigarette Paper Band Width	7	6.7	7.3	mm
15	TOB07

CIG01a

TOCUTSIZTobacco Cut SizeDESIGN PARAMETER SPECIFICATIONmm or cuts per inch ²mm or cuts per inch ²

CPBSPC

Cigarette Paper Band Space

19.8

20.2

MAXIMUM


16	TOB07

CIG01a

FLTRVENT

FLTREFF

Filter

VentilationDESIGN PARAMETER SPECIFICATION

Efficiency

TARGET

TOB07

CIG01a

FLTRVENTFilter VentilationDESIGN PARAMETER SPECIFICATION%%

DPF

Denier Per Filament

3.6

4.4

MINIMUM


18	TOB07

CIG01a

FLTRVENT

TDENIER

Filter VentilationDESIGN PARAMETER SPECIFICATION%%

Total Denier

30000

29100

30900

g/9000m

MAXIMUM


19	TOB07

CIG01a

TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATIONmmmm

FLTRDEN

Filter Density

0.1234

0.105

0.1419

g/cm3

TARGET


20	TOB07

CIG01a

TPNPLGTH

FLTRLGTH

Tipping Paper

Filter Length

DESIGN PARAMETER SPECIFICATION

24.5

25.5

MINIMUM

TOB07

CIG01a

FLTPRDRP

TPNPLGTHTipping Paper LengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM

Filter Pressure Drop	60	51	69	mm H2O
22	TOB07

CIG01a

CIGBPPORCigarette Base Paper Porosity or PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)

TORODDEN

Tobacco Rod Density

0.2678

0.2437

0.2919

g/cm3

TARGET


23	TOB07

CIG01a

CIGBPPOR

CIGPLGTH

Cigarette

Base

Paper

Porosity or PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)MINIMUM24TOB07DPCIG01a24CIGBPPORCigarette Base Paper Porosity or PermeabilityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu)CORESTA Unit (Cu)MAXIMUM25TOB07DPCIG01a25BNDDIFCigarette Paper Band Porosity or Permeability or Band DiffusivityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm²/sCORESTA Unit (Cu) or cm²/sTARGET26TOB07DPCIG01a26BNDDIFCigarette Paper Band Porosity or Permeability or Band DiffusivityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm²/sCORESTA Unit (Cu) or cm²/sMINIMUM27TOB07DPCIG01a27BNDDIFCigarette Paper Band Porosity or Permeability or Band DiffusivityDESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or cm²/sCORESTA Unit (Cu) or cm²/sMAXIMUM28TOB07DPCIG01a28CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmTARGET29TOB07DPCIG01a29CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM30TOB07DPCIG01a30CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM31TOB07DPCIG01a31CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmTARGET32TOB07DPCIG01a32CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM33TOB07DPCIG01a33CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM34TOB07DPCIG01a34FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION%%TARGET35TOB07DPCIG01a35FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION%%MINIMUM36TOB07DPCIG01a36FLTREFFFilter EfficiencyDESIGN PARAMETER SPECIFICATION%%MAXIMUM37TOB07DPCIG01a37DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION/filament/filamentTARGET38TOB07DPCIG01a38DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION/filament/filamentMINIMUM39TOB07DPCIG01a39DPFDenier Per FilamentDESIGN PARAMETER SPECIFICATION/filament/filamentMAXIMUM40TOB07DPCIG01a40TDENIERTotal DenierDESIGN PARAMETER SPECIFICATIONg/9000 mg/9000 mTARGET41TOB07DPCIG01a41TDENIERTotal DenierDESIGN PARAMETER SPECIFICATIONg/9000 mg/9000 mMINIMUM42TOB07DPCIG01a42TDENIERTotal Denier DESIGN PARAMETER SPECIFICATIONg/9000 mg/9000 mMAXIMUM43TOB07DPCIG01a43FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATIONg/cm³g/cm³TARGET44TOB07DPCIG01a44FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATIONg/cm³g/cm³MINIMUM45TOB07DPCIG01a45FLTRDENFilter DensityDESIGN PARAMETER SPECIFICATIONg/cm³g/cm³MAXIMUM46TOB07DPCIG01a46FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATIONmmmmTARGET47TOB07DPCIG01a47FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM48TOB07DPCIG01a48FLTRLGTHFilter LengthDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM49TOB07DPCIG01a49FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATIONmm H2Omm H2OTARGET50TOB07DPCIG01a50FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATIONmm H2Omm H2OMINIMUM51TOB07DPCIG01a51FLTPRDRPFilter Pressure DropDESIGN PARAMETER SPECIFICATIONmm H2Omm H2OMAXIMUM52TOB07DPCIG01a52TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATIONg/cm³g/cm³TARGET53TOB07DPCIG01a53TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATIONg/cm³g/cm³MINIMUM54TOB07DPCIG01a54TORODDENTobacco Rod DensityDESIGN PARAMETER SPECIFICATIONg/cm³g/cm³MAXIMUM55TOB07DPCIG01a55Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmTARGET56TOB07DPCIG01a56Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmMINIMUM57TOB07DPCIG01a57Cigarette Paper LengthCIGPLGTHDESIGN PARAMETER SPECIFICATIONmmmmMAXIMUM

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

...

Name	tt

...

The following tables illustrate the controlled terminology for the the --TESTCD and --TEST values that should be submitted for in datasets according to the examples above. for each tobacco product category. (We'll add more language as necessary to make this clearer)

Info
Sponsors should always verify controlled terminology using the published CDISC controlled terminology for the associated codelists below

...

title	Waterpipe Tobacco Products

...

title	Waterpipe Tobacco Product Identifiers and Descriptors

...

*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

...

title	Waterpipe Tobacco Product Design Parameters and Conformance Testing

...

Length

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

Name	pt

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	IGDCMPID	PTSEQ	PTTESTCD	PTTEST	PTCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM
1	TOB07	PT	CIG01a		1	LENGTH	Length	DESIGN PARAMETER TESTING	83.9	mm	83.9	83.9	mm	1
2	TOB07	PT	CIG01a		2	CIRCUMF	Circumference	DESIGN PARAMETER TESTING	24.9	mm	24.9	24.9	mm	1
3	TOB07	PT	CIG01a		3	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER TESTING	779	mg	779	779	mg	1
4	TOB07	PT	CIG01a		4	MOISTURE	Moisture	DESIGN PARAMETER TESTING	13.1	%	13.1	13.1	%	1
5	TOB07	PT	CIG01a	Burley tobacco	5	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER TESTING	22	cuts/in	22	22	cuts/in	1
6	TOB07	PT	CIG01a	Reconstituted tobacco	6	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER TESTING	27	mm	27	27	mm	1
7	TOB07	PT	CIG01a		7	VENTLFLT	Filter Ventilation	DESIGN PARAMETER TESTING	35	%	35	35	%	1
8	TOB07	PT	CIG01a		8	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER TESTING	30	mm	30	30	mm	1
9	TOB07	PT	CIG01a		9	CBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER TESTING	48	Cu	48	48	Cu	1
10	TOB07	PT	CIG01a		10	CBPPERM	Cigarette Base Paper Permeability	DESIGN PARAMETER TESTING	50	Cu	50	50	Cu	1
11	TOB07	PT	CIG01a		11	CPBPOR	Cigarette Paper Band Porosity	DESIGN PARAMETER TESTING	9.8	Cu	9.8	9.8	Cu	1
12	TOB07	PT	CIG01a		12	CPBPERM	Cigarette Paper Band Permeability	DESIGN PARAMETER TESTING	10	Cu	10	10	Cu	1
13	TOB07	PT	CIG01a		13	CPBDIFF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER TESTING	0.06	cm2/s	0.06	0.06	cm2/s	1
14	TOB07	PT	CIG01a		14	CPBWID	Cigarette Paper Band Width	DESIGN PARAMETER TESTING	7.1	mm	7.1	7.1	mm	1
15	TOB07	PT	CIG01a		15	CPBSPC	Cigarette Paper Band Space	DESIGN PARAMETER TESTING	19.9	mm	19.9	19.9	mm	1
16	TOB07	PT	CIG01a		16	FLTREFF	Filter Efficiency	DESIGN PARAMETER TESTING	28	%	28	28	%	1
17	TOB07	PT	CIG01a		17	DPF	Denier Per Filament	DESIGN PARAMETER TESTING	4.1		4.1	4.1		1
18	TOB07	PT	CIG01a		18	TDENIER	Total Denier	DESIGN PARAMETER TESTING	29900	g/9000m	29900	29900	g/9000m	1
19	TOB07	PT	CIG01a		19	FLTRDEN	Filter Density	DESIGN PARAMETER TESTING	0.1112	g/cm3	0.1112	0.1112	g/cm3	1
20	TOB07	PT	CIG01a		20	FLTRLGTH	Filter Length	DESIGN PARAMETER TESTING	25	mm	25	25	mm	1
21	TOB07	PT	CIG01a		21	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER TESTING	62	mm H2O	62	62	mm H2O	1
22	TOB07	PT	CIG01a		22	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER TESTING	0.2701	g/cm3	0.2701	0.2701	g/cm3	1
23	TOB07	PT	CIG01a		23	CIGPLGTH	Cigarette Paper Length	DESIGN PARAMETER TESTING	53	mm	53	53	mm	1

References:

...

title	Smokeless Tobacco Products

...

title	Smokeless Tobacco Product Identifiers and Descriptors

...

*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology

...

title	Smokeless Tobacco Product Design Parameters and Conformance Testing

...

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:

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
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

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