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.
Device Identifiers Tobacco Products (DITO) is a study reference dataset that provides a mechanism for uniquely identifying a device ( tobacco product. It is similar to Device Identifiers (DI) in function. The primary purpose of this dataset is to provide a list of the devices ( products ) used in an application or study and to provide identifying information for each device ( product) --note: will update as domains change or change the explanatory text--, such as device ( 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 device ( product ) may be found.
JON - DEVTYPE???? PRODTYPE???? SPTOBID... ?SPTOBID - should it be SPTOBID for Sponsor Tobacco Product Identifier???
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| Rows 1-5: | Show the records for a device tobacco product given SPDEVID SPTOBID of CIG01a. | | Rows 3-5: | Show the tobacco product is a filtered, combusted type of cigarette. | |
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| Row | STUDYID | DOMAIN | SPDEVIDSPTOBID | DISEQTOSEQ | DIPARMCDTOPARMCD | DIPARMTOPARM | DIVALTOVAL |
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| 1 | TOB07 | DITO | CIG01a | 1 | DEVTYPE | Device Type | Tobacco Product | | 2 | TOB07 | DITO | CIG01a | 2 | TBPRDCAT | Tobacco Product Category | Cigarette | | 3 | TOB07 | DITO | CIG01a | 3 | TBPRSCAT | Tobacco Product Subcategory | Filtered, Combusted | | 4 | TOB07 | DITO | CIG01a | 4 | MANUF | Manufacturer | Joes Cigs USA | | 5 | TOB07 | DITO | CIG01a | 5 | TRADENAM | Trade Name | Treetop Methol King Size |
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The Device-In-Use (DU) domain represents properties of the device (tobacco product) as used. The DU domain now contains information that was previously found in Tobacco Product Design Parameters (TP) is (similar to the Device Properties (DO) domain) . The domain now captures characteristics and properties of a device that do not change and can include characteristics and properties that can vary from subject to subject (not applicable here but added for reviewers comprehension)represents properties of the tobacco product as used. This is a findings domain and defines important characteristics of a device ( product ) that the sponsor manufacturer (tobacco researcher) wishes to include in the submission but do not form part of the unique sponsor-defined identification of the device ( product). Each property is identified using controlled terminology and is stored in DUTESTCDTTTESTCD/DUTESTTTTEST.
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| Rows 1-4: | Show the package type is a hard pack that each contain 20 cigarettes that are 86.0 mm long and 26.0 mm in circumference. | | Row 5: | Shows the ventilation flow expressed as a percentage. Ventilation is the aspiration of atmospheric air in an unlit cigarette. (ISO 9512:2019) - 1 | | Row 6: | Shows the characterizing flavor is menthol for this package of cigarettes. | | Row 7: | Shows the heat source is xxx. | |
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| Row | STUDYID | DOMAIN | SPDEVIDSPTOBID | DUSEQTTSEQ | DUTESTCDTTTESTCD | DUTESTTTTEST | DUCATTTCAT | DUSCATTTSCAT | DUORRESTTORRES | DUORRESUTTORRESU | DUSTRESCTTSTRESC | DUSTRESNTTSTRESN | DUSTRESUTTSTRESU |
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| 1 | TOB07 | DUTT | CIG01a | 1 | PACKTYP | Package Type | CIGARETTE | FILTERED, COMBUSTED | HARD PACK |
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| | 2 | TOB07 | DUTT | CIG01a | 2 | PRDQUAN | Product Quantity | CIGARETTE | FILTERED, COMBUSTED | 20 | CIGARETTE | 20 | 20 | CIGARETTE | | 3 | TOB07 | DUTT | CIG01a | 3 | LENGTH | Length | CIGARETTE | FILTERED, COMBUSTED | 86.0 | mm | 86.0 | 86.0 | mm | | 4 | TOB07 | DUTT | CIG01a | 4 | CIRCUM | Circumference | CIGARETTE | FILTERED, COMBUSTED | 26.0 | mm | 26.0 | 26.0 | mm | | 5 | TOB07 | DUTT | CIG01a | 5 | VENTLTN | Ventilation | CIGARETTE | FILTERED, COMBUSTED | 10.0 | % | 10.0 | 10.0 | % | | 6 | TOB07 | DUTT | CIG01a | 6 | CHARFLAV | Characterizing Flavor | CIGARETTE | FILTERED, COMBUSTED | MENTHOL |
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| | 7 | TOB07 | DUTT | CIG01a | 7 | HTSOURCE | Heat Source | CIGARETTE | FILTERED, COMBUSTED | xxx |
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| Row | STUDYID | DOMAIN | SPTOBID | TTSEQ | TTGRPID | TTTESTCD | TTTEST | TTCAT | TTORRES | TTORRESU | TTSTRESC | TTSTRESN | TTSTRESU | TTCOLSRT |
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| 1 | TOB07 | TT | CIG01a | 1 |
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| Tobacco Filler mass |
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| | 1 | TOB07 | TT | CIG01a | 1 |
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| Tobacco Filler mass |
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| | 1 | TOB07 | TT | CIG01a | 1 |
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| Tobacco Filler mass |
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| | 2 | TOB07 | TT | CIG01a | 2 |
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| Tobacco moisture or Oven Volatiles |
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| % |
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| % |
| | 3 | TOB07 | TT | CIG01a | 3 |
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| Tobacco cut size |
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| mm or cuts per inch 2 |
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| mm or cuts per inch 2 |
| | 4 | TOB07 | TT | CIG01a | 4 |
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| Tobacco Rod density |
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| g/cm3 |
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| g/cm3 |
| | 5 | TOB07 | TT | CIG01a | 5 |
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| Filter Ventilation |
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| % |
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| | 6 | TOB07 | TT | CIG01a | 6 |
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| Cigarette base paper Porosity or Permeability |
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| CORESTA Unit (Cu) |
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| CORESTA Unit (Cu) |
| | 7 | TOB07 | TT | CIG01a | 7 |
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| Cigarette Paper band porosity or permeability or band diffusivity |
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| CORESTA Unit (Cu) or cm2/s |
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| CORESTA Unit (Cu) or cm2/s |
| | 8 | TOB07 | TT | CIG01a | 8 |
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| Filter efficiency 1 |
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| % |
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| % |
| | 9 | TOB07 | TT | CIG01a | 9 |
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| Denier per Filament |
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| DPF |
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| DPF |
| | 10 | TOB07 | TT | CIG01a | 10 |
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| Total Denier |
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| g/9000 m |
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| g/9000 m |
| | 11 | TOB07 | TT | CIG01a | 11 |
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| Filter Density |
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| g/cm3 |
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| g/cm3 |
| | 12 | TOB07 | TT | CIG01a | 12 |
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| Filter Pressure Drop |
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This images shows the filtration zone where the ventilation occurs.
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