SDTM Example. Cigarette Design Parameters

This images shows the filtration zone where the ventilation occurs.

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

Tobacco domains

DI = TO for Tobacco Product Identifier

SPDEVID = SPTOBID for Sponsor Tobacco Product 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.

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.

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCD	TOTEST	TOCAT	TOORRES	TOORRESU	TOSTRESC	TOSTRESN	TOSTRESU
1	TOB07	TO	CIG01a	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	Cigarette		Cigarette
2	TOB07	TO	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Filtered, Combusted		Filtered, Combusted
3	TOB07	TO	CIG01a	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	Joes Cigs USA		Joes Cigs USA
4	TOB07	TO	CIG01a	4	TRADENAM	Trade Name	PRODUCT IDENTIFIER	Treetop Menthol King Size		Treetop Menthol King Size
5	TOB07	TO	CIG01a	5	PACKTYP	Package Type	PRODUCT DESCRIPTOR	HARD PACK		HARD PACK
6	TOB07	TO	CIG01a	6	PRDQUAN	Product Quantity	PRODUCT DESCRIPTOR	20	CIGARETTE	20	20	CIGARETTE
7	TOB07	TO	CIG01a	7	LENGTH	Length	PRODUCT DESCRIPTOR	86.0	mm	86.0	86.0	mm
8	TOB07	TO	CIG01a	8	CIRCUMF	Circumference	PRODUCT DESCRIPTOR	26.0	mm	26.0	26.0	mm
9	TOB07	TO	CIG01a	9	VENTLTN	Ventilation	PRODUCT DESCRIPTOR	10.0	%	10.0	10.0	%
10	TOB07	TO	CIG01a	10	CHARFLAV	Characterizing Flavor	PRODUCT DESCRIPTOR	MENTHOL		MENTHOL

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The Tobacco Product Design Parameters (DP) 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.

dp.xpt

Row	STUDYID	DOMAIN	SPTOBID	DPSEQ	DPTESTCD	DPTEST	DPCAT	DPORRESU	DPSTRESU	DPCOLSRT
1	TOB07	DP	CIG01a	1	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
2	TOB07	DP	CIG01a	2	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
3	TOB07	DP	CIG01a	3	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
4	TOB07	DP	CIG01a	4	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
5	TOB07	DP	CIG01a	5	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
6	TOB07	DP	CIG01a	6	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
7	TOB07	DP	CIG01a	7	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	mg	TARGET
8	TOB07	DP	CIG01a	8	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	mg	MINIMUM
9	TOB07	DP	CIG01a	9	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	mg	MAXIMUM
10	TOB07	DP	CIG01a	10	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	%	TARGET
11	TOB07	DP	CIG01a	11	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	%	MINIMUM
12	TOB07	DP	CIG01a	12	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	%	MAXIMUM
13	TOB07	DP	CIG01a	13	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	cuts per inch2	cuts per inch2	TARGET
14	TOB07	DP	CIG01a	13	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
15	TOB07	DP	CIG01a	14	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	cuts per inch2	cuts per inch2	MINIMUM
16	TOB07	DP	CIG01a	14	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
17	TOB07	DP	CIG01a	15	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	cuts per inch2	cuts per inch2	MAXIMUM
18	TOB07	DP	CIG01a	15	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
19	TOB07	DP	CIG01a	16	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	%	%	TARGET
20	TOB07	DP	CIG01a	17	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	%	%	MINIMUM
21	TOB07	DP	CIG01a	18	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	%	%	MAXIMUM
22	TOB07	DP	CIG01a	19	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
23	TOB07	DP	CIG01a	20	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
24	TOB07	DP	CIG01a	21	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
25	TOB07	DP	CIG01a	22	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	TARGET
26	TOB07	DP	CIG01a	22	CIGBPPOR	Cigarette Base Paper Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	TARGET
27	TOB07	DP	CIG01a	23	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MINIMUM
28	TOB07	DP	CIG01a	23	CIGBPPOR	Cigarette Base Paper Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MINIMUM
29	TOB07	DP	CIG01a	24	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MAXIMUM
30	TOB07	DP	CIG01a	24	CIGBPPOR	Cigarette Base Paper Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MAXIMUM
31	TOB07	DP	CIG01a	25	BNDDIF	Cigarette Paper Band Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	TARGET
32	TOB07	DP	CIG01a	25	BNDDIF	Cigarette Paper Band Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	TARGET
33	TOB07	DP	CIG01a	25	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	TARGET
34	TOB07	DP	CIG01a	26	BNDDIF	Cigarette Paper Band Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	MINIMUM
35	TOB07	DP	CIG01a	26	BNDDIF	Cigarette Paper Band Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	MINIMUM
36	TOB07	DP	CIG01a	26	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	MINIMUM
37	TOB07	DP	CIG01a	27	BNDDIF	Cigarette Paper Band Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	MAXIMUM
38	TOB07	DP	CIG01a	27	BNDDIF	Cigarette Paper Band Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	MAXIMUM
39	TOB07	DP	CIG01a	27	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	MAXIMUM
40	TOB07	DP	CIG01a	28	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
41	TOB07	DP	CIG01a	29	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
42	TOB07	DP	CIG01a	30	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
43	TOB07	DP	CIG01a	31	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
44	TOB07	DP	CIG01a	32	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
45	TOB07	DP	CIG01a	33	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
46	TOB07	DP	CIG01a	34	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	%	%	TARGET
47	TOB07	DP	CIG01a	35	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	%	%	MINIMUM
48	TOB07	DP	CIG01a	36	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	%	%	MAXIMUM
49	TOB07	DP	CIG01a	37	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION		/filament	TARGET
50	TOB07	DP	CIG01a	38	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION		/filament	MINIMUM
51	TOB07	DP	CIG01a	39	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION		/filament	MAXIMUM
52	TOB07	DP	CIG01a	40	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	g/9000 m	g/9000 m	TARGET
53	TOB07	DP	CIG01a	41	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	g/9000 m	g/9000 m	MINIMUM
54	TOB07	DP	CIG01a	42	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	g/9000 m	g/9000 m	MAXIMUM
55	TOB07	DP	CIG01a	43	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	TARGET
56	TOB07	DP	CIG01a	44	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	MINIMUM
57	TOB07	DP	CIG01a	45	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	MAXIMUM
58	TOB07	DP	CIG01a	46	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
59	TOB07	DP	CIG01a	47	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
60	TOB07	DP	CIG01a	48	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
61	TOB07	DP	CIG01a	49	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	mm H2O	mm H2O	TARGET
62	TOB07	DP	CIG01a	50	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	mm H2O	mm H2O	MINIMUM
63	TOB07	DP	CIG01a	51	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	mm H2O	mm H2O	MAXIMUM
64	TOB07	DP	CIG01a	52	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	TARGET
65	TOB07	DP	CIG01a	53	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	MINIMUM
66	TOB07	DP	CIG01a	54	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	MAXIMUM
67	TOB07	DP	CIG01a	55	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
68	TOB07	DP	CIG01a	56	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
69	TOB07	DP	CIG01a	57	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM

Dataset Debug Messages

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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.

tt.xpt

Row	STUDYID	DOMAIN	SPTOBID	TTSEQ	TTTESTCD	TTTEST	TTORRES	TTORRESU	TTSTRESU
1	TOB07	TT	CIG01a	1	LENGTH	Length		mm	mm
2	TOB07	TT	CIG01a	2	CIRCUMF	Circumference		mm	mm
3	TOB07	TT	CIG01a	3	TBFLMASS	Tobacco Filler Mass		mg	mg
4	TOB07	TT	CIG01a	4	MOISTURE	Moisture		%	%
5	TOB07	TT	CIG01a	5	TOCUTSIZ1	Tobacco Cut Size 1		cuts per inch	cuts per inch
6	TOB07	TT	CIG01a	5	TOCUTSIZ2	Tobacco Cut Size 2		mm	mm
7	TOB07	TT	CIG01a	6	FLTRVENT	Filter Ventilation		%	%
8	TOB07	TT	CIG01a	7	TPNPLGTH	Tipping Paper Length		mm	mm
9	TOB07	TT	CIG01a	8	CIGBPPOR	Cigarette Base Paper Porosity		CORESTA Unit (Cu)	CORESTA Unit (Cu)
10	TOB07	TT	CIG01a	8	CIGBPPERM	Cigarette Base Paper Permeability	check this	cm²/s	cm²/s
11	TOB07	TT	CIG01a	9	BNDDIF	Cigarette Paper Band Porosity		CORESTA Unit (Cu)	CORESTA Unit (Cu)
12	TOB07	TT	CIG01a	9	BNDDIF	Cigarette Paper Band Permeability	check this	cm²/s	cm²/s
13	TOB07	TT	CIG01a	9	BNDDIF	Cigarette Paper Band Band Diffusivity		TODO	TODO
14	TOB07	TT	CIG01a	10	CPBNDWID	Cigarette Paper Band Width		mm	mm
15	TOB07	TT	CIG01a	11	CPBNDSPC	Cigarette Paper Band Space		mm	mm
16	TOB07	TT	CIG01a	12	FLTREFF	Filter Efficiency		%	%
17	TOB07	TT	CIG01a	13	DPF	Denier Per Filament			/filament
18	TOB07	TT	CIG01a	14	DENIER	Total Denier		g/9000 m	g/9000 m
19	TOB07	TT	CIG01a	15	FLTRDEN	Filter Density	check this	g/cm³	g/cm³
20	TOB07	TT	CIG01a	16	FLTRLGTH	Filter Length		mm	mm
21	TOB07	TT	CIG01a	17	FLTPRDRP	Filter Pressure Drop		mm H2O	mm H2O
22	TOB07	TT	CIG01a	18	TORODDEN	Tobacco Rod Density		g/cm³	g/cm³
23	TOB07	TT	CIG01a	19	CIGPLGTH	Cigarette Paper Length		mm	mm

Dataset Debug Messages

There are nine leading, trailing, or non-breaking spaces in the dataset.
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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)

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

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Cigarettes
TBPRSCAT	Tobacco Product Subcategory	Filtered
TBPRSCAT	Tobacco Product Subcategory	Non-Filtered
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
CIRCUMF	Circumference
VENTLTN	Ventilation
CHARFLAV	Characterizing Flavor

*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

DPTESTCD /TTESTCD	DPTEST/TTTEST	Description
LENGTH	Length
CIRCUMF	Circumference
TBFLMASS	Tobacco Filler Mass
MOISTURE	Moisture
TOCUTSIZ	Tobacco Cut Size
FLTRVENT	Filter Ventilation
TPNPLGTH	Tipping Paper Length
CIGBPPOR	Cigarette Base Paper Porosity or Permeability
BNDDIF	Cigarette Paper Band Porosity or Permeability or Band Diffusivity
CPBNDWID	Cigarette Paper Band Width
CPBNDSPC	Cigarette Paper Band Space
FLTREFF	Filter Efficiency
DPF	Denier Per Filament
TDENIER	Total Denier
FLTRDEN	Filter Density
FLTRLGTH	Filter Length
FLTPRDRP	Filter Pressure Drop
TORODDEN	Tobacco Rod Density
CIGPLGTH	Cigarette Paper Length
TODO	Acetaldehyde
TODO	Acrolein
TODO	Acrylonitrile
TODO	4-Aminobiphenyl
TODO	1-Aminonaphthalene
TODO	2-Aminonaphthalene
TODO	Ammonia
TODO	Benzene
TODO	Benzo[a]pyrene
TODO	1,3-Butadiene
TODO	Carbon monoxide
TODO	Crotonaldehyde
TODO	Formaldehyde
TODO	Isoprene
TODO	Nicotine (total)
TODO	NNK - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone
TODO	NNN - N-nitrosonornicotine
TODO	Toluene

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Roll-Your-Own Tobacco Products	Roll-your-own tobacco is defined in section 900(15) of the FD&C Act to mean “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.” The term cigarette filler is not defined in the FD&C Act. For purposes of this draft guidance, we intend cigarette filler to mean the cut, ground, powdered, or leaf tobacco that is a component of a cigarette.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-under
TBPRSCAT	Tobacco Product Subcategory	Roll-Your-Own Tobacco Filler
TBPRSCAT	Tobacco Product Subcategory	Roll-Your-Own Tobacco Rolling Paper
TBPRSCAT	Tobacco Product Subcategory	Filtered Cigarette Tube
TBPRSCAT	Tobacco Product Subcategory	Non-Filtered Cigarette Tube
TBPRSCAT	Tobacco Product Subcategory	Non-Filtered Cigarette Tube Filter
TBPRSCAT	Tobacco Product Subcategory	Non-Filtered Cigarette Tube Paper-Tip
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
PRDQUAN	Product Quantity
CHTRFLAV	Characterizing Flavor
PACKTYP	Package Type
LENGTH	Length
WIDTH	Width
DIAMETER	Diameter
VENTLTN	Ventilation

*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

DPTESTCD /TTESTCD	DPTEST/TTTEST	DPCAT
TOCUTSIZ	Tobacco Cut Size	Roll-Your-Own Tobacco
TMOISTURE	Tobacco Moisture	Roll-Your-Own Tobacco
TUBELENG	Tube Length	Roll-Your-Own Filtered Tubes
TUBECIRC	Tube Circumference	Roll-Your-Own Filtered Tubes
TUBEDIAM	Tube Diameter	Roll-Your-Own Filtered Tubes
TUBEMASS	Tube Mass	Roll-Your-Own Filtered Tubes
TPNPLGTH	Tipping Paper Length	Roll-Your-Own Filtered Tubes
CIGBPPOR	Cigarette Base Paper Porosity or Permeability	Roll-Your-Own Filtered Tubes
BNDDIF	Cigarette Paper Band Porosity or Permeability	Roll-Your-Own Filtered Tubes
CPBNDWID	Cigarette Paper Band Width	Roll-Your-Own Filtered Tubes
CPBNDSPC	Cigarette Paper Band Space	Roll-Your-Own Filtered Tubes
FLTRLGTH	Filter Length	Roll-Your-Own Filtered Tubes
FLTREFF	Filter Efficiency	Roll-Your-Own Filtered Tubes
FLTPRDRP	Filter Pressure Drop	Roll-Your-Own Filtered Tubes
FLTRVENT	Filter Ventilation	Roll-Your-Own Filtered Tubes
TODO	Ammonia
TODO	Arsenic
TODO	Cadmium
TODO	Nicotine (total)
TODO	NNK - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone
TODO	NNN - N-nitrosonornicotine

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-under

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Cigars
TBPRSCAT	Tobacco Product Subcategory	Filtered, Sheet-Wrapped
TBPRSCAT	Tobacco Product Subcategory	Unfiltered, Sheet-Wrapped
TBPRSCAT	Tobacco Product Subcategory	Unfiltered, Leaf-Wrapped
TBPRSCAT	Tobacco Product Subcategory	Cigar Component
TBPRSCAT	Tobacco Product Subcategory	Cigar Tobacco Filler
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
DIAMETER	Diameter
TIP	Tip
VENTLTN	Ventilation
CHARFLAV	Characterizing Flavor
WRAPMTL	Wrapper Material

*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

DPTESTCD /TTESTCD	DPTEST/TTTEST	DPCAT
TODO	Cigar Mass	Cigar, Filtered Sheet Wrapped
TODO	Cigar Wrapper Basis Weight	Cigar, Filtered Sheet Wrapped
TODO	Cigar Binder Length	Cigar, Filtered Sheet Wrapped
TODO	Cigar Binder Width	Cigar, Filtered Sheet Wrapped
TODO	Cigar Binder Basis Weight	Cigar, Filtered Sheet Wrapped
TODO	Cigar Length	Cigar, Filtered Sheet Wrapped
TODO	Cigar Overall Diameter	Cigar, Filtered Sheet Wrapped
TODO	Cigar Minimum Diameter	Cigar, Filtered Sheet Wrapped
TODO	Cigar Maximum Diameter	Cigar, Filtered Sheet Wrapped
TODO	Tobacco filler mass	Cigar, Filtered Sheet Wrapped
TODO	Tobacco rod density	Cigar, Filtered Sheet Wrapped
TODO	Tobacco moisture or oven volatiles	Cigar, Filtered Sheet Wrapped
TODO	Tobacco cut size	Cigar, Filtered Sheet Wrapped
TODO	Cigar wrapper porosity or permeability	Cigar, Filtered Sheet Wrapped
TODO	Cigar wrapper length	Cigar, Filtered Sheet Wrapped
TODO	Cigar wrapper width	Cigar, Filtered Sheet Wrapped
TODO	Cigar wrapper band porosity or permeability	Cigar, Filtered Sheet Wrapped
TODO	Cigar wrapper band width	Cigar, Filtered Sheet Wrapped
TODO	Cigar wrapper band space	Cigar, Filtered Sheet Wrapped
TODO	Tipping paper length	Cigar, Filtered Sheet Wrapped
TODO	Cigar binder porosity or permeability	Cigar, Filtered Sheet Wrapped
TODO	Cigar binder band porosity or permeability	Cigar, Filtered Sheet Wrapped
TODO	Cigar binder band width	Cigar, Filtered Sheet Wrapped
TODO	Cigar binder band space	Cigar, Filtered Sheet Wrapped
FLTREFF	Filter efficiency	Cigar, Filtered Sheet Wrapped
TODO	Filter pressure drop	Cigar, Filtered Sheet Wrapped
FLTRLGTH	Filter length	Cigar, Filtered Sheet Wrapped
TODO	Filter diameter	Cigar, Filtered Sheet Wrapped
TODO	Filter ventilation	Cigar, Filtered Sheet Wrapped
TODO	Cigar length	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar mass	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar overall diameter	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar minimum diameter	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar maximum diameter	Cigar, Unfiltered Sheet Wrapped
TODO	Tobacco filler mass	Cigar, Unfiltered Sheet Wrapped
TODO	Tobacco rod density	Cigar, Unfiltered Sheet Wrapped
TODO	Tobacco moisture or oven volatiles	Cigar, Unfiltered Sheet Wrapped
TODO	Tobacco cut size	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar wrapper porosity or permeability	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar wrapper length	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar wrapper width	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar wrapper basis weight	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar binder porosity or permeability	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar binder width	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar binder basis weight	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar tip mass	Cigar, Unfiltered Sheet Wrapped
TODO	Tip length	Cigar, Unfiltered Sheet Wrapped
TODO	Tip inner diameter	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar binder band porosity or permeability	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar binder band width	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar binder band space	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar wrapper band porosity or permeability	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar wrapper band width	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar wrapper band space	Cigar, Unfiltered Sheet Wrapped
TODO	Cigar Length	Cigar, Unfiltered Leaf-wrapped
TODO	Cigar Mass	Cigar, Unfiltered Leaf-wrapped
TODO	Overall Diameter	Cigar, Unfiltered Leaf-wrapped
TODO	Cigar Minimum Diameter	Cigar, Unfiltered Leaf-wrapped
TODO	Cigar Maximum Diameter	Cigar, Unfiltered Leaf-wrapped
TODO	Tobacco Filler Mass	Cigar, Unfiltered Leaf-wrapped
TODO	Tobacco Rod Density	Cigar, Unfiltered Leaf-wrapped
TODO	Tobacco Moisture	Cigar, Unfiltered Leaf-wrapped
TODO	Tobacco Cut Size	Cigar, Unfiltered Leaf-wrapped
TODO	Cigar Wrapper Length	Cigar, Unfiltered Leaf-wrapped
TODO	Cigar Wrapper Width	Cigar, Unfiltered Leaf-wrapped
TODO	Cigar Wrapper Basis Weight	Cigar, Unfiltered Leaf-wrapped
TODO	Cigar Binder Width	Cigar, Unfiltered Leaf-wrapped
TODO	Cigar Binder Basis Weight	Cigar, Unfiltered Leaf-wrapped
TMOISTURE	Tobacco Moisture	Cigar Filler
TOCUTSIZ	Tobacco Cut Size	Cigar Filler

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Smokeless Tobacco Products
TBPRSCAT	Tobacco Product Subcategory	Loose Moist Snuff
TBPRSCAT	Tobacco Product Subcategory	Portioned Moist Snuff
TBPRSCAT	Tobacco Product Subcategory	Loose Snus
TBPRSCAT	Tobacco Product Subcategory	Portioned Snus
TBPRSCAT	Tobacco Product Subcategory	Loose Dry Snuff
TBPRSCAT	Tobacco Product Subcategory	Dissolvable
TBPRSCAT	Tobacco Product Subcategory	Loose Chewing Tobacco
TBPRSCAT	Tobacco Product Subcategory	Portioned Chewing Tobacco
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
PACKTYP	Package Type
PRDQUAN	Product Quantity
CHARFLAV	Characterizing Flavor
PRTNCT	Portion count
PRTNMS	Portion mass
PRTNLGTH	Portion length
PRTNWDTH	Portion width
PRTNTHCK	Portion thickness

*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

DPTESTCD /TTESTCD	DPTEST/TTTEST	Description
TOCUTSIZ	Tobacco Cut Size
MOISTURE	Moisture
PRTNLGTH	Portion length
PRTNWDTH	Portion width
PRTNMS	Portion mass
PCHMTHK	Pouch material thickness
PCHMPORS	Pouch material porosity or permeability
PCHMBWT	Pouch material basis weight
NICDISRT	Nicotine dissolution rate
TODO	Acetaldehyde
TODO	Arsenic
TODO	Benzo[a]pyrene
TODO	Cadmium
TODO	Crotonaldehyde
TODO	Formaldehyde
TODO	Nicotine (total and free)
TODO	NNK - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone
TODO	NNN - N-nitrosonornicotine
TODO	pH
TODO	Temperature
TODO	Moisture Content
TODO	?Method to stabilize or stop fermentation
TODO	Duration of fermentation
TODO	Type of heat treatment process
TODO	Conditions of heat treatment process - time, temperature, moisture

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Electronic Nicotine Delivery System (ENDS) (Vapes)
TBPRSCAT	Tobacco Product Subcategory	Open E-Liquid
TBPRSCAT	Tobacco Product Subcategory	Closed E-Liquid
TBPRSCAT	Tobacco Product Subcategory	Closed E-Cigarette
TBPRSCAT	Tobacco Product Subcategory	Open E-Cigarette
TBPRSCAT	Tobacco Product Subcategory	Ends Component
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
DIAMETER	Diameter
NICTNCNC	Nicotine Concentration
PGVGRT	PG/VG Ratio*
CHTRFLAV	Characterizing Flavor
VOLUMEE	Volume, E-liquid
WATT	Wattage
BATTCAP	Battery Capacity
DISPCRTG	Disposable Cartridge
CRTVOL	Cartridge volume
HTELNUM	Number of heating elements
BATCAPC	Battery capacity
BATNOMV	Battery nominal voltage
BTCRTRT	Battery Current Rating
VENTLTN	Ventilation
ELQDVISC	E-Liquid viscosity
ELQDVOL	E-liquid volume
PNUMCNC	Particle number concentration
CTMDDIAM	Count median diameter
PM	PM 2.5

*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

DPTESTCD /TTESTCD	DPTEST/TTTEST	Description
DRWRST	Draw Resistance
PUFCNT	Puff count (for full tank/cartridge)
CRTVOL	Cartridge volume
HTELNUM	Number of heating elements
HTELGTH	Heating element length
HTELRST	Heating element resistance
HTELRNG	Heating element range
HTELCFG	Heating element configuration
BTVLTORG	Battery voltage operating range
BTCRTORG	Battery current operating range
BATCAPC	Battery capacity
BATNOMV	Battery nominal voltage
BTCRTRT	Battery Current Rating
BTCHTPL	Battery Charging Temperature Limits
BTDCTMPL	Battery Discharge Temperature Limits
BTENDCV	Battery end of discharge voltage
BTMXCHC	Battery maximum charging current
BTMXDCC	Battery maximum discharging current
BTULCHV	Battery upper limits charging voltage
PDUVOR	Power Delivery Unit (PDU) voltage operating range
PDUCOR	PDU current operating range
PDUWTOR	PDU wattage operating range
PDUTCTOF	PDU temperature cut-off (if applicable)
AIRFLRT	Airflow rate
PDUCRCOF	PDU current cut-off (if applicable)
INHAERT	Inhaled aerosol temperature
VENTLTN	Ventilation
ELQDVISC	E-Liquid viscosity
ELQDVOL	E-liquid volume
PNUMCNC	Particle number concentration
CTMDDIAM	Count median diameter
PM	PM 2.5

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Pipe Tobacco Products
TBPRSCAT	Tobacco Product Subcategory	Pipe
TBPRSCAT	Tobacco Product Subcategory	Pipe Tobacco Filler
TBPRSCAT	Tobacco Product Subcategory	Pipe Tobacco Component
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
DIAMETER	Diameter
CHARFLAV	Characterizing Flavor
TBCUTSTL	Tobacco Cut Style

*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

DPTESTCD /TTESTCD	DPTEST/TTTEST	DPCAT
TODO	Bowl chamber outer diameter	Pipe
TODO	Bowl chamber inner diameter	Pipe
TODO	Draught hole diameter	Pipe
TODO	Draught hole location.	Pipe
TODO	Draught hole shape.	Pipe
TODO	Bowl chamber hole shape.	Pipe
TODO	Bowl chamber volume	Pipe
TODO	Stem length	Pipe
TODO	Stem diameter	Pipe
TODO	Shank length	Pipe
TODO	Shank diameter	Pipe
TODO	Draught hole area	Pipe
TODO	Pressure drop through air valve	Pipe
TODO	Air flow through air valve	Pipe
TODO	Filter efficiency	Pipe
TODO	Filter pressure drop	Pipe
TMOISTURE	Tobacco Moisture	Pipe Filler
TOCUTSIZ	Tobacco Cut Size	Pipe Filler

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Waterpipe Tobacco Product
TBPRSCAT	Tobacco Product Subcategory	Waterpipe
TBPRSCAT	Tobacco Product Subcategory	Waterpipe Filler
TBPRSCAT	Tobacco Product Subcategory	Waterpipe Heat Source
TBPRSCAT	Tobacco Product Subcategory	Waterpipe Component
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
PACKTYP	Package Type
PRDQUAN	Product Quantity
PORTLGTH	Portion Length
TODO	Portion Width
TODO	Portion Mass
TODO	Portion Thickness
TODO	Number of Hoses
TODO	Source(s) of Energy
CHARFLAV	Characterizing Flavor

*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

DPTESTCD /TTESTCD	DPTEST/TTTEST	DPCAT
TODO	Hose length	Waterpipe
TODO	Hose internal diameter	Waterpipe
TODO	Hose materials	Waterpipe
TODO	Stem length	Waterpipe
TODO	Stem internal diameter	Waterpipe
TODO	Base diameter	Waterpipe
TODO	Heating element mass	Heating source, Waterpipe
TODO	Heating element density	Heating source, Waterpipe
TODO	Heating element resistance	Heating source, Waterpipe
TODO	No. of heating elements.	Heating source, Waterpipe
TODO	Heating element configuration.	Heating source, Waterpipe
TODO	Heating element diameter	Heating source, Waterpipe
TODO	Battery current rating	Heating source, Waterpipe
TODO	Battery capacity	Heating source, Waterpipe
TODO	Battery voltage operating range	Heating source, Waterpipe
TODO	Battery current operating range	Heating source, Waterpipe
TODO	Power delivery unit	Heating source, Waterpipe
TODO	PDU current operating range	Heating source, Waterpipe
TODO	PDU wattage operating range	Heating source, Waterpipe
TODO	PDU temperature cut-off	Heating source, Waterpipe

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Heated Tobacco Products
TBPRSCAT	Tobacco Product Subcategory	Closed Htp
TBPRSCAT	Tobacco Product Subcategory	Open Htp
TBPRSCAT	Tobacco Product Subcategory	Htp Consumable
TBPRSCAT	Tobacco Product Subcategory	Htp Component
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
DIAMETER	Diameter
WATT	Wattage
BATTCAP	Battery Capacity
CHARFLAV	Characterizing Flavor
VENTLTN	Ventilation

*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. The DPCAT variable provides the category or target of the Heated Tobacco Product the tests where the tests are administered.

DPTESTCD /TTESTCD	DPTEST/TTTEST	DPCAT	Description
MASS	Mass	HTP Overall Product
LENGTH	Length	HTP Overall Product
HEIGHT	Height	HTP Overall Product
DIAMETER	Diameter	HTP Overall Product
DRWRST	Draw Resistance	HTP Overall Product
PUFCNT	Puff count (for full tank/cartridge)	HTP Overall Product
PUFVOL	Puff volume	HTP Overall Product
AIRFLRT	Airflow rate	HTP Overall Product
VENTLTN	Ventilation	HTP Overall Product
OPTEMP	Operational Temperature	HTP Overall Product
TMPSENSR	Temperature sensor	HTP Overall Product
TODO	Material wrapper length	HTP Overall Product
TODO	Material wrapper width	HTP Overall Product
TODO	Material basis weight	HTP Overall Product
TODO	Material porosity or permeability	HTP Overall Product
TODO	Heating element source/type/approach	Heating Element, HTP	Examples: electrical, carbon, aerosol, etc.
TODO	Heating element temperature range	Heating Element, HTP
TODO	Heating element operational temperature	Heating Element, HTP
TODO	Heating element maximum temperature	Heating Element, HTP
TODO	Heating element material	Heating Element, HTP
TODO	Heating element configuration	Heating Element, HTP
TODO	Heating element length	Heating Element, HTP
TODO	Heating element mass	Heating Element, HTP
TODO	Heating element location	Heating Element, HTP
TODO	Tobacco mass	Tobacco/E-liquid
TODO	Tobacco density	Tobacco/E-liquid
TODO	Tobacco moisture or oven volatiles	Tobacco/E-liquid
TODO	Tobacco cut size	Tobacco/E-liquid
TODO	E-liquid volume	Tobacco/E-liquid
TODO	E-liquid viscosity	Tobacco/E-liquid
TODO	Battery capacity	Battery
TODO	Battery voltage operating range	Battery
TODO	Battery current charging range	Battery
TODO	Battery nominal voltage	Battery
TODO	Battery current rating	Battery
TODO	Battery charging temperature limits	Battery
TODO	Battery discharge temperature limits	Battery
TODO	Battery end of discharge voltage	Battery
TODO	Battery maximum charging current	Battery
TODO	Battery maximum discharging current	Battery
TODO	Battery upper limits charging voltage	Battery
TODO	Power Delivery Unit	Battery
TODO	PDU current operating range	Battery
TODO	PDU wattage operating range	Battery

References:

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SDTM Example. Cigarette Design Parameters