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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 foundThe following example illustrates the representation of cigarette product design parameter specifications using the PD domain. First, the TO example below shows the identifiers and descriptors associated with this product.
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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. |
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOPARMCD | TOPARM | TOCAT | TOVAL | TOVALU |
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1 | TOB07 | TO | CIG01a | | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | Cigarette |
| 2 | TOB07 | TO | CIG01a | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Filtered, Combusted |
| 3 | TOB07 | TO | CIG01a | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | Joes Cigs USA |
| 4 | TOB07 | TO | CIG01a | 4 | TRADENAM | Trade Name | PRODUCT IDENTIFIER | Treetop Menthol King Size |
| 5 | TOB07 | TO | CIG01a | 5 | PACKTYP | Package Type | PRODUCT DESCRIPTOR | HARD PACK |
| 6 | TOB07 | TO | CIG01a | 6 | PRDQUAN | Product Quantity | PRODUCT DESCRIPTOR | 20 | CIGARETTE | 7 | TOB07 | TO | CIG01a | 7 | LENGTH | Length | PRODUCT DESCRIPTOR | 86.0 | mm | 8 | TOB07 | TO | CIG01a | 8 | CIRCUMF | Circumference | PRODUCT DESCRIPTOR | 26.0 | mm | 9 | TOB07 | TO | CIG01a | 9 | VENTLTN | Ventilation | PRODUCT DESCRIPTOR | 10.0 | % | 10 | TOB07 | TO | CIG01a | 10 | CHARFLAV | Characterizing Flavor | PRODUCT DESCRIPTOR | MENTHOL |
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Row | STUDYID | DOMAIN | SPTOBID | PDSEQ | PDPARMCD | PDPARM | PDVALTRG | PDVALMIN | PDVALMAX | PDVALU |
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1 | | PD | CIG01a | | LENGTH | Length | | | 84.5 | | 2 | TOB07 | PD | CIG01a | 4 | CIRCUMF | Circumference | 24.8 | 24.6 | 25 | mm | 3 | TOB07 | PD | CIG01a | 7 | TBFLMASS | Tobacco Filler Mass | 783 | 753 | 814 | mg | 4 | TOB07 | PD | CIG01a | 10 | MOISTURE | Moisture | 14 | 12.09 | 13.91 | % | 5 | TOB07 | PD | CIG01a | 13 | TOCUTSIZ | Tobacco Cut Size | | | 24 | | 6 | TOB07 | PD | CIG01a | 14 | TOCUTSIZ | Tobacco Cut Size | | | 29 | | 7 | TOB07 | PD | CIG01a | 19 | FLTRVENT | Filter Ventilation | | | 37 | | 8 | TOB07 | PD | CIG01a | 22 | TPNPLGTH | Tipping Paper Length | 31 | 30 | 32 | mm | 9 | TOB07 | PD | CIG01a | 25 | CIGBPPOR | Cigarette Base Paper Porosity | NA | NA | NA | CORESTA Unit (Cu) | 10 | TOB07 | PD | CIG01a | 26 | CIGBPPOR | Cigarette Base Paper Permeability | | | 55 | | 11 | TOB07 | PD | CIG01a | 31 | BNDPOR | Cigarette Paper Band Porosity | NA | NA | NA | CORESTA Unit (Cu) or cm2/s | 12 | TOB07 | PD | CIG01a | 32 | BNDPERM | Cigarette Paper Band Permeability | 10 | 0.2 | 13 | CORESTA Unit (Cu) or cm2/s | 13 | TOB07 | PD | CIG01a | 33 | BNDDIF | Cigarette Paper Band Diffusivity | NA | NA | NA | CORESTA Unit (Cu) or cm2/s | 14 | TOB07 | PD | CIG01a | 40 | CPBNDWID | Cigarette Paper Band Width | | | 7.3 | | 15 | TOB07 | PD | CIG01a | 43 | CPBNDSPC | Cigarette Paper Band Space | 20 | | 20.2 | | 16 | TOB07 | PD | CIG01a | 46 | FLTREFF | Filter Efficiency | | | N/A | | 17 | TOB07 | PD | CIG01a | 49 | DPF | Denier Per Filament | 4 | 3.6 | 4.4 | 4 | 18 | TOB07 | PD | CIG01a | 52 | TDENIER | Total Denier | | | 30900 | | 19 | TOB07 | PD | CIG01a | 55 | FLTRDEN | Filter Density | 0.1234 | 0.105 | 0.1419 | g/cm3 | 20 | TOB07 | PD | CIG01a | 58 | FLTRLGTH | Filter Length | 25 | 24.5 | 25.5 | mm | 21 | TOB07 | PD | CIG01a | 61 | FLTPRDRP | Filter Pressure Drop | 60 | 51 | 69 | mm H2O | 22 | TOB07 | PD | CIG01a | 64 | TORODDEN | Tobacco Rod Density | 0.2678 | 0.2437 | 0.2919 | g/cm3 | 23 | TOB07 | PD | CIG01a | 67 | Cigarette Paper Length | CIGPLGTH | 53 | 52 | 54 | mm |
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The Finally, the Tobacco Product Testing (PT) domain is used to represent the actual results of testing the manufactured product for conformance to the tobacco product design parameters shown in PD above.
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